alginate--aluminium-hydroxide--magnesium-trisilicate--sodium-bicarbonate-drug-combination and Gastroesophageal-Reflux

Gastroesophageal reflux disease is a highly frequent disorder classically characterized by the presence of heartburn and/or acid regurgitation that improves with drug therapy that reduces acid content in the stomach. However, especially in patients with non-erosive disease, response to proton pump inhibitors is unsatisfactory in approximately 1 out of 3 patients, and consequently, in these patients, it is important to establish a definitive diagnosis and an alternative therapeutic strategy. In the last few years, advances have been made in knowledge of the physiopathology of reflux, such as identification of the role of the acid pocket in producing reflux, technological advances that allow differentiation among acid reflux, non-acid reflux and slightly acid reflux, and advances in the treatment of reflux with drugs that attempt to act on the barrier function of the esophagogastric junction.

Topics: Alginates; Aluminum Hydroxide; Antacids; Comorbidity; Drug Combinations; Electric Impedance; Esophageal pH Monitoring; Esophagogastric Junction; Fundoplication; Gastric Emptying; Gastroesophageal Reflux; Gastroscopy; Hernia, Hiatal; Humans; Manometry; Overweight; Postprandial Period; Posture; Prevalence; Proton Pump Inhibitors; Silicic Acid; Sodium Bicarbonate

Gastro-oesophageal reflux (GOR) is a common disorder, characterised by regurgitation of gastric contents into the oesophagus. GOR is a very common presentation in infancy in both primary and secondary care settings. GOR can affect approximately 50% of infants younger than three months old (Nelson 1997). The natural history of GOR in infancy is generally that of a functional, self-limiting condition that improves with age; < 5% of children with vomiting or regurgitation continue to have symptoms after infancy (Martin 2002). Older children and children with co-existing medical conditions can have a more protracted course. The definition of gastro-oesophageal reflux disease (GORD) and its precise distinction from GOR are debated, but consensus guidelines from the North American Society of Gastroenterology, Hepatology and Nutrition (NASPGHAN-ESPGHAN guidelines 2009) define GORD as 'troublesome symptoms or complications of GOR.'. This Cochrane review aims to provide a robust analysis of currently available pharmacological interventions used to treat children with GOR by assessing all outcomes indicating benefit or harm.. We sought to identify relevant published trials by searching the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 5), MEDLINE and EMBASE (1966 to 2014), the Centralised Information Service for Complementary Medicine (CISCOM), the Institute for Scientific Information (ISI) Science Citation Index (on BIDS-UK General Science Index) and the ISI Web of Science. We also searched for ongoing trials in the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com).Reference lists from trials selected by electronic searching were handsearched for relevant paediatric studies on medical treatment of children with gastro-oesophageal reflux, as were published abstracts from conference proceedings (published in Gut and Gastroenterology) and reviews published over the past five years.No language restrictions were applied.. Abstracts were reviewed by two review authors, and relevant RCTs on study participants (birth to 16 years) with GOR receiving a pharmacological treatment were selected. Subgroup analysis was considered for children up to 12 months of age, and for children 12 months to 16 years of age, and for those with neurological impairment.. Trials were critically appraised and data collected by two review authors. Risk of bias was assessed. Meta-analysis data were independently extracted by two review authors, and suitable outcome data were analysed using RevMan.. A total of 24 studies (1201 participants) contributed data to the review. The review authors had several concerns regarding the studies. Pharmaceutical company support for manuscript preparation was a common feature; also, because common endpoints were lacking, study populations were heterogenous and variations in study design were noted, individual drug meta-analysis was not possible.Moderate-quality evidence from individual studies suggests that proton pump inhibitors (PPIs) can reduce GOR symptoms in children with confirmed erosive oesophagitis. It was not possible to demonstrate statistical superiority of one PPI agent over another.Some evidence indicates that H₂antagonists are effective in treating children with GORD. Methodological differences precluded performance of meta-analysis on individual agents or on these agents as a class, in comparison with placebo or head-to-head versus PPIs, and additional studies are required.RCT evidence is insufficient to permit assessment of the efficacy of prokinetics. Given the diversity of study designs and the heterogeneity of outcomes, it was not possible to perform a meta-analysis of the efficacy of domperidone.In younger children, the largest RCT of 80 children (one to 18 months of age) with GOR showed no evidence of improvement in symptoms and 24-hour pH probe, but improvement in symptoms and reflux index was noted in a subgroup treated with domperidone and co-magaldrox(Maalox(®) ). In another RCT of 17 children, after eight weeks of therapy. 33% of participants treated with domperidone noted an improvement in symptoms (P value was not significant). In neonates, the evidence is even weaker; one RCT of 26 neonates treated with domperidone over 24 hours showed that although reflux frequency was significantly increased, reflux duration was significantly improved.Diversity of RCT evidence was found regarding efficacy of compound alginate preparations(Gaviscon Infant(®) ) in infants, although as a result of these studies, Gaviscon Infant(®) was changed to become aluminium-free and has been assessed in its current form in only two studies since 1999. Given the diversity of study designs and the heterogeneity of outcomes, as well as the evolution in formulation, it was not possible to perform a meta-analysis on the efficacy of Gaviscon Infant(®) . Moderate evidence indicates that Gaviscon Infant(®) improves symptoms in infants, including those with functional reflux; the largest study of the current formulation sho. Moderate evidence was found to support the use of PPIs, along with some evidence to support the use of H₂ antagonists in older children with GORD, based on improvement in symptom scores, pH indices and endoscopic/histological appearances. However, lack of independent placebo-controlled and head-to-head trials makes conclusions as to relative efficacy difficult to determine. Further RCTs are recommended. No robust RCT evidence is available to support the use of domperidone, and further studies on prokinetics are recommended, including assessments of erythromycin.Pharmacological treatment of infants with reflux symptoms is problematic, as many infants have GOR, and little correlation has been noted between reported symptoms and endoscopic and pH findings. Better evidence has been found to support the use of PPIs in infants with GORD, but heterogeneity in outcomes and in study design impairs interpretation of placebo-controlled data regarding efficacy. Some evidence is available to support the use of Gaviscon Infant(®) , but further studies with longer follow-up times are recommended. Studies of omeprazole and lansoprazole in infants with functional GOR have demonstrated variable benefit, probably because of differences in inclusion criteria.No robust RCT evidence has been found regarding treatment of preterm babies with GOR/GORD or children with neurodisabilities. Initiation of RCTs with common endpoints is recommended, given the frequency of treatment and the use of multiple antireflux agents in these children.

Topics: Alginates; Aluminum Hydroxide; Child; Child, Preschool; Domperidone; Drug Combinations; Gastroesophageal Reflux; Gastrointestinal Agents; Histamine H2 Antagonists; Humans; Infant; Infant, Newborn; Magnesium Hydroxide; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Drug Therapy, Combination; Gastric Acid; Gastroesophageal Reflux; Heartburn; Humans; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Alginate-based raft-forming formulations have been marketed word-wide for over 30 years under various brand names, including Gaviscon. They are used for the symptomatic treatment of heartburn and oesophagitis, and appear to act by a unique mechanism which differs from that of traditional antacids. In the presence of gastric acid, alginates precipitate, forming a gel. Alginate-based raft-forming formulations usually contain sodium or potassium bicarbonate; in the presence of gastric acid, the bicarbonate is converted to carbon dioxide which becomes entrapped within the gel precipitate, converting it into a foam which floats on the surface of the gastric contents, much like a raft on water. Both in vitro and in vivo studies have demonstrated that alginate-based rafts can entrap carbon dioxide, as well as antacid components contained in some formulations, thus providing a relatively pH-neutral barrier. Several studies have demonstrated that the alginate raft can preferentially move into the oesophagus in place, or ahead, of acidic gastric contents during episodes of gastro-oesophageal reflux; some studies further suggest that the raft can act as a physical barrier to reduce reflux episodes. Although some alginate-based formulations also contain antacid components which can provide significant acid neutralization capacity, the efficacy of these formulations to reduce heartburn symptoms does not appear to be totally dependent on the neutralization of bulk gastric contents. The strength of the alginate raft is dependant on several factors, including the amount of carbon dioxide generated and entrapped in the raft, the molecular properties of the alginate, and the presence of aluminium or calcium in the antacid components of the formulation. Raft formation occurs rapidly, often within a few seconds of dosing; hence alginate-containing antacids are comparable to traditional antacids for speed of onset of relief. Since the raft can be retained in the stomach for several hours, alginate-based raft-forming formulations can additionally provide longer-lasting relief than that of traditional antacids. Indeed, clinical studies have shown Gaviscon is superior to placebo, and equal to or significantly better than traditional antacids for relieving heartburn symptoms. Alginate-based, raft-forming formulations have been used to treat reflux symptoms in infants and children, and in the management of heartburn and reflux during pregnancy. While Gaviscon is effective when use

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Carbon Dioxide; Child; Cost-Benefit Analysis; Drug Combinations; Female; Gastric Acid; Gastroesophageal Reflux; Heartburn; Humans; Infant; Infant, Newborn; Male; Pregnancy; Pregnancy Complications; Proton Pumps; Silicic Acid; Sodium Bicarbonate

Gastro-oesophageal reflux (GOR) is an extremely common and usually self limiting condition in infants. When treatment is required, Cisapride, a pro-kinetic agent, has been commonly prescribed for the symptomatic management of GOR. There have been recent reports of possibly serious adverse events e.g. an increased QTc interval, cardiac arrhythmias, and death, associated with the use of Cisapride.. To determine the effectiveness of Cisapride for symptoms of GOR in children compared with placebo or any other non-surgical treatments.. Searches were conducted of the Cochrane Central Trials Register and the specialised Trials register of the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group, MEDLINE and Embase. Reference lists of relevant review articles and identified trials were scrutinised and forward citation searches were performed in the Science Citation Index on all trials identified.. Randomised controlled trials that compared oral Cisapride therapy with placebo or with other non-surgical treatments for children with a diagnosis of GOR were included. Only studies in which Cisapride was administered orally for a minimum of one week and which documented at least one of the primary outcomes were included.. The primary outcomes were defined as a change in symptoms at the end of treatment, presence of adverse events, occurrence of clinical complications, and weight gain. The secondary outcomes included physiological measures of GOR or histological evidence of oesophagitis. We dichotomised symptoms into 'same or worse' vs 'improved' and calculated summary odds ratios. Continuous measures of GOR (e.g. reflux index) were summarised as a weighted mean difference. All outcomes were analysed using a random effects method. Sensitivity analyses were also performed.. Searches identified eight trials which met the inclusion criteria. Seven trials (a total of 236 participants) compared Cisapride with placebo. The odds ratio for 'same or worse' vs 'improved symptoms' at the end of treatment was 0.34 (95%CI 0.10, 1.19), thus showing no statistically significant difference between the two interventions. There was significant heterogeneity between the studies and the funnel plot suggested substantial publication bias. In the sensitivity analysis, the definition of outcomes was changed to 'any symptoms' vs 'no symptoms'. This resulted in the exclusion of three trials (one of them the largest, best quality trial). The resulting pooled odds ratio showed a significant effect of Cisapride (OR 0.19, 95%CI 0.08, 0.44). There were fewer adverse events with placebo than with Cisapride, but the difference was not statistically significant (OR 1.80, 95%CI 0.87, 3.70) and the result was based on small numbers. Cisapride compared with placebo produced a statistically significant reduction in the reflux index (weighted mean difference -6.49, 95%CI -10.13, -2.85), but as reflux index and clinical symptoms are poorly correlated, the clinical importance of this finding is uncertain. Other measures of oesophageal pH monitoring did not reach significance. One included study compared Cisapride with Gaviscon (or Gaviscon and Carobel). The odds ratio for 'same or worse' vs 'improvement' in the Cisapride group compared with Gaviscon was 3.26 (95%CI 0.93, 11.38).. We found no clear evidence that Cisapride reduces symptoms of GOR. The results suggested substantial publication bias favouring studies showing a positive effect of Cisapride. Due to reports of serious adverse events, the company will stop marketing the drug as of July 14th, 2000 and therefore a larger study to provide more conclusive evidence of the effect of Cisapride is no longer possible.

Topics: Alginates; Aluminum Hydroxide; Anti-Ulcer Agents; Cisapride; Drug Combinations; Gastroesophageal Reflux; Gastrointestinal Agents; Humans; Infant; Infant, Newborn; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Antacids; Child; Cisapride; Drug Combinations; Gastroesophageal Reflux; Humans; Piperidines; Serotonin Antagonists; Silicic Acid; Sodium Bicarbonate

Topics: Age Factors; Aged; Alginates; Aluminum Hydroxide; Bethanechol Compounds; Bicarbonates; Deglutition Disorders; Dilatation; Domperidone; Drug Combinations; Female; Gastroesophageal Reflux; Histamine H2 Antagonists; Humans; Male; Metoclopramide; Middle Aged; Silicic Acid; Sodium Bicarbonate

Late-night supper increases the risk of postprandial reflux from the acid pocket especially in obesity. An alginate-based, raft-forming medication may be useful for obese patients with GERD.. To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants.. Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH < 4 at lower oesophagus and improvement in frequency and visual analogue score (VAS) of regurgitation.. Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5 years, males 77.8% and BMI 32.8 kg/m. Among obese individuals, Gaviscon Advance was superior to a non-alginate antacid in post-supper suppression of the acid pocket. (Clinical trial registration unique identifier: NCT03516188).

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Anti-Ulcer Agents; Drug Combinations; Female; Gastric Acid; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Malaysia; Male; Meals; Middle Aged; Obesity; Postprandial Period; Silicic Acid; Sodium Bicarbonate; Time Factors; Treatment Outcome; Young Adult

The alginate-antacid Gaviscon Double Action (Gaviscon DA) has a combined acid-neutralizing and reflux-suppressing action. Response to treatment in a symptomatic gastro-oesophageal reflux disease (GERD) population has not yet been tested in a large-scale clinical study.. The aim of this study was to assess the efficacy and safety of Gaviscon DA compared with matched placebo tablets in the reduction of upper gastrointestinal symptoms in patients with GERD.. In this multicentre, randomized, double-blind, placebo-controlled study, adults with GERD symptoms (N=424) received Gaviscon DA or placebo tablets for 7 days. The primary endpoint was a clinically important reduction of at least 1.5 points in the Reflux Disease Questionnaire (RDQ) GERD dimension (combined heartburn/regurgitation) between baseline and the end of the treatment. Secondary endpoints included the change in RDQ score from baseline for individual RDQ dimensions and Overall Treatment Evaluation.. A significantly greater proportion of patients treated with Gaviscon DA met the primary endpoint compared with placebo (47.8 vs. 33.2%, respectively, P=0.0031; odds ratio: 1.85, 95% confidence interval: 1.23-2.78). A significant treatment effect was also observed for heartburn, regurgitation and dyspepsia individually. Patients in the Gaviscon DA group rated their overall treatment response greater than patients in the placebo group [mean Overall Treatment Evaluation (SD): 3.2 (3.08) vs. 2.2 (3.34); P<0.001]. No notable differences in the incidence of adverse events were observed between treatments.. The alginate-antacid combination, Gaviscon DA, is an effective and well-tolerated treatment to reduce reflux symptoms and associated dyspepsia in symptomatic GERD patients.

Topics: Administration, Oral; Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Double-Blind Method; Drug Combinations; Europe; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Mastication; Middle Aged; Patient Satisfaction; Remission Induction; Silicic Acid; Sodium Bicarbonate; Surveys and Questionnaires; Tablets; Time Factors; Treatment Outcome

To investigate the intragastric acid neutralization activity of a combined alginate-antacid formulation.. Published studies have investigated the reflux-suppressing alginate component of Gaviscon Double Action (Gaviscon DA; RB, UK) but intragastric acid neutralization activity of the antacid component has not been evaluated in vivo.. Intragastric pH monitoring, using a custom-made 10-electrode catheter, was evaluated in a two-part exploratory study in healthy subjects; Part I (n = 6) tested suitability of the catheter using antacid tablets (Rennie; Bayer, Germany); Part II (n = 12) evaluated gastric acid neutralization activity of Gaviscon DA liquid (20 ml) versus placebo in fasted subjects using a randomized, open-label, crossover design. The primary endpoint was the percentage of time that intragastric pH ≥4 was measured during 30 min post-treatment. A confirmatory study of identical design was subsequently conducted (n = 20).. Monitoring pH using the multielectrode catheter was a viable approach, directly detecting changes in intragastric pH following a single dose of antacid tablets. In the exploratory study, the percentage of time that pH ≥4 during 30 minutes post-treatment was 46.8% with Gaviscon DA liquid versus 4.7% with placebo (p = 0.0004). These findings were supported by the confirmatory study, where pH ≥4 was recorded 50.8% of the time with Gaviscon DA versus 3.5% with placebo (p = 0.0051). In this study, Gaviscon DA was safe and well tolerated.. These studies demonstrate the effective acid neutralizing capacity of Gaviscon DA versus placebo in healthy, fasted subjects. This adds to the evidence base for the combination of alginates and antacids.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Anti-Ulcer Agents; Calcium Carbonate; Chemistry, Pharmaceutical; Cross-Over Studies; Drug Combinations; Female; Gastric Acid; Gastroesophageal Reflux; Healthy Volunteers; Humans; Hydrogen-Ion Concentration; Magnesium; Male; Silicic Acid; Sodium Bicarbonate; Tablets; Young Adult

Symptomatic breakthrough in proton pump inhibitor (PPI)-treated gastro-oesophageal reflux disease (GERD) patients is a common problem with a range of underlying causes. The nonsystemic, raft-forming action of alginates may help resolve symptoms.. To assess alginate-antacid (Gaviscon Double Action, RB, Slough, UK) as add-on therapy to once-daily PPI for suppression of breakthrough reflux symptoms.. In two randomised, double-blind studies (exploratory, n=52; confirmatory, n=262), patients taking standard-dose PPI who had breakthrough symptoms, assessed by Heartburn Reflux Dyspepsia Questionnaire (HRDQ), were randomised to add-on Gaviscon or placebo (20 mL after meals and bedtime). The exploratory study endpoint was change in HRDQ score during treatment vs run-in. The confirmatory study endpoint was "response" defined as ≥3 days reduction in the number of "bad" days (HRDQ [heartburn/regurgitation] >0.70) during treatment vs run-in.. In the exploratory study, significantly greater reductions in HRDQ scores (heartburn/regurgitation) were observed in the Gaviscon vs placebo (least squares mean difference [95% CI] -2.10 [-3.71 to -0.48]; P=.012). Post hoc "responder" analysis of the exploratory study also revealed significantly more Gaviscon patients (75%) achieved ≥3 days reduction in "bad" days vs placebo patients (36%), P=.005. In the confirmatory study, symptomatic improvement was observed with add-on Gaviscon (51%) but there was no significant difference in response vs placebo (48%) (OR (95% CI) 1.15 (0.69-1.91), P=.5939).. Adding Gaviscon to PPI reduced breakthrough GERD symptoms but a nearly equal response was observed for placebo. Response to intervention may vary according to whether symptoms are functional in origin.

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Anti-Ulcer Agents; Breakthrough Pain; Double-Blind Method; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Alginate-based formulations are frequently used as add-on proton pump inhibitor (PPI) therapy to help control of heartburn and regurgitation. There are limited data regarding the mechanisms and effects of alginate-based formulations. We aimed to evaluate the effects of the sodium alginate intake and its likely temporal relations on intraesophageal reflux events by MII-pH in patients with and without hiatal hernia (HH). Fifty GERD patients (18 with HH, 32 without HH) with heartburn or regurgitation once a week or more common were included. After combined multichannel intraluminal impedance and pH-metry (MII-pH) had been performed, all patients were asked to eat the same standard meal (double cheeseburger, 1 banana, 100 g regular yoghurt, and 200 mL water with total energy value of 744 kcal: 37.6% of carbohydrates, 21.2% of proteins, and 41.2% of lipids) during two consecutive days. On separate random two consecutive days, all patients took 10 mL of sodium alginate (GA; Gaviscon Advance; Reckitt Benckiser Healthcare, Hull, UK) or 10 mL of water, 30 minutes after the refluxogenic meal. After eating refluxogenic meal, patients were examined ½ hour for basal conditions, 1 hour in upright, and 1 hour in supine positions. Alginate significantly decreased acid reflux after intake at the first hour in comparison to water in patients with HH (6.1 vs. 13.7, P = 0.004) and without HH (3.5 vs. 5.5, P = 0.001). Weakly acid reflux were increased at the first hour in patients with HH (3.4 vs. 1.3, P = 0.019) and without HH (1.7 vs. 5, P = 0.02) compared to water. There was no distinctive effect of alginate on the height of proximal migration of reflux events in patients with HH and without HH. Alginate decreases acid reflux events within a limited time period, especially at the first hour both in patients with and without HH. Alginate has no effect on the height of reflux events along the esophagus both in patients with and without HH.

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Electric Impedance; Esophageal pH Monitoring; Female; Gastroesophageal Reflux; Hernia, Hiatal; Humans; Male; Meals; Middle Aged; Postprandial Period; Posture; Prospective Studies; Silicic Acid; Sodium Bicarbonate; Time Factors

Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression.. To assess the efficacy of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI.. This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment compared to baseline.. One hundred and thirty-six patients were randomised. Change in HRDQ reflux score was significantly greater for Gaviscon Advance (mean: -5.0, s.d.: 4.7) than for placebo (mean: -3.5, s.d.: 5.5) with an LS mean difference of 1.6 [95% CI -3.1 to -0.1], P = 0.03. A decrease in the mean (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. This reduction was significantly greater in the Gaviscon Advance group than in the placebo group [LS mean difference = -0.9, 95% CI (-1.6 to -0.2), P < 0.01].. In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21).

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Double-Blind Method; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

To assess the efficacy of Gaviscon Double Action (DA) alginate antacid chewable tablets for reducing esophageal acid exposure in Chinese patients with gastroesophageal reflux disease (GERD).. Altogether 44 patients reporting moderate to severe heartburn symptoms underwent two pH monitoring visits. The treatment sequence was randomized to patients received DA alginate antacid or placebo at one visit and the alternate treatment 7 days later. After a standardized reflux-provoking meal, patients took four tablets of DA alginate antacid or placebo. Esophageal pH was measured for 4 h post-dosing using an electrode positioned 5 cm above the lower esophageal sphincter. The primary end-point was the percentage of 4-h post-dosing period with pH <4. Secondary end-points were number of acid reflux episodes (pH <4), longest reflux time and DeMeester scores.. All 44 patients completed the study and provided data for analysis. With DA alginate antacid, the mean percentage time with pH <4 was 5.1%, significantly less (P = 0.0003) than with placebo (14.8%). DA alginate antacid was statistically significantly superior (P = 0.0290) to placebo (from at least twofold to threefold better) for all other end-points. Two patients reported two mild adverse events (AEs) that resolved within a month of completing the study. No patients had serious and/or severe AEs and none withdrew due to AEs.. DA alginate antacid was statistically significantly superior to placebo in reducing post-prandial acid exposure without serious clinically relevant health risks. These findings suggest DA alginate antacid tablets are appropriate for treating acid reflux in Chinese GERD patients with heartburn symptoms.

Topics: Administration, Oral; Adult; Alginates; Aluminum Hydroxide; Antacids; Asian People; Cross-Over Studies; Drug Combinations; Esophageal pH Monitoring; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Manometry; Middle Aged; Silicic Acid; Sodium Bicarbonate; Tablets

There is a paucity of large-scale studies evaluating the clinical benefit of the Gaviscon Double Action (DA) alginate-antacid formulation for treating gastroesophageal reflux disease (GERD) symptoms.. Randomised double-blind placebo-controlled parallel-group study to evaluate efficacy and safety of Gaviscon DA in reducing heartburn, regurgitation and dyspepsia symptoms in individuals with mild-to-moderate GERD in China.. Participants with symptomatic GERD (n = 1107) were randomised to receive Gaviscon DA or placebo (two tablets four times daily) for seven consecutive days. The primary endpoint compared the change in Reflux Disease Questionnaire (RDQ) score for the GERD (heartburn + regurgitation) dimension between Gaviscon DA and placebo. Secondary endpoints compared the change in RDQ scores for individual heartburn, regurgitation and dyspepsia dimensions, overall treatment evaluation (OTE) scores and incidence of adverse events (AEs).. Mean RDQ GERD scores: 2.51 for Gaviscon DA and 2.50 for placebo at baseline; 1.25 for Gaviscon DA and 1.46 for placebo post treatment. Gaviscon DA was statistically superior to placebo in reducing GERD and dyspepsia RDQ scores [least-squares mean (LSM) difference: GERD -0.21, P < 0.0001; dyspepsia -0.18, P = 0.0004], despite a substantial placebo response. The Gaviscon DA group reported more favourable overall treatment responses than the placebo group across all OTE categories (P < 0.0001). Superior relief of GERD symptoms was observed both in those with non-erosive and those with erosive reflux disease (LSM difference -0.14 [P = 0.038] and -0.29 [P < 0.0001] respectively). Incidence of AEs was similar in both groups.. Gaviscon DA tablets provide effective and safe reduction in acid reflux and dyspepsia symptoms in Chinese individuals with mild-to-moderate GERD. ClinicalTrials.gov: NCT01869491.

Topics: Adolescent; Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Anti-Ulcer Agents; China; Double-Blind Method; Drug Combinations; Dyspepsia; Female; Gastroesophageal Reflux; Heartburn; Humans; Laryngopharyngeal Reflux; Male; Middle Aged; Placebos; Silicic Acid; Sodium Bicarbonate; Surveys and Questionnaires; Treatment Outcome; Upper Gastrointestinal Tract; Young Adult

The alginate-antacid, Gaviscon Double Action (Gaviscon DA; Reckitt Benckiser, Slough, UK) suppresses reflux after meals by creating a gel-like barrier that caps and displaces the acid pocket distal to the oesophago-gastric junction. The effect of Gaviscon DA on reflux and dyspepsia symptoms has not yet been demonstrated with a modern trial design.. A pilot study to assess the efficacy and safety of Gaviscon DA compared with matched placebo for decreasing upper gastrointestinal symptoms in symptomatic gastro-oesophageal reflux disease (GERD) patients.. A randomised, double-blind, parallel group study was performed in 110 patients with symptoms of GERD. Patients received Gaviscon DA or placebo tablets for 7 consecutive days. The primary endpoint compared the change in overall Reflux Disease Questionnaire (RDQ) symptom score (combined heartburn/regurgitation/dyspepsia). Secondary endpoints assessed individual dimensions, GERD dimension (heartburn and regurgitation) and overall treatment evaluation (OTE).. There was a greater decrease in overall RDQ symptom score in the Gaviscon DA group compared with the placebo group (Least Squares Mean difference -0.55; P = 0.0033), and for each of the dimensions independently. Patients in the Gaviscon DA group evaluated their overall treatment response higher than patients in the placebo group [mean (standard deviation) OTE 4.1 (2.44) vs. 1.9 (3.34); P = 0.0005]. No differences in the incidence of adverse events were observed between treatment groups.. Gaviscon DA decreases reflux and dyspeptic symptoms in GERD patients compared with matched placebo and has a favourable benefit-risk balance. Larger scale clinical investigations of medications targeting the acid pocket are warranted. (EudraCT, 2012-002188-84).

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Double-Blind Method; Drug Combinations; Dyspepsia; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Pilot Projects; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Recent studies have shown that Gaviscon Double Action Liquid (a combination alginate-antacid) administered post-prandially co-localises with the acid pocket, the 'reservoir' for post-prandial acid reflux.. To compare the effectiveness of Gaviscon Double Action Liquid to an equivalent strength antacid without alginate in controlling post-prandial acid reflux in GERD patients.. Fourteen GERD patients undertook two 3.5-h high-resolution manometry/pH-impedance studies during which they ate a standardised meal. In a double-blinded randomised crossover design they then took Gaviscon or CVS brand antacid, each with ~18 mmol/L acid neutralising capacity. The primary outcome was distal oesophageal acid exposure; secondary outcomes were number of reflux events, proximal extent of reflux, nadir pH of the refluxate, mechanism of reflux and reflux symptoms scored with a validated instrument.. Ten patients completed the study. Gaviscon studies had significantly less distal oesophageal acid exposure and greater nadir refluxate pH in the 30-150 min post-prandial period than antacid studies. There were no differences in the number of reflux events (acid or weakly acidic) or the number of proximal reflux events (15-17 cm above the LES) with either study medication.. Gaviscon Double Action Liquid is more effective than an antacid without alginate in controlling post-prandial oesophageal acid exposure. However, the number and spatial distribution of reflux events within the oesophagus are similar. This suggests that Gaviscon main effectiveness relates to its co-localisation with and displacement/neutralisation of the post-prandial acid pocket, rather than preventing reflux.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Calcium Carbonate; Cross-Over Studies; Double-Blind Method; Drug Combinations; Electric Impedance; Esophagus; Female; Gastric Acid; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Magnesium Hydroxide; Male; Manometry; Middle Aged; Postprandial Period; Silicic Acid; Sodium Bicarbonate

Alginates form a raft above the gastric contents, which may suppress gastro-oesophageal reflux; however, inconsistent effects have been reported in mechanistic and clinical studies.. To visualise reflux suppression by an alginate-antacid [Gaviscon Advance (GA), Reckitt Benckiser, UK] compared with a nonraft-forming antacid using magnetic resonance imaging (MRI), and to determine the feasibility of pH-impedance monitoring for assessment of reflux suppression by alginates.. Two studies were performed: (i) GA and antacid (Alucol, Wander Ltd, Switzerland) were visualised in the stomach after ingestion in 12 healthy volunteers over 30 min after a meal by MRI, with reflux events documented by manometry. (ii) A randomised controlled, double-blind cross-over trial of post-prandial reflux suppression documented by pH-impedance in 20 patients randomised to GA or antacid (Milk of Magnesia; Boots, UK) after two meals taken 24 h apart.. MRI visualized a "mass" of GA form at the oesophago-gastric junction (OGJ); simple antacid sank to the distal stomach. The number of post-prandial common cavity reflux events was less with GA than antacid [median 2 (0-5) vs. 5 (1-11); P < 0.035]. Distal reflux events and acid exposure measured by pH-impedance were similar after GA and antacid. There was a trend to reduced proximal reflux events with GA compared with antacid [10.5 (8.9) vs. 13.9 (8.3); P = 0.070].. Gaviscon Advance forms a 'mass' close to the OGJ and significantly suppresses reflux compared with a nonraft-forming antacid. Standard pH-impedance monitoring is suitable for clinical studies of GA in gastro-oesophageal reflux disease patients where proximal reflux is the primary outcome.

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Cross-Over Studies; Double-Blind Method; Drug Combinations; Electric Impedance; Esophageal pH Monitoring; Female; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Magnesium Oxide; Magnetic Resonance Imaging; Male; Manometry; Middle Aged; Postprandial Period; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Medical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon®, 4 × 10 mL/day) and omeprazole (20 mg/day) on GERD symptoms in general practice.. A 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14.. 278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon® and 2.0 (± 2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups.. Gaviscon® was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care.. ISRCTN62203233.

Topics: Adolescent; Adult; Alginates; Aluminum Hydroxide; Double-Blind Method; Drug Combinations; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Omeprazole; Proton Pump Inhibitors; Severity of Illness Index; Silicic Acid; Sodium Bicarbonate; Time Factors; Treatment Outcome; Young Adult

Gastro-oesophageal reflux is common in preterm newborns; at present, no studies have evaluated the efficacy of sodium alginate in this population.. To evaluate the effect of sodium alginate on gastro-oesophageal reflux features in preterm newborns by combined pH and impedance monitoring (pH-MII).. Thirty-two symptomatic preterm newborns underwent a 24 h pH-MII, during which each baby was fed eight times. Sodium alginate was given four times at alternate meals [drug-given (DG) vs. drug-free (DF) meals]. Gastro-oesophageal reflux features (i.e. number, acidity, duration and height of gastro-oesophageal reflux) after DG and DF meals were compared by Wilcoxon signed ranks test.. Sodium alginate significantly decreased the number of acid gastro-oesophageal reflux detected either by pH monitoring (DG vs. DF: median 17.00 vs. 29.00, P = 0.002) and MII (DG vs. DF: 4.0 vs. 6.00, P = 0.050), and also acid oesophageal exposure (DG vs. DF: 4.0% vs. 7.6%, P = 0.030), without any influence on non-acid gastro-oesophageal reflux. Furthermore, it decreased the number of gastro-oesophageal reflux reaching proximal oesophagus (DG vs. DF: 5.50 vs. 7.50, P = 0.030).. The use of sodium alginate in preterm infants seems to be promising, because this drug decreases gastro-oesophageal reflux acidity and height with the advantage of a nonsystemic way of action and a more favourable safety profile over H2 blockers and PPIs.

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Female; Gastric Acidity Determination; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Infant; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Male; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Apnoea of prematurity (AOP) frequently recurs in preterm infants. We have previously shown that a significant but variable proportion of AOP is induced by gastro-oesophageal reflux (GOR).. The aim of this study is to evaluate the efficacy of sodium alginate in reducing the frequency of GOR-related AOP.. Twenty-eight preterm infants with AOP were studied by a six-hour recording of combined multichannel intraluminal impedance and pH monitoring and polysomnography, including two three-hour postprandial periods: sodium alginate was given after one single meal named as drug-given (DG) meal, while the other as drug-free (DF).. During 165h of registration, 715 apnoeas were recorded, 368 after-DG and 347 after-DF (p=.99); furthermore, 851 GOR episodes were detected, 315 after-DG and 536 after-DF (p=.001). No differences in the number of AOP were found between DG and DF. A significant reduction in the number of acid GORs and in acid exposure was found during DG, while the administration of sodium alginate didn't influence non-acid GOR indexes. The frequency of GOR-related apnoeas didn't differ between DG and DF.. Sodium alginate doesn't reduce the total number of AOP nor GOR-related apnoeas. On the other hand, it reduces acid GOR features, while it had no effect on non-acid GOR indexes.

Topics: Alginates; Aluminum Hydroxide; Apnea; Drug Combinations; Female; Gastroesophageal Reflux; Glucuronic Acid; Hexuronic Acids; Humans; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Male; Silicic Acid; Sodium Bicarbonate

Was conducted a muIticenter study VIA APIA, in which the impact of gaviscon forte (suspension) on symptoms, general state and quality of life of 148 patients (male 53, female 95, age 42.9 +/- 15.6) with gastroesophageal reflux disease (GERD) were investigated. The patients had undergone clinical evaluation of dynamics of GERD symptoms (Likert scale), general state (Visual Analogue Scale, questionnaire SAN) and quality of life (SF-36). It was shown that 14-days treatment with gaviscon forte provided symptoms relief in 84.5% patients and conducted improvement of general state and quality of life. Gaviscon forte recommended as drug of choice in initial treatment for the first time visited patient with heartburn before endoscopy and for pathogenetic treatment of typical reflux syndrome.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Prospective Studies; Quality of Life; Severity of Illness Index; Silicic Acid; Sodium Bicarbonate; Surveys and Questionnaires; Suspensions; Treatment Outcome

To compare the clinical efficacy of alginate drug Geviskon and aluminum-magnesium antacids to relieve symptoms of esophageal, extraesophageal syndrome and functional dyspepsia at 3 and 7 days of study in patients with GERD elderly.. An open, longitudinal, randomized, parallel-group. The study included 60 patients with "A" degree of ERD, consistently received in-patient treatment in the Municipal KGVV, mean age 79.0 +/- 6.8 years. During the first 12 hours of hospital stay by "sealed envelopes" them randomly divided into equal groups of comparison, given 3 times a day: alginate product--Geviskon forte dose of 10 ml and aluminum-magnesium antacid drug at a dose of 1 sachet. Assess the frequency and severity of esophageal symptoms, extraesophageal syndrome, functional dyspepsia at 3 and 7 days of study on 5-point scale Likert. The degree of esophageal mucosal injury was determined during endoscopy before the study.. The technique of alginate compared with antacids provided significantly more complete and earlier effect on the relief of heartburn, regurgitation, chronic cough, sore throat, and EBS. Only Geviskon influenced the symptoms of PPD in patients with GERD.. The clinical features Geviskon the frequency and timing of relief of symptoms of esophageal, extraesophageal syndrome, functional dyspepsia with GERD in the older age groups is higher than that of antacids. Suspension Geviskon may be recommended in patients with middle and old age as an effective and safe symptomatic funds in the first days of exchange rate earlier generations of PPI therapy, as well as monotherapy--to maintain remission.

Topics: Aged; Aged, 80 and over; Alginates; Aluminum Hydroxide; Antacids; Cough; Drug Combinations; Dyspepsia; Female; Gastroesophageal Reflux; Humans; Laryngitis; Male; Middle Aged; Silicic Acid; Sodium Bicarbonate; Syndrome; Treatment Outcome

We conducted a crossover study, in which the efficacy and the onset of action of a single dose of Gaviscon (suspension) and Gaviscon forte (suspension) in 52 patients with heartburn of moderate intensity and gastroesophageal reflux disease (GERD) have been investigated. The average age of the patients was 44.0 +/- 17.3-years-old. The patients have undergone clinical evaluation of intensity of GERD symptoms and psychological assessment (questionnaires SF-36, SMOL, LOBI). Alginates' effects and qualities were evaluated using stopwatch technique, clinical examination, and organoleptic assessment. Primary sensation of a cooling (soothing) effect after use of a single dose of Gaviscon has been reported in 65.7 seconds (on average), and Gaviscon forte--in 66.1 seconds. Fourty three (82.7%) patients with heartburn have described the effects of both medications as "instant" cooling effects. Heartburn was relieved in 3.3 minutes in all patients after a single dose of Gaviscon, and in 3.6 minutes in 51 (98.1%) patients who have received a single dose of Gaviscon forte. Organoleptic qualities averaged at 3.6 points (on a scale of 1-5) for Gaviscon, and at 3.5 points for Gaviscon forte. Assessment of mental status of the patients suggested that a "delayed" effect of the medications in relieving heartburn in some patients may have occurred due to possible physical disadaptation.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Cross-Over Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Quality of Life; Silicic Acid; Sodium Bicarbonate; Taste; Time Factors; Treatment Outcome

Laryngopharyngeal reflux (LPR) refers to the backflow of stomach contents into the laryngopharynx. Increasing evidence has demonstrated that LPR is a contributing factor in some cases of hoarseness, vocal fatigue, voice breaks, cough and globus and chronic throat clearing. However, several randomised placebo-controlled trials of proton pump inhibitors in the treatment of LPR have been reported with the majority showing no significant benefit in patient symptom scores over placebo. The aim of this pilot clinical study was to investigate whether any improvement in LPR-related symptoms, using the Reflux Symptom Index (RSI), and clinical findings, using the Reflux Finding Score (RFS), could be achieved with treatment with a liquid alginate suspension compared to control (no treatment). Patients presenting with the symptoms of LPR to the Otorhinolaryngology Outpatient Department at the Queen's Medical Centre, Nottingham, UK were considered eligible if they had an RSI of greater than 10 and an RFS greater than 5 based on a fibreoptic examination of the larynx. A total of 49 patients were randomised into the open, parallel group study; 24 patients were randomised to receive 10 ml liquid alginate suspension (Gaviscon Advance) four times daily after meals and at bedtime, and 25 patients into the control group (no treatment). Patients were assessed pre-treatment and at 2, 4 and 6 months post treatment. Mean (SD) RSI and RFS pre-treatment scores were 23.9 (7.0) and 10.4 (3.6) for the treatment group and 24.6 (7.4) and 10.3 (3.3) for the control group, respectively. Significant differences between treatment and control were observed for RSI at the 2-month (11.2 (7.0) vs. 16.8 (6.4), P=0.005) and 6-month (11.2 (8.1) vs. 18.3 (9.4), P=0.008) assessments and for RFS at the 6-month (7.1 (2.8) vs. 9.5 (3.4), P=0.005) assessment. Significant improvement in symptom scores and clinical findings were achieved with liquid alginate suspension (Gaviscon Advance) compared to control and further evaluation for the management of patients presenting with LPR is warranted.

Topics: Administration, Oral; Adult; Alginates; Aluminum Hydroxide; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Combinations; Female; Follow-Up Studies; Gastroesophageal Reflux; Humans; Hypopharynx; Laryngitis; Laryngoscopy; Male; Middle Aged; Multivariate Analysis; Observer Variation; Probability; Reference Values; Risk Assessment; Severity of Illness Index; Silicic Acid; Sodium Bicarbonate; Suspensions; Treatment Outcome

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Administration Schedule; Drug Combinations; Female; Gastric Acid; Gastric Acidity Determination; Gastric Mucosa; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Quality of Life; Silicic Acid; Sodium Bicarbonate

The aim of this study was to compare alginate products with the same amount of active ingredients but different dosage forms, in the suppression of reflux provoked by a standard meal in healthy human volunteers, using ambulatory oesophageal pH monitoring.. This was a single centre, randomised, open, three-period crossover, controlled study comparing Gaviscon Advance (10 ml) with a control (10 ml water) and with a new tablet product containing the same active ingredients as Gaviscon Advance. Volunteers who had oesophageal pH < 4 for at least 2% of the 4-h period after ingestion of a test meal followed by control at a reflux screening visit were included in the study.. The difference between Gaviscon Advance and control in the mean angular transformed percentage of time for which oesophageal pH fell below four was statistically significant (p < 0.0001) demonstrating the sensitivity of the method. No significant difference between the two alginate products was found based on the least squares adjusted mean angular transformed percentage of time for which pH fell below four. There were also no significant differences between the two alginate dosage forms in the angular transformed percentage of time for which oesophageal pH fell below five and in the log-transformed number of occasions on which oesophageal pH fell below four and five.. The study shows that alginate reflux suppressants containing a low amount of antacid are effective in suppressing acid reflux and that suspension and tablet forms are able to give equivalent acid suppression.

Topics: Adolescent; Adult; Alginates; Aluminum Hydroxide; Antacids; Cross-Over Studies; Drug Combinations; Esophageal pH Monitoring; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Sensitivity and Specificity; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Acid pockets at the gastro-oesophageal junction escape buffering from meals in the stomach. Combining high-dose antacid with alginate may therefore be of benefit in gastro-oesophageal reflux disease.. To characterize the antacid and raft-forming properties of Rennie alginate suspension (containing high-dose antacid and alginate; Bayer Consumer Care, Bladel, the Netherlands).. The in vitro acid-neutralizing capacity of Rennie algniate was compared with Gaviscon (Reckitt Benckiser, Slough, UK) by pH-recorded HCl titration. Alginate raft weight formed in vitro at different pH was used to evaluate the pH dependency of raft formation with each product. A double-blind, placebo-controlled, randomized crossover study also compared the antacid activity of Rennie alginate vs. placebo in vivo using continuous intragastric pH monitoring in 12 healthy fasting volunteers.. Compared with Gaviscon, Rennie alginate had a higher acid-neutralizing capacity, greater maximum pH and longer duration of antacid activity in vitro. However, the two products produced comparable alginate rafts at each pH evaluated. In vivo, Rennie alginate provided rapid, effective and long-lasting acid neutralization, with an onset of action of <5 min, and duration of action of almost 90 min.. The dual mode of action of Rennie alginate offers an effective treatment option for mild symptomatic gastro-oesophageal reflux disease particularly considering recent findings regarding 'acid pockets'.

Topics: Adolescent; Adult; Alginates; Aluminum Hydroxide; Antacids; Calcium Carbonate; Carbonates; Cross-Over Studies; Double-Blind Method; Drug Combinations; Female; Gastric Acid; Gastric Acidity Determination; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Magnesium; Male; Silicic Acid; Sodium Bicarbonate

Gaviscon Infant (GI) has been recommended for gastro-oesophageal reflux (GOR) in infants. Its efficacy has not been examined with a physiologically appropriate denominator to define the degree of GOR.. To investigate the influence of Gaviscon Infant on GOR in infants using combined pH and intraluminal impedance measurement.. Twenty infants (mean age 163.5 days, range 34-319 days) exclusively bottle fed, with symptoms clinically suggestive of GOR, underwent 24 hour studies of intra-oesophageal 6 channel impedance and dual channel pH monitoring, during which six random administrations (3+3) of Gaviscon Infant (625 mg in 225 ml milk) or placebo (mannitol and Solvito N, 625 mg in 225 ml milk) were given in a double blind fashion. Impedance/pH reflux data were recorded and analysed blind by one observer.. The median number of reflux events/hour (1.58 v 1.68), acid reflux events/hour (0.26 v 0.43), minimum distal or proximal pH, total acid clearance time per hour (time with pH below pH 4), and total reflux duration per hour were not significantly different after GI than after placebo. Reflux height was marginally lower after GI (median 66.6% v 77.3% oesophageal length) compared with placebo.. Results showed a marginal but significant difference between Gaviscon Infant and placebo in average reflux height, and raises questions regarding any perceived clinical benefit of its use.

Topics: Alginates; Aluminum Hydroxide; Antacids; Double-Blind Method; Drug Combinations; Electric Impedance; Female; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Infant; Male; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

This study investigated the efficacy and safety of a novel reflux suppressant, Gaviscon Advance, in the treatment of heartburn during pregnancy. The study was an open-label, multicentre, phase IV study in general practice and antenatal clinics in the UK and Republic of South Africa. Pregnant women (< or = 38 weeks gestation; n=150) aged 18-40 years suffering from heartburn were instructed to take Gaviscon Advance 5-10 ml, as required, to relieve symptoms. The main outcome measures were the efficacy rating of the study medication by the investigator and women after four weeks using a five-point efficacy scale. After four weeks the investigators' and women's rating of efficacy was 'very good' or 'good' in 88% and 90% of women, respectively. Most women (57%, n=83) reported symptom relief within 10 minutes. Thus Gaviscon Advance effectively and rapidly treats heartburn during pregnancy. Its use during pregnancy presents no known significant safety concerns for mother or child.

Topics: Adolescent; Adult; Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Patient Satisfaction; Pregnancy; Pregnancy Complications; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

The aim of this study was to compare the efficacy of the sodium alginate preparation, Gaviscon Advance, with placebo in the relief of symptoms of reflux oesophagitis. This was a randomised, double-blind, parallel-group, multicentre study conducted at 13 GP centres in the UK. Patients aged between 18 and 70 years, who had experienced symptoms of reflux oesophagitis within the previous 24 h, and on two other occasions within the previous week, were recruited into the study. Patients were evaluated at baseline, and then reassessed after two and four weeks of treatment with sodium alginate or placebo, for symptoms of reflux oesophagitis in the previous 24 h. Patients were required to fill out a diary card twice daily, from which frequency and severity of symptoms were assessed, and the percentage of symptom-free days and nights calculated. Of the 100 patients recruited into the study, 98 received medication (safety population; placebo, n = 50; sodium alginate, n = 48) and 94 were eligible for inclusion in the intention-to-treat (ITT) population (placebo, n = 48; sodium alginate, n = 46). For this population, sodium alginate was assessed as significantly superior by both investigators and patients at week two (p < 0.001 and p = 0.004, respectively) and at week four (p = 0.001 and p < 0.001, respectively). Significantly more patients in the safety population on placebo withdrew from the study (40%) compared with sodium alginate (21%; p = 0.04), due primarily to lack of effect and adverse events. The sodium alginate preparation demonstrated a superior efficacy compared with placebo, which was achieved in a more acceptable volume of medication than a previous standard preparation, Liquid Gaviscon. The reduced dosage volume of the 'new' preparation (Gaviscon Advance) may be expected to improve patient compliance, and thereby increase treatment efficacy.

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Consumer Product Safety; Double-Blind Method; Drug Combinations; Female; Gastroesophageal Reflux; Humans; Male; Medical Records; Middle Aged; Silicic Acid; Sodium Bicarbonate; Statistics, Nonparametric; United Kingdom

The aim of the present study was to compare the efficacy and safety of a new aluminium-free formulation of alginate with placebo in infants with recurrent gastro-oesophageal reflux. This was a double-blind, randomised, parallel-group study conducted at 25 centres in the UK. Of the 90 paediatric patients recruited in a general practice setting, 42 were randomised to receive alginate and 48 to receive placebo. Infants were assessed before treatment and again after seven and 14 days of treatment. Analyses were based on the last, valid, non-missing observation for each variable for the intent-to-treat (ITT) population of 42 alginate and 46 placebo patients. For the primary efficacy measure (number of vomitting/regurgitation episodes), alginate was significantly superior to placebo (p = 0.009). For the secondary efficacy measure (severity of vomiting), a trend in favour of alginate was observed (p = 0.061). Patients receiving alginate achieved superior assessments of treatment outcome by both investigators (p = 0.008) and parent/guardians (p = 0.002) alike. In addition, alginate achieved a significantly greater reduction in the mean severity of vomiting episodes recorded in a daily diary compared with placebo (p = 0.027) and resulted in more patients having at least 10% symptom-free days (p = 0.027). For none of the variables measured did placebo have a superior effect. More than one-half of all patients experienced some adverse event, although no statistically significant differences were observed between the two treatment groups (p > 0.1), and adverse events accounted for withdrawal in only 12.5% of the patients (alginate, n = 4; placebo, n = 7). Aluminium-free alginate demonstrated superior efficacy over placebo in treating recurrent gastro-oesophageal reflux in paediatric patients. The safety profile of alginate was similar to that of placebo.

Topics: Age of Onset; Alginates; Aluminum Hydroxide; Analysis of Variance; Antacids; Area Under Curve; Chronic Disease; Consumer Product Safety; Double-Blind Method; Drug Combinations; Female; Gastroesophageal Reflux; Humans; Infant; Infant, Newborn; Male; Silicic Acid; Sodium Bicarbonate; Statistics, Nonparametric; Vomiting

Food and acid have been shown to be refluxed independently of each other in healthy volunteers, and anti-reflux agents decrease the reflux of both parameters. Until now this phenomenon had not been studied in patients with low-grade oesophagitis, who are the group most likely to use anti-reflux medication.. To assess patterns of gastro-oesophageal reflux of acid and food in 12 ambulant patients with endoscopically proven oesophagitis of between grades I and II, but who were otherwise healthy. Also to assess the effectiveness of a single dose of an alginate-containing anti-reflux agent in controlling food and acid reflux in this patient group.. Oesophageal pH monitoring and external ambulatory gamma detection were used to study food and acid reflux. A pH electrode was positioned 5 cm above the cardia and the gamma detector was positioned externally over the pH electrode. The patients then received a technetium-99m labelled meal designed to provoke reflux. Thirty minutes later the patients were given a 20 ml dose of alginate (Liquid Gaviscon), or 20 ml of tap water. Incidence of reflux was monitored for approximately 4 h from the end of the meal. Allocation to treatment group was randomized, with patients receiving the alternative treatment on the second study day after approximately a 7-day washout period.. The mean percentage time oesophageal pH remained below 4 was 16.3 min for the control group and 5.4 min for the treatment group (P = 0.03). Food reflux was detected 23.7% of the time in the control group compared to 12% of the time in the treatment group (P = 0.02). The anti-reflux agent was also successful in decreasing the number of events, but the duration of the reflux events was not significantly different.. Patients with grades I and II oesophagitis reflux food and acid independently, and are predominantly either food refluxers or acid refluxers, but not both. Liquid alginate decreases the number of both food and acid reflux events, but does not change their duration.

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Eating; Esophagitis, Peptic; Female; Gastric Acid; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Silicic Acid; Sodium Bicarbonate

This study was designed to compare the effectiveness of single doses of either Liquid Gaviscon or Algicon Suspension in the suppression of food and acid reflux into the oesophagus after a test meal in volunteers. After the pH electrode and gamma detector were positioned 5 cm above the cardia, the volunteers received a refluxogenic radiolabelled meal. The subjects then remained untreated, or thirty minutes later they were given a dose of unlabelled Algicon Suspension, or Liquid Gaviscon and a recording was made for a minimum of 3 hours. Allocation to the treatment group was randomized with the cross-overs performed 1 week apart. Liquid Gaviscon suppressed gastro-oesophageal reflux of both food and acid whereas only an insignificant reduction in reflux was seen after Algicon Suspension. The oesophageal pH remained below 4 for 3.21 +/- 0.92% (S.E.M.) of the recording period in the control study, 0.88 +/- 0.33 after Gaviscon and 2.91 +/- 0.68 after Algicon. The reflux of food was reduced from 17,070 x 10(3) +/- 4713 x 10(3) counts in the control study to 224 x 10(3) +/- 93 x 10(3) counts after the Gaviscon and 16,080 x 10(3) +/- 7131 x 10(3) counts after Algicon. The suppression of reflux by Liquid Gaviscon was significantly better than that produced by Algicon Suspension.

Topics: Adult; Alginates; Aluminum Hydroxide; Ambulatory Care; Antacids; Bicarbonates; Calibration; Carbonates; Drug Combinations; Electrodes, Implanted; Esophagus; Female; Food; Gamma Cameras; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Monitoring, Physiologic; Radionuclide Imaging; Silicic Acid; Sodium Bicarbonate; Technetium

An open multicenter study was performed to assess the efficacy and safety of alginic acid in two different dosages in 76 pediatric patients with gastroesophageal reflux confirmed by pH monitoring. Among the 69 patients in whom endoscopy was carried out before treatment, 18 had erythematous esophagitis and 5 had erosive esophagitis. Irrespective of the dosage used, the frequency of regurgitation and vomiting decreased significantly (p < 0.00001 and p = 0.01, respectively). Clinical and biochemical tolerance were outstanding and no adverse effects were recorded. On the basis of these data, the recommended dosage is 1 to 2 ml/kg/day in divided doses after meals.

Topics: Alginates; Aluminum Hydroxide; Bicarbonates; Child, Preschool; Drug Combinations; Endoscopy, Gastrointestinal; Female; France; Gastric Acidity Determination; Gastroesophageal Reflux; Humans; Infant; Infant, Newborn; Male; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Cisapride; Drug Combinations; Drug Therapy, Combination; Galactans; Gastroesophageal Reflux; Humans; Infant; Mannans; Piperidines; Plant Gums; Polysaccharides; Serotonin Antagonists; Silicic Acid; Sodium Bicarbonate

This study tested the hypothesis that (alginic) acid may have a preferential effect on reflux in the upright position. We evaluated the effect of a compound containing alginic acid plus antacid (extra-strength Gaviscon) versus active control antacid with equal acid-neutralizing capacity on intraesophageal acid exposure following a high-fat meal (61% fat: sausage, egg, and biscuit). In random sequence, each of the 10 volunteers received either alginic acid-antacid or control antacid immediately following and 1, 2, and 3 hr after the meal. The sequence was repeated for both test drugs in the supine and upright positions with constant pH monitoring. Alginic acid-antacid significantly decreased postprandial reflux in the upright position compared to an equal amount of antacid. This effect did not occur in the supine position. These findings support the hypothesis that alginic acid is primarily effective in the upright position and the clinical observations of the effectiveness of alginic acid on daytime reflux symptoms.

Topics: Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Drug Combinations; Eating; Female; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Monitoring, Physiologic; Posture; Reference Values; Silicic Acid; Sodium Bicarbonate

We compared the efficacy of the prokinetic agent cisapride with that of Gaviscon (an alginate/alkaline compound) plus Carobel (carob seed flour) in the treatment of gastrooesophageal reflux (GOR). Fifty infants with confirmed GOR received either oral cisapride (0.8 mg/kg/day) or Gaