tetracycline and bismuth-tripotassium-dicitrate

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

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

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: 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The objective of this study was to determine the impact of omeprazole on bismuth (Bi) bioavailability when given in a three-in-one capsule containing bismuth biskalcitrate, metronidazole, and tetracycline. Thirty-four healthy volunteers were randomly assigned to receive three capsules (each containing bismuth biskalcitrate 140 mg + metronidazole 125 mg + tetracycline 125 mg) qid alone x 6 days or the same treatment + omeprazole (OM) 20 mg bid. Blood was drawn at intervals for 24 hours after the last dose. After the last dose, mean (CV) C(min) for plasma bismuth was 2882 pg/mL (36%) and 1195 pg/mL (23%) (p< 0.001), with and without OM, respectively. Mean (CV) C(max) was 25493 pg/mL (69%) and 8061 pg/mL (28%) (p < 0.001) with and without OM, respectively. AUC(0-24) increased by 2.9 in presence of OM (p < 0.001). Adverse events in both groups were usually mild and of a gastrointestinal nature, and all had resolved by the end of the trial. This study confirms an interaction between Bi biskalcitrate and OM. Risk of Bi toxicity, seen after long-term use of Bi compounds, is minimal here because plasma levels of Bi remained well below the toxic levels of 50 microg/L, and the treatment period with this triple capsule + OM is only 10 days, a substantially lower number of days compared to that which might produce Bi toxicity.

Topics: Adult; Anti-Infective Agents; Anti-Ulcer Agents; Area Under Curve; Biological Availability; Drug Interactions; Drug Synergism; Half-Life; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Tetracycline

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

To investigate differences between omeprazole and Helicobacter pylori eradication in patients with duodenal ulcers refractory to H2-receptor antagonists and to compare the recurrence rates after the two treatments.. Forty-five patients with endoscopically proven duodenal ulcers refractory to H2-receptor antagonists and H. pylori infection were randomly assigned to 8 weeks of treatment with omeprazole 40 mg/day or 4 weeks of treatment with colloidal bismuth subcitrate 480 mg/day plus metronidazole 750 mg/day and tetracycline 1000 mg/day from day 1 to day 14. Patients were evaluated endoscopically and clinically at the end of treatment. Patients with healed ulcers were followed up for 1 year after cessation of the treatment. Endoscopy was performed at 3 and 12 months.. Ulcer healing occurred in 100% (21/21) of patients on triple therapy and 70.5% (12/17) of those treated with omeprazole alone (P = 0.0123). The relapse rate at the 3rd month was 11.7% (2/17) in the triple therapy group and 60% (6/10) in the omeprazole group (P = 0.0248). Of the patients followed to study endpoint (relapse or endoscopy at 12 months) three of 12 (25%) receiving triple therapy, compared to six of eight (75%) receiving omeprazole, relapsed (P = 0.0648).. These results show that triple therapy is more effective than omeprazole in the treatment of refractory duodenal ulcers and reduces the rate of ulcer relapse.

Topics: Adult; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Antitrichomonal Agents; Duodenal Ulcer; Female; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Recurrence; Tetracycline

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

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

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

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

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

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

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

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

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

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

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

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

The role of Campylobacter pylori gastritis in dyspepsia could be clarified more readily if reliable eradication therapy were available. Antibiotic monotherapy and combined therapy with an antibiotic agent plus a bismuth compound have yielded poor long-term results. In this study, bismuth-tetracycline-metronidazole triple therapy has been used to eradicate C. pylori infection in 100 consecutive patients who were suffering from either a duodenal ulcer or non-ulcer dyspepsia. Examination of a follow-up endoscopic biopsy at eight weeks after treatment showed an eradication rate of C. pylori of 94%. Of 64 patients whose biopsy samples were free of C. pylori infection at eight weeks and who were available for reassessment, 60 (94%) patients had samples that remained free of C. pylori infection on examination of a repeat endoscopic biopsy at 12-37 months (mean, 19.3 months). It is concluded that "triple chemotherapy" can achieve long-term eradication of C. pylori infection effectively in the majority of treated patients and that the recurrence of duodenal ulcers thus may be diminished.

Topics: Administration, Oral; Adult; Aged; Campylobacter Infections; Clinical Trials as Topic; Drug Administration Schedule; Drug Evaluation; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Female; Follow-Up Studies; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Prospective Studies; Recurrence; Tetracycline; Time Factors

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

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

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

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

THE AIM OF INVESTIGATION: To study the effect of schemes second line quadruple therapy on the state of gastric mucosal barrier and NO formation in experimental ulcer.. The study included 60 white male rats weighing 150-190 gr, mixed population. The effect of the standard second-line regimens on the content of the fractions of insoluble glycoproteins, on indicators of NO formation and anaerobic glycolysis in gastric mucosal tissue in experimental ulcer.. Quadruple therapy consisting of omeprazole, de-nol, amoxicillin and tetracycline stimulates mechanisms of protective barrier, which has a positive effect on the mechanisms of NO formation. Scheme with omeprazole, de-nol, tetracycline and metronidazole inhibits the synthesis of mucosal barrier, the key mechanisms of NO formation.. In the plan of correction of mechanisms of cytoprotection in the gastric mucosal tissue quadruple therapy with omeprazole, de ethanol, amoxicillin, and tetracycline is considered to be effective.

Topics: Amoxicillin; Animals; Anti-Bacterial Agents; Anti-Ulcer Agents; Disease Models, Animal; Drug Therapy, Combination; Gastric Mucosa; Male; Nitric Oxide; Omeprazole; Organometallic Compounds; Rats; Stomach Ulcer; Tetracycline

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

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

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

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

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

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

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

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

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

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

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: 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

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

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

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

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

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

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 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

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

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

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

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

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 urease inhibitor acetohydroxamic acid (AHA) was assessed for its bacteriostatic and bactericidal effects on Helicobacter pylori. For eight isolates of H pylori, the minimum inhibitory concentration (MIC) was either 200 mg/l or 400 mg/l. Interactions between AHA and antimicrobial drugs used to treat H pylori were also determined. For most isolates AHA reduced the MIC for colloidal bismuth subcitrate (CBS), tetracycline, metronidazole, and amoxicillin. In a few isolates, however, AHA increased the minimum bactericidal concentration (MBC) for these antimicrobial treatments. In vitro AHA is active against H pylori and it interacts with other agents directed against H pylori.

Topics: Amoxicillin; Anti-Ulcer Agents; Drug Interactions; Helicobacter pylori; Humans; Hydroxamic Acids; In Vitro Techniques; Metronidazole; Microbial Sensitivity Tests; Organometallic Compounds; Tetracycline

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

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

Eighty-two patients, whose duodenal ulcers were recurrent or resistant to H2-receptor antagonist therapy, were entered in a treatment protocol of ranitidine followed by a four-week "triple therapy" course to eradicate Helicobacter pylori (HP) infection. The triple therapy consisted of colloidal bismuth subcitrate, tetracycline and metronidazole. Duodenal ulcer healed in all 78 patients available for endoscopy and H. pylori infection was shown to be eliminated in 75 patients (96%) at rebiopsy four weeks after cessation of therapy. In these 75 remaining patients the relapse rates for H. pylori infection and duodenal ulcer were studied endoscopically, yearly and at any recurrence of symptoms. At Year 1, 71 of 73 patients remained free of H. pylori infection (HP-negative) and duodenal ulcer. The corresponding figures subsequently were: Year 2, 57/57; Year 3, 34/34; Year 4, 15/15. No duodenal ulcers recurred in HP-negative patients who were followed for up to four years. Two patients of the original cohort of 75 HP-negative patients were HP-positive with endoscopic duodenitis at 12 months, and one at 36 months, but all were without reulceration. Distorted duodenal caps gradually returned to near-normal appearance in 80% of patients by two years. From this four-year follow-up study we conclude that duodenal ulcer disease will not recur provided the patient remains free of H. pylori.

Topics: Adult; Aged; Anti-Ulcer Agents; Campylobacter Infections; Duodenal Ulcer; Duodenitis; Duodenum; Female; Follow-Up Studies; Gastroscopy; Histamine H2 Antagonists; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Recurrence; Tetracycline

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