bismuth-tripotassium-dicitrate and Helicobacter-Infections

As one of the most prevalent infections globally, Helicobacter pylori (H. pylori) continues to present diagnostic and therapeutic challenges for clinicians worldwide. Diagnostically, the "test-and-treat" strategy is the recommended approach for healthcare practitioners when managing this potentially curable disease. The choice of testing method should be based on several factors including patient age, presenting symptoms, and medication use, as well as test reliability, availability, and cost. With rising antibiotic resistance, particularly of macrolides, care must be taken to ensure that therapy is selected based on regional resistance patterns and prior antibiotic exposure. In the USA, macrolide antibiotic resistance rates in some areas have reached or exceeded a generally accepted threshold, such that clarithromycin triple therapy may no longer be an appropriate first-line empiric treatment. Instead, bismuth quadruple therapy should be considered, while levofloxacin-based or alternative macrolide-containing therapies are also options. Once treated, it is essential to test for eradication as untreated H. pylori is associated with serious complications including peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma, and gastric cancer. This review article aims to consolidate current knowledge of H. pylori infection with a particular emphasis on diagnostic and treatment strategies.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Antigens, Bacterial; Biopsy; Bismuth; Breath Tests; Clarithromycin; Culture Techniques; Doxycycline; Drug Resistance, Bacterial; Drug Therapy, Combination; Dyspepsia; Feces; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Lymphoma, B-Cell, Marginal Zone; Metronidazole; Nitro Compounds; Organometallic Compounds; Peptic Ulcer; Polymerase Chain Reaction; Proton Pump Inhibitors; Rifabutin; Salicylates; Salvage Therapy; Serologic Tests; Stomach Neoplasms; Tetracycline; Thiazoles; Treatment Outcome; Urea

Marginal zone lymphomas of the MALT type are a type of B-cell neoplasms that involve extranodal tissues and have an indolent clinical behaviour. The stomach is the most common site and most patients are infected by Helicobacter pylori. An increase in the resistance of this bacterium to several antibiotics has been observed in the last years and this fact has determined the review of treatment guidelines. In areas with resistance to clarithromycin greater than 15%, classical triple therapy should be abandoned and quadruple regimens with or without bismuth are currently recommended. Thus, these new guidelines for eradication treatment should be applied to patients with gastric MALT lymphoma associated with H. pylori infection.

Topics: Anti-Bacterial Agents; Breath Tests; Clarithromycin; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Lymphoma, B-Cell, Marginal Zone; Omeprazole; Organometallic Compounds; Practice Guidelines as Topic; Proton Pump Inhibitors; Salvage Therapy; Stomach Neoplasms

Current approaches to treatment of Helicobacter pylori infection, basic international recommendations, problems of growing H. pylori resistance to antibiotics are reviewed. Much attention is given to prospects of new eradication schemes, for example combinations based on bismuth tripotassium dicitrate and successive treatment schedules.

Topics: Anti-Bacterial Agents; Anti-Infective Agents; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Proton Pump Inhibitors; Treatment Outcome

Peptic ulcer disease had a tremendous effect on morbidity and mortality until the last decades of the 20th century, when epidemiological trends started to point to an impressive fall in its incidence. Two important developments are associated with the decrease in rates of peptic ulcer disease: the discovery of effective and potent acid suppressants, and of Helicobacter pylori. With the discovery of H pylori infection, the causes, pathogenesis, and treatment of peptic ulcer disease have been rewritten. We focus on this revolution of understanding and management of peptic ulcer disease over the past 25 years. Despite substantial advances, this disease remains an important clinical problem, largely because of the increasingly widespread use of non-steroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin. We discuss the role of these agents in the causes of ulcer disease and therapeutic and preventive strategies for drug-induced ulcers. The rare but increasingly problematic H pylori-negative NSAID-negative ulcer is also examined.

Topics: Antacids; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Aspirin; Biopsy; Gastroscopy; Global Health; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Incidence; Morbidity; Organometallic Compounds; Peptic Ulcer; Prostaglandins, Synthetic; Proton Pump Inhibitors; Risk Factors; Severity of Illness Index

To evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) in the treatment of Helicobacter pylori (H. pylori) infection.. We electronically and manually searched electronic databases, references lists and conferences compilations, and included all randomized clinical trials comparing the treatment of H. pylori using TCM with proton pump inhibitor or colloidal bismuth subcitrate-based triple therapy as controls. The Jadad score was used to assess trial quality, H. pylori eradication rate and the incidence of side effects were taken as outcome measurements, and heterogeneity analysis, meta-analysis and funnel plot analysis were conducted.. Sixteen trials were included. The Jadad scores of all the trials were not more than 2. Clinical heterogeneity and substantial statistical heterogeneity existed among the trials (P = 0.001, I(2) = 59%) and meta-analysis was not conducted. The average eradication rates following TCM and triple therapy were 72% and 78% and the incidence of side effects were 2% and 29%, respectively. The funnel plot was obviously asymmetric.. Available evidence is not convincing enough to show that TCM has the same efficacy as triple therapy in H. pylori treatment. TCM may be safer than triple therapy. TCM should not be recommended as monotherapy in H. pylori infection.

Topics: Drug Therapy, Combination; Drugs, Chinese Herbal; Helicobacter Infections; Helicobacter pylori; Humans; Medicine, Chinese Traditional; Organometallic Compounds; Phytotherapy; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Treatment Outcome

Meta-analyses evaluated several aspects of Helicobacter pylori eradication based on the randomised controlled trials.. to perform a meta-analysis of the papers presented at the European Helicobacter Pylori Study Group and United European Gastroenterology Week meetings from 1997 to 2002.. Abstracts dealing with the eradication of Helicobacter pylori have been reviewed and the randomised, controlled studies from European countries were included. The studies were classified into groups based on eradication schedules, antibiotics used and country of provenience. The pooled eradication rates were calculated and the differences were assessed by multiple variance analysis.. One-hundred and two studies were accepted comprising 25,644 cases and 398 treatment arms. The eradication rate of proton pump inhibitor-based first line triple therapies was 80.4% (confidence interval: 78.9-81.8); no difference was observed between the five proton pump inhibitors (p > 0.05). Ranitidine bismuth citrate based regimens were efficient in 79.9% (75.7-84.0) (p = 0.95 vs PPI). H2 blockers-based therapies achieved 68.6% (59.0-78.1) (p = 0.0007 vs proton pump inhibitor and p = 0.005 vs ranitidine bismuth citrate-based regimens). Proton pump inhibitor-based double combinations were efficient in 47.1 (31.9-62.4) (p = 0.001 vs triple regimens). Clarithromycin+amoxicillin/nitroimidazole combinations achieved rates of 79.6% and 84.1%, respectively, while amoxicillin-nitroimidazole regimens were less efficient (72.5%, 66.6-78.5) (p = 0.006). The pooled eradication rate of second-line triple regimens was 75.5% (69.9-86.4)(p = 0.08 vs primary treatment). Quadruple therapies were successful in 81.1% (76.6-85.6) of cases as first-line and 73.8% (61.2-86.4) as second-line regimens (p = 0.77 and p = 0.02 vs triple regimens). The pooled eradication rates varied from 58% to 92% in the European countries.. The pooled eradication rate of the primary proton pump inhibitor/ranitidine bismuth citrate-based triple regimens are comparable with the results of meta-analyses. H2 blocker-based triple and proton pump inhibitor-based double regimens are of lower efficacy. Quadruple regimens were not better than triple therapies. The eradication rates per country varied, approaching 80% in most places. The results confirm in part post-hoc the validity of the Maastricht consensus recommendations.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Europe; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Imidazoles; Organometallic Compounds; Practice Guidelines as Topic; Prevalence; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Ranitidine; Reproducibility of Results

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Clinical Trials as Topic; Drug Administration Schedule; Drug Resistance; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Enzyme Inhibitors; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Organometallic Compounds; Proton Pump Inhibitors; Ranitidine

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Amoxicillin; Animals; Clarithromycin; Drug Therapy, Combination; Gastritis; Helicobacter heilmannii; Helicobacter Infections; Humans; Lansoprazole; Metronidazole; Omeprazole; Organometallic Compounds; Tetracycline

To assess the effect of eradication therapy for Helicobacter pylori on symptoms of nonulcer dyspepsia.. Duplicate searches of bibliographic databases, reviews of proceedings of annual gastroenterology and H. pylori meetings from 1995 to 1999, reviews of reference lists, and contact with primary investigators and pharmaceutical manufacturers.. Included studies 1) examined patients with nonulcer dyspepsia and H. pylori infection; 2) used combination therapy for H. pylori and a control therapy without efficacy against H. pylori; 3) were randomized, controlled trials; 4) lasted for at least 1 month after the end of therapy; and 5) assessed symptoms of nonulcer dyspepsia. Ten studies were included.. Independent, duplicate data extraction of the methodologic quality, population, intervention, study design, duration, and outcome of the trials.. The odds ratio (OR) for treatment success in nonulcer dyspepsia with H. pylori eradication therapy compared with control therapy was 1.29 (95% CI, 0.89 to 1.89; P = 0.18). However, significant heterogeneity (P = 0.04) calls the validity of aggregating the data into question. Heterogeneity resolved with the exclusion of one study (OR, 1.07 [CI, 0.83 to 1.37]; P > 0.2). For predefined analysis of trials that used a specifically stated definition of dyspepsia (that is, upper abdominal pain or discomfort), the OR was 1.04 (CI, 0.80 to 1.35) without heterogeneity. For treatment that resulted in cure rather than persistent infection, the OR was 1.17 (CI, 0.87 to 1.59) without heterogeneity.. This meta-analysis provides little support for the use of H. pylori eradication therapy in patients with nonulcer dyspepsia.

Topics: Anti-Bacterial Agents; Dyspepsia; Helicobacter Infections; Helicobacter pylori; Humans; Odds Ratio; Organometallic Compounds; Randomized Controlled Trials as Topic; Sensitivity and Specificity; Treatment Outcome

taking into account the small amount of infection eradication treatments carried out in our country and some characteristics arising from the resistances to some antibiotics, the Spanish Club for the Study of Helicobacter pylori decided to organize a Spanish Consensus Conference to clarify the use of the different infection diagnostic tests, to establish the exact indications of its diagnosis and treatment, to recommend the best treatment guidelines for our country and to promote the use of eradication treatments in adequate indications.. on April 23, 1999 in Madrid, physicians who were experts in infection by Helicobacter pylori representing the different Scientific Societies of our country were gathered. Prior to this, three work areas, diagnosis, indications and treatments, were created and the participants freely joined them. One month before the conference, all of the participants were sent the questions which would be debated. An 80% consensus level, always based on scientific evidence, was required for a recommendation. In the first session, a meeting by work areas was held and in a second session, all of the recommendations were voted on in the meeting of the representatives.. the conference recommends the eradication of the infection in all the gastric or duodenal ulcers, in the erosive duodenitis, in the MALT lymphomas and in gastrectomized patients due to gastric cancer with residual stomach. In the de novo diagnoses of gastroduodenal ulcer, the rapid test of urease is recommended, and a histological study is recommended only if it is negative. In the case of a history of ulcers and also to know the eradication treatment result, the C13 urea breath test is recommended. The culture is reserved for primary treatment and rescue treatment failures so as to select the adequate antibiotic. The primary treatment regimes recommended for our country mean the combination of amoxicillin, clarithromycin and any proton pump inhibitor or with Ranitidine bismuth citrate. If there is allergy to penicillin, amoxycillin will be substituted by metronidazol.

Topics: Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Clarithromycin; Duodenal Ulcer; Duodenitis; Gastrectomy; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Lymphoma, B-Cell, Marginal Zone; Organometallic Compounds; Penicillins; Proton Pump Inhibitors; Ranitidine; Stomach Neoplasms; Stomach Ulcer

Eradication therapies for Helicobacter pylori evolved from monotherapy, through dual therapies and finally to bismuth-based triple therapies by the mid-1980s. The advent of proton pump inhibitors (PPI) and clarithromycin added a new impetus in the development of newer and often more effective regimens. Following large numbers of therapeutic trials, two broad groups of therapies stand out which consistently achieve over 90% eradication. Both are PPI-based. PPI/amoxycillin/clarithromycin twice daily therapy is the simplest but perhaps the most expensive. The 7-day quadruple (quad) therapy, consisting of a PPI and bismuth/tetracycline/metronidazole, is rapidly emerging as the "all rounder" therapy able not only to overcome metronidazole and clarithromycin resistance but to also have a consistently high eradication rate of well over 90%. Extensive clinical use of older and cut-down versions of combination therapies is resulting in a rising population of treated patients who continue to be infected with H. pylori, often resistant to further eradication attempts. Failure to recognise the need to use regimens which achieve high first-time eradication success will lead inexorably to an enlarging pool of patients with resistant strains and "difficult-to-eradicate" H. pylori.

Topics: Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Dyspepsia; Enzyme Inhibitors; Helicobacter Infections; Helicobacter pylori; Humans; Omeprazole; Organometallic Compounds; Stomach Diseases

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Duodenal Neoplasms; Endoscopy, Digestive System; Enzyme Inhibitors; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Middle Aged; Organometallic Compounds; Peptic Ulcer; Practice Guidelines as Topic; Proton Pump Inhibitors; Ranitidine; Stomach Neoplasms

Bismuth salts have been used in medicine for over three centuries, particularly in the treatment of dyspepsia. Commonly used agents include colloidal bismuth subcitrate (CBS), bismuth subsalicylate (BSS) and the newer ranitidine bismuth citrate (RBC). These are safe drugs which exert local effects on the gastroduodenal mucosa. Gastric mucosal levels of bismuth exceed the concentrations required to kill Helicobacter pylori in vitro. The mechanisms of actions of bismuth on gastrointestinal pathogens including H. pylori are complex and include inhibition of protein and cell wall synthesis, membrane function and ATP synthesis. Adherence of H. pylori to surface epithelial cells is also impaired. Bismuth monotherapy is effective in vivo to suppress H. pylori but cure rates are low. CBS, BSS and RBC have synergistic activity with one or two antibiotics and are effective in eradicating H. pylori. CBS and RBC also exert other effects on the mucosa including cytoprotective and ulcer healing properties. In addition, RBC is effective in inhibiting gastric acid secretion.

Topics: Anti-Bacterial Agents; Bismuth; Drug Synergism; Duodenum; Gastric Acid; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Organometallic Compounds; Ranitidine; Salicylates; Treatment Outcome

Topics: Animals; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Duodenal Ulcer; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Stomach Ulcer

Helicobacter pylori is becoming increasingly important as a gastrointestinal pathogen and aetilogical agent in several disease states. This review attempts to clarify the role of Helicobacter pylori and importantly, simplify treatment options.

Topics: Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Penicillins; Stomach Neoplasms; Stomach Ulcer; Tetracycline; Time Factors

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Cost-Benefit Analysis; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds

Topics: Amoxicillin; Anti-Bacterial Agents; Bismuth; Clarithromycin; Clinical Trials as Topic; Drug Resistance, Microbial; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Randomized Controlled Trials as Topic; Tetracycline

Topics: Anti-Bacterial Agents; Cost-Benefit Analysis; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Tissue Distribution

Within the last ten years an increasing number of Helicobacter pylori-related inflammatory gastroduodenal diseases in children has been reported. The aim of this paper is to describe the range of Helicobacter pylori infections in children including diagnosis and treatment by application of colloidal bismuth salts.

Topics: Ampicillin; Anti-Ulcer Agents; Child; Drug Therapy, Combination; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds

The relationship between Helicobacter pylori (HP) and gastric ulcer therapy is examined by analyzing both the data that suggest that eradication of HP renders the gastric mucosa less susceptible to development of gastric ulcer as well as the substantial body of evidence that does not support this contention. The results reported in clinical trials with colloidal bismuth citrate, antimicrobial agents (furazolidone), and combinations of anti-ulcer and antimicrobial agents (H2-antagonist+cefixime, H2-antagonist+metronidazole) are reviewed. Also analyzed is the relationship between HP eradication and ulcer recurrence. Only one study is available on this aspect, and the limited evidence it provides in favour of a prophylactic effect of eradication therapy is not entirely convincing. The authors conclude that there is no reasonable case for the dogmatic assumption that eradication of HP facilitates either acute healing or long-term prophylaxis of gastric ulcer, though certain subgroups of gastric ulcer patients may benefit from eradication therapy.

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Cefixime; Cefotaxime; Cimetidine; Drug Therapy, Combination; Furazolidone; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Stomach Ulcer

The discovery of Helicobacter pylori has stimulated great interest in its role in gastritis, non-ulcer dyspepsia and peptic ulceration. Treatment regimens to eradicate this organism from gastric mucosa have also received considerable attention. Current recommendations limit the use of triple drug combinations only to specific patient groups.

Topics: Amoxicillin; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Gastritis; Helicobacter Infections; Helicobacter pylori; Metronidazole; Organometallic Compounds

Colloidal bismuth subcitrate (CBS) is very effective in the treatment of gastroduodenal disorders and appears to act via several mechanisms. It has little acid-neutralizing effect and does not affect acid secretion. It is uncertain whether CBS affects pepsin secretion, but it does inhibit peptic activity. It causes an increase in mucus glycoprotein secretion and may also bind to the gastric mucus layer to act as a diffusion barrier to HCl. CBS accelerates ulcer healing and causes an accumulation of epidermal growth factor around the ulcer. In addition, it has a cytoprotective effect and increases mucosal secretion of prostaglandins and bicarbonate. CBS has bactericidal effects against Helicobacter pylori (which is associated with gastritis and peptic ulcers). It also prevents adhesion of H. pylori to epithelial cells and can inhibit enzymes secreted by H. pylori, such as proteases, lipases, glycosidases, and phospholipases.

Topics: Animals; Anti-Ulcer Agents; Colloids; Gastric Acid; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Mucus; Organometallic Compounds; Pepsin A; Peptic Ulcer

Colloidal bismuth subcitrate (CBS; DeNol) has been studied in clinical trials investigating the treatment of duodenal and gastric ulcer, non-ulcer dyspepsia, duodenitis, non-steroidal anti-inflammatory drug (NSAID)-induced disease, and Helicobacter pylori-induced gastroduodenitis. Healing rates for duodenal ulcer with CBS are significantly better than with placebo and are similar to results obtained with cimetidine or ranitidine. CBS is significantly better in the treatment of duodenal ulcer resistant to standard doses of H2 antagonists than increased doses of H2 antagonists. Duodenal ulcer relapse at 12 months after initial healing with CBS is significantly less than with H2-antagonist therapy. Ulcer healing with CBS is not influenced by smoking. H. pylori eradication with CBS appears to have little effect in ulcer healing but is of major importance in preventing ulcer relapse. CBS is effective in combination with antibiotics in eradicating H. pylori-associated gastritis. In gastric ulcer disease CBS therapy resulted in significant healing advantages over placebo and was comparable to treatment with cimetidine and sucralfate. CBS has been shown to be effective in the treatment of erosive duodenitis. The role of CBS in treatment of non-ulcer dyspepsia and NSAID-induced damage awaits further clinical studies.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Colloids; Dyspepsia; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Peptic Ulcer

The recent isolation and classification of the spiral gastric bacteria Helicobacter pylori has led to an explosion of worldwide research. The data strongly suggest that H. pylori is the causative agent for type-B active chronic gastritis. The role of H. pylori in duodenal ulcer awaits clarification, and, more importantly, potential treatment regimens need clear documentation and further detailed research. The past decade has revealed many intriguing facts about H. pylori infection. If, during the 1990s, eradication of H. pylori by means of appropriate and safe medication can lead to the control and prevention of gastroduodenal disease, then major clinical and economic benefits can be anticipated.

Topics: Anti-Ulcer Agents; Bismuth; Duodenal Ulcer; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Prevalence

To compare the efficacy and safety between modified quadruple- and bismuth-containing quadruple therapy as first-line eradication regimen for. This study was a multicenter, randomized-controlled, non-inferiority trial. Subjects endoscopically diagnosed with. In total, 233 participants were randomized, 27 were lost to follow-up, and four violated the protocol. Both regimens showed an acceptable eradication rate in the intention-to-treat (PAMB: 87.2% vs. PBMT: 82.8%,. Modified quadruple therapy comprising rabeprazole, amoxicillin, metronidazole, and bismuth is an effective first-line treatment for the

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Organometallic Compounds; Patient Compliance; Penicillin Resistance; Rabeprazole; Tetracycline; Tetracycline Resistance

The treatment regimen for the eradication of Helicobacter pylori may be best when therapy is susceptibility guided. However, it is unrealistic to use a strategy based on susceptibility testing to prioritize therapy for every patient in China. Empirical therapy of H. pylori is still widely used. The study was designed to discuss the best first-line treatment regimen depending on empirical therapy. The focal point of the study was the optimal length of the therapy. Also, the selection of antibiotics was discussed in the article. This was a prospective, randomized, non-inferiority trial. H. pylori-infected patients who have no previous eradication therapy were randomly assigned to the following: 20 mg of rabeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, and 220 mg of bismuth potassium citrate (BACPPI), administered twice a day for 10 or 14 days. The efficacy, side effects, and remission rate of clinical symptoms were determined. A total of 240 subjects were included in the study. The eradication rate with 14 and 10 days was essentially identical in both intention-to-treat (90.83% [95% CI, 86%-96%] vs. 87.50% [95% CI, 82%-93%]) and per-protocol (94.78% [95% CI, 91%-99%] vs. 92.11% [95% CI, 87%-97%]) analyses. Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment. Side effects were generally mild and similar between groups. Our results showed that a 10-day amoxicillin-clarithromycin-containing bismuth quadruple therapy may be recommended for the primary empirical treatment of H. pylori infection in Beijing, China.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; China; Clarithromycin; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Prospective Studies; Rabeprazole; Treatment Outcome

The aim of this study was comparison the effectiveness of sequential and standard quadruple therapy on eradication of H. pylori infection.. This clinical trial study was conducted on 160 patients with dyspepsia or gastroduodenal ulcer. Patients were randomly divided into two groups. Group A (standard regimen) received omeprazole, amoxicillin, clarithromycin and bismuth subcitrate for 2 weeks. Group B (sequential regimen) received omeprazole and amoxicillin in 5 days and omeprazole, tinidazole and levofloxacin in 5 days. After the end of treatment regimens, 20 mg omeprazole was administered twice daily for 3 weeks. H. pylori eradication was assessed 2 months after antibiotic treatment via fecal antigen.. Frequency of H. pylori eradication in group A and B was observed in 55 (68.8%) and 63 patients (78.8%), respectively. No significant difference was seen between two groups, regarding H. pylori eradication (p = 0.15). The most common side effects in group A, B were bitterness of mouth (63.8%) and nausea (16.2%), respectively (p H. pylori infection, higher rate of H. pylori eradication was seen in group B than group A. Thus, sequential regimen was a more appropriate regimen with fewer complications.

Topics: Adult; Aged; Amoxicillin; Clarithromycin; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Middle Aged; Omeprazole; Organometallic Compounds; Tinidazole

Bismuth is no longer available in Europe except as part of combination therapy. Lactobacillus reuteri has also been used as an adjuvant for Helicobacter pylori therapy. We aimed to investigate the efficacy of a b.i.d. quadruple therapy containing Pylera® or L reuteri for H pylori infection.. We performed two open-label randomized pilot studies. Adult patients positive for H pylori were randomly assigned to b.i.d therapy with quadruple therapy containing bismuth (2 capsules of Pylera® plus 250 mg each of tetracycline and metronidazole for a total of 500 mg of each), or the same dose of antibiotics plus 2 × 10. A total of 99 subjects (29% men) were enrolled; 92 completed the study. In the Pylera® group, H pylori infection was cured in 95.7%; 95% CI = 85%-99% (44/46) PP and 88%; 95% CI = 75%-95% (44/50) ITT vs. 84.8%; 95% CI = 71%-95% (39/46) PP and 79.6%; 95% CI = 65%-89% (39/49) ITT in the Gastrus® group, respectively. Cure rates in naїve patients were 100%; 95% CI = 85%-100% (25/25) PP with Pylera®, and 89.7%; 95% CI = 72%-97% (26/29) with Gastrus®. Compliance was excellent and side effects mild with both regimens.. B.i.d. bismuth quadruple therapy was highly effective for H pylori eradication in treatment of naïve patients in Sardinia. Replacement of bismuth with Gastrus® might be considered when bismuth is contraindicated or unavailable.

Topics: Adult; Aged; Anti-Bacterial Agents; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Limosilactobacillus reuteri; Male; Metronidazole; Middle Aged; Organometallic Compounds; Pilot Projects; Probiotics; Prospective Studies; Proton Pump Inhibitors; Tetracycline

In first-line treatment of Helicobacter pylori, we have previously shown that the eradication frequency was 83·7% (95% CI 80·4-86·6) for triple therapy for 14 days (T14; lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg, all given twice daily), 85·9% (82·7-88·6) for concomitant therapy for 10 days (C10; lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, all given twice daily), and 90·4% (87·6-92·6) for bismuth quadruple therapy for 10 days (BQ10; bismuth tripotassium dicitrate 300 mg four times a day, lansoprazole 30 mg twice daily, tetracycline 500 mg four times a day, and metronidazole 500 mg three times a day). In this follow-up study, we assess short-term and long-term effects of these therapies on the gut microbiota, antibiotic resistance, and metabolic parameters.. This was a multicentre, open-label, randomised trial done at nine medical centres in Taiwan. Adult patients (>20 years) with documented H pylori infection were randomly assigned (1:1:1, with block sizes of six) to receive T14, C10, or BQ10. We assessed long-term outcomes (reinfection frequency, changes in the gut microbiota, antibiotic resistance, and metabolic parameters) in patients with available data, excluding all protocol violators and those with unknown post-treatment H pylori status. Faecal samples were collected before treatment and 2 weeks, 2 months, and at least 1 year after eradication therapy. Amplification of the V3 and V4 hypervariable regions of the 16S rRNA was done followed by high-throughput sequencing. Susceptibility testing for faecal Escherichia coli and Klebsiella pneumoniae was done. This trial is complete and registered with ClinicalTrials.gov, NCT01906879.. Between July 17, 2013, and April 20, 2016, 1620 participants were randomly assigned to the three treatment groups (540 [33%] per group). 1214 (75%) attended 1-year follow-up and are included in this analysis. Compared with baseline, alpha diversity was significantly reduced 2 weeks after T14 (p=0·0002), C10 (p<0·0001), and BQ10 (p<0·0001) treatment. Beta diversity was also significantly altered 2 weeks after T14 (p=0·0010), C10 (p=0·0001), and BQ10 (p=0·0001). Alpha diversity and beta diversity were restored at week 8 (p=0·14 and p=0·918, respectively) and 1 year (p=0·14 and p=0·918) after T14, but were not fully recovered at week 8 and after 1 year in patients treated with C10 (p=0·0001 and p=0·013 at week 8; p=0·019 and p=0·064 at 1 year) and BQ10 (p<0·0001 and p=0·0002; p=0·001 and p=0·029). A transient increase at week 2 after T14 and C10 of the resistance rates of E coli to ampicillin-sulbactam (12% [15/127] to 66% [38/58] for T14, 7% [10/135] to 64% [28/44] for C10), cefazolin (13% [16/127] to 43% [25/58] for T14, 10% [13/135] to 41% [18/44] for C10), cefmetazole (8% [10/127] to 26% [15/58] for T14, 4% [5/135] to 18% [8/44] for C10), levofloxacin (8% [10/127] to 35% [20/58] for T14, 7% [10/135] to 32% [14/44] for C10), gentamicin (13% [19/146] to 47% [27/58] for T14, 15% [22/149] to 45% [20/44] for C10), and trimethoprim-sulfamethoxazole (33% [48/146] to 86% [50/58] for T14, 28% [42/148] to 86% [38/44] for C10; p<0·05 in paired samples in the above analyses) returned to basal state at week 8 and after 1 year. Although bodyweight and body-mass index slightly increased, there were significant improvements in metabolic parameters, with a decrease in insulin resistance, triglycerides, and LDL and an increase in HDL. Overall, there was no significant change in the prevalence of metabolic syndrome at week 8 and 1 year after T14, C10, and BQ10.. Eradication of H pylori infection has minimal disruption of the microbiota, no effect on antibiotic resistance of E coli, and some positive effects on metabolic parameters. Collectively, these results lend support to the long-term safety of H pylori eradication therapy.. National Taiwan University Hospital and Ministry of Science and Technology of Taiwan.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Body Mass Index; Clarithromycin; Disease Eradication; Drug Administration Schedule; Drug Resistance, Microbial; Drug Therapy, Combination; Escherichia coli; Female; Follow-Up Studies; Gastrointestinal Microbiome; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metabolic Syndrome; Metronidazole; Middle Aged; Organometallic Compounds; Prevalence; Tetracycline

Helicobacter pylori (Hp) drug resistant rate to clarithromycin (CLA) has increased to 20% to 50%, which cause concerns regarding its effectiveness in eradicating Hp, we aim to evaluate the cost-effectiveness of CLA-based versus furazolidone (FZD)-based quadruple therapy, and assess factors that affect anti-Hp efficacy.One hundred eighty-five patients were enrolled in this single-center, prospective, randomized, open-label study. In FZD group, 92 patients were treated with FZD plus esomeprazole, bismuth potassium citrate, and amoxicillin for 14 days. In CLA group, 93 patients were treated with the same regimen except FZD was replaced by CLA. Patients were tested 4 weeks post-treatment to confirm eradication.Of the 185 enrolled patients, 180 completed the study. On intention-to-treat analysis, Hp eradication rates in FZD and CLA groups were 90.22% and 86.02% (P = .378); in per-protocol analysis, their eradication rates were 93.26% and 87.91%, respectively (P = .220). Overall incidence of total side effects in FZD and CLA groups was 19.57% and 13.98%, and their severe side effects were 3.26% and 2.15%, respectively (P > .05). Cost-effectiveness ratios of FZD and CLA groups were 0.75 and 1.02, and incremental cost-effectiveness ratio of FZD group over CLA group was -3.62. Eradication failures were not associated with factors including gender, age, body mass index, smoking, alcohol consumption, educational level, and urban-rural distribution in this observation (P > .05).Despite increasing drug resistance to CLA, Hp eradication rates in FZD and CLA groups have no significant difference at present; as FZD-based quadruple therapy is more cost-effective, we recommend this regimen be a first-line choice for Hp eradication.

Topics: Adult; Anti-Bacterial Agents; Clarithromycin; Cost-Benefit Analysis; Drug Resistance, Bacterial; Drug Therapy, Combination; Esomeprazole; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Intention to Treat Analysis; Male; Middle Aged; Organometallic Compounds; Prospective Studies; Treatment Outcome

This study assessed the effectiveness, adverse events, patient adherence, and costs of modified dual therapy compared with bismuth-containing quadruple therapy for treating Helicobacter pylori infection in Chinese patients. We also sought to determine whether modified dual therapy could be used as an alternative first-line treatment for H. pylori infection.. A total of 232 H. pylori-infected, treatment-naive patients were enrolled in this open-label, randomized controlled clinical trial. Patients were randomly allocated into 2 groups: the 14-day modified dual therapy group and the bismuth-containing quadruple therapy group. Eradication rates, drug-related adverse events, patient compliance, and drug costs were compared between the 2 groups.. The modified dual therapy group achieved eradication rates of 87.9%, 91.1%, and 91.1% as determined by the intention-to-treat, per-protocol, and modified intention-to-treat analyses, respectively. The eradication rates were similar compared with the bismuth-containing quadruple therapy group: 89.7%, 91.2%, and 90.4%. In addition, modified dual therapy ameliorated variations in the CYP2C19, IL-1B-511, and H. pylori VacA genotypes. There were no significant differences in the compliance rates between the 2 groups. The modified dual therapy group exhibited significantly less overall side effects compared with the bismuth-containing quadruple therapy group (P < 0.001). Furthermore, the cost of medications in the modified dual therapy was lower compared with that in the bismuth-containing quadruple therapy.. Modified dual therapy at high dose and administration frequency is equally effective and safer and less costly compared with bismuth-containing quadruple therapy.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Carbon Isotopes; Clarithromycin; Drug Costs; Drug Resistance, Bacterial; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Medication Adherence; Middle Aged; Organometallic Compounds; Treatment Outcome; Urea

The success rate of Helicobacter pylori (H. pylori) eradication with the classical triple therapy is gradually declining. In this study, we aimed to compare and assess the efficacies of six different eradication regimens including sequential protocols.. Endoscopically confirmed nonulcer dyspepsia patients were enrolled. H. pylori presence was determined either histologically or by a rapid urease test. Treatment-naive patients were randomly assigned to an either one of three 10-day (OAC, OTMB, and OACB) or one of three sequential protocols (OA+OCM, OA+OCMB, and OA+OMDB) (O=omeprazole, A=amoxicillin, C=clarithromycin, T=tetracycline, M=metronidazole, B=bismuth, D=doxycycline). The eradication was assessed 6-8weeks after the completion of the treatment by a. In total, 301 patients were included. Fifty-two percent of the participants (n=157) were female, and the mean age was 44.9years (range=18-70). The intention to treat (ITT) and per protocol (PP) eradication rate for each regimen is as follows: OAC (ITT=61.2%, PP=75%), OTMB (83.3%, 87%), OACB (76.5%, 79.6%), OA+OCM (72.3%, 73.9%), OA+OCMB (82.7%, 89.6%), and OA+OMDB (59.3%, 65.3%). Smoking significantly affected the eradication rate (P=0.04).. In this study, OTMB and OA+OCMB were significantly superior to the triple therapy and succeeded to reach the eradication rate proposed by the Maastricht consensus (over 80%). These two bismuth-containing regimens could be considered for first-line therapy in the regions with high clarithromycin resistance.

Topics: Adolescent; Adult; Aged; Amoxicillin; Antacids; Anti-Bacterial Agents; Breath Tests; Clarithromycin; Doxycycline; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Intention to Treat Analysis; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Smoking; Tetracycline; Treatment Outcome; Young Adult

This was a prospective study aiming to investigate whether levofloxacin plus bismuth-based quadruple therapy was more effective than levofloxacin-based triple therapy after failed first-line eradication therapies for Helicobacter pylori (H. pylori) infection.. Sixty-seven patients infected with H. pylori were randomly assigned to two groups; the levofloxacin plus bismuth-based quadruple therapy group (RBAL [n = 33]; rabeprazole 20 mg twice daily, bismuth subcitrate 120 mg four times daily, amoxicillin 1 g twice daily and levofloxacin 500 mg once daily, for 10 days) and the levofloxacin-based triple therapy group (RAL [n = 34]; rabeprazole 20 mg twice daily, amoxicillin 1 g twice daily and levofloxacin 500 mg once daily, for 10 days). Endoscopy was performed 4-8 weeks after H. pylori eradication to assess treatment response. We followed up patient response and compliance and checked their resistance to antibiotics.. Intention-to-treat analysis revealed that both groups had similar eradication rates (RBAL vs RAL: 84.8% [95% confidence interval {CI} 72.6-97.1%] vs 67.6% [95% CI 51.9-83.4%], P = 0.0987). No significant differences in compliance or adverse events were found (P = 0.9829 and 0.0720). Epsilometer test showed that most eradication failure cases were levofloxacin-resistant.. Adding bismuth subcitrate to levofloxacin-based triple therapy was not more effective than not doing so, but no further side effects were noted. Both eradication therapies were equally safe and patients had the same tolerance to both regimens. Resistance rate to levofloxacin may be important when choosing second-line therapy.

Topics: Adult; Aged; Amoxicillin; Antacids; Anti-Bacterial Agents; Disk Diffusion Antimicrobial Tests; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Medication Adherence; Middle Aged; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Rabeprazole; Retreatment

Hybrid therapy is a novel two-step treatment achieving a high eradication rate for

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Amoxicillin; Clarithromycin; Drug Administration Schedule; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Pantoprazole; Prospective Studies; Tetracycline

To investigate the effectiveness of 10-day bismuth-containing quadruple (B-quadruple) treatment as first-line therapy in patients with Helicobacter pylori-related chronic gastritis.. A randomized controlled trial was conducted from October 2011 to December 2013 in Zhejiang, China, including patients with H. pylori-related chronic gastritis who were randomly provided either 10-day omeprazole-based triple therapy (OM-triple; omeprazole 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily) or 10-day B-quadruple therapy (OM-triple + bismuth subcitrate 120 mg four times daily). H. pylori status, pathologic findings and dyspeptic symptoms were assessed at baseline and after 3 months. The primary outcome was H. pylori eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses. The secondary outcomes were the histologic and symptomatic benefits from H. pylori eradication.. A total of 351 patients with H. pylori-related chronic gastritis were recruited. The eradication rates of the OM-triple and B-quadruple groups were 58.4% (108/185) and 86.1% (143/166) respectively according to ITT analysis (p <0.01). PP rates of H. pylori eradication were 63.2% (108/171) and 92.3% (143/155) respectively (p <0.01). According to the PP analysis, active and chronic inflammation in gastric mucosa was substantially improved in all treated patients (n=326). However, pathologic atrophic gastritis and intestinal metaplasia did not regress in both groups (n=326). The reduction of dyspeptic symptoms score was significantly higher in the B-quadruple group than in the OM-triple group (0.59±0.057 vs. 0.39±0.046) (p <0.01).. Ten-day B-quadruple therapy is more effective than OM-triple therapy as first-line therapy for patients with H. pylori-induced chronic gastritis in China.

Topics: Adult; China; Drug Administration Schedule; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Intention to Treat Analysis; Male; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Treatment Outcome

Currently, there is a need to study the genetic diversity of H.pylori in patients with variety of acid-related dis- eases to develop new strategies for the treatment of patients with H.pylori to predict high efficiency of treatment.. To assess the effectiveness of schemes of eradication therapy in patients with chronic pancreatitis and concom- itant H.pylori infection.. The study included 108 patients with H.pylori infection: 63 patients had chronic pancreatitis and were concomitant with H.pylori-infection and 45 patients were without chronic pancreatitis and had H.pylori infection with a chronic gastritis. All patients were determined by factors of pathogenicity of H.pylori by immunoblotting. After forming the group randomized patients received eradication therapy scheme I and the scheme I with inclusion of bismuth tripotassium dicitrate.. The effectiveness of H.pylori eradication therapy is dependent on the genetic component of H.pylori. In the presence of H.pylori pathogenicity factors p33, p30, p26, p19, p17 in order to increase the effectiveness of treatment the scheme of eradication therapy I line drugs bismuth tri dicitrate should be included.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Pancreatitis, Chronic; Rabeprazole; Treatment Outcome; Virulence; Virulence Factors

The effectiveness of Helicobacter pylori therapies has declined with an increase in antibiotic resistance. To overcome this problem, the efficacy of tailored H. pylori eradication therapy based on antimicrobial susceptibility testing was compared with that of empirical second-line rescue regimens.. Patients who had persistent H. pylori infection after the first eradication were recommended to undergo culture for determining the minimal inhibitory concentration (MIC) via gastroscopy, which increased the cost by 300%. Fourteen-day esomeprazole, tripotassium dicitrate bismuthate, metronidazole and tetracycline (EBMT) therapy or esomeprazole, moxifloxacin and amoxicillin (MEA) therapy was performed according to the results of antibiotic susceptibility testing. In case of refusal to undergo culture, the participants were treated with either 14-day empirical EBMT or MEA regimen for second eradication after explaining the complexity, side effects and costs associated with each regimen. This trial was registered at ClinicalTrials.Gov (NCT 02349685).. In the 219 patients included, the intention to treat (ITT) and per protocol (PP) eradication rates was 75.3% and 79.8% in the 14-day EBMT group (n = 89), 70.8% and 72.4% in the 14-day MEA group (n = 89) and 87.8% and 100.0% in the 14-day tailored therapy group (n = 41), respectively. Based on the PP analysis, the 14-day tailored therapy group showed a significantly higher eradication rate than the 14-day EBMT or MEA group (both p ≤ 0.001).. Tailored therapy based on H. pylori culture and MIC test could be an option as a second-line eradication regimen in the presence of high level of antimicrobial resistance.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Drug Therapy, Combination; Esomeprazole; Female; Fluoroquinolones; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Intention to Treat Analysis; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Moxifloxacin; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Republic of Korea; Tertiary Care Centers; Tetracycline; Young Adult

We aimed to evaluate the effectiveness and safety of bismuth-containing quadruple therapy plus postural change after dosing for Helicobacter pylori eradication in gastrectomized patients. We compared 76 gastric stump patients with H. pylori infection (GS group) with 50 non-gastrectomized H. pylori-positive patients who met the treatment indication (controls). The GS group was divided into GS group 1 and GS group 2. All groups were administered bismuth potassium citrate (220 mg), esomeprazole (20 mg), amoxicillin (1.0 g), and furazolidone (100 mg) twice daily for 14 days. GS group 1 maintained a left lateral horizontal position for 30 min after dosing. H. pylori was detected using rapid urease testing and histologic examination of gastric mucosa before and 3 months after therapy. Mucosal histologic manifestations were evaluated using visual analog scales of the updated Sydney System. GS group 1 had a higher prevalence of eradication than the GS group 2 (intention-to-treat [ITT]: P=0.025; per-protocol [PP]: P=0.030), and the control group had a similar prevalence. GS group 2 had a lower prevalence of eradication than controls (ITT: P=0.006; PP: P=0.626). Scores for chronic inflammation and activity declined significantly (P<0.001) 3 months after treatment, whereas those for atrophy and intestinal metaplasia showed no significant change. Prevalence of adverse reactions was similar among groups during therapy (P=0.939). A bismuth-containing quadruple therapy regimen plus postural change after dosing appears to be a relatively safe, effective, economical, and practical method for H. pylori eradication in gastrectomized patients.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Esomeprazole; Female; Furazolidone; Gastrectomy; Gastric Stump; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metaplasia; Middle Aged; Organometallic Compounds; Patient Positioning; Potassium Citrate; Treatment Outcome; Young Adult

To observe the effects and safety of quadruple regimens including domestically manufactured rabeprazole used as first line/initial therapy for Helicobacter pylori(H.pylori) eradication in gastritis and duodenal ulcer patients, and to investigate the effects of extended use of bismuth after the quadruple therapy on eradication of H. pylori.. From January to August 2013, 430 patients with chronic gastritis or duodenal ulcer who were confirmed as H. pylori positive in gastroscopy for upper gastrointestinal symptoms were enrolled from 12 centers in China for initial treatment using quadruple regimens for H. pylori eradication. The study was a prospective, multicenter, randomized double-blinded double-dummy parallel-controlled clinical trial. The 310 chronic gastritis patients were divided into 2 groups: group A1 was given quadruple regime (rabeprazole+ amoxicillin+ clarithromycin+ bismuth potassium citrate) for 10 days followed by bismuth-placebo for 21 days; group A2 was given the quadruple regimen for 10 days and then bismuth potassium citrate for 21 days. The duodenal ulcer patients were given the quadruple for 10 days, then rabeprazole for 14 days. All the patients took (13)C urea breath test to detect H. pylori 28 days after medicine withdrawal.. Altogether 428 cases were enrolled and 404 completed the trial. The total eradication rate in the chronic gastritis patients was 85.1% (262/308, intention-to-treat (ITT)analysis), which was 81.7% (125/153, ITT) in the A1 group and 88.4% (137/155, ITT) in the A2 group; the eradication rate in the duodenal ulcer patients was 85.8% (103/120, ITT). No severe adverse effects were reported. The symptoms (pain, burning sensation, reflux, belching, nausea, and vomiting) improvement status was similar among A1 and A2 groups.. The quadruple regimen using rabeprazole manufactured in China and administered for 10 days as first line/initial therapy in chronic gastritis and duodenal ulcer patients could achieve good H. pylori eradication rate. The extended use of bismuth after 10-day quadruple regimen might further improve the eradication rate. The regimens containing proton-pump inhibitor and bismuth may be well tolerated and safe in clinical application.

Topics: Amoxicillin; Antacids; Bismuth; Breath Tests; Drug Therapy, Combination; Duodenal Ulcer; Gastritis; Gastroesophageal Reflux; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Urea

Whether concomitant therapy is superior to bismuth quadruple therapy or 14-day triple therapy for the first-line treatment of Helicobacter pylori infection remains poorly understood. We aimed to compare the efficacy and safety of 10-day concomitant therapy, 10-day bismuth quadruple therapy, and 14-day triple therapy in the first-line treatment of H pylori.. In this multicentre, open-label, randomised trial, we recruited adult patients (aged >20 years) with H pylori infection from nine medical centres in Taiwan. Patients who had at least two positive tests from the rapid urease test, histology, culture, or serology or who had a single positive. Between July 17, 2013, and April 20, 2016, 5454 patients were screened for eligibility. Of these, 1620 patients were randomly assigned in this study. The eradication frequencies were 90·4% (488/540 [95% CI 87·6-92·6]) for 10-day bismuth quadruple therapy, 85·9% (464/540 [82·7-88·6]) for 10-day concomitant therapy, and 83·7% (452/540 [80·4-86·6]) for 14-day triple therapy in the intention-to-treat analysis. 10-day bismuth quadruple therapy was superior to 14-day triple therapy (difference 6·7% [95% CI 2·7-10·7, p=0·001), but not 10-day concomitant therapy. 10-day concomitant therapy was not superior to 14-day triple therapy. The frequency of adverse events was 67% (358/533) in patients treated with 10-day bismuth quadruple therapy, 58% (309/535) in patients treated with 10-day concomitant therapy, and 47% (252/535) in patients treated with 14-day triple therapy.. Bismuth quadruple therapy is preferable to 14-day triple therapy in the first-line treatment in the face of rising prevalence of clarithromycin resistance. Concomitant therapy given for 10 days might not be optimum and a longer treatment length should be considered.. National Taiwan University Hospital and Ministry of Science and Technology of Taiwan.

Topics: Amoxicillin; Antacids; Anti-Bacterial Agents; Breath Tests; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Organometallic Compounds; Proton Pump Inhibitors; Taiwan; Tetracycline; Urea

Chronic gastritis associated with H. pylori infection causes oxidative stress in the stomach. This study aimed to evaluate the therapeutic effects of coenzyme q10 among gastric patients infected by H. pylori. By a clinical trial, chronic gastric patients infected by H. pylori were randomly divided into 2 groups: intervention and placebo. The placebo group received a standard triple therapy regimen, and the intervention group received the triple regimen + coenzyme Q10 (CoQ10). Mean inflammation score; serum levels of 3 serum markers were then compared. A total of 100 participants of whom 67% were female were evaluated. The mean age of participants was 59.4 ± 11.4 years. The mean inflammation score was considerably decreased at the end of the study, in the intervention group. The mean levels of total antioxidant capacity (TAC) and glutathione peroxidase (GPx) at the end of the study were reduced among the triple therapy group (P < .05, P =.03 respectively). The mean levels of TAC and GPx were significantly higher among the intervention group at the end of the study compared with those at the start of the study. The combination of triple therapy with CoQ10 demonstrated an effective outcome on the mucosal inflammation, and stress oxidative in patients with chronic gastritis.

Topics: Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Antioxidants; Double-Blind Method; Drug Therapy, Combination; Female; Gastritis; Glutathione Peroxidase; Helicobacter Infections; Helicobacter pylori; Humans; Lipid Peroxidation; Male; Malondialdehyde; Metronidazole; Middle Aged; Organometallic Compounds; Oxidative Stress; Tetracycline; Ubiquinone

To evaluate the efficacy and safety of modified sequential therapy and to compare modified sequential therapy with standard quadruple therapy for Helicobacter pylori (H. pylori) eradication.. In total, 200 consecutive patients who were diagnosed with H. pylori-infected chronic gastritis by electronic endoscopy and rapid urease testing from December 2012 to October 2013 were enrolled in this study. The patients had not previously received H. pylori eradication treatment, and were randomized into two groups. The patients in Group A (n = 101) were treated with ilaprazole + bismuth potassium citrate + amoxicillin and clavulanate potassium + levofloxacin, and the patients in Group B (n = 99) were administered a modified sequential therapy composed of ilaprazole at 5 mg bid and amoxicillin and clavulanate potassium at 914 mg for the first five days followed by ilaprazole at 5 mg bid, furazolidone at 100 mg bid and levofloxacin at 500 mg qid for the next five days. Four to six weeks after the end of treatment, a 14C-urea breath test was performed for all the subjects to confirm the eradication of H. pylori. The intention-to-treat and per-protocol eradication rates were determined.. A total of 190 of the 200 patients completed the study. All 200 patients were included in the intention-to-treat analysis, whereas 190 patients were included in the per-protocol analysis. In the intention-to-treat analysis, the rates of H. pylori eradication in Groups A and B were 85.15% (86/101) and 81.82% (81/99), respectively. In the per-protocol analysis, the H. pylori eradication rates in Groups A and B were 88.66% (86/97) and 87.09% (81/93), respectively. No significant difference was observed (χ(2) = 0.109, P = 0.741) in the eradication rate between Groups A and B. The rates of adverse effects observed in the groups were similar at 6.19% (6/97) for Group A and 7.53% (7/93) for Group B (P > 0.05). No mortality or major morbidities were observed in any of the patients. Symptomatic improvements in the presentation of stomachache, acid regurgitation, and burning sensation were not significantly different between the two groups.. Ilaprazole-based 10-d standard quadruple therapy does not offer an incremental benefit over modified sequential therapy for the treatment of H. pylori infection, as both treatment regimens appear to be effective, safe, and well-tolerated as initial treatment options.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Amoxicillin; Anti-Bacterial Agents; Breath Tests; China; Chronic Disease; Clavulanic Acid; Drug Administration Schedule; Drug Therapy, Combination; Female; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Intention to Treat Analysis; Male; Middle Aged; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Time Factors; Treatment Outcome

The aim of this study is to assess efficacy and safety of reinforced H. pylori eradication therapy.. During 2013-2014, 40 outpatients were examined. The study included men and women 18-65 y.o. They have been devided in to 2 group by randomized choice (20 patients in each group). Patients were treated with the reinforced H. pylori eradication therapy: PPI (40 mg,/q12h), clarithromycin (500mg/q12h), amoxicillin (1000 mg/q12h), bismuth subcitrate (240 mg/q12h) for 10 days. The first group given bismuth subcitrate--De-Nol, the second group given Novobismol. Eradication was confirmed by a 13C-urea breath test and monoclonal stool antigen test 6-8 weeks after therapy.. A total of 34 patients underwent eradication treatment. Two were lost to follow-up (one patient in each group), four patients (two patients in each group) did not complete treatment due to adverse events. The eradication rates were 97.1% (95% CI, 88.9% -100.0%) by per-protocol (PP) and 82.5% (95% CI, 69.4% - 92.5%) by intention-to-treat (ITT) in the two groups. The ITT analyses resulted in rates of 85% (95% CI, 66.5-96.9) for the 10-d reinforced therapy with DeNol and was 80% (95% CI: 60.2-94.1) for the 10-d reinforced therapy with Novobismol (P = 0.68), while the PP analyses resulted in 100% (95% CI, 94.5-100.0) and 94.1% (95% CI: 78.3-99.9), respectively (P = 0.31).. The reinforced H. pylori eradication therapy (10-day high-dose PPI bismuth-containing standard triple therapy) achieves a significantly high eradication rates in patients with H. pylori - associated diseases. Both drugs (De- Nol and Novobismol) are both effective and safe for the first-line eradication of H. pylori.

Topics: Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds

Helicobacter pylori eradication therapy with a proton pump inhibitor (PPI), clarithromycin, and amoxicillin fails in >20 % of cases. A rescue therapy with PPI-amoxicillin-levofloxacin still fails in >20 % of patients.. To evaluate the efficacy and tolerability of a bismuth-containing quadruple regimen in patients with two consecutive eradication failures.. Prospective multicenter study of patients in whom 1st treatment with PPI-clarithromycin-amoxicillin and 2nd with PPI-amoxicillin-levofloxacin had failed. A 3rd eradication regimen with a 7- to 14-day PPI (standard dose b.i.d.), bismuth subcitrate (120 mg q.i.d. or 240 mg b.i.d.), tetracycline (from 250 mg t.i.d. to 500 mg q.i.d.) and metronidazole (from 250 mg t.i.d. to 500 mg q.i.d.). Eradication was confirmed by (13)C-urea-breath-test 4-8 weeks after therapy. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by means of a questionnaire.. Two hundred patients (mean age 50 years, 55 % females, 20 % peptic ulcer/80 % uninvestigated-functional dyspepsia) were initially included, and two were lost to follow-up. In all, 97 % of patients complied with the protocol. Per-protocol and intention-to-treat eradication rates were 67 % (95 % CI 60-74 %) and 65 % (58-72 %). Adverse effects were reported in 22 % of patients, the most common being nausea (12 %), abdominal pain (11 %), metallic taste (8.5 %), and diarrhea (8 %), none of them severe.. A bismuth-containing quadruple regimen is an acceptable third-line strategy and a safe alternative after two previous H. pylori eradication failures with standard clarithromycin- and levofloxacin-containing triple therapies.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Clarithromycin; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Salvage Therapy; Spain; Surveys and Questionnaires; Tetracycline; Time Factors; Treatment Failure

This study aimed to compare the efficacy and safety of bismuth-included standard regimen and modified sequential treatments in Turkey, where the success rate of standard triple therapy is very low.. One-hundred and sixty patients with dyspeptic complaints and naïve Helicobacter pylori infection were randomized into four groups: 41 patients received standard 14-day quadruple treatment (STD) (Rabeprazole 20mg-bid, bismuth subcitrate (120 mg-qid), Tetracycline 500 mg-qid, Metronidazole 500 mg-tid) for 2 weeks. The modified sequential therapy groups received 20 mg rabeprazole and 1g amoxicillin, twice daily for the first 5 days, followed by Rabeprazole 20mg-bid, bismuth subcitrate (120 mg-qid), Tetracycline 500 mg-qid, Metronidazole 500 mg-tid for the remaining 5 (10 day sequential therapy group-10S) (42 patients), 7 (12 day sequential therapy group-12S) (42 patients) and 9 (14 day sequential therapy group-14S) (41 patients) days.. The overall compliance and H. pylori eradication rate among the 160 patients who completed the H. pylori eradication regimens were 86.9% (139/160) and 78.1% (125/160), respectively. The results were not statistically different between groups in the eradication rates. Per-protocol eradication rates were 76.5% in STD, 71.4% in 10S, 82.4% in 12S and 83.3% in 14S groups (p=0.7). Intention-to-treatment rates were 77.5% in STD, 72.5% in 10S, 82.5% in 12S and 80.0% in 14S groups (p=0.5).. The eradication rates of standard 14-day and different sequential quadruple treatment regimens are comparable and much more higher than with standard 14-day triple H. pylori eradication treatment that has been reported previously in Turkey.

Topics: Adult; Anti-Infective Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Rabeprazole; Remission Induction; Tetracycline; Time Factors; Turkey

Treatments with sequential therapy (SEQ) or bismuth quadruple (QUAD) therapy have been proposed as empirical firstline regimens for Helicobacter pylori. We compared the efficacy and tolerability of 10 day SEQ with 10 day modified QUAD as both firstline and secondline treatments for H pylori in a randomised crossover study.. H pylori positive and treatment naïve patients were randomly assigned to receive either 10 day SEQ (esomeprazole for 10 days, amoxicillin for an initial 5 days, followed by clarithromycin and metronidazole for a subsequent 5 days) or modified QUAD (esomeprazole, bismuth subcitrate, tetracycline and metronidazole). H pylori eradication was confirmed by urea breath test at 8 weeks. Patients who failed the initial assigned treatment were crossed over to receive the alternate regimen. The primary outcome was eradication rates of firstline treatment by intention to treat (ITT) and per protocol (PP) analyses.. 357 patients were randomised to receive either SEQ or QUAD. The PP eradication rates of the SEQ and QUAD groups were 95.2% and 98.8%, respectively (p=0.10). Based on ITT analysis, the corresponding eradication rates were 89.4% and 92.7%, respectively (p=0.36). Eight (4.8%) patients in the SEQ and two (1.2%) patients in the QUAD who failed the firstline treatment were crossed over to the alternate regimen with 100% retreatment success. The overall incidence of adverse events was higher in the QUAD (16.7%) than in the SEQ (8.1%; p=0.032) group.. Ten day sequential and modified bismuth quadruple therapies are both highly effective as empirical firstline therapies for H pylori in Chinese patients.. NCT 01760824.

Topics: Adult; Aged; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Asian People; Breath Tests; China; Clarithromycin; Cross-Over Studies; Drug Administration Schedule; Drug Therapy, Combination; Esomeprazole; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Intention to Treat Analysis; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Tetracycline; Treatment Outcome

Helicobacter pylori infection occurs in children and adults worldwide. Standard triple therapy of omeprazole, amoxicillin and clarithromycin (OAC) may not be optimal.. To evaluate quadruple therapy with bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, given with omeprazole in H. pylori infected subjects who failed previous OAC eradication therapy.. This was a multicenter, open-label, single-arm, multinational study. Helicobacter pylori-positive subjects who had failed ≥1 previous course of OAC therapy with or without up to three supplemental treatments in the previous year. Subjects were treated for 10 days with a combination formulation containing bismuth subcitrate potassium 140 mg, tetracycline hydrochloride 125 mg, and metronidazole 125 mg, three capsules four times daily (q.d.s.), and omeprazole 20 mg twice daily (b.d.). The primary endpoint was H. pylori eradication rate defined as one negative (13) C-urea breath test ≥28 days post-treatment.. Helicobacter pylori eradication rates ranged from 93.2% to 93.8% in the intent-to-treat population (n = 49), and from 94.7% to 95.0% in the PP population (n = 40). No clinically meaningful differences were observed when analysed by country. Metronidazole resistance was observed in 16/49 (32.7%) subjects and clarithromycin resistance in 31/49 (63.3%) subjects. Thirty-three subjects (67.3%) reported 87 adverse events, and only one (2%) discontinued the study for an adverse event.. A quadruple regimen of bismuth, metronidazole and tetracycline plus omeprazole produces a high eradication rate in subjects previously failing H. pylori eradication regimens. This bismuth-based regimen offers an effective option as rescue therapy.

Topics: Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Drug Combinations; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Helicobacter Infections; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Tetracycline; Treatment Outcome; Urea; Young Adult

Although triple (omeprazole, amoxicillin, and metronidazole) and quadruple (omeprazole, tetracycline, metronidazole, and bismuth subcitrate) therapeutic regimens for H. pylori eradication has been studied much in the general population, there is a lack of data in renal transplanted patients. So, this study aimed at comparing regimens in these patients who were considered being immunocompromised. The present clinical trial was carried out in Mashhad, Iran in 2010. Fifty-five patients who had received a kidney transplant in six months or earlier and referred for chronic dyspepsia were selected. They were resistant to H2-receptor antagonists or proton pump inhibitors therapy and had positive Rapid ‎Urea Test. They randomly divided into two groups: triple and quadruple therapy. The treatment duration in both groups was similar (antibiotics for two weeks plus omeprazole for 4 weeks). Urea Breath Test (UBT) was performed two weeks after treatment for assessment of its result. Total numbers of 39 patients (71%) were positive for H. Pylori which were divided into triple therapy group (21 patients) and quadruple therapy (18 patients). Overall, the treatment was successful in 80% (71% in triple therapy and 89% in quadruple one) which was not different significantly between the groups (p=0.247). The result of this study revealed that the prevalence of H. pylori infection in renal transplant patients is similar to the normal population. In these cases, triple and quadruple therapies were similar in eradication of H. pylori. So, triple therapy can be recommended in renal transplant recipients.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Breath Tests; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Immunocompromised Host; Iran; Kidney Transplantation; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Proton Pump Inhibitors; Tetracycline; Treatment Outcome

To evaluate the efficacy of furazolidone-based triple and quadruple therapy in eradicating Helicobacter pylori (H. pylori) in a multi-center randomized controlled trial.. A total of 720 H. pylori positive patients with duodenal ulcer disease were enrolled at 10 different hospitals in Jiangxi province in China. The patients were randomly assigned to four treatment groups as follows: patients in Groups 1 and 3 received rabeprazole (10 mg), amoxicillin (1000 mg) and furazolidone (100 mg) twice daily for 7 and 10 d, respectively; patients in Groups 2 and 4 received rabeprazole (10 mg), bismuth (220 mg), amoxicillin (1000 mg) and furazolidone (100 mg) twice daily for 7 and 10 d, respectively. The primary outcome measure was H. pylori eradication rate 4 wk after treatment by intention-to-treat and per protocol analysis, while the secondary outcome measures were symptom and sign changes at the end of treatment and 4 wk after the end of treatment, as well as the proportion of patients who developed adverse events.. The demographic data of the four groups were not significantly different. Overall, 666 patients completed the scheme and were re-assessed with the (13)C-urea breath test. The intention-to-treat analysis of the H. pylori eradication rates in Groups 1, 2, 3 and 4 were 74.44%, 82.78%, 78.89% and 86.11%, respectively. The H. pylori eradication rate in Group 4 was significantly higher than that in Group 1. According to the per protocol analysis, the H. pylori eradication rates in Groups 1, 2, 3 and 4 were 81.21%, 89.22%, 85.54% and 92.26%, respectively. The H. pylori eradication rate in Group 4 was significantly higher than that in Group 1. The number of adverse events was 15 (8.3%), 16 (8.9%), 15 (8.3%) and 17 (9.4%) in Groups 1, 2, 3 and 4, respectively, including dizziness, vomiting, diarrhea, nausea, skin rash, itchy skin, and malaise. The symptoms were relieved without special treatment in all of the patients.. Both 7- and 10-d quadruple furazolidone-based therapies achieve satisfactory H. pylori eradication rates.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; China; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Intention to Treat Analysis; Male; Middle Aged; Organometallic Compounds; Proton Pump Inhibitors; Rabeprazole; Time Factors; Treatment Outcome

Antibiotic resistance is the main reason for failure of Helicobacter pylori (H. pylori) treatment. Currently, guidelines recommend a treatment guided by antimicrobial susceptibility testing after two failures. However, microbial culture is not feasible everywhere, and the limited number of effective antibiotics against the bacterium narrows the options; thus a rescue therapy combining antibiotics with a low resistance may be fitting.. Patients who have failed a first-line treatment (either prolonged triple or sequential regimens) and, successively, a levofloxacin-based triple therapy were considered for the study. Subjects underwent urea breath test (UBT), stool antigen test (ST) and endoscopy/histology to confirm the diagnosis. Cytopenia and impaired liver and kidney function were exclusion criteria. Fifty-four subjects were randomized 1:1 to two regimens: RMB Rabeprazole/Rifabutin/Minocycline/Bismuth sub-citrate or MTB Rabeprazole/Tinidazole/Minocycline/Bismuth sub-citrate both for 10 days. The results were checked 6 weeks after the end of therapy with ST/UBT plus endoscopy when indicated.. RMB eradicated the bacterium in 21 patients. Two subjects dropped out. The eradication rate was 77.7% (CI 62.0-93.4%) at intention-to-treat and 84.0% (CI 69.6-98.4%) at per-protocol analysis. MTB was successful in 14 patients (51.9%, CI 33.1-70.7%). No patient withdrew from the treatment for adverse events. Drug-related side effects were reported only in 3 subjects, but in all cases the treatment was carried on.. The association minocycline/rifabutin seems to have a synergic effect and a good therapeutic outcome in patients who have failed at least two previous regimens, although a trial on a large population is needed.

Topics: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Breath Tests; Drug Resistance, Bacterial; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Feces; Female; Helicobacter Infections; Helicobacter pylori; Humans; Italy; Male; Middle Aged; Minocycline; Organometallic Compounds; Proton Pump Inhibitors; Rabeprazole; Rifabutin; Time Factors; Tinidazole; Treatment Failure; Young Adult

Selection of the best drug regimens for eradication of Helicobacter pylori infection especially in patients at risk of peptic ulcer relapses and the development of complications is challenging. This study assessed and compared the efficacy of the two common PPI based triple therapies to a quadruple therapy including PPI, metronidazole, amoxicillin and a bismuth compound in Iranian population.. Three hundred and thirty patients with peptic ulcer and H. pylori infection were included in the study. Patients were randomly assigned to one of the three treatment protocols all given twice daily: (a) A 14-day quadruple therapy (OMAB group) comprising omeprazole 20mg, metronicazole 500 mg, amoxicillin 1g, and bismuth subcitrate 240 mg; (b) A 14-day triple regimen (OCP group) comprising omeprazole 20mg plus clarithromycine 500 mg and penbactam 750 mg and (c) A 14-day triple regimen (OCA group) comprising omeprazole 20mg plus clarithromycine 500 mg and amoxicillin 1g. Cure was defined as a negative urea breath test at least six weeks after treatment.. The per-protocol eradication rates achieved with both OCP regimen (87.0%) and OCA treatment (90.8%) were significantly higher than the OMAB treatment protocol (56.0%); however, no significant difference emerged in eradication rates between the two triple treatment schedules. No significant differences between the groups were found in most side-effects.. Two-week quadruple therapy showed a lower eradication rate compared to common triple treatment schedules when used as first-line eradication treatment for H. pylori infection in Iranian population.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Ampicillin; Analysis of Variance; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Clarithromycin; Drug Combinations; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Iran; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Proton Pump Inhibitors; Sulbactam; Urea; Young Adult

Bismuth-containing quadruple therapy given four times a day is effective in the first-line treatment of Helicobacter pylori. We aimed to investigate whether twice daily posology could eradicate H. pylori at a comparable rate in an area with a high prevalence of antibiotic resistance.. The study group consisted of 90 patients with treatment naïve H. pylori. Patients were randomized to BOMT1 group (Bismuth citrate 2 x 600 mg, omeprazole 2 x 20 mg, metronidazole 2 x 500 mg, tetracycline 2 x 500 mg; for 14 days) and BOMT2 group (Bismuth citrate 2 x 600 mg, omeprazole 2 x 20 mg, metronidazole 3 x 500 mg, tetracycline 4 x 500 mg; for 14 days). H. pylori eradication was assessed by both C14-urea breath test and stool antigen test at least 8 weeks after treatment.. Demographic characteristics and endoscopy findings of the groups were similar. Eighty-two patients completed the study (BOMT1= 38 and BOMT2 = 44) including H. pylori eradication assessment. The eradication rates determined by PP and ITT analyses were 86.8% and 733% for BOMT1 group, 90.1% and 88.9% for BOMT2 group, respectively. BOMT1 was found to be non-inferior to BOMT2 treatment. Patients in BOMT2 group had a significantly higher rate of drug associated adverse events than BOMT1 (34.1% vs 9.3%; p = 0.008).. Twice a day quadruple therapy is as effective as four times a day quadruple therapy in the first line treatment of H. pylori in a country with high resistance to metronidazole and clarithromycin and is more tolerable.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Resistance, Bacterial; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Prevalence; Prospective Studies

The increasing trend of antibiotic resistance requires effective second-line Helicobacter pylori (H. pylori) treatment in high prevalence area of H. pylori. The aim of our study was to evaluate the reinfection rate of H. pylori after second-line treatment that would determine the long-term follow up effect of the rescue therapy.. A total of 648 patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test or invasive tests. In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.. The recrudescence rate of the EBMT was 1.7% and of the MEA group 3.3% (p = 0.67). The annual reinfection rate of H. pylori of EBMT was found to be 4.45% and the MEA group 6.46%. Univariate analysis (Log-rank test) showed no association with any clinical risk factor for reinfection.. The long-term reinfection rate of H. pylori stayed low in both of bismuth-containing quadruple therapy and moxifloxacin-based triple therapy; thus reinfection cannot affect the choice of second-line treatment.. Clinical Trial Registration Number NCT01792700.

Topics: Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Aza Compounds; Breath Tests; Disease-Free Survival; Drug Therapy, Combination; Esomeprazole; Female; Fluoroquinolones; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Kaplan-Meier Estimate; Longitudinal Studies; Male; Metronidazole; Middle Aged; Moxifloxacin; Organometallic Compounds; Peptic Ulcer; Quinolines; Recurrence; Stomach Neoplasms; Tetracycline; Treatment Outcome

This prospective study was designed to compare the efficacies of levofloxacin-containing and high-dose metronidazole-containing quadruple therapies after failure of standard triple therapies.. A total of 150 Helicobacter pylori-infected patients were enrolled in our study and randomly assigned to levofloxacin-containing quadruple therapy (EBTL group) (40 mg of esomeprazole twice daily, 300 mg of bismuth subcitrate four times daily, 500 mg of tetracycline four times daily and 500 mg of levofloxacin once daily for 10 days) (n = 76) or high-dose metronidazole-based quadruple therapy (EBTM group) (40 mg of esomeprazole twice daily, 300 mg of bismuth subcitrate four times daily, 500 mg of tetracycline four times daily and 500 mg of metronidazole four times daily for 10 days) (n = 74). Follow-up endoscopy or urea breath test was done 16 weeks later to assess the treatment response. Patients' responses, CYP2C19 genotypes and antibiotic resistances were also examined. All participants, caregivers and those assessing the outcomes were blinded to group assignment.. Intention-to-treat analysis revealed that both groups showed similar eradication rates: EBTL, 78.9% (60/76) (95% CI 69.7%-88.1%) and EBTM, 79.7% (59/74) (95% CI 70.5%-88.7%) [risk ratio (RR) 0.97, 95% CI 0.44-2.14]. Per-protocol results were EBTL = 87.0% (60/69) (95% CI 79.4%-94.9%) and EBTM = 90.8% (59/65) (95% CI 83.8%-97.8%) (RR 0.68, 95% CI 0.23-2.0). We did not find significant differences in compliance (RR 0.5, 95% CI 0.54-2.3) and adverse events (RR 1.11, 95% CI 0.54-2.3) between the two groups. Logistic regression analysis showed that only compliance was an important predictor for eradication failure. CYP2C19 polymorphism did not influence the eradicating effect.. The 10 day bismuth quadruple therapies with high-dose metronidazole or levofloxacin were effective even in areas with high resistance. These two therapies were equally safe and tolerated. Besides this, the metronidazole-containing therapy was cheaper. So it is persuasive that high-dose metronidazole-containing quadruple therapy could be a good choice for second-line H. pylori eradication in areas with high resistance.

Topics: Adult; Aged; Anti-Bacterial Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Metronidazole; Middle Aged; Ofloxacin; Organometallic Compounds; Surveys and Questionnaires; Treatment Outcome; Young Adult

Topics: Adult; Aged; Antacids; Anti-Bacterial Agents; Aza Compounds; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Female; Fluoroquinolones; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Medication Adherence; Middle Aged; Moxifloxacin; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Quinolines; Tetracycline; Young Adult

In the present study, we investigated the prevalence of anaemia and Fe deficiency anaemia (IDA) and explored the relationship between Helicobacter pylori infection and IDA in adolescent girls. A total of 1037 adolescent girls from Suihua, China were enrolled. Hb, serum ferritin (SF), serum transferrin receptor (sTfR) and serum IgG antibodies to H. pylori were measured. Participants with IDA and co-existing H. pylori infection (n 80) who had an intake of >25 mg/d of Fe were assigned randomly to the intervention and control groups. Patients in the intervention group were administered a 12-week course of oral EDTA-Na-Fe (60 mg Fe/dose, three times a week) and a 2-week course of colloidal bismuth subcitrate, amoxicillin and metronidazole. Subjects in the control group were administered EDTA-Na-Fe alone. Hb, SF and sTfR were reassessed 3 months after the 12-week regimen ended. Prevalence of anaemia, Fe deficiency (defined as SF < 12·0 μg/l), IDA and H. pylori infection in the population of 1037 was 19.5, 40.4, 17.1 and 31.2 %, respectively. The prevalence of H. pylori infection in the IDA group was 46.9 %, while the non-anaemic group had 28.1 % prevalence. A significant increase in Hb and SF and a decrease in sTfR value were found in the intervention group and the H. pylori-negative group. Findings suggest that IDA is still one of the prominent problems in adolescent girls. There is an association between H. pylori infection and IDA. Treatment of H. pylori infection is associated with a more rapid response to oral Fe therapy.

Topics: Adolescent; Amoxicillin; Anemia, Iron-Deficiency; Anti-Bacterial Agents; Anti-Ulcer Agents; Antibodies, Bacterial; Child; China; Dietary Supplements; Drug Therapy, Combination; Edetic Acid; Female; Ferric Compounds; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Mass Screening; Metronidazole; Organometallic Compounds; Prevalence; Suburban Health; Urban Health

Sequential regimens have been recently reported to be superior to the standard triple therapies in Helicobacter pylori eradication, but most of these studies were performed in Europe and data from developing countries are lacking. So we designed a study to compare a sequential regimen with a bismuth-based quadruple therapy that contains a short course of furazolidone, in Iran.. Two hundred and ninety-six patients with duodenal ulcer and naïve H. pylori infection were randomized into two groups: 148 patients received (PAB-F) pantoprazole (40mg-bid), amoxicillin (1g-bid), and bismuth subcitrate (240mg-bid) for 2weeks and furazolidone (200mg-bid) just during the first week. And 148 patients received (PA-CT) pantoprazole (40mg-bid) for 10days, amoxicillin (1g-bid) for the first 5days, and clarithromycin (500mg-bid) plus tinidazole (500mg-bid) just during the second 5days. C(14) -urea breath test was performed 8weeks after the treatment.. Two hundred and sixty-one patients completed the study (137 patients in the PA-CT and 124 in the PAB-F group). The results were not statistically different between the two groups in the eradication rates and the severity of side effects. The intention to treat eradication rate was 80.4% in the PAB-F group and 83.7% in the PA-CT group. Per-protocol eradication rates were 88.7% and 89.1%, respectively.. Because the two regimens showed acceptable and similar abilities in H. pylori eradication and because of much higher cost of clarithromycin in Iran, the furazolidone containing regimen seems to be superior. Further modifications of sequential therapies are needed to make them ideal regimens in developing countries.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Amoxicillin; Anti-Bacterial Agents; Bismuth; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Iran; Male; Middle Aged; Organometallic Compounds; Pantoprazole

This study aimed to compare the efficacy and safety of quadruple therapy containing doxycycline and routine quadruple therapy for Helicobacter (H.) pylori rescue eradication in patients who had failed the one-week triple therapy.. Patients who failed the first-line eradication therapy were allocated into two groups. Group A patients (n = 43) were administered esomeprazole 20 mg, bismuth potassium citrate 220 mg, amoxicillin 1 g and doxycycline 100 mg, all bid for ten days, while Group B patients (n = 42) were administered esomeprazole 20 mg bid, bismuth potassium citrate 220 mg bid, metronidazole 400 mg bid and tetracycline 750 mg q.6h, for ten days. The results of H. pylori eradication were assessed with 13C urea breath test four weeks after the therapy, and the side effects were recorded.. A total of 85 patients (average age 46.9 years) were enrolled in the study. Successful eradication rate for H. pylori was 72.5% in Group A and 64.1% in Group B, with no significant difference between the two groups. 11.6% (5/43) of patients from group A and 31.0% (13/42) from group B reported at least one adverse event. The adverse events of all 18 patients disappeared after the therapy ceased.. Quadruple therapy containing doxycycline is as effective as routine quadruple therapy for H. pylori rescue eradication. The regimen is well tolerated by most patients and causes fewer adverse events than routine quadruple therapy. Hence, it may be recommended as a suitable alternative H. pylori rescue regimen in China.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Doxycycline; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Tetracycline; Treatment Outcome; Young Adult

To compare triple therapy vs quadruple therapy for 10 d as first-line treatment of Helicobacter pylori (H. pylori) infection.. Consecutive H. pylori positive patients never treated in the past for this infection were randomly treated with triple therapy of pantoprazole (PAN) 20 mg bid, amoxicillin (AMO) 1 g bid and moxifloxacin (MOX) 400 mg bid for 10 d (PAM) or with quadruple therapy of PAN 20 mg bid, AMO 1 g bid, MOX 400 mg bid and bismuth subcitrate 240 mg bid for 10 d (PAMB). All patients were found positive at 13 C-Urea breath test (UBT) performed within ten days prior to the start of the study. A successful outcome was confirmed with an UBT performed 8 wk after the end of treatment. χ(2) analysis was used for statistical comparison. Per protocol (PP) and intention-to-treat (ITT) values were also calculated.. Fifty-seven patients were enrolled in the PAM group and 50 in the PAMB group. One patient in each group did not return for further assessment. Eradication was higher in the PAMB group (negative: 46 and positive: 3) vs the PAM group (negative: 44 and positive: 12). The H. pylori eradication rate was statistically significantly higher in the PAMB group vs the PAM group, both with the PP and ITT analyses (PP: PAMB 93.8%, PAM 78.5%, P < 0.02; ITT: PAMB 92%, PAM 77.1 %, P <0.03).. The addition of bismuth subcitrate can be considered a valuable adjuvant to triple therapy in those areas where H. pylori shows a high resistance to fluoroquinolones.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Amoxicillin; Anti-Infective Agents; Aza Compounds; Drug Therapy, Combination; Female; Fluoroquinolones; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Moxifloxacin; Organometallic Compounds; Pantoprazole; Proton Pump Inhibitors; Quinolines; Treatment Outcome

Eradication rates of Helicobacter pylori with standard triple therapy are not satisfactory. Sequential therapy is an alternative method to overcome this problem.. The aim of this study was to assess efficacy of a modified sequential therapy with the addition of a bismuth preparation, as first-line treatment in the eradication of H. pylori infection.. One hundred and forty-two H. pylori-positive patients were included in the study. Patients were given a 14-day sequential therapy program consisting of pantoprazole, 40 mg (b.i.d. for 14 days); colloidal bismuth subcitrate, 300 mg 4 (two tablets before breakfast and dinner, for 14 days); amoxicillin, 1 g (b.i.d.for the first 7 days); tetracycline, 500 mg (q.i.d. for the second 7 days); and metronidazole, 500 mg (t.i.d. for the second 7 days). Eradication was tested by urea breath test (UBT) 6 weeks after completion of treatment.. Of the 142 patients included, 131 completed the study. "Per-protocol" and "intention-to-treat" analyses revealed high eradication rates in this group (92.0-95% CI, 87.2-96.8%, and 81.0-95% CI, 74.5-87.4%, respectively). There was no relation to sex and age with this modified sequential therapy. Compliance was satisfactory (11 patients - four women and seven men were unavailable for follow-up), and side effects were minimal (six patients had to stop treatment - metronidazole-related facial swelling and numbness on the face and hands in two patients; tetracycline-related fever and epigastric pain and nausea and vomiting in two patients; and amoxicillin-related diarrhea and vaginal discharge in two patients). These side effects were reversible and resolved after the cessation of the related medication.. This 14-day modified sequential treatment, including bismuth, achieves a significantly high eradication rates in patients with H. pylori infection, with five satisfactory patient compliance and minor side effects.

Topics: Adult; Anti-Bacterial Agents; Breath Tests; Drug Therapy, Combination; Female; Helicobacter Infections; Humans; Male; Middle Aged; Organometallic Compounds; Prospective Studies; Treatment Outcome; Turkey; Urea

Helicobacter pylori is associated with benign and malignant diseases of the upper gastrointestinal tract, and increasing antibiotic resistance has made alternative treatments necessary. Our aim was to assess the efficacy and safety of a new, single-capsule treatment versus the gold standard for H pylori eradication.. We did a randomised, open-label, non-inferiority, phase 3 trial in 39 sites in Europe, comparing the efficacy and safety of 10 days of quadruple therapy with omeprazole plus a single three-in-one capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline (quadruple therapy) versus 7 days of omeprazole, amoxicillin, and clarithromycin (standard therapy) in adults with recorded H pylori infection. Patients were randomly assigned treatment according to a predetermined list independently generated by Quintiles Canada (Ville St-Laurent, QC, Canada). Our study was designed as a non-inferiority trial but was powered to detect superiority. Our primary outcome was H pylori eradication, established by two negative (13)C urea breath tests at a minimum of 28 and 56 days after the end of treatment. Our assessment for non-inferiority was in the per-protocol population, with subsequent assessment for superiority in the intention-to-treat population (ie, all participants randomly assigned treatment). This study is registered with ClinicalTrials.gov, number NCT00669955.. 12 participants were lost to follow-up and 101 were excluded from the per-protocol analysis. In the per-protocol population (n=339), the lower bound of the CI for treatment with quadruple therapy was greater than the pre-established non-inferiority margin of -10% (95% CI 15·1-32·3; p<0·0001). In the intention-to-treat population (n=440), eradication rates were 80% (174 of 218 participants) in the quadruple therapy group versus 55% (123 of 222) in the standard therapy group (p<0·0001). Safety profiles for both treatments were similar; main adverse events were gastrointestinal and CNS disorders.. Quadruple therapy should be considered for first-line treatment in view of the rising prevalence of clarithromycin-resistant H pylori, especially since quadruple therapy provides superior eradication with similar safety and tolerability to standard therapy.. Axcan Pharma Inc.

Topics: Adolescent; Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Clarithromycin; Drug Combinations; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Tablets; Tetracycline; Young Adult

Body mass index (BMI) increased following Helicobacter pylori eradication in several Japanese cohorts, which requires further investigation.. To determine the impact of H. pylori eradication on BMI in a European population.. A total of 10,537 unselected people aged 20-59 years were screened for H. pylori; 1558 of the 1634 infected participants were randomised to intervention (eradication therapy: ranitidine bismuth citrate 400 mg and clarithromycin 500 mg twice daily) or placebo for 2 weeks with follow-up at 6 months (92%) for weight and dyspepsia symptoms (epigastric pain).. The mean weight of participants in the intervention group increased from 77.7 kg at baseline to 78.4 kg at 6 months (unadjusted increase of 0.7 kg) and from 76.8 to 77.2 kg (0.5 kg) in the placebo group. The adjusted difference between randomised groups was statistically significant at 0.6 kg [95% confidence interval (CI) 0.31, 0.88]. Significantly, more participants gained ≥3 kg in the intervention group (138/720, 19%) compared with the placebo group (92/706, 13%) [odds ratio (OR) 1.57 (95% CI: 1.17, 2.12)]. The mean BMI increased from 27.5 to 27.8 kg/m(2) at 6 months in the intervention group compared with the increase from 27.0 to 27.2 kg/m(2) in the placebo group [adjusted difference between groups was statistically significant at 0.2 kg/m(2) (95% CI: 0.11, 0.31)]. Dyspepsia was less frequently reported by intervention group participants (168/736, 23%, placebo group 209/711, 29%), OR 0.71 (95% CI: 0.55, 0.93).. Body mass index increased significantly following randomisation to H. pylori eradication therapy, possibly due to resolution of dyspepsia.

Topics: Adult; Body Mass Index; Body Weight; Clarithromycin; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Placebos; Ranitidine; Treatment Outcome

Antibiotic resistance to amoxicillin in second-line eradication therapy for Helicobacter pylori infection is much less frequent than resistance to metronidazole. We conducted a randomized, controlled study to compare the efficacies of standard quadruple rescue therapy and a new therapy with amoxicillin replacing metronidazole for patients failing first-line eradication treatment. We randomly assigned 120 patients who failed H. pylori eradication using a proton pump inhibitor plus clarithromycin and amoxicillin to undergo a 1-week rescue therapy with esomeprazole, bismuth subcitrate, and tetracycline plus either metronidazole (EBTM group, n = 62) or amoxicillin (EBTA group, n = 58). We used follow-up endoscopy 8 weeks after the end of treatment to assess the treatment response. We also examined and analyzed antibiotic resistances and CYP2C19 genotypes. Intention-to-treat analysis demonstrated that the EBTA group had a significantly lower eradication rate than the EBTM group (62% vs. 81%, respectively, p = 0.02). Per-protocol analysis showed similar results (64% vs. 83%, p = 0.01). However, the EBTA group had less frequency of adverse events than the EBTM group (19% vs. 44%, p < 0.01). Both groups had good drug compliance (both 97%). Antibiotic susceptibility tests showed that the frequency of amoxicillin-resistant strains was much less than that of metronidazole-resistant strains (0% vs. 54%, respectively), and there were no significant differences between H. pylori eradication rates and antibiotic resistances. In conclusion, EBTA quadruple therapy demonstrated a lower eradication rate than standard EBTM therapy in second-line rescue treatment. The discrepancy between in vitro antibiotic susceptibility and in vivo eradication response is probably due to drug interactions between combined antibiotics or some unknown causes, and should not be neglected in H. pylori therapy.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Aryl Hydrocarbon Hydroxylases; Cytochrome P-450 CYP2C19; Drug Resistance, Bacterial; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Polymorphism, Genetic; Tetracycline; Treatment Outcome

The eradication rates of first-line treatment for Helicobacter pylori infection are not satisfactory. Various regimens including quadruple therapies have been recommended as rescue therapies after the first H. pylori eradication attempt failed.. To compare the efficacy and safety between quadruple therapies with medications containing either rufloxacin or levofloxacin in the Chinese nonulcer dyspepsia patients infected with H. pylori.. One hundred and thirty-eight patients after an unsuccessful 10-day standard triple therapy were enrolled in this study. They were randomized to receive a 14-day quadruple therapy with pantoprazole, bismuth citrate, and furazolidone in combination with either rufloxacin (Group Ruf, n=70) or levofloxacin (Group Lev, n=68). The H. pylori eradication was evaluated by (13) C-urea breath test 4 and 12 weeks after therapy was completed.. One hundred and twenty-seven patients (65 in Group Ruf and 62 in Group Lev) completed the study. The H. pylori eradication rates in Group Ruf were 81.4% for intention-to-treat (ITT) analysis and 87.7% for per-protocol (PP) analysis. The rates were statistically significantly higher than those in Group Lev (66.2% and 72.6%) (p<0.05). There were no severe adverse effects found in these two groups.. Fourteen-day quadruple therapy with a combination of proton-pump inhibitor, bismuth citrate, furazolidone, and rufloxacin is considered an effective and safe rescue therapy for H. pylori eradication after failure of standard triple treatment.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; China; Drug Therapy, Combination; Female; Fluoroquinolones; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Organometallic Compounds; Pantoprazole; Pilot Projects; Salvage Therapy; Treatment Outcome; Young Adult

The success rate of currently recommended 7-day triple therapy with a PPI plus amoxicillin and clarithromycin has fallen into the unacceptable range. It is urgent to look for a new strategy to treat the infection of Helicobacter pylori.. To observe the efficacy of triple therapy-based, bismuth-containing quadruple therapy for H. pylori treatment.. A total of 160 patients with functional dyspepsia who were Hp+ were randomly assigned into two groups. Regimen: Omeprazole 20 mg, Amoxicillin 1.0 g, Clarithromycin 500 mg and Bismuth Potassium Citrate 220 mg, twice a day. Eighty patients received 7-day quadruple therapy and 80 patients received the same therapy for 14 days. Six weeks after treatment, H. pylori eradication was assessed by (13)C-urea breath test. Minimal inhibitory concentrations of metronidazole, clarithromycin and amoxicillin of clinical isolates were determined by the twofold agar dilution method.. Fourteen-day therapy led to a significant increase of H. pylori eradication success when compared to 7-day therapy in the intention-to-treat analysis (93.7 vs 80.0%; p = .01), and the per-protocol analysis (97.4 vs 82.0%; p = .0016). The H. pylori resistance rates to metronidazole, clarithromycin and amoxicillin were 42.1, 18.0 and 0%. Fourteen-day therapy was significantly more effective in patients with clarithromycin-resistant strains. Incidences of adverse events were comparable.. Addition bismuth and prolonging treatment duration can overcome H. pylori resistance to clarithromycin and decrease the bacterial load. Fourteen-day triple therapy-based, bismuth-containing quadruple therapy achieved ITT success rate 93% and could be recommended as the first line eradication regimen.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Clarithromycin; Colony Count, Microbial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Omeprazole; Organometallic Compounds; Proton Pump Inhibitors; Time Factors; Treatment Outcome; Young Adult

Our aim was to compare the efficacy and safety of Helicobacter pylori (H. pylori) eradication with pantoprazole-based 7-day standard triple therapy (PAC) and 10-day quadruple therapy (PBMT), and to study the primary resistance of H. pylori to amoxicillin, clarithromycin, metronidazole and tetracycline.. A total of 170 patients with non-ulcer dyspepsia (NUD) and H. pylori infection were allocated to two study groups. The PAC group received pantoprazole 40 mg b.i.d., amoxicillin 1.0 g b.i.d. and clarithromycin 500 mg b.i.d. for 7 days; the PBMT group received pantoprazole 40 mg b.i.d., colloidal bismuth subcitrate 220 mg b.i.d, metronidazole 400 mg t.i.d. and tetracycline 750 mg b.i.d. for 10 days. A total of 80 H. pylori strains were isolated and antibiotic resistance was measured by the agar dilution method.. A total of 166 patients completed the therapy. The intention-to-treat eradication rates in the PAC and PBMT groups were 63.5% and 89.4%, respectively (P < 0.05). By per protocol analysis, the eradication rates of the two groups were 65.1% and 91.6%, respectively (P < 0.05). Overall 77 clinical isolated H. pylori strains were cultured successfully. The H. pylori primary resistance rates to metronidazole and clarithromycin were 41.6% and 20.8%, respectively, whereas all the H. pylori isolates were sensitive to amoxicillin and tetracycline.. The efficacy of PAC declines in many regions in China because of high antibiotic resistance rates. The PBMT regimen achieved a high eradication rate of H. pylori and might be used as a first-line therapy.

Topics: Adolescent; Adult; Aged; Amoxicillin; Clarithromycin; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Tetracycline

Helicobacter pylori (H. pylori) cure rates vary in different geographical regions because of differences in hosts as well as in H. pylori strains. In this study we evaluated the efficacy of different treatment regimens for eradication of H. pylori infection in children, in order to select a treatment regimen that is most effective with the least adverse effects and cost.. Through a randomized clinical trial study we enrolled 120 pediatric patients (age

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Breath Tests; Child; Child, Preschool; Clarithromycin; Clavulanic Acid; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Iran; Male; Metronidazole; Omeprazole; Organometallic Compounds; Proton Pump Inhibitors; Single-Blind Method; Treatment Outcome; Urea

The influence of gastritis patterns in Helicobacter pylori eradication rates has been poorly investigated.. To compare the efficacy of bismuth or proton pump inhibitors triple therapy for H. pylori eradication in pangastritis.. One hundred and eight patients with pangastritis were assigned to either lansoprazole 30 mg once a day (n=54) or bismuth 240 mg bis in die (n=54) for 14 days combined, for the first week, with amoxicillin 1g plus metronidazole 250 mg tris in die. Eradication was confirmed by (13)C-urea breath test.. With bismuth, successful eradication was observed in 75.9% (41/54) in the intention-to-treat analysis and 78.8% (41/52) in the per-protocol analysis. With lansoprazole, the eradication rates were respectively 46.3% (25/54) and 51.0% (25/49). Bismuth had a significant higher efficacy according to both intention-to-treat analysis (p=0.0029) and per-protocol analysis (p=0.0038) with OR of 3.66 (95% CI: 1.61-8.32) and 3.58 (95% CI: 1.50-8.54) respectively. At regression analysis, the only independent variable affecting eradication was the type of regimen (p=0.026) with an OR of 3.31 (95% CI: 1.16-9.44).. In pangastritis patients, bismuth is more effective than PPI in first-line eradication. For improving the overall eradication rates, an evaluation of gastritis extent might need to be considered.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Amoxicillin; Anti-Infective Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Organometallic Compounds; Proton Pump Inhibitors; Young Adult

This prospective study was designed to determine the efficacy of a levofloxacin-based rescue therapy for Helicobacter pylori infection after failure of standard triple therapies. We also surveyed the predictors of this rescue therapy.. From June 2005 to March 2007, 1036 patients infected with H. pylori received standard triple regimens (proton pump inhibitor, clarithromycin and amoxicillin). H. pylori eradication was achieved in 855 (82.5%) subjects. One hundred and sixty-six eradication-failure patients were enrolled and randomly assigned to receive a 7 day eradication therapy with esomeprazole, bismuth subcitrate, tetracycline and metronidazole (EBTM) or esomeprazole, amoxicillin and levofloxacin (EAL). Follow-up endoscopy was done 16 weeks later to assess the treatment response. Patients' response, CYP2C19 genotypes and antibiotic resistances were also examined.. Intention-to-treat analysis revealed that both groups showed similar eradication rates [EBTM 63.9%; 95% confidence interval (CI): 53.6-74.2 and EAL 69.9%; 95% CI: 60.1-79.7] (P = 0.89). Per-protocol results were EBTM = 84.1% (95% CI: 75.1-93.1) and EAL = 75.3% (95% CI: 65.8-84.8) (P = 0.82). Both regimens had similar compliance (P = 0.32), but the EBTM group had more adverse events (P = 0.27). Logistic regression analysis showed that poor compliance, CYP2C19 homozygous extensive metabolizer genotype and levofloxacin resistance were important predictors for eradication failure.. The EAL regimen can achieve an efficacy similar to that of the standard EBTM therapy. It may be very useful in countries where bismuth salts are not available. Compliance, CYP2C19 genotype and resistances to antibiotics may influence the outcome of levofloxacin-based rescue therapy. It seems advisable to reserve levofloxacin for rescue treatment to avoid an increase in the resistance phenomenon.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Endoscopy, Gastrointestinal; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Metronidazole; Middle Aged; Ofloxacin; Organometallic Compounds; Prospective Studies; Salvage Therapy; Tetracycline; Treatment Outcome; Young Adult

In eradication of Helicobacter pylori infection, standard quadruple second-line therapy consisting of proton pump inhibitor (PPI), bismuth, metronidazole and tetracycline often fails and shows poor patient compliance. The aim of our study was to evaluate the efficacy and tolerability of moxifloxacin-based triple therapy as an alternative second-line protocol.. A total of 160 patients, in whom the initial standard PPI triple therapy had failed to eradicate H. pylori infection, were included in the study. The initial H. pylori status was assessed using the (13)C-urea breath test. Patients were randomized to one of the following 7-day treatment regimens: (1) OMM: omeprazole 20 mg twice a day, moxifloxacin 400 mg/day, metronidazole 500 mg three times a day; and (2) OBMT: omeprazole 20 mg twice a day, colloidal bismuth subcitrate 120 mg four times a day, metronidazole 500 mg three times a day, tetracycline 500 mg four times a day. Patient compliance and adverse events were evaluated one week after completion of therapy. H. pylori status was re-assessed with the (13)C-urea breath test six weeks after the end of therapy.. The eradication rates were 73.2% (60/82) and 78.9% (60/76) with moxifloxacin-based triple therapy, and 53.8% (42/78) and 64.6% (42/65) with bismuth-based quadruple therapy, by intention-to-treat (p = 0.018) and per-protocol (p = 0.088) analyses, respectively. Adverse events/intolerability were described in 12/82 patients in the OMM group and 18/78 patients in the OBMT group. Compliance with treatment was 92.7% in the OMM group and 83.3% in the OBMT group.. Moxifloxacin-based triple therapy is a highly effective second-line eradication treatment in H. pylori infection. Because of its high levels of safety and tolerability, this protocol represents an adequate alternative to the standard bismuth-based quadruple therapy.

Topics: Adult; Anti-Infective Agents; Anti-Ulcer Agents; Aza Compounds; Breath Tests; Drug Administration Schedule; Drug Therapy, Combination; Female; Fluoroquinolones; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Moxifloxacin; Omeprazole; Organometallic Compounds; Proton Pump Inhibitors; Quinolines; Recurrence; Retreatment; Single-Blind Method; Tetracycline; Young Adult

This study aims to assess the antioxidant property of vitamins E and C in Helicobacter pylori infection, and to determine if adding them to standard triple therapy plus bismuth subcitrate increases the H. pylori eradication rate.. This study included 160 patients infected with H. pylori, who were randomized into one of two groups. Patients in group A (n = 80) received lansoprazole (30 mg, b.i.d.), amoxicillin (1000 mg, b.i.d.), clarithromycin (500 mg, b.i.d.), and bismuth subcitrate (300 mg, q.i.d.) for 14 days, while patients in group B (n = 80) received vitamin C (500 mg, b.i.d.) and vitamin E (200 IU, b.i.d.) for 30 days, in addition to lansoprazole (30 mg, b.i.d.), amoxicillin (1000 mg, b.i.d.), clarithromycin (500 mg, b.i.d.), and bismuth subcitrate (300 mg, q.i.d.) for 14 days. Total antioxidant capacity (TAC) was evaluated with a Randox kit. Success rate was calculated using both intention-to-treat (ITT) and per-protocol (PP) analyses.. One hundred and sixty patients were analyzed using ITT analysis. One hundred and fifty-three patients completed the study. In group A, H. pylori eradication was achieved in 48 (60%) of the 80 patients included in the ITT analysis, and in 48 (64%) of the 75 patients included in the PP analysis. In group B, H. pylori eradication was achieved in 73 (91.25%) of the 80 included in the ITT analysis and in 73 (93.5%) of the 78 patients included in the PP analysis. The eradication rate was significantly higher in group B than in group A (p < .005). TAC was at the lower limit of normal in both groups and the difference between them was not statistically significant (p > .05).. In group B, H. pylori eradication rate was 91.25%, which is higher than the ideal 80% eradication rate. The results of the present study show that adding the prescribed doses of vitamins E and C to antimicrobial therapy is effective in eradicating H. pylori infection.

Topics: Adult; Antioxidants; Ascorbic Acid; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Oxidative Stress; Treatment Outcome; Vitamin E

To provide a pilot study of empiric rifaximin, bismuth subcitrate, furazolidone/nifuratel triple therapy for H. pylori gastritis in childhood.. Forty one pediatric outpatients (27 females, mean age 14.5+/-1.4 ys) with H. pylori-associated chronic gastritis who underwent endoscopy for dyspeptic symptoms received the combination of bismuth subcitrate (8 mg/kg/day, q. d. s.) for 14 days, rifaximin (800 mg/day) for 10 days and furazolidone (10 mg/kg/day, q. d. s.) or nifuratel (15 mg/kg/two times daily) for 10 days. H. pylori status was determined before the treatment by modified Giemsa staining/urease test and after the treatment (in 4-6 weeks) by ammonia breath test.. H. pylori was eradicated in 35 children (85.4%; 95%CI: 75.4-96.4 ITT and PP tests). There were no serious adverse reactions and were no withdrawals due to any side effects.. The combination of rifaximin, bismuth subcitrate and furazolidone/nifuratel was an effective and tolerable regimen for initial H. pylori eradication.

Topics: Adolescent; Anti-Infective Agents; Breath Tests; Child; Drug Therapy, Combination; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Nifuratel; Organometallic Compounds; Pilot Projects; Rifamycins; Rifaximin; Treatment Outcome

Bismuth-based quadruple therapy for second-line eradication treatment achieves the eradication rate ranging from 70% to 81% due to antimicrobial resistance and poor compliance. The aim of this study was to compare the eradication rate of levofloxacin-based triple therapy with that of bismuth-based quadruple therapy in second-line Helicobacter pylori (H. pylori) eradication therapy.. Seventy-six outpatients with persistent H. pylori infection after first-line triple therapy were enrolled in this prospective randomized trial. The subjects were randomized to receive levofloxacin 300 mg, amoxicillin 1 g, and pantoprazole 20 mg, given twice daily for 7 days (LAP group), or metronidazole 500 mg twice, tetracycline 500 mg four times, and pantoprazole 20 mg twice, bismuth subcitrate 600 mg twice daily for 7 days (MTPB group). Eradication was confirmed with (13)C-urea breath test or rapid urease test 4 weeks after the cessation of therapy.. Among Seventy-six patients initially included, eleven were lost during follow-up. The eradication rates, expressed as intention to treat (ITT) and per protocol (PP) analyses, were 51.6% and 53.3% in the LAP group, and 48.9% and 62.9% in the MTPB group, respectively. There was no significant difference in H. pylori eradication rates between the two groups (p=0.815 by ITT, p=0.437 by PP). LAP regimen was better tolerated than MTPB regimen with lower incidence of side effects (10.0% versus 31.4%, p=0.03).. H. pylori eradication rates of levofloxacin-based triple therapy and bismuth-based quadruple therapy were not significantly different in second-line H. pylori eradication therapy, and low incidence of side effects was observed in levofloxacin-based triple therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Data Interpretation, Statistical; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Organometallic Compounds; Pantoprazole; Time Factors; Treatment Outcome

To compare a lansoprazole-based triple versus quadruple therapy for Helicobacter pylori (H pylori) eradication with emphasis on side effect profile, patient compliance and eradication rate at a rural district general hospital in Wales, United Kingdom.. One hundred one patients with H pylori infection were included in the study. Patients were randomised to receive triple therapy comprising of lansoprazole 30 mg, amoxycillin 1 g, clarithromycin 500 mg, all b.d. (LAC), or quadruple therapy comprising of lansoprazole 30 mg b.d., metronidazole 500 mg t.d.s., bismuth subcitrate 240 mg b.d., and tetracycline chloride 500 mg q.d.s. (LMBT). Cure was defined as a negative (13)C urea breath test 2 mo after treatment.. Seven patients were withdrawn after randomisation. Fifty patients were assigned to LAC group and 44 to LMBT group. The intention-to-treat cure rates were 92% and 91%, whereas the per-protocol cure rates were 92% and 97%, respectively. Side effects were common, with 56% experiencing moderate to severe symptoms in the LAC group and 59% in the LMBT group. Symptoms of vomiting, diarrhoea and black stools were significantly more common in the LMBT group. Patient compliance was 100% for triple therapy and 86% for quadruple therapy (P < 0.01). One-third of patients in both groups were still taking acid-reducing medications at six-month follow-up.. One-week triple and quadruple therapies have similar intention-to-treat eradication rates. Certain side effects are more common with quadruple therapy, which can compromise patient compliance. Patient education or modifications to the regimen are alternative options to improve compliance of the quadruple regimen.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Clarithromycin; Drug Therapy, Combination; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Hospitals, General; Hospitals, Rural; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Organometallic Compounds; Patient Compliance; Prospective Studies; Tetracycline; Treatment Outcome

To establish the efficacy and safety of a 7-d therapeutic regimen using omeprazole, bismuth subcitrate, furazolidone and amoxicillin in patients with peptic ulcer disease who had been previously treated with other therapeutic regimens without success.. Open cohort study which included patients with peptic ulcer who had previously been treated unsuccessfully with one or more eradication regimens. The therapeutic regimen consisted of 20 mg omeprazole, 240 mg colloidal bismuth subcitrate, 1000 mg amoxicillin, and 200 mg furazolidone, taken twice a day for 7 d. Patients were considered as eradicated when samples taken from the gastric antrum and corpus 12 wk after the end of treatment were negative for Helicobacter pylori (H pylori) (rapid urease test and histology). Safety was determined by the presence of adverse effects.. Fifty-one patients were enrolled. The eradication rate was 68.8% (31/45). Adverse effects were reported by 31.4% of the patients, and these were usually considered to be slight or moderate in the majority of the cases. Three patients had to withdraw from the treatment due to the presence of severe adverse effects.. The association of bismuth, furazolidone, amoxicillin and a proton-pump inhibitor is a valuable alternative for patients who failed to respond to other eradication regimens. It is an effective, cheap and safe option for salvage therapy of positive patients.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Proton Pump Inhibitors; Recurrence; Salvage Therapy; Treatment Outcome; Young Adult

In treatment 60 patients with duodenal and stomach peptic ulcer in composition standard eradication therapy was used de-nol. Thus, along with the positive dynamics of clinical symptoms of disease, there is renewal of motor activity of stomach, improvement of microcirculation and renewal of protective properties of gastric mucus. There is a decline of frequency of relapses of disease from data of remote supervisions on a background high-quality reparation of ulcerous defect at the used of de-nol.

Topics: Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Gastric Acid; Helicobacter Infections; Humans; Male; Microcirculation; Middle Aged; Organometallic Compounds; Peptic Ulcer; Secondary Prevention; Treatment Outcome; Young Adult

Failure of Helicobacter pylori treatment is a growing problem in daily practice.. To evaluate the efficacy of two new regimes as second-line options in a randomized and prospective study.. Patients in whom a first eradication regime containing clarithromycin had failed were included. After performing gastroscopy and a 13C-urea breath test (UBT), the patients were randomized to receive a combination of 20 mg of rabeprazole, 500 mg of levofloxacin, and 200 mg (two tablets) of furazolidone administered once daily for 10 days (RLF) or the combination of 20 mg of rabeprazole, 120 mg (two tablets) of bismuth subcitrate, 100 mg of doxycycline, and 200 mg of furazolidone, administered twice daily for 10 days (RBDF). Clinical examinations and new UBT were performed 60 days after therapy.. Sixty patients were included (mean age, 46 years, 57% females). Two patients were excluded: one because of adverse effects and another as a result of protocol violation. Compliance was similar in both groups (90% took all medications correctly). Side-effects (96% mild) were observed in 87% of the patients and were comparable between groups, except diarrhea, which was more frequent in group RLF (p= .025). Intention-to-treat cure rates were 77% (95% confidence interval (CI): 62-93%) in the RLF group and 83% (95% CI: 68-97%) in the RBDF group (p= .750). Per-protocol cure rates were 80% (95% CI: 65-95%) in the RLF group and 82% (95% CI: 67-96%) in the RBDF group (p= 1.0).. Both once-daily triple (rabeprazole, levofloxacin, and furazolidone) and twice-daily quadruple therapy (rabeprazole, bismuth subcitrate, doxycycline, and furazolidone) for 10 days achieved encouraging results. Subsequent studies should be performed to evaluate antibiotic resistance, doses, dosing intervals, duration of treatment, and safety of these two regimes.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Infective Agents, Local; Anti-Ulcer Agents; Breath Tests; Clarithromycin; Doxycycline; Female; Furazolidone; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Organometallic Compounds; Prospective Studies; Rabeprazole; Treatment Failure; Treatment Outcome; Urea

Many studies have reported poor results with standard first-line treatment for Helicobacter pylori. Second-line regimens that may overcome bacterial resistance can minimize side-effects and optimize compliance. The aim of this study was to evaluate the efficacy of proton pump inhibitor (PPI) and bismuth subcitrate-based quadruple therapy, after failure of a PPI plus clarithromycin and amoxicillin as first-line therapy.. Patients who failed to eradicate the infection after initial therapy were randomly separated into three groups. The first group received lansoprazole, bismuth subcitrate, metronidazole and amoxicillin (LBMA); in the second group metronidazole was replaced by tetracycline (LBTA); and the third group was given metronidazole and tetracycline in addition to same doses of lansoprazole and bismuth subcitrate (LBMT).. In the LBMA group, the eradication rate was 74.7% and was significantly related to sex, with no relationship to age. In the LBTA group the eradication rate was 81.5% with similar rates in males and females. No relation to sex or age was observed. In the LBMT group the eradication rate was 82.1% with no difference between women and men and it was not related to age, either. Eradication rates in study groups were similar (P > 0.05).. A-14-day regimen of lansoprazole, bismuth subcitrate and antibiotic pairs, tetracycline-amoxicillin and tetracycline-metronidazole, is an effective quadruple therapy after one failed course of standard triple therapy. The evaluation of tolerability of and compliance with quadruple therapy needs further studies.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Amoxicillin; Anti-Infective Agents; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Organometallic Compounds; Proton Pump Inhibitors; Tetracycline; Treatment Failure; Treatment Outcome; Turkey

Several 'rescue' therapies have been recommended to eradicate Helicobacter pylori, but they still fail in >20% of the cases, and these patients constitute a therapeutic dilemma.. To evaluate the efficacy of different 'rescue' therapies empirically prescribed during 10 years to 500 patients in whom at least one eradication regimen had failed to cure H. pylori infection.. Prospective single-centre study.. Consecutive patients in whom at least one eradication regimen had failed.. Rescue regimens included: (i) quadruple therapy with omeprazole-bismuth-tetracycline-metronidazole; (ii) ranitidine bismuth citrate-tetracycline-metronidazole; (iii) omeprazole-amoxicillin-levofloxacin; and (iv) omeprazole-amoxicillin-rifabutin. Antibiotic susceptibility was unknown (rescue regimens were chosen empirically).. Eradication was defined as a negative (13)C-urea breath test 4-8 weeks after completing therapy.. Five hundred patients were included (76% functional dyspepsia, 24% peptic ulcer). Compliance rates with first-, second- and third-line regimens were 92%, 92%, and 95%, respectively. Adverse effects were reported by 30%, 37%, and 55% of the patients receiving second-, third-, and fourth-line regimens. Overall, H. pylori cure rates with the second-, third-, and fourth-line rescue regimens were 70%, 74%, and 76%, respectively. Cumulative H. pylori eradication rate with four successive treatments was 99.5%.. It is possible to construct an overall treatment strategy to maximize H. pylori eradication, on the basis of administration of four consecutive empirical regimens; thus, performing bacterial culture even after a second or third eradication failure may not be necessary.

Topics: Amoxicillin; Antacids; Anti-Infective Agents; Anti-Ulcer Agents; Breath Tests; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Ranitidine; Rifabutin; Tetracycline; Treatment Failure

Proton pump inhibitor-containing triple therapy with amoxicillin and metronidazole is recommended as initial treatment of Helicobacter pylori in childhood. However, eradication rate with this "classic" regimen is relatively low in Russia.. To evaluate empiric nifuratel, amoxicillin, and bismuth triple therapy for H. pylori gastritis in childhood.. Pediatric outpatients with H. pylori-associated chronic gastritis who underwent endoscopy for dyspeptic symptoms received the combination of bismuth subcitrate (8 mg/kg/day, q.d.s.), nifuratel (30 mg/kg/day, q.d.s.), and amoxicillin (50 mg/kg/day, q.d.s.) for 10 days. H. pylori status was determined before and after the treatment (in 4-6 weeks) by modified Giemsa staining.. Seventy-three children (48 boys, 25 girls, age range 9-14) were entered. H. pylori was eradicated in 63 patients (86%; 95% confidence interval: 76.6-93.2; intention-to-treat and per protocol). There were no serious adverse reactions and were no withdrawals due to any side-effects. All of side-effects were self-limiting (dark stools, urine discoloration, blackening of the tongue, and others).. The combination of nifuratel, bismuth subcitrate, and amoxicillin was an effective and tolerable regimen for H. pylori eradication.

Topics: Adolescent; Amoxicillin; Child; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Nifuratel; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Treatment Outcome

Rifabutin has been found to be effective in multi-resistant patients after various treatment cycles for Helicobacter pylori (HP) infection, but it has not been analysed as a second-line treatment. Therefore, we seek to compare the effectiveness of a treatment regimen including rifabutin versus conventional quadruple therapy (QT).. Open clinical trial, randomised and multi-centre, of two treatment protocols: A) Conventional regime -QT- (omeprazole 20 mg bid, bismuth citrate 120 mg qid, tetracycline 500 mg qid and metronidazole 500 mg tid); B) Experimental one -OAR- (omeprazole 20 mg bid, amoxicillin 1 gr bid, and rifabutin 150 mg bid), both taken orally for 7 days, in patients with HP infection for whom first-line treatment had failed. Eradication was determined by Urea Breath Test (UBT). Safety was determined by the adverse events.. 99 patients were randomised, QT, n = 54; OAR, n = 45. The two groups were homogeneous. In 8 cases, treatment was suspended (6 in QT and 2 in OAR). The eradication achieved, analysed by ITT, was for QT, 38 cases (70.4%), and for OAR, 20 cases (44.4%); p = 0.009, OR = 1.58. Of the cases analysed PP, QT were 77.1%; OAR, 46.5%; p = 0.002. Adverse effects were described in 64% of the QT patients and in 44% of the OAR patients (p = 0.04).. A 7-day rifabutin-based triple therapy associated to amoxicillin and omeprazole at standard dose was not found to be effective as a second-line rescue therapy. The problem with quadruple therapy lies in the adverse side effects it provokes. We believe the search should continue for alternatives that are more comfortably administered and that are at least as effective, but with fewer adverse side effects.. Current Controlled Trials ISRCTN81058036.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Rifabutin; Tetracycline; Treatment Outcome

To elucidate the influences of H pylori infection on oral iron treatment for iron deficiency anemia (IDA).. A total of 86 patients were divided into two groups: group A, receiving ferrous succinate combined with triple therapy for H pylori eradication, and group B (control), treated with ferrous succinate only. During treatment of IDA, dynamic changes in hemoglobin (Hb) level, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), serum iron (SI), and serum ferritin (SF) were compared between the groups.. Hb was slightly higher in group A at d 14 after the start of triple therapy for H pylori eradication (P > 0.05). After the therapy, the increase of Hb in group A became significantly faster than that in group B (P < 0.05). At d 56, the mean Hb in group A returned to the normal level, however, in group B, it was lower than that in group A (P < 0.05) although it had also increased compared with that before oral iron treatment. The MCV and MCH in group A recovered to the normal level, and were much higher than those in group B (P < 0.05) at d 21. In Group B, the MCV and MCH remained at lower than normal levels until d 42 after the start of therapy. And then, they reached a plateau in both groups and the differences disappeared (P > 0.05). The SF in group A was higher than that in group B (P < 0.05) 28 d after the treatment and its improvement was quicker in group A (P < 0.05) , and the difference between the two groups was even more significant (P < 0.01) at d 56. The SI in group A was higher than that in group B (P < 0.05) at d 14 and this persisted until d 56 when the follow-up of this research was finished.. Treatment of H pylori can enhance the efficacy of ferrous succinate therapy in IDA patients with H pylori-positive chronic gastritis.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anemia, Iron-Deficiency; Anti-Infective Agents; Chronic Disease; Drug Therapy, Combination; Erythrocyte Indices; Female; Ferritins; Ferrous Compounds; Gastritis; Helicobacter Infections; Helicobacter pylori; Hemoglobins; Humans; Iron; Male; Metronidazole; Middle Aged; Organometallic Compounds; Risk Factors

The aim of this study was to test the efficacy of 10-day moxifloxacin-based triple therapy versus 2-week quadruple therapy for the second-line treatment of Helicobacter pylori infection.. One hundred and ninety-two patients who had failed previous H. pylori eradication on standard triple therapy were randomized to one of two regimens: 1, moxifloxacin (400 mg q.d.), amoxicillin (1000 mg b.i.d.), and esomeprazole (20 mg b.i.d.) for 10 days (the 10MEA group), or 2, esomeprazole (20 mg b.i.d.), tripotassium dicitrate bismuthate (300 mg q.i.d.), metronidazole (500 mg t.i.d.), and tetracycline 500 mg (q.i.d.) for 14 days (the 14EBMT group). The eradication rates, drug compliances, and side-effect rates of these two regimens were compared.. Eradication rates by intention-to-treat and per-protocol analyses in the 10MEA and 14EMBT groups were 71.9% and 82.6%, and 71.7% and 90.5% (p = .973 and .321), respectively. The 10MEA group was significantly superior to the 14EMBT group in terms of side-effect rates (12.2% vs. 39.6%, p = .001), and discontinuation rates due to side-effects were lower in the 10MEA group than in the 14EMBT group (0.7% vs. 13.2%, p < .001). Moreover, compliance was higher in the 10MEA group (94.2% (131/139)) than in the 14EBMT group (83.0% (44/53)) (p = .014).. The 10-day moxifloxacin-based triple therapy was found to have a high eradication rate with few side-effects and good drug compliance. These findings suggest that this regimen is a safe and effective second-line treatment option for H. pylori infection in Korea.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Aza Compounds; Drug Administration Schedule; Drug Therapy, Combination; Esomeprazole; Female; Fluoroquinolones; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Moxifloxacin; Organometallic Compounds; Patient Compliance; Quinolines; Tetracycline

To test the efficacy of levofloxacin-based second-line therapy for resistant Helicobacter pylori infection.. One hundred and six patients who failed H. pylori eradication were randomized to receive (i) lansoprazole 30 mg, amoxicillin 1 g, levofloxacin 500 mg, all given twice daily for 7 days (LAL); or (ii) lansoprazole 30 mg twice daily, metronidazole 400 mg thrice daily, bismuth subcitrate 120 mg and tetracycline 500 mg four times daily for 7 days (quadruple). Post-treatment H. pylori status was determined by (13)C-urea breath test.. Intention-to-treat and per-protocol H. pylori eradication rates were 57/60% for the LAL group and 71/76% for the quadruple group respectively. Metronidazole, clarithromycin, amoxicillin and levofloxacin resistance were found in 76%, 71%, 0% and 18% of patients, respectively. Levofloxacin resistance led to treatment failure in the LAL group. For patients with dual resistance to metronidazole and clarithromycin, the eradication rates were 79% in the LAL group (levofloxacin-sensitive) and 65% in the quadruple group (P=0.34).. Lansoprazole, amoxicillin plus levofloxacin second-line therapy is comparable with quadruple therapy in efficacy. Subjects, especially those with dual resistance to metronidazole and clarithromycin, may consider levofloxacin-based therapy for levofloxacin-sensitive strains.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Hong Kong; Humans; Lansoprazole; Levofloxacin; Male; Metronidazole; Middle Aged; Ofloxacin; Omeprazole; Organometallic Compounds; Tetracycline; Treatment Outcome

Metronidazole and tetracycline-based second-line quadruple therapy, widely used for Helicobacter pylori infection, often ends up in failure due to antibiotic resistance and poor compliance in Korea. Our aim is to evaluate the efficacy and tolerability of moxifloxacin-based triple therapy as an alternative second-line treatment for H. pylori infection.. The subjects consisted of 85 patients infected with H. pylori, in whom initial proton pump inhibitor triple therapy had failed. They were randomized to receive the following 7-day therapy: 1, moxifloxacin 400 mg q.d., esomeprazole 20 mg b.i.d., and amoxicillin 1 g b.i.d.; and 2, esomeprazole 40 mg b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d., metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d. Eradication rates, drug compliance, and side-effect rates of each group were evaluated.. The eradication rates were 75.6 and 83.8% with moxifloxacin triple therapy, and 54.5 and 72.7% with quadruple therapy by intention-to-treat (p = .042) and per-protocol analyses (p = .260), respectively. Moxifloxacin triple therapy was significantly superior to quadruple therapy in terms of side-effect rates (p = .039). Compliance for therapy, i.e., the percentage of tablets taken (> 85%), was 90.2 and 75.0%, numerically higher in moxifloxacin triple therapy group than in quadruple therapy group, but without statistical difference (p = .065).. Moxifloxacin-based triple therapy showed high eradication rates with few side effects and good drug compliance, suggesting this regimen could be a safe and effective option as second-line therapy for H. pylori infection in Korea.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Aza Compounds; Esomeprazole; Female; Fluoroquinolones; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Moxifloxacin; Organometallic Compounds; Patient Compliance; Quinolines; Tetracycline; Treatment Outcome

Midday and evening twice-a-day quadruple therapy appears to be the most effective therapy for Helicobacter pylori infection in Northern Sardinia, a site where antibiotics resistance is common.. The objective of our study was to estimate the efficacy, side-effects, and compliance of a quadruple therapy containing esomeprazole in a group of dyspeptic elderly patients.. Consecutive elderly patients positive for H. pylori infection and not previously treated for eradication were enrolled. Therapy consisted of esomeprazole 20 mg, tetracycline 500 mg, metronidazole 500 mg, and bismuth subcitrate tablets 240 mg, all twice-a-day with the midday and evening meals, for 10 days. Efficacy was evaluated using 13C-urea breath testing. Compliance was assessed after completing treatment and at follow up. Side effects were graded based on daily activities.. Ninety-five dyspeptic patients (range 65-81 years), 52 men and 43 women, were enrolled. The intention-to-treat cure rate was 91% (81 of 89; 95% CI = 88-99%) and, 95% (81 of 85; 95% CI = 83-96%) per-protocol analysis. Compliance was excellent. Mild-moderate side effects occurred in 27 patients.. Esomeprazole containing quadruple therapy was highly successful for initial eradication of H. pylori in elderly patients.

Topics: Aged; Aged, 80 and over; Anti-Bacterial Agents; Breath Tests; Dyspepsia; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Intestines; Male; Metronidazole; Nausea; Organometallic Compounds; Patient Compliance; Prospective Studies; Tetracycline

To study the effects of drug treatment on hyperplastic gastric polyps infected with Helicobacter pylori (H pylori).. Forty-eight patients with hyperplastic gastric polyps (3-10 mm in diameter) infected with H pylori were randomly assigned to a treatment group (n = 24) which received proton-pump inhibitor (omeprazole or lansoprazole), clarithromycin, bismuth citrate and tinidazole, and a control group (n = 24) which received protective agent of gastric mucosa (tepretone). Patients underwent endoscopy and H pylori examination regularly before enrollment and 1-12 mo after treatment.. Twenty-two patients in the treatment group and 21 in the control group completed the entire test protocol. In the treatment group, polyps disappeared 1-12 mo (average, 6.5+/-1.1 mo) after the treatment in 15 of 22 patients (68.2%) and H pylori infection was eradicated in 19 of the 22 patients (86.4%). However, 12 months after the study, no change in polyps or H pylori status was seen in any controls ((b)P<0.01).. Most hyperplastic gastric polyps disappear after eradication of H pylori.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Incidence; Lansoprazole; Male; Middle Aged; Omeprazole; Organometallic Compounds; Polyps; Proton Pump Inhibitors; Stomach Neoplasms; Tinidazole

Clinical trials in children concerning Helicobacter pylori eradication treatments are scarce. The purpose of this study was to assess the efficacy of proton pump inhibitor (PPI)-based triple therapy using PPI, amoxicillin and clarithromycin in Iranian children. We also evaluated the efficacy of quadruple therapy with PPI, metronidazole, amoxicilin and bismuth citrate in Iranian children.. This was a randomized clinical trial performed in Emam Khomeini Hospital between 2003 and 2004. Patients with confirmed H. pylori infection by histology were divided into two groups in a randomized 1:1 scheme: the triple regimen group (omeprazole, clarithromycin and amoxicillin for 10 days) and the quadruple regimen group (omeprazole, amoxicillin, metronidazole and bismuth citrate for 10 days). The eradication was assessed by the C-urea breath test 4 weeks after the end of treatment and analyzed by per-protocol and intention-to-treat approaches.. One hundred and twenty-two patients (mean age 12.36+/-3.06 years) were entered into the study. Only 100 patients completed the study (50 patients in each regimen group). The eradication rates by triple therapy were 92% and 75.5% for the "per-protocol" and "intention-to-treat" approaches, respectively. In the quadruple regimen group, the eradication rates were 84% by the per-protocol approach and 68.8% in the intention-to-treat approach. Symptom responses to therapy were reported in all patients with successful eradication (88% of all patients).. With regard to recent recommendations, we also suggest PPI, amoxicillin and clarithromycin triple therapy as a first-line eradication treatment, and quadruple therapies as a second-line option, in Iranian children.

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Child; Child, Preschool; Clarithromycin; Drug Therapy, Combination; Enzyme Inhibitors; Female; Helicobacter Infections; Helicobacter pylori; Humans; Infant; Iran; Male; Metronidazole; Omeprazole; Organometallic Compounds; Proton Pump Inhibitors; Treatment Outcome

To compare the efficacies of one-day quadruple therapy and seven-day triple therapy in Chinese patients.. Sixty consecutive patients with nonulcer dyspepsia and confirmed H pylori infection were randomized to receive either omeprazole 40 mg, amoxycillin 1 g, and furazolidone 100 mg, all twice a day for 7 d or omeprazole 20 mg (at breakfast and dinner), amoxicillin 1 g, furazolidone 200 mg, and colloidal bismuth subcitrate 220 mg four times for only one day. H pylori status was determined before and at least 5 weeks after therapy by endoscopy with antral and corpus biopsies for rapid urease test and histology.. H pylori eradication was successful in 66.67% (20/30) patients in the 7-d group and in 36.67% (11/30) patients in the 1-d group (P = 0.037). Side effects were induced by the treatment in 13.3% (4/30) patients of each group, but these were all self-limiting, short-lasting, and did not require any specific treatment.. The one-day quadruple therapy is less effective than the one-week regimen in curing H pylori infection in Chinese patients.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents, Local; Anti-Ulcer Agents; Asian People; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Pyloric Antrum; Time Factors

To compare the one-day quadruple therapy with a standard 7-d triple therapy for H pylori eradication in a rural population of China.. A total of 396 patients with (13)C-urea breath test positive for H pylori were assigned into two groups: 239 patients received one-day quadruple therapy (amoxicillin 2000 mg qid; metronidazole 500 mg qid; bismuth citrate 900 mg qid and lansoprazole 60 mg once daily) and 157 patients received 7-d standard triple therapy (amoxicillin 1000 mg bid; clarithromycin 500 mg bid and lansoprazole 30 mg bid). All the patients underwent a (13)C-UBT to assess the eradication of H pylori infection six weeks after treatment.. Two hundred and twenty-nine patients completed the one-day therapy (95.8%) and 148 patients completed the 7-d therapy (94.2%). The one-day therapy eradicated H pylori infection in 64 patients (27.95%). In contrast, 103 patients (69.59%) were H pylori negative after the 7-d therapy (P < 0.01).. This pilot study suggests there is no beneficial effect of the one-day therapy in treatment of H pylori infection compared with the 7-d standard therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Clarithromycin; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Pilot Projects; Prospective Studies; Rural Population

To investigate eradication rates, patient compliance and tolerability of a 1-wk Azithromycin-based quadruple therapy versus the 2-wk conventional therapy.. A total of 129 H pylori-positive patients were randomized to either omeprazole 20 mg, bismuth subcitrate 240 mg, azithromycin 250 mg, and metronidazole 500 mg, all twice daily for 1-wk (B-OAzM) or omeprazole 20 mg, bismuth subcitrate 240 mg, amoxicillin 1 g, and metronidazole 500 mg all twice daily for 2-wk (B-OAM). H pylori infection was defined at entry by histology and rapid urease test and cure of infection was determined by negative urea breath test.. H pylori eradication rates produced by B-OAzM and B-OAM were 74.1% and 70.4% respectively based on an intention to treat analysis, and 78.1% versus 75.7% respectively based on a per-protocol analysis. The incidence of poor compliance was lower, although not significantly so, in patients randomized to B-OAzM than for B-OAM (3.5% versus 4.3%) but intolerability was similar in the two groups ( 35% versus 33.3%).. 1-wk azithromycin based quadruple regimen achieves an H pylori eradication rate comparable to that of standard 2-wk quadruple therapy, and is associated with comparable patient compliance and complications.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Azithromycin; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Iran; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Patient Compliance

The purpose of the present paper was to evaluate the efficacy and tolerability of amoxicillin-clavulanate and tetracycline-based quadruple therapy as an alternative second-line treatment for H. pylori infection.. The study subjects consisted of 54 patients infected with H. pylori, in whom initial triple therapy had failed. Subjects were randomized to receive the following 7-day therapies: (i) pantoprazole 40 mg b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d., amoxicillin-clavulanate 1000 mg b.i.d., and tetracycline 500 mg q.i.d. (PBAT); or (ii) pantoprazole 40 mg b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d., metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d. (PBMT). Eradication rates based on antibiotic susceptibility, drug compliance and side-effect rates were evaluated and compared.. The H. pylori eradication rates were 16.0%/17.4% with PBAT and 65.5%/70.4% with PBMT by intention-to-treat (P<0.001) and per-protocol analyses (P<0.001), respectively. In patients who received PBAT, the eradication rates were only 16.7% (2/12) for both amoxicillin and tetracycline-susceptible H. pylori strains. Drug compliance and side-effect rates were similar in the two groups.. Despite high individual in vitro antimicrobial activity, amoxicillin-clavulanate and tetracycline-based quadruple therapy showed low eradication rates, which strongly suggests that it should not be considered as a therapeutic option for H. pylori eradication.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Ulcer Agents; Biopsy; Bismuth; Contraindications; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Pantoprazole; Pyloric Antrum; Stomach Ulcer; Tetracycline; Treatment Failure

To compare the effectiveness of triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H. pylori eradication in a comparative three-armed randomized clinical trial.. A total of 360 H. pylori-positive patients suffering from dyspepsia and aging 24-79 years with a median age of 42 years were enrolled in the study and randomly allocated into the following three groups: group A (n = 120) received a standard 1-wk triple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 500 mg clarithromycin b.i.d.); group B (n = 120) received a 10-d standard quadruple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 240 mg colloidal bismuth subcitrate b.i.d., and 500 mg metronidazole b.i.d.); group C (n = 120) received the new protocol, i.e. 375 mg sultamicillin (225 mg ampicillin plus 150 mg sulbactam) b.i.d. (before breakfast and dinner), instead of amoxicillin in the standard quadruple therapy for the same duration. Chi-square test with the consideration of P<0.05 as significant was used to compare the eradication rates by intention-to-treat and per-protocol analyses in the three groups.. The per-protocol eradication rate was 91.81% (101 patients from a total of 110) in group A, 85.84% (97 patients from a total of 113) in group B, and 92.85% (104 patients from a total of 112) in group C. The intention-to-treat eradication rate was 84.17% in group A, 80.83% in group B, and 86.67% in group C. The new protocol yielded the highest eradication rates by both per-protocol and intention-to-treat analyses followed by the standard triple and quadruple regimens, respectively. However, the differences were not statistically significant between the three groups.. The results of this study provide further support for the equivalence of triple and quadruple therapies in terms of effectiveness, compliance and side-effect profile when administered as first-line treatment for H. pylori infection. Moreover, the new protocol using ampicillin-sulbactam instead of amoxicillin in the quadruple regimen is a suitable first-line alternative to be used in regions with amoxicillin-resistant H. pylori strains.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds

Bismuth salts are not available worldwide. It remains unknown whether clarithromycin can replace bismuth salts as an adjuvant agent in the rescue regimens for Helicobacter pylori infection. We therefore designed the prospective study to compare the efficacies of two rescue therapies for H. pylori infection after standard triple therapies.. Ninety-three patients who failed H. pylori eradication using proton pump inhibitor plus clarithromycin and amoxicillin were randomly assigned to undergo rescue therapy with esomeprazole, clarithromycin, tetracycline and metronidazole (ECTM group, n = 46) or esomeprazole, bismuth subcitrate, tetracycline and metronidazole (EBTM group, n = 47). Follow-up endoscopy was performed at 8 weeks after the end of treatment to assess the treatment response.. Intention-to-treat analysis demonstrated both groups had similar eradication rates (ECTM 74% vs. EBTM 77%; P = 0.76) and drug compliance (ECTM 94% vs. EBTM 96%; P = 0.68). However, the frequency of adverse events in the ECTM group was higher than that in EBTM group (ECTM 57% vs. EBTM 36%, P = 0.05). In the EBTM group, eradication rate of metronidazole-resistant strains was lower than that of metronidazole-susceptible strains (67%[8/12] vs. 100%[9/9], P = 0.05). However, eradication rates were similar between metronidazole-susceptible and metronidazole-resistant strains in ECTM group (69%[9/13] vs. 70%[7/10], P = 1.00).. The new ECTM second-line therapy can achieve similar eradication rate as standard EBTM therapy. It may be very useful in countries where bismuth salts are not available.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Tetracycline

Helicobacter pylori is the most important etiologic agent for development of peptic ulcer, chronic gastritis and gastric carcinomas. It is now well established that H. pylori eradication treatment is more cost-effective than acid suppressing therapies alone for the treatment of peptic ulcer disease. However, the comparative cost-effectiveness of various H. pylori eradication regimens is still not clear.. This study was designed to make a pharmacoeconomic comparison of different H. pylori eradication regimens in patients with peptic ulcer disease or chronic gastritis, using real-world cost and effectiveness data.. Istanbul University Hospital and Marmara University Hospital.. A total of 75 patients diagnosed as H. pylori (+) by endoscopy were randomized to receive one of the seven H. pylori treatment protocols. These protocols were as follows: (LAC) = 'lansoprazole 30 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid' for 7 days and (OCM) = 'omeprazole 20 mg bid + clarithromycin 250 mg bid + metronidazole 500 mg bid'; (OAM) = 'omeprazole 40 mg qd + amoxicillin 500 mg tid + metronidazole 500 mg tid'; (MARB) = 'metronidazole 250 mg tid + amoxicillin 500 mg qid + ranitidine 300 mg hs + bismuth 300 mg qid'; (OAC) = omeprazole 20 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid'; (OCA) = omeprazole 40 mg bid + clarithromycin 500 mg bid + amoxicillin 1 g bid'; (OAB) = 'omeprazole 20 mg bid + amoxicillin 500 mg tid + bismuth 300 mg qid' each for 14 days. Only direct costs were included in the analysis. Effectiveness was measured in terms of "successful eradication". The cost-effectiveness ratios of the regimens were calculated using these effectiveness and cost data. The perspective of the study was assumed as the Government's perspective.. Cost-effectiveness ratios of eradication regimens.. MARB and OCA regimens were found to be more cost-effective than the other treatment regimens. The eradication rates and cost-effectiveness ratios calculated for these protocols were 90% (158.7 euros) for MARB and 90% (195.8 euros) for OCA regimen.. This study confirms the importance of using local pharmacoeconomic data. Analyses such as this give decision-makers the tools to choose a better treatment option which is both highly effective yet and has a low cost.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Amoxicillin; Anti-Infective Agents; Clarithromycin; Cost-Benefit Analysis; Drug Therapy, Combination; Economics, Pharmaceutical; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Melena; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Ranitidine; Taste Disorders; Time Factors; Treatment Outcome

First-line proton pump inhibitor-based triple and quadruple therapies for Helicobacter pylori eradication present similar levels of efficacy. Cross-over treatment (quadruple following triple failure, and triple following quadruple failure) seems the most sensible approach to treatment failures, but the two strategies -'quadruple first' versus 'triple first'- have not been previously compared. The aims of our study were to assess the usefulness and the cost-effectiveness of the two treatment strategies.. Forty-nine out of 344 patients included in a previous study comparing triple therapy - 7 days of omeprazole, amoxicillin and clarithromycin twice a day - with quadruple therapy - 7 days of omeprazole twice a day, plus tetracycline, metronidazole and bismuth subcitrate three times a day - failed initial treatment and were assigned to cross-over therapy. Cure was determined by urea breath test. A decision analysis was performed to compare the two eradication strategies.. Intention to treat cure rates were 46% (10/22 patients; 95% CI 24-68%) for second-line triple therapy and 63% (17/27 patients; 95% CI 42-81%) for second-line quadruple therapy. Per protocol cure rates were 71% and 85%, respectively. Intention to treat cure rates were 87% (95% CI 81-92%) for the 'triple first' versus 86% (95% CI 80-91%) for the 'quadruple first' strategy (p = .87). The 'quadruple first' strategy was more cost-effective. The incremental cost of 'triple first' strategy per person was 19 in the low-cost area and 65 US dollars in the high-cost area.. The effectiveness of 'triple first' and 'quadruple first' strategies is similar, although the latter seems slightly more cost-effective.

Topics: Adult; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Clarithromycin; Clinical Protocols; Cost-Benefit Analysis; Drug Therapy, Combination; Enzyme Inhibitors; Female; Helicobacter Infections; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Tetracycline; Treatment Outcome

The eradication of Helicobacter pylori (HP) is dependent on several bacteriologic and geographic variables. Multiple-drug regimens have been tried in order to eradicate HPi; however, the optimal drug has not yet been found.. In this single-blind, randomized clinical trial, 245 dyspeptic patients with positive rapid urease tests or positive cultures for HP were entered in the study and randomly treated with one of 3 drug regimens A, B, or C for 14 days. Each regimen was administered to 76 patients. Regimen A consisted of omeprazole 20 mg bid + bismuth subcitrate 120 mg 2 tab. bid + metronidazole 250 mg 2 tab. bid + tetracycline 250 mg 2 cap. bid. Regimen B consisted of omeprazole 20 mg bid + bismuth subcitrate 120 mg 2 tab. bid + furazolidone 100 mg 2 tab. bid + tetracycline 250 mg 2 cap. bid. Regimen C consisted of omeprazole 20 mg bid + bismuth subcitrate 120 mg 2 tab. bid + ciprofloxacin 500 mg bid. A urea breath test was performed 1-2 months after eradication.. Of the 245 patients, 228 completed their treatment course. 57% were male and 43% female. Eradication rates were 76.3%, 68.4%, and 67.1% in groups A, B, and C, respectively (P=0.05). The eradication rate of drug regimen A was greater than B in males (86% vs. 63%; p<0.05), and that of B was greater than C in females (76.7 vs. 53.6%; P<0.05).. The therapeutic regimen containing ciprofloxacin is preferable, although all drug regimens were less effective in Iran than in other parts of the world.

Topics: Analysis of Variance; Anti-Bacterial Agents; Breath Tests; Ciprofloxacin; Drug Therapy, Combination; Dyspepsia; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Single-Blind Method; Tetracycline; Treatment Outcome; Urea

To evaluate efficiency of colloid bismuth subcitrate (CBS) in gastropathies induced by nonsteroid anti-inflammatory drugs (NSAID).. 45 patients with rheumatic diseases (RD) taking NSAID with gastric and/or duodenal up to 1 cm in size or multiple (more than 10) gastric mucosa erosions detected at esophagogastroduodenoscopy were randomized into two groups. Patients of group 1 (n = 30) received CBS (240 mg twice a day + amoxicillin 2 g/day and furozolidon 400 mg/day--subgroup 1a, n = 10 or CBS monotherapy in the same dose--subgroup 1b, n = 20). Patients of group 2 (n = 15) received ranitidine 150 mg twice a day. Older women, RA patients, patients with gastric ulcer prevailed. H. pylori was detected in 73.3 and 90% patients, respectively. Dispepsia and heartburn occurred in 90 and 93.3%, respectively. The efficacy was assessed after 4 weeks of therapy.. Healing of ulcers and erosions were achieved in 22 of 26 patients of group 1 (84.6%) and in 7 of 14 (50%) of group 2 (p = 0.036, chi-square). After therapy dyspepsia persisted in 4 patients of group 1 and 9 patients of group 2. Side effects were in 3 patients on CBS. Untiulcer effect did not differ between the subgroups (88.8 and 82.4%, respectively) and was effective in 6 of 7 HP-negative patients (85.7%) and in 8 of 10 HP-positive patients (80%).. De-Nol is effective in NSAID-induced gastropathies. Its action is not related with influence on HP.

Topics: Aged; Anti-Infective Agents, Local; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthritis, Rheumatoid; Diarrhea; Drug Administration Schedule; Duodenal Ulcer; Duodenoscopy; Esophagoscopy; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Prevalence; Ranitidine; Severity of Illness Index; Sex Distribution; Stomach Ulcer

Topics: Adult; Anti-Bacterial Agents; Clarithromycin; Drug Therapy, Combination; Enzyme Inhibitors; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Peptic Ulcer; Proton Pump Inhibitors; Treatment Outcome

Failures of Helicobacter pylori eradication in children are common.. To evaluate the efficacy of amoxicillin, bismuth subcitrate and omeprazole and nifuratel or furazolidone for H. pylori eradication in children who failed initial treatment with a standard triple therapy.. Seventy-six consecutive H. pylori-positive paediatric out-patients (aged 12-16 years; mean age 13.7 +/- 1.4) with chronic abdominal complaints who had failed one attempt of eradication of H. pylori using metronidazole-containing triple therapy were enrolled. It was an open prospective study. Patients were randomized to receive a 2-week course of bismuth subcitrate (8 mg/kg/day, q.d.s.), amoxicillin (50 mg/kg/day, q.d.s.), with either nifuratel (15 mg/kg/day, q.d.s.) or furazolidone (10 mg/kg/day, q.d.s.), plus omeprazole (0.5 mg/kg, once daily).. There were 37 patients in the nifuratel group and 39 in the furazolidone group. Helicobacter pylori was eradicated in 33 of 37 (89%; 95% CI: 74.5-96.9; intention-to-treat) in nifuratel group and in 34 of 39 (87%; 95% CI: 72.5-95.7) in furazolidone group, respectively. Frequency of severe side-effects was greater with furazolidone (21%) than with nifuratel (3%; P = 0.0289).. Nitrofuran-containing therapies consisting of a proton-pump inhibitor, amoxicillin and bismuth citrate plus either nifuratel or furazolidone produced good cure rates even among those who had failed prior therapy. Nifuratel is preferred because of the lower frequency of side-effects.

Topics: Adolescent; Amoxicillin; Antacids; Anti-Bacterial Agents; Child; Drug Therapy, Combination; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Nifuratel; Omeprazole; Organometallic Compounds; Pilot Projects; Prospective Studies; Proton Pump Inhibitors; Treatment Outcome

The proton pump inhibitor (PPI)-based 7-day triple therapy is the regimen with the highest cure rates for eradication of Helicobacter pylori infection and has been recommended as the first-line regimen in the world. It had been reported that a 1-day quadruple therapy could also successfully cure 95% of the H. pylori infected patients.. To observe the efficacy of 1-day high-dose quadruple therapy versus 7-day triple therapy for treatment of H. pylori infection, and to observe side-effects of the two different regimens.. This randomized, open, parallel-controlled study was conducted at Renji Hospital between November 2004 to March 2005. A total of 80 consecutive patients with non-ulcer dyspepsia, who were H. pylori positive proven by both rapid urease test and histology were included and randomly assigned to 1-day quadruple therapy or 7-day triple therapy. Thirty-nine patients were administered with 1-day high-dose quadruple therapy including esomeprazole 40 mg b.i.d., colloidal bismuth subcitrate 440 mg q.i.d., amoxicillin 2 g q.i.d. and metronidazole (400 mg q.i.d.) for 1 day. Forty-one patients received a standard 7-day triple therapy consisting of esomeprazole 20 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1 g b.i.d. for 7 days. The eradication rates were evaluated by the (13)C-urea breath test at least 4 weeks after completion of a course treatment.. Seventy-seven patients completed the trial and three patients dropped out. The eradication rates in the 1-day therapeutic group and the 7-day therapeutic group were 39.5% (15/38) and 84.6% (33/39), respectively. There was a statistically significant difference between the two groups (P < 0.0001). Short-lasting and self-limiting side effects including thirst, a metallic taste, diarrhea and abdominal pain were reported in three patients (7.9%) in the 1-day group and seven patients (18%) in the 7-day group (P = 0.31).. A 1-day high-dose quadruple therapy with amoxicillin, metronidazole, bismuth salt, and esomeprazole is not effective for eradication of H. pylori compared with the standard 7-day triple therapy.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Breath Tests; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Proton Pump Inhibitors

The purpose of the study was to compare the effectiveness of tri- and quadri-component therapy of Helicobacter pylori (HP)-associated peptic ulcer (PU). The subjects were 65 patients with duodenal ulcer (DU), divided into two groups. The first, OKM/A group, included 35 patients receiving omeprazole in a dose of 20 mg twice a day, clarythromycin--500 mg twice a day, and metronidazole--500 mg or amoxicillin--1,000 mg twice a day. The second, OBTM group, included 30 patients receiving omeprazole in a dose of 20 mg twice a day, colloid bismuth subcitrate (de-nol)--120 mg four times a day, tetracycline--500 mg four times a day, and metronidazole--500 mg twice or 250 mg four times a day. The study demonstrated high effectiveness of these regimens in HP eradication, time of coping with pain syndrome, and time of ulcer healing. Although the difference between the results in the groups was insignificant, there were certain trends observed. On the one hand, the regimen including clarythromycin seemed to be more effective vs. the regimen including tetracycline. On the other hand, the cost of the clarythromycin regimen is about 1.8 times higher than the tetracycline regimen, due to high cost of clarythromycin. The study shows that quadri-therapy in patients with a DU relapse allows maintenance of the intragastric acidity at the level which is optimal for quick coping with pain and dyspeptic syndromes, lowering of the degree of inflammatory alterations in the gastric and duodenal mucosa, HP eradication, and ulcer healing.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Administration Schedule; Drug Costs; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Russia; Tetracycline; Treatment Outcome

Furazolidone-based regimens for the eradication of Helicobacter pylori are low cost and effective. Unfortunately, the usual dose of furazolidone is not tolerable in many patients. Lower doses of furazolidone are expected to cause fewer adverse effects.. To investigate the efficacy of low-dose furazolidone in the eradication of H. pylori.. One hundred and fifty patients with duodenal ulcer and H. pylori infection were randomly assigned to one of three treatment groups: omeprazole 20 mg b.d., amoxicillin 1000 mg b.d. and furazolidone 100 mg b.d. for 14 days (OAF); omeprazole 20 mg b.d., amoxicillin 1000 mg b.d., furazolidone 100 mg b.d. and bismuth subcitrate 240 mg b.d. for 14 days (OABF1); or omeprazole 20 mg b.d., amoxicillin 1000 mg b.d., furazolidone 200 mg b.d. and bismuth subcitrate 240 mg b.d. for 14 days (OABF2).. Of the 150 patients, 145 completed treatment. The intention-to-treat and per protocol eradication rates were 54% (27/50), 72% (36/50) and 92% (46/50) for the OAF, OABF1 and OABF2 groups, respectively. The OAF and OABF1 groups showed significantly lower eradication rates than the OABF2 group (P<0.001 and P<0.01, respectively).. Triple and quadruple furazolidone-based H. pylori eradication regimens do not yield acceptable success rates when a low dose of furazolidone (100 mg b.d.) is used.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Treatment Outcome

The eradication rate of Helicobacter pylori (H pylori) shows variation among countries and regimens of treatment. We aimed to study the eradication rates of different regimens in our region and some factors affecting the rate of eradication.. One hundred and sixty-four H pylori positive patients (68 males, 96 females; mean age: 48+/-12 years) with duodenal or gastric ulcer without a smoking history were included in the study. The patients were divided into three groups according to the treatment regimens. Omeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1 g were given twice daily for 1 week (Group I) and 2 weeks (Group II). Patients in Group III received bismuth subsitrate 300 mg, tetracyline 500 mg and metronidazole 500 mg four times daily in addition to Omeprazole 20 mg twice daily. Two biopsies each before and after treatment were obtained from antrum and corpus, and histopathologically evaluated. Eradication was assumed to be successful if no H pylorus was detected from four biopsy specimens taken after treatment. The effects of factors like age, sex, H pylori density on antrum and corpus before treatment, the total H pylori density, and the inflammation scores on the rate of H pylori eradication were evaluated.. The overall eradication rate was 42%. The rates in groups II and III were statistically higher than that in group I (P<0.05). The rates of eradication were 24.5%, 40.7% and 61.5% in groups I, II and III, respectively. The eradication rate was negatively related to either corpus H pylori density or total H pylori density (P<0.05). The median age was older in the group in which the eradication failed in comparison to that with successful eradication (55 yr vs 39 yr, P<0.001). No correlation between sex and H pylori eradication was found.. Our rates of eradication were significantly lower when compared to those reported in literature. We believe that advanced age and high H pylori density are negative predictive factors for the rate of H pylori eradication.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Stomach Ulcer; Tetracycline; Treatment Outcome; Turkey

Re-infection with Helicobacter pylori is more common in children than adults, and it is generally accepted that the family unit plays a significant role in primary childhood infection. We investigated whether the family unit plays a significant role in pediatric re-infection and if eradication of H. pylori from the entire family reduces the risk of childhood re-infection.. Fifty families, each with an H. pylori-infected pediatric index case (mean age 9.48 years), were recruited. A 13carbon urea breath test was performed on all family members in the same house as the index case. Each family unit was randomized into a 'family unit treatment' group (all infected family members treated) or an 'index case treatment' group (index case only treated).. At long-term follow-up (mean 62.2 months), there were three re-infected children in the 'index case treatment' group compared with one in the 'family unit treatment' group. The re-infection rate was 2.4% per patient per year in the 'index case treatment' group and 0.7% per patient per year in the 'family unit treatment' group (p = .31).. This study is the first to evaluate the effect of total family unit H. pylori eradication on pediatric re-infection rates and reports the longest period of re-infection follow-up in children. In childhood, re-infection with H. pylori is not significantly reduced by family unit H. pylori eradication.

Topics: Adolescent; Amoxicillin; Breath Tests; Child; Child, Preschool; Clarithromycin; Community-Acquired Infections; Family Health; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Recurrence; Urea

This multicenter, randomized, active-controlled trial assessed efficacy of bismuth-based quadruple therapy with omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline (OBMT) using a single-triple capsule of BMT compared with triple therapy with omeprazole, amoxicillin, and clarithromycin (OAC) in treatment of patients with Helicobacter pylori infection and duodenal ulcers.. Patients with active duodenal ulcer or diagnosed within the past 5 yr and with infection documented by (13)C-urea breath test plus histology or culture were randomly assigned to 10-day course of OBMT using a single-triple capsule containing bismuth biskalcitrate 140 mg, metronidazole 125 mg, and tetracycline 125 mg given as three capsules q.i.d. with omeprazole 20 mg b.i.d., or a 10-day course of OAC, omeprazole 20 mg plus amoxicillin 1 g plus clarithromycin 500 mg, all b.i.d. Eradication was confirmed by two negative urea breath tests at >1 month and >2 months after therapy.. One hundred thirty-eight patients received OBMT and 137 OAC. Modified intent-to-treat eradication rates were 87.7% for OBMT and 83.2% for OAC (95% CI = -3.9%-12.8%; p = 0.29). OBMT eradicated 91.7% metronidazole-sensitive and 80.4% metronidazole-resistant strains (p = 0.06). OAC eradicated 92.1% clarithromycin sensitive and 21.4% clarithromycin-resistant strains (p < 0.001). Adverse events occurred in 58.5% of OBMT patients and 59.0% of OAC patients.. OBMT regimen using the single-triple capsule is as efficacious and well-tolerated as the widely used OAC regimen for H. pylori eradication. This OBMT therapy largely overcomes H. pylori metronidazole resistance, present in 40% of patients in this study.

Topics: Administration, Oral; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Capsules; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; North America; Omeprazole; Organometallic Compounds; Tetracycline; Treatment Outcome

Although effective therapies are available for curing Helicobacter pylori infection, the problem persists about what to do for patients who fail two or more treatment courses despite a good compliance.. To test a twice a day midday quadruple therapy as salvage therapy.. Dyspeptic H. pylori-infected patients who failed two or more courses of anti-H. pylori therapy received omeprazole 20 mg, tetracycline 500 mg, metronidazole 500 mg, and bismuth subcitrate caplets 240 mg twice a day (with the midday and evening meals) for 14 days. H. pylori status was evaluated by 13C-urea breath test and histology 4-6 weeks after therapy. Eradication was defined as no positive test.. Seventy-one patients were enrolled and 68 completed the full 14 days of therapy (mean age 46 years; 28 men). Thirty-three patients had failed prior treatment twice, 19 had failed three times, and 16 had failed four or more times. The cure rates were: intention to treat=93% (66/71); (95% CI=84% to 98%), per protocol=97% (66/68); (95% CI=89%- 100%). Success was excellent irrespective of diagnosis, age, prior treatment protocols, or smoking status. Moderate side-effects were experienced by only two patients.. Midday bismuth subcitrate based twice a day quadruple therapy was an excellent salvage therapy. BID midday quadruple regimen should be considered as the therapy of choice.

Topics: Adult; Antacids; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Bismuth; Breath Tests; Drug Therapy, Combination; Dyspepsia; Female; Gastric Mucosa; Helicobacter Infections; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Salvage Therapy; Tetracyclines; Urea

Failure of primary anti-H. pylori therapy results in a high rate of antimicrobial resistance. Here, we investigated the efficacy of high-dose dual therapy and quadruple therapy as salvage treatments for eradication of H. pylori resistant to both metronidazole and clarithromycin.. Patients with at least one treatment failure and infected with H. pylori resistant to both metronidazole and clarithromycin, were randomized to receive either omeprazole 4 x 40 mg and amoxicillin 4 x 750 mg; or omeprazole 2 x 20 mg, bismuthcitrate 4 x 107 mg, metronidazole 4 x 500 mg and tetracycline 4 x 500 mg. Both regimens were given for 14 days. In cases of persistent infection, a cross-over therapy was performed.. Eighty-four patients were randomized. Cure of H. pylori infection was achieved in 31 patients after dual therapy and in 35 patients after quadruple therapy (per protocol: 83.8% (95% CI, 67.9-93.8) and 92.1% (95% CI, 78.6-98.3), respectively (p=0.71); intention to treat: 75.6% (95% CI: 59.7-87.6) and 81.4% (95% CI: 66.6-91.6), respectively (p=0.60)). Cross-over therapy was performed in six of nine patients, four of whom were cured of the infection.. Both high-dose dual therapy and quadruple therapy are effective in curing H. pylori infection resistant to both metronidazole and clarithromycin in patients who experienced previous treatment failures.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Clarithromycin; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Female; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Tetracycline; Urea

It is well accepted that in patients with uncomplicated peptic ulcers, Helicobacter pylori eradication therapy does not need to be followed by further antisecretory treatment. However, it is uncertain whether patients with bleeding peptic ulcers should receive maintenance antiulcer therapy after successful H pylori eradication and ulcer healing. The aim of this 5-year, prospective, randomized, controlled study was to investigate the role of long-term maintenance therapy after successful H pylori eradication and healing of bleeding ulcers.. A total of 82 consecutive patients with H pylori-associated bleeding peptic ulcers were enrolled in the study. After successful H pylori eradication with the 1-week proton pump inhibitor-based triple therapy and an additional 3-week treatment with 20 mg of omeprazole daily for ulcer healing, the patients were assigned to one of four 16-week maintenance treatment groups as follows: group A received 15 mL of an antacid suspension 4 times daily; group B received 300 mg of colloidal bismuth subcitrate 4 times daily; group C received 20 mg of famotidine twice daily; and group D, the control group, received placebo twice daily. Follow-up included an urea breath test labeled with carbon 13, biopsy-based tests, and repeated endoscopic examination.. An analysis of variance revealed no difference in mean age and mean follow-up time among the groups. During a mean follow-up of 56 months, there was no peptic ulcer recurrence among the 3 treatment groups, and all of the patients remained free of H pylori infection during the study period.. In patients with bleeding peptic ulcers, antiulcer maintenance treatment was not necessary to prevent ulcer recurrence after successful H pylori eradication and ulcer healing. In addition, the 1-week proton pump inhibitor-based triple therapy had the efficacy to ensure long-term eradication of H pylori in a region of high prevalence.

Topics: Adult; Aged; Antacids; Anti-Ulcer Agents; Breath Tests; Carbolines; Clarithromycin; Drug Therapy, Combination; Famotidine; Female; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer Hemorrhage; Prospective Studies; Secondary Prevention; Treatment Outcome

Topics: Adult; Amoxicillin; Anti-Infective Agents; Anti-Ulcer Agents; Clarithromycin; Drug Administration Schedule; Female; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Ranitidine; Treatment Outcome

Seven-day triple therapy including omeprazole, clarithromycin and amoxicillin has become the treatment of choice for Helicobacter pylori infection. However, 7 days of classical quadruple therapy combining omeprazole, tetracycline, metronidazole and bismuth may be an alternative to triple therapy.. To compare triple vs. quadruple therapy for H.pylori eradication.. Three hundred and thirty-nine patients with peptic ulcer and H. pylori infection were included in the study. Patients were randomized to receive omeprazole, 20 mg, amoxicillin, 1 g, and clarithromycin, 500 mg, all b.d., or omeprazole, 20 mg b.d., tetracycline chloride, 500 mg, metronidazole, 500 mg, and bismuth subcitrate, 120 mg, all t.d.s. Cure was defined as a negative urea breath test at least 2 months after treatment.. Per protocol and intention-to-treat cure rates were 86%[95% confidence interval (CI), 80-91%] and 77% (95% CI, 70-83%) for triple therapy, and 89% (95% CI, 82-93%) and 83% (95% CI, 76-88%) for quadruple therapy. No significant differences between the groups were found in the cure rates, compliance or side-effects.. One-week triple and quadruple therapy show similar results when used as first-line eradication treatment.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Breath Tests; Clarithromycin; Drug Administration Schedule; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Tetracycline; Treatment Outcome

The optimal treatment of patients with Helicobacter pylori resistant to metronidazole has not been established.. To compare the efficacy of quadruple and furazolidone-based triple therapy in the eradication of H. pylori resistant to metronidazole.. Duodenal ulcer patients (n = 70) in whom initial eradication therapy failed and who harboured H. pylori strains resistant to metronidazole were randomized to receive one of the following 7-day regimens: colloidal bismuth subcitrate, 240 mg, tetracycline, 750 mg, and furazolidone, 200 mg, each given twice daily (BTF), or omeprazole, 20 mg b.d., colloidal bismuth subcitrate, 240 mg b.d., tetracycline, 500 mg q.d.s., and metronidazole, 500 mg b.d. (OBTM). H.pylori status was assessed by culture, histology and rapid urease test before treatment and 4-6 weeks after therapy. Susceptibility to metronidazole was assessed by the agar dilution method.. H. pylori eradication rates with intention-to-treat/per protocol analyses were: BTF, 85.7%/90.9%; OBTM, 74.2%/89.6%. Duodenal ulcers were healed in nine of 10 (90%) patients in the BTF group and in all patients (12/12) (100%) in the OBTM group (P = N.S.). A significantly lower rate of adverse events was observed in the BTF group than in the OBTM group (31.4% vs. 60%, P = 0.03), but there was no difference in terms of discontinuation of treatment (2/35 vs. 6/35, P = N.S.).. The 1-week BTF regimen was as effective as the OBTM regimen, and produced less adverse events. Thus, it may be used in patients in whom resistance of H. pylori to metronidazole is suspected.

Topics: Adolescent; Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Resistance, Bacterial; Drug Therapy, Combination; Duodenal Ulcer; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Omeprazole; Organometallic Compounds; Patient Compliance; Tetracycline

To study the efficacy of a 7-day quadruple regimen combining pantoprazole, bismuth, tetracycline and metronidazole as rescue treatment for Helicobacter pylori infection after failure of standard triple therapy.. A prospective study was made of 140 patients infected with H. pylori and diagnosed with peptic ulcer or non-ulcer dyspepsia in whom triple therapy with proton pump inhibitor, clarithromycin and amoxicillin had failed. The patients were treated with quadruple therapy including pantoprazole, 40 mg twice daily, colloidal bismuth subcitrate, 120 mg four times daily, tetracycline, 500 mg four times daily, and metronidazole, 500 mg three times daily, for 7 days. Two months after completion of therapy, a 13C-urea breath test was performed to confirm eradication.. With quadruple therapy, the H. pylori eradication rates were 82% (95% confidence interval (CI), 75-88%) by 'intention-to-treat' and 85% (95% CI, 79-91%) by 'per protocol'. No major side-effects were observed. No differences in eradication success were observed in relation to underlying disease (peptic ulcer: 85% (95% CI, 76-91%) vs. non-ulcer dyspepsia: 83% (95% CI, 68-93%)) or smoking habits (smokers: 86% (95% CI, 75-93%) vs. non-smokers: 83% (95% CI, 71-91%)).. Quadruple therapy with pantoprazole, bismuth, tetracycline and metronidazole for 7 days is an effective H. pylori eradication treatment for patients in whom standard triple therapy has failed.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Benzimidazoles; Bismuth; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Pantoprazole; Peptic Ulcer; Prospective Studies; Sulfoxides; Tetracycline; Treatment Failure; Treatment Outcome

The role of Helicobacter pylori infection in nonulcer dyspepsia remains controversial. To date studies exploring the effect of H. pylori eradication on symptoms have reported conflicting results. Randomised control trials employing validated outcome measures have also been difficult to interpret because of several important issues such as the large placebo response seen in patients with nonulcer dyspepsia and both the natural variability in symptoms and symptom severity with time. The association of symptom improvement with resolution of gastritis has meant that the length of follow up employed in most studies has been insufficient. We report the findings of a randomised placebo controlled trial (n = 100), using a validated symptom questionnaire and 5 year follow up to determine the effect of H. pylori eradication on symptoms in nonulcer dyspepsia. In all 64 that were reviewed at 5 years there was a significant difference between patients who were H. pylori negative and those who remained positive with regard to complete symptom resolution, consumption of relevant medications and peptic ulcer disease development, in favour of active treatment. There was a trend for gradual symptom improvement over time irrespective of H. pylori status, which may reflect the natural history of this condition. For those who remained symptomatic at 5 years, there was no difference in symptom severity based on H. pylori status. The findings of this study support the use of H. pylori eradication in symptomatic patients with nonulcer dyspepsia both to induce symptom resolution and to prevent disease progression.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Drug Therapy, Combination; Dyspepsia; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Randomized Controlled Trials as Topic; Recurrence; Tetracycline; Treatment Outcome

To evaluate the efficacy of omeprazole triple therapy versus omeprazole quadruple therapy for Helicobacter pylori infection.. Prospective, randomized, single-centre, investigator-blind study.. Departments of Gastroenterology and Histopathology, Evangelismos Hospital, Athens, Greece.. One hundred and forty-nine consecutive patients with active duodenal ulcer were randomized to receive omeprazole (20 mg b.d.), amoxicillin (1 g b.d.) and clarithromycin (0.5 g b.d.) (OAC, n = 78), or omeprazole (20 mg b.d.), colloidal bismuth subcitrate (120 mg q.i.d.), metronidazole (0.5 g t.i.d.) and tetracycline hydrochloride (0.5 g q.i.d.) (OBMT, n = 71) for 10 days. Patients' symptoms were scored, and compliance and treatment-related side effects were assessed. Endoscopy was performed before treatment and at 10-12 weeks and 12 months after treatment. H. pylori infection and its successful eradication were sought by histology, immunohistochemistry and campylobacter-like organisms (CLO) tests on multiple biopsies taken from the gastric antrum, corpus and fundus. Patients were re-evaluated clinically and underwent a C-urea breath test (UBT) at 21-24 months. Those with dyspepsia and/or recrudescence of H. pylori were re-endoscoped.. Patient groups were comparable for age, sex, smoking, occasional use of nonsteroidal anti-inflammatory drugs (NSAIDs), and current or past bleeding episodes. Six and seven patients in the OAC and OBMT treatment groups, respectively, were lost to follow-up. Eight patients were non-compliant. Two ulcers in the OAC group and one in the OBMT group did not heal. By intention-to-treat (ITT) and per-protocol (PP) analyses, ulcer healing rates were 86% (67/78) and 97% (67/69), respectively, for the OAC group, and 82% (58/71) and 98% (58/59), respectively, for the OBMT group. H. pylori eradication at 10-12 weeks after treatment was 78% (61/78) and 88% (61/69) for OAC, and 65% (46/71) and 78% (46/59) for OBMT, by ITT and PP analyses, respectively (P > 0.1). Side effects were more common with OBMT. Relapse rates of H. pylori were 3% and 2% for the first and second years, respectively. Four H. pylori-negative patients developed reflux symptoms, but only two developed erosive oesophagitis between 12 and 24 months.. OAC and OBMT were equally effective in healing active duodenal ulcers and eradicating H. pylori, but OAC should be used as a first-line treatment because of its better tolerance.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Tetracycline; Wound Healing

Direct comparisons of bismuth and proton pump inhibitor (PPI)-based triple and quadruple therapies for Helicobacter pylori eradication are lacking. To address this, a randomized study was conducted.. Infected dyspeptic patients received pantoprazole 40 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, all twice daily, for 7 days (PAC7); or pantoprazole 40 mg twice daily, bismuth subcitrate 108 mg, and tetracycline 500 mg, both 4 times daily, and metronidazole 200 mg 3 times daily and 400 mg at night for 7 days (PBTM7); bismuth subcitrate 108 mg and tetracycline 500 mg, both 4 times daily, and metronidazole 200 mg 3 times daily and 400 mg at night for 14 days (BTM14). Outcome was assessed with (13)C-urea breath test.. Eradication rates (intention to treat [n = 405]/per protocol [n = 320]) were similar for PAC7 (78%/82%) and PBTM7 (82%/88%); the latter significantly superior to BTM14 (69%/74%; P < 0.01). Pretreatment metronidazole resistance (MR) was 53% and clarithromycin resistance was 8%. Eradication rates for primary metronidazole sensitive/resistant isolates were 74%/87% with PAC7 and 80%/81% for PBTM7, compared with 76%/55% (P < 0.02) for BTM14. Noncompliance was greater with BTM14 (15%; P < 0.001) than PAC7 (3%) or PBTM7 (6%). Moderate-severe adverse events were more common with BTM14 (45%; P < 0.001), than PAC7 (23%) or PBTM7 (25%) with more discontinuations (9%, 2%, 3%, respectively).. One-week PPI triple therapy is well tolerated and effective. The addition of PPI to bismuth triple therapy allows reduction of treatment duration with improved efficacy and tolerability, despite a high rate of MR. Quadruple therapy appears to overcome pretreatment MR in most cases. Two-week bismuth triple therapy is significantly inferior to quadruple therapy and less well tolerated than both 1-week therapies.

Topics: Adult; Anti-Bacterial Agents; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Patient Compliance; Proton Pump Inhibitors; Treatment Outcome

Helicobacter pylori (H. pylori) eradication rates in northern Sardinia using standard 1-wk triple therapies (i.e., a proton pump inhibitor and two antibiotics) are typically <60%, primarily because of antibiotic resistance. The aim of this study was to test b.i.d. quadruple therapy as primary and as salvage therapy in this population.. This was a prospective, single center study of consecutive dyspeptic H. pylori-infected patients. Therapy consisted of omeprazole 20 mg, tetracycline 500 mg, metronidazole 500 mg, and bismuth subcitrate caplets 240 mg, all b.i.d. with the midday and evening meals for 14 days. H. pylori status was evaluated by 13C-urea breath test and histology before and 4-6 wk after therapy. Eradication was defined as no positive test.. We enrolled 118 consecutive dyspeptic patients (mean age 46 yr; 73 men, including 15 with peptic ulcer disease). Of the patients, 42 (38%) had failed prior therapy: twice in 21 cases, three times in 12, and four or more times in nine. The intention-to-treat cure rate was 95% (110 of 116) (95% CI = 90-98%) overall, and 98% per protocol, irrespective of diagnosis, age, prior treatment failure, or smoking status. Moderate or severe side effects were experienced by only 5% of patients.. Bismuth subcitrate-based b.i.d. quadruple therapy was an excellent primary and salvage therapy and should be considered as first line therapy.

Topics: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Drug Therapy, Combination; Enzyme Inhibitors; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Salvage Therapy; Tetracycline

A novel rifabutin-based therapy is able to cure Helicobacter pylori infection in most patients who have failed eradication after standard proton pump inhibitor (PPI)-based triple therapy. We compared this regimen with the quadruple therapy.. A total of 135 patients were randomized into three groups who were treated for 10 days with pantoprazole 40 mg b.i.d., amoxycillin 1 g b.i.d., and rifabutin 150 mg o.d. (RAP50150 group), or 300 mg o.d. (RAP300 group), and pantoprazole 40 mg b.i.d., metronidazole 250 mg t.i.d., bismuth citrate 240 mg b.i.d., and tetracycline 500 mg q.i.d. (QT group). Before therapy, patients underwent endoscopy with biopsies for histology, culture and antibiotic susceptibility tests. H. pylori eradication was assessed by the 13C-urea breath test.. On intention-to-treat analysis, eradication rates (with 95% confidence intervals [CI]) were 66.6% (53-80%) in the RAP150 and QT groups, respectively, and 86.6% (76-96%) in RAP300 group (p < 0.025). Most patients harboring metronidazole- and clarithromycin-resistant strains were eradicated at an equal rate by each of the three regimens. Side effects were observed in 9% and 11% of rifabutin-treated patients, and in 47% of those on quadruple therapy (p < 0.0001).. In patients who failed standard eradicating treatments, a 10-day course of rifabutin with pantoprazole and amoxycillin is more effective and well tolerated than the quadruple therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Benzimidazoles; Biopsy, Needle; Confidence Intervals; Drug Administration Schedule; Drug Therapy, Combination; Enzyme Inhibitors; Female; Follow-Up Studies; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Pantoprazole; Probability; Prospective Studies; Rifabutin; Sulfoxides; Tetracycline; Treatment Failure

The eradication of Helicobacter pylori plays a pivotal role in the treatment of peptic ulcer disease. Metronidazole resistance, common in Iran, is claimed to be a major reason for the failure of metronidazole-containing regimens. Both clarithromycin and furazolidone are potential alternatives for metronidazole.. To assess and compare the effectiveness of clarithromycin- and furazolidone-based regimens in eradicating H. pylori in a population with a high metronidazole resistance rate.. Patients with proven duodenal ulcer and H. pylori infection were randomly assigned to one of two groups. The patients received 2 weeks of omeprazole 20 mg b.d., amoxicillin 1000 mg b.d, bismuth subcitrate 240 mg b.d. and either clarithromycin 500 mg b.d. (the OABC group) or furazolidone 200 mg b.d. (the OABF group).. A total of 118 patients were randomized, 55 in the OABC group and 63 in the OABF group. The intention-to-treat eradication rate was 84% and 85% for the OABF and OABC groups, respectively. The per protocol eradication rates were 90% for both groups.. OABC and OABF are both effective in eradicating H. pylori in areas where metronidazole resistance is a problem. OABF is a good alternative in the face of growing resistance to clarithromycin in developed countries, and is attractive for developing countries where clarithromycin is not readily available.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents, Local; Anti-Ulcer Agents; Clarithromycin; Drug Resistance; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Incidence; Iran; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Treatment Outcome

Many patients who have had upper gastrointestinal bleeding continue to take low-dose aspirin for cardiovascular prophylaxis or other non-steroidal antiinflammatory drugs (NSAIDs) for musculoskeletal pain. It is uncertain whether infection with Helicobacter pylori is a risk factor for bleeding in such patients.. We studied patients with a history of upper gastrointestinal bleeding who were infected with H. pylori and who were taking low-dose aspirin or other NSAIDs. We evaluated whether eradication of the infection or omeprazole treatment was more effective in preventing recurrent bleeding. We recruited patients who presented with upper gastrointestinal bleeding that was confirmed by endoscopy. Their ulcers were healed by daily treatment with 20 mg of omeprazole for eight weeks or longer. Then, those who had been taking aspirin were given 80 mg of aspirin daily, and those who had been taking other NSAIDs were given 500 mg of naproxen twice daily for six months. The patients in each group were then randomly assigned separately to receive 20 mg of omeprazole daily for six months or one week of eradication therapy, consisting of 120 mg of bismuth subcitrate, 500 mg of tetracycline, and 400 mg of metronidazole, all given four times daily, followed by placebo for six months.. We enrolled 400 patients (250 of whom were taking aspirin and 150 of whom were taking other NSAIDs). Among those taking aspirin, the probability of recurrent bleeding during the six-month period was 1.9 percent for patients who received eradication therapy and 0.9 percent for patients who received omeprazole (absolute difference, 1.0 percent; 95 percent confidence interval for the difference, -1.9 to 3.9 percent). Among users of other NSAIDs, the probability of recurrent bleeding was 18.8 percent for patients receiving eradication therapy and 4.4 percent for those treated with omeprazole (absolute difference, 14.4 percent; 95 percent confidence interval for the difference, 4.4 to 24.4 percent; P=0.005).. Among patients with H. pylori infection and a history of upper gastrointestinal bleeding who are taking low-dose aspirin, the eradication of H. pylori is equivalent to treatment with omeprazole in preventing recurrent bleeding. Omeprazole is superior to the eradication of H. pylori in preventing recurrent bleeding in patients who are taking other NSAIDs.

Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Aspirin; Drug Therapy, Combination; Gastrointestinal Hemorrhage; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Naproxen; Omeprazole; Organometallic Compounds; Secondary Prevention; Tetracycline

Current treatment for the eradication of Helicobacter pylori in patients with peptic disease is based on the combination of antibiotic and anti-acid regimens. Multiple combinations have been investigated, however no consensus has been reached regarding the optimal duration and medications.. To assess the efficacy of two treatment regimens in patients with peptic ulcer disease and non-ulcer dyspepsia, and to determine the need for gastric mucosal culture in patients failing previous treatment.. Ninety patients with established peptic ulcer and NUD (with previously proven ulcer) were randomly assigned to receive either bismuth-subcitrate, amoxycillin and metrnidazole (BAM) or lansoprasole, clarithromycine and metronidazole (LCM) for 7 days. Patients with active peptic disease were treated with ranitidine 300 mg/day for an additional month.. Eradication failed in 8 of the 42 patients in the BAM group and in 2 of the 43 patients in the LCM group, as determined by the 13C urea breath test or rapid urease test (19% vs. 5%, respectively, P = 0.05). Five of these 10 patients were randomly assigned to treatment with lansoprazole, amoxycillin and clarithromycin (LAC) regardless of the culture obtained, and the other 5 patients were assigned to treatment with lansoprazole and two antibacterial agents chosen according to a susceptibility test. Eradication of H. pylori was confirmed by the 13C urea breath test. The same protocol (LAC) was used in all patients in the first group and in four of the five patients in the second group. The culture results did not influence the treatment protocol employed.. Combination therapy based on proton pump inhibitor and two antibiotics is superior to bismuth-based therapy for one week. Gastric-mucosal culture testing for sensitivity of H. pylori to antibiotics is probably unnecessary before the initiation of therapy for patients with eradication failure.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Aged; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Clarithromycin; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Omeprazole; Organometallic Compounds; Patient Selection; Penicillins; Peptic Ulcer; Time Factors; Treatment Failure

To compare the efficacy of two protocols for the eradication of Helicobacter pylori infection and the healing of active duodenal ulcer: (i) ranitidine bismuth citrate (RBC) plus two antibiotics for 7 days, and (ii) the same triple therapy followed by 3 weeks of anti-secretory drug treatment.. The study comprised 102 patients with active duodenal ulcer and H. pylori infection; the patients were randomized to open treatment with either RBC 400 mg b.d. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 7 days, or the same treatment followed by 3 weeks of RBC 400 mg b.d. alone. Ulcer healing was confirmed by endoscopy. H. pylori eradication was assessed by endoscopy, rapid urease test and histology.. The ulcer healed in 48/50 patients on RBC-based triple therapy alone (96.0%) and in 51/52 patients on triple therapy plus further anti-secretory treatment (98.1%). On an intention-to-treat basis, H. pylori had been successfully eradicated in 42/50 patients on triple therapy (84.0%) and in 44/52 patients on triple therapy plus anti-secretory treatment (84.6%), while by per protocol analysis the H. pylori eradication rates were 91.3% (42/46) and 89.8% (44/49), respectively.. One-week triple therapy with RBC, amoxycillin and clarithromycin is highly effective in eradicating H. pylori and healing duodenal ulcers, even if not followed by anti-secretory drug treatment.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Clinical Protocols; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Duodenoscopy; Female; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Male; Middle Aged; Organometallic Compounds; Ranitidine; Sucralfate; Treatment Outcome

Cure rates of 7-day triple therapy seem to be decreasing. Quadruple therapies may be an alternative, although their complex administration makes patient acceptance difficult.. To test the usefulness of a thrice a day, quadruple therapy to cure Helicobacter pylori infection.. A total of 122 consecutive patients with peptic ulcer and Helicobacter pylori infection were treated with omeprazole 20 mg b.d., tetracycline chlorhydrate 500 mg t.d.s., metronidazole 500 mg t.d.s., and bismuth subcitrate 120 mg t.d.s. administered with meals for 7 days. Cure was tested by either endoscopy or breath test after 2 months, and by urea breath test 6 months after therapy.. Seven patients were lost to follow-up. Of the remaining 115, 110 were cured at the first control, giving an intention-to-treat cure rate of 90.2% (95% CI: 83-95%) and a per protocol cure rate of 95.7% (95% CI: 90-98%). One hundred three patients returned for a 6-month breath test; all but one were cured. Side-effects were minimal or minor in 47 patients (40.8%) and moderate in four (3.4%). Compliance was good, 95% of patients taking more than 90% of the pills. Six (5%) patients stopped treatment after 1, 2, 4 (two patients) and 6 (two patients) days.. Thrice a day quadruple therapy shows excellent cure rates, far above 90%, is well-tolerated and compliance is easy. Head-to-head comparison with triple therapies as first line Helicobacter pylori treatment seems warranted.

Topics: Administration, Oral; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Patient Compliance; Peptic Ulcer; Tetracycline; Treatment Outcome

When standard triple therapy fails to eradicate Helicobacter pylori, quadruple 'rescue' therapy is often used which, in Europe, generally comprises colloidal bismuth subcitrate (CBS) based triple therapy and a proton pump inhibitor. Since hypochlorhydria could greatly increase absorption of the toxic bismuth ion from CBS, we investigated the bismuth status of patients receiving anti-H. pylori quadruple therapy.. In a prospective open label study 34 patients with nonulcer dyspepsia or peptic ulcer disease, who had failed to eradicate H. pylori with standard triple therapy, were subsequently treated with CBS, omeprazole, amoxycillin and metronidazole (BOAM). A further 35 patients received triple therapy for the eradication of H. pylori: CBS, amoxycillin and metronidazole (BAM) (n = 18); placebo bismuth, amoxycillin and metronidazole (AM) (n = 9); or omeprazole, amoxycillin and metronidazole (OAM) (n = 8). Whole blood bismuth levels were determined before and within 24 hours of completing treatment. Analysis of bismuth was by inductively coupled plasma mass spectrometry, and concentrations were compared between groups and with the Hillemand 'alarm level' for blood bismuth (50-100 microg/l).. BOAM gave higher blood bismuth levels than BAM (difference in means 13.1, CI 6.0-20.2, p <.001); three (8.8%) patients taking BOAM had concentrations within the Hillemand alarm level at 54.2, 64.7 and 91.8 microg/l. OAM and AM did not alter baseline blood bismuth levels.. Caution should be observed in prescribing CBS with gastric acid suppression, and alternative bismuth preparations should be considered.

Topics: Adult; Amoxicillin; Bismuth; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Safety

Both iron deficiency anaemia and Helicobacter pylori infection are rare in developed countries. A possible connection has been suggested between these two diseases and our aim was to define the clinical picture and to study the effect of bacterial eradication in H. pylori colonized children with severe anaemia.. Eight children with iron deficiency anaemia refractory to iron supplementation were examined with gastroscopy because of suspicion of H. pylori infection. Anaemia was treated with oral ferrous sulphate. Two patients needed blood transfusions. Eradication therapy was given either with combination of colloidal bismuth subcitrate and metronidazole or with omeprazole, clarithromycin and amoxycillin. Eradication was confirmed by urea breath test 4 weeks post-treatment.. H. pylori infection was confirmed histologically and microbiologically in all children, who also presented with chronic, active gastritis. Bacteria were successfully eradicated in 7/8 patients. Correction of haemoglobin values was observed post-treatment, iron stores still being deficient at control in 4/8 children.. Our results suggest that H. pylori might have a role in causing iron deficiency anaemia in school-age children. Screening for H. pylori should be extended to cover those patients with other clinical manifestations than symptoms from gastrointestinal tract.

Topics: Adolescent; Amoxicillin; Anemia, Iron-Deficiency; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Child; Chronic Disease; Clarithromycin; Drug Therapy, Combination; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Hemoglobins; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Proton Pump Inhibitors; Urea

One of the most economical and effective therapeutic regimens for eradication of Helicobacter pylori is the classic triple therapy with amoxycillin or tetracycline, metronidazole and a bismuth derivative. Addition of H2-receptor antagonists to these drugs may heighten the rate of eradication and shorten the duration. We therefore performed a randomized controlled trial comparing twice daily metronidazole, bismuth derivative and amoxycillin for 2 weeks with additional ranitidine for 1 or 2 weeks.. In total, 240 adult patients with duodenal ulcer and H. pylori infection were randomly assigned to one of the following regimens: (1) amoxycillin 1 g bid, metronidazole 500 mg bid, bismuth sub-citrate 240 mg bid and ranitidine 300 mg bid for 1 week; (2) triple therapy without ranitidine for 2 weeks; or (3) triple therapy plus ranitidine 300 mg bid for 2 weeks. Side-effects of the drugs were evaluated two weeks after starting the treatment. The rapid urease test and histology from antrum and corpus, and/or 14C- urea breath test were used to determine H. pylori eradication six weeks after starting the treatment.. In total, 195 patients were followed up for 6 weeks. The most frequent drug side-effects were unpleasant taste (46%), dry mouth (41%) and fatigue (26%), which had an equal distribution in all treatment groups. Endoscopy and 14C- urea breath test were performed for 178 and 123 patients, respectively. Eradication of H. pylori was documented in 19/64 (29.7%), 29/63 (46%) and 50/68 (73.5%) of patients in groups 1, 2 and 3, respectively (P < 0.000001 for group 1 versus group 3; P < 0.0014 for group 2 versus group 3; difference not significant for group 1 versus group 2). An intention-to-treat analysis showed eradication rates of 19/80 (23.75%), 29/80 (36.25%) and 50/80 (62.5%) for groups 1, 2 and 3, respectively. At four weeks post-treatment, the most sensitive test for evaluation of eradication of H. pylori was histology.. Although combined use of an H2-receptor antagonist and twice daily triple therapy in a two-week regimen is more effective than two-week triple or one-week quadruple therapy in Iranian patients, none of these regimens is ideal in countries with a probable high rate of resistant and strongly toxic strains of H. pylori.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Biopsy, Needle; Bismuth; Breath Tests; Drug Administration Schedule; Drug Therapy, Combination; Esophagoscopy; Female; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Male; Metronidazole; Organometallic Compounds; Penicillins; Peptic Ulcer; Ranitidine; Urea

A previous study showed that 14 days of qid bismuth-based triple therapy with tetracycline 500 mg, metronidazole 250 mg and colloidal bismuth subcitrate 120 mg resulted in excellent Helicobacter pylori eradication rates (89.5%). The present study looked at a shorter treatment period by adding omeprazole and by reducing the dose of tetracycline.. One hundred sixty-one patients with H pylori confirmed by histology and (13)carbon urea breath test were included in the study. They were treated for seven days with bismuth subcitrate 120 mg plus metronidazole 250 mg plus tetracycline 250 mg qid plus omeprazole 20 mg bid (OBMT). Patients were 18 to 75 years of age and had dyspepsia with or without a history of peptic ulcer. Patients with irritable bowel syndrome, active ulcer or previous attempt at eradication, or those who had used antibiotics or antiulcer drugs in the previous 30 days were excluded. Eradication was determined by two (13)carbon urea breath tests done one and three months, respectively, after treatment. Strains with minimal inhibitory concentrations of 8 microg/mL or higher were considered to be resistant to metronidazole.. The overall per protocol eradication rate was 84%-89.5% in metronidazole-sensitive and 70.8% in metronidazole-resistant strains. Modified intent-to-treat analysis resulted in a 80% eradication rate--82.5% in metronidazole-sensitive and 66.7% in metronidazole-resistant strains. Only one patient discontinued treatment because of adverse events.. The OBMT regimen used in this study is safe and effective against metronidazole-sensitive H pylori strains.

Topics: Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Resistance; Drug Therapy, Combination; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Omeprazole; Organometallic Compounds; Probability; Tetracycline; Treatment Outcome

Recently a new 'all in one' single capsule with the three components of bismuth-based triple therapy became available in trials for treating Helicobacter pylori.. To investigate the efficacy and tolerability of this new capsule when combined with lansoprazole.. A total of 66 consecutive infected patients from a single centre received two single triple capsules four times daily and lansoprazole 30 mg b.d. for 7 days. Each capsule contained 60 mg of bismuth subcitrate, 125 mg of tetracycline and 125 mg of metronidazole. Endoscopy with biopsies for CLO-test, histology and culture from antrum and corpus was performed before and at least 5 weeks after treatment.. The per protocol cure rate was 56/64 (88%, 95% CI: 79-95%); by intention-to-treat 56/65 (86%, 95% CI: 78-95%). The per protocol cure rate in metronidazole sensitive strains was 40/43 (93%, 95% CI: 85-100%); in resistant strains 5/9 (56%, 95% CI: 23-88%). There was one drop-out due to adverse events.. It is possible to combine the components of bismuth-based triple therapy into a single capsule. Based on the results it can be assumed that the capsule releases its content in the stomach. When combined with lansoprazole it reaches high cure rates, especially in metronidazole sensitive strains. This new approach simplifies bismuth-based anti-Helicobacter therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Aged, 80 and over; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Combinations; Enzyme Inhibitors; Female; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Proton Pump Inhibitors; Tetracycline

The best regimen for the treatment of Helicobacter pylori infection has yet to be defined. Four-day quadruple therapy with tetracycline, metronidazole, bismuth, and a proton pump inhibitor has been shown to obtain a very high cure rate. However, the fact that it must be taken four times daily may interfere with compliance. The objective of the study was to test the efficacy and tolerability of a new 4-day therapy with 4 drugs taken every 12 hours to cure H. pylori infection. Patients and Methods. Fifty-six consecutive patients with peptic ulcer disease and H. pylori infection were treated with an oral 4-day course with omeprazole (20 mg/12 hours), clarithromycin (500 mg/12 hours), amoxicillin (1 g/12 hours) and tinidazole (500 mg/12 hours). Efficacy of the treatment was determined at least 2 months after therapy either by biopsy (in the case of gastric ulcer) or by 13C-urea breath test. A second breath test was performed at least 6 months after therapy.. Two patients were lost to follow-up. Forty-nine of the remaining 54 patients were cured at the first control [intention-to-treat cure rate: 87.5% (CI 95% 75-94%); per protocol cure rate: 90.7% (CI 95% 81-98%)]. Forty-three of these 49 cured patients returned for a second 13C urea breath-test at 6-12 months. Two of them were not cured, giving a long-term cure rate of 85.5% per protocol and 73.2% by intention-to-treat. Compliance was good, although 25 patients had mild side effects.. This particular four-day therapy is well tolerated, easy to follow, and achieves an acceptably high cure rate.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Diarrhea; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Nausea; Omeprazole; Organometallic Compounds; Patient Compliance; Pilot Projects; Tetracycline; Time Factors; Tinidazole; Treatment Outcome

Virulence factors of Helicobacter pylori are associated with peptic ulcer disease and may be also associated with the efficacy of treatment.. To determine the relation between the vacA and the cagA status of H pylori, clinical disease, and treatment outcome.. 121 patients with H pylori infection and peptic ulcer disease or functional dyspepsia were treated by quadruple antibiotic therapy in two groups for one and two days, respectively.. DNA was isolated from gastric antral biopsy specimens, taken before and after treatment, and the vacA and cagA status was determined by polymerase chain reaction and reverse hybridisation.. Peptic ulcer disease was significantly associated with the vacA s1 type, and cagA positivity, but not with the vacA m type. Treatment efficacy was significantly higher in patients with peptic ulcer disease, or infected with cagA+/vacA s1 strains.. The strong association between the cagA and vacA status and peptic ulcer disease was confirmed. Cure rates seem to be higher for patients with cagA+/vacA s1 H pylori strains, which is consistent with the higher cure rate observed among ulcer patients compared with functional dyspepsia patients. Therefore, treatment studies may require stratification for presence of ulcers as well as H pylori genotypes.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Regression Analysis; Tetracycline; Treatment Outcome

To evaluate the effect of a therapeutic regimen of 7 days versus 14 days on the clinical manifestations of Helicobacter pylori gastritis in children.. Ninety children (age 2-19 years) who had abdominal pain and/or recurrent vomiting were determined to have H. pylori gastritis by endoscopy, histology, and a Giemsa stain positive for H. pylori. The patients were randomized to receive amoxicillin, metronidazole, and bismuth subcitrate for 7 days (group A; 45 children) or 14 days (group B; 45 children) and were observed clinically for 19 +/- 11.5 months. Resolution of all abdominal and gastrointestinal symptoms was considered a good response.. A good response was obtained in 36 (80%) children from group A, and in 37 (82%) from group B. A recurrence of symptoms occurred in four (11%) of the responders from group A, and in six (15.2%) from group B.. A 7-day course of bismuth-based triple therapy for H. pylori gastritis in children appears to be clinically as effective as a 14-day regimen. The feasibility of a shorter therapeutic regimen may enhance patient compliance and provide a better chance of clinical benefit.

Topics: Abdominal Pain; Adolescent; Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Child; Child, Preschool; Clarithromycin; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Omeprazole; Organometallic Compounds; Recurrence; Treatment Failure; Vomiting

Nine helicobacter-positive pet dogs with upper gastrointestinal signs were studied to evaluate the effect of a triple therapy, normally applied to humans for the eradication of gastric helicobacters, on clinical signs and gastric histology, as well as the recurrence of helicobacters after eradication in an extended follow-up in four dogs. Endoscopy was performed at entry to the study and repeated after eradication therapies and additional treatments. If the triple therapy (amoxycillin, metronidazole and bismuth subcitrate) failed, tetracycline and omeprazole were prescribed. Additional therapies were instituted if clinical signs persisted after eradication therapies. Helicobacter status was verified from gastric biopsy specimens by the urease test and histological examination, and in a few dogs also by brush cytology. Triple therapy eradicated gastric helicobacters in 7/9 dogs; gastric helicobacters were also eradicated in one dog treated with tetracycline and omeprazole. Eradication of helicobacters resulted in significant improvement, but not total resolution, of clinical signs. Subsequent additional therapies resulted in further alleviation of clinical signs. Neither triple therapy nor additional therapies had a significant effect on gastric histological changes. Gastric helicobacters recurred in 4/4 dogs within three years of the eradication treatment. Because canine gastric helicobacters alone were not definitively shown to induce clinical signs, routine eradication therapy seems not to be warranted at present.

Topics: Amoxicillin; Animals; Antacids; Anti-Bacterial Agents; Dog Diseases; Dogs; Drug Therapy, Combination; Female; Helicobacter; Helicobacter Infections; Male; Metronidazole; Organometallic Compounds; Penicillins; Stomach Diseases

Few data are available on the efficacy of second-line H. pylori eradication regimens.. To compare the efficacy of either omeprazole or ranitidine in a second-line quadruple regimen in patients with duodenal ulcer or erosive duodenitis.. A total of 37 patients with erosive duodenitis and 119 with duodenal ulcer who have failed eradication of H. pylori with double or triple regimens, without metronidazole, were randomly assigned to receive tripotassium dicitrato bismuthate 600 mg t.d.s. + metronidazole 500 mg t.d.s. + tetracycline hydrochloride 500 mg t.d. s. combined with either omeprazole 20 mg b.d. (group O, 78 patients) or ranitidine 300 mg b.d. (group R, 78 patients) for 14 days. H. pylori eradication was verified by histology, rapid urease test and 13C-urea breath test.. t-test, chi2-test.. A total of 143 patients had a post-treatment endoscopy. Eradication rates were: intention-to-treat: group O 77% (67-87), group R 76% (66-85), P=0.85; per protocol analysis: group O 86% (77-95), group R 82 (71-93), P=0.58. Side-effects were frequent but mild.. Omeprazole 20 mg b.d. and ranitidine 300 mg b.d. were equally effective as antisecretory agents combined in a second-line quadruple eradication regimen.

Topics: Administration, Oral; Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Duodenitis; Female; Gastric Acid; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Ranitidine; Tetracycline; Treatment Outcome

To analyze cost-effectiveness of two different strategies to treat H. pylori infection in peptic ulcer in the primary care setting.. Consecutive patients with endoscopic diagnosis of peptic ulcer were randomized to one of two strategies: a) treatment during 7 days with omeprazole, tetracycline, metronidazole and bismuth subcitrate ("quadruple" therapy) and if failure second-line treatment with omeprazole, amoxycillin and clarithromycin during 7 days (OCA7), and b) initial treatment with OCA7 and if failure treatment with "quadruple therapy". End point was eradication 8 weeks after last treatment dose. Direct and indirect costs were estimated (euros, 1997) and a cost-effectiveness analysis using a decision-tree model was undertaken after real clinical data. 95% confidence intervals are given.. After screening 255 patients, 97 were finally included. 48 patients were given strategy a and 49 strategy b. Eradication was obtained (intention-to-treat) in 72.9% (CI 95%: 58.2-84.7) in group a versus 91.8% (CI 95%: 80.4-97.7) (p < 0.05) in group b. Mean cost per case treated was lower in group a (237 versus 268 euros) but cost per case eradicated was lower in group b (320 versus 296 euros). The cost was primarily determined by efficacy.. Treatment with OCA7 followed by rescue with "quadruple" therapy if failure is more efficient in our area that the inverse strategy. Efficiency is mostly determined by efficacy.

Topics: Adolescent; Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Cost-Benefit Analysis; Data Interpretation, Statistical; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Primary Health Care; Prospective Studies; Stomach Ulcer; Tetracycline; Time Factors

Topics: Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Clarithromycin; Double-Blind Method; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Omeprazole; Organometallic Compounds; Penicillins; Prospective Studies; Ranitidine; Time Factors

Bismuth is widely used for the eradication of H. pylori, especially in developing countries, although there are concerns over its neurotoxicity. Whether bismuth has to be absorbed in humans to act against H. pylori is not known. In this study, we compared "absorbable" (colloidal bismuth subcitrate) and "nonabsorbable" (bismuth subnitrate) bismuth as part of triple therapy in the eradication of H. pylori.. A double-blind, randomized, placebo-controlled trial was carried out with 120 H. pylori-positive patients with nonulcer dyspepsia. Group CBS + Ab (n = 35) received colloidal bismuth subcitrate (one tablet qds), amoxicillin (500 mg qds), and metronidazole (400 mg tds). Group BSN + Ab (n = 35) received bismuth subnitrate (two tablets tds) and the same antibiotics. Group Ab (n = 35) received placebo bismuth (two tablets tds) and the antibiotics. Group BSN (n = 15) received bismuth subnitrate (two tablets tds) and placebo antibiotics. Bismuth was taken for 4 weeks and the antibiotics for the first 2 weeks. H. pylori eradication, side effects, compliance, pre- and post-treatment symptom scores, and bismuth absorption were assessed.. H. pylori eradication was 69%, 83%, 31%, and 0% in CBS + Ab, BSN + Ab, Ab, and BSN, respectively. Side effects, compliance, and symptom relief were similar in all groups, but blood bismuth levels were significantly greater in CBS + Ab than the other three groups.. The efficacy of bismuth-based therapies as part of triple therapy in the eradication of H. pylori is unrelated to absorption. Hence, the use of effective but poorly absorbed bismuth preparations should be encouraged for bismuth-based eradication therapies.

Topics: Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Double-Blind Method; Dyspepsia; Helicobacter Infections; Helicobacter pylori; Humans; Intestinal Absorption; Middle Aged; Organometallic Compounds; Treatment Outcome

In our previous study, a triple therapy using tripotassium dicitrato bismuthate (TDB), josamycin and furazolidone achieved a suboptimal cure rate of Helicobacter pylori infection.. To investigate whether the addition of an antisecretory agent raises the cure rate using this regimen.. One hundred and twenty H. pylori positive patients with peptic ulcer disease or functional dyspepsia were randomly assigned to receive 1-week quadruple therapy of TDB 240 mg b.d., furazolidone 100 mg b.d., josamycin 1000 mg b.d. and famotidine 20 mg b.d. (BFJF group), or triple therapy of TDB 240 mg b.d., furazolidone 100 mg b.d. and clarithromycin 250 mg b.d. (BFC group). H. pylori status was assessed by histology and culture of gastric biopsy specimens before and at least 4 weeks after completion of therapy.. Seven patients (three in the BFJF group and four in the BFC group) dropped out. Eradication rates (intention-to-treat/per protocol) were 90%/95% in the BFJF group and 82%/88% in the BFC group, respectively (P > 0.05). Duodenal ulcer healing rates were 94% (16/17) in the BFJF group and 80% (20/25) in the BFC group, respectively (P > 0.05). Mild side-effects occurred in 11 (18%) patients in the BFJF group and 10 (17%) in the BFC group (P > 0.05).. One-week quadruple therapy consisting of TDB, furazolidone, josamycin and famotidine achieves a high cure rate of H. pylori infection.

Topics: Adult; Aged; Anti-Bacterial Agents; Anti-Infective Agents, Local; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Famotidine; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Josamycin; Male; Middle Aged; Organometallic Compounds; Treatment Outcome

The role of H. pylori in non-ulcer dyspepsia is controversial. Colloidal bismuth subcitrate (CBS) is known to suppress H. pylori. We hypothesized that if H. pylori is a causal factor in dyspepsia, then suppression of H. pylori would lead to a decrease in symptoms.. To assess the relationship between H. pylori status and the effect of CBS on dyspeptic symptoms in patients visiting their general practitioner for dyspeptic complaints.. In total 446 patients between 17 and 81 years of age (median 44 years) were included. All patients were treated with CBS (240 mg Bi2O3) twice a day for 4 weeks. Symptoms were scored at baseline, and after 2 and 4 weeks of treatment. At the first visit, blood was taken for serological H. pylori testing.. During follow up, 65 patients were lost due to violation of protocol. Positive H. pylori serology was found in 110 (24.7%) of the 446 initially selected patients, and in 90 (23.6%) of the 381 patients who completed the protocol (NS). The mean overall symptom score decreased significantly after 4 weeks of CBS (P<0.001). This reduction in overall symptom score was not significantly different between the H. pylori-positive and -negative groups.. The H. pylori status does not influence the outcome of CBS therapy in patients who consult their general practitioner for dyspepsia. This finding suggests that H. pylori does not play an important role in the etiology of dyspepsia in patients seen by the general practitioner.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antacids; Dyspepsia; Family Practice; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Patient Satisfaction; Probability; Statistics, Nonparametric; Treatment Outcome

To test the usefulness of a twice-a-day, simplified quadruple therapy to cure Helicobacter pylori infection.. Helicobacter pylori-positive ulcer patients were treated with omeprazole 20 mg twice a day (b.d.), amoxicillin 1 g b.d., tinidazole 500 mg b.d. and bismuth subcitrate 240 mg b.d. for 7 days in an experimental, noncomparative pilot study.. The gastroenterology unit of a county hospital.. Forty-four consecutive patients with peptic ulcer disease and H. pylori infection.. Cure was tested by either endoscopy or breath test after 2 months, and by urea breath test 6 months after therapy.. One patient was lost to follow-up. Of the remaining 43, 37 were cured at the first control, giving an intention-to-treat cure rate of 84.1% (95% CI 69-93%) and a per protocol cure rate of 86% (95% CI 71-94%). Thirty-three cured patients agreed to return for a six-month breath test. All but one were cured (long-term per protocol cure rate 82.1%; 95% CI 66-92%).. This particular quadruple therapy is well tolerated and easy to comply with. However, cure rates did not reach 90%.

Topics: Adult; Aged; Amoxicillin; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Pilot Projects; Stomach Ulcer; Tinidazole; Treatment Outcome

The efficacy of 1 wk bismuth triple therapy is adversely influenced by the presence of metronidazole resistance. In vitro studies suggest that ranitidine bismuth citrate (RBC) plus metronidazole exhibit synergistic activity against metronidazole resistant strains of Helicobacter pylori (H. pylori). Whether this confers a superior clinical efficacy remains unproven. This study compared the efficacy of RBC-based triple therapy with bismuth triple therapy in eradication of H. pylori.. Patients with H. pylori-related ulcer disease or gastritis were randomized to receive either 400/mg of RBC twice daily plus 400/mg of metronidazole and 500/mg of tetracycline four times daily for 1 wk (RMT) or 120/mg of colloidal bismuth subcitrate, 400/mg of metronidazole, and 500/mg of tetracycline, all given four times daily for 1 wk (BMT). Metronidazole susceptibility was determined by the E-test and pretreatment resistance was defined as minimum inhibitory concentration > or = 32/mg/L.. Of 100 consecutive patients randomized, two patients were lost to follow-up in each group. Forty-three of 85 (51%) H. pylori isolates were metronidazole resistant. Per-protocol cure rate for RMT and BMT was 40 of 41 (98%) and 37 of 44 (84%), respectively (p = 0.058). Intent-to-treat cure rate for RMT and BMT was 46 of 50 and 41 of 50, respectively (92% vs 82%, p = 0.23). A significantly higher eradication of metronidazole resistant H. pylori was observed in the RMT group (25 of 25, 100%) than in the BMT group (12 of 16, 75%), (p = 0.018). Side effects observed in the two treatment groups were comparable.. One week of RBC triple therapy with metronidazole and tetracycline is an effective anti-Helicobacter therapy. This regimen is more appropriate in areas of high prevalence of metronidazole resistance.

Topics: Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Administration Schedule; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Ranitidine; Tetracycline

When metronidazole is used in bismuth-based or proton pump inhibitor-based triple therapy, the cure rate of Helicobacter pylori is usually high. However, metronidazole-resistant H. pylori strains, which are increasing in frequency, are a major cause of failed H. pylori eradication.. To evaluate the efficacy of non-metronidazole containing bismuth-based triple therapy for H. pylori infection.. One-hundred and eighty H. pylori-positive patients with endoscopically documented peptic ulcer disease or functional dyspepsia were randomly assigned to one of three 1-week regimens containing tripotassium dicitrato bismuthate (also called colloidal bismuth subcitrate) 240 mg b.d. and two antibiotics: furazolidone 100 mg b.d. plus clarithromycin 250 mg b.d. (Group A); or clarithromycin 250 mg b.d. plus amoxycillin 1000 mg b.d. (Group B); or furazolidone 100 mg b.d. plus josamycin 1000 mg b.d. (Group C). H. pylori status was assessed by rapid urease test, histology and culture of gastric biopsy specimens taken from both the antrum and corpus, both before and at least 4 weeks after completion of therapy.. Thirteen patients dropped out (3 in group A, 5 in group B and 5 in group C). Based on an intention-to-treat analysis, the eradication rates achieved in groups A, B and C were 88% (53/60), 58% (35/60) and 77% (46/60), respectively. These differences were significant between groups A and B (P < 0.001), as well as between groups B and C (P < 0.05). Side-effects occurred in 7 (12%) patients in group A, 3 (5%) in group B and 8 (13%) in group C, and were mild, with the exception of vomiting in one patient (group C) that resulted in withdrawal from the study.. One-week triple therapy, consisting of tripotassium dicitrato bismuthate, low-dose furazolidone and low-dose clarithromycin, achieves a high cure rate of H. pylori.

Topics: Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Infective Agents, Local; Anti-Ulcer Agents; Clarithromycin; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Peptic Ulcer; Proton Pump Inhibitors

A furazolidone-containing therapeutic regimen for Helicobacter pylori infection has attracted special interest in the face of a rising world-wide metronidazole resistant H. pylori, and the expense of currently used antimicrobial regimens.. To evaluate the efficacy of furazolidone-containing regimens in eradicating H. pylori.. One-hundred and forty H. pylori positive patients with endoscopically confirmed duodenal ulcer or functional dyspepsia received one of four different regimens to eradicate H. pylori. In the first trial, the patients were randomly assigned to receive a 1-week course of furazolidone 100 mg b.d. and clarithromycin 250 mg b.d., with either tripotassium dicitrato bismuthate (TDB) 240 mg b.d. (FCB group) or lansoprazole 30 mg daily (FCL group). In the second trial, the patients were randomly assigned to receive a 1-week course of clarithromycin 250 mg b.d. and omeprazole 20 mg daily, with either furazolidone 100 mg b.d. (FCO group) or metronidazole 400 mg b.d. (MCO group). Endoscopy was repeated 4 weeks following completion of therapy with re-assessment of H. pylori status on gastric biopsies by histology and culture.. Four patients (1 in FCB, 1 in FCO and 2 in MCO groups) dropped out because they refused a follow-up endoscopy. Eradication rates of H. pylori on an intention-to-treat basis in the FCB, FCL, FCO and MCO groups were 91% (32/35, 95% CI: 82-99%), 91% (32/35, CI: 82-99%), 86% (30/35, CI: 74-97%) and 74% (26/35, CI: 60-89%) (all P > 0.05), respectively. Mild side-effects occurred in 15% of the 140 patients. In MCO group, the eradication rate in the patients infected with metronidazole-sensitive isolates of H. pylori was 86%, but dropped to 67% in those with metronidazole-resistance strains (P = 0.198).. One-week regimens containing furazolidone and clarithromycin in combination with TDB or a proton pump inhibitor fulfil the criteria for successful H. pylori therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Anti-Bacterial Agents; Anti-Infective Agents, Local; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Female; Follow-Up Studies; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Middle Aged; Omeprazole; Organometallic Compounds

Conventional bismuth-based triple therapy has multiple problems, such as inadequate drug compliance, side effects, and drug resistance. Combination of omeprazole and clarithromycin with or without combination with antibiotics like amoxycillin has been shown to be effective in eradication of Helicobacter pylori. Reports from India are few on the efficacy of clarithromycin-based drug combinations. Therefore, we evaluated efficacy of omeprazole and clarithromycin with or without amoxycillin for treating H. pylori infection. Sixty-four consecutive patients with upper gastrointestinal symptoms and having H. pylori infection were included. In every patient, complete upper gastrointestinal endoscopy was done. H. pylori infection was diagnosed by identification of organism on antral biopsies and positive rapid urease test. Patients were treated with omeprazole 40 mg/day + clarithromycin 250 mg twice daily (group I, n = 22), or omeprazole 40 mg/day + clarithromycin 250 mg twice daily + amoxycillin 500 mg three times daily (group II, n = 20), or bismuth subcitrate 120 mg four times daily + amoxycillin 500 mg three times daily + metronidazole 400 mg three times daily (group III, n = 22) for 2 weeks. H. pylori status was reevaluated 1 month after completion of treatment. One patient in each group stopped drugs due to side effects. Eradication rate was not significantly different in group I (15/22, 68%), group II (14/20, 70%), and group III (13/22, 59%). Of those completing therapy, side effects were observed in three patients in group III (nausea, skin rash, metallic taste), whereas none of the patients in group I and group II had any side effects. Addition of amoxycillin did not appear to improve efficacy of dual omeprazole and clarithromycin therapy and appeared to be no different than bismuth, metronidazole, and amoxycillin triple therapy. Overall, none of regimens was particularly good.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Pilot Projects; Treatment Outcome

A few cases relating H. pylori infection to iron-deficiency anemia have been described recently. We investigated the role of H. pylori infection in iron-deficiency anemia in preadolescent children and adolescents.. We conducted a double-blind, placebo-controlled therapeutic trial in 43 subjects (mean age, 15.4 years) with iron-deficiency anemia. Endoscopy was performed, and biopsy specimens were examined by urease test and histological analysis. Twenty-two of 25 H. pylori-positive patients were assigned randomly to three groups. Group A patients were given oral ferrous sulfate and a 2-week course of bismuth subcitrate, amoxicillin, and metronidazole. Group B patients were given placebo for iron and a 2-week course of triple therapy. Group C patients were given oral ferrous sulfate and a 2-week course of placebo. Iron status was reassessed 4 weeks and 8 weeks after the 2-week regimen ended.. Of the 43 subjects with iron-deficiency anemia, 25 (58.1%) had H. pylori in the antrum. Group A and B subjects, who received eradication therapy, showed a significant increase in hemoglobin level as compared with group C subjects at 8 weeks after therapy (p = .0086).. Treatment of H. pylori infection was associated with more rapid response to oral iron therapy as compared with the use of iron therapy alone. Such treatment also led to enhanced iron absorption even in those subjects who did not receive oral iron therapy.

Topics: Adolescent; Amoxicillin; Anemia, Iron-Deficiency; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Child; Double-Blind Method; Drug Therapy, Combination; Female; Ferrous Compounds; Helicobacter Infections; Helicobacter pylori; Hemoglobins; Humans; Intestinal Absorption; Male; Metronidazole; Nutritional Status; Organometallic Compounds; Placebos; Pyloric Antrum

Bismuth triple therapy provides consistently good results in Helicobacter pylori eradication worldwide, whereas quadruple therapy using a combination of omeprazole and bismuth triple regimen has produced cure rates in excess of 90%. The prevalence of metronidazole-resistant strains was 26.8% in our area. Colloidal bismuth pectin (CBP) is a new, lower-priced bismuth salt made in China. The purpose of this study was to investigate the efficacy and safety of CBP triple and quadruple regimens in the treatment of H. pylori-positive duodenal ulcer.. In this prospective trial, 205 patients with H. pylori-positive duodenal ulcer were allocated randomly to receive one of four regimens: metronidazole, 200 mg; amoxicillin, 250 mg; and colloidal bismuth subcitrate (CBS), 120 mg (group 1), or CBP, 100 mg qid (group 2) for 2 weeks, then continued CBS, 240 mg, or CBP, 200 mg bid for a further 2 weeks. A quadruple regimen using a combination of omeprazole, 20 mg bid, and CBS triple therapy (group 3) or CBP triple therapy (group 4), respectively, was given to patients for 1 week, followed by omeprazole, 20 mg once daily for a further 3 weeks. Further endoscopy was performed at least 4 weeks after cessation of the treatment. H. pylori status was determined by histology, a 14C urea breath test, and a urease test.. The per-protocol H. pylori cure rates were 85% (22 of 26 patients), 90% (35 of 39), 96% (46 of 48), and 95% (75 of 79) for groups 1 through 4. In the intention-to-treat analysis, cure rates were 79% (22 of 28), 83% (35 of 42), 90% (46 of 51), and 89% (75 of 84), respectively. The cure rates of quadruple therapy were higher than those of triple therapy; an 8.2% difference was not statistically significant (95% confidence interval [CI], 2.3-18.7%). The ulcer-healing rates were 88%, 87%, 98%, and 97%, respectively, for groups 1 through 4. The ulcer pain was relieved more rapidly in quadruple- than in triple-therapy regimens. Two patients discontinued treatment prematurely owing to drug-related side effects.. One-week quadruple therapy is highly effective and safe in H. pylori eradication in Chinese patients. CBP is as effective as CBS.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; China; Colloids; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Pectins

The efficacy of anti-Helicobacter pylori treatment and cytoprotective drugs in H. pylori-positive and -negative non-ulcer dyspepsia (NUD), respectively, is debatable.. In a randomized study, the efficacy of anti-H. pylori treatment versus sucralphate was tested in patients with NUD. One hundred and twelve patients with NUD, 62 positive and 50 negative for H. pylori were studied. Of 62 patients positive for H. pylori, 32 were treated with triple therapy (colloidal bismuth subcitrate, tetracycline and metronidazole) for 2 weeks and the remaining 30 were treated with sucralphate (1 g, q.i.d.) for 4 weeks. Of 50 patients negative for H. pylori, 25 each were treated with either sucralphate (1 g, q.i.d.) or ranitidine (150 mg, b.d.) for 4 weeks.. In patients with NUD and H. pylori infection, triple therapy eradicated H. pylori in 88% and was superior to sucralphate in producing symptom relief (81 vs 33%, P = 0.0003) and histological improvement in gastritis (73 vs 30%, P = 0.003). In the H. pylori-negative group, sucralphate was superior to ranitidine with regard to symptom relief (68 vs 36%, P = 0.04) and improvement in gastritis (44 vs 12%, P = 0.09). The symptomatic improvement persisted until 12 weeks after the start of treatment in triple therapy group only.. In patients with NUD associated with H. pylori, triple therapy was better than sucralphate in terms of symptomatic and histological improvement. However, sucralphate was superior to ranitidine in providing symptom relief in patients with H. pylori-negative NUD.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Biopsy; Double-Blind Method; Drug Therapy, Combination; Dyspepsia; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; India; Male; Metronidazole; Organometallic Compounds; Prospective Studies; Ranitidine; Sucralfate; Tetracycline; Treatment Outcome

Few patients with a history of peptic ulcer are treated by their GP for H. pylori infection, even though theoretical evidence supports such an approach.. We aimed to determine the validity of this recommendation and to test the feasibility of quadruple therapy in primary health care.. In this prospective, non-randomized intervention study, 51 unselected patients with a history of proven ulcer disease received a 7-day quadruple therapy (lansoprazole, colloidal bismuth subcitrate, tetracycline and metronidazole) from their GP. Main outcome measures were: (i) endoscopically confirmed cure of the infection; (ii) results of serology at entry and at 6 months follow-up; (iii) quality of life at entry, at 6 weeks and at 6 months follow-up; (iv) gastric symptoms at entry, at 6 weeks and at 6 months follow-up; and (v) medication at entry and at 6 months follow-up.. Quadruple therapy was well tolerated and there were no drop-outs with this regimen. Intention to treat cure rate was 48/51 (94%, 95% CI 87-100%), per protocol cure rate was 48/49 (98%, 95% CI 94-100%). 45/50 (90%) had positive serology at entry. IgG antibody titres decreased > 40% in 95.2% of patients. Quality of life improved significantly after treatment, gastric symptoms decreased and medication use decreased.. GPs should be encouraged to identify patients with a history of ulcer disease and chronic use of acid suppressants and offer them treatment for H. pylori infection. This approach will cure the infection in almost all patients, it will improve the quality of life and decrease costs. Quadruple therapy does not lose efficacy when employed in primary care. Pre-treatment serological testing is potentially useful for narrowing down the treatment group to those with actual infection, and serology is promising as an easy and cheap follow-up instrument in primary health care.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Bacterial Agents; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Quality of Life; Surveys and Questionnaires; Tetracycline; Time Factors; Treatment Outcome

One-week triple therapy has been shown to be effective in Helicobacter pylori eradication and duodenal ulcer healing. However, the optimal therapeutic combination has not yet been identified. Bismuth-containing regimens have the advantage of requiring only one antibiotic. It has been suggested that high doses of omeprazole improve the bactericidal efficacy of antimicrobial regimens against H. pylori. We evaluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing.. On an intention-to-treat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated with omeprazole and clarithromycin at the same doses plus amoxicillin 1 g b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient received follow-up treatment.. H. pylori eradication rates achieved in the OCB and OCA groups were similar whether by intention-to-treat (82.4% vs 88.9% ;p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OCA in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92.2% vs 92.1%), respectively (p = 0.98).. High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloidal bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradication in these therapeutic combinations.

Topics: Adult; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Data Interpretation, Statistical; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Time Factors

Topics: Antacids; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Naproxen; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Tetracycline

Both proton pump inhibitor drug treatment and Helicobacter pylori infection cause hypergastrinaemia in man.. To determine whether eradicating H pylori is a means of reducing hypergastrinaemia during subsequent proton pump inhibitor treatment.. Patients with H pylori were randomised to treatment with either anti-H pylori or symptomatic treatment. One month later, all received four weeks treatment with omeprazole 40 mg/day for one month followed by 20 mg/day for six months. Serum gastrin concentrations were measured before and following each treatment.. In the patients randomised to anti-H pylori treatment, eradication of the infection lowered median fasting gastrin by 48% and meal stimulated gastrin by 46%. When gastrin concentrations one month following anti-H pylori/symptomatic treatment were used as baseline, omeprazole treatment produced a similar percentage increase in serum gastrin in the H pylori infected and H pylori eradicated patients. Consequently, in the patients in which H pylori was not eradicated, median fasting gastrin concentration was 38 ng/l (range 26-86) at initial presentation and increased to 64 ng/l (range 29-271) after seven months omeprazole, representing a median increase of 68% (p < 0.005). In contrast, in the patients randomised to H pylori eradication, median fasting gastrin at initial presentation was 54 ng/l (range 17-226) and was unchanged after seven months omeprazole at 38 ng/l (range 17-95).. Eradicating H pylori is a means of reducing the rise in gastrin during subsequent long term omeprazole treatment. In view of the potential deleterious effects of hypergastrinaemia it may be appropriate to render patients H pylori negative prior to commencing long-term proton pump inhibitor treatment.

Topics: Adult; Alginates; Aluminum Hydroxide; Amoxicillin; Antacids; Anti-Ulcer Agents; Drug Combinations; Drug Therapy, Combination; Esophagitis; Female; Gastrins; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Silicic Acid; Sodium Bicarbonate

To determine the usefulness of four serological tests in confirming cure of H pylori infection before the previously reported six-month post-treatment delay.. As part of a prospective, blinded, controlled trial, in which patients with duodenal ulcers were randomized to receive different combinations of antibiotics, serum samples were obtained in 89 patients before treatment, as well as on several occasions after treatment. Antibody titres were determined by ELISA with Bio-Rad immunoglobulin (Ig) A, Bio-Rad IgG, Pyloriset EIA-A for IgA and Pyloriset EIA-G for IgG. Eradication was confirmed with antral biopsy three months after therapy.. The percentage drop in titre following treatment was significantly larger for the group of patients who were treated successfully with all four kits. Optimal cut-offs for identifying successful therapy were determined, and accuracy improved as the interval between testing and therapy was prolonged. Six months after therapy, the IgG test from Bio-Rad achieved 100% sensitivity and 80% specificity, and that from Pyloriset achieved 88% sensitivity and 100% specificity. At three months, however, test performance was quite good, with 90% sensitivity and 80% specificity when using a Pyloriset IgA titre drop of 20% or greater to predict successful eradication.. Serology is a simple, easily available, noninvasive method that exhibits good positive predictive value in the confirmation of successful cure of H pylori infection three or six months after treatment.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Antibodies, Bacterial; Double-Blind Method; Drug Therapy, Combination; Duodenal Ulcer; Enzyme-Linked Immunosorbent Assay; Female; Helicobacter Infections; Helicobacter pylori; Humans; Immunoenzyme Techniques; Immunoglobulin A; Immunoglobulin G; Male; Metronidazole; Organometallic Compounds; Predictive Value of Tests; Sensitivity and Specificity

Ulcer patients need to be treated for Helicobacter pylori infection. Seven days of quadruple therapy achieves the highest cure rates. In this study a 4-day quadruple regimen of lansoprazole, bismuth, tetracycline and metronidazole is investigated.. In an open study 66 consecutive infected patients with ulcer disease or non-ulcer dyspepsia were treated with 4-day quadruple therapy after 3 days of lansoprazole pretreatment. H. pylori status was determined before and at least 6 weeks after therapy by endoscopy with antral and corpus biopsies for rapid urease test, histology and culture.. Sixty-four patients took the medication and complete compliance was achieved in 60 (94%). Tolerability was excellent and there were no drop-outs due to side-effects. Overall 55 out of 64 (86%, 95% CI 77.4-94.4%) were cured, including 41/44 with a metronidazole-sensitive strain 5/8 with a resistant strain.. Four-day quadruple therapy is well tolerated and very effective especially in metronidazole-sensitive strains. This study lends further support for the use of one-week quadruple therapy as empiric first line anti-Helicobacter therapy for Dutch ulcer patients. If patients suffer from side-effects during this therapy stopping treatment at day 4 can be advised.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Bacterial Agents; Drug Administration Schedule; Drug Resistance, Microbial; Drug Therapy, Combination; Dyspepsia; Female; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Netherlands; Omeprazole; Organometallic Compounds; Tetracycline; Treatment Outcome

Two groups of 12 human volunteers, who had been treated with colloidal bismuth subcitrate, because of Helicobacter pylori-associated gastritis, participated in the study. The patients received a single dose of meso-2,3-dimercaptosuccinic acid (DMSA) or D,L-2,3-dimercaptopropane-1-sulfonic acid (DMPS) at a dose of 30 mg kg-1 in a randomized single blind study. In contrast to DMPS, increasing concentrations of bismuth in blood were observed during the first 4 h after intake of DMSA. In urine, both chelators induced a 50-fold increase in urinary bismuth excretion compared with the control urines. The treatment was well tolerated. The results indicate that both DMSA and DMPS effectively increase the elimination of bismuth in human urine. Consequently, both chelators may be of benefit in the treatment of patients with bismuth intoxication.

Topics: Adult; Aged; Analysis of Variance; Antacids; Bismuth; Chelating Agents; Gastritis; Helicobacter Infections; Humans; Middle Aged; Organometallic Compounds; Single-Blind Method; Succimer; Unithiol

We sought to compare a 2-day quadruple therapy with a 14-day triple therapy in the treatment of Helicobacter pylori infection.. Eighty-one consecutive patients with an endoscopically diagnosed peptic ulcer and demonstrated infection by H. pylori were included in the study. Patients were randomized to receive omeprazole 40 mg b.i.d., amoxicillin 2.5 g once daily, metronidazole 500 mg t.i.d., and bismuth subcitrate 360 mg t.i.d. for 2 days, followed by omeprazole 20 mg once daily for 6 additional days (Group 1) or a 14-day course of omeprazole 20 mg b.i.d., amoxicillin 1 g t.i.d., and metronidazole 500 mg t.i.d. (Group 2). Eradication was evaluated by antral biopsy and rapid urease test at 2 months after therapy and by C13-urea breath test after a year.. Two patients were lost to follow-up at 2 months. Intention-to-treat analysis showed that H. pylori infection was cured in 29 of 42 patients (69%; 95% CI: 53-82%) in Group 1 versus 36 of 39 (92%; 95% CI: 78-98%) of patients in Group 2 (p = 0.009). Per-protocol analysis showed a cure rate of 71% (95% CI: 55-84%) (29/41 patients) and 95% (95% CI: 81-99%) (36/38 patients), respectively (p = 0.007). Fifty-five of 65 cured patients returned 1 year after treatment (26 in Group 1, 29 in Group 2). All but one in Group 2 remained cured. There were no significant differences in compliance (88% in Group 1 versus 92% in Group 2) or in the presence of side effects (27%; 95% CI: 15-43% versus 41%; 95% CI: 26-58%; ns).. Two-day quadruple therapy is significantly less effective than 2-wk triple treatment.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Ulcer Agents; Bismuth; Drug Administration Schedule; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Peptic Ulcer; Treatment Outcome

The very high cure rate of 1-week quadruple therapy offers an opportunity to study a shorter treatment duration. This is needed to construct a time-response curve for the regimen.. Fifty-two patients with endoscopically proven H. pylori infection received lansoprazole 30 mg b.d., tripotassium dicitrato bismuthate 120 mg q.d.s., tetracycline 500 mg q.d.s. and metronidazole 500 mg q.d.s., following 3 days of lansoprazole pre-treatment. A second endoscopy was performed at least 6 weeks later. A patient was cured if histology, CLO-test, and culture of antrum and corpus were negative.. We achieved an intention-to-treat cure rate of 30/50 (60%, 95%, CI: 46-73%) and a per protocol cure rate of 30/48 (63%, 95% CI: 48-75%). Cure rate in metronidazole-sensitive strains was 24/37 (65%, 95% CI: 48-79%) and 2/5 (40%) in resistant strains. All patients that failed the regimen had a metronidazole-resistant strain post-treatment. Compliance was excellent and moderate or severe side-effects occurred in only 4% of patients.. A 2-day 'weekend' quadruple therapy cures only 60% of patients and cannot be recommended, but these findings provide an insight into the mode of action of quadruple therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Ulcer Agents; Antitrichomonal Agents; Biopsy; Clinical Protocols; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Tetracycline

We sought to evaluate the effect of Helicobacter pylori eradication in patients with fundic atrophic gastritis.. Acid secretion, gastric emptying, and histology were evaluated in 20 patients with fundic atrophic gastritis and H. pylori infection. After investigation, 10 patients (Group 1) received an eradicating treatment and 10 (Group 2) did not receive any treatment. One year later, the baseline investigations were repeated. Subsequently, patients in Group 2 received the same treatment given to patients in Group 1 and were reevaluated 12 months later. A further follow-up was performed in both groups 36 months after the treatment.. At 1-yr follow-up, all the patients in Group 1 were H. pylori negative whereas all the patients in Group 2 were still infected. In Group 1, there was a significant improvement of both fundic atrophy and acid secretion, compared with baseline (p < 0.01). In Group 2, no substantial modification of either histological or functional parameters was observed at the first follow-up; conversely, a significant (p < 0.01) improvement of fundic atrophy and acid secretion was detected in these patients 12 months after eradication of the bacterium. Histological pattern remained unchanged at 36 months of follow-up in both groups. Gastric emptying remained, on the average, unaffected by the treatment; however, three patients with delayed gastric emptying at entry had normal gastric emptying after eradication of H. pylori.. Our data suggest that mucosal atrophy can be reduced or even reversed by the eradication of H. pylori, and this is associated with a recovery of gastric function.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Atrophy; Female; Follow-Up Studies; Gastric Acid; Gastric Emptying; Gastric Fundus; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds

Despite the widely accepted view that Helicobacter pylori is the most important cause of peptic ulcer disease, recent studies have suggested that the microbe protects against nonsteroidal anti-inflammatory drug (NSAID)-associated gastroduodenal lesions and promotes ulcer healing. We investigated the effects of H. pylori eradication on the healing of NSAID-associated bleeding peptic ulcers.. Chronic NSAID users presenting with peptic ulcer haemorrhage underwent endoscopy to secure haemostasis and to document H. pylori infection by rapid urease test and culture. They were prospectively randomized to receive either omeprazole (20 mg once daily) for 8 weeks or a 1-week course of triple therapy (bismuth subcitrate 120 mg, tetracycline 500 mg, metronidazole 400 mg, all given four times daily) plus omeprazole (20 mg once daily) for 8 weeks. Endoscopy was repeated after 8 weeks. Final H. pylori status was determined by a 13C-urea breath test that was performed at least 4 weeks after discontinuation of omeprazole.. 195 H. pylori-infected NSAID users, complicated by bleeding ulcers, were randomized to receive omeprazole alone (102) or triple therapy plus omeprazole (93). 174 patients returned for second endoscopy at 8 weeks (91 in the omeprazole group, 83 in the triple therapy group). Urea breath test was negative in 14% in the omeprazole group vs. 92% in the triple therapy group (P < 0.001). Complete ulcer healing was achieved in 88 (97%) patients in the omeprazole group and 77 (93%) in the triple therapy group (P=0. 31). On intention-to-treat analysis, ulcers were healed in 86% of the omeprazole group and 83% of the triple therapy group (P=0.50). There was no significant difference in the healing rates of gastric or duodenal ulcers between the two groups.. Eradication of H. pylori did not impair the healing of NSAID-associated bleeding peptic ulcers.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer Hemorrhage; Tetracycline

A controlled, randomized study was performed in patients with active peptic ulcer disease and positive Helicobacter pylori (Hp) status to assess the clinical efficacy (endoscopic healing and eradication of Hp) of different combined treatments. In the first part of the study a treatment with omeprazole (CAS 73590-58-6) (40 mg once daily) alone (group A) or in combination with tripotassium dicitrato bismuthate (TDB; 240 mg bid, group B) for 4 weeks was evaluated in 20 and 13 patients, respectively. As expected healing rates were high and comparable (75 vs. 85%), however, Hp-eradication was zero in both groups. In the subsequent second part of the trial group A (n = 19) received omeprazole (20 mg bid) for 2 weeks + amoxicillin (CAS 26787-78-0) tablets (1 g bid only 2nd week). Accumulated healing rate increased to 95% but Hp-eradication was 37%. From group B only 8 patients participated in a second 4-week course of monotherapy with TDB. Whereas healing occurred in all individuals, Hp-eradication was still low (12.5%). In addition plasma levels (omeprazole, Bi) and urinary excretion (Bi) were monitored to test whether drug interaction and/or noncompliance of the patients could help to explain the clinical findings. Systemic availability of Bi was increased by the coadministration of omeprazole and plasma levels of omeprazole were in general higher in Hp-positive patients if compared to those of Hp-negative patients. The following conclusions could be drawn from the 4 parts of the study: Treatment of peptic ulcer disease with omeprazole either alone or in combination with TDB is effective for ulcer healing but not for eradicating Hp. Omeprazole seems to decrease the Hp-eradicating potential of Bi probably due to a drug interaction. A second treatment course with TDB is apparently not of much benefit. One week pretreatment with omeprazole does not affect healing but might attenuate Hp-eradication rate of subsequent combined treatment with amoxicillin. One week coadministration of amoxicillin is not sufficient. The magnitude of omeprazole's plasma levels has no effect on Hp-eradication rates. As the numbers of patients in this study was relatively small these conclusions need to be confirmed by larger trials.

Topics: Adult; Amoxicillin; Anti-Ulcer Agents; Drug Interactions; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Peptic Ulcer

To compare cure rates of Helicobacter pylori (H. pylori) infection, ulcer healing, and side effects of three simplified regimens of triple therapy in patients with peptic ulcer disease.. Two hundred thirty-one patients were prospectively randomized to receive either regimen OAM (omeprazole 20 mg b.i.d., amoxicillin 750 mg b.i.d., and metronidazole 400 g b.i.d.), OCM (omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d., and metronidazole 400 mg b.i.d.), or BCM (bismuth subcitrate 240 mg b.i.d., clarithromycin 250 mg b.i.d., and metronidazole 400 mg b.i.d.), all for 10 days. Side effects were reported immediately afterward in a self-administered questionnaire. Upper endoscopy was carried out before treatment and 2 months after treatment. Three antral and three corpus biopsy specimens were analyzed microbiologically and with rapid urease test to determine the presence of H. pylori. Altogether 143 patients (62%) had an active ulcer at start of treatment. Metronidazole resistant (M-R) H. pylori strains were found in 30% of patients, while none had clarithromycin resistant (C-R) strains.. According to intention-to-treat analysis, H. pylori cure rates were 91, 95, and 95% with OAM, OCM, and BCM, respectively (p = 0.63). In patients with metronidazole-sensitive (M-S) strains versus M-R strains, the cure rates were 96 versus 77% with OAM (p = 0.025), 94 versus 94% with OCM, and 94 versus 96% with BCM. Ulcer healing rates were 95, 94, and 92%, respectively (p = 0.91). There were no significant differences in side effects between the regimens, and only five patients (2%) had to stop the treatment prematurely.. All treatment regimens were highly effective for cure of H. pylori infection and for ulcer healing. Metronidazole resistance reduced the efficacy of OAM, but was of no importance for the efficacy of OCM or BCM. Side effects were of minor importance.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Resistance; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Norway; Omeprazole; Organometallic Compounds; Penicillins; Prospective Studies; Stomach Ulcer

Peptic ulcer patients need to be treated with antimicrobials to cure Helicobacter pylori infection. Seven-day quadruple therapy is the regimen with the highest cure rates. An ultra-short quadruple therapy was evaluated prospectively.. Forty-six consecutive H. pylori positive patients (33 had proven ulcer disease) were prescribed lansoprazole 30 mg b.d. on days 1-4, and on day 4 they received in addition tripotassium dicitrato bismuthate 120 mg, tetracycline 250 mg and metronidazole 250 mg at 09.00, 11.00, 13.00, 15.00, 17.00, 19.00, 21.00, 23.00 hours. Repeat endoscopy with biopsies for CLOtest, Giemsa stain and culture was carried out 6 weeks later.. Follow-up was complete. Overall cure rate (all three biopsy-based tests negative) was 26/46 (57%; 95% CI: 41-71%). Antibiotic sensitivity was available in 42. Thirty-nine carried a metronidazole sensitive strain and 23/39 (59%) were cured, three carried a resistant strain and therapy failed in all. Three out of four in whom susceptibility was unknown were cured. Metronidazole resistance was induced in 8 out of 16 with a sensitive strain. Only one patient (3%) reported severe side effects.. This convenient quadruple regimen showed that a short contact time is sufficient to kill H. pylori in vivo. Since 57% of patients are cured with a 14-h treatment, a slightly longer treatment duration may increase the cure rate to above 90%.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Diarrhea; Drug Therapy, Combination; Dyspepsia; Endoscopy, Gastrointestinal; Enzyme Inhibitors; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Proton Pump Inhibitors; Tetracycline

One-week bismuth triple therapy has been established to be highly effective in curing H. pylori infection, but patient compliance has been the major factor of success in therapy. For patients hospitalized for ulcer bleeding, an effective regimen that can completed before discharge will ensure full compliance.. To compare 2-day versus 1-wk bismuth triple therapy plus omeprazole in curing H. pylori infection and bleeding peptic ulcers.. 100 patients with non-actively bleeding duodenal (DU) or gastric ulcers (GU) and confirmed H. pylori infection were randomized to receive either bismuth subcitrate 120 mg, tetracycline 500 mg, and metronidazole 400 mg four times daily for 1 wk (OBTM-7) or bismuth subcitrate 240 mg, tetracycline 500 mg, and metronidazole 400 mg four times daily for 2 days (OBTM-2). Both groups of patients also received omeprazole 20 mg twice daily for the first week. In the OBTM-2 group, the anti-Helicobacter therapy was finished during hospitalization. Endoscopy was repeated 5 wk after randomization to monitor ulcer healing and determine H. pylori status. Side effects related to the anti-Helicobacter therapy was graded as follows: A, mild discomfort, which did not affect daily activity; B, moderate discomfort affecting daily activity; and C, severe discomfort and patients discontinued therapy.. Forty-six patients in the OBTM-2 group and 50 in the OBTM-7 group returned for follow-up endoscopy. With an intention-to-treat analysis, ulcer healing was achieved in 44 of 46 patients (95.7%) in the OBTM-2 group versus 49 of 50 (98%) in the OBTM-7 group, p = 0.61. H. pylori eradication was successful in 35 of 46 patients (76.1%) in the OBTM-2 and in all 50 patients (100%) in the OBTM-7 group, p = 0.00024. There was no difference in the severity of side effects experienced by the patients in the OBTM-2 group than in the OBTM-7 group (19 vs 32%, p = 0.16). None of the patients had rebled during the period of follow-up.. Despite similar efficacy in ulcer healing, the 2-day quadruple therapy is less effective than the 1-wk regimen in curing H. pylori infection.

Topics: Activities of Daily Living; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Administration Schedule; Duodenal Ulcer; Endoscopy, Gastrointestinal; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Hospitalization; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Patient Compliance; Peptic Ulcer Hemorrhage; Stomach Ulcer; Tetracycline

Helicobacter pylori is associated with primary antral gastritis, duodenal ulceration, and gastric cancer. Current regimens for treating infection in children using bismuth and antibiotics for two to six weeks are cumbersome. The aim of this study was to evaluate a one week course of treatment. All children undergoing endoscopy were assessed for the presence of H pylori by culture, histology, rapid urease test, and 13C urea breath test. Infected children received a one week course of colloidal bismuth subcitrate 480 mg/1.73 m2/day (maximum 120 mg four times a day), combined with metronidazole 20 mg/kg/day (maximum 200 mg three times a day), and clarithromycin 15 mg/kg/day (maximum 250 mg twice a day). To optimise compliance, drugs were dispensed in a 'Redidose' box containing a compartment for each day, and subcompartments marked 'breakfast', 'lunch', 'dinner', and 'bedtime'. Compliance and side effects were assessed immediately after treatment. A urea breath test was performed at least one month after treatment. Twenty two children infected with H pylori were entered into the study; 20 of these took all doses; two children suffered significant side effects (diarrhoea and vomiting). H pylori was eradicated in 21 of the 22 children (95.45%; 95% confidence interval 77% to 100%). This study shows that H pylori infection in children can be cleared by a one week course of treatment.

Topics: Adolescent; Anti-Bacterial Agents; Antitrichomonal Agents; Bismuth; Breath Tests; Child; Child, Preschool; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Infant; Metronidazole; Organometallic Compounds

The relationship between Helicobacter pylori infection and non-ulcer dyspepsia is controversial.. In a prospective, long-term, double-blind study we randomized 100 patients with non-ulcer dyspepsia and H. pylori infection to receive either of two treatment regimens: 1) bismuth-based triple therapy (n = 50) or 2) bismuth + placebo (n = 50).. Triple therapy: subjects who became H. pylori-negative (n = 42) showed a significant symptomatic response when interviewed at 8 weeks, 6 months, and 1 year (P < 0.01). This improvement was evident in the 'ulcer-like' dyspepsia group at all times (P < 0.01) but in the 'reflux-like' and 'motility-like' groups at 6 months only (P < 0.01). Those who remained H. pylori-positive showed no decrease in symptoms at 8 weeks, 6 months, and 1 year. Bismuth-placebo therapy: subjects who became H. pylori-negative (n = 7) showed an improvement in symptoms at 8 weeks, 6 months, and 1 year. Those who continued to harbour the infection after treatment (n = 42) showed an insignificant improvement in the motility and non-specific groups only.. This study shows that eradication of H. pylori results in a significant long-term reduction in symptoms of non-ulcer dyspepsia.

Topics: Adult; Anti-Bacterial Agents; Bismuth; Double-Blind Method; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Prospective Studies; Tetracycline; Time Factors

In this random study, the efficacy of either colloidal bismuth subcitrate (CBS) or metronidazole in combination with an H2-antagonist in the treatment of various gastric pathologies was evaluated, along with the trends in antibody levels. Among the 40 Helicobacter pylori-positive patients with various gastroduodenal pathologies who underwent chemotherapy, 27 were treated with CBS and 13 with metronidazole. H. pylori was eradicated in 48.14% of the patients treated with CBS and 53.8% of those treated with metronidazole. After therapy, no statistically significant or slight decrease in the serum levels of antibodies was found.

Topics: Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Immunoglobulin A; Immunoglobulin G; Metronidazole; Middle Aged; Organometallic Compounds

Helicobacter pylori (Hp) eradication in peptic ulcer disease is associated with a greatly reduced recurrence rate. The optimal drug regimen for HP eradication remains uncertain. It is also unclear if eradication of Hp in duodenitis and antral gastritis improves symptoms. The aims of this study were to compare the efficacy of three drug regimens in the eradication of Hp and to assess if Hp eradication improved symptoms in patients with duodenitis and antral gastritis. Patients (n = 79) found to have duodenal ulcer, duodenitis and/or antral gastritis with a positive urease test (CLO) at endoscopy were allocated to one of the three regimens: A. omeprazole 20 mg b.d. and clarithromycin 500 mg t.d.s. for two weeks (n = 27), B. De-Nol 240 mg b.d. for four weeks, metronidazole 400 mg t.d.s. and amoxicillin 500 mg t.d.s. for one week (n = 26), and C. omeprazole 20 mg b.d. and amoxicillin 500 mg t.d.s. for two weeks (n = 26). In conclusion, traditional 'triple' therapy with bismuth and two antibiotics achieved the highest Hp eradication rate and was best tolerated. Recolonisation with Hp was uncommon after eradication. Dyspeptic symptoms improved with Hp eradication in duodenitis and antral gastritis.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Bismuth; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Duodenitis; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Treatment Outcome

Helicobacter pylori infection is common in patients with peptic ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). But the pathogenic role of H pylori in this disease is controversial. We studied the efficacy of eradication of H pylori in the prevention of NSAID-induced peptic ulcers.. We recruited patients with musculoskeletal pain who required NSAID treatment. None of the patients had previous exposure to NSAID therapy. Patients who had H pylori infection but no pre-existing ulcers on endoscopy were randomly allocated naproxen alone (750 mg daily) for 8 weeks or a 1-week course of triple therapy (bismuth subcitrate 120 mg, tetracycline 500 mg, metronidazole 400 mg, each given orally four times daily) before administration of naproxen (750 mg daily). Endoscopy was repeated after 8 weeks of naproxen treatment or when naproxen treatment was stopped early because of bleeding or intractable dyspepsia. All endoscopic examinations were done by one endoscopist who was unaware of treatment assignment. The primary endpoint was the cumulative rate of gastric and duodenal ulcers.. 202 patients underwent endoscopic screening for enrolment in the trial, and 100 eligible patients were randomly assigned treatment. 92 patients completed the trial (47 in the naproxen group, 45 in the triple-therapy group). At 8 weeks, H pylori had been eradicated from no patients in the naproxen group and 40 (89%) in the triple-therapy group (p < 0.001). 12 (26%) naproxen-group patients developed ulcers: five had ulcer pain and one developed ulcer bleeding. Only three (7%) patients on triple therapy had ulcers, and two of these patients had failure of H pylori eradication (p = 0.01). Thus, 12 (26%) patients with persistent H pylori infection but only one (3%) with successful H pylori eradication developed ulcers with naproxen (p = 0.002).. Eradication of H pylori before NSAID therapy reduces the occurrence of NSAID-induced peptic ulcers.

Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Bismuth; Drug Administration Schedule; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Naproxen; Organometallic Compounds; Prospective Studies; Stomach Ulcer; Tetracycline

In an attempt to increase the efficacy and simplicity of FDA-approved regimens for Helicobacter pylori, we studied (1) addition of an inexpensive antibiotic (amoxicillin) to twice-daily ranitidine bismuth citrate (RBC)-clarithromycin dual therapy, and (2) substitution of RBC for bismuth subsalicylate + H2-receptor antagonist in bismuth-based triple therapy.. Subjects with previously untreated Helicobacter pylori infection documented by 13C-urea breath test plus either endoscopic biopsy or serology were randomly assigned to a 2-wk course of (1) RBC 400 mg b.i.d., amoxicillin 1 g b.i.d., and clarithromycin 500 mg b.i.d. (RAC), or (2) RBC 400 mg b.i.d., metronidazole 250 mg t.i.d., and tetracycline 500 mg t.i.d. (RMT). Repeat breath test was performed 4 wk after the completion of therapy.. Intent-to-treat and per-protocol cure rates for RAC were 46 of 50 patients (92%) and 45 of 47 patients (96%); for RMT they were 40 of 50 patients (80%) and 37 of 42 patients (88%). Study drugs were stopped due to side effects in three patients (6%) taking RAC and six patients (12%) taking RMT.. Twice-daily RBC-based triple therapy with clarithromycin and amoxicillin produces Helicobacter pylori eradication rates over 90%, which is comparable to rates seen with proton pump inhibitor-based triple therapies. RBC also may be substituted for bismuth subsalicylate and an + H2-receptor antagonist in standard bismuth-based triple therapy.

Topics: Adult; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Biopsy; Bismuth; Breath Tests; Carbon Isotopes; Clarithromycin; Drug Combinations; Female; Follow-Up Studies; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Male; Metronidazole; Organometallic Compounds; Penicillins; Peptic Ulcer; Proton Pump Inhibitors; Ranitidine; Salicylates; Tetracycline; Urea

One hundred twenty-two patients were randomly assigned to three groups of treatment (A, B, and C), with (1) ranitidine (300 mg q.d. for 6 weeks), (2) ranitidine (300 mg q.d. for 6 weeks) with amoxicillin (500 mg t.i.d.) and metronidazole (500 mg b.i.d.) for the first 12 days, or (3) colloidal bismuth subcitrate (120 mg q.i.d. for 6 weeks) with amoxicillin and metronidazole (at same dosages as in the latter group). Six weeks after the beginning of treatment, an endoscopy showed that ulcers had healed in 49 of 52 patients (94.2%) from whom Helicobacter pylori had been eradicated and in 59 of 70 patients (84.3%) from whom it had not (NS). The rates of H. pylori eradication in groups A, B, and C were zero, 47.5%, and 86.8%, respectively. At 6, 12, and 18 months, an endoscopy was repeated for monitoring ulcer recurrence and H. pylori status. Reinfection rates at 6 months were 42.1% and 15.1% in groups B and C, respectively (P < .05). At 18 months, ulcers recurred in 82.9% (63) of 76 patients with noneradicated H. pylori infection, vs. 5.7% (2) of 35 patients without H. pylori infection (P < .001). We conclude that colloidal bismuth subcitrate is more effective for eradication of H. pylori than ranitidine when given with amoxicillin plus metronidazole for the treatment of duodenal ulcer, as both early reinfection and ulcer recurrence are diminished.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptic Ulcer; Ranitidine; Recurrence

We investigated whether addition of bismuth subcitrate (BSC, 4 x 120 mg) to a two week therapy scheme of omeprazole (OME, 2 x 40 mg)/amoxicillin (AMO, 4 x 500 mg) increases Helicobacter pylori eradication.. Patients with dyspepsia underwent upper endoscopy. H. pylori positive patients were randomized to treatment A (OME/AMO, 83 patients) or treatment B (OME/AMO/BSC, 84 patients).. In 65 patients of group A (78%) H. pylori was eradicated as determined from the histological assessment (Sydney classification) of antrum and corpus biopsies. In comparison, in 68 patients of group B (81%) H. pylori was eradicated (p = NS between groups). H. pylori eradication in both groups was associated similarly with a decrease of inflammation and activity whereas atrophy and intestinal metaplasia were not affected. A positive association was revealed between the decrease of H. pylori score and the decrease of both inflammation and activity scores for antrum as well as corpus biopsies.. Addition of BSC to OME/AMO does not increase H. pylori eradication in patients with dyspepsia. Eradication of H. pylori is associated with disappearance of epithelial damage (inflammation and activity) in antral and corpus mucosa.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Atrophy; Biopsy; Data Interpretation, Statistical; Diarrhea; Digestive System; Drug Therapy, Combination; Female; Gastroenteritis; Helicobacter Infections; Helicobacter pylori; Humans; Inflammation; Male; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Pyloric Antrum; Time Factors; Treatment Outcome

Helicobacter pylori infection is mainly acquired in childhood, and studies on the epidemiology of this infection depend on the availability of a noninvasive diagnostic test for use in children. The aim of this study was to determine whether the carbon 13-labeled urea breath test (UBT) can be used in children by evaluating: (1) its sensitivity and specificity compared with either culture or both rapid urease test and histologic examination, (2) whether a test meal or a prolonged fast is required, (3) the usefulness after treatment for H. pylori. Eighty-eight children (mean age, 10.6 +/- 4.19 years) who were undergoing upper endoscopy were studied while fasting, not fasting, and after treatment. Children were given 50 mg of 13C-urea if they weighed less than 50 kg or 75 mg of 13C-urea if they weighed more than 50 kg with 50 mg of a glucose polymer solution in 7.5 ml of water. Breath samples were collected at baseline and at 15, 30, 45, and 60 minutes. In 63 fasting children the UBT was 100% sensitive and 97.6% specific at 30 minutes with a cutoff value of 3.5 delta 13CO2 per mil. Nonfasting tests in 23 children, performed between 1 and 2 hours after their usual meal, were 100% sensitive and 91.6% specific. In 13 children fed directly before the UBT, the sensitivity of the test was reduced to 50%. Thirty minutes was the optimal sampling time. There was a significant decrease in specificity when samples were obtained at 15 minutes, possibly caused by the interference of oral urease-producing organisms. The test was 100% sensitive and specific in 20 children after treatment for H. pylori infection. The UBT is a highly sensitive and specific test for the diagnosis of H. pylori infection in children. Neither a prolonged fast nor a test meal is required.

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Biopsy; Breath Tests; Carbon Radioisotopes; Child; Child, Preschool; Fasting; Female; Gastric Mucosa; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Infant; Male; Metronidazole; Organometallic Compounds; Predictive Value of Tests; Sensitivity and Specificity; Urea

In a pilot study, ranitidine bismuth citrate (RBC; Pylorid, Tritec) in coprescription with clarithromycin achieved a Helicobacter pylori eradication rate (based on 13C urea breath test alone) of 83%. The aim of the current study was to validate this finding by using three diagnostic tests and a larger group of H. pylori-positive patients with active duodenal ulcer.. In a blinded study, 95 patients were given either 4 weeks of treatment with RBC, 400 mg bid, alone (RBC400, n = 31) or RBC, 400 mg bid or 800 mg bid, in coprescription with clarithromycin, 250 mg qid for 14 days, followed by 14 days of RBC, 400 mg bid, alone (RBC400 + CLAR and RBC800 + CLAR, respectively; n = 32 for each). Rates of ulcer healing at week 4 and of H. pylori eradication (assessed by antral and corpus urease tests and histology and by 13C urea breath test) at week 8 were compared, together with the incidence of adverse events.. All three regimens were effective at duodenal ulcer healing and were tolerated well. The coprescription regimens gave significantly higher observed H. pylori eradication rates (82% and 74% for RBC400 + CLAR and RBC800 + CLAR) compared with RBC400 (0%; p < .001).. RBC in dual therapy with clarithromycin provides excellent H. pylori eradication therapy and is an effective duodenal ulcer healing drug.

Topics: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Double-Blind Method; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Middle Aged; Organometallic Compounds; Ranitidine; Treatment Outcome

In this study we compared the cure rates of two clarithromycin-based regimens in patients in whom anti-Helicobacter pylori therapy had previously failed.. Thirty-three patients were randomized to receive either regimen OAC (20 mg omeprazole, 750 mg amoxicillin, and 250 mg clarithromycin) or BTC (240 mg bismuth subcitrate, 750 mg oxytetracycline, and 250 mg clarithromycin), all twice daily for 10 days. A further 28 patients were all treated with OAC. Previously failed therapy included combinations of bismuth (B), omeprazole (O), tetracycline (T), metronidazole (M), amoxicillin (A), or clarithromycin (C) in BTM (n = 48), OAM (n = 13), OA (n = 7), OCM (n = 2), or BCM (n = 1). H. pylori infection was confirmed by culture of biopsy specimens, and antimicrobial susceptibility testing was performed with the E test.. H. pylori infection was cured in all patients (n = 18) with OAC and in 8 patients (53%) with BTC (P = 0.001) in the randomized group and in 27 patients (96%) receiving OAC in the open-label group.. Ten-day OAC is highly effective and superior to BTC in patients in whom metronidazole-based treatment has previously failed.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Antitrichomonal Agents; Clarithromycin; Drug Evaluation; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Omeprazole; Organometallic Compounds; Oxytetracycline; Prospective Studies

Bleeding peptic ulcer is the most important cause of upper gastrointestinal bleeding. Our aim was to compare the effect of anti-Helicobacter therapy with maintenance treatment of H2-receptor antagonist in the prevention of relapses of ulcer and bleeding. Patients with bleeding duodenal or gastric ulcers and H. pylori infection were randomized to receive either a one-week course of triple therapy with bismuth subcitrate, metronidazole, and tetracycline plus ranitidine or a six-week course of ranitidine 300 mg/day. After the ulcers healed, the antibiotic-treated patients were not given any medication, whereas the ranitidine-treated patients continued to receive a maintenance dose of 150 mg/day. One hundred twenty-six patients were randomized to receive anti-Helicobacter therapy and 124 patients to receive long-term ranitidine. H. pylori eradication was achieved in 98.2% in those who received triple therapy and 6.1% in those who received ranitidine (P < 0.0001). At the six-week follow-up, ulcer healing was documented in 88.2% in those who received triple therapy and 86.1% in those who received ranitidine (P = 0.639). Recurrent ulcer developed in nine of the ranitidine-treated patients and three of them presented with recurrent upper gastrointestinal bleeding. One patient in the antibiotic group developed recurrent ulcer without rebleeding (P = 0.01). It is concluded that eradication of H. pylori is sufficient for the prevention of recurrent bleeding ulcers.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptic Ulcer Hemorrhage; Ranitidine; Recurrence; Tetracycline

To investigate the efficacy and safety of daily low-dose colloidal bismuth subcitrate in reducing duodenal ulcer relapse.. Double-blind, double-dummy group comparative clinical trial with random allocation. Healing Phase: colloidal bismuth subcitrate 240 mg twice daily vs ranitidine 150 mg twice daily for up to 12 weeks. Maintenance Phase: nightly, colloidal bismuth subcitrate 120 mg vs ranitidine 150 mg vs placebo for up to 12 months (high-risk patients received active treatment only).. clinical, endoscopy, random blood bismuth levels (and rapid urease test for Helicobacter pylori in a subgroup).. 194 with active duodenal ulcer.. Cumulative healing at 12 weeks was 93% on colloidal bismuth subcitrate (of 92 patients) and 97% on ranitidine (of 102 patients). Relapse at 1 year was significantly less on active treatment as follows: placebo (50 patients) 60%; ranitidine (71 patients) 21%; colloidal bismuth subcitrate (64 patients) 33%. This was independent of the results of the rapid urease test which was positive in 78%, 88% and 76% of the patients respectively. Treatment was well tolerated. The highest median blood bismuth level (mcg/L) was 25 in the healing phase and fluctuated between 6 and 10 in the maintenance phase.. Colloidal bismuth subcitrate, 120 mg nightly, is effective in reducing duodenal ulcer relapse and is well tolerated.

Topics: Adult; Aged; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Double-Blind Method; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Ranitidine; Recurrence

this study compares the efficacy and side effects of the two commonly used treatment regimens for Helicobacter pylori infection.. 118 patients with culture-proven H. pylori infection (61 with duodenal ulcer, 19 with gastric ulcer, three with both duodenal and gastric ulcer, and 35 with non-ulcer dyspepsia) were randomized to receive either triple therapy (tetracycline 250 mg, metronidazole 250 mg, colloidal bismuth subcitrate 120 mg, four times daily) for 14 days or amoxicillin 1000 mg and omeprazole 40 mg both twice daily for 14 days. The isolated H. pylori strain was metronidazole susceptible in 93%. Antral biopsy samples were taken for culture, urease testing, histology and, in most patients, for PCR at least 6 wk after treatment. A separate corpus sample was taken for culture. Eradication was defined as the absence of H. pylori in all specimens. In seven cases, when only histology was doubtfully positive, and all other tests including PCR were negative, a 13C-urea breath test was performed, the result of which was recorded by the patient on a semi-quantitative scale.. H. pylori was eradicated by triple therapy in 96.3% and by amoxicillin/omeprazole in 77.2% of the patients (p = 0.008). Side effects occurred more often with triple therapy (72.7% vs. 50.8%; p< 0.05) but were mild in most cases. Severe side effects occurred equally in both treatment groups.. When the prevalence of metronidazole resistance is low, triple therapy is more effective than amoxicillin/omeprazole. Side effects occur more often in triple therapy but are mild in most cases.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Colloids; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Patient Compliance; Penicillins; Prospective Studies; Tetracycline; Time Factors

The pathogenesis of gastric metaplasia (GM) in the duodenum is unclear. The aim of this investigation was to study the effect on the extent of GM of ulcer healing, Helicobacter pylori eradication, and acid suppression singly and in combination. The relationship between GM and gastroduodenal inflammation and H. pylori infection density was also studied.. Duodenal and gastric antral biopsy specimens were obtained from H. pylori-positive patients with duodenal ulcer and from H. pylori-positive nonulcer subjects. Biopsy procedures from patients with duodenal ulcer were repeated after 6 months of treatment. Nonulcer subjects were treated symptomatically and did not undergo re-endoscopy.. Ulcer healing alone produced no change in GM or in gastroduodenal inflammation. H. pylori eradication produced a 42% reduction in GM and improvement in inflammation. Acid suppression produced a 43% reduction in GM but without a significant change in inflammation. A combination of H. pylori eradication and acid suppression produced an additive effect with a 66% reduction in GM. A positive relationship was detected between the extent of GM and antral H. pylori density, duodenitis score, and antral gastritis score.. This study shows that the extent of duodenal GM is unrelated to the presence or absence of ulceration but is partly due to H. pylori and partly due to acid.

Topics: Adult; Aged; Amoxicillin; Antacids; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Duodenitis; Duodenum; Female; Gastric Acid; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metaplasia; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins

We compared the ulcer healing effect and eradication of H. pylori by one-week triple therapy of bismuth, metronidazole, and tetracycline with two-week dual therapy of amoxicillin and omeprazole. One hundred twelve patients with confirmed H. pylori infection and duodenal ulcers were recruited in a prospective, randomized, single-blinded trial. Ulcer healing, eradication of H. pylori in the stomach six weeks after randomization and side effect reported by patients during the therapy. Duodenal ulcers were healed in 44 of 49 (89.8%, 95% CI, 81.3-98.3 %) patients receiving triple therapy and in 44 of 53 (83.0%, 95% CI, 72.9-93.1%) patients receiving dual therapy (P=0.32). H. pylori was successfully eradicated in 41 of 49 (83.6%, 95% CI 73.4-94%) patients and in 40 of 53 (75.5%, 95% CI 63.9-87.1%) patients in the triple therapy group and the dual therapy group respectively (P=0.31). Side effects experienced by patients who received triple therapy were significantly more frequent than those who received dual therapy (P=0.0076). In conclusion, a two-week course of omeprazole and amoxicillin achieves a comparable rate of H. pylori and ulcer healing with fewer side effect.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Chi-Square Distribution; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Prospective Studies; Single-Blind Method; Tetracycline; Time Factors

Our objective was to assess the effectiveness of therapy for Helicobacter pylori (HP) on the prevention of recurrent bleeding in patients with recent upper gastrointestinal hemorrhage from peptic ulcers.. We performed a prospective follow-up study without randomization on 125 consecutive patients (83 males and 42 females) who had presented with their first major episode of upper gastrointestinal hemorrhage from peptic ulcer (22 gastric and 103 duodenal ulcers). All 125 patients were HP-positive. During the acute phase of bleeding, all patients were treated with standard supportive measures. After the acute bleeding phase, patients were allocated to two treatment groups: 1) antimicrobial therapy-84 patients received one of the following three regimens: 1) amoxicillin 500 mg t.i.d. for 10 days + omeprazole 20 mg b.i.d. for 30 days; 2) clarythromycin 500 mg t.i.d. for 12 days + omeprazole 20 mg b.i.d. for 30 days; or 3) amoxicillin 500 mg t.i.d. for 10 days + metronidazole 500 mg t.i.d. for 10 days + colloidal bismuth subcitrate 240 mg b.i.d. for 30 days. For long-term antisecretion maintenance treatment, 41 patients were allocated to either omeprazole 20 mg once a day or ranitidine 150 mg once a day, for 1 yr.. During the follow-up period, peptic ulcers recurred in six patients in the antibiotic group (7.14%) and 13 patients in the maintenance group (31.7%) (p < 0.001). The fraction of patients without recurrent bleeding was greater in the antibiotic group than in the maintenance group. Two patients in the antibiotic group (2.3%) and five in the maintenance group (12.1%) had recurrent hemorrhages (p < 0.1).. Cure of HP infection reduces the recurrence of peptic ulcer and of rebleeding from ulcer disease more effectively than does long-term maintenance therapy.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer Hemorrhage; Prospective Studies; Ranitidine; Recurrence; Stomach Ulcer; Time Factors

The aim of this study was to assess the effect of colloidal bismuth subcitrate (CBS) and metronidazole on Helicobacter pylori eradication and on the course of symptoms due to functional dyspepsia. Forty-one patients with functional dyspepsia were entered into the study and randomized to treatment with CBS (120 mg four times a day) for four weeks combined with metronidazole (250 mg four times a day) for one week (group A, N = 21) or matching placebo (group B, N = 20). The severity of gastritis and of bacterial colonization and the symptom score was assessed by endoscopy and clinical evaluation at baseline and after four, eight, and 24 weeks from the start of the treatment. With intent-to-treat analysis eradication was achieved in 16/25 (64%) patients in group A and in 6/24 (25%) in group B. At eight and 24 weeks the gastritis score was significantly lower only in those patients with eradication. No change was seen in patients in whom the bacteria was not eradicated. The symptom score at eight weeks was considerably lower both in patients with eradication and in those with infection. However, at 24 weeks a gradual decrease in the symptom score in patients with eradication and a worsening of symptoms in controls was observed. No differences were observed between patients with ulcerlike and those with dysmotility-like dyspepsia. The study confirms the need for a long observation period after antibacterial treatment in patients with functional dyspepsia and suggests that Helicobacter pylori-eradicating treatment improves the course of this functional syndrome.

Topics: Adolescent; Adult; Anti-Bacterial Agents; Double-Blind Method; Drug Therapy, Combination; Dyspepsia; Female; Follow-Up Studies; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds

To evaluate clarithromycin 500 mg t.d.s., tripotassium dicitrato bismuthate 240 mg b.d. and omeprazole 20 mg b.d. for 7 days as a Helicobacter pylori treatment regimen.. The H. pylori status of dyspeptic patients undergoing endoscopy was assessed by histology, culture and rapid urease testing of biopsies and by 13C-urea breath test. Fifty patients who were H. pylori-positive were treated with the above treatment regimen for 7 days. Those patients with active duodenal ulcers present at endoscopy were given omeprazole 20 mg nocte for a further 21 days. Not less than 28 days after completing treatment, all tests were repeated to reassess H. pylori status. Bacterial sensitivity of H. pylori cultures was determined and patients recorded any side-effects.. On an intention-to-treat basis, H. pylori infection was cured in 90% (95% CI: 78-96%) of patients. Taste disturbance was experienced by 35% patients. Compliance was excellent, with 96% patients taking more than 95% of tablets. Metronidazole resistance was 41% but all cultures were sensitive to clarithromycin.. This 7-day treatment achieved a high level of cure of H. pylori infection with relatively minor side-effects. It may have a role to play, particularly where there is a high level of metronidazole resistance.

Topics: Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Patient Compliance; Urea

We have advocated quadruple therapy as the optimal therapy for cure of Helicobacter pylori infection. In this study, we investigated the efficacy and tolerability of 4-day therapy with lansoprazole, bismuth, tetracycline, and metronidazole.. In a prospective open study, 51 consecutive patients, most of them with chronic peptic ulcer disease and biopsy proven H. pylori infection, received 4-day lansoprazole quadruple therapy after 3 days of lansoprazole pretreatment. Repeat endoscopy was performed 6 wk later, with antral and corpus biopsies for rapid urease test, histology, and culture. A patient was considered cured if three methodologies had negative results.. By intention-to-treat, 48 of 51 patients (94%) (95% CI 84%-99%) were cured; per protocol, 48 of 49 (98%) (95% CI 89%-100%) were cured. In 14 patients, the bacterial isolates were tested for metronidazole susceptibility: 12/12 with a sensitive strain were cured, as were 2/2 with a resistant strain. The regimen was well tolerated. Most side effects were mild, and none caused treatment to be stopped prematurely.. Four-day lansoprazole quadruple therapy achieves a very high cure rate in an unselected population of mainly ulcer patients. Furthermore, the regimen is short, can be used in patients allergic to penicillin, and is well tolerated, with no dropouts due to side effects. Presently, this regimen should be used only in patients with a metronidazole-sensitive pre-treatment bacterial isolate. When empiric treatment is used, 7-day quadruple therapy remains the therapy of choice, because it has well-documented efficacy against metronidazole-resistant strains. Further studies are needed to define the optimal treatment duration for quadruple therapy in patients with metronidazole-resistant strains.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Bacterial Agents; Bismuth; Drug Therapy, Combination; Duodenal Ulcer; Enzyme Inhibitors; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Premedication; Prospective Studies; Proton Pump Inhibitors; Tetracycline; Time Factors

There is a need to develop alternative regimen(s) for treating Helicobacter pylori infection because of problems of drug compliance, side-effects and resistance with the conventional regimen consisting of bismuth, metronidazole and an antibiotic.. To compare prospectively the efficacy of conventional triple therapy (bismuth subcitrate 120 mg QID, amoxycillin 500 mg QID and metronidazole 400 mg TID for 2 weeks with one containing omeprazole (20 mg OD), bismuth subcitrate and amoxycillin (regimen B).. Sixty two consecutive patients with H pylori infection associated with antral gastritis and/or duodenal ulcer were randomized to two treatment groups and re- evaluated after completion of 2 weeks of therapy and then after a further 4 weeks for eradication of H pylori, ulcer healing and drug side-effects.. Regimen B resulted in higher H pylori eradication rate as compared to regimen A (76.7% vs 63.3%, better ulcer healing rate (90.9%, vs 70.6%), lesser side-effects (10.0% vs 36.7%) and better drug compliance (100% vs 93.3%). The difference between the two regimens was significant (p < 0.05) only in respect to side-effects.. For H pylori eradication, omeprazole, bismuth and amoxycillin combination for 2 weeks is as effective as the conventional therapy and is better tolerated.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Omeprazole; Organometallic Compounds; Prospective Studies; Time Factors

Colloidal bismuth subcitrate (CBS) causes endoscopic and histological improvement in gastritis and eradication of Helicobacter pylori in patients with non-ulcer dyspepsia (NUD). The effect of sucralfate, a cytoprotective drug, on endoscopic and histologic gastritis and H pylori clearance is not clear. We studied the effect of CBS and sucralfate on these features in patients with NUD.. Sixty three patients with NUD and H pylori infection were randomized to receive one of the following for four weeks: (i) CBS (240 mg twice daily) (Group 1); (ii) placebo I, similar in size, color and shape to CBS (Group 2); (iii) sucralfate (2.0 g twice daily) (Group 3) and (iv) placebo II, similar to sucralfate (Group 4). Symptoms, endoscopic and histological findings and H pylori status were assessed before and after treatment.. Similar symptomatic improvement was observed with each treatment, indicating a placebo effect. Significant endoscopic and histological improvement was observed with CBS only. CBS was better than sucralfate in inducing endoscopic and histological improvement. Clearance rate of H pylori was 46.6% with CBS, 16.6% with its placebo, 33.3% with sucralfate and 13.3% with its placebo.. CBS is more effective than sucralfate in inducing endoscopic and histologic healing of H pylori-related gastritis among NUD patients.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Dyspepsia; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Organometallic Compounds; Sucralfate

The efficacy of a new combination preparation containing bismuth citrate and amoxicillin in one tablet was compared with the efficacy of bismuth citrate monotherapy in a randomised double-blind study on the eradication of Helicobacter pylori. The study involved 70 H. pylori positive (antrum biopsies showing a positive urease test) patients with non-ulcer dyspepsia and chronic gastritis. The treatment period was 14 days; 35 patients in group 1 received 2 tablets tid containing the bismuth citrate amoxicillin combination (BIAM tablet; 250 mg amoxicillin base and 120 mg bismuth); 35 patients in group 2 were treated with 2 tablets tid containing bismuth citrate (BI tablet; 120 mg bismuth). Total daily dose was therefore 1500 mg amoxicillin + 720 mg bismuth in group 1 patients resp. 720 mg bismuth in group 2 patients. 4 weeks after therapy H. pylori could not be histologically detected in the antrum of 22 patients (63%) in group 1 and 8 patients (24%) in group 2. Thus in group 1 (BIAM) a significantly higher eradication rate (p < 0.001) was shown than in group 2 (BI). Inflammation characterized by the infiltration of polymorphonuclear cells was significantly (p < 0.01) less pronounced in group 1 (BIAM) than in group 2 (BI) 4 weeks after the end of treatment. Gastrointestinal distress was quantified by evaluation of 13 different symptoms using a fourpoints scale at the beginning of the study and after 2 and 6 weeks. The sum of scores decreased by 81% in group 1 (BIAM) and 71% in group 2 (BI) after 6 weeks.

Topics: Adult; Aged; Amoxicillin; Anti-Ulcer Agents; Double-Blind Method; Drug Combinations; Dyspepsia; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds

We have shown that 4 days of quadruple therapy after omeprazole pre-treatment is an effective therapy for curing H. pylori infection. In this study we investigated whether this regimen would maintain the high cure rate during long-term follow-up. Some recent studies have reported high recurrence rates after apparent cure. Apparently not all methods to test for cure have sufficient sensitivity to pick up small numbers of residual bacteria. This study also served to investigate whether our methods to test for cure 5-6 weeks post-treatment were reliable.. All patients from a previous study were invited to return for a 14C-urea breath test and serology. A representative group of 37 patients (76%) returned for a urea breath test and serology. The mean follow-up was 14.7 months (range 11.4-23.6 months).. None of the 37 patients had a positive urea breath test results. IgG antibody titres fell steadily in all patients, showing a mean decrease of 83% at the end of the follow-up. None of the patients showed an increase in titre. Reinfection was therefore 0% (0 of 37).. Four days of quadruple therapy seems to be an effective therapy for the eradication of H. pylori as evidenced after long-term follow-up. Our biopsy methodology is reliable in identifying treatment failures 5-6 weeks post-treatment.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Dyspepsia; Helicobacter Infections; Helicobacter pylori; Humans; Immunoglobulin G; Metronidazole; Omeprazole; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Recurrence; Serologic Tests; Tetracycline

A double-blind, placebo-controlled trial is being conducted in a population at high risk for gastric cancer in Venezuela. The main aim of the trial is to assess the effect of antioxidant vitamins (beta-carotene, vitamin C and vitamin E) in blocking the progression of precancerous lesions of the stomach. Within the framework of a screening programme for stomach cancer, 2200 subjects of 35-69 years of age have been recruited. At study entry, a dietary questionnaire was completed, and gastroscopy with the collection of seven gastric biopsies was performed. After baseline examinations, the study participants were randomized to receive antioxidant treatment or placebo for three years. The treatment phase will be completed in mid-1998. At the end of the treatment phase, the investigations performed at study entry will be repeated. Before the initiation of the trial, various pilot studies were carried out that showed an extremely high prevalence of Helicobacter pylori infection (over 90%). Two eradication trials using anti-H. pylori treatments that give good results in Europe and North America gave very poor results in our study population. The low eradication rates achieved (5-20%) suggest a high prevalence of antibiotic-resistant H. pylori strains or high reinfection rates. These disappointing results led to deletion of an anti-H. pylori treatment phase of the main trial.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anticarcinogenic Agents; Antioxidants; Clarithromycin; Double-Blind Method; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Placebos; Precancerous Conditions; Stomach Neoplasms; Vitamins

To determine the reinfection rate of Helicobacter pylori and duodenal ulcer relapse rate in a group of patients followed up long term.. Prospective study.. Patients were followed up endoscopically at 3, 6, 12 and 24 months after successful H. pylori eradication and duodenal ulcer healing. H. pylori status was determined by culture, rapid urease test, Gram's stain of a fresh tissue smear and histological examination of antral biopsies and rapid urease test and histological examination of corpus biopsies.. Duodenal ulcer healing, H. pylori reinfection.. Thirty-eight patients with duodenal ulcer disease (35 active, 3 healed) had successfully eradicated H. pylori following treatment with omeprazole/amoxycillin (n = 11), omeprazole/amoxycillin/metronidazole (n = 16) and colloidal bismuth subcitrate/ amoxycillin/metronidazole (n = 11). All patients with active duodenal ulcer had healed ulcers at the end of therapy. Thirty-five of 38 patients were seen according to schedule up to 2 years; two patients were seen up to 12 months and one up to 6 months only. Reinfection with H. pylori was not recorded in any of our patients. Shallow duodenal ulcers were noted in three patients at 1-year follow-up, two of whom admitted to taking non-steroidal anti-inflammatory drugs (NSAIDs); H. pylori status was negative in all three. Subsequent follow-up revealed spontaneous healing of the ulcers in all three patients. At 2 years, one patient whose H. pylori status was negative had recurrence of duodenal ulcer. All of the three patients who defaulted subsequent to follow-up were negative for H. pylori and had healed ulcers on follow-up endoscopy at 6 and 12 months.. Reinfection rate with H. pylori was zero in a group of South-East Asian patients who had successfully eradicated the infection. Duodenal ulcer relapse was also low (2.9%) in this group of patients at 2 years.

Topics: Amoxicillin; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Malaysia; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Prospective Studies; Recurrence; Time Factors

To evaluate a twelve-month effect of Helicobacter pylori eradication, 258 consecutive out-patients with H. pylori related active duodenal ulcer were given a ten-day eradicating treatment. After healing no maintenance antiulcer medication was given. On entering the study and then 2, 6 and 12 months after the completion of therapy patients were scored for symptoms and underwent endoscopy to assess the presence of duodenal ulcer and to score antrum and corpus gastritis. Statistical analysis was performed by means of the chi 2 test. Histological eradication, defined as the inability to detect H. pylori six months after the completion of the eradication course, was proved in 85 subjects while the 123 non-eradicated ones were considered as the control group. Ulcer relapse rate and ulcer-like symptoms were significantly less frequent among eradicated than non eradicated throughout the follow-up. As compared to non eradicated, gastritis significantly improved among eradicated in both antrum and corpus. H. pylori eradication may be recommended since, by reducing ulcer relapse rate and related symptoms, there is no need for further antiulcer maintenance therapy with a significant drop in socioeconomic costs.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Ranitidine; Tetracycline

Topics: Antacids; Drug Therapy, Combination; Enzyme Inhibitors; Famotidine; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Patient Dropouts; Peptic Ulcer; Proton Pump Inhibitors; Research Design; Tetracycline; Time Factors; Treatment Outcome

The NIH Consensus Conference in 1994 (1) concluded that all patients with peptic ulcer disease should be tested and treated for Helicobacter pylori and that further evaluation was needed for patients in remission.. We evaluated in a double blind randomization 30 patients whose duodenal ulcers had been healed with H2-receptor antagonists and who remained in remission on maintenance therapy. After ulcer healing and the presence of H. pylori had been confirmed, these patients were randomized to receive eradication therapy or placebo and were followed for a mean period of 23 months.. Almost all patients receiving placebo had ulcer recurrence, whereas the patients treated with antibiotics demonstrate a low recurrence rate.. These data suggest, for the first time to our knowledge, the importance of treating with antibiotics duodenal ulcer patients whose disease is in remission.

Topics: Adult; Aged; Antacids; Anti-Ulcer Agents; Disease-Free Survival; Double-Blind Method; Doxycycline; Drug Therapy, Combination; Duodenal Ulcer; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Life Tables; Male; Metronidazole; Middle Aged; Organometallic Compounds; Ranitidine; Recurrence; Remission Induction

Omeprazole enhances the efficacy of bismuth-based triple therapy. It is unknown whether the same is true for other proton pump inhibitors. Lansoprazole has superior anti-Helicobacter activity in vitro and possibly also in vivo; therefore we investigated quadruple therapy with lansoprazole.. In two studies performed in separate hospitals, a total of 67 Helicobacter pylori-positive patients were treated with 7-day quadruple therapy (lansoprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole) after 3 days of lansoprazole pretreatment. Testing for cure was done by endoscopy in study 1 and by breath test in study 2.. Cure rates per protocol were 31 of 31 (100%) in study 1 and 30 of 32 (94%) in study 2. Intention-to-treat cure rates were 31 of 35 (89%) in study 1 and 30 of 32 (94%) in study 2. Cured overall were 32 of 34 with a metronidazole sensitive strain and 3 of 3 with a metronidazole-resistant strain. Data on side effects were collected from 51 patients. Twelve (21%) had no side effects, 27 (53%) had mild side effects, 10 (20%) had moderate side effects, but only 2 (4%) had severe side effects. Side effects, never were the reason that a patient stopped taking the medication.. The results with lansoprazole-quadruple therapy are comparable to the historic control group treated with omeprazole-quadruple therapy. The cure rare is very high, and although mild to moderate side effects occurred in many patients, everybody finished the treatment regime.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Antacids; Anti-Ulcer Agents; Bacterial Proteins; Breath Tests; Carbon Isotopes; Drug Resistance, Microbial; Drug Therapy, Combination; Dyspepsia; Enzyme Inhibitors; Female; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Proton Pump Inhibitors; Tetracycline; Treatment Outcome; Urea; Urease

In order to explore the optimal regimens for the eradication of Helicobacter pylori (Hp), eighty-eight patients with duodenal ulcer (DU) or non-ulcer dyspepsia and Hp infection, defined by culture and histology, received the one-week triple therapy with clarithromycin (Cla), furazolidone (Fur) plus lansoprazole (Lan) or colloidal bismuth subcitrate (CBS). Twenty-eight patients entered the phase one preliminary study, randomized to receive the treatment of Cla 500 mg b.i.d and Fur 200 mg b.i.d plus either CBS 240 mg b.i.d (group I A) or Lan 30 mg b.i.d (group I B). Sixty patients entered the phase two main study, receiving the treatment of Cla 250 mg b.i.d and Fur 100 mg b.i.d plus either CBS 240 mg b.i.d (group II A) or Lan 30 mg q.d (group II B). Five patients (2 in group I A, 2 in group I B, 1 in group II A) were withdrawn because of the side effects of the treatment, and two (in group II A) dropped out. The eradication rates of Hp in group I A, I B, II A, II B were 100.0% (12/12), 91.7% (11/12), 92.6% (25/27) and 90.0% (27/30) respectively. There was no significant difference in the eradication rates of Hp between the treatment groups (P > 0.05). The primary resistant rate of Hp isolates to Cla was 7.5% (4/53) and no patient infected with the strain resistant to Cla succeeded in the eradication of Hp. The healing rates of DU were 94.4% (17/18) in group II A and 100.0% (18/18) in group II B (P > 0.05). The main side effects were nausea, vomiting and taste disturbance. Eighteen of the 28 (64.2%) patients in the phase one study had side effects with a rate significantly higher than that of 5.1% (3/58) in the phase two study (P < 0.001).. (1) Both of the regimens used in the phase two study with low-dose, one week triple therapy are highly effective in the eradication of Hp infection and healing of DU, and are well tolerated. (2) The primary resistance of Hp strains to Cla is the principal factor of treatment failure in these two regimens.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Middle Aged; Omeprazole; Organometallic Compounds

Triple therapy has been recommended as the most effective treatment for Helicobacter pylori eradication. Despite achieving a comparatively high eradication result, however, around 10% of patients still fail to be cured. Omeprazole can enhance efficacy of single and double antibiotic protocols and is particularly effective when combined with clarithromycin and a nitroimidazole. This study examined the effect of combining triple therapy with omeprazole. A prospective, randomised, unblinded, single centre trial was carried out on consecutive patients with symptoms of dyspepsia and H pylori infection confirmed by rapid urease test, microbiological culture, and histological assessment. Patients were given a five times/day, 12 day course of colloidal bismuth subcitrate chewable tablets (108 mg), tetracycline HCl (250 mg), and metronidazole (200 mg) with either 20 mg omeprazole twice daily (triple therapy+omeprazole) or 40 mg famotidine (triple therapy+famotidine) at night. Compliance and side effects were determined using a standard questionnaire form. One hundred and twenty five of 165 triple therapy+omeprazole patients and 124 of 171 triple therapy+famotidine patients returned for rebiopsy four weeks after completion of treatment. Significantly more triple therapy+omeprazole patients achieved eradication 122 of 125 (97.6%) as assessed by negative urease test, culture, and histological assessment, when compared with 110 of 124 (89%) triple therapy+famotidine patients (p = 0.006; chi 2). There were 30 triple therapy+omeprazole (24%) and 26 triple therapy+famotidine (21%) patients with de novo metronidazole resistant H pylori included in the study. Side effects were mild and infrequent and were comparable in both groups, although pain in duodenal ulcer, gastric ulcer, and oesophagitis patients seemed to subside earlier in those taking omeprazole. Compliance (>95% of drugs taken) was achieved by 98% of patients of both groups. A 12 days regimen of triple therapy with omeprazole is more effective in achieving H pylori eradication than is triple therapy plus famotidine. Use of 20 mg omeprazole twice daily rather than 40 mg famotidine with a 12 day, low dose triple therapy enhances eradication to over 97% whether the H pylori is metronidazole sensitive or resistant.

Topics: Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Dyspepsia; Famotidine; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Tetracycline

The aim of this study was to compare the healing effect of a gastroprotective agent and antisecretory drugs in gastric body ulcer where failure of the mucosal defense might be an important factor. Eighty-five patients with benign gastric ulcer were divided into four groups: treated with antacids (I), cimetidine (II), ranitidine (III), and colloidal bismuth subcitrate (De-Nol) (IV). Endoscopically confirmed complete healing was achieved in 57, 61, and 63% in groups I, II, and III, respectively, and in 88% in group IV (P < 0.05). Gastric secretion did not change significantly. Relapses during the next three years occurred several times more frequently in groups I, II, and III than in group IV. Helicobacter pylori was positive in about half the relapsing patients in groups I, II, and III but negative in those of group IV. It is concluded that De-Nol treatment of gastric body ulcer was more efficient than antisecretory drugs both initially and in reducing relapses.

Topics: Adult; Antacids; Anti-Ulcer Agents; Bismuth; Cimetidine; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Organometallic Compounds; Ranitidine; Recurrence; Stomach Ulcer; Time Factors

The aim of this work was to investigate whether the normal use of colloidal bismuth subcitrate (CBS) and bismuth subnitrate (BSN) exhibits neurotoxic side-effects. A randomised, single-blind controlled study was carried out in 66 patients with H. pylori associated gastritis. Patients were randomised to receive either amoxicillin (control group) for 4 weeks or BSN for 8 weeks or CBS for 8 weeks. Clinical and neurophysiological tests including electroneurography (ENG) and spectral electroencephalography (EEG) were performed before and after therapy. No clinically relevant changes were observed with clinical tests as well as with ENG and spectral EEG recordings within each group and between the groups. It was concluded that the normal use of CBS and BSN does not exhibit clinical neurotoxicity.

Topics: Adult; Aged; Anti-Bacterial Agents; Bismuth; Electroencephalography; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Nervous System; Neurologic Examination; Organometallic Compounds; Single-Blind Method

The effect of Helicobacter pylori eradication on ulcer healing and the relapse rate were investigated in a multicentre trial of 239 gastric ulcer patients. Patients with H pylori positive gastric ulcer were randomly assigned to one of three groups: (A) 10 days' treatment with metronidazole and eight weeks' treatment with colloidal bismuth subcitrate (CBS) (84 patients); (B) 10 days' treatment with metronidazole placebo and eight weeks with CBS (73 patients); or (C) ranitidine (82 patients). At 12 weeks in 210 patients, gastric ulcer was present in three (9%) of 35 H pylori negative patients, and in 45 (26%) of 175 H pylori positive patients (p < 0.05). Results after one year of follow up were available for 205 patients. Between 12 and 52 weeks, two (7%) ulcer relapses occurred in 29 H pylori negative patients and in 60 (47%) of 128 H pylori positive patients (p < 0.001). After two weeks of open triple therapy (CBS 120 mg four times daily, amoxicillin 500 mg four times daily, and metronidazole 400 mg three times daily), given to the patients with ulcer relapse, only one (an NSAID user) of 55 successfully treated patients had an ulcer relapse during the one year follow up. Healing of gastric ulcer is rapid and recurrence is infrequent after successful H pylori eradication. H pylori eradication changes the natural history of the gastric ulcer disease.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Ranitidine; Recurrence; Stomach Ulcer

To determine the 12-month posttherapy recurrence (recrudescence) of Helicobacter pylori in patients with healed duodenal ulcer after apparent eradication of the organism with anti-H. pylori treatment. The influence of original anti-H. pylori treatment regimens on the recrudescence was also evaluated.. One hundred and ninety patients who had duodenal ulcer healed and H. pylori eradicated (as assessed by four routine techniques 4 wk after the end of anti-H. pylori therapy) with one of five regimens were studied. The five regimens were: 1) colloidal bismuth subcitrate (CBS) 120 mg; 2) CBS plus amoxicillin (500 mg); 3) CBS plus metronidazole (400 mg); 4) CBS plus metronidazole and amoxicillin; and 5) CBS plus metronidazole and tetracycline (500 mg). CBS was taken four times daily for 4 wk, and antibiotics were taken three times daily for the first week. The patients were re-endoscoped, and the status of H. pylori, duodenal ulcer, and gastritis was assessed after a period of follow-up (mean 14 months after commencement of treatment).. H. pylori infection recurred in 36 (18.9%) of these patients. Recrudescence rate with monotherapy was 47.1%, with dual therapy 29.2-35% and with triple therapy 9.2-14.3%. Nineteen (52.7%) of the 36 patients with recrudescent infection had ulcer relapse, and the rate for H. pylori-negative patients was 3.2% (5/154).. Recrudescence of H. pylori infection after apparent eradication can occur, but it could be that the treatment was only suppressing the organism. The definition of eradication of H. pylori infection may need to be revised, and more sensitive techniques to assess eradication of H. pylori are required.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Bismuth; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Prospective Studies; Recurrence; Tetracycline; Time Factors

There is a strong association between infection with Helicobacter pylori and gastric ulcers that are unrelated to the use of nonsteroidal antiinflammatory medications. We studied the efficacy of antibacterial therapy without medication to suppress gastric acid for the treatment of patients with H. pylori infection and gastric ulcers unrelated to the use of nonsteroidal agents.. Patients with gastric ulcers seen on endoscopy and with H. pylori infection confirmed by smear or culture were randomly assigned to receive either a one-week course of antibacterial agents (120 mg of bismuth subcitrate, 500 mg of tetracycline, and 400 mg of metronidazole, each given orally four times a day) or a four-week course of omeprazole (20 mg orally per day). Follow-up endoscopies were performed after five and nine weeks. The patients and their physicians were aware of the treatment assignments, but the endoscopists were not.. A total of 100 patients were randomly assigned to treatment, and 85 completed the trial. At five weeks, H. pylori had been eradicated in 41 of the 45 patients in the antibacterial-treatment group (91.1 percent; 95 percent confidence interval, 82.9 to 99.3) and in 5 of the 40 in the omeprazole group (12.5 percent; 95 percent confidence interval, 2.3 to 22.7; P < 0.001). The gastric ulcers were healed in 38 of the patients treated with antibacterial drugs (84.4 percent; 95 percent confidence interval, 73.9 to 95.0) and in 29 of those treated with omeprazole (72.5 percent; 95 percent confidence interval, 58.6 to 86.4; P = 0.28). At nine weeks, ulcer healing was confirmed in 43 of the patients receiving antibacterial therapy and in 37 of those receiving omeprazole (P = 1.0). The mean (+/- SD) duration of pain during the first week of treatment was 1.9 +/- 2.6 days in the omeprazole group, as compared with 3.6 +/- 3.0 days in the antibacterial-treatment group (P = 0.004). One year after treatment, recurrent gastric ulcers were detected in 1 of 22 patients (4.5 percent) in the antibacterial-treatment group and in 12 of 23 (52.2 percent) in the omeprazole group (P = 0.001). H. pylori was detected in the 1 patient with a recurrent ulcer who had received antibacterial treatment and in 10 of the 12 patients with recurrent ulcers who had received omeprazole.. In patients with H. pylori infection and gastric ulcers unrelated to the use of nonsteroidal antiinflammatory drugs, one week of antibacterial therapy without acid suppression heals the ulcers as well as omeprazole and reduces the rate of their recurrence.

Topics: Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Confidence Intervals; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Recurrence; Stomach Ulcer; Tetracycline

Helicobacter pylori is present in up to 87% of patients with nonulcer dyspepsia. This study assessed the effect of eradicating Helicobacter pylori infection on the symptoms of nonulcer dyspepsia at four weeks and one year after treatment. Dyspepsia was assessed on the frequency and severity of six symptoms [epigastric pain (night and day), nausea and vomiting, upper abdominal discomfort, and regurgitation] where each symptom was scored from 0 to 4. Helicobacter pylori status was assessed before treatment and four weeks after treatment with histology and microbiology, and at one year with a carbon-13 urea breath test. Eighty-three patients (23 males, 60 females; mean age 56.3 years; mean symptom duration 3.6 months) with nonulcer dyspepsia and Helicobacter pylori infection entered the study. Seventy-five were available at one year follow-up. Four weeks after treatment, the mean symptom score improved in those with eradication (6.95-2.3, P = 0.01, N = 41) or persistent infection (6.69-3.0, P = 0.015, N = 42). At one year, those with persistent Helicobacter pylori infection (N = 38, score 5.24) had a higher score than those remaining clear of infection (N = 24, score 1.4, P < 0.0001) and those with reinfection (N = 13, score 2.2, P < 0.0001). In addition, persistent Helicobacter pylori infection was associated with more additional treatments than those with eradication (34/38 versus 4/37, P < 0.001). These results suggest that Helicobacter pylori plays an important role in the symptoms of nonulcer dyspepsia.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Drug Administration Schedule; Drug Therapy, Combination; Dyspepsia; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies

The aim of this study was twofold: first, to investigate the effectiveness of a standard triple therapy (tripotassium dicitrato bismuthate, 125 mg q.i.d., tetracycline hydrochloride 500 mg q.i.d., and metronidazole 500 mg t.i.d.) in eradicating Helicobacter pylori in patients with duodenal ulcer successfully healed with omeprazole or ranitidine; second, to examine the influence of the eradication on duodenal ulcer recurrence rate after 12 months. Two hundred forty-five consecutive H. pylori-positive patients with healed duodenal ulcer either with omeprazole (20 mg/day, 126 patients) or with ranitidine (150 mg b.i.d., 119 patients) given at random, began triple therapy for 15 days. H. pylori eradication was looked for 4-5 weeks later by culture of biopsy material, hematoxylin-eosin stain, and rapid urease test. H. pylori-eradicated patients were followed up for 12 months. Endoscopy was carried out at the end of the follow-up or whenever symptoms appeared. Five patients (2.0%) withdrew because of triple-therapy-related side effects. The eradication rate was 92% (220 of 240 patients); no difference was found between those healed with omeprazole (93%, 114 of 123 patients) or ranitidine (91%, 106 of 117 patients). Of 220 successfully treated patients, 132 completed the 12-month follow-up. The duodenal ulcer recurrence rate was 4% (5 of 132 patients); 3% (2 of 70) in the omeprazole group and 5% (3 of 62) in the ranitidine group healed. All the recurrences were asymptomatic. H. pylori recurrence rate was 11% (14 of 132 patients); no difference was found between patients healed with omeprazole (10%, 7 of 70 patients) or with ranitidine (11%, 7 of 62 patients). All the recurrent duodenal ulcers occurred in H. pylori-positive patients (36%, 5 of 14 patients). Standard triple therapy after duodenal ulcer healing with omeprazole or ranitidine eradicates H. pylori in comparable high rates. Side effects were mild and dropouts were only 2%. Ulcer recurrence rate 12 months after eradication was low and comparable between those healed with omeprazole or ranitidine.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Chi-Square Distribution; Confidence Intervals; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Ranitidine; Recurrence; Statistics as Topic; Tetracycline

Eradication of Helicobacter pylori from the stomach by triple therapy with bismuth, tetracycline, and metronidazole cures peptic ulcer disease. We investigated whether concomitant acid inhibition with omeprazole would improve the results of triple therapy. 108 consecutive patients with peptic-ulcer disease and biopsy-proven H pylori infection were randomised to 7 days of triple therapy with or without omeprazole 20 mg twice daily. Patients in the omeprazole-treated group were pretreated with 3 days of omeprazole. Eradication of H pylori was assessed by 10 endoscopic biopsies for urease test, histology, and culture 4-6 weeks after treatment. 53 of 54 (98.1%) patients treated with omeprazole were cured compared with 45 of 54 (83.3%) of those not treated (p = 0.02), a difference in efficacy of 14.8% (95% Cl 4.2-25.4%). Most side effects were mild and did not interfere with compliance; 105 patients (97.2%) finished treatment. Gastro-intestinal side effects were significantly fewer in the omeprazole group. We conclude that the addition of omeprazole to triple therapy improves efficacy, lessens side effects, and is sufficiently efficacious to obviate the need for a diagnostic test of cure in compliant patients.

Topics: Adult; Aged; Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Tetracycline; Time Factors

This study evaluated one week of quadruple therapy as treatment for Helicobacter pylori infection. Sixty duodenal ulcer patients were randomised to receive either standard triple therapy (tripotassium dicitrato bismuthate 120 mg qds+tetracycline 500 mg qds+metronidazole 400 mg qds), quadruple therapy A (triple therapy+omeprazole 20 mg od) or quadruple therapy B (triple therapy+omeprazole 40 mg od), for 7 days. H. pylori eradication rates were 65%, 60% and 60%, respectively, with no significant differences between the groups. These results suggest that quadruple therapy provides no benefits over one week of triple therapy for treatment of H. pylori infection.

Topics: Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Tetracycline

Two 4-week triple-therapy treatment regimens, metronidazole+tetracycline+bismuth subcitrate and omeprazole+amoxycillin+bismuth subcitrate, were compared in a randomly allocated double-blind trial for their efficacy in eradicating Helicobacter pylori from the gastric mucosa of patients with gastritis and/or peptic ulcer disease.. The presence of gastritis and/or peptic ulcers was confirmed by endoscopy in all patients included in the study. To evaluate drug effects, we used the urease test on gastric mucosa, and haematoxylin-eosin and specific Giemsa stains on biopsy tissues obtained by endoscopic procedures; we also evaluated the improvement in clinical symptoms before and after the 4-week treatments.. Among 164 patients with gastritis and/or peptic ulcers, H. pylori infection was confirmed in 93.9% (154 patients) by the urease test and in 87.8% (144 patients) by haematoxylin-eosin stain. Following 4 weeks of treatment with both combination regimens, negative conversion rates by the urease test and haematoxylin-eosin staining and rates of recovery from clinical symptoms were similar in both regimens (metronidazole+tetracycline+bismuth subcitrate: 82.3, 72.9 and 73.9%; omeprazole+amoxycillin+bismuth subcitrate: 89.6, 83.4 and 76.1%, respectively). Also, the extent of inflammatory activity and the H. pylori score by the Giemsa method indicated high rates of recovery, with improvements to grade 0 (lowest grade) from higher grades with both combination regimens (60.4 and 66.7% of patients taking metronidazole+tetracycline+bismuth subcitrate and 64.6 and 83.3 of those taking omeprazole+amoxycillin+bismuth subcitrate). However, the prevalence of side effects during the 4 weeks of treatment was doubled in the former group compared to the latter (25.5 versus 12.5% of patients).. Significant improvements in biochemical and histopathological findings and in the clinical symptoms of gastritis and/or peptic ulcer disease in patients with a high rate of H. pylori infection were observed equally with both regimens. However, there were notably fewer side effects in patients treated with omeprazole+amoxycillin+bismuth subcitrate. We therefore recommended this regimen in preference to metronidazole+tetracycline+bismuth subcitrate for the treatment of H. pylori-related gastritis and peptic ulcer disease.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Double-Blind Method; Drug Therapy, Combination; Duodenal Ulcer; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Stomach Ulcer; Tetracycline; Treatment Outcome

Randomised trials have shown that duodenal ulcers treated by H2 blockers heal faster if Helicobacter pylori is eradicated concurrently. It remains unknown whether eradication of H pylori without suppression of acid-secretion, is sufficient to allow healing. 153 patients with H pylori infection and duodenal ulcer were randomised to receive either a 1-week course of bismuth subcitrate, tetracycline, and metronidazole (76), or omeprazole for 4 weeks with the same three-drug regimen for the first week (77). Endoscopy and antral biopsies were done at entry and 4 weeks after treatment. 132 patients were suitable for analysis. Duodenal ulcers healed in 60 (92%; 95% CI 86-100%) patients taking bismuth, tetracycline, and metronidazole compared with 63 (95%; 88-100%) taking omeprazole in addition to the three other drugs. H pylori was eradicated in 61 (94%; 88-100%) who received only three drugs compared with 66 (98%; 96-100%) who received omeprazole as well. Symptoms were reduced more effectively during the first week in patients who received omeprazole (p = 0.003). We conclude that a 1-week regimen of bismuth, tetracycline, and metronidazole for patients with H pylori and duodenal ulcer eradicates the organism and heals the ulcer in most patients. Concurrent administration of omeprazole reduces ulcer pain more rapidly but has no effect on ulcer healing.

Topics: Adult; Aged; Antacids; Biopsy; Drug Resistance, Microbial; Drug Therapy, Combination; Duodenal Ulcer; Endoscopy, Gastrointestinal; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Pain; Stomach Diseases; Tetracycline; Wound Healing

Ninety patients with endoscopically proven duodenal ulcer were followed for 1 year. All patients were initially treated with an H2-receptor antagonist. Those with more than two relapses within 1 year received triple therapy consisting of colloidal bismuth subcitrate, amoxicillin, and metronidazole. Results showed that 27 patients were symptom-free after one full course of H2 antagonist, 47 had one or two clinical recurrences, and 16 patients had more than two recurrences. Twelve of the latter group were Helicobacter pylori positive and were treated with triple therapy. We conclude that only a minority of duodenal ulcer patients needs to be treated with triple therapy; most of them can be treated with antisecretory agents.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Cimetidine; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Patient Selection; Ranitidine; Recurrence; Retrospective Studies; Time Factors

We investigated whether the recommended 2-wk triple therapy for eradicating Helicobacter pylori could be reduced to 1 wk, and thus we tried to determine the optimal treatment duration for triple therapy.. A group of 111 consecutive patients with H. pylori-proven chronic peptic ulcer disease was entered in a randomized study comparing the side effects, compliance, and eradication rates with either 1 wk or 2 wk of traditional triple therapy in combination with an H2 receptor antagonist (quadruple therapy).. Follow-up data were available for 109 patients. Eradication for 1 wk of treatment was 53/56 (95%) [95% confidence interval (CI), 89-100%] and for the 2-wk treatment schedule was 50/53 (94%) (95% CI, 88-100%). Therefore 1-wk quadruple therapy appears sufficient, and prolonging treatment does not increase efficacy. Compliance with quadruple therapy is better when the duration of treatment decreases from 2 to 1 wk. One-week quadruple therapy seems feasible for most patients.. Because of the high eradication rate and good tolerability of this short course of quadruple therapy, we recommend it as first-line anti-Helicobacter treatment in a compliant population.

Topics: Anti-Bacterial Agents; Bismuth; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Patient Compliance; Tetracycline; Time Factors

Topics: Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Omeprazole; Organometallic Compounds; Piperidines; Roxithromycin

Topics: Anti-Ulcer Agents; Drug Resistance, Microbial; Drug Therapy, Combination; Duodenal Ulcer; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Oxytetracycline; Ranitidine

In the present study we evaluated the efficacy and tolerability of two different therapeutic schedules in eradicating Helicobacter pylori. Forty-six consecutive patients (suffering from either peptic ulcer or non-ulcer dyspepsia) with helicobacter pylori infection were randomly allocated to one of the following two groups: group 1 (n = 23) 2 weeks of treatment with bismuth subcitrate tablets (120 mgx4) + amoxycillin capsules (500 mgx4) + metronidazole tablets (250 mgx4); group 2 (n = 23) 2 weeks of treatment with amoxycillin capsules (500 mgx4) + metronidazole tablets (250 mgx4). Endoscopy, histology and bacterial culture were performed at entry, and 30 and 90 days after treatment. Two group 1 patients and one group 2 patient did not complete the treatment. Successful eradication was obtained in 20/21 (95%) patients treated with triple therapy (group 1) and in 17/22 (77%) patients treated with double therapy (group 2) (p = 0.2). Side-effects occurred in 9/21 (43%) patients of group 1 and in 9/22 (41%) patients of group 2 (p = 0.9). These were all self-limiting and required no specific treatment. These data suggest that combined therapy with amoxycillin and metronidazole, with or without bismuth subcitrate, represents a safe and effective therapeutic approach for the treatment of Helicobacter pylori infection. In our series, triple therapy determined a numerically higher eradication rate than double therapy.

Topics: Adult; Amoxicillin; Anti-Ulcer Agents; Bismuth; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Time Factors

Triple therapy for Helicobacter pylori using metronidazole is less effective in patients with a metronidazole resistant strain. Moreover, metronidazole is responsible for many side-effects. This open study examined the efficacy and side-effects of a triple treatment regimen substituting clarithromycin for metronidazole.. 36 patients with a H. pylori infection, proven by culture, were treated with tripotassium dicitrato bismuthate 120 mg q.d.s., tetracycline 250 mg q.d.s. and clarithromycin 250 mg q.d.s. for 10 days. Eradication was defined as a negative culture and histological examination of antral biopsy specimens, taken at least 6 weeks after completion of the treatment.. Eradication was achieved in 26 patients (72%). The treatment was well tolerated with only 4 (11%) of the patients having significant side-effects.. Triple therapy with clarithromycin seems to be less effective than standard triple treatment when the prevalence of metronidazole resistance is low. It is suggested, however, that this combination could be a valuable alternative in areas with a high prevalence of metronidazole resistance.

Topics: Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Female; Helicobacter Infections; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Tetracycline

To evaluate two triple-therapy (TT) regimens of colloidal bismuth subcitrate (CBS), metronidazole, and tetracycline HCl in eradicating Helicobacter pylori, with particular attention to the frequency of resulting adverse effects of the two therapies.. A prospective, randomized controlled trial was conducted in patients with symptoms of dyspepsia who were positive for H. pylori. Subjects received a 14-day course of either 4 x/day therapy of CBS (108 mg), tetracycline HCl (500 mg), and metronidazole (250 mg), or 5 x/day therapy of CBS (108 mg), tetracycline HCl (250 mg), and metronidazole (200 mg). H. pylori status was determined endoscopically by urease test, histology, and culture. Standard questionnaires were administered to determine compliance to treatment and side effects of therapy.. H. pylori was eradicated in 196/213 (92%) patients in the 4 x/day group and 202/210 (96%) in the 5 x/day group (p = 0.07). Side effects were significantly less frequent and less severe in the 5 x/day group (p < 0.01).. We conclude that a lower dose, 5 x/day triple therapy treatment of H. pylori is equally efficacious to the standard 4 x/day therapy, but is accompanied by fewer and milder adverse effects.

Topics: Abdominal Pain; Anti-Bacterial Agents; Constipation; Diarrhea; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Nausea; Organometallic Compounds; Patient Compliance; Prospective Studies; Tetracycline; Vomiting

to study the ulcer recurrence rate of Helicobacter pylori-positive duodenal ulcers at 1 yr after eradication of the bacteria by triple therapy.. Patients with H. pylori-positive duodenal ulcers were randomized to receive either triple therapy for 1 wk plus omeprazole for 4 wk (Triple+OMP) (n = 78), or omeprazole alone (OMP) for 4 wk (N = 77). Patients were followed up every 3 months for symptom enquiry. At 1 yr, all asymptomatic patients were invited to attend for gastroscopy.. At 8 wk, 16 patients in the OMP group and four in the Triple+OMP group had an ulcer. During the 1-yr period, 12 patients in the OMP group and no patient in the Triple+OMP group developed symptomatic ulcers. At follow-up endoscopy at 1 yr, another 10 ulcers were detected in the OMP group and two in the Triple+OMP group. Fifteen patients in the OMP group and 13 in the Triple+OMP group were lost to follow-up. In total, ulcers were detected in 39 of 61 (64%) assessable patients in the OMP group, and in six of 65 (9%) assessable patients in the Triple+OMP group after 1 yr (chi 2 test: p < 0.001). Of the patients whose H. pylori were successfully eradicated by Triple+OMP at 8 wk, 90% remained H. pylori negative at 1 yr.. Triple therapy for 1 wk eradicates H. pylori infection and significantly reduces duodenal ulcer relapses.

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Recurrence; Tetracycline

The purpose of this study was to compare the performance of different regimens on Helicobacter pylori (H. pylori) eradication and duodenal ulcer recurrence. During a four-week period, 59 patients with duodenal ulcers who were positive for H. pylori infection were randomly treated with one of three regimens. Seventeen patients were treated with ranitidine, 19 with colloidal bismuth subcitrate (CBS), and 23 with triple therapy (CBS, tetracycline and metronidazole). Forty-six patients with healed ulcers after treatment received follow-up for six months without maintenance therapy. The recurrence rates of duodenal ulcers confirmed by endoscopy in these three groups were 64%, 33% and 0% at the third month, and 73%, 67% and 5% at the sixth month, respectively. In the ranitidine therapy group, H. pylori infection was still present at the final follow-up. In the CBS therapy group, H. pylori was suppressed initially, but recurred in all cases. In the triple therapy group, there was only one case in which H. pylori infection persisted and where ulcer recurrence occurred after 3.5 months. The remaining cases were all H. pylori negative and had no recurrence of duodenal ulcers during the six months of follow-up. Overall, 19/27 (70%) patients positive for H. pylori had a recurrence of duodenal ulcers, while none of the 19 patients who were negative for H. pylori had a recurrence of ulcers at the sixth month. This study shows that triple therapy is more effective than the other two regimens in the eradication of H. pylori and in reducing the recurrence of ulcers. H. pylori may play a role in the recurrence of the duodenal ulcer.

Topics: Adolescent; Adult; Aged; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Ranitidine; Recurrence; Tetracycline

Ascorbic acid, the reduced form of vitamin C, may protect against gastric cancer and is secreted by the normal stomach. Secretion is impaired in Helicobacter pylori (H pylori) associated chronic gastritis. This study examined if eradication of H pylori improves gastric juice ascorbate values. Fasting gastric juice and plasma samples were collected at endoscopy from patients participating in trials of H pylori eradication for duodenal ulcer disease and intestinal metaplasia before and up to 15 months after attempted eradication. Ascorbic acid and total vitamin C concentrations were determined by high performance liquid chromatography. In 12 patients in whom H pylori was successfully eradicated gastric juice ascorbate and total vitamin C concentrations and the ratio of juice to plasma vitamin C rose after treatment. Analysis after treatment suggested that the rise was greatest in patients with high final plasma vitamin C concentrations, even though these did not change with treatment. By contrast, in 22 patients in whom H pylori eradication was unsuccessful there were no significant changes in juice or plasma concentrations after treatment. It is concluded that successful eradication of H pylori improves secretion of vitamin C into gastric juice. It is speculated that this increases protection against gastric cancer.

Topics: Aged; Ampicillin; Anti-Ulcer Agents; Ascorbic Acid; Drug Therapy, Combination; Duodenal Ulcer; Fasting; Follow-Up Studies; Gastric Juice; Helicobacter Infections; Helicobacter pylori; Humans; Intestines; Male; Metaplasia; Metronidazole; Organometallic Compounds; Oxytetracycline; Treatment Outcome

Helicobacter pylori (H pylori) raises serum gastrin but it is unclear whether this stimulates increased acid secretion. Gastrin mediated acid secretion and plasma gastrin after the intravenous infusion of gastrin releasing peptide was studied in nine H pylori negative and nine H pylori positive healthy volunteers, and in 11 duodenal ulcer patients. Nine of the last group were re-examined one month after eradication of H pylori. The median acid output (mmol/h) to gastrin releasing peptide (40 pmol/kg/h) in the H pylori positive healthy volunteers was 15.1 (range 3.3-38.3), which was three times that of the H pylori negative healthy volunteers (median = 5.5, range 1.0-9.0) (p < 0.02). The median acid output in the duodenal ulcer patients with H pylori was 37 (range 8.5-57), which was > six times that of the H pylori negative healthy volunteers. Eradication of H pylori in the duodenal ulcer patients lowered their acid secretion by a median of 66% (range 30%-80%) (p < 0.01) and to values equivalent to the H pylori positive healthy volunteers. The pepsin output in response to gastrin releasing peptide followed the same pattern as the acid output. The median plasma gastrin concentrations during gastrin releasing peptide were similar in the H pylori positive duodenal ulcer patients (150 ng/l, range 95-400) and H pylori positive healthy volunteers (129 ng/l, range 23-420) and both were appreciably higher than H pylori negative healthy volunteers (60 ng/l, range 28-135) (p < 0.005 for each). Eradication of H pylori lowered the plasma gastrin in the duodenal ulcer patients to values equivalent to the H pylori negative healthy volunteers. These findings show a threefold increase in acid secretion in H pylori positive healthy volunteers that is explained by H pylori induced hypergastrinaemia and a sixfold increase in acid secretion in the duodenal ulcer patients that is explained by the combination of H pylori induced hypergastrinaemia and an exaggerated acid response to stimulation by gastrin. Eradicating H pylori lowers gastrin mediated acid secretion by 66% in duodenal ulcer patients as a result of the resolution of the hypergastrinaemia. Increased gastrin mediated acid secretion seems to be the key factor in the pathophysiology of duodenal ulceration and explains the role of H pylori infection in the disorder.

Topics: Amoxicillin; Anti-Bacterial Agents; Basal Metabolism; Breath Tests; Carbon Radioisotopes; Duodenal Ulcer; Female; Gastric Acid; Gastrin-Releasing Peptide; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Infusions, Intravenous; Male; Metronidazole; Organometallic Compounds; Pepsin A; Peptides; Time Factors; Urea

One hundred consecutive patients with Helicobacter pylori infection, as proven by culture, were treated with 120 mg colloidal bismuth subcitrate (CBS) four times daily, 250 mg tetracycline four times daily, and 250 mg metronidazole four times daily during 15 days. The patients were amply instructed in how to take the medicine and strongly urged to complete the prescribed course. In 66 of the 100 patients pretreatment metronidazole susceptibility was determined. Endoscopy was performed 3 months after cessation of treatment to check for H. pylori eradication by culture, urease testing, and histology. Side effects of the treatment were registered and classified into five groups on the basis of severity. Eradication was achieved in 93 of 100 patients (93%), in 61 of 62 patients with a metronidazole-sensitive strain (98.4%), and in 2 of 4 patients with a metronidazole-resistant strain (50%). Eighty-two per cent of the patients experienced no or just minor side effects; 15% had moderate side effects, and just 3% had severe side effects. Non-ulcer dyspepsia patients reported significantly more side effects than patients with peptic ulcer disease. With proper patient instruction, this treatment regimen is well tolerated and very effective for the eradication of metronidazole-sensitive H. pylori strains.

Topics: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptic Ulcer; Stomach Ulcer; Tetracycline; Treatment Outcome

To compare the efficacy of imprint cytology, histology and CLO-test (for biopsy urease) in detecting Helicobacter pylori infection, antral biopsies were taken from 239 patients undergoing upper gastrointestinal endoscopy. Both imprint cytology and histology showed the presence of H. pylori in 215 (90%) patients. The sensitivity and specificity of imprint cytology vis-à-vis histology was noted to be 100%. The CLO-test was performed in 165 patients and was positive in 130 (79%) patients. The sensitivity and specificity of the CLO-test were 89% and 95%, respectively. The median time required for the CLO-test to become positive and for imprint was 60 minutes for each. The sensitivity of the CLO-test was reduced further in patients receiving colloidal bismuth subcitrate. Of the 27 patients receiving the drug the sensitivity of the CLO-test was only 9% after 4 weeks of therapy. However, the specificity was 100%. The sensitivity and specificity of imprint cytology were unaffected by the antimicrobial therapy and after 4 weeks of treatment were still 100%. It is concluded that the CLO-test has a lower sensitivity and specificity for diagnosing H. pylori infection compared to imprint cytology, which had a sensitivity and specificity equal to that of histology. Imprint cytology may be prepared as an adjunct to histology in patients in whom antral biopsies are taken as it offers a relatively quick diagnosis of H. pylori infection, is considerably cheaper than the CLO-test and does not require additional biopsy material.

Topics: Anti-Ulcer Agents; Biopsy; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Predictive Value of Tests; Pyloric Antrum; Sensitivity and Specificity; Urease

A controlled, prospective clinical trial of colloidal bismuth subcitrate (CBS), ranitidine and ranitidine plus metronidazole for the treatment of duodenal ulcer (DU) is reported here, with evaluation of the possible pathogenic role of Helicobacter pylori (HP) on DU in a six-month follow-up. A total of 42 patients with active DU on endoscopy were randomly selected to receive oral CBS (300 mg 1 hour before each meal, and at bedtime, n = 16), ranitidine (150 mg bid; n = 12) or ranitidine (150mg b.i.d.) plus metronidazole (250 mg t.i.d; n = 14) treatment for one month. Ulcer healing was endoscopically evaluated. Healed patients received another two-week treatment; unhealed subjects received another one-month treatment with the same agents. Healed patients were followed endoscopically at 1, 3, and 6 months after the cessation of medication without maintenance therapy. Unhealed or relapsed subjects were excluded. To assess HP status, during each endoscopy two prepyloric mucosal biopsies were taken for urease testing and culture of HP. The prevalence of HP in patients with DU was 95.2%. Data showed that those treated with CBS had a lower DU healing rate than those treated with ranitidine or ranitidine plus metronidazole after the one-month treatment, but there was no statistical significance in the DU healing rates after the two-month treatment, and at follow-up six months after the cessation of medication. After one month of treatment those treated by CBS showed the highest rates of HP clearance on gastric antral mucosa among the three groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Anti-Ulcer Agents; Colloids; Drug Therapy, Combination; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Prospective Studies; Ranitidine

Fifty-three patients with previously uninvestigated chronic dyspepsia symptoms in the absence of gastrointestinal or extra-gastrointestinal disease (functional dyspepsia) underwent antral and duodenal mucosal biopsies to detect the role of such samplings in the presence of normal endoscopic findings. Patients were enrolled in a randomized, placebo-controlled, double-blind trial, receiving either eradicating treatment (colloidal bismuth subcitrate plus metronidazole) or placebo if they had Helicobacter pylori-associated gastritis (20 patients), or cisapride or placebo if they had normal antral mucosa (28 cases). Unsuspected celiac sprue was found in one patient. Eradicating treatment ameliorated histological gastritis (p = 0.01). However, owing to great placebo efficacy, symptom remission rates following a 1-month wash-out period in both treatment groups were no higher than that in controls. Independent of the initial randomization, an extremely low symptom recurrence rate was observed during a drug-free follow-up study equivalent to the mean duration of symptoms before enrollment. We conclude that in functional dyspepsia, bulbar and antral biopsies are not useful in clinical management, equivalent symptom relief can be achieved in patients randomly assigned to both drugs and placebos, and such improvement can be long lasting in the absence of any maintenance treatment. We believe the prevalence of unsuspected villous atrophy and the therapeutic role of investigation-based reassurance deserve further assessment.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Biopsy; Bismuth; Cisapride; Double-Blind Method; Duodenum; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Piperidines; Pyloric Antrum

Thirty two patients with Helicobacter pylori positive duodenal ulcers resistant to treatment were randomly assigned to 4 weeks' treatment with sucralphate 4 g/day or colloidal bismuth subcitrate 480 mg/day plus amoxycillin from days 1 to 7 and tinidazole from days 8 to 14. After 4 weeks, patients with unhealed ulcers were crossed over to the other form of treatment for a further 4 week period. Patients with healed ulcers were followed up for 1 year without maintenance therapy with clinical and endoscopic investigations 3, 6, and 12 months after healing. Complete healing rates at 4 weeks were 88% (15 of 17) in the colloidal bismuth subcitrate plus antibiotics group and 40% (six of 15) in the sucralphate group (p < 0.05). After cross over, overall healing rates were 88% (22 of 25) and 47% (eight of 17), respectively (p < 0.05). H pylori eradication occurred in 83% of patients treated with the triple therapy. Cumulative relapse rates at 12 months were 12% (two of 17) in patients in whom H pylori had been eradicated and 100% (10 of 10) in those with persistent infection after short term therapy (p < 0.05). These results show that a colloidal bismuth subcitrate plus antibiotics regimen is highly effective in the short term treatment of resistant duodenal ulcers and that H pylori eradication can change the natural tendency to early recurrence of these ulcers.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Sucralfate; Tinidazole

In this study, 26 patients with duodenal ulcers refractory to treatment with H2-receptor antagonists for 8-12 weeks were randomly assigned to eight weeks of treatment with colloidal bismuth subcitrate (120 mg four times a day) alone (N = 12) or in combination with tetracycline hydrochloride (500 mg four times a day, days 0-14) and metronidazole (500 mg three times a day, days 15-28). Symptoms were scored and endoscopy, histology, and CLO tests were performed before, on completion of treatment, and 3, 6, 12, and 18 months after treatment. Treatment was considered successful when Helicobacter pylori was not detected by CLO tests and Warthin-Starry stains on gastric biopsies taken from antrum, body, and fundus. On triple therapy, ulcers healed in 12/14 patients (85.71%) and 10/14 (71.42%) patients became Helicobacter pylori-negative. On bismuth, only one patient became Helicobacter pylori-negative (8.33%, P < 0.0001), but ulcers healed in 8/12 patients (67%, P = NS). Six patients on bismuth, whose ulcers remained unhealed or relapsed early after healing, were offered triple therapy, which resulted in ulcer healing in three and Helicobacter pylori clearance in two patients. At 18 months, none of the Helicobacter pylori-negative patients had ulcer relapse. On the contrary, ulcers relapsed in all but one patient, who remained Helicobacter pylori-positive. Smoking and drinking did not influence the therapeutic outcome. The data confirm previous reports that many duodenal ulcers are infectious and therefore curable.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Chi-Square Distribution; Colloids; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Recurrence; Remission Induction; Single-Blind Method; Tetracycline; Time Factors

We have carried out a double blind placebo controlled trial to assess the effects of treatment with colloidal bismuth subcitrate in Helicobacter pylori associated non-ulcer dyspepsia. Eighty patients with dyspepsia, normal upper gastrointestinal appearances at endoscopy and H pylori associated active chronic gastritis on histology of gastric antral biopsies were included in the trial. The patients were randomised to receive colloidal bismuth subcitrate 240mg twice daily for four weeks or matching placebo and were reassessed four weeks after completing treatment. Twenty-six patients (67%) receiving colloidal bismuth subcitrate had normal histology or improved inflammation compared with five (13%) receiving placebo (p less than 0.001), and symptoms were absent or improved in 32 (82%) and two (5%) respectively (p less than 0.001). Serum IgG level was a marker of infection, and fell with successful treatment. Colloidal bismuth subcitrate is effective treatment for H pylori associated non-ulcer dyspepsia with improved gastric antral histological appearances and has a beneficial effect on symptoms.

Topics: Adult; Anti-Ulcer Agents; Bismuth; Double-Blind Method; Dyspepsia; Female; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Prospective Studies

In a controlled, prospective, randomized trial, 10 patients with Helicobacter pylori positive gastritis were treated either with triple therapy (tetracycline, ornidazole, bismuth subcitrate; T, Or, CBS), or omeprazole/CBS (O/CBS) to test the eradication rate of each treatment, its effect on gastritis and meal stimulated gastrin release.. 6 patients were treated with triple therapy and 4 patients with O/CBS for 2 weeks. Initially, and 0.5, 1, 3, 6, and 12 months after therapy, patients were investigated by a highly specific, quantitative Helicobacter serology, 13C-urea breath test and measurement of meal-stimulated gastrin release. After 3 and 12 months antral biopsies were taken endoscopically for rapid urease testing and culture. Activity of histological gastritis was graded.. Eradication for at least 12 months was achieved in 5 out of 6 patients with triple therapy. Serology normalized and gastritis activity improved. In all patients treated with O/CBS, HP was suppressed only temporarily. No eradication was achieved. Urease testing and histology proved to be reliable tests for detecting HP. Culturing of HP was successful in only 66% due to technical problems. The 13C-urea breath test was correct in all cases. The initially, increased meal-stimulated gastrin release was normalized after eradication of HP.. (1) Triple therapy is also successful in short term treatment in up to 80% of patients with HP gastritis and improves gastritis activity. (2) The combination O/CBS failed to eradicate HP in all treated patients. (3) The 13C-urea breath test and HP serology are reliable non-invasive parameters during follow-up. (4) Normalization of meal stimulated gastrin release after eradication of HP supports the hypothesis that HP induces increased gastrin release and hyperacidity.

Topics: Antacids; Breath Tests; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Ornidazole; Prospective Studies; Tetracycline; Urea

At the 1990 World Congresses of Gastroenterology, the Working Party on Helicobacter pylori (H. pylori) recommended that, in suitable patients, the bacterium should be eradicated using a therapeutic regimen comprising a bismuth salt, tetracycline and metronidazole for two weeks. We have treated 40 patients infected with H. pylori with 'triple' therapy consisting of 120 mg tripotassium dicitrato bismuthate q.d.s., 500 mg tetracycline q.d.s. and 400 mg metronidazole t.d.s. for two weeks. The success rate, in terms of bacterial eradication, was 19/21 (90.5%) in patients with metronidazole-sensitive organisms, compared with only 6/19 (31.6%) in patients whose H. pylori were resistant to metronidazole (P less than 0.01). Side effects, particularly diarrhoea and vomiting/nausea, were common: 23/40 patients reported such symptoms during the 14-day course of therapy. Fifteen of these 23 patients completed the entire 14-day course, although suffering from significant side effects, while the remaining eight patients had to discontinue the treatment because side effects became intolerable. If a form of triple therapy is going to be widely used to eradicate H. pylori infection, the regimen will have to be simpler, shorter, produce fewer side effects and be more effective in patients with metronidazole-resistant bacteria.

Topics: Adult; Aged; Aged, 80 and over; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Organometallic Compounds; Tetracycline

We have investigated the possibility that hypergastrinaemia in chronic Helicobacter pylori infection is a compensatory response to reduced parietal cell sensitivity to gastrin. The acid response to 45-min infusions of pentagastrin at sequential doses (micrograms/kg/h) of 0, 0.031, 0.062, 0.124, and 0.6 was compared before and 1 month after eradication of H. pylori in eight duodenal ulcer patients. The median acid outputs (mmol/h) with the respective infusions were 5.0, 7.5, 26.5, 30.8, and 37.0 when H. pylori-positive and similar at 4.5, 7.1, 22.7, 28, and 31.5 when H. pylori-negative. The median estimated dose of pentagastrin required to produce 50% maximal response (D50) was similar before (0.060 micrograms/kg/h) and after (0.057 micrograms/kg/h) eradication of H. pylori. The median estimated maximal response to pentagastrin (mmol/h) was also similar before (39.2) and after (32.3) treatment. The median basal gastrin concentration was 48 ng/l (range, 22-77) before treatment and fell to 33 ng/l (range, 8-37) after eradication of H. pylori (p = 0.03). These findings show that the parietal cell sensitivity to pentagastrin is unaffected by chronic H. pylori infection in duodenal ulcer subjects and that the hypergastrinaemia cannot be attributed to the bacterium inhibiting parietal cell function.

Topics: Adult; Amoxicillin; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Gastric Acidity Determination; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Parietal Cells, Gastric; Pentagastrin; Stomach Diseases

This randomised double blind placebo controlled study evaluated the effectiveness of colloidal bismuth subcitrate (CBS), ampicillin and their combination in the treatment of Helicobacter Pylori in non-ulcer dyspepsia (NUD) and assessed if elimination of this organism is associated with improvement of gastritis and the symptoms. Forty-eight NUD patients with H. pylori and histologic gastritis were randomly allocated to one of the three regimens for 28 days. Symptoms were assessed before and after treatment. Forty-three patients completed the trial. Repeat endoscopy within 48 hours of completing treatment showed suppression of H. pylori in 6 of 7 patients (85.7%) on combined therapy and one of 8 patients (12.5%) on CBS therapy (p = 0.0205). There was no suppression of the bacteria in patients treated with ampicillin. Repeat endoscopy performed 2 weeks after completing treatment showed suppression of H. pylori in 3 of 7 patients (42.9%) on combined therapy and none in the other two groups. Patients on combined therapy who had suppression of H. pylori, 48 hours or 2 weeks after completing treatment were noted to have historical improvement of their gastritis (p = 0.0001 and p = 0.05 respectively). This was also associated with improvement of symptoms in these patients.

Topics: Adolescent; Adult; Aged; Ampicillin; Antacids; Double-Blind Method; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds

The relationship between Helicobacter pylori (HP) and gastric ulcer therapy is examined by analyzing both the data that suggest that eradication of HP renders the gastric mucosa less susceptible to development of gastric ulcer as well as the substantial body of evidence that does not support this contention. The results reported in clinical trials with colloidal bismuth citrate, antimicrobial agents (furazolidone), and combinations of anti-ulcer and antimicrobial agents (H2-antagonist+cefixime, H2-antagonist+metronidazole) are reviewed. Also analyzed is the relationship between HP eradication and ulcer recurrence. Only one study is available on this aspect, and the limited evidence it provides in favour of a prophylactic effect of eradication therapy is not entirely convincing. The authors conclude that there is no reasonable case for the dogmatic assumption that eradication of HP facilitates either acute healing or long-term prophylaxis of gastric ulcer, though certain subgroups of gastric ulcer patients may benefit from eradication therapy.

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Cefixime; Cefotaxime; Cimetidine; Drug Therapy, Combination; Furazolidone; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Stomach Ulcer

Triple therapy containing tetracycline HCl is currently among the most efficient combination therapies for eradication of Helicobacter pylori. Substitution of doxycycline for tetracycline HCl offers advantages of less frequent dosing and extrarenal excretion. In this study patients with duodenal ulcer or non-ulcer dyspepsia positive for H. pylori were randomized to either doxycycline or tetracycline HCl triple therapy in conjunction with bismuth subcitrate and metronidazole. Of the 34 patients taking doxycycline, only 22 (65%) achieved H. pylori eradication at the 4-week rebiopsy, compared with 36 of 39 (92%) taking tetracycline HCl (p = 0.004). We conclude that doxycycline-containing triple therapy is less effective for H. pylori eradication and offers no clinical advantage over tetracycline HCl-containing triple therapy.

Topics: Adult; Aged; Antacids; Bismuth; Doxycycline; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Tetracycline

Although Helicobacter pylori is both a frequent cause of gastritis and an important factor in duodenal ulcer recurrence, no treatment regimen exists that is completely safe and effective. We have studied a short eradication regimen of tripotassium dicitrato bismuthate 120 mg four times daily and amoxycillin 500 mg four times daily for seven days with metronidazole 400 mg five times daily for three days (days 5-7). 106 patients with peptic ulceration and non-ulcer dyspepsia, who were also infected with H pylori, were entered into the study. H pylori was successfully eradicated in 76/106 (72%) patients (median follow-up 9.3 months). The rate of eradication was higher among patients with metronidazole-sensitive H pylori (40/43, 93%). In 17/30 patients in whom eradication failed, pretreatment metronidazole-resistant strains were subsequently isolated. Side-effects were mild, the commonest (24/106, 24%) being taste disturbance with metronidazole. A one-week eradication regimen is a safe, effective, cheap, and well-tolerated treatment for metronidazole-sensitive H pylori.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Algorithms; Amoxicillin; Anti-Ulcer Agents; Drug Administration Schedule; Drug Combinations; Drug Resistance, Microbial; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Patient Compliance; Pyloric Antrum; Time Factors

To examine the effect of eradication of Helicobacter pylori on symptoms of non-ulcer dyspepsia.. Four week prospective study.. One hospital outpatient and endoscopy department.. 90 adults with persistent symptoms typical of non-ulcer dyspepsia but no clinical or endoscopic evidence of other peptic, biliary, pancreatic, or malignant disease; all had histological and microbiological evidence of infection with H pylori. 83 patients completed the treatment regimen.. Colloidal bismuth subcitrate 120 mg four times a day for four weeks (27 patients); metronidazole 400 mg and amoxycillin 500 mg each three times a day for one week (27); and bismuth subcitrate 120 mg four times a day for four weeks, metronidazole 400 mg three times a day for one week, plus amoxycillin 500 mg three times a day for the first week (29).. Change in symptom scores determined with questionnaire; histological evidence of gastritis and microbiological evidence of presence of H pylori in biopsy specimens.. Overall, H pylori was eradicated in 41 (49%) patients. Although gastritis scores improved significantly in only patients in whom H pylori had been eradicated (from 1.56 to 0.61, p less than 0.01 v from 1.83 to 1.07, p = 0.52) mean symptom scores after treatment were similar in patients in whom H pylori had or had not been eradicated (3.0 v 2.3, NS). Similarly the mean symptom score improved whether or not gastritis improved (2.8 v 3.1 respectively, p = 0.72). The observations were similar for treatment groups analysed individually.. Antral infection with the organism does not seem to have an important aetiological role in non-ulcer dyspepsia short term.

Topics: Adult; Aged; Amoxicillin; Bismuth; Drug Administration Schedule; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies

A study was undertaken to determine the role of Helicobacter pylori in non-ulcer dyspepsia (NUD) and to determine the efficacy of colloidal bismuth subcitrate (CBS) in the treatment of NUD. Seventy-one patients were randomly allocated (double blind) to CBS or placebo, two tablets twice daily for 4 weeks. The severity of dyspepsia was scored and endoscopies performed before and after treatment, and antral biopsy specimens were taken for bacteriologic and histologic examination. Forty patients had H. pylori infection, and all had changes of chronic active gastritis. H. pylori was cleared from 17 to 21 patients (81%) treated with CBS, whereas none of the 19 patients treated with placebo cleared the bacteria. Improvement in histology was noted in 15 of 21 patients (71.4%) treated with CBS, whereas no improvement was noted in any of the placebo controls. Thirty-one patients were negative for H. pylori. All had either normal gastric histology or minor degrees of inflammation. Seventeen of these patients received CBS, and 14 received placebo. All groups reported improvement in the symptom score; however, the H. pylori-positive, CBS-treated group recorded a significantly higher improvement than the other groups (p less than 0.001). Relapse of H. pylori infection after initial clearance of the bacteria was high. Twelve of 16 patients evaluated relapsed 1 month after withdrawal of CBS.

Topics: Adult; Antacids; Bismuth; Double-Blind Method; Dyspepsia; Female; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Male; Organometallic Compounds; Recurrence

Sixty patients with Helicobacter Pylori positive non ulcer dyspepsia were randomly allocated to one of the following treatment groups: Group I--norfloxacin 400 mg bid for 10 days, Group II--amoxycillin 500 mg bid plus tinidazole 500 mg bid for 15 days, Group III--colloidal bismuth subcitrate (CBS) 240 mg bid for 4 weeks. H pylori elimination was achieved in 14%, 81%, and 62% in Groups I, II and III respectively. Eradication of H pylori was not observed in Groups I and II, but was achieved in 25% of patients in Group III. Antral gastritis improved in 69% in Group II and 50% in Group III. We conclude that norfloxacin is not effective in H pylori infection. A combination of amoxycillin and tinidazole is highly effective in H pylori elimination with improvement in associated gastritis, but H pylori eradication is not observed with this therapy. CBS is also effective in H pylori elimination though H pylori eradication is achieved in only 25%.

Topics: Adult; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Norfloxacin; Organometallic Compounds; Tinidazole

Topics: Amoxicillin; Antacids; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Ranitidine; Recurrence

Helicobacter pylori infection of gastric antrum is associated with a majority of cases of peptic ulcer (70-100%). Studies have shown that when this organism is eradicated, the recurrence of ulcer falls to less than one-third of those in whom the infection persists or relapses. Monotherapy with bismuth salts, tinidazone or amoxycillin has been shown to result in early relapse and recurrence of ulcers. However, dual or triple therapy regimens are more effective. We conducted a randomised controlled study using tripotassium dicitrato bismuthate (TDB) (10 patients); amoxycillin (combined with ranitidine for ulcer healing) (9 patients) and dual therapy with both amoxycillin and TDB (10 patients). Our study showed that relapse rates at the end of 3 months was significantly less if dual therapy with TDB and amoxycillin is used as compared to TDB alone (p less than 0.05).

Topics: Amoxicillin; Anti-Ulcer Agents; Drug Therapy, Combination; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Peptic Ulcer; Ranitidine; Recurrence

Antral G cell hyperfunction (AGCH) is a rare condition, often associated with severe duodenal ulcer disease poorly responsive to medical therapy. Up to now, no studies have been designed to investigate a possible role of medical treatment in the management of this syndrome. In this study we treated 9 AGCH patients with duodenal ulcer, unhealed with the prolonging standard doses of H2 antagonists (300 mg/day ranitidine or 800 mg/day cimetidine), with a nonantacid therapy, tripotassium dicitrato bismuthate (TDB). 6 out of 9 patients showed a complete healing after 8 weeks of treatment. The healing was irrespective to eradication of Campylobacter pylori. After 9 weeks' suspension of H2 blockers basal gastrin levels decreased significantly by 31.5%, whereas peak meal-stimulated levels, although decreased in 6 out 9 patients, were not significantly affected by the withdrawal of the H2 antagonists. Nonantisecretory therapy seems to be an efficacious alternative in the management of AGCH patients.

Topics: Adolescent; Adult; Anti-Ulcer Agents; Bismuth; Cimetidine; Duodenal Ulcer; Enterochromaffin Cells; Female; Gastric Acid; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Ranitidine

Eighty patients with Campylobacter pylori-associated duodenal ulcer disease were randomly allocated to receive colloidal bismuth subcitrate (CBS)tablet 120 mg four times a day or ranitidine 150 mg twice daily in a trial comparing the effects of these drugs in short-term healing and post-healing relapse rates of duodenal ulceration. At 8 weeks 88.1% (37/42) of those on CBS and 92.1% (35/38) of those on ranitidine had ulcers healed. The difference is not significant. After ulcer healing, the cumulative rates of relapse, as determined endoscopically, for symptomatic and asymptomatic ulcers were 19.4% (6/31) for CBS and 46.7% (14/30) for ranitidine at 6 months (P less than 0.05) and 41.9% (13/31) for CBS and 73.3% (22/30) for ranitidine at 12 months (P less than 0.05). As campylobacter pylori was cleared in 35 of the 42 patients (83.3%) in the CBS group, while only one of the 38 patients (2.63%) in the ranitidine group (P less than 0.005), it is possible that the clearance of Campylobacter pylori by CBS is instrumental to the reduction of the rate of reulceration.

Topics: Adult; Anti-Ulcer Agents; Duodenal Ulcer; Female; Helicobacter Infections; Humans; Male; Organometallic Compounds; Ranitidine

This study aimed to investigate the efficacy and safety of vonoprazan in the eradication of Helicobacter pylori (H. pylori).. A total of 120 cases of H. pylori-infected outpatients were selected and randomly divided into the traditional quadruple therapy, vonoprazan triple therapy, and vonoprazan quadruple therapy groups. The traditional quadruple therapy group patients were orally treated with esomeprazole (20 mg) 30 minutes before breakfast and supper, amoxicillin (1000 mg orally) 30 minutes after breakfast and supper, furazolidone (100 mg orally) 30 minutes after breakfast and supper, and bismuth potassium citrate (0.6 g orally) 30 minutes before breakfast and supper. The vonoprazan triple therapy group patients were treated with vonoprazan (20 mg orally) 30 minutes following breakfast and supper, amoxicillin (1000 mg orally) 30 minutes following breakfast and supper, and bismuth potassium citrate (0.6 g orally) 30 minutes before breakfast and supper. The vonoprazan quadruple therapy group patients were treated with vonoprazan (20 mg orally) 30 minutes following breakfast and supper, amoxicillin (1000 mg orally) 30 minutes after breakfast and supper, furazolidone (100 mg orally) 30 minutes after breakfast and supper, and bismuth potassium citrate (0.6 g orally) 30 minutes before breakfast and supper. The 3 groups were treated for 14 days, and adverse reactions, such as vomiting and abdominal distension, were recorded during the treatment period. The 14C urea breath test was used to detect whether H. pylori was successfully eradicated in the patients.. The eradication rates of the vonoprazan triple therapy, vonoprazan quadruple therapy, and the traditional quadruple therapy groups were 80%, 95%, and 97.5%, respectively. The eradication rate was higher in the vonoprazan triple therapy and in the vonoprazan quadruple therapy groups compared with that noted in the control group. The adverse reactions were mild in these groups, and the main adverse reactions were nausea, abdominal distension, diarrhea, and constipation. The adverse reaction rate was 25%, 7.5%, and 15%, respectively. This rate was lower in the vonoprazan triple therapy and vonoprazan quadruple therapy groups than that noted in the control group.. Both vonoprazan triple therapy and vonoprazan quadruple therapy regimens could increase the eradication rate of H. pylori. Vonoprazan triple therapy exhibited reduced side effects and could be applied in the eradication of H. pylori in the clinic.

Topics: Amoxicillin; Anti-Bacterial Agents; Bismuth; Drug Therapy, Combination; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Potassium Citrate; Proton Pump Inhibitors; Treatment Outcome

The prevalence of antimicrobial resistance in Helicobacter pylori (HP) infection has increased globally. This study aimed to compare the efficacy of Biling Weitong granules (BLWTG) combined with quadruple therapy in patients with refractory HP infection who had previously failed eradication therapy.. This single-center prospective study enrolled patients with two or more consecutive failed HP treatments. A total of 122 patients with previously failed HP treatment from our hospital were recruited as participants and randomly (1:1) allocated to two eradication groups: patients treated with bismuth-containing quadruple therapy (esomeprazole 40 mg, amoxicillin 1.0 g, bismuth potassium citrate 220 mg, and clarithromycin 500 mg, twice daily [EACB group]) for 14 days. And those treated with BLWTG (5 g three times daily) combined with the EACB group for 14 days (BLWTG+EACB group). The therapeutic effects of the two treatment programs were comprehensively evaluated.. The study group had a significantly higher improvement rate in symptoms (dull stomach pain, nausea, gastric distension, loss of appetite, and belching) compared to the control group (P < .05). Eight weeks after drug withdrawal, the eradication rates in the control and study groups were 49.18% and 73.77%, respectively. The levels of interleukin-6, C-reactive protein, and tumor necrosis factor-α were significantly lower in both groups after treatment but were significantly lower in the study group than in the control group (P < .05).. The combination of BLWTG and standard four-drug therapy had a high eradication rate and low recurrence rate in patients with refractory HP infection. Additionally, this combined therapy could regulate inflammatory reactions and reduce drug-related adverse reactions.

Topics: Amoxicillin; Anti-Bacterial Agents; Bismuth; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Prospective Studies; Treatment Outcome

Topics: COVID-19; Diarrhea; Helicobacter Infections; Humans; SARS-CoV-2

Conventional second-line, bismuth-containing quadruple therapy is administered four times a day. We aimed to evaluate the efficacy and safety of twice a day administration compared to the four times a day therapy.. Medical records of consecutive patients with positive. Ninety-eight patients from the twice a day group and 99 patients from the four times a day group were analyzed. The eradication rate did not differ between the twice a day group (92/98, 93.9%) and the four times a day group (92/99, 92.9%). Adverse drug effects were found in 36 patients from the twice a day group and 50 patients from the four times a day group (P = .051). Abdominal pain, discomfort, and distention were more common with four times a day intake (13.1%) than with twice a day intake (4.1%; P = .024).. We determined for the first time that twice a day intake of bismuth-containing quadruple therapy using 2 g/d of tetracycline, 1.5 g/d of metronidazole, and 600 mg/d of bismuth subcitrate for one week is effective and safe as the conventional four times a day therapy. Twice a day intake decreased abdominal pain, discomfort, and distention.

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Middle Aged; Organometallic Compounds; Pantoprazole; Proton Pump Inhibitors; Tetracycline

Topics: Anti-Bacterial Agents; Clarithromycin; Colombia; Drug Combinations; Drug Resistance, Multiple, Bacterial; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Point Mutation; Tetracycline

Guidelines for selecting the eradication regimen for Helicobacter pylori reinfection remain unclear. This study aimed to evaluate the eradication rate of H. pylori reinfection in patients with a previous infection successfully eradicated with index triple therapy.. This was a single-center, retrospective case-control study. A total of 10 468 H. pylori-infected patients treated with proton-pump inhibitor-based triple eradication therapy at a tertiary medical institution between 2005 and 2016 were enrolled. We reviewed the medical records of the enrolled patients and compared the treatment outcomes in those with H. pylori reinfection after a successful eradication.. Helicobacter pylori infection was successfully eradicated with the index triple therapy in 7770 patients (74.2%). Among 3567 patients followed up for > 1 year, H. pylori reinfection occurred in 420 (11.8%; 3.06% per person-year) during a median follow-up of 39.1 months (interquartile range, 23.5-58.7 months). Of these patients, 164 received eradication therapy for reinfection (triple therapy in 102 and quadruple therapy in 62) and had follow-up data. Triple therapy showed an eradication rate of 78.4% for H. pylori reinfection, which was not significantly different from that of the index triple therapy (P = 0.394). Quadruple therapy for reinfection exhibited a better eradication rate (87.1%) than triple therapy but without statistical significance (P = 0.237).. Retreatment with triple therapy for H. pylori reinfection after successful eradication of prior infection showed comparable outcomes to the index triple therapy. Bismuth-containing quadruple therapy for reinfection tended to have a better eradication rate than did triple therapy.

Topics: Aged; Anti-Bacterial Agents; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Proton Pump Inhibitors; Recurrence; Republic of Korea; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

Topics: Aged; Amoxicillin; Anti-Bacterial Agents; Bacterial Load; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Pilot Projects; Prospective Studies; Proton Pump Inhibitors; Tetracycline; Time Factors; Treatment Outcome

A fixed-dose association of bismuth subcitrate, metronidazole and tetracycline (BMT) (Pylera. The aim of the study was to measure eventual bismuth accumulation and neurological toxicity in patients prescribed BMT.. Patients initiating BMT for H. pylori between March 2014 and December 2015 were included. A blood sample was taken before first BMT intake and 24 h after the last intake, for assay of bismuth. A concentration > 50 μg/L was considered abnormal. Neurological complaints were assessed at inclusion, at the end of the 10-day treatment course, and 28 days later.. 202 patients were included, of whom 190 took at least one dose of BMT, and 167 provided both required blood samples. Mean blood bismuth concentrations after the BMT course were 16.9 μg/L (95% confidence interval 15.6-18.3). Concentrations were > 50 μg/L (56.0 μg/L and 50.9 μg/L) in two elderly patients, one of whom presented mild, transient memory impairment during treatment. Non-serious neurological symptoms occurred in 20% of all patients and treatment failure was documented in 5% of patients.. In this study measuring blood bismuth concentrations in real-life practice, in < 1% of patients the BMT course resulted in blood bismuth concentrations > 50 μg/L. No serious neurological adverse events were observed.. EU-PAS register EUPAS3142 at www.encepp.eu ; ENCePP study seal.

Topics: Aged; Bismuth; Cohort Studies; Drug Combinations; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Neurotoxicity Syndromes; Organometallic Compounds; Tetracycline; Treatment Failure

quadruple therapy with bismuth is recommended as a first line treatment for Helicobacter pylori (H. pylori) infection. The aim of this study was to evaluate the compliance, adverse effects and effectiveness of this treatment with the new galenic three-in-one capsule formulation containing bismuth subcitrate, metronidazole and tetracycline (Pylera®).. a prospective, non-controlled, single center observational study was performed in a cohort of 200 consecutive patients with an untreated H. pylori infection; 58% were female. The subjects were treated for ten days with Pylera® of three capsules four times daily with meals and a proton pump inhibitor taken before breakfast and dinner. The Pylera® capsule contains 140 mg of bismuth subcitrate, 125 mg of metronidazole and 125 mg of tetracycline. The compliance and adverse effects of the treatment were evaluated via telephone contact and via an interview during the clinical revision. Eradication of infection was controlled for at least four weeks after treatment termination via the urea breath test, the stool antigen test with monoclonal antibodies or by histology.. treatment compliance was observed in 96% (192/200) of the patients. Only 28.5% (57/200) of the patients experienced adverse effects, which led to abandoning the treatment in only seven subjects. Severe adverse effects developed in only one case due to Clostridium difficile infection. The effectiveness based on intention to treat was 91.5% (183/200, 95% CI: 87.1-96.8) and per protocol was 95.2% (182/191, 95% CI: 90.9-98.9).. in our experience, Pylera® is an effective and safe treatment that should be considered as a first line therapeutic option for the eradication of H. pylori infection.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Infective Agents; Capsules; Drug Combinations; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Medication Adherence; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Tetracycline; Treatment Outcome; Young Adult

The eradication of Helicobacter pylori infection represents a clinical challenge.. To evaluate the efficacy and safety of quadruple therapy with esomeprazole plus a 3-in-1 capsule containing bismuth subcitrate, metronidazole and tetracycline, plus probiotics in patients diagnosed with H. pylori infection in routine clinical practice.. A prospective, interventional, single-centre and open-label study in consecutive patients with a confirmed indication for eradication of H. pylori infection. Patients were treated with three capsules of Pylera. A total of 100 patients were consecutively enrolled. Twenty-five patients (25.0%) had a prior history of treatment for their H. pylori infection. In the intention-to-treat population, eradication rates were 90.7% (68/75) and 80.0% (20/25) in patients treated with Pylera. Ten days of treatment with a quadruple regimen of bismuth, metronidazole and tetracycline plus esomeprazole and probiotics is an effective and safe strategy in patients with H. pylori infection.

Topics: Anti-Infective Agents; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Tetracycline; Treatment Outcome

Italian guideline suggests 10-day sequential or bismuth-based quadruple therapies for first-line Helicobacter pylori treatment. Comparison between these regimens is lacking. We assessed the efficacy of these therapies in clinical practice and evaluated the role of primary bacterial resistance toward clarithromycin and metronidazole.. Consecutive patients with H. pylori infection were enrolled. Bacterial culture with antibiotics susceptibility testing was attempted in all cases. Patients received either a sequential therapy with esomeprazole 40 mg for 10 days plus amoxicillin 1000 mg for the first 5 days followed by clarithromycin 500 mg and tinidazole 500 mg (all twice daily) for the remaining 5 days, or bismuth-based therapy with esomeprazole 20 mg twice daily and Pylera 3 tablets four times daily for 10 days. H. pylori eradication was assessed by using C-urea breath test.. A total of 495 patients were enrolled. Following sequential (250 patients) and quadruple (245 patients) therapies, the eradication rate were 92 and 91%, respectively, at intention-to-treat analysis and 96 and 97%, respectively, at per protocol analysis. Overall, the pattern of bacterial resistance did not significantly affect the cure rate, but the presence of clarithromycin and metronidazole dual resistance tended to reduce the success rate of both sequential (84.8 vs. 90.1%; P=0.4) and quadruple (85 vs. 94.1%; P=0.06) therapies. Adverse events occurred more frequently with the quadruple than with sequential therapy (56.9 vs. 25.8%; P<0.001).. In our country, sequential and bismuth-based quadruple therapy achieved similarly high eradication rates as first-line treatments for H. pylori infection in clinical practice.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Breath Tests; Clarithromycin; Drug Administration Schedule; Drug Combinations; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Italy; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Tetracycline; Time Factors; Tinidazole; Treatment Outcome

Our aims were to assess the real life effectiveness and safety of the new bismuth-containing quadruple therapy in a large population of patients infected by Helicobacter pylori.. Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients were treated with Pylera® 3 capsules 4 times/daily plus omeprazole 20 mg or esomeprazole 40 mg 2 times/daily for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of the treatment). Efficacy and safety were assessed.. A total of 349 patients were treated. H. pylori eradication was achieved in 316 (90.5%, 95% CIs 80.8-1.0) patients in the intention-to-treat population, and in 93.5% (95% CIs 83.5-1.0) in the per-protocol population. No difference in the eradication rate was found between naïve and previously treated patients (91.3 vs. 90.0%, p = 0.901). Adverse events occurred in 55 patients (15.8%, 95% CIs 11.9-20.1). Five patients discontinued treatment: 2 patients suffered from severe abdominal pain, one patient from headache, one patient from diarrhea, and one patient from diffuse urticarial rush.. Pylera® achieved a remarkable eradication rate in real life both as first treatment and as a rescue therapy, with a good safety profile.

Topics: Anti-Bacterial Agents; Bismuth; Demography; Drug Therapy, Combination; Endoscopy; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Retrospective Studies; Tetracycline; Treatment Outcome

The resistance of Helicobacter pylori to antibiotics is a growing problem in Spain and eradication rates must be improved. The new Spanish consensus considers quadruple therapy with bismuth as first- or second-line therapy. This study evaluated the use of Pylera. A cross-sectional descriptive study was conducted to evaluate the eradication rate of Helicobacter pylori in patients treated with Pylera. A total of 185 patients were included (51.6±16.19 years); 63.8% were women and 9.2% had a family history of gastric cancer. The most frequent indication was dyspepsia (55.1%). Approximately 57.8% received Pylera. Pylera

Topics: Adult; Aged; Breath Tests; Cross-Sectional Studies; Drug Evaluation; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Recurrence; Retrospective Studies; Tetracycline; Treatment Outcome; Young Adult

Clarithromycin-containing triple regimen for eradication of Helicobacter pylori is no longer acceptable in Korea due to high clarithromycin resistance. Concomitant therapy or bismuth-containing quadruple therapy is recommended as an alternative regimen. A recent study in Korea has shown that modified quadruple therapy has comparable efficacy and safety to concomitant therapy as a first-line regimen. However, there has been no comparative study of modified quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the efficacy and safety of modified quadruple therapy with those of bismuth-containing quadruple therapy as a first-line regimen and to present the phenotypic and genotypic antibiotic resistance profile of H pylori.. This study is an open-label, multicenter, randomized controlled trial. We are recruiting subjects endoscopically diagnosed with H pylori infection from 2 hospitals in Korea. Subjects will be randomly allocated either to modified quadruple therapy (proton-pump inhibitor bid, amoxicillin 1 g bid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid daily) or bismuth-containing quadruple therapy (proton-pump inhibitor bid, tetracycline 500 mg qid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid daily) for 14 days. The rate of eradication success and adverse events will be checked at least 4 weeks after the treatment. Antibiotic resistance will be established using both a bacterial culture with agar dilutions and DNA sequencing of the clarithromycin resistance point mutations in the 23S rRNA gene of H pylori.. The results of this study will provide solid evidence for determining the optimal treatment regimen for first-line H pylori eradication in Korea.

Topics: Adult; Amoxicillin; Anti-Infective Agents; Clinical Protocols; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Genotype; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Multicenter Studies as Topic; Organometallic Compounds; Phenotype; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Republic of Korea; Tetracycline; Treatment Outcome

To evaluate the efficacy and safety of a quadruple regimen (BMTO) of the "3-in-1 capsule" (containing bismuth subcitrate potassium, metronidazole and tetracycline) plus omeprazole in naïve and previously treated patients diagnosed with Helicobacter pylori (H. pylori) infection in the clinical setting in Seville (Spain).. This is a prospective study carried out on consecutive patients with a confirmed H. pylori infection and upper gastrointestinal symptoms. After providing their informed consent, the patients were treated for ten days with a 3-in-1 capsule containing bismuth subcitrate potassium (140 mg), metronidazole (125 mg) and tetracycline (125 mg: Pylera®), three capsules four times daily, plus omeprazole (20 or 40 mg) twice daily. Eradication of infection was determined by a negative urea breath test at least 28 days after the end of treatment.. A total of 58 consecutive patients were enrolled into this study, two of whom withdrew early due to vomiting on days three and five, respectively. In this cohort, 17 patients (29.3%) had a prior history of medication to treat H. pylori. In the intent-to-treat population, eradication was achieved in 97.6% (40/41) and 82.4% (14/17) of cases in patients treated with BMTO as a first-line or rescue therapy, respectively. At least one adverse event was reported by 28 (48%) patients, mostly mild effects (86%).. A ten day treatment with BMTO is an effective and safe strategy to combat confirmed H. pylori infection in patients.

Topics: Adult; Aged; Anti-Bacterial Agents; Cohort Studies; Drug Combinations; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Tetracycline; Treatment Outcome

The aim of this study was to evaluate the efficacy, tolerability and safety of modified bismuth-based quadruple therapy for the second-line eradication treatment of Helicobacter pylori (H. pylori) infection.. Out of 758 patients treated between January 2010 and December 2015, 155 patients (20.45%) remained H. pylori positive after the first line treatment and received the second-line treatment consisting of colloidal bismuth subcitrate (240 mg twice daily), pantoprazole (40 mg twice daily), metronidazole (500 mg twice daily) and moxifloxacin (400 mg once daily) for 14 days. Six weeks after the completion of treatment patients were retested for the presence of H. pylori infection with 13C urea breath test.. Out of 155 patients, 142 patients completed their second-line regimens. 13 patients were excluded from the study: 4 experienced adverse effects that have led to discontinuation of treatment, 5 were lost to follow-up and 4 complied poorly with medication. The eradication rates were 80.64% (125/155) and 88.02% (125/142) according to intention-to-treat and per-protocol analyses. Compliance with the therapy was 89%.. Moxifloxacin in modified bismuth-based quadruple therapy was found to be effective and safe with good drug compliance; therefore it may be an acceptable alternative to other second-line eradication protocols.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Bacterial Agents; Anti-Infective Agents; Breath Tests; Drug Therapy, Combination; Female; Fluoroquinolones; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Moxifloxacin; Organometallic Compounds; Pantoprazole; Patient Compliance; Proton Pump Inhibitors; Retrospective Studies; Treatment Outcome

Topics: Anti-Infective Agents; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Proton Pump Inhibitors; Tetracycline

The emergence of H. pylori strains that are resistant to clarithromycin, metronidazole and fluoroquinolone requires the evaluation of new and effective salvage therapies.. To test the efficacy of a new formulation of a bismuth-containing quadruple therapy as a rescue therapy in patients who were infected with a H. pylori strain resistant to metronidazole, clarithromycin and fluoroquinolone or who failed multiple lines of treatment using these three antibiotics.. A total of 103 patients with confirmed H. pylori infection with a resistance profile described above were treated with Pylera(®) (3-in-1 capsules containing bismuth subcitrate potassium 140mg, metronidazole 125mg and tetracycline 125mg) 3 capsules four times a day plus omeprazole 20mg two times a day for 10 days in a named patient program. Eradication was confirmed using a urea breath test at least 28 days after the end of treatment. Efficacy and safety were studied.. A total of 103 patients were prospectively included from June 2010 to October 2011. The eradication rate for the intent-to-treat analysis was 83% (CI95%[75-89%]); an 87% eradication rate (CI95%[80-94%]) was found for the per-protocol analysis and 81% (CI95%[80-82%]) for the intent-to-treat analysis in patients with proven resistance to metronidazole. Nine patients discontinued treatment, all due to adverse events. Two serious adverse events (AEs) were reported (memory disorders of unknown significance). Fifty-six (54%) patients reported at least one AE.. This bismuth-containing quadruple therapy achieved a remarkable eradication rate as a salvage therapy in patients infected with metronidazole-resistant H. pylori strain, despite the frequent occurrence of mild-to-moderate adverse events.

Topics: Anti-Infective Agents; Drug Combinations; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Salvage Therapy; Tetracycline

We aimed to compare the plasma pantoprazole level (PPL) between patients with type 2 diabetes mellitus and non-diabetic patients during Helicobacter pylori (H. pylori) eradication treatment and to explore the role of PPL in predicting the treatment success rates.. This study included 40 diabetic and 40 non-diabetic treatment-naive H. pylori-infected patients. Bismuth-based standard quadruple treatment for H. pylori eradication was used for 14 days in both groups. PPL was measured using the square-wave voltammetry method.. H. pylori eradication rate (60.0% vs 87.5%, P = 0.005) and PPL (0.25 ± 0.03 μg/mL vs 0.34 ± 0.03 μg/mL, P < 0.001) was significantly lower in the diabetic group compared with the controls. Patients with treatment failure had lower PPL than those with successful treatment (P < 0.001). The receiver operating characteristics curve demonstrated that PPL had a significant predictive value for the outcome of H. pylori eradication.. Type 2 diabetic patients had lower PPL than the non-diabetic controls, which led to their lower H. pylori eradication rates.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Pantoprazole; Predictive Value of Tests; Proton Pump Inhibitors; ROC Curve; Tetracycline; Treatment Failure

To compare the efficacy of 14- and 7-d bismuth-based quadruple therapies as second-line eradication treatment for Helicobacter pylori (H. pylori) infection.. Between 2004 and 2014, the medical records of 790 patients who had experienced failure of first-line proton pump inhibitor (PPI)-based eradication therapy and were then treated with bismuth-based quadruple therapy were retrospectively reviewed. Those who received bismuth-based quadruple therapy [PPI, bismuth, metronidazole, and tetracycline (PBMT)] for either 7 d or 14 d were assigned to a PBMT-7 group (n = 543) or a PBMT-14 group (n = 247), respectively. The eradication rates for both groups were determined by intention-to-treat (ITT) and per-protocol (PP) analyses. ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated. Successful eradication therapy for H. pylori infection was defined as a negative (13)C-urea breath test 4 wk after the end of eradication treatment.. The overall ITT eradication rate was 69.1% (546/790). Final ITT eradication rates were 67.4% (366/543; 95%CI: 63.1%-71.7%) in the PBMT-7 group and 72.8% (180/247; 95%CI: 67.4%-78.2%) in the PBMT-14 group (P = 0.028). The overall PP eradication rate was 80.0% (546/682), and the final PP eradication rates were 78.2% (366/468; 95%CI: 72.1%-84.0%) in the PBMT-7 group and 84.1% (180/214; 95%CI: 76.8%-90.8%) in the PBMT-14 group (P = 0.009). The H. pylori eradication rates in the PBMT-14 group were significantly higher than in the PBMT-7 group according to both ITT (P = 0.028) and PP analysis (P = 0.009). Compliance was similar in both groups (PBMT-7 group: 97.9%; PBMT-14 group: 96.4%). Adverse event rates were 10.7% (51/478) and 17.1% (38/222) in the PBMT-7 and PBMT-14 groups, respectively (P = 0.487).. The 14-d bismuth-based quadruple therapy is a significantly more effective second-line eradication treatment for H. pylori infection than the 7-d alternative.

Topics: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Breath Tests; Drug Administration Schedule; Drug Therapy, Combination; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Intention to Treat Analysis; Male; Medical Records; Medication Adherence; Metronidazole; Middle Aged; Organometallic Compounds; Proton Pump Inhibitors; Rabeprazole; Remission Induction; Retrospective Studies; Tetracycline; Time Factors; Treatment Outcome

Successful eradication of Helicobacter pylori is becoming more difficult, mainly due to emerging antibiotic resistance. Treatment regimens containing bismuth have increased efficacy, but the mechanism is unknown. Helicobacter pylori is a neutralophile adapted to survive the acidic gastric environment via acid acclimation, but demonstrates more robust growth at neutral pH. Many antibiotics used to treat H. pylori rely on bacterial growth.. To investigate the mechanism of increased efficacy of bismuth-containing H. pylori treatment regimens.. RNAseq and qPCR, urease activity in permeabilised and intact bacteria, internal pH and membrane potential were measured with and without colloidal bismuth subcitrate (CBS). Bacterial survival was assessed with CBS and/or ampicillin.. Genes involved with metabolism and growth were upregulated in the presence of CBS at acidic pH. Urease activity of permeabilised H. pylori at pH 7.4 and 4.5 decreased in the presence of CBS, but intact urease activity decreased only at acidic pH. The fall in cytoplasmic pH with external acidification was diminished by CBS. The increase in membrane potential in response to urea addition at acidic medium pH was unaffected by CBS. The impact of CBS and ampicillin on H. pylori survival was greater than either agent alone.. Bismuth is not acting directly on urease or the urea channel. Colloidal bismuth subcitrate impedes proton entry into the bacteria, leading to a decrease in the expected fall in cytoplasmic pH. With cytoplasmic pH remaining within range for increased metabolic activity of a neutralophile, the efficacy of growth-dependent antibiotics is augmented.

Topics: Antacids; Anti-Bacterial Agents; Colloids; Gene Expression Regulation, Bacterial; Helicobacter Infections; Helicobacter pylori; Humans; Hydrogen-Ion Concentration; Ion Transport; Microbial Sensitivity Tests; Microbial Viability; Organometallic Compounds; Protons

In our study, we aimed to assess the effect of vitamin E and C supplementation to triple and quadruple Helicobacter pylori eradication regimens.. Four hundred patients with H. pylori infection were classified into four groups. Patients in group A (n=100) received amoxicillin, clarithromycin, and lansoprazole for 2 weeks. In group B, patients (n=100) received vitamins C and E for a month, in addition to amoxicillin, clarithromycin, and lansoprazole for 2 weeks. Patients in group C (n=100) received amoxicillin, clarithromycin, lansoprazole, and bismuth subcitrate for 2 weeks, whereas those in group D (n=100) received vitamins C and E for a month, in addition to amoxicillin, clarithromycin, lansoprazole, and bismuth subcitrate for 2 weeks. H. pylori eradication was assessed with the C14 urea breath test 2 months after the end of the therapy. The eradication rate was assessed using per-protocol (PP) and intention-to-treat (ITT) analyses.. Three hundred forty-eight patients finished the study. The eradication of H. pylori was achieved in 63 of 84 patients (75%) by PP and 63 of 100 (63%) by ITT analysis in group A, 60 of 84 (71.4%) by PP and 60 of 100 (60%) by ITT analysis in group B, 72 of 89 (80.9 %) by PP and 72 of 100 (72%) by ITT analysis in group C, and 76 of 91 (83.5%) by PP and 76 of 100 (76%) by ITT analysis in group D. There was no remarkable change between groups A and B (p>0.05). Similar results were also found between groups D and C (p>0.05).. This study revealed that supplementing vitamins C and E to either the triple or quadruple therapies did not provide an additional advantage for achieving significantly higher eradication rates for H. pylori.

Topics: Adult; Aged; Amoxicillin; Anti-Infective Agents; Anti-Ulcer Agents; Ascorbic Acid; Breath Tests; Clarithromycin; Dietary Supplements; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Middle Aged; Organometallic Compounds; Retrospective Studies; Treatment Outcome; Vitamin E; Vitamins; Young Adult

Two new Bi3+-Hericium erinaceus polysaccharide (BiHEP) complexes were prepared using Bi3+ and two purified polysaccharides from H. erinaceus (HEPs), respectively. The complexes were characterized by elemental analysis, FT-IR, CD, SEM, AFM, XRD, and TG. The anti-Helicobacter pylori (Hp) activities in vitro by agar dilution assay of the complexes were evaluated. The molecular weights of HEPs were 197 and 20 kDa, respectively. All the analyses confirmed the formation of new BiHEP complexes with lower content of Bi3+ compared with colloidal bismuth subcitrate (CBS), the most utilized bismuth preparation clinically. Furthermore, HEPs themselves have definite inhibition effects on Hp, and BiHEP complexes have lower content of Bi exhibited strong inhibition effects on Hp (MIC=20 μg/mL), similar to that of CBS with higher content of Bi. The study provides a basis for further development of multiple treatments of Hp infection or new medicines.

Topics: Anti-Bacterial Agents; Basidiomycota; Bismuth; Coordination Complexes; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Polysaccharides

Retreatment after initial treatment failure for Helicobacter pylori is very challenging. The purpose of this study was to evaluate the efficacies of moxifloxacin-containing triple and bismuth-containing quadruple therapy.. A total of 151 patients, who failed initial H. pylori treatment, were included in this retrospective cohort study. The initial regimens were standard triple, sequential, or concomitant therapy, and the efficacies of the two following second-line treatments were evaluated: 7-day moxifloxacin-containing triple therapy (rabeprazole 20 mg twice a day, amoxicillin 1,000 mg twice a day, and moxifloxacin 400 mg once daily) and 7-day bismuth-containing quadruple therapy (rabeprazole 20 mg twice a day, tetracycline 500 mg 4 times a day, metronidazole 500 mg 3 times a day, and tripotassium dicitrate bismuthate 300 mg 4 times a day).. The overall eradication rates after moxifloxacin-containing triple therapy and bismuth-containing quadruple therapy were 69/110 (62.7%) and 32/41 (78%), respectively. Comparison of the two regimens was performed in the patients who failed standard triple therapy, and the results revealed eradication rates of 14/28 (50%) and 32/41 (78%), respectively (p=0.015). The frequency of noncompliance was not different between the two groups, and there were fewer adverse effects in the moxifloxacin-containing triple therapy group (2.8% vs 7.3%, p=0.204 and 25.7% vs 43.9%, p=0.031, respectively).. Moxifloxacin-containing triple therapy, a recommended second-line treatment for initial concomitant or sequential therapy failure, had insufficient efficacy.

Topics: Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Cohort Studies; Drug Therapy, Combination; Female; Fluoroquinolones; Gastroesophageal Reflux; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Moxifloxacin; Organometallic Compounds; Peptic Ulcer; Rabeprazole; Republic of Korea; Retrospective Studies; Salvage Therapy; Stomach; Tetracycline; Treatment Failure; Treatment Outcome; Urea

The standard treatment for peptic ulcer associated with Helicobacter pylori is a combination of omeprazole, amoxicillin and clarithromycin, which renders the bacterium undetectable in about 70% of cases. A fixed-dose combination of bismuth subcitrate potassium + metronidazole + tetracycline has been authorised in some European countries for use in this setting, combined with high-dose omeprazole. In a European trial with 440 patients, the 4-drug combination of omeprazole + bismuth subcitrate + metronidazole + tetracycline was significantly more active than the standard 3-drug regimen in terms of H. pylori eradication, as measured with the urea breath test (79.8% with bismuth, 55.4% without bismuth). In a North American trial with 275 patients the success rate was similar with the two treatments, again based on the urea breath test. There are no comparative trials of the 4-drug regimen in patients in whom standard treatment has failed. The main adverse effects of the 4-drug regimen observed in clinical trials were black stools, nausea, headache and dizziness. However, the trials were too small to detect infrequent but serious adverse effects such as bismuth encephalopathy. Safety during pregnancy is not known. Some patients included in clinical trials had detectable plasma bismuth concentrations. Omeprazole increases the absorption of bismuth subcitrate potassium. In practice, the 4-drug regimen combining omeprazole + bismuth subcitrate potassium + metronidazole + tetracycline is probably more effective than standard 3-drug therapy against H. pylori, at least in Europe, but this combination should be avoided due to uncertainties on the possible neurotoxicity of bismuth. Other antibiotic combinations are preferable, and there are too many questions surrounding the adverse effects of this combination for it to replace the standard 3-drug regimen in France.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Combinations; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Tetracycline

To investigate the presence of any possible association between H. pylori density in the stomach and the efficacy of triple (lansoprazole 30 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1g b.i.d. for 14 days) and bismuth-containing quadruple (colloidal bismuth subcitrate 300 mg q.i.d., lansoprazole 30 mg b.i.d., tetracycline 500 mg q.i.d. and metronidazole 500 mg t.i.d. for 14 days) eradication therapies.. Eighty-five cases with H. pylori infection (proved by rapid urease test and histology) were studied. In each case, the density of H. pylori colonization was graded according to the updated Sydney classification. H. pylori eradication was determined via the (14)C-Urea breath test performed 4 weeks after the end of therapy.. The eradication rate of H. pylori was 50% (30 out of 60) in the triple therapy and 92% (23 of 25) in the quadruple therapy group. In the triple therapy group, the eradication rate of H. pylori decreased as the initial density of H. pylori increased (density of H. pylori: 1, 58.3%; 2, 54.5%; 3, 52.4%; 4, 38.5%; 5, 33.3%). In two cases with eradication failure after quadruple therapy, the grades of bacterial density were 1 and 3.. H. pylori density, as assessed by histological grading, may predict the usefulness of triple therapy. The higher the H. pylori density, the less effective triple therapy will be at successful eradication of H. pylori. Quadruple therapy does not seem to be negatively affected by bacterial density.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Infective Agents; Breath Tests; Case-Control Studies; Clarithromycin; Drug Therapy, Combination; Dyspepsia; Endoscopy, Gastrointestinal; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Proton Pump Inhibitors; Stomach; Tetracycline; Treatment Outcome; Urea; Young Adult

Topics: Amoxicillin; Anti-Infective Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Tetracycline

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Combinations; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Tablets; Tetracycline

To analyze the triple antimicrobial therapy in positive Helicobacter spp. dogs and to investigate recurrence.. A total of 20 dogs underwent endoscopy followed by gastric biopsy using the rapid urease test and histopathology stained with Giemsa. Ten animals were treated with triple therapy recommended for humans and divided into control and experimental group. The control group was kept in isolation while the experimental group was placed in contact with positive animals during 60 days.. The prevalence of infection in animals in this experiment was 100%, and more frequent in the fundus and the gastric body. Therapy for 7 days using clarithromycin, amoxicillin and lansoprazole was effective in 100% of the animals. Recurrence of the infection in 80% of dogs in the experimental group, while the control group remained eradicated after 60 days.. Crowded environments associated with close contact with dogs infected with helicobacter are a determinant for transmission of Helicobacter spp. between canines.

Topics: Amoxicillin; Animals; Anti-Infective Agents; Dog Diseases; Dogs; Drug Therapy, Combination; Gastric Mucosa; Helicobacter; Helicobacter Infections; Metronidazole; Organometallic Compounds; Prevalence; Recurrence

To provide a pilot study of empiric rifaximin, bismuth subcitrate, furazolidone/nifuratel triple therapy for H. pylori gastritis in childhood.. Forty one pediatric outpatients (27 females, mean age 14.5 +/- 1.4 ys) with H. pylori-associated chronic gastritis who underwent endoscopy for dyspeptic symptoms received the combination of bismuth subcitrate (8/mg/kg/day, q. d. s.) for 14 days, rifaximin (800 mg/day) for 10 days and furazolidone (10 mg/kg/day, q. d. s.) or nifuratel (15 mg/kg/two times daily) for 10 days. H. pylori status was determined before the treatment by modified Giemsa staining/urease test and after the treatment (in 4-6 weeks) by ammonia breath test.. H. pylori was eradicated in 35 children (85.4%; 95% CI: 75.4-96.4 ITT and PP tests). There were no serious adverse reactions and were no withdrawals due to any side effects.. The combination of rifaximin, bismuth subcitrate and furazolidone/nifuratel was an effective and tolerable regimen for initial H. pylori eradication.

Topics: Adolescent; Anti-Infective Agents; Child; Drug Therapy, Combination; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Organometallic Compounds; Rifamycins; Rifaximin

A 20-year-old male presented with low-grade fever, abdominal pain, anorexia, and weight loss of 4-month duration. On examination, he was emaciated. Barium meal follow-through examination showed extensive nodularity and thickening of duodenal and jejunal folds. Contrast-enhanced computed tomography of the abdomen revealed extensive proximal small-bowel thickening with mesenteric lymphadenopathy. Upper gastrointestinal endoscopy and enteroscopy revealed thickening of folds with multiple small superficial ulceration involving antrum, duodenum, and jejunum. The duodenal and jejunal biopsy was suggestive of immunoproliferative small intestinal disease, stage 0 (Salem) or stage A (Galian). Antral biopsy showed presence of Helicobacter pylori infection. He underwent H. pylori eradication following which he had significant clinical improvement; repeat evaluation at 6 months showed dramatic improvement in his clinical, radiological, and histological parameters.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Amoxicillin; Anti-Bacterial Agents; Clarithromycin; Doxycycline; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Immunoproliferative Small Intestinal Disease; Lansoprazole; Male; Omeprazole; Organometallic Compounds; Tinidazole; Young Adult

Topics: Anti-Bacterial Agents; Bismuth; Drug Therapy, Combination; Helicobacter Infections; Humans; Organometallic Compounds; Proton Pump Inhibitors; Salicylates

Topics: Anemia; Anti-Bacterial Agents; Antineoplastic Agents, Alkylating; Cyclophosphamide; Drug Therapy, Combination; Helicobacter Infections; Humans; Lymphoma, B-Cell, Marginal Zone; Male; Melena; Metronidazole; Middle Aged; Organometallic Compounds; Positron-Emission Tomography; Tetracycline

There is increasing evidence of Helicobacter pylori (H. pylori) resistance to the classical triple therapy consisting of a proton-pump inhibitor and clarithromycin with either amoxicillin or metronidazole. This study is aimed at establishing the efficacy and safety of a 14-day regimen to eradicate H. pylori in patients who have failed with the classical triple therapy given for 14 days. One hundred seventy-six patients diagnosed to have H. pylori infection were given triple therapy for 14 days. Fifty-two patients who failed to respond as evident from positive 14C-urea breath test (UBT) done 4-6 weeks after the completion of triple therapy were offered a combination regimen comprised of furazolidone 200 mg b.i.d, co-amoxiclav 1 g b.i.d., colloidal bismuth subcitrate 240 mg b.i.d., and esomeprazole 40 mg b.i.d. for 14 days. The mean age of these patients was 41 +/- 13 years (range 20-67). Thirty-four were males. To document eradication of H. pylori, UBT was repeated 4 weeks after the completion of treatment. On an intention-to-treat analysis, the eradication rate was 81% (42 out of 52) whereas on per-protocol basis, the eradication rate was 82.4% (42 out of 51). In conclusion, this new regimen represents a suitable second-line therapy.

Topics: Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Drug Therapy, Combination; Esomeprazole; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Treatment Failure; Young Adult

The European Helicobacter Study Group has recently issued the current concepts in the management of Helicobacter pylori infection (Maastricht III Consensus Report, 2005). The aim of the study was to examine the cumulative H. pylori eradication rates that can be achieved in clinical practice by adopting first and second regimens as proposed by the Maastricht III consensus and a third-line empirical levofloxacin-based regimen.. H. pylori-positive patients were treated initially with a first-line eradication triple regimen consisting of omeprazole, amoxicillin, and clarithromycin and subsequently with a second-line quadruple regimen consisting of omeprazole, bismuth, metronidazole, and tetracycline. Finally, after two previous H. pylori eradication failures, patients received omeprazole, amoxicillin, and levofloxacin, as a third-line empirical strategy. The success rate was calculated by both intention-to-treat (ITT) and per protocol (PP) analyses.. In total, 540 consecutive H. pylori-positive patients received first-line treatment (omeprazole, amoxicillin, and clarithromycin). H. pylori were eradicated in 380 patients and 40 patients were withdrawn (ITT, 70.3%; PP, 76%). The remaining 120 H. pylori-positive patients received second-line treatment (omeprazole, bismuth, metronidazole, and tetracycline). H. pylori were eradicated in 83 patients and 7 patients were withdrawn (ITT, 69.1%; PP, 73.45%). Finally, the remaining 30 H. pylori-positive patients received third-line treatment (omeprazole, amoxicillin, and levofloxacin). H. pylori were eradicated in 21 patients and 0 patients were withdrawn (ITT, 70%; PP, 70%). Thus, out of 540 patients initially included in the study, H. pylori were eradicated in 484 patients, 47 were withdrawn, and only 9 remained positive. These results give 89.6% ITT and 98.1% PP cumulative H. pylori eradication rates.. By adopting first- and second-line regimens, as proposed by the Maastricht III consensus and a third-line levofloxacin-based empirical regimen, high cumulative H. pylori eradication rates can be achieved. Thus, a substantial number of cultures to determine sensitivity to antibiotics can be avoided with beneficial consequences concerning cost.

Topics: Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Practice Guidelines as Topic; Proton Pump Inhibitors; Young Adult

A standard third-line therapy for Helicobacter pylori infection is lacking, and antimicrobial sensitivity data for patients who failed eradication therapy are often unavailable in clinical practice. We therefore designed the prospective study to assess the efficacy of levofloxacin, amoxicillin, bismuth and rabeprazole quadruple therapy as a third-line treatment for H. pylori infection.. From September 2005 to August 2007, 37 consecutive H. pylori-infected patients who had failed standard first-line and second-line treatments underwent a 10-day quadruple therapy comprising rabeprazole (20 mg b.i.d.), bismuth subcitrate (300 mg q.d.s.), amoxicillin (500 mg q.d.s.) and levofloxacin (500 mg o.d.). Follow-up endoscopy with rapid urease test, histological examination and culture was performed at 6 weeks after the end of treatment to evaluate the response to therapy.. Helicobacter pylori was successfully eradicated in 31 out of 37 patients (84% by both intention-to-treat analysis and per-protocol analysis). All patients complied with the eradication therapies, and only seven patients (19%) complained of mild-to-moderate adverse events. Amoxicillin- and levofloxacin-resistant strains were observed in 17% and 22% of the patients, respectively. There were no significant differences between H. pylori eradication rates and antibiotic resistances.. The 10-day levofloxacin- and amoxicillin-based quadruple therapy is well tolerated and achieves a high eradication rate as a third-line empirical treatment for H. pylori infection.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Amoxicillin; Anti-Bacterial Agents; Aryl Hydrocarbon Hydroxylases; Chi-Square Distribution; Cytochrome P-450 CYP2C19; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Genotype; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Organometallic Compounds; Patient Selection; Polymorphism, Genetic; Prospective Studies; Rabeprazole; Salvage Therapy; Treatment Outcome

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Antacids; Anti-Ulcer Agents; Cost-Benefit Analysis; Drug Therapy, Combination; Famotidine; Health Care Costs; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Omeprazole; Organometallic Compounds; Peptic Ulcer; Rabeprazole; Ranitidine; Russia

Initial proton pump inhibitor (PPI)-based triple therapy for Helicobacter pylori (H. pylori) infection is less effective in patients with nonulcer dyspepsia (NUD) than those with peptic ulcer disease (PUD). To date, there have been no studies on the difference in eradication rates in NUD compared to PUD with regard to second-line therapy. Therefore, we retrospectively analyzed the difference in eradication rates of a second-line quadruple therapy for NUD and PUD patients.. Between June 2003 and December 2005, patients who failed to respond to initial PPI-based triple therapy, received 7 days of quadruple therapy (PPI b.i.d., bismuth 300mg q.i.d., metronidazole 500mg t.i.d., tetracycline 500mg q.i.d.) as a second-line treatment regimen. Four weeks after the completion of the course of medication, a 13C-urea breath test was performed for detection of H. pylori.. A total of 87 patients received second-line quadruple therapy. Of these, 43 patients had NUD and 44 patients had PUD (19 gastric ulcers, 23 duodenal ulcers, 2 both ulcers). The eradication rates were 76.7% (33/43) in the NUD group and 90.9% (40/44) in the PUD group by per-protocol analysis. Therefore, the eradication rates in the NUD group were significantly lower than those in the PUD group (p = 0.034).. A 7-day bismuth-based second-line quadruple therapy for H. pylori infection was less effective in patients with NUD than those with PUD. Therefore, a more potent second-line treatment regimen or extension of treatment duration of quadruple therapy should be considered for the eradication of H. pylori in patients with NUD.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Proton Pump Inhibitors; Retrospective Studies; Treatment Outcome

To study the incidence of Helicobacter pylori recurrence, its chronological aspects, and the variables that might influence it.. A total of 1000 patients in whom H. pylori had been eradicated were prospectively studied. Therapies were classified as low and high efficacy regimens. Four to eight weeks after completion of therapy, 13C-urea-breath-test was performed, and it was repeated yearly up to 5 years. In some patients, endoscopy with biopsies was also performed to confirm H. pylori eradication.. A total of 1000 patients were included, giving 2744 patient-years of follow-up. Seventy-one H. pylori recurrences were observed (2.6% per patient-year). Probability of being H. pylori-negative at 1 year was 94.7%, and at 5 years 90.7%. In the multivariate analysis, low age (OR: 1.84; 95% CI: 1.04-3.26) and low efficacy therapies (OR: 2.5; 1.23-5.04) correlated with 1-year H. pylori recurrence. Differences were observed when Kaplan-Meier curves were compared depending on age and therapy regimen.. Risk of posteradication H. pylori recurrence is higher during the first year, which suggests that most recurrences during this period are recrudescence and not true reinfections. H. pylori recurrence is more frequent in younger patients and in those treated with low efficacy therapies, but is exceptional if high efficacy therapies are used, in which case post-therapy eradication can be safely confirmed at 4 weeks with 13C-urea-breath-test.

Topics: Amoxicillin; Anti-Infective Agents; Anti-Ulcer Agents; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Recurrence; Risk Factors; Tetracycline

To determine the long-term outcomes in terms of Helicobacter pylori and ulcer recurrence after second-line eradication with bismuth-containing quadruple regimens in Korea.. Sixty-seven patients with peptic ulcer disease after successful eradication using second-line quadruple therapies were prospectively followed up 1 month after treatment and then every 6 months or when dyspeptic symptoms reappeared to ascertain H. pylori and ulcer status.. Three patients were lost during follow-up. The median duration of follow-up of the remaining 64 patients was 26.8 months. H. pylori recurrence occurred in 11 of these 64 patients (17.2%), giving a calculated reinfection rate of 6.0% per patient-year. Only one of the 11 patients was reinfected by 12 months after treatment completion. Four of 11 patients (36.4%) who became reinfected experienced peptic ulcer recurrence, but none of 53 patients who were not reinfected experienced recurrence. No evidence was obtained to indicate that the reinfection rate depended on the age, sex, ulcer location, or eradication regimens. The relapse of dyspeptic symptoms was the only factor predictive of H. pylori recurrence.. This study suggests that the recurrence rate of H. pylori at 1 year after second-line, bismuth-containing quadruple therapy is low, but the annual reinfection rate is as high as 6%. Surveillance for H. pylori reinfection facilitating peptic ulcer recurrence may be warranted even after a second eradication, especially when dyspeptic symptoms reappear in Korea.

Topics: Adult; Aged; Aged, 80 and over; Anti-Infective Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Korea; Male; Middle Aged; Organometallic Compounds; Peptic Ulcer; Recurrence; Treatment Outcome

Topics: Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Incidence; Metronidazole; Omeprazole; Organometallic Compounds; Peptic Ulcer Perforation; Randomized Controlled Trials as Topic; Recurrence; Tetracycline; Time Factors

Scientific evidence based on controlled clinical research confirm substantial benefits resulting from the eradication of H. pylori infection in such pathologies of the alimentary tract as: gastric peptic and duodenal ulcer (active or confirmed in the future and ulcer disease complications), MALT (Mucosa Associated Limphoid Tissue) lymphoma, atrophic gastritis, past stomach resection, gastric cancer in the family. The above group of indications is strongly recommended for eradicative treatment. During the last several years there have been many guidelines made by international and national specialist groups. "Test and treat" strategy of undiagnosed dyspepsia treatment is based on possibility to carry out non-invasive tests confirming H. pylori infection. First symptoms of dyspepsia in people over 45 years of age constitute recommendation for endoscopy, as well as symptoms assumed to be "alarming" (loss of weight, anaemia, bloody vomiting, tarry stool, dysphagia) regardless of patient age. An individual approach to eradication is proposed in gastroesophageal reflux disease, and use of non-steroid anti-inflammatory drugs. Antibacterial activity towards H. pylori is shown by many antibiotics (amoxicillin, macrolides, tetracyclines) and some other chemotherapeutic agents (nitroimidazoles) and bismuth. PPIs are recommended, because through increase of pH in stomach they create conditions to act for antibiotics. During the stage of first line triple therapy, it is advised to apply PPI and two antibacterial medicines at the same time (PPI + amoxicillin+metronidazole or clarithromycin). Such therapeutic action ensures achievement of eradication of H. pylori infection in 80-90% of cases. In case of lack of treatment efficiency in the first-line therapy, 7-14 day treatment may be repeated using triple therapies (PPI + 2 antibiotics) substituting the antibiotic with the metronidazole or tetracycline, or quadruple therapies (PPI + bismuth citrate + 2 antibiotics). Side effects during eradicative treatments occur quite rarely (from 15 to 30%).

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Clarithromycin; Dyspepsia; Europe; Gastroesophageal Reflux; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Peptic Ulcer; Proton Pump Inhibitors

Current anti-Helicobacter pylori treatment regimens are costly and because of the increasing antibiotic resistance, are becoming ineffective.. To evaluate a triple-layer tablet containing 100 mg bismuth subcitrate, 250 mg metronidazole, and 250 mg tetracycline in a single triple-layer tablet.. H. pylori-infected adult patients received bismuth-metronidazole-tetracycline (two tablets, t.d.s.) and ranitidine (300 mg) once daily for 14 days. Efficacy was determined using 13C-urea breath testing.. Thirty-three of 35 enrolled patients were available for evaluation; using the protocol-specified modified intention-to-treat analysis, five failed treatment, two were lost to follow-up (cure rate per-protocol = 85.7%, intention-to-treat = 78.7%). The cure rate among metronidazole-susceptible strains was 100% (22 of 22) (95% confidence interval 84-100%) compared with 55% (five of nine intention-to-treat) (95% confidence interval 21-86%) among metronidazole-resistant strains. In four cases, therapy was truncated at 4-7 days because of side-effects; yet the treatment was effective in three. The three metronidazole-susceptible but clarithromycin-resistant infections were cured.. This novel triple-layer tablet combination therapy was effective in all patients with metronidazole-susceptible H. pylori and many of those with resistant organisms. A greater degree of acid suppression may further improve effectiveness.

Topics: Adolescent; Adult; Aged; Antacids; Anti-Infective Agents; Anti-Ulcer Agents; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Patient Compliance; Pilot Projects; Ranitidine; Tablets; Tetracycline; Treatment Outcome

Helicobacter pylori (HP) infection is one of the most prevalent human infections and has been implicated as a predisposing factor in gastric cancer, chronic active gastritis, duodenal ulcer, gastric ulcer and gastric lymphoma. Reinfection after successful eradication is quite uncommon in adults. In the only study carried out in Iran, a reinfection rate of 19.1% after 1 year has been reported. We studied the rate of reinfection 3 years after successful HP eradication.. All patients who had undergone HP eradication 3 years before the study and had successful eradication verified by a negative (14)C urea breath test (UBT) 1 year after eradication were invited to complete a questionnaire and undergo another UBT. In addition, spouses and the offspring of those testing positive were offered an UBT.. Ninety-eight patients were enrolled (49% male). Mean age was 44 +/- 13 years (range: 18-75 years). Twenty patients (20.4%) had a positive UBT. Epigastric burning (25%vs 69%) and pyrosis (50%vs 67%) were seen less commonly in those who were HP free at 3 years compared to those who tested positive for HP.. According to our data, in our region the HP reinfection rate is 20.4% 3 years after successful eradication.

Topics: Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Infective Agents; Breath Tests; Calcium Channel Agonists; Drug Therapy, Combination; Female; Follow-Up Studies; Gastrointestinal Diseases; Helicobacter Infections; Helicobacter pylori; Histamine Antagonists; Humans; Iran; Male; Middle Aged; Organometallic Compounds; Prevalence; Recurrence; Retrospective Studies; Risk Factors; Surveys and Questionnaires; Urea

The study revealed changes in the oesophagogastroduodenal mucosa in 110 patients with IBD; in 60.9% of cases these changes were associated with Helicobacter pylori. 35 patients with IBD were examined to form two groups. The first group (20 patients) received rabeprazol (pariet) in a dose of 20 mg per day; the rest 15 patients were administered 120 mg of de-nol four times a day; amoxicicline and furazolidon were used as additional therapy in cases with Helicobacter pylori. The study showed that successful eradication did not always result in erosion epithelization but, on the contrary, only 40% cases of clinical and endoscopic remission were associated with Helicobacter pylori elimination. These data suggest that anti-helicobacter therapy is not a rational approach in treatment of this category of patients.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Benzimidazoles; Drug Therapy, Combination; Female; Furazolidone; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Inflammatory Bowel Diseases; Intestinal Mucosa; Male; Middle Aged; Omeprazole; Organometallic Compounds; Rabeprazole; Time Factors

To investigate whether the acid suppression therapy influences the absorption of bismuth from colloidal bismuth subcitrate (CBS); to locate the deposit position of bismuth in mice's organs and to detect the consequential change of cell functions in these deposited organs.. 48 male SD rats weighing from 200-250 g were randomly divided into five groups: Group A(1), kill the rats on the cessation day of administration CBS; Group B(1), kill the rats on the day 8 weeks after the cessation of administration CBS; Group A(2) (CBS + amoxicillin + metronidazole + omeprazole), kill the rats on the cessation day of administration; Group B(2) (CBS + amoxicillin + metronidazole + omeprazole), kill the rats on the day 8 weeks after the cessation of administration; Control group. These medicines had been taken every day for 14 days. The issue sections (liver, brain and kidney) were counterstained after AMG development. The bismuth deposited in tissues was observed by microscopy. At the same time, the gray level of kidney tissue sections were measured and compared through image processing program. The deposition of bismuth and the degrees of cell organ's impairment were observed through electron microscopy. By the use of electron probe microanalysis, bismuth can be distinguished from chemical element.. The bismuth can be accumulated in cell bodies of proximal convoluted renal tubule, portal area, hypothalamus, and hypoglossal nuclei after its absorption. Under the light microscopy, heavy AMG staining granules were found in cell bodies of proximal convoluted renal tubule. It was discovered that the amounts of bismuth accumulation in kidney of quadruple therapy group were much more than that of single compound therapy group (P < 0.05). The amounts of bismuth accumulation in kidney on the cessation day of administration are more than that 8 weeks later (P < 0.01). What is more, under the electron microscopy, heavy AMG staining granules were found exclusively in lysosomes of proximal convoluted renal tubule cell. The electron microscopy found some cell impairment in quadruple therapy group: the impairment to these cells can be recovered 8 weeks after the cessation of administration.. The acid suppression therapy causes an increase of bismuth absorption and accumulation from CBS in the rats' kidney. Finally, the absorbed bismuth can be discharged out of the body via kidney. Large amounts of bismuth accumulation in kidney can impair the functions of proximal convoluted renal tubule cell.

Topics: Absorption; Amoxicillin; Animals; Antacids; Bismuth; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Kidney; Male; Metronidazole; Omeprazole; Organometallic Compounds; Random Allocation; Rats; Rats, Sprague-Dawley

Several independent clinical studies have reported that Helicobacter pylori eradication therapy could achieve complete remission in some patients with H. pylori-positive early-stage gastric mucosa-associated lymphoid tissue (MALT) lymphoma.. To compare the long-term results of anti-H. pylori therapy in early-stage, gastric low-grade and high-grade transformed MALT lymphoma, two multicenter prospective studies of anti-H. pylori therapy for early-stage gastric lymphoma conducted in Taiwan, one for low-grade MALT lymphoma, with 34 patients enrolled from March 1996 through April 1999, and one for high-grade transformed tumors (diffuse large B-cell lymphoma with features of MALT, DLBCL[MALT] lymphoma), with 24 patients enrolled since June 1995, were directly compared. In both studies, patients generally received 2 weeks of antibiotics and had multiple sequential follow-up endoscopic examinations until complete histologic remission (CR) or disease progression; patients were monitored through January 31, 2004. CR was defined as regression of lymphoid infiltration to Wotherspoon's score of 2 or less on all pathologic sections of endoscopic biopsy specimens. All statistical tests were two-sided.. The H. pylori-positive rate among the 34 low-grade patients was 94% (32 of 34). All 24 selected high-grade patients were H. pylori positive. H. pylori was eradicated in 97% (30 of 31) of evaluable H. pylori-positive low-grade patients and in 92% (22 of 24) of high-grade patients, which led to CR in 80% (24 of 30, 95% confidence interval [CI] = 65% to 95%) and 64% (14 of 22, 95% CI = 42% to 86%) of patients, respectively. None of the five patients who were either initially H. pylori negative or had persistent H. pylori infection after antibiotics achieved CR. After median follow-up of more than 5 years in complete responders, tumor recurrence was observed in three (13%) low-grade patients but not in high-grade patients.. Anti-H. pylori therapy may be considered as one of the treatment options for early-stage H. pylori-positive gastric DLBCL(MALT), and large-scale prospective studies to validate its use as first-line therapy for such tumors should be undertaken.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Disease Progression; Disease-Free Survival; Drug Administration Schedule; Female; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Lymphoma, B-Cell, Marginal Zone; Male; Metronidazole; Middle Aged; Multicenter Studies as Topic; Omeprazole; Organometallic Compounds; Prospective Studies; Severity of Illness Index; Stomach Neoplasms; Survival Analysis; Taiwan; Time Factors; Treatment Outcome

Topics: Anti-Inflammatory Agents, Non-Steroidal; Comorbidity; Drug Therapy, Combination; Esophagitis, Peptic; Helicobacter Infections; Helicobacter pylori; History, 20th Century; Humans; Metronidazole; Organometallic Compounds; Peptic Ulcer; Prevalence; Stomach Neoplasms; Tetracycline

Helicobacter pylori infection, is seen in more than 80% of adult population in Turkey. The aims of this study were 1) to evaluate the importance of the diagnostic tests 2) to investigate the relationship between Hp infection and functional dyspepsia.. A total 75 patients with functional-dyspepsia were involved into the study. Hp infection was diagnosed by histopathological examination. CLO, cytology, culture, stool antigen and breath test. Symptom score using ROME II criteria was also evaluated to all patients. All patients were taken ranitidine-bismuth-citrate (400mg bid/day), clarithromycin (500 mg bid/day) and amoxicillin (1000 mg bid/day) for 14 days. All tests and symptom score analyses were re-applied at month 1 and 6.. The eradication rate was 95.9%. The baseline specifity of breath test, CLO, cytology, culture and stool antigen were 87.3%, 95.4%, 95.4% 94.5% and 86.4%, respectively. The sensitivity of such tests at first month after stopping the treatment were 86.1%, 100%, 100%, 100%, 84.7%, respectively, and were 91.6%, 100%, 100%, 100%, 87.5%, respectively at six months after treatment. Symptom scores were 29.6+/-5.4, 15.8+/-4.7 and 17.9+/-5.3 at baseline, first month and six months after treatment, respectively (p<0.001).. The success of eradication may be related to use of bismuth which prevents antibiotic resistance development. Stool antigen and breath tests are less effective than invasive diagnostic-tests. The finding of improved symptomscores after eradication suggests that Hp may play a role in functional dyspepsia.

Topics: Adolescent; Adult; Aged; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Antigens; Biopsy; Breath Tests; Clarithromycin; Colony Count, Microbial; Cytological Techniques; Dyspepsia; Endoscopy, Gastrointestinal; Feces; Female; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Prospective Studies; Ranitidine; Sensitivity and Specificity; Treatment Outcome; Young Adult

Helicobacter pylori infection is common in Estonia: 87% of adults and 56% of children aged 9-15 years have been found to be H. pylori seropositive. The aim of this study was to evaluate the long-term recurrence rate after treatment in children and adolescents in a setting of high H. pylori prevalence.. All children (n = 27) who underwent gastroscopy at the Children's Clinic of Tartu University Clinics during 1993--95 and in whom H. pylori infection was verified by histological examination and rapid urease test and who had completed a treatment course against H. pylori infection were invited for a post-treatment follow-up endoscopy 4-6 weeks after completion of therapy (1st follow-up visit) and to the follow-up control by [13C]-urea breath test in 1997 (2nd follow-up visit) and 2002 (3rd follow-up visit).. Recurrence of H. pylori infection occurred in I patient out of 16 at the 2nd follow-up visit (mean 17.8+/-7.1 months after treatment), and in 5 patients out of 15 at the 3rd follow-up visit (mean 6.6+/-0.9 years after treatment). The recurrence rate calculated for the period between the 1st and the 2nd follow-up visits was 4.2% per patient-year, and between the 2nd and the 3rd follow-up visits the rate was 7.6% (95% CI 2.5%-17.6%) per patient-year. The recurrence rate calculated for the whole follow-up period was 6.7% (95% CI 2.5%-14.5%) per patient-year.. The post-treatment recurrence rate of H. pylori infection in children and adolescents is higher in Estonia than in low prevalence settings.

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Child; Estonia; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Recurrence; Time Factors

Current combination therapies cure Helicobacter pylori infection in 75 to 85% of cases. However, many treatment failures are not explained by antibiotic resistance. Our goal was to explore treatment failures under in vivo conditions by using the H. pylori Sydney strain (SS1) mouse model. Mice infected with H. pylori (SS1) were treated with monotherapies or combination therapies used in human trials. Bacterial levels and distribution of organisms within the stomach were assessed 24 h after treatment to determine clearance and location of treatment failures and 29 days after treatment to determine cure rates. Except for treatment with metronidazole, mono- and dual therapies did not cure infection but resulted in decreases in bacterial levels and differences in distribution within the stomach. In cases of treatment failure when clarithromycin was used, omeprazole and dual therapy with omeprazole and amoxicillin resulted in organisms being cleared from the antrum, but organisms remained in the antrum-body transitional zone. The triple therapies of OMC and bismuth subcitrate, metronidazole, and tetracycline were successful in eradicating infection. Except for metronidazole monotherapy and triple therapy with OAC, there was good correlation between the Sydney strain mouse model and humans with respect to the success of antimicrobial therapy. The antrum-body transitional zone was identified as a sanctuary site in treatment failure. This could result from antimicrobial agents not functioning effectively at this site or bacteria in this location expressing products that protect them against antimicrobial agents. This is the first demonstration of a possible sanctuary site as a reason for failure of therapy.

Topics: Amoxicillin; Animals; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Disease Models, Animal; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Metronidazole; Mice; Mice, Inbred C57BL; Microbial Sensitivity Tests; Omeprazole; Organometallic Compounds; Penicillins; Pyloric Antrum

Topics: Anti-Bacterial Agents; Drug Resistance, Bacterial; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Tetracycline

Success of first H. pylori eradication attempts in the literature is around 80-90% and based on urea breath test of 1027 patients in Hungary is 75%. Repeated eradication attempts are needed in 10-25% of cases. In the clinical practice in Hungary second and third eradication attempts were successful only in 36% and 20% of cases. To improve efficacy the following suggestions has to be kept in mind: 1. Do not repeat the same combination if the first attempt is failed. 2. After failure of the first PPI + amoxicillin + clarithromycin triple therapy, either the quadriple therapy (PPI + tetracycline + metronidazole + bismuth) or the replacement of PPI with ranitidine bismuth citrate in the triple therapy is suggested. 3. If PPI + amoxicillin + metronidazole/tinidazole therapy fails, the metronidazole/tinidazole can be replaced by clarythromycin. 4. Do not start with clarithromycin + metronidazole/tinidazole therapy. 5. In case of uncertain previous therapies and for third eradication treatment send the patient to specialist. Rifabutin-based combinations seem to be effective, but the use of them in general practice is not advised due to the possible development of mycobacterium tuberculosis resistance.

Topics: Age Distribution; Amoxicillin; Anti-Bacterial Agents; Clarithromycin; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Hungary; Metronidazole; Organometallic Compounds; Ranitidine; Rifabutin; Tinidazole; Treatment Failure

Bacopa monniera is an Indian tratidional medicine widely used to improve intellectual functions. Earlier, we had reported the prophylactic and curative effects of standardized extract of Bacopa monniera (BME) in various gastric ulcer models. The effect was due to augmentation of the defensive mucosal factors like increase in mucin secretion, life span of mucosal cells and gastric antioxidant effect rather than on the offensive acid-pepsin secretion. The present study includes evaluation of standardized BME (bacoside A content--35.5 +/- 0.9) on other contributing factors towards ulcerogenesis. BME in the dose of 1000 microg/ml showed anti-Helicobacter pylori activity in vitrol and in the dose of 10 microg/ml increased in vitro of prostanoids (PGE and PGI2) in human colonic mucosal incubates. It may be concluded that these factors may contribute to antiulcerogenic activity of BME.

Topics: Anti-Infective Agents; Bacopa; Epoprostenol; Helicobacter Infections; Helicobacter pylori; Humans; India; Intestinal Mucosa; Medicine, Traditional; Microbial Sensitivity Tests; Organometallic Compounds; Phytotherapy; Plant Extracts; Prostaglandins E; Stomach Ulcer

The efficiency of antihelicobacter therapy was evaluated in 36 and 22 patients from experimental and control groups, respectively. In the control group, antihelicobacter agents were given in usual doses in the control group and in the experimental one; they were used in doses depending on the level of Helicobacter pylori (HP) infection of the gastric mucosa (GM). The findings showed that the efficiency of antihelicobacter therapy was much higher in the group of patients taking antihelicobacter agents in a daily dose depending on the level of GM HP infection.

Topics: Adolescent; Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; Duodenal Ulcer; Female; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Omeprazole; Organometallic Compounds; Treatment Outcome

Topics: Anti-Bacterial Agents; Bismuth; Drug Combinations; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Peptic Ulcer; Tetracycline

Dyspepsia is a common complaint and represents an important health problem in the community. The aim of the study was to survey the diagnostic approach and management of dyspepsia and Helicobacter pylori (H. pylori) infection by primary care physicians.. Questionnaires were given to 70 medical officers (MO) working in government polyclinics and 70 general practitioners (GP) in private practice.. Questionnaires were returned from 68 MO's (response rate 97%) and 61 GP's (response rate 87%). Only 20% of MO and 50% of GP prescribed H. pylori eradication therapy. Of those who have prescribed eradication therapy, 70% would confirm H. pylori infection before therapy (50% for gastroscopy, 19% for Urea Breath test, 25% for laboratory based serology, 6% for office based serology test kits). 85% would prescribe triple therapy against 15% for dual therapy. Proton pump inhibitor (PPI) is the acid suppression agent most commonly prescribed (77%) in regimens of eradication therapy; the remaining would prescribe either bismuth subcitrate or H2 antagonists. Only 8% of respondents would confirm eradication after therapy.. Less than half of the primary care physicians surveyed prescribed H. pylori eradication therapy. The main reason given for not prescribing therapy was lack of facility for testing the infection. Of those who prescribed eradication therapy, majority would order the correct and reliable investigations to confirm the infection. Most of them would prescribe triple therapy which is the recommended eradication regimens.

Topics: Community Health Services; Dyspepsia; Health Care Surveys; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Organometallic Compounds; Practice Patterns, Physicians'; Proton Pump Inhibitors; Surveys and Questionnaires; Urea

Comparative assessment of treatment results in 618 patients with gastroduodenal ulcer (GDU) was carried out. 3 groups of patients were compared. Different combinations of drugs were used in 384 patients, 234 patients have undergone open resections of the stomach or organsaving operations, 83 patients--analogous laparoscopic operations. Immediate and long-term results of the treatment were studied. After drug therapy, including antihelicobacter drugs, healing of ulcers was achieved in 96.9-97.9% cases. 1 year after drug therapy the recurrence of CDU is revealed in 16.2-20.3% patients, rate of the recurrence increases with years. After surgical treatment of CDU (more often in complicated course of the disease) rate of recurrences is 2-3 times lower (6.5-7.4% cases). Laparoscopic resections of the stomach and organsaving operations are atraumatic, accompanied by physiologic course of postoperative period and reduction of postoperative complication rate.

Topics: Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Follow-Up Studies; Gastrectomy; Helicobacter Infections; Helicobacter pylori; Humans; Laparoscopy; Metronidazole; Omeprazole; Organometallic Compounds; Peptic Ulcer; Postoperative Complications; Ranitidine; Recurrence; Stomach Ulcer; Tetracycline; Time Factors

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Resistance, Bacterial; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds

In developing countries where Helicobacter pylori infection is widespread, posttherapeutic recurrence rates may be high. Many of the limited studies available have methodological problems and show varied recurrence rates. We determined late recrudescence rates, true reinfection, and ulcer recurrence.. One hundred five Bangladeshi patients with H. pylori infection and duodenal ulcer disease were treated with a triple therapy. Follow-up included 13C-urea breath tests, endoscopy, and biopsy-based tests. In reinfected patients, genomic typing compared pretherapeutic and posttherapeutic strains.. Recrudescence, associated with nitroimidazole-based treatment, occurred in 15 of 105 patients (14%) within the first 3 months, but only 8 of 105 patients tested positive 4 weeks after therapy ended. True reinfection was diagnosed in 11 of 105 patients between 3 and 18 months after therapy. The annual reinfection rate was 13%, based on a total follow-up of 84.7 patient years. Ulcer relapse occurred in 2 of 15 (13%) recrudescence cases and in 6 of 11 (55%) reinfection cases, but also in 4 of 73 (5%) H. pylori-negative patients.. In Bangladesh, late recrudescence of H. pylori after eradication therapy occurs within the first 3 months. The reinfection rate is high and might influence cost-benefit analyses for determining diagnostic and therapeutic procedures.

Topics: Adult; Amoxicillin; Anti-Ulcer Agents; Bangladesh; Body Mass Index; Breath Tests; Carbon Isotopes; Developing Countries; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Omeprazole; Organometallic Compounds; Patient Compliance; Peptic Ulcer; Ranitidine; Recurrence; Tinidazole; Urea

High-grade mucosa-associated lymphoid tissue (MALT) lymphomas of the stomach are generally believed to be Helicobacter pylori-independent, autonomously growing tumors. However, anecdotal cases of regression of high-grade lymphomas after the cure of H pylori infection had been described. The present prospective study was conducted to evaluate the effect of anti-H pylori therapy in stage I(E) high-grade gastric MALT lymphomas.. Sixteen patients with H pylori infection and stage I(E) gastric high-grade MALT lymphoma consented to a brief antibiotic therapy as first-line treatment from June 1995 through April 2000. Then, patients underwent intensive endoscopic follow-up examinations (+/- endoscopic ultrasonography) with biopsy to evaluate tumor response. Patients with significant improvement of gross lesions that accompanied regression of large cells were followed up without additional treatment. Patients without significant improvement were immediately referred to systemic chemotherapy.. Eradication of H pylori was achieved in 15 patients and was accompanied by rapid gross tumor regression and disappearance of large cells in 10. All 10 of these patients with early response had subsequent complete histologic remission of lymphoma. The complete remission rate was 62.5% (95% confidence interval, 35.8% to 89.1%). The response rate was not affected by the tumor grading (proportion of large blast cells within the tumor) but was adversely affected by the depth of tumor invasion. At a median follow-up of 43.5 months (range, 21.1 to 67.4 months), all 10 of these patients remained lymphoma-free. The median duration of complete response was 31.2 months (range, 14.4 to 49.1 months).. These results suggest that high-grade transformation is not necessarily associated with the loss of H pylori dependence in early-stage MALT lymphomas of the stomach.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Lymphoma, B-Cell, Marginal Zone; Male; Metronidazole; Middle Aged; Neoplasm Staging; Omeprazole; Organometallic Compounds; Penicillins; Prospective Studies; Stomach Neoplasms; Treatment Outcome

We question whether Helicobacter pylori eradication in peptic ulcer disease patients leads to a decrease in symptoms and reduced use of anti-dyspeptic drugs. Therefore, the recurrence rate of H. pylori, upper abdominal symptoms and the use of acid-suppressive drugs were determined 6 years after successful triple therapy.. Peptic ulcer disease patients successfully treated in 1990-1993 with 'classic' triple therapy were eligible. Patients were asked about symptoms and invited for a 13C-urea breath test or endoscopy in 1997-1998. Data on the use of anti-dyspeptic drugs were obtained from the pharmacy or general practitioner.. Of the 113 eligible patients, 90 could be included in the study. The mean follow-up time was 6 years (range 4.6-7.6 years). H. pylori infection recurred in one patient (recurrence rate: 0.19% per patient-year; 95% confidence interval: 0.01-1.1%). Moderate or severe symptoms were experienced before therapy by 79% of the patients and after therapy by 18% of the patients (P< 10(-7)). Before triple therapy, 98% of the patients used H2-receptor antagonists and 54% were on maintenance treatment. After treatment, 30% used anti-dyspeptic medication and only 13% were on maintenance treatment (P < 10(-7)).. Six years after successful triple therapy in peptic ulcer disease patients, the recurrence rate of H. pylori infection is low and both symptoms and the use of anti-dyspeptic drugs have decreased significantly.

Topics: Aged; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptic Ulcer; Quality of Life; Recurrence; Retrospective Studies; Tetracycline; Treatment Outcome

In developing countries the standard quadruple therapy containing metronidazole results in suboptimal eradication rates of Helicobacter pylori (<75%). In a retrospective study, we undertook to evaluate efficacy and tolerability of a furazolidone-based regimen (omeprazole, furazolidone, bismuth, and tetracycline) in patients who had previously failed the standard metronidazole-based regimen (omeprazole, metronidazole, bismuth, and amoxicillin).. The records of H. pylori infected patients who were referred to outpatient clinic (from March 1999 to August 1999) and who underwent previous eradication regimens were studied. A total of 320 cases were noted to have received a metronidazole-based quadruple regimen. From these 320 patients, 80 were noted to have failed this regimen based on a urea breath test. These 80 patients were enrolled in the study and given the furazolidone-based regimen. Side effects were assessed at follow-up visits. At least 2 months after the end of each therapy regimen, a (14)C-urea test was performed in each subject to document the cure of the patients.. A total of 80 patients (39 males and 41 females) with a mean age of 43.8 +/- (SD) 13.3 years were studied. The H. pylori eradication rate was 90% with the furazolidone-based regimen. The side effects of this regimen were minor.. A furazolidone-based regimen is effective in patients who do not achieve cure of H. pylori infection with the metronidazole-based quadruple therapy. In areas where the metronidazole resistance is high, initial therapy with a furazolidone-based regimen is recommended.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents, Local; Drug Therapy, Combination; Enzyme Inhibitors; Female; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Iran; Male; Medical Records; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Retrospective Studies; Tetracycline; Treatment Failure; Treatment Outcome

Topics: Amoxicillin; Anti-Bacterial Agents; Case-Control Studies; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Rosacea; Severity of Illness Index; Stomach Ulcer

In this pilot study we investigated the efficacy and tolerability of a new monocapsule that contains a bismuth compound, tetracycline, and metronidazole. If proven to be effective, this monotherapy would turn the well-accepted multidrug regimen of standard bismuth-based triple therapy into an easy and more patient-friendly regimen. It can be used in patients allergic to penicillin.. A total of 53 consecutive H. pylori-infected patients (30 with proven ulcer disease, 23 with gastritis only) from a single center were prescribed two monocapsules q.i.d. after the three meals and after an evening snack during 10 days. Each capsule contained 60 mg colloidal bismuth subcitrate (as Bi2O3 equivalent), 125 mg tetracycline, and 125 mg metronidazole. Repeat endoscopy with biopsies for urease test, Giemsa stain, and culture was carried out > or =5 wk later. Side effect data were collected.. One patient was lost to follow-up, two failed to respond, and 50 were cured. The intention-to-treat cure rate was 50 of 53 (94.4%, 95% CI 88.1-100%). Antibiotic sensitivity was available from 51 isolates. The cure rate in the metronidazole sensitive strains was 44 of 45 (97.8%, 95% CI: 93.5-100%), whereas it was four of five in the resistant strains. The regimen was well tolerated, with only two drop-outs (4%) because of side effects.. The new monocapsule is an inexpensive, well tolerated, and patient-friendly formulation of a bismuth based triple therapy. A 10-day course with this multidrug capsule reached a very high cure rate in metronidazole-sensitive strains. The number of cases with resistant strains was insufficient to allow firm conclusions about its efficacy in case of resistance. The results are in agreement with previous data with bismuth triple therapy using separate drugs. From the high cure rate, we can conclude that the new capsule dissolves adequately, with proper delivery of its ingredients at the site of action.

Topics: Adult; Aged; Anti-Ulcer Agents; Capsules; Female; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptic Ulcer; Pilot Projects; Tetracycline; Treatment Outcome

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Child; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Ranitidine

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Cost-Benefit Analysis; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Penicillins; Peptic Ulcer; Primary Health Care; Tetracycline

The aim of this study was to compare the dissolution, bioavailability, and anti-Helicobacter pylori activity of bismuth subnitrate and colloidal bismuth subcitrate. This could, first, provide insights into the mechanism of action of bismuth and, second, help to develop optimal therapeutic strategies.. Solubility and aquated size of bismuth species were determined in human gastric juice, while absorption into blood and urinary excretion of bismuth was determined in volunteers. Activity against H. pylori was determined in vitro in the presence and absence of antibiotics, while H. pylori eradication was compared in vivo.. Bismuth from colloidal bismuth subcitrate was at least 10% soluble and ultrafilterable and was absorbed in volunteers (>0.5%), whereas that from bismuth subnitrate was insoluble and not absorbed (<0.01%). Colloidal bismuth subcitrate was active against H. pylori (mean inhibitory concentration, 400 microg/ml); neither was synergistic with antibiotics. With in vivo triple therapy, bismuth subnitrate was as effective as colloidal bismuth subcitrate in eradicating H. pylori (74% and 70% eradicated, respectively).. Colloidal bismuth subcitrate, unlike bismuth subnitrate, is partially soluble, absorbed in humans, and directly toxic to H. pylori in vitro. Surprisingly, however, these preparations had similar efficacy in vivo against H. pylori within triple therapy, suggesting that bismuth compounds may also exhibit indirect antimicrobial effects. We propose that this is an effect on the gastric mucus layer. Nonabsorbable bismuth compounds should be preferentially considered in bismuth-based therapies against H. pylori, as they would minimize toxicity while maintaining efficacy.

Topics: Anti-Bacterial Agents; Bismuth; Helicobacter Infections; Helicobacter pylori; Humans; Intestinal Absorption; Male; Microbial Sensitivity Tests; Organometallic Compounds; Predictive Value of Tests; Solubility

Treatment with a proton pump inhibitor (PPI) and antimicrobials cures Helicobacter pylori infection in about 90% of patients. This is a retrospective overview of our studies aiming to cure the infection in all compliant patients with failed initial therapy.. We retreated 120 (19% of 644) H. pylori-infected patients whose initial therapy had failed. The retreatments included (i) triple therapy (TT): colloidal bismuth subcitrate, metronidazole, amoxicillin (or tetracycline); (ii) quadruple therapy (QT): TT and a PPI; or (iii) high doses of both a PPI and clarithromycin combined with a further 1-3 individually selected antimicrobials. The eradication results were determined after 6-12 months.. The 1st retreatment was successful in 70 of 120 patients. The 2nd retreatment cured 25 of the remaining 42 patients, the 3rd 13 of 17, and the 4th the last 4 patients. The cumulative eradication rate (ITT) was 93% (95% CI: 88.9%-97.9%; 8 patients withdrew after a failed 1st retreatment) and the rate was 100% in the remaining 112 patients who accepted several retreatments. The 1st retreatment with TT cured 23% (95% CI: 12%-34%) of 57 patients and QT 85% (95% CI: 74%-96%) of 41 patients who had initially undergone a failed metronidazole-based treatment. All retreatments were well tolerated.. In this study, high doses of a PPI and clarithromycin combined with 1-3 antimicrobials according to susceptibility data proved to be the best drug combination in the cure of H. pylori infection after failed primary treatment. Giving imidazole- and bismuth-based QT (without clarithromycin) as the first-line treatment of H. pylori infection ensures that the number of failures remains low.

Topics: Anti-Bacterial Agents; Clarithromycin; Drug Therapy, Combination; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Proton Pump Inhibitors; Retreatment; Retrospective Studies; Time Factors; Treatment Failure

Bismuth compounds remain useful for Helicobacter pylori eradication therapy. These include colloidal bismuth subcitrate (CBS), bismuth subsalicylate (BSS) and, most recently, ranitidine bismuth citrate (RBC). CBS appears to prevent the development of imidazole resistance when coadministered with nitroimidazoles. Traditional triple therapy with bismuth, metronidazole and tetracycline or amoxicillin (BMT/A) only partially overcomes metronidazole resistance. However, the addition of a PPI to bismuth triple therapy largely overcomes established metronidazole resistance if treatment is given for at least one week or more. When RBC rather than PPI is used with clarithromycin, this dual regimen appears to be more effective in preventing the development of secondary clarithromycin resistance. The triple combination of RBC, metronidazole and clarithromycin appears to be effective against metronidazole resistant strains of H pylori. Thus, overall, there is some evidence that bismuth compounds may prevent the development of antibiotic resistance and that existing antibiotic resistance may at least be partially overcome in vitro and in vivo. With the growing emergence of H pylori resistance to metronidazole and clarithromycin, further research to clarify the role of bismuth compounds is required.

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Clarithromycin; Drug Resistance, Microbial; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Ranitidine; Salicylates

A higher prevalence of Helicobacter pylori infection in rosacea patients than in healthy controls has been reported.. The aim of this study was to investigate the effect of H. pylori eradication therapy in patients with rosacea.. Twenty-five rosacea patients and 87 age- and sex-matched healthy controls were included in this study. We detected IgG and IgA antibodies against H. pylori in both groups. An upper gastrointestinal endoscopy and a rapid urease test were performed on the 13 patients with rosacea who accepted this procedure. Amoxicillin 500 mg 3 times daily, metronidazole 500 mg 3 times daily, and bismuth subcitrate 300 mg 4 times daily were administered to patients positive for H. pylori. The severity of rosacea was scored before and after treatment.. There was no statistical difference in seropositivity in either group. In H. pylori-positive rosacea patients there was a significant decrease in the severity of rosacea at the end of the treatment as compared with the initial scores.. Our findings suggest that H. pylori may be involved in rosacea and that eradication treatment may be beneficial.

Topics: Adult; Aged; Amoxicillin; Antacids; Anti-Bacterial Agents; Antibodies, Bacterial; Bismuth; Female; Helicobacter Infections; Helicobacter pylori; Humans; Immunoglobulin A; Immunoglobulin G; Male; Metronidazole; Middle Aged; Organometallic Compounds; Rosacea; Treatment Outcome

The eradication rate obtained using the classical triple therapy containing metronidazole, amoxicillin and bismuth citrate, was determined in 57 paediatric patients with digestive disorders, according to the susceptibility to metronidazole of the Helicobacter pylori strains (determined by agar dilution) and the cagA and vacA status (determined by PCR). Eradication was obtained in 38 out of 43 patients (88.3%) infected by H. pylori with metronidazole MIC < or = 2 mg l(-1), in 3 out of 6 patients (50%) when MIC was 4-8 mg l(-1) and in 4 out of 8 patients (50%) when MIC was > 8 mg l(-1). Among patients infected with cagA+ and cagA- strains an eradication rate of 75% (6/8) and 75% (18/24) was found, and 50% (3/6) and 80% (21/26) among vacA s1- and vacA s2-infected subjects (P > 0.05). H. pylori eradication depends on the susceptibility of the strain to metronidazole, being higher in patients infected with susceptible H. pylori. However, according to our data the cagA or vacA status was not an important factor in treatment failure in the eradication of H. pylori.

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Antigens, Bacterial; Bacterial Proteins; Child; Child, Preschool; Drug Resistance, Microbial; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Microbial Sensitivity Tests; Organometallic Compounds; Penicillins; Treatment Failure; Virulence

In a 2- to 4-year prospective study, the reversibility of gastritis after Helicobacter pylori eradication was analysed. Sixty-three H. pylori-positive, chronic duodenal ulcer patients were studied after the successful eradication of bacteria in the period from 1990 to 1993. H. pylori eradication was obtained by triple antimicrobial regimens (colloidal bismuth subcitrate, amoxycillin, and metronidazole) applied for at least 14 days. The criteria for eradication were the absence of bacteria from two antral and two body of stomach biopsies stained with haematoxylin, eosin, and Warthin Starry, and a negative antral biopsy culture. The same diagnostic procedures were repeated, at regular follow-up endoscopies, each year for up to 4 years. Neutrophil-granulocyte infiltration of gastric mucosa disappeared in 2 months after bacterial eradication. Mononuclear cellular infiltration was disappearing with statistical significance up to the second year and normal mucosa was observed in the majority of patients in the fourth year of follow-up. Degeneratively changed lymphoid aggregates were also present in the fourth year in the antrum (12.5 per cent of patients) and in the body of stomach (14 per cent of patients). There was no significant change in antral intestinal metaplasia during the 4 years of follow-up. Antral atrophy declined significantly in the period from 1 to 3 years of follow-up. In conclusion, 3-4 years are needed for gastric mucosa to become normal after H. pylori eradication, although some residual lymphoid aggregates persist even after that period.

Topics: Adult; Aged; Amoxicillin; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Gastric Mucosa; Gastritis; Helicobacter; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metaplasia; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Statistics, Nonparametric

Topics: Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Clinical Trials as Topic; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Ranitidine

Helicobacter pylori produces Hpn, a 60-amino acid, histidine-rich protein that avidly binds nickel and zinc ions, and NixA, a high-affinity nickel transporter in the cytoplasmic membrane. We tested the hypothesis that Hpn and NixA govern susceptibility to metal ions in H. pylori.. Hpn-negative mutants of four H. pylori strains were constructed by standard allelic exchange techniques to yield isogenic Hpn+/Hpn-deficient pairs. A metal concentration that inhibited growth by 50% (IC50) was calculated for Ni2+, Zn2+, Cu2+, and Co2+ by comparing OD600 of cultures in metal-supplemented and control media.. Among all four pairs of isogenic strains, the tolerance for Ni2+ was reduced significantly (p <.001) in the Hpn mutants; the mean IC50 value for wild-type strains was 1.9 mM; for the mutant, it was 0.8 mM. In contrast, growth inhibition by Zn2+ was identical within the fours pairs, as was Cu2+ and Co2+ tolerance in one pair tested. We also found that deletion of the hpn gene increases susceptibility to therapeutic forms of bismuth by testing a mutant and wild-type pair with ranitidine bismuth citrate, bismuth citrate, and four antibiotics. Minimal inhibitory concentrations of ranitidine bismuth citrate dropped from 9.2 to 2.3 microg/ml, and those of bismuth citrate dropped from 7.4 to 3.2 microg/ml (p <.05 for both comparisons), while susceptibility to the antibiotics was unaffected. Disruption of the nixA gene encoding the specific Ni2+ transport protein of H. pylori did not change susceptibility to bismuth.. We concluded that bacteria lacking Hpn, cultured in vitro, are more susceptible than is the wild type to bismuth and Ni2+.

Topics: Bacterial Proteins; Bismuth; Carrier Proteins; Cation Transport Proteins; Drug Resistance, Microbial; Helicobacter Infections; Helicobacter pylori; Humans; Membrane Proteins; Metals, Heavy; Microbial Sensitivity Tests; Organometallic Compounds; Proteins; Ranitidine

Metronidazole-containing eradication therapies are less effective for metronidazole resistant Helicobacter pylori. Although early data suggested improvement of the efficacy of bismuth triple therapy after the addition of acid suppressives, these findings were based on studies with small numbers of patients, incomplete post-eradication follow up, or omission of pretreatment susceptibility testing.. To study the efficacy of quadruple therapy in the Amsterdam area, where the efficacy of bismuth triple therapy has been proved to be affected by metronidazole resistance.. Eighty two consecutive dyspeptic H pylori positive patients with either metronidazole susceptible (group I) or metronidazole resistant H pylori strains (group II) received quadruple therapy for one week: omeprazole 20 mg twice daily; colloidal bismuth subcitrate 120 mg four times a day; tetracycline 500 mg four times a day; metronidazole 500 mg three times a day. Susceptibility to metronidazole was determined by the E-test.. Intention to treat analysis showed that H pylori infection had been cured in 42/43 patients (98%) in group I and 32/39 patients (82%) in group II (p = 0.02).. The efficacy of quadruple therapy is significantly impaired in patients infected with metronidazole resistant H pylori. Therefore a non-metronidazole-containing regimen should preferably be used in areas known to have a high prevalence of pretreatment metronidazole resistance.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Antitrichomonal Agents; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Omeprazole; Organometallic Compounds; Patient Selection; Tetracycline; Treatment Outcome

Topics: Abdominal Pain; Adolescent; Adult; Age Factors; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Antibodies, Bacterial; Child; Chronic Disease; Clarithromycin; Clinical Trials as Topic; Drug Therapy, Combination; Duodenal Ulcer; Endoscopy; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Penicillins; Recurrence; Risk Factors; Stomach Ulcer

Thirty-eight clinical strains of Helicobacter pylori were isolated from patients with chronic gastritis and gastroduodenal ulceration, and their susceptibility to macrolide antibiotics (roxithromycin, flurithromycin, azithromycin, erythromycin) in combination with proton-pump inhibitors (lansoprazole and omeprazole) and bismuth subcitrate was assayed. Chequerboard titration was used to analyse the results of antimicrobial interactions and showed that the activity of macrolides was enhanced by combining them with lansoprazole, omeprazole or, to a lesser extent, bismuth subcitrate. While the interactions between erythromycin and the proton-pump inhibitors or bismuth subcitrate were always additive, the combinations of roxithromycin-lansoprazole, flurithromycin-omeprazole and azithromycin-lansoprazole acted synergically on 82%, 60% and 60% of H. pylori strains, respectively. These results may, in part, account for the enhanced clinical efficacy of macrolides administered with proton-pump inhibitors in the treatment of H. pylori-associated diseases.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Bacterial Agents; Anti-Ulcer Agents; Azithromycin; Drug Synergism; Erythromycin; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Microbial Sensitivity Tests; Omeprazole; Organometallic Compounds; Peptic Ulcer; Proton Pump Inhibitors; Roxithromycin

The aim of the present study was to evaluate the efficacy and the safety of a short-term regimen (weekend therapy) in the cure of Helicobacter pylori infection and to analyze the factors that may influence the success of the treatment.. Seventy-one patients with gastric colonization by a tinidazole sensitive H. pylori strain (34 duodenal ulcer and 37 nonulcer dyspepsia) received omeprazole 40 mg o.m. for 7 days (from Monday to Sunday) and bismuth 240 mg q.i.d. + amoxicillin 1000 mg/q.i.d. + tinidazole 500 mg q.i.d. for only 2 days (Saturday and Sunday). Endoscopy, histology, culture, urease test, and susceptibility studies were done at entry and 30 days after treatment.. Successful eradication was obtained in 84% of patients. The percentage of eradication was higher in duodenal ulcer patients (94%) than in those with nonulcer dyspepsia (74%; p < 0.05), and in patients who received the treatment during hot weather (94%) than in those who received the treatment during cold weather (74%; p < 0.05). Side-effects were induced by the treatment in 17% of patients, and these were all not severe, self-limiting, short-lasting, and did not require specific treatment.. These data suggested that weekend therapy with high doses of drugs represents an effective, safe, and inexpensive therapeutic approach for the treatment of H. pylori infection, particularly in patients with duodenal ulcer. Furthermore, they also confirm the relevant role that short-term treatments may play in the therapeutic approach to H. pylori infection, and highlight some important aspects influencing short-term schedules.

Topics: Adult; Aged; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Tinidazole

Helicobacter pylori eradication therapy is routinely used for treating patients with peptic ulcer disease.. To assess the value of symptomatic response to H pylori eradication therapy as a marker of post-treatment H pylori status.. One hundred and nine dyspeptic patients with active duodenal or gastric ulceration association with H pylori infection had their symptoms measured by a validated questionnaire before and three months following H pylori eradication therapy. The symptomatic response was compared with post-treatment H pylori status as determined by the 14C urea breath test.. An eradication rate of 84% was achieved. Of the 92 patients eradicated of H pylori, 47% experienced complete or near complete resolution of dyspepsia. Of the 17 patients in whom the infection was not eradicated, only one (6%) experienced resolution of dyspepsia. Resolution of dyspepsia was therefore a powerful predictor of eradication of H pylori with a predictive value of 98%. In contrast, persistence of dyspepsia was a weak predictor of persisting infection with a predictive value of only 25%. Excluding patients with endoscopic evidence of coexisting oesophagitis and/or retrosternal discomfort or reflux at initial presentation did not increase the predictive value of persisting dyspepsia for persisting infection.. Complete resolution of dyspeptic symptoms is a powerful predictor of eradication of H pylori infection in ulcer patients. Persistence of symptoms is a weak predictor of persisting infection and patients with persisting dyspepsia must have their H pylori status rechecked to guide future management.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Antitrichomonal Agents; Breath Tests; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Peptic Ulcer; Predictive Value of Tests; Treatment Outcome

Under observation there were 82 patients operated on for ulcer disease of the stomach and duodenum. Dissemination of the mucosa with Helicobacter pylori (HP) was studied by means of using the urease test. Before the operation the positive result of the study was obtained in 73 patients (89%). In 1-6 months after the operation the HP infection was found in 29 patients (39.7%). The HP persistence retained in 39.7% of the patients subjected to resection of the stomach in spite of the preoperative treatment including De-nol and Metronidazole. Post-resectional reflux-gastritis and anastomositis were more pronounced in HP carriers. The antireflux variants of anastomoses (transversal, terminolateral gastroduodenal anastomosis and gastrojejunal anastomosis by Roux) were followed by much less HP persistence and less frequent cases of anastomositis and gastritis of the gastric stump.

Topics: Adult; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Duodenal Ulcer; Evaluation Studies as Topic; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Stomach Ulcer

The current standard of Helicobacter pylori treatment has been confirmed by the studies presented at the Lisbon workshop--that is, one of three one week proton pump inhibitor (PPI) based triple therapies comprising a twice daily standard dose of a PPI in combination with two of the following antimicrobial agents: clarithromycin, amoxycillin, or a nitromidazole. This standard of treatment is also highly efficacious and cost-effective in routine community practice. The current data confirm the equivalence of ranitidine bismuth citrate to PPI, and of azithromycin to clarithromycin. The optimum dose for azithromycin has not yet been defined. There is some evidence that in certain regions treatment for more than one week may be advantageous. The reasons are still not clear. However, microbial resistance may be one important factor, as it has a substantial effect on treatment outcome and the prevalence of resistance varies considerably in different areas. The negative impact of resistance is increased by shortening the treatment time. At present, there is no general necessity to test for resistance before treatment. However, before selection of a second line treatment, testing for resistance is recommended.

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Clinical Trials as Topic; Drug Therapy, Combination; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Portugal; Proton Pump Inhibitors; Ranitidine

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Clarithromycin; Drug Combinations; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Omeprazole; Organometallic Compounds; Penicillins; Peptic Ulcer; Ranitidine

Duodenal ulcer disease is strongly associated with Helicobacter pylori infection of the gastric mucosa. Eradication of H pylori from the gastric mucosa in adults is associated with long term healing of ulcers.. To follow a cohort of children with duodenal ulcer disease for a minimum of two years after the eradication of H pylori.. Over a three year period, all children diagnosed with duodenal ulcer disease had their symptoms documented and their H pylori status evaluated. The histories of these children were carefully screened to determine previous symptoms and to document previous treatment regimens.. Sixteen children were diagnosed with ulcers and 15 were available for treatment and long term follow up. The median age at which symptoms first occurred was 10.5 years (range, 6-14) and the median duration of symptoms was 24 months (range, 2-60). Ten of the children had been treated with H2 receptor antagonists for a median of 3.5 months (range, 1-60). Duodenal ulcers healed in all children after eradication of H pylori and all children have remained asymptomatic for a median of 37 months (range, 26-62). No child has required subsequent admission to hospital.. Eradication of H pylori is very effective in the long term healing of duodenal ulcer disease. H pylori eradication should be the standard treatment for all infected children who present with duodenal ulcer disease.

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Child; Drug Therapy, Combination; Duodenal Ulcer; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Metronidazole; Organometallic Compounds; Tetracycline; Treatment Outcome

The addition of omeprazole to 1 week of standard triple therapy (tripotassium dicitrato bismuthate, tetracycline and metronidazole) has given a 98% eradication rate in 54 patients at 4-6 weeks in a research setting. We report the result of a similar 1-week regimen in 52 patients in routine clinical practice assessed at a mean of 8 months.. Fifty-two patients with peptic ulcer disease and antral biopsies containing Helicobacter pylori sensitive to metronidazole were given a 7-day course of treatment: omeprazole 20 mg b.d., tetracycline 500 mg q.d.s. and tripotassium dictitrato bismuthate chelate tablets 120 mg q.d.s., with metronidazole 400 mg five times daily for the last 3 days only. Completeness of eradication was assessed by a 13C-urea breath test at 4-26 months (mean 8 months).. Forty-eight patients (92%) had a negative breath test. Three patients vomited on the last day of the course, otherwise the treatment was well tolerated with the expected minor side-effects of tongue discoloration, nausea and unpleasant taste.. The efficacy of a modified 1-week standard triple therapy with omeprazole is confirmed and shown to be almost as effective in routine clinical practice as a similar regimen in a research setting.

Topics: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Breath Tests; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Tetracycline

To evaluate the efficacy of triple-drug therapy for Helicobacter pylori infection and the effect of its eradication on relapse of ulcer in patients with duodenal ulcer (DU) disease.. Patients with uncomplicated DU who were H. pylori-positive on urease test or histology were given triple-drug therapy (metronidazole, tetracycline, colloidal bismuth subcitrate). Ulcer healing and H. pylori status were assessed one month after completion of therapy. Those with healed ulcers were followed up endoscopically for ulcer recurrence at 3-month intervals for one year or more.. Fifty seven of 60 consecutive DU patients (95%) who were H. pylori-positive were taken up for the study; 46 patients (36 men; median age 40 years, range 13-70) completed the study. Thirty one of them (67%) eradicated H. pylori and had healed ulcers at one month post therapy; of 15 patients with persistent H. pylori infection, ulcers healed in 12 (p = ns). After an average follow up of 11 months, 8 of 12 H. pylori-positive patients had relapse of DU compared to 5 of 31 (16%) H. pylori-negative patients (p < 0.01).. Triple-drug therapy was effective and safe for H. pylori infection, the lower rate of eradication observed compared to results elsewhere probably being related to bacterial resistance. Eradication of H. pylori was associated with healing of ulcers, resolution of antral gastritis and a significant fall in the rate of ulcer relapse.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Recurrence; Tetracycline; Time Factors

Our aims were 1) to study the influence of several factors (age, sex, smoking, previous ulcer disease, ulcer size, chronic gastritis, serum gastrin and pepsinogen I levels, therapy regimen and, especially, eradication of Helicobacter pylori) on duodenal ulcer healing; 2) to evaluate the frequency of duodenal ulcer healing failure despite eradication of H. pylori, to study why this failure occurs, and to verify its evolution without antisecretory therapy; and 3) to confirm whether a week's prescription of omeprazole is sufficient to obtain ulcer healing.. Three-hundred and eight patients (mean age, 45 +/- 13 years; 71% males) with duodenal ulcer and H. pylori infection were studied prospectively. Biopsy specimens were obtained at initial endoscopy, and serum gastrin and pepsinogen I levels were measured. A repeat endoscopy (with biopsies) was performed 1 month after eradication therapy had been completed, and a 13C-urea breath test was also carried out. Three eradication therapies were used: omeprazole plus amoxycillin for 2 weeks (OA group, n = 61); 'classic' triple therapy (with bismuth; CTT group, n = 65); and 'new' triple therapies for 1 week (NTT group, n = 182): omeprazole plus two of the following antibiotics: clarithromycin, metronidazole, and amoxycillin. When the ulcer did not heal despite successful H. pylori eradication, antacids were prescribed on an as-needed basis, and endoscopy was repeated 1 month later (2nd control endoscopy). If the ulcer was still present, the acid output (basal and pentagastrin-stimulated) was measured, a secretin test was performed, and a final endoscopy (3rd control endoscopy) was carried out after an additional month. The statistical method used was multiple logistic regression.. Overall eradication was achieved in 69% (n = 212) of the patients, and ulcer healing in 76% (n = 233): 57% in the OA group, 80% in the CTT group, and 81% in the NTT group (P < 0.01 when comparing the OA group with the others). Ulcer healing was achieved in 90% of H. pylori-eradicated patients and in only 45% of patients with eradication therapy failure (P < 0.001). Similar results were obtained when only patients treated with NTT were considered: ulcer healing in 90% of patients with the organisms eradicated. Eradication of H. pylori (odds ratio (OR), 11.8; 95% confidence interval (CI), 6.3-22) and sex (OR, 2.5; 95% CI, 1.2-5.1) were the only variables that correlated with ulcer healing in the multivariate analysis. The ulcer persisted despite successful eradication of H. pylori in 22 patients. The duodenal ulcer had healed spontaneously in 73% of these patients at the 2nd control endoscopy. Finally, by the 3rd control endoscopy, only three patients still had duodenal ulcer. Therefore, ulcer healing was finally achieved in 98.1% (95-99%) of patients in whom H. pylori was eradicated. Gastrin, pepsinogen I, acid output, and the secretin test had normal values in all patients.. Eradication of H. pylori favours ulcer healing, which is achieved in most patients in whom the organism is eradicated. Just 1 week of omeprazole therapy (that is, the antibiotic administration period in the new triple therapies) is enough to obtain a high ulcer healing rate. Most duodenal ulcers that do not heal initially despite H. pylori eradication will ultimately do so after several weeks without additional therapy.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Case-Control Studies; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Logistic Models; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Risk Factors; Tetracyclines; Time Factors; Treatment Outcome; Wound Healing

The presence of gastric metaplasia in the duodenal mucosa and Helicobacter pylori infection play an important role in the development of duodenal ulcers and the risk for ulcer relapses. The purpose of the present study was to identify the presence of gastric metaplasia in the duodenum and observation of changes in its extent during eradication therapy for Helicobacter pylori. The study population consisted of 40 patients, 15 women (aged from 29 to 65 years) and 25 men (aged from 22 to 62 years). At baseline and after 6 weeks all patients underwent endoscopic examinations of the upper alimentary tract during which two gastric antral and duodenal biopsies were obtained. The first endoscopy revealed the presence of duodenal ulcers in 22 patients, no ulcers in 11 cases, and postulceration scar in the duodenal bulb in 7 cases. The specimens were stained with hematoxylin and eosin, Giemsa and periodic acid Schiff/Alcian Blue. On first examination Helicobacter pylori infection in gastric antral specimens was detected in 40 patients. Therapy with amoxycillin, metronidazole, ventrisol and omeprazole for two weeks was administered in patients without duodenal ulcers and with omeprazole and ventrisol for additional 14 days in patients with duodenal ulcers. After therapy the presence of Helicobacter pylori was found in 10 cases, thus the degree of Hp eradication in the present study was 75%. Gastric metaplasia in duodenal samples was seen in 15 patients with duodenal ulcers and in 10 nonulcer patients. After therapy only in 4 cases gastric metaplasia was reduced along with Hp eradication, whereas in 9 cases gastric metaplasia in the duodenum was still present despite effective Hp eradication. The present findings indicate that gastric metaplasia is a reversible lesion, although this process is not dynamic and requires more time. The presence of gastric metaplasia in the duodenum after Hp eradication indicates an increased risk for the recurrence of duodenal ulcers, thus providing a useful information for a clinician.

Topics: Adult; Aged; Amoxicillin; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metaplasia; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Stomach

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Ulcer Agents; Drug Evaluation; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Time Factors

Topics: Antacids; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Bismuth; Chronic Disease; Drug Therapy, Combination; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Peptic Ulcer; Peptic Ulcer Hemorrhage; Recurrence

H. pylori eradication usually involves treatment with three or four drugs for at least 7 days. Possible advantages of short treatment regimens are better patient compliance and tolerability. and less adverse effects. Recently two reports have shown a cure rate of > 90% using a 4-day quadruple therapy.. To confirm these data and to evaluate the efficacy and tolerability of 4-day quadruple therapy in a single centre.. Thirty-eight consecutive patients with non-ulcer dyspepsia or peptic ulcer disease, and proven H. pylori infection, received 4 days of quadruple therapy (bismuth, tetracycline, metronidazole, lansoprazole). At least 6 weeks after treatment, endoscopy was repeated with six biopsies of antrum and corpus for histology and culture.. The intention-to-treat cure rate was 34/38 (89.5%, 95% CI: 79.7-99.2%). In the per protocol analysis the cure rate was 34/37 (91.9%, 95% CI: 83.1-100%). Primary metronidazole resistance was observed in two patients; both were cured. Metronidazole resistance induction was observed in one patient in whom therapy failed. The treatment was generally well tolerated.. Routine use of 4-day quadruple anti-H. pylori treatment is effective and well tolerated.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Tetracycline

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Peptic Ulcer

Azithromycin, a new antibiotic chemically related to erythromycin, has been proposed for the cure of Helicobacter pylori, achieving high gastric tissue levels (above the MIC for H. pylori) after oral administration. The aim of the study was to establish whether azithromycin plus metronidazole in association with either omeprazole or bismuth subcitrate is useful in curing H. pylori infection of the stomach.. The study involved 132 dispeptic patients who proved to be H. pylori infected by antral and corpus histology (Giemsa, modified) and rapid urease test (CLOtest); the Sydney system was used to classify the gastritis. Sixty-three patients received bismuth subcitrate 120 mg q.i.d. for 14 days plus azithromycin 500 mg o.d. for the first 3 days plus metronidazole 250 mg q.i.d. for the first 7 days; 69 patients received omeprazole 40 mg for 14 days plus azithromycin 500 mg o.d. for the first 3 days plus metronidazole 250 mg q.i.d. for the first 7 days. Patients were well matched for common clinical variables. Cure of H. pylori infection was assessed by the same methods 2 months after completion of treatment.. Eleven patients dropped out of the study, only one reporting side effects (nausea, vomiting, and epigastric pain). Cumulative "per protocol" cure rate was 66.1% (CI 95%, 58.5-75.3%). There was no statistically significant difference between the two treatment groups: 58.9% (CI 95% 48.4-74.6%) versus 72.3% (CI 95%, 60.7-82.5%). Intention to treat does not substantially modify results. Few side effects were recorded. Cured patients showed a significant reduction in the activity of gastritis.. Azithromycin, combined with omeprazole and metronidazole, the cure rate of H. pylori was about 70%. The cure of H. pylori infection improves the activity of gastritis.

Topics: Adult; Aged; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Azithromycin; Drug Therapy, Combination; Dyspepsia; Female; Follow-Up Studies; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Time Factors

We wanted to demonstrate the effect of Helicobacter pylori eradication on basal and stimulated pepsinogen-I levels in duodenal ulcer patients and to verify whether modification of such levels is a useful method for determining the success of eradication therapy.. Thirty-two patients (24 men; mean age, 45 years) with active duodenal ulcer were studied. In all patients three biopsy specimens were taken from the duodenal bulb, gastric antrum, body and fundus for microbiologic and histologic examination. Triple therapy consisting of bismuth, metronidazole, and tetracycline was administered. Endoscopy was repeated 1 month after completing therapy, and biopsy specimens were again taken from the gastric antrum and body. Serum samples were taken at initial and repeat endoscopies, to measure basal and stimulated (120 min) pepsinogen-I levels after injection of pentagastrin.. H. pylori was eradicated in 26 patients (81%). Significant histologic improvement, in both the antrum and body, was observed (p < 0.001). Basal pepsinogen-I levels (mean and 95% confidence interval) at diagnosis and after eradication were 106 (92-119) and 87 (74-100) ng/ml, respectively (P < 0.001). Similarly, stimulated pepsinogen-I levels (integrated values) decreased from 4790 (4199-5381) before therapy to 3970 (3383-4557) ng/ml.min after eradication (P < 0.001). Pepsinogen I levels did not change in patients in whom H. pylori was not eradicated. The area under the receiver operating characteristic curve for decreased basal and stimulated pepsinogen-I levels was 0.77 (SE, 0.09) and 0.79 (SE, 0.1), respectively.. H. pylori eradication in duodenal ulcer patients was associated with a significant decrease in basal and stimulated pepsinogen-I levels. Measurement of these levels could determine how successful response to therapy has been in both the eradication and resolution of associated gastritis. Other advantages of this procedure are that it has low cost and results are evident at an early stage.

Topics: Adult; Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Biopsy; Drug Therapy, Combination; Duodenal Ulcer; Duodenoscopy; Duodenum; Female; Follow-Up Studies; Helicobacter Infections; Humans; Intestinal Mucosa; Male; Metronidazole; Middle Aged; Organometallic Compounds; Pentagastrin; Pepsinogens; Tetracycline; Treatment Outcome

Topics: Adolescent; Amoxicillin; Anti-Ulcer Agents; Child; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Omeprazole; Organometallic Compounds; Penicillins

Hepatocyte growth factor (HGF) is increasingly recognized for its role in a variety of hepatic and systemic diseases. Its relationship to gastritis has not been studied. We aimed at measuring gastric mucosal HGF levels in the presence or absence of Helicobacter pylori gastritis, in peptic ulcers, and in response to H. pylori eradication.. Fifty one patients were studied. Patients were not entered if they had liver disease, malignancy, or any systemic illness. HGF was measured in gastric antral incubates using an enzyme-linked immunosorbent assay. Assessments were repeated 6 wk after a 2-wk course of anti-H. pylori triple therapy in 12 patients. Code numbers were used for blinding.. The median gastric mucosal HGF level was 36 ng/gm/tissue in patients with H. pylori gastritis (n = 33) compared with 19 ng/gm in 18 negative controls (p = 0.0024), 18 ng/gm after the eradication of H. pylori (p = 0.021), 23 ng/gm in all patients with ulcers (n = 10), and 26 ng/gm/tissue in H. pylori-positive ulcers (n = 7).. Gastric mucosal HGF levels were elevated in H. pylori gastritis and reduced by its eradication. These results are relevant to our understanding of the increased gastric cell proliferation in patients with H. pylori-related gastritis.

Topics: Adult; Amoxicillin; Anti-Ulcer Agents; Biopsy; Drug Therapy, Combination; Female; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Hepatocyte Growth Factor; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Penicillins; Peptic Ulcer; Statistics, Nonparametric; Time Factors

Helicobacter pylori (H. pylori) eradication rates with omeperazole/amoxicillin range from 0-90%. The best regimen for retreatment after failure of omeprazole/amoxicillin has not been established so far. The aim of this prospective study was to evaluate the efficacy of triple therapy with bismuth, tetracycline and ornidazole in eradicating H. pylori after failure of omeprazole/amoxicillin. 79 duodenal ulcer patients with H. pylori infection were treated with oral omeprazole (40 mg bid) and amoxicillin solute (750 mg tid) for 10 days. Eradication rate was 28/79 (35%) and was distinctly lower in smokers (> 10 cigarettes/day) vs nonsmokers (10/49 [20%] vs 18/30 [60%], p < 0.001). 37 patients with persistent H. pylori infection in whom omeprazole/amoxicillin had failed agreed to retreatment with triple therapy. Persistence of H. pylori was confirmed by histology (3 antral and 2 gastric body biopsies; H&E, Giemsa), urease test (CLO) and/or H. pylori culture. Patients smoking > 10 cigarettes/day were classified as smokers. Retreatment consisted of oral bismuth-subcitrate 4 x 120 mg/d for 28 days (day 1-28), tetracycline 4 x 500 mg/d and ornidazole 3 x 500 mg/d for 10 days (day 1-10). Control endoscopy was done 30 days after the end of treatment. Criteria for H. pylori eradication was negative urease test, culture and histology. 34/37 patients (6 females/28 males; 39 [23-64] years) completed the study (24/34 smokers, 10/34 nonsmokers). 3/37 patients dropped out because of side effects (n = 1) or incompliance (n = 2). H. pylori subcultures for resistance testing were possible in 32/34 patients: H. pylori was metronidazole-sensitive in 11/32 (1 female, 10 males; 38 [24-55] years; 9 smokers, 2 nonsmokers) and metronidazole-resistant (minimal inhibitory concentration for metronidazole > 8 mg/ml) in 21/32 (5 females, 16 males; 40 [23-64] years; 13 smokers, 8 nonsmokers). The overall H. pylori eradication rate of the triple therapy was 27/34 (79%). H. pylori was eradicated in 19/24 (79%) smokers and in 8/10 (80%) nonsmokers. Eradication rate for metronidazole-sensitive H. pylori was 11/11 (100%) vs 14/21 (67%) for metronidazole-resistant H. pylori (p = 0.012). Triple therapy is effective and safe in eradicating H. pylori in patients after failure of omeprazole/amoxicillin. Smoking had no negative effect on the eradication rate of the triple therapy after failure of omeprazole/amoxicillin. Eradication failures were due to metronidazole-resistance.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Prospective Studies; Tetracycline; Treatment Outcome

The aims of the present study were to assess the usefulness of the Helicobacter felis mouse model in the evaluation of antimicrobial therapies and the effect of Helicobacter infection on gastric mucosal prostaglandin E2 release.. Barrier-maintained BALB/c mice were infected with H. felis and treated with different antibacterial therapies. H. felis status was determined by bacterial culture, urease test, and bacterial and histologic stainings. Release of prostaglandin E2 from the gastric mucosa was measured by radioimmunoassay.. All triple-treated mice were cleared of bacteria both 24 h and 1 month after treatment. However, tinidazole alone also resulted in 100% eradication. Monotherapies with erythromycin acistrate, tetracycline, colloidal bismuth subcitrate, and nitecapone failed to eradicate the bacteria. The release of gastric prostaglandin E2 was doubled in the infected mice (554 +/- 39, mean +/- SE) compared with the noninfected mice (270 +/- 35) (p < 0.01).. The H. felis mouse model proved satisfactory for assessing both anti-Helicobacter therapies and the prostaglandin E2 release. The reliability of this method was improved when several methods to assess the H. felis status were used in parallel.

Topics: Amoxicillin; Animals; Anti-Ulcer Agents; Catechols; Dinoprostone; Disease Models, Animal; Drug Therapy, Combination; Erythromycin; Gastric Mucosa; Helicobacter Infections; Male; Mice; Mice, Inbred BALB C; Organometallic Compounds; Pentanones; Tetracycline; Tinidazole

Triple therapy (bismuth and two antibiotics) will eradicate Helicobacter pylori infection in 70-90% of subjects. Treatment failure has been attributed to patient compliance and antimicrobial drug resistance. The aim of this study was to examine factors influencing the eradication of H. pylori following triple therapy. Thirty seven subjects with H. pylori cultured from antral biopsies were treated with colloidal bismuth subcitrate (120 mg qid for 2 weeks), metronidazole (400 mg tid for 1 week) and amoxycillin (500 mg tid for 1 week). Pretreatment isolates of H. pylori were tested for metronidazole susceptibility by agar dilution according to the National Committee for Clinical Laboratory Standards guidelines. Factors including age, sex, clinical diagnosis and metronidazole resistance were evaluated in relation to H. pylori. The overall metronidazole resistance was 32%. Metronidazole resistant strains were more frequent in females, with a resistance rate of 54%. Helicobacter pylori eradication occurred in 68% of patients with a metronidazole susceptible stain and only 17% of patients with a metronidazole resistant strain (P < 0.03). Helicobacter pylori eradication is dependent upon susceptibility to metronidazole. This data would support the role for routine metronidazole susceptibility testing using appropriate standardized methods when triple therapy is to be considered.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Penicillins; Predictive Value of Tests; Treatment Failure

Standard triple therapy remains the recommended first line treatment for Helicobacter pylori in New Zealand. The real eradication rate achieved in busy hospital clinics may be different from data obtained from clinical trials outside of New Zealand.. One hundred and thirty patients with proven H pylori infection (by at least two tests) were treated with low dose triple therapy (DeNol 1 qid, tetracycline 250 mg qid and metronidazole 200 mg qid for 2 weeks; dosing with meals and at night); 83 were given a standard prescription for triple therapy (dispensed in bottles) and 47 were given a medication pack with times of dosing clearly marked. Eradication was proven by a negative 13C urea breath test at least 4 weeks after finishing treatment.. Follow up urea breath test was obtained in 120 patients (92%). The eradication rate for separate bottles was 79% and for the medication pack 76%. Compliance was estimated to be greater than 90% in 92% of patients who attended for followup. H pylori culture and sensitivity results were available for 41 patients. Overall rate of metronidazole resistance was 32%. The eradication rate for metronidazole sensitive strains was 89% and for resistant strains 46%. Mild side effects were reported in 10% and moderate side effects in 10%. No patient stopped treatment because of side effects. There was no effect of age, ethnicity, smoking, alcohol intake, pretreatment with H2-antagonists or endoscopic diagnoses on eradication rates.. The low dose triple therapy has an acceptable real eradication rate. The most important determinant of success was metronidazole resistance. The eradication rate was not improved by using medication packs.

Topics: Adult; Aged; Anti-Bacterial Agents; Antitrichomonal Agents; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Medical Audit; Metronidazole; Middle Aged; Organometallic Compounds; Patient Compliance; Peptic Ulcer; Tetracycline; Treatment Outcome

The aim of this study was to assess the clinical outcome of two different durations of triple therapy in children with Helicobacter pylori infection. We established two treatment groups: 1) Short treatment, including 2 week of bismuth subcitrate, amoxycillin and metronidazole treatment (n = 21) and 2) Long treatment, which included the same therapy for two weeks plus bismuth subcitrate alone for two weeks more (n = 26). We found no difference between the short and long treatments. The infection remained in 14% and 19%, respectively. In both groups, we observed children (19%) with persistent abdominal pain in spite of Helicobacter pylori eradication and gastritis healing. We conclude that it is not necessary to prolong triple therapy more than 2 weeks in order to have therapeutic success.

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Bismuth; Child; Child, Preschool; Drug Evaluation; Drug Therapy, Combination; Duodenitis; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Penicillins; Time Factors

Thirty-nine Helicobacter pylori (HP) positive chronic duodenal ulcer patients completed the 4 weeks treatment of triple therapy (Denol, Metronidazole and Amoxil). Of these 29 showed healed duodenal ulcer and negative CLO test at 8 weeks (eradication). They were followed at 3,6 and 12 months and at each follow-up, endoscopy and CLO testing were repeated. At 12 weeks, 54% showed a healed ulcer and negative CLO and these figures reached to 69 and 66% at 6 and 12 months respectively. Thirty percent relapsed within 1 year. The present study indicates a prolonged remission of duodenal ulcer following HP eradication.

Topics: Adult; Amoxicillin; Anti-Ulcer Agents; Chronic Disease; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Pakistan; Treatment Outcome; Wound Healing

The eradication of Helicobacter pylori is becoming the therapy of choice for peptic ulcers, if the infection is present. Published data from primary care settings are, however, limited.. An open-ended, prospective study was undertaken that included 31 patients with active peptic ulcer demonstrated by endoscopy and H pylori infection confirmed by urease and histologic tests. After a 14-day period of treatment with omeprazole, bismuth, tetracycline, and metronidazole, healing and H pylori status were evaluated by repeat endoscopy done at least 28 days after the last treatment dose. Eradication is defined as absence of H pylori in at least four (two from the fundus and two from the antrum) samples taken from the gastric mucosa and a negative urease test. Drug side effects and patient compliance were monitored in all cases.. Twenty-eight patients completed the protocol. Healing was obtained in all cases, and eradication was accomplished in 25 (89%). Side effects were common (69%) but mild. Compliance was good. After a mean follow-up of 300 days (range, 180 to 400), one ulcer recurrence was observed in an H pylori-positive patient and none in H pylori-negative patients.. The treatment of H pylori infection is an effective way of healing peptic ulcers, and can be applied in primary care settings. Further studies with more patients and with shorter and easier therapies should be undertaken to confirm our findings.

Topics: Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Chronic Disease; Drug Therapy, Combination; Endoscopy; Evaluation Studies as Topic; Family Practice; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Tetracycline; Treatment Outcome

We studied whether different initial bacterial densities of Helicobacter pylori would alter the eradication rate of H. pylori by triple therapy (amoxicillin 500 mg t.i.d. and metronidazole 500 mg t.i.d. for 14 days; bismuth subcitrate 120 mg t.i.d. for 28 days) in patients with duodenal ulcer bleeding.. One hundred thirty-six cases with duodenal ulcer bleeding and H. pylori infection (proved by rapid urease test and histology during emergency endoscopy) were studied. One hundred twenty-seven of these patients completed a course of triple therapy. In each case, anti-H. pylori IgG titer, gastric biopsies for H. pylori density (score 1 to 5), and evaluation of severity of gastritis were collected at the first endoscopy and 1 month after completion of the triple therapy.. The ulcer healing rate was 84.3% (107 of 127) at the time of the second evaluation. The eradication rate of H. pylori was 76.4% (97 or 127). Eradication for H. pylori failed in 30 cases. In these eradication failure cases, initial serologic titer and density of H. pylori were higher than those of eradication success cases. The eradication rate of H. pylori decreased as the initial density of H. pylori increased (density of H. pylori: 1, 88.3%; 2, 83.8%; 3, 74.2%; 4, 68%; 5, 50%). At the second evaluation, the serologic titer was lower and continued to decline in eradication success cases whose mean residual titer ratio (100% x follow-up titer/initial titer) was lower than that of eradication failure cases (57.1% +/- 14.6% vs 107.1% +/- 24.1%, p < 0.001). The mean residual titer ratio also disclosed an upward trend as the density of H. pylori increased (density of H. pylori 1 to 5: 57.5%, 66.6%, 73.5%, 75.3%, 81.8%, respectively).. We suggest routine gastric biopsy to detect both the presence of H. pylori and its density inasmuch as quantitative results may predict the usefulness of triple therapy. The higher the H. pylori density, the less effective triple therapy will be at successful eradication of H. pylori.

Topics: Adult; Amoxicillin; Anti-Ulcer Agents; Biopsy; Drug Therapy, Combination; Duodenal Ulcer; Female; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Penicillins; Peptic Ulcer Hemorrhage; Predictive Value of Tests; Ranitidine; Treatment Failure

To study the concordance between 13C-urea breath test and histology in the diagnosis of Helicobacter pylori infection, and to evaluate whether there is a correlation between breath test values and histologic lesions of the gastric mucosa.. Sixty-nine patients with duodenal ulcer were prospectively studied. An endoscopy with biopsy samples (H&E stain) taken from the antrum and body was performed, and a 13C-urea breath test (measuring 13C difference: delta 13CO2) was also done. Both procedures were repeated one month after completing therapy ["classic" triple therapy (n = 28), and omeprazole+amoxycillin (n = 41)]. Eradication was defined as the absence of H. pylori both by histological and breath test methods.. At the beginning of the study, 94.2% of patients (n = 65) were H. pylori positive by histological methods, and 98.6% (n = 68) were positive by the breath test (ratio of positive agreement = 0.96). Kappa for H. pylori diagnosis after therapy was 0.83 (95% CI: 0.69-0.96). A correlation between delta 13CO2 and histologic lesions was observed, both in the antrum at before treatment (Spearman coef = 0.34; p = 0.007) and after therapy in both the gastric antrum (0.63; p < 0.001) and body (0.35; p = 0.005). A significant difference was observed when comparing mean delta 13CO2 in patients with different degrees of histologic gastritis, both before treatment (antrum: W Kruskal-Wallis = 6; p < 0.05) and after therapy (antrum: W = 17; p < 0.001; body: W = 10; p < 0.05).. A high concordance was observed between the 13C-urea breath test and histology in the diagnosis of H. pylori infection. A correlation exists between breath test values and histologic lesions of the gastric mucosa.

Topics: Adult; Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Biopsy; Breath Tests; Drug Therapy, Combination; Duodenal Ulcer; Endoscopy; Female; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Penicillins; Prospective Studies; Tetracycline

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Antitrichomonal Agents; Child; Child, Preschool; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Penicillins; Time Factors

In the present study, the effectiveness of a triple therapy for eradication of Helicobacter pylori was evaluated. Therapy consisted of 120 mg tripotassium dicitrato bismuthate q.d.s. for four weeks, 500 mg amoxycillin q.d.s. and 500 mg metronidazole t.d.s. for two weeks. In 77 Helicobacter pylori-positive patients with duodenal ulcers (n = 32), gastritis (n = 18) and after gastric resection (n = 7), rapid urease-based test, culture, histology and serology were used to confirm the eradication, or relapse. The overall eradication rate was 75.3%, ulcers were healed in 82.1% and an improvement of the endoscopic gastritis was observed in 75.3% of the patients. The eradication rates were not statistically different among the subgroups. 1-3 months after the treatment IgG titres had fallen by 25% and over in 67.5% of the patients irrespective of the success of bacterial eradication. Side effects, particularly diarrhoea and nausea, were common (53.2%) but mild. Only 6.5% of the patients' had to discontinue the treatment because side effects became intolerable.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Stomach Ulcer; Treatment Outcome

Topics: Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Duodenal Ulcer; Duodenitis; Evaluation Studies as Topic; Gastritis; Gastroesophageal Reflux; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Peptic Ulcer; Stomach Ulcer; Time Factors

This study tested the influence of pretreatment bacterial density on the eradication rate of Helicobacter pylori with triple therapy. One hundred and thirty two patients with endoscopically confirmed H pylori positive, duodenal ulcer or antral gastritis were treated with triple therapy (colloidal bismuth/metronidazole/amoxicillin) for two weeks. Pretreatment urease activity was assessed by the 14C-urea breath test (UBT) in all patients. The mean (SD) pretreatment UBT concentration was similar in patients with duodenal ulcers (318.4 (175.0)) and patients with antral gastritis (288.9 (165.5)). Overall eradication of H pylori was achieved in 85 of 132 patients (64.4%), but was significantly different between patients with high, intermediate, or low pretreatment urease activity (37.5%, 69.5%, and 87.8% respectively). The mean post-treatment UBT value of patients in whom eradication failed was in direct correlation with the pretreatment UBT values. In conclusion, bacterial density, as assessed by urease activity, is an important factor in predicting H pylori eradication. It is suggested that the pretreatment UBT has the potential to identify patients who require modification of the standard therapeutic regimen.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Breath Tests; Chronic Disease; Colony Count, Microbial; Drug Therapy, Combination; Duodenal Ulcer; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Urea; Urease

Topics: Anti-Bacterial Agents; Bismuth; Drug Therapy, Combination; Duodenal Ulcer; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Recurrence; Tetracycline; Time Factors

The mechanism by which Helicobacter pylori predisposes to duodenal ulcers (DUs) remains unclear. The aim of this study was to investigate the effect of the infection on acid secretion.. Acid output was examined basally and in response to gastrin-releasing peptide (GRP) and gastrin in healthy volunteers with and without H. pylori infection and in patients with DUs before and after eradication of the infection.. Compared with H. pylori-negative healthy volunteers, patients with DUs with H. pylori had the following abnormalities of acid secretion: (1) threefold increase in basal acid output, (2) sixfold increase in acid response to GRP, (3) increased maximal acid response to exogenous gastrin, (4) increased ratio of basal acid output to maximal gastrin-stimulated output, and (5) increased ratio of maximal GRP-stimulated acid output to maximal gastrin-stimulated output. All of these abnormalities resolved fully after H. pylori eradication except for increased maximal acid output to gastrin, which was unchanged. Infected healthy volunteers showed a threefold increase in acid response to GRP that resolved after eradication of H. pylori infection.. These disturbances in acid secretion caused by H. pylori infection are consistent with impaired inhibitory control and are likely to be relevant to the mechanism by which the infection predisposes to DU.

Topics: Amoxicillin; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Gastric Acid; Gastric Mucosa; Gastrin-Releasing Peptide; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Linear Models; Male; Metronidazole; Organometallic Compounds; Peptides; Reproducibility of Results

Helicobacter pylori causes chronic (type B) gastritis. The 'intestinal' form of gastric cancer arises against a background of chronic gastritis, and prospective epidemiological studies have shown that H pylori is a major risk factor for this. An increase in mucosal cell proliferation increases the likelihood of a neoplastic clone of epithelial cells emerging where there is chronic epithelial cell injury associated with H pylori gastritis. In vitro bromodeoxyuridine labelling of endoscopic antral biopsy specimens was used to measure mucosal cell proliferation in H pylori associated gastritis before and after therapy for H pylori triple infection. Cell proliferation was increased in H pylori associated gastritis patients compared with normal controls and patients with H pylori negative chronic gastritis (p = 0.0001; Tukey's Studentised range). There was no difference in antral epithelial cell proliferation between duodenal ulcer and non-ulcer subjects infected with H pylori (p = 0.62; Student's t test). Antral mucosal cell proliferation fell four weeks after completing triple therapy, irrespective of whether or not H pylori had been eradicated (p = 0.0001). At retesting six to 18 months later (mean = 12 months), however, those in whom H pylori had not been successfully eradicated showed increased mucosal proliferation compared with both H pylori negative subjects at a similar follow up interval and all cases (whether H pylori positive or negative) four weeks after completion of triple therapy (p = 0.024). These findings suggest that H pylori infection causes increased gastric cell proliferation and in this way may play a part in gastric carcinogenesis.

Topics: Adult; Cell Division; Chronic Disease; Drug Therapy, Combination; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Immunohistochemistry; Metronidazole; Organometallic Compounds; Tetracycline

In a prospective study designed to assess the effect of Helicobacter pylori eradication on peptic ulcer healing, 85 consecutive patients with H. pylori-positive peptic ulcer disease were treated with a triple therapy regimen consisting of colloidal bismuth subcitrate 120 mg four times daily for 28 days, with metronidazole 400 mg three times daily and tetracycline 500 mg three times daily for the first seven days of treatment. H. pylori status was assessed by CLO test and histology at least four weeks after completing therapy. Of 75 patients (88%) H. pylori-negative after therapy, 69 (92%) had healed ulcers compared with only five of 10 patients (50%) who remained H. pylori-positive (p = 0.003). Cigarette smoking had no significant effect on ulcer healing. Our results suggest that H. pylori eradication may accelerate ulcer healing and provide further evidence that an effective helicobactericidal regimen is the treatment of choice in H. pylori-positive peptic ulcer.

Topics: Adult; Aged; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptic Ulcer; Prospective Studies; Smoking; Stomach Ulcer; Tetracycline

Helicobacter pylori plays an important role in the pathogenesis of peptic ulcer disease, and many therapy regimens have been used to eradicate it.. To assess the efficacy of triple therapy in duodenal ulcer patients, in ulcer healing and eradication of H. pylori, early after treatment and 6 months later.. In a prospective study, 32 patients with duodenal ulcer disease and H. pylori infection were studied. Biopsy specimens from the duodenal bulb, antrum, body and gastric fundus were taken and were analyzed by a microbiology (Gram and specific culture) and histology process (hematoxylin and eosin). All patients were treated with triple therapy (bismuth, tetracyclin and metronidazole). Patients were investigated endoscopically one month after cessation the triple therapy and 4 months later, with taking of antrum and body biopsy specimens.. During the therapy, adverse events were elucidated in 3 patients (9.4%). Eradication (no evidence on ongoing H. pylori infection 4 wk after cessation treatment) was obtained in 26 patients (81.25%). Eradication reached 92% when H. pylori was metronidazole sensitive (N:25; 78.13%) and 42.86% (p < 0.05) when it was resistant. Reinfection rate was 3.85% (N = 1). Healing ulcer was observed in 28 patients (87.5%) 1 month after cessation of treatment. When triple therapy regimen was successful the healing rate was 96.15%, and it was 50% (p < 0.05) when it failed.. Triple therapy (with low doses of metronidazole, and tetracyclins) has a high efficacy (81.25%) in the eradication of H. pylori (metronidazole sensitivity plays an important role), with few (9.4%) and non-serious adverse events. Healing rate is 96.15% when eradication is obtained and 50% (p < 0.05) when it failed.

Topics: Adult; Aged; Anti-Ulcer Agents; Drug Evaluation; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Recurrence; Remission Induction; Tetracycline; Time Factors

Our major goals in this study were to determine the prevalence of Helicobacter pylori among Israeli children with recurrent abdominal pain and to establish whether a link exists between eradication of Helicobacter pylori and the recovery from abdominal pain. The alternative target was to examine whether the serological test can replace endoscopy in children.. Upper gastrointestinal endoscopy was performed in 80 children with recurrent abdominal pain. During endoscopy, antral biopsies were taken and sent for histological and bacteriological examination.. The prevalence of H. pylori, which was indicated by Gram stain and urease test, was 54%. The positive cases were treated with bismuth combined with amoxycillin and metronidazole. Two months after completion of the treatment, 34 patients were reexamined. Twenty-nine of them (85%) became symptom free, and five (15%) remained symptomatic. These five children were retreated, and they also became symptom free. Eight months after completion of treatment, all 34 patients were reexamined and found to be asymptomatic.. We found a high prevalence of H. pylori (54%) among Israeli children with recurrent abdominal pain; we also found that symptoms were effectively and significantly reduced by the eradication of H. pylori. The endoscopic examination cannot be replaced by serological test.

Topics: Abdominal Pain; Adolescent; Amoxicillin; Antacids; Antibodies, Bacterial; Child; Child, Preschool; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Female; Gastrointestinal Diseases; Helicobacter Infections; Helicobacter pylori; Humans; Male; Organometallic Compounds; Predictive Value of Tests; Recurrence; Sensitivity and Specificity; Serologic Tests

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Stomach Ulcer

Topics: Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Stomach Ulcer

Topics: Anti-Bacterial Agents; Helicobacter Infections; Helicobacter pylori; Humans; Omeprazole; Organometallic Compounds; Stomach Ulcer

H. pylori has recently been recognized as a novel risk factor of gastric cancer, but its precise role in gastric carcinogenesis is as yet unknown. The aim of the present study was to assess the relationship between H. pylori infection and vitamin C levels in gastric juice and also to examine whether eradication of H. pylori could have any impact on these levels. Gastric juice and plasma vitamin C levels were measured in 88 dyspeptic patients who had an upper gastrointestinal endoscopy. In the subgroup of H. pylori-positive patients, eradication was attempted with triple therapy. This subgroup was studied on two occasions, ie, before and after treatment. There were 58 H. pylori-positive and 30 -negative patients. Gastric juice vitamin C levels in H. pylori-positive patients were statistically lower (P < 0.001) than the levels in the H. pylori-negative patients. Triple therapy achieved eradication in 45 patients (77.6%) of the 58 H. pylori-positive patients. Before H. pylori was eradicated in these 45 patients gastric juice vitamin C levels were significantly (P < 0.001) lower than those after eradication, the latter being no different than the group of 30 H. pylori-negative patients. There was a significant (P < 0.001) improvement of gastritis after eradication, which paralleled the elevation of gastric juice vitamin C levels. No difference was noted in plasma vitamin C levels between H. pylori-negative and -positive patients or in the latter before and after H. pylori treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Ascorbic Acid; Bismuth; Drug Therapy, Combination; Female; Gastric Juice; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Stomach Neoplasms

Topics: Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Peptic Ulcer; Tetracycline

Topics: Aged; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Omeprazole; Organometallic Compounds; Pyloric Stenosis; Tetracycline

Helicobacter pylori was cultured and Helicobacter-like organisms (HLO) were seen in 6 (16%) of 37 children with recurrent abdominal pain. Five children had concomitant histological inflammation, but none had endoscopic changes. All 6 children demonstrated positive serology. Compared with the total group, they were more often from developing countries, larger families and lower social groups. Treatment with phenoxymethyl penicillin and colloidal bismuth subcitrate did not result in side effects or elevated serum levels of serum bismuth. Three children demonstrated metronidazole-resistant strains and the treatment of these children remained an unsolved problem. Among the 31 H. pylori/HLO negative children 8 (26%) demonstrated histological changes, 5 (16%) endoscopic changes and 11 (35%) had positive serology. In conclusion, pathological findings at upper gastrointestinal endoscopy are common in children with recurrent abdominal pain. Because of disconcordance between endoscopy, histology and culture, we recommend that biopsies should always be taken to clarify the diagnosis.

Topics: Abdominal Pain; Adolescent; Anti-Ulcer Agents; Biopsy; Child; Child, Preschool; Endoscopy, Gastrointestinal; Female; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Microbial Sensitivity Tests; Organometallic Compounds; Recurrence

A human in vitro model to study the interaction between Helicobacter pylori and gastric epithelial cells was developed using primary cultures of gastric mucosal cells (isolated from gastric biopsies or operative specimen and maintained in culture for 2 weeks) as well as the well-differentiated human gastric carcinoma cell line HM02, the undifferentiated gastric tumour cell line HM51, and the laryngeal epithelial cell line HEp-2. Primary cultures and all cell lines were exposed to seven isolates of H. pylori isolated from gastritis and duodenal ulcer patients. Microbial adherence was assessed by microscopical evaluation of Giemsa-stained preparations and by culturing the viable bacteria attached to the epithelial cells. All H. pylori isolates adhered to the gastric cells in primary culture, to HM02 cells, and to HEp-2 cells with the greatest binding affinity found in primary gastric cells. No adherence was detected in HM51 cells. H. pylori adherence was dependent on bacterial load, incubation time, and temperature. There was no difference in microbial binding between H. pylori isolates derived from gastritis and duodenal ulcer patients. The effect of antiulcer drugs on H. pylori adherence was investigated by pre-incubating isolates of H. pylori with omeprazole, cimetidine, and bismuth subcitrate. Omeprazole and cimetidine failed to significantly influence microbial adherence. In contrast, bismuth subcitrate already in concentrations below the MIC range decreased H. pylori adherence in gastric epithelial cells and in HEp-2 cells substantially. Our study shows that primary cultured human gastric mucosal cells and the human gastric carcinoma cell line HM02 provide suitable in vitro models for the study of the interactions between H. pylori and the gastric epithelium. This gastric cell model is characterized by a high affinity for H. pylori binding.

Topics: Anti-Ulcer Agents; Bacterial Adhesion; Carcinoma; Cells, Cultured; Cimetidine; Duodenal Ulcer; Epithelial Attachment; Epithelial Cells; Epithelium; Gastric Mucosa; Gastritis; Gastrointestinal Neoplasms; Helicobacter Infections; Helicobacter pylori; Humans; Laryngeal Neoplasms; Microscopy, Phase-Contrast; Omeprazole; Organometallic Compounds; Tumor Cells, Cultured

Topics: Amoxicillin; Drug Therapy, Combination; Enterocolitis, Pseudomembranous; Female; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Middle Aged; Organometallic Compounds

To study the efficacy and acceptability of low dose, short duration triple therapy in eradicating Helicobacter pylori from patients with duodenal ulcer.. A prospective study of 105 patients with H. pylori associated duodenal ulcer presenting consecutively to a regional Melbourne general hospital and a local private endoscopy clinic.. Patients were treated with H2-antagonists (if required), followed by two weeks of triple therapy consisting of colloidal bismuth subcitrate (Denol) one tablet four times daily between meals, tetracycline hydrochloride 250 mg four times daily and metronidazole 400 mg twice daily. Four weeks, and again 12 months after treatment, patients were assessed by gastroscopy and antral biopsy for ulceration and H. pylori as measured by rapid urease test. Side effects of treatment were documented.. Four patients withdrew because of drug side effects. Of 101 patients completing treatment, H. pylori was eradicated in 91 (90%, or 87% of total). Eight of the 10 patients in whom initial treatment failed received one or more further courses of triple therapy, with H. pylori being eradicated in five. Mild nausea occurred in 6% and possible candida infection in 3%. Of 68 patients who were reassessed after 12 months, 66 were still clear of H. pylori but, in four, small superficial ulcers were present. Two patients were positive for H. pylori, one with and one without ulceration, giving an H. pylori recurrence rate of 3% and an ulcer recurrence rate of 7%.. This particular regimen of triple therapy was highly effective, safe and acceptable and could be offered to all patients with H. pylori associated duodenal ulcer.

Topics: Adult; Aged; Anti-Ulcer Agents; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Tetracycline; Treatment Outcome

The purpose of this study was to monitor the change of IgG antibodies to Helicobacter pylori during the course of a long-term follow-up after the eradication of H. pylori, as well as to evaluate the efficacy of triple therapy in preventing the recurrence of duodenal ulcer (DU).. Twenty-three DU patients with positive H. pylori were studied; among those patients, 20 ulcers healed after initial treatment of triple therapy. Each patient received a follow-up endoscopy and biopsy examination every 3 months for 1 yr, or whenever the ulcer symptoms recurred. Serological tests for IgG antibodies were performed with a commercial ELISA.. Of the 20 patients with healed ulcers, one dropped out of this study; the recurrence rate of DU at 1 yr was 5% (1/19). There was no recurrence of ulcer in 17 H. pylori-negative patients and only one recurrence out of two H. pylori-positive patients. After the eradication of H. pylori, the seroconversion rates of IgG were 5%, 21%, 42%, 76%, and 94% at 0, 3, 6, 9, and 12 months, respectively. After 6 months, 95% (18/19) of the patients in which H. pylori was eradicated had at least a one-grade fall in IgG titers (p < 0.001). One patient had a relapse of H. pylori which was accompanied with re-elevating IgG titers.. We conclude that seroconversion, which usually occurs after 1 yr, indicates complete eradication of H. pylori. Furthermore, we suggest that the success of the eradication of H. pylori can be judged without endoscopic examination, 8 months after treatment by triple therapy, according to the fall of IgG titers or seroconversion. Re-elevating IgG titers may be a warning of the possibility of relapse or reinfection of H. pylori.

Topics: Anti-Ulcer Agents; Antibodies, Bacterial; Drug Therapy, Combination; Duodenal Ulcer; Enzyme-Linked Immunosorbent Assay; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Immunoglobulin G; Metronidazole; Organometallic Compounds; Recurrence; Serologic Tests; Tetracycline

Metronidazole-susceptible pretreatment isolates and metronidazole-resistant posttreatment isolates of Helicobacter pylori from 11 patients before and after unsuccessful triple therapy consisting of metronidazole, amoxicillin, and colloidal bismuth subcitrate were studied. Ribotyping (rRNA gene restriction pattern analysis) of the isolates demonstrated that all patients except one had identical digest patterns for pre- and posttreatment isolates.

Topics: Amoxicillin; Anti-Ulcer Agents; DNA, Bacterial; DNA, Ribosomal; Drug Resistance, Microbial; Drug Therapy, Combination; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Peptic Ulcer

To understand the short-term and long-term effects of the eradication of Helicobacter pylori on serum pepsinogen I, gastrin, and insulin concentration, we studied 53 patients with endoscopically proven duodenal ulceration and H. pylori infection.. All patients received a 2-wk course of colloidal bismuth subcitrate, amoxycillin, and metronidazole, and endoscopy was performed at 1.5, 3, 6, and 12 months after entry. H. pylori status was assessed by a urease test and histology.. Among 43 patients in whom H. pylori was eradicated throughout the follow-up year, the mean basal pepsinogen I was 108 ng/ml at pretreatment, decreasing significantly to 85, 77, 80, and 75 ng/ml at 1.5, 3, 6, and 12 months, respectively, at posttreatment. The basal gastrin was 100 pg/ml at pretreatment and fell significantly to 72, 64, 65, and 59 pg/ml, respectively, posttreatment. Of the four patients in whom the H. pylori was not eradicated, there was no significant change in the median basal pepsinogen I and gastrin concentration. Among the six patients in whom the H. pylori was again detectable within the follow-up year, the fallen serum concentration of pepsinogen I and gastrin returned to the pretreatment level. There was no significant change of basal insulin concentration after triple therapy in either the successfully eradicated or failed group.. We conclude that H. pylori is the leading and direct cause of higher serum concentration of pepsinogen I and gastrin in duodenal ulcer patients.

Topics: Amoxicillin; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Duodenal Ulcer; Female; Follow-Up Studies; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Insulin; Male; Metronidazole; Middle Aged; Organometallic Compounds; Pepsinogens; Time Factors

Topics: Adolescent; Amoxicillin; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Hemoptysis; Humans; Organometallic Compounds

The connection between dyspeptic symptoms and Helicobacter pylori infection was studied prospectively in 21 children treated for verified H. pylori infection with bismuth subcitrate and tinidazole. Gastroscopy with biopsy was performed before and a mean of 4 months after discontinuation of the treatment. A second post-treatment check with determination of H. pylori antibodies and serum pepsinogen 1 level was made a mean of 1.5 years after cessation of treatment. The therapy given cleared the bacteria in 67% of the patients. No significant difference in symptoms was observed between treatment successes and failures. The histopathologic diagnosis of H. pylori infection was accompanied by positive IgG serology in 15 (75%) of the 20 patients tested, and a decrease in antibody levels was observed in children with successful eradication. Serum pepsinogen 1 seemed to be even a better marker in the follow-up. The healing of acute and also to some extent of chronic gastritis took place closely after successful eradication. Our results suggest that healing of H. pylori-induced gastritis should be confirmed at reendoscopy only, independent of the symptoms.

Topics: Adolescent; Biomarkers; Child; Child, Preschool; Drug Therapy, Combination; Dyspepsia; Female; Follow-Up Studies; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Immunoglobulin G; Male; Organometallic Compounds; Pepsinogens; Prospective Studies; Tinidazole

Fifteen elderly patients with type B gastritis caused by Helicobacter pylori infection were treated with triple therapy consisting of colloidal bismuth subcitrate, amoxycillin and metronidazole. All were followed up every 6 weeks for 3 months. After triple therapy, eradication of the infection was confirmed in 12 patients (85%) by histology and bacteriology. In this group, a significant reduction in IgG antibody levels against H. pylori was detected (p < 0.001). In a control group of 15 patients with type B gastritis who received no antibacterial treatment, the specific IgG antibody titre remained unchanged during 3 months of follow-up. We conclude that this simple and noninvasive serological test would be suitable for follow-up after treatment of H. pylori infection in elderly patients.

Topics: Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Antibodies, Bacterial; Drug Therapy, Combination; Female; Follow-Up Studies; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Immunoglobulin G; Male; Metronidazole; Organometallic Compounds

In this study we measured phospholipase A (PLA) and C (PLC) activity of media filtrates and French Press lysates of the gastritis-inducing bacteria Helicobacter pylori. We report here that both H. pylori lysates and filtrates contain PLA1, PLA2, and C enzymes, which readily hydrolyze a radiolabeled dipalmitoylphosphatidylcholine (DPPC) and phosphorylcholine substrates, respectively. The specific activity of both PLA and C enzymes were greatest in the 6.5-7.0 and 8.4-8.8 pH ranges, respectively. Colloidal bismuth subcitrate (CBS) induced a dose-dependent inhibition of PLA2 and C activity of both H. pylori lysates and filtrates. This inhibitory effect of CBS on PLA2 was antagonized in a dose-dependent fashion by the addition of CaCl2 to the incubation mixture, suggesting that calcium and bismuth may be competing for the same site on the enzyme. In contrast, the ability of bismuth salts to inhibit PLC activity of H. pylori lysates was not antagonized by CaCl2. Employing a biophysical assay system for surface wettability, it was determined that H. pylori lysates had the capacity to remove a synthetic phospholipid monolayer off a glass in a dose-dependent fashion. This ability of the bacterial lysates to catalyze the transformation of a hydrophobic surface to a wettable state was significantly attenuated in the presence of bismuth salts. Our experimental results are, therefore, consistent with the possibility that H. pylori colonization compromises the stomach's barrier to acid by eroding a phospholipid lining, possibly a monolayer, on the surface of the gastric mucus gel and that this process is blocked in response to bismuth therapy.

Topics: Anti-Bacterial Agents; Bismuth; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Hydrogen-Ion Concentration; Organometallic Compounds; Phospholipases A; Phospholipases A1; Phospholipases A2; Stomach Ulcer; Type C Phospholipases

Topics: Amoxicillin; Anemia, Hypochromic; Anti-Bacterial Agents; Antibodies, Bacterial; Child; Chronic Disease; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Immunoglobulin G; Male; Organometallic Compounds; Pyloric Antrum

Topics: Anti-Ulcer Agents; Drug Resistance; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds

Topics: Adult; Anti-Ulcer Agents; Drug Resistance; Duodenitis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Organometallic Compounds

A 14-year-old girl was transferred to our unit after 6 weeks of repeating episodes of what was thought to be 'hemoptysis'. Apart from discrete nausea, she did not have any other complaints. The episodes of 'hemoptysis' occurred once every 3 days, mostly in the late evening. The physical examination was strictly normal. A thorough investigation revealed a chronic active gastritis and Helicobacter pylori infection. No lung disease could be confirmed. Treatment consisted of a combination therapy with amoxycillin (50 mg/kg/day orally in 3 doses) and colloidal bismuth subcitrate (120 mg orally, 3 times daily) during a period of 1 week. Together with the clearance of Helicobacter pylori and healing of the chronic active gastritis, as demonstrated by histology, the symptoms disappeared. An eradication of the microorganism was obtained. Since that time, she has had no further similar complaints. This case reflects an atypical presentation of Helicobacter pylori infection.

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Hemoptysis; Humans; Organometallic Compounds

Bismuth salts belong do basic drugs used for elimination of Helicobacter pylori (HP), a microorganism which is postulated to participate in etiopathogenesis of duodenal ulcer. The study was aimed at evaluation of effectiveness of application of tripotassium bismuth citrate (Ventrisol-Polfa) in elimination of HP and its influence on treatment of the ulcer. In 30 patients with diagnosed endoscopically duodenal ulcer, Ventrisol in tablets was applied (2 x 2); it was also used in its fluid form (4 x 5 ml). The time of treatment amounted to 28 days. During endoscopy, samples from various parts of the stomach were taken for microbiological inspection and they were studied in direct smear and in culture. HP was isolated from 20 out of 30 patients (37%) before treatment. After application of Ventrisol, the bacteria were present in 11/30 (34%) treated patients (p < 0.05). There was no influence of the form of drug for elimination of HP. No dependence was also found between elimination of HP and healing of the ulcer.

Topics: Adult; Anti-Ulcer Agents; Duodenal Ulcer; Female; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds

Helicobacter pylori may be difficult to detect in individuals with intestinal metaplasia or atrophic gastritis, even though bacteria may persist in the mucosa in low numbers, maintaining elevated serum H. pylori antibody levels. We report a patient with marked, endoscopically visible gastric mucosal changes and focal changes of histological atrophic gastritis, who was negative for H. pylori on urease test, culture, and histology, but had positive H. pylori serology. When treated with triple therapy and reassessed at 6 months, his H. pylori antibody titer fell to low/negative levels, abnormal mucosa was replaced by a velvety, normal lining, and the previous evidence of histological atrophic gastritis was no longer detectable.

Topics: Anti-Bacterial Agents; Antibodies, Bacterial; Bismuth; Drug Therapy, Combination; Gastric Mucosa; Gastritis, Atrophic; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Tetracycline

The effect of ulcer healing with eradication of Helicobacter pylori (H pylori) on gastric function was investigated in nine patients with duodenal ulcer disease. One month after eradication there were significant reductions in both basal plasma gastrin concentration, from a median (range) of 19 (1-22) to 6 (2-15) pmol/l (p < 0.05), and of basal acid secretion from 8.3 (2.4-24) to 2.6 (1.4-8.1) mM H+/h, (p < 0.01). The peak acid secretion rate was unchanged from 37 (16-59) to 37 (21-59) mM H+/h. After treatment there was no change in the parietal cell sensitivity to stepped infusions of gastrin heptadecapeptide: the median concentration of gastrin required for 50% of maximal acid secretion (EC50) was 41 (14.8-126) before and 33 (23-125) pmol/l after eradication of H pylori. The metabolic clearance rate of gastrin was also unaffected by the eradication of H pylori. Thus eradication of H pylori infection from patients with active duodenal ulcers is accompanied by falls in both basal gastrin release and basal acid secretion without a change in the parietal cell sensitivity to gastrin. Cyclical changes in H pylori infection may cause the variations in basal acid secretion that are seen in duodenal ulcer disease.

Topics: Acute Disease; Adult; Aged; Bismuth; Drug Therapy, Combination; Duodenal Ulcer; Gastric Acid; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Parietal Cells, Gastric; Tetracycline

The present study evaluated the effect of a one-day high-dose combined therapy on Helicobacter pylori infection. Thirty-two consecutive patients (suffering from either peptic ulcer or nonulcer dyspepsia) with Helicobacter pylori infection received omeprazole (40 mg) + bismuth subcitrate (240 mg x 4) + amoxicillin suspension (2000 mg x 4) + metronidazole (500 mg x 4), for only one day. Endoscopy, histology, culture, and susceptibility studies were done at entry and 30 and 90 days after the treatment day. Successful eradication was obtained in 23/32 (72%) patients and gastritis had resolved in 95% of these. Side effects were induced by the treatment in 6/32 (19%) patients, but these were all self-limiting, short-lasting, and did not require any specific treatment. Development of bacterial resistance to metronidazole occurred in 6/9 (67%) non-eradicated patients. These data suggest that one-day treatment with high doses of amoxicillin, metronidazole, bismuth, and omeprazole represents an effective, safe, and inexpensive therapeutic approach for the treatment of H. pylori infection.

Topics: Adult; Amoxicillin; Anti-Ulcer Agents; Chronic Disease; Drug Administration Schedule; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Peptic Ulcer; Treatment Outcome

Ranitidine bismuth citrate is a novel compound formed from ranitidine and a bismuth citrate complex. In conscious dogs, ranitidine bismuth citrate had similar activity to ranitidine hydrochloride as an inhibitor of histamine-induced gastric acid secretion when oral doses containing equivalent amounts of ranitidine base (0.1 or 0.3 mg/kg) were compared. In the rat, ranitidine bismuth citrate (3-30 mg/kg p.o.) prevented gastric mucosal damage induced by ethanol (fundic damage) and indomethacin (antral damage). Ranitidine hydrochloride and tripotassium dicitrato bismuthate were also effective against indomethacin-induced damage, but were both significantly less potent than ranitidine bismuth citrate in this model. Ranitidine hydrochloride was inactive against ethanol-induced damage. In vitro, ranitidine bismuth citrate (1 mmol/L) inhibited human pepsin isoenzymes 1, 2, 3 and 5. Pepsin 1 was inhibited to a similar extent by ranitidine bismuth citrate, bismuth citrate and tripotassium dicitrato bismuthate at concentrations equivalent to 1 mmol/L bismuth, but ranitidine (1 mmol/L) was inactive. Ranitidine bismuth citrate was more potent than tripotassium dicitrato bismuthate as an inhibitor of pepsins 2, 3 and 5. Ranitidine bismuth citrate inhibited both Helicobacter pylori (effective concentration 4-32 micrograms bismuth/ml) and H. mustelae (1-4 micrograms bismuth/ml); similar results were obtained with tripotassium dicitrato bismuthate. Bismuth citrate was slightly less effective, and ranitidine hydrochloride was inactive (> 125 micrograms/ml). In ferrets naturally colonized with H. mustelae, oral treatment with ranitidine bismuth citrate, 12 or 24 mg/kg twice daily for 4 weeks, caused a dose related clearance of H. mustelae. Qualitatively similar results were obtained in a small study with tripotassium dicitrato bismuthate and bismuth citrate.

Topics: Animals; Anti-Ulcer Agents; Bismuth; Citrates; Dogs; Ethanol; Female; Ferrets; Gastric Acid; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Indomethacin; Isoenzymes; Male; Microbial Sensitivity Tests; Organometallic Compounds; Pepsin A; Ranitidine; Rats; Stomach Ulcer

We have analyzed the effect of treatment with colloidal bismuth subcitrate (CBS) and amoxicillin in a series of 60 children (age range: 2.9-18 years) infected by Helicobacter pylori (HP). The following results were found: clinical remission 70%; endoscopic normalization 55%; histological normalization 61.6% and HP eradication 53.3%. The improvement of histological activity (100% vs 11.7%) and histological normalization (90.6% vs 28.5%) were significantly more frequent in the HP eradicated group as compared with the persistent HP group (p < 0.001). The present study suggests that combined therapy with CBS and amoxicillin is not the most adequate treatment to eradicate HP in children and supports the role played by HP in the development of antral histologic lesions.

Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Child; Child, Preschool; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Organometallic Compounds

The presence of Helicobacter was tested on a group with antral or duodenal ulcer with or without gastritis, versus a group without gastric or duodenal pathology. Furthermore an open trial was performed between omeprazole and colloidal bismuth subcitrate (CBS) on patients similarly affected by peptic disease. Although CBS did eliminate Helicobacter in more than a half of patients, what was not obtained by omeprazole, this result did not mean a better control of peptic disease: in fact the omeprazole was remarkably more active in our series on clinical and endoscopic ground, whether the Helicobacter was present or not, and further studies are required to assess the real significance of Helicobacter pylori in the above conditions.

Topics: Adult; Aged; Anti-Ulcer Agents; Colloids; Drug Evaluation; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Organometallic Compounds; Stomach Ulcer

At present there is no generally accepted treatment regimen for eradicating metronidazole-resistant Helicobacter pylori. This study determines the eradication rate after treatment with 40 mg omeprazole o.m. and 500 mg amoxycillin q.d.s. for 14 days, with 120 mg tripotassium dicitrato bismuthate q.d.s. for the first week (Days 1-7) and 750 mg ciprofloxacin b.d. for the second week (Days 8-14). Thirty patients (16 male, mean age 45 years, range 16-80 years) with duodenal ulcers (n = 18) or non-ulcer dyspepsia (n = 2) and metronidazole-resistant H. pylori detected by histology, culture, in vitro sensitivity tests and a positive 13C-urea breath test entered the study. Follow-up was by 13C-urea breath test at the end of treatment and at 1, 3, 6, and 12 months. Eradication was defined as a negative 13C-urea breath test at least 1 month after finishing treatment. H. pylori was successfully eradicated in 21/30 (71%) patients (median follow-up 10.2 months, range 4-12 months). A pre-treatment ciprofloxacin-resistant strain was isolated in 1/9 patients in whom eradication failed. Of 30 patients 29 completed the 2-week regimen; one patient experienced dizziness after 3 days of treatment. The most common side-effect was increased stool frequency (n = 6). This 2-week treatment regimen for metronidazole-resistant H. pylori is well tolerated and achieves an eradication rate of 70%.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Ulcer Agents; Breath Tests; Ciprofloxacin; Drug Resistance, Microbial; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Female; Gastrointestinal Diseases; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds

Topics: Amoxicillin; Drug Administration Schedule; Drug Resistance, Microbial; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds

Necropsy gastric mucus infected with Helicobacter pylori has a reduced capacity to concentrate colloidal bismuth subcitrate when compared with non-infected mucus. Mucus mounted in a modified in vitro diffusion chamber was bathed with colloidal bismuth subcitrate solutions at different concentrations and pH levels. Bismuth was measured by atomic absorption spectrophotometry to assess intramucus colloidal bismuth subcitrate concentrations. Bismuth concentrations in non-infected mucus were higher than in Helicobacter pylori infected mucus at all experimental colloidal bismuth subcitrate concentrations and pH levels. Regardless of the infection status, the intramucus concentration of colloidal bismuth subcitrate was dependent upon the concentration of the bathing solution and independent of the pH and the mucus thickness. Colloidal bismuth subcitrate solubility in saline solution varied with pH, and was least soluble in the pH range 1.1 to 3.25 and more soluble above and below this pH range. This study suggests that Helicobacter pylori infection is associated with physicochemical changes in the gastric mucus with a reduction in its capacity to concentrate colloidal bismuth subcitrate. Such a reduction may compromise the attainment of optimum colloidal bismuth subcitrate concentrations necessary for its bactericidal activity.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Bismuth; Gastric Mucins; Helicobacter Infections; Helicobacter pylori; Humans; Hydrogen-Ion Concentration; Middle Aged; Organometallic Compounds; Solubility

Cigarette smoking is believed to be one of the major factors influencing duodenal ulcer (DU) recurrence. However, the influence of cigarette smoking on DU recurrence after the eradication of Helicobacter pylori has not been separately addressed. The aim of this study was to investigate DU relapse rate in smokers and nonsmokers, both with confirmed eradication of H. pylori. Patients with H. pylori eradication, demonstrated at endoscopy 4 wk post-treatment, were included in the study. Smoking history was obtained with a standard questionnaire, and patients were followed endoscopically, both yearly and at symptomatic recurrence, to detect anatomical DU recurrence. Of the 197 (121M:76F) patients enrolled in the study and followed for 1-6 yr, 80 (41%) were smokers, smoking 5-40 cigarettes/day. The 117 (59%) nonsmokers included 31 (26%) patients who had ceased smoking 4-20 yr ago. Another seven (9%) smokers ceased smoking during the follow-up period. In the 197 patients with eradicated H. pylori and cured DU, there has been no recurrence of ulcer, regardless of smoking status. We conclude that in patients with DU in whom H. pylori infection is eradicated, ulcer disease does not recur, as observed for up to 6 yr. Furthermore, cigarette smoking is not a risk factor for DU recurrence, provided H. pylori is eradicated.

Topics: Anti-Ulcer Agents; Duodenal Ulcer; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Recurrence; Risk Factors; Smoking; Tetracycline; Time Factors

The significance of Helicobacter pylori (HP) infection was assessed prospectively in forty-two patients with dyspepsia using histological, bacteriological and biopsy urease techniques. Thirty-eight patients (90.5%) were positive for HP infection and were treated with bismuth subcitrate (De Nol), tinidazole and doxycycline. HP was present in the antrum, corpus, fundus, duodenum and gastric juice in 36, 26, 23, 2 and 2 patients respectively (p < 0.01, X2 test). Histological assessment yielded more positive identifications of HP than the urease test (36 vs 28 positive cases, p < 0.01, McNemar's X2 test), while histology and bacteriology were virtually identical (38 vs 37 of 41 pairs, p > 0.5, X2 test). There was a good correlation between bacterial and polymorphonuclear leucocyte (PMNL) counts per high power field (r = 0.8; p < 0.001; n = 34 pairs). There was resistance to metronidazole in 10 out of 16 isolates, but no resistance was recorded against tetracycline (p < 0.001, X2 test). Among the sixteen patients who attended follow-up endoscopy, there was clinical improvement and no evidence of HP in 5 individuals (31.25%). One patient had amelioration of his symptoms, 5 experienced no change and in 5 their symptoms became worse. Metronidazole resistance may be one of the important factors in the United Arab Emirates and elsewhere.

Topics: Adolescent; Adult; Antacids; Bacteriological Techniques; Bismuth; Doxycycline; Drug Resistance, Microbial; Dyspepsia; Female; Follow-Up Studies; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Patient Compliance; Prevalence; Prospective Studies; Stomach; Tinidazole; United Arab Emirates

Topics: Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Recurrence; Sucralfate

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Chronic Disease; Drug Therapy, Combination; Duodenitis; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Peptic Ulcer; Recurrence

A study of 90 patients with endoscopically proved duodenal ulcer revealed that dalargin and trichopol+dalargin treatment resulted in early scarring of the ulcer and control of gastroesophageal and duodenogastric reflux in the majority of patients. Gastroduodenitis symptoms were not eliminated in a half of all patients. It was shown that persistent manifestations of gastroduodenitis remained in patients with a pronounced pyloric helicobacteriosis and a high titer of antibodies to cells of the gastric mucosa.

Topics: Adolescent; Adult; Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Evaluation; Drug Therapy, Combination; Duodenal Ulcer; Enkephalin, Leucine-2-Alanine; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds

This study was undertaken to evaluate the success of triple therapy in peptic ulcer patients and ulcer relapses. One hundred and one consecutive Helicobacter pylori-positive peptic ulcer patients were assigned to an open trial with 2 weeks of treatment with colloidal bismuth subcitrate, amoxicillin, and metronidazole. At the 6-week follow-up only 1 duodenal ulcer was unhealed of 57 active ulcers, and H. pylori was found to be eradicated in 84% of the 100 subjects. The sensitivity to metronidazole was determined from 71 pretreatment strains of H. pylori. Eradication of H. pylori succeeded in 89% of the patients with metronidazole-susceptible strains and in 61% of patients with metronidazole-resistant strains (p < 0.03). All 16 patients in whom the treatment failed to eradicate the organism had metronidazole-resistant strains after treatment. The ulcer relapse rate was low. At the 12-month follow-up of 93 patients only 1 of the 84 H. pylori-negative patients (including 4 patients after new successful therapy) had relapsing ulcers (2 asymptomatic episodes), and 1 had H. pylori reinfection, whereas 3 of the 9 bacteria-positive patients relapsed (p = 0.002); at the 2-year control 2 more patients had ulcer relapses. The eradication of H. pylori infection clearly prevents relapses of peptide ulcer, but the success of triple therapy depends on the frequency of pretreatment metronidazole-resistant H. pylori strains.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptic Ulcer

Patients with duodenal ulcers and Helicobacter pylori infection have elevated plasma gastrin concentrations which fall after suppression of the organism. This may be due to H. pylori elevating the pH of the antral mucous layer, therefore preventing luminal acid from inhibiting gastrin release. To test this idea, we measured the plasma gastrin concentrations under basal conditions and in response to 4% peptone when the gastric lumen was maintained at pH 2.5 and at pH 5.5 by gastric perfusion. We studied 11 duodenal ulcer patients before and after suppression of H. pylori. Gastrin concentrations were significantly higher before suppression of H. pylori than after treatment in all three states; basal gastrin (pmol/l) fell from 9.2 (3.7-23, median and range) to 5.1 (1.7-15) after treatment; from 11.3 (3.8-29) to 5.9 (5.7-6.1) at pH 2.5 and from 15.2 (3.9-32) to 7.15 (6.1-14) at pH 5.5. The ratio of peptone-stimulated gastrin at pH 2.5/pH 5.5 was similar before (0.8; 0.5-1.7) and after (0.8; 0.5-1.1) suppression of H. pylori. These results indicate that infection with H. pylori increases basal and peptone-stimulated plasma gastrin concentrations, and that this response is independent of luminal pH.

Topics: Amoxicillin; Anti-Ulcer Agents; Duodenal Ulcer; Female; Gastric Acid; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Hydrogen-Ion Concentration; Male; Metronidazole; Middle Aged; Organometallic Compounds

The exact pathophysiological mechanism of halitosis is not clear, and in many patients the etiology is an enigma. We followed three couples in which one member or both had halitosis. All the subjects had evidence of Helicobacter pylori infection. All received a treatment course of colloidal bismuth subcitrate four times a day and 250 mg metronidazole three times a day. There was impressive improvement in their symptoms, the halitosis disappearing along with eradication of the organism. We call the attention of physicians to the possible connection between halitosis, H. pylori infection, and familial occurrence. Further studies to confirm this surprising association are in order.

Topics: Antacids; Family Health; Female; Halitosis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds

It has been postulated that Helicobacter pylori-related hypergastrinaemia is due to bacterial ammonia raising antral surface pH and thus preventing acid inhibition of gastrin release. If true, the infection should not alter gastrin release at neutral intragastric pH. To test this, we have studied basal and meal-stimulated gastrin at uncontrolled pH and at pH greater than 6 in duodenal ulcer patients before and after eradication of H. pylori. The median integrated gastrin response to the meal alone was 2525 ng/l.min (range, 550-8725) before and 725 ng/l.min (range, 250-2925) after eradication of H. pylori (p less than 0.01). The corresponding values when intragastric pH was maintained above 6 were 3700 ng/l.min (range, 1900-14,100) and 1400 ng/l.min (range, 400-3400) (p less than 0.01). The median reduction in gastrin after eradication of H. pylori was thus similar when the meal was taken at uncontrolled pH (61%; range, 0-97%) and at pH greater than 6 (69%; range, 36-89%). Likewise, 5 h of gastric alkalinisation did not cause the basal gastrin values when H. pylori was eradicated to increase to those observed when H. pylori was present. These findings indicate that the hypergastrinaemia is not due to elevated antral surface pH.

Topics: Adult; Amoxicillin; Antacids; Duodenal Ulcer; Female; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Hydrogen-Ion Concentration; Male; Metronidazole; Middle Aged; Organometallic Compounds; Pyloric Antrum

Gastritis associated with Helicobacter pylori was present in gastric biopsies from 24/95 (25%) children and adolescents undergoing endoscopy for recurrent abdominal pain and upper gastrointestinal symptoms. H pylori associated gastritis occurred mainly in older children (8-16 years) and was significantly associated with low socioeconomic class and a family history of peptic ulcer disease. Antral nodularity was a common endoscopic finding in H pylori positive children. Eighteen children, all over 5 years of age, were treated with tripotassium dicitratobismuthate (De-Nol) for two months and ampicillin for two weeks. In 12 children follow up gastric biopsies were obtained six weeks after completion of treatment. In 9/12 (75%) children H pylori was eradicated, and gastritis improved.

Topics: Age Factors; Ampicillin; Antacids; Biopsy; Bismuth; Child; Drug Therapy, Combination; Gastric Mucosa; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Prevalence; Prospective Studies; Sex Factors; Socioeconomic Factors

Thirty consecutive patients with endoscopically proven duodenal ulceration who had Helicobacter pylori infection on culture and histology, were treated with tripotassium dicitrato bismuthate (1 tablet q.d.s., 400 mg metronidazole t.d.s. and 500 mg tetracycline t.d.s. for one week, followed by the bismuth salt for a further 3 weeks. All patients were endoscoped at entry and 4 weeks after cessation of treatment, to check for ulcer healing and H. pylori eradication. Two antral biopsies were taken at each endoscopy for histological and microbiological evidence of H. pylori infection. Complete healing of duodenal ulcers was observed in 27/30 patients (90%). Gastritis improved or completely resolved in 26 patients. Eradication of H. pylori was achieved in 27 patients. Of the three patients who failed to heal, two were H. pylori-positive at follow-up and one was H. pylori-negative.

Topics: Adult; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Duodenal Ulcer; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Tetracycline

Susceptibility to metronidazole was determined by disk diffusion tests for 559 strains of Helicobacter pylori isolated from patients. The overall metronidazole resistance was 26%. In males metronidazole-resistant strains made 18% of all H. pylori strains, and in females the corresponding figure was 40% (P less than 0.001). MICs of metronidazole were determined for H. pylori strains from 86 patients undertaking triple therapy, i.e., treatment with colloidal bismuth subcitrate, amoxicillin, and metronidazole. Of the nonresponders who remained culture positive despite the therapy, 69% had strains with metronidazole MICs of greater than or equal to 32 micrograms/ml before the therapy, and all nonresponders had metronidazole-resistant strains after the therapy. Metronidazole resistance was, however, also found in 27% of responders before therapy. To find whether the MICs of metronidazole for H. pylori strains remained constant for longer periods, consecutive isolates sampled several years apart from the same patients were tested in parallel and no changes in the MICs were found. H. pylori was successfully eradicated by the triple therapy from 91% of patients with metronidazole-susceptible pretreatment strains and from 63% of patients with metronidazole-resistant strains before the therapy (P less than 0.01). Although resistance to metronidazole has a significant role in treatment failures in H. pylori infections, high eradication rates can be achieved with the use of the present triple therapy even in populations with a high overall metronidazole resistance rate.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Anti-Ulcer Agents; Drug Resistance, Microbial; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Organometallic Compounds; Sex Factors

We have performed a retrospective study of 103 patients with either peptic ulcer or non-ulcer dyspepsia, infected with metronidazole-sensitive strains of Helicobacter pylori (H. pylori), who were treated with a combination of tripotassium dicitrato bismuthate and metronidazole for a period of at least two weeks. Dual therapy with tripotassium dicitrato bismuthate plus metronidazole showed similarly high eradication rates (greater than or equal to 80%) of H. pylori from patients irrespective of age, gender or clinical diagnosis. Most importantly, dual therapy achieved a similar eradication rate of H. pylori infection in 41 patients who had previously been treated with tripotassium dicitrato bismuthate alone or in combination with an antibiotic other than metronidazole. It therefore appears that H. pylori does not become resistant to treatment with tripotassium dicitrato bismuthate.

Topics: Adult; Aged; Drug Administration Schedule; Drug Resistance, Microbial; Duodenal Ulcer; Dyspepsia; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Retrospective Studies; Stomach Ulcer

Topics: Colloids; Drug Therapy, Combination; Dyspepsia; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds

Helicobacter pylori increases gastrin release in duodenal ulcer patients. This may be through disruption or changes in the mucus layer affecting the access of luminal stimulants to gastrin releasing cells. The effect of suppressing H pylori on gastrin release stimulated by a non-luminal stimulus, gastrin releasing peptide (GRP), was examined. Eleven patients with active duodenal ulcer disease and colonised with H pylori received an intravenous infusion of GRP (2.9 pmol/kg/minute for 30 minutes) and the plasma gastrin response was measured. Basal and peak pentagastrin stimulated acid output were also determined. Patients were treated with tripotassium dicitratobismuthate (De-Nol) and metronidazole to suppress H pylori and the tests were repeated. Suppression of H pylori decreased plasma gastrin concentrations during GRP infusion, but acid output was not affected. Chromatographic analysis of the forms of gastrin in plasma showed a significant fall in gastrin 17, the predominant form found in the gastric antrum. Gastrin 34 did not fall significantly. This study shows that suppression of H pylori decreases the hypergastrinaemia caused by the nonluminal stimulant, GRP, mainly via decreasing gastrin 17.

Topics: Adult; Duodenal Ulcer; Female; Gastrin-Releasing Peptide; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Peptides; Secretory Rate

Topics: Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Renal Dialysis

The importance of pro-inflammatory leukotriene C4 in Helicobacter pylori (H. pylori) associated gastritis in man is unknown. Fresh gastric biopsy specimens from 28 dyspeptic patients were obtained: 10 showed normal antral histology with no evidence of H. pylori, the remaining 18 patients exhibited histological gastritis and were H. pylori positive as assessed by histology, culture and urease test. Twelve of these 18 patients received 240 mg twice daily colloidal bismuth subcitrate for four weeks before re-endoscopy. Gastric biopsies from H. pylori positive patients were incubated under basal and Ca(2+)-ionophore mediated conditions: Radioimmunoassay analysis of the supernatant showed basal release of prostaglandin E2 and leukotriene C4 was slightly but not significantly elevated in H. pylori positive mucosa. However in H. pylori positive mucosa there was an 85% increase in leukotriene C4 synthesis when biopsies were incubated with ionophore, compared to only 13% increase in H. pylori negative mucosa (p less than 0.02). After eradication of H. pylori by colloidal bismuth subcitrate, there was a clearance of inflammatory cell infiltrate as assessed by histology and a significant reduction in ionophore-mediated leukotriene C4 formation compared with before treatment (p less than 0.02). These results suggest that H. pylori gastritis is associated with increased capacity to generate leukotriene C4, which may amplify the damaging effects of the bacteria on gastric mucosa.

Topics: Adult; Aged; Calcimycin; Dinoprostone; Female; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; SRS-A

In our patient population with chronic aspecific abdominal complaints Helicobacter pylori gastritis is no rarity. This entity has been diagnosed in 10 children out of 48 (mean age: 8 years 11 months) who underwent an endoscopy of the upper gastrointestinal tract. After treatment with amoxicillin and colloidal bismuth subcitrate during a period of 2 weeks the complaints disappeared and an eradication was obtained in 7. Histology of the antral mucosa demonstrated a type B chronic active gastritis in all patients. A Helicobacter pylori specific serology was positive in all 10 patients. This test was also positive in 17 out of 35 asymptomatic first degree family members; this is an illustration for the high family prevalence of Helicobacter pylori.

Topics: Adolescent; Amoxicillin; Antacids; Biopsy; Bismuth; Breath Tests; Child; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Organometallic Compounds

Topics: Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Recurrence

The aim of the study was to observe the relationship between the two reservoirs of Helicobacter pylori--that is, dental plaque and the stomach. With the Campylobacter-like organism (CLO) test, H. pylori was detected in dental plaque and in gastric antral and body mucosa in 98%, 67% and 70%, respectively, of 43 consecutive patients with dyspepsia. The rapidity of the CLO test indicates that the density of H. pylori is heaviest in dental plaque, less in the antrum, and least in the body mucosa of the stomach. Triple drug therapy (bismuth, tinidazole, and amoxycillin or doxycycline) was administered for 15 days to 24 patients. By the CLO test, H. pylori was eliminated from the gastric mucosa in all 24 patients but persisted in dental plaque in all of them. Our observations indicate that dental plaque is unaffected by triple drug therapy and is perhaps a permanent reservoir of H. pylori if local therapy also fails to eradicate the organism.

Topics: Adolescent; Adult; Aged; Amoxicillin; Antacids; Dental Plaque; Doxycycline; Drug Therapy, Combination; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Stomach; Tinidazole

A 30-year-old man with AIDS presented with symptoms of fever, epigastric pain and weight loss, together with histological findings of Helicobacter pylori-induced gastritis. His symptoms resolved with treatment, as indicated by the clearing of his H. pylori infection on repeat gastric biopsy. Although uncommon, H. pylori infection can cause severe illness in patients with AIDS.

Topics: Acquired Immunodeficiency Syndrome; Adult; Ampicillin; Animals; Biopsy; Drug Therapy, Combination; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds; Pyloric Antrum

Fifty Helicobacter pylori- (H. pylori) positive patients entered an open study and were assigned to one of four treatment regimens comprising: pivampicillin (500 mg b.d.) for 2 weeks +/- tripotassium dicitrato bismuthate (tablet or liquid form) for one month. The 14C-urea breath test was used to evaluate clearance (negative at the end of treatment) and eradication (negative at 1 month post-treatment) of H. pylori. Clearance rates were 20% (2/10) after pivampicillin alone, 86% (12/14) after tripotassium dicitrato bismuthate tablets (240 mg b.d.) plus pivampicillin, 67% (6/9) after tripotassium dicitrato bismuthate tablets (120 mg q.d.s.) plus pivampicillin, and 100% (13/13) after tripotassium dicitrato bismuthate liquid (120 mg in 5 ml q.d.s) plus pivampicillin. The eradication rates were 0% (0/10), 13% (2/15), 0% (0/11) and 54% (7/13), respectively. Combination of the results from the 2 tripotassium dicitrato bismuthate tablet/pivampicillin groups gave an eradication rate of 7.7% (2/26) which was significantly lower than the 53.9% (7/13) obtained with tripotassium dicitrato bismuthate liquid/pivampicillin (P less than 0.02). In conclusion, a liquid tripotassium dicitrato bismuthate pivampicillin combination may be of special use in the treatment of H. pylori-positive patients when triple therapy is contraindicated (e.g. patient sensitivity/allergy to metronidazole) or when the H. pylori isolate is resistant to metronidazole.

Topics: Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Organometallic Compounds; Pivampicillin

Nine patients with Helicobacter pylori-related antral gastritis and history of duodenal ulceration were studied before and at 1 and 7 months after eradication of the infection by a 4-week course of tripotassium dicitrato bismuthate, metronidazole, and amoxycillin. The median basal gastrin concentration before eradication was 30 ng/l (range, 20-60) and fell to 20 ng/l (5-20) at 1 month (p less than 0.02) and 15 ng/l (5-20) at 7 months (p less than 0.01) after eradication. The integrated gastrin response to a peptide meal was 3650 ng/l.min (range, 1875-6025) before treatment compared with 1800 ng/l.min (range, 1200-3075) at 1 month (p less than 0.01) and 1312 ng/l.min (875-2625) at 7 months (p less than 0.03). Daytime intragastric pH (0900-2100 h) was similar before treatment (median, 1.4; range, 1.1-2.1) and at 1 month (1.4; 1.1-2.3) and 7 months (1.4; 1-2.2) after eradication. In five of the patients nighttime acid output (2300-0900 h) was also studied and was similar before (median, 86 mmol/10 h; range, 52-114) and at 1 month (76 mmol/10 h; 50-143) and 7 months (94 mmol/10 h; 63-106) after eradication. In conclusion, eradication of H. pylori is accompanied by a sustained fall in serum gastrin concentrations but is not accompanied by an early or late reduction of daytime intragastric acidity or nighttime acid output.

Topics: Adult; Aged; Amoxicillin; Anti-Ulcer Agents; Bismuth; Circadian Rhythm; Duodenal Ulcer; Female; Gastric Acid; Gastrins; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Hydrogen-Ion Concentration; Male; Metronidazole; Middle Aged; Organometallic Compounds; Stomach; Time Factors

In a prospective study, eight young healthy subjects (five with an active H. pylori infection in the antral mucosa) were treated with a course of tripotassium dicitrato bismuthate, amoxycillin and metronidazole. The triple therapy eradicated infection when assessed 20-24 weeks later by antral biopsy (urease, histology, and 13C urea breath test [4 out of 5 subjects]). Twenty-four hour intragastric acidity and plasma gastrin concentration were measured before treatment, and 4-6 weeks and 20-24 weeks post-treatment. Treatment did not affect acidity in either the H. pylori-positive or H. pylori-negative groups, nor did it affect the plasma gastrin profile in the H. pylori-negative group. Eradication of H. pylori infection in five subjects caused a drop of the median integrated 24-hour plasma gastrin concentration from 558 pmol.h/L before treatment to 307 and 289 pmol.h/L at 4-6 and 20-24 weeks post-treatment, respectively. It is concluded that H. pylori infection is associated with 24-hour hypergastrinaemia, and that in apparently healthy subjects normal gastric physiology can be restored by eradication of the infection.

Topics: Adult; Amoxicillin; Circadian Rhythm; Duodenal Ulcer; Female; Gastric Acidity Determination; Gastrins; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Organometallic Compounds

A 15-year-old girl was admitted after 1 week of increasing fatigue and pallor. She had no gastro-intestinal complaints. The patient had suffered from four episodes of syncope during the last 3 days prior to admission. Besides pallor and a discrete cardiac murmur, the physical examination was normal. A further thorough investigation revealed an iron deficiency anaemia related to a Helicobacter pylori positive chronic active haemorrhagic gastritis. Treatment consisted of amoxycillin and colloidal bismuth subcitrate (500 mg and 120 mg orally respectively, 3 times daily) during a period of 6 weeks. Iron supplements were not administered. Together with the clearance of H. pylori and healing of the haemorrhagic gastritis, as demonstrated by histology, haemoglobin values returned to normal and the symptoms disappeared. An eradication of the micro-organism was obtained. She has since had no further similar complaints.

Topics: Adolescent; Amoxicillin; Anemia, Hypochromic; Anti-Ulcer Agents; Biopsy; Chronic Disease; Female; Gastric Mucosa; Gastritis; Gastrointestinal Hemorrhage; Helicobacter Infections; Helicobacter pylori; Humans; Organometallic Compounds; Syncope

The duration of colloid bismuth subcitrate (de-nol) and bismuth subnitrate (BSN) fixation on the mucosa was studied in animal experiments and in patients suffering from peptic ulcer using scanning electron microscopy and roentgenospectral analysis. In patients suffering from peptic ulcer with pyloric chelicobacter (PC), a study was made of the relationship between the duration of bismuth drugs fixation on the mucosa and the degree of PC elimination as well as of the therapeutic efficacy in such patients of the use of de-nol and BSN. The characteristic features of the structure of de-nol granules were defined, enabling those granules to be fixed on the mucosa for more than 12 hours. In contrast to BSN, de-nol was found to possess a higher assanation capacity as regards PC. After 3 weeks of the treatment the therapeutic efficacy of de-nol was 75%, that of BSN 54%. Scanning electron microscopy is an effective method of demonstrating bismuth salts on the mucosa in negligible concentrations.

Topics: Adult; Animals; Anti-Ulcer Agents; Bismuth; Helicobacter Infections; Helicobacter pylori; Humans; Microscopy, Electron, Scanning; Middle Aged; Organometallic Compounds; Peptic Ulcer; Pyloric Antrum; Rats

Topics: Amoxicillin; Drug Interactions; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole; Organometallic Compounds; Tetracycline

Seventy-two patients with H. pylori infection in their antral mucosa took part in the study. Forty-three received metronidazole 400 mg t.d.s. for two weeks, plus De-Nol tabs 2 b.d. for four weeks, and the remaining 29 patients received metronidazole 400 mg t.d.s. for two weeks plus De-Nol liquid 5 ml q.d.s. for four weeks. Seven of 57 H. pylori isolates were found to have pre-treatment metronidazole resistance. Success, in terms of eradication of H. pylori, was assessed using a one-month post-treatment 14C urea breath test. Successful eradication of H. pylori was achieved in 72% and 79%, respectively, of the metronidazole/De-Nol tablet and metronidazole/De-Nol liquid groups. These figures increased to 87% and 84%, respectively, if the patients whose organisms were known to be metronidazole-sensitive were considered in isolation. H. pylori was successfully eradicated in only one of seven patients with a metronidazole-resistant organism.

Topics: Aged; Anti-Ulcer Agents; Breath Tests; Drug Resistance, Microbial; Drug Therapy, Combination; Helicobacter Infections; Humans; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Organometallic Compounds; Urea

The authors investigated the effect of one month bismuth treatment (Bismuthi citrici 120 mg per capsule), 4 x 120 mg/day, on morphological changes of the gastric mucosa along with the effect on Campylobacter pylori (CP) in a group of 23 probands with histologically verified active superficial CP positive antrum gastritis. The probands suffered only from functional dyspepsia, to eliminate the action of other disease of the digestive tract on chronic gastritis. Complete eradication of CP occurred in 65.2% and disappearance of granulocytic infiltration as a manifestation of activity in 73.9%. The disappearance of activity correlated with the eradication of CP in 88.2. The authors evaluated also the degree of circular nuclear cellulization (grade 1-3). After one-month treatment it was reduced by 1 grade in 56.5% in the antrum, while in the corpus it remained unaltered in the majority. Complete histological normalization of the mucosa was not recorded.

Topics: Adult; Antacids; Chronic Disease; Gastric Mucosa; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Middle Aged; Organometallic Compounds

Twenty-three children with Helicobacter (Campylobacter) pylori-associated chronic gastritis are reported. Family history of peptic disease, previous digestive procedures, and nonspecific epigastric pain were the most frequently encountered clinical features. Antral nodularity at endoscopy and histologic evidence of follicular gastritis were characteristic morphological aspects. Rapid urease tests suggested the diagnosis in 90% of patients. Significant increases of serum IgG and IgA against Helicobacter pylori allowed the identification of infected children with 95% cumulative sensitivity. Treatment with amoxicillin and bismuth subcitrate eradicated the infection and improved gastritis in 13 of 19 children. These findings provide further evidence for the etiologic role of Helicobacter pylori in chronic antral gastritis in children.

Topics: Adolescent; Amoxicillin; Antacids; Child; Child, Preschool; Drug Therapy, Combination; Enzyme-Linked Immunosorbent Assay; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Immunoglobulins; Male; Organometallic Compounds; Stomach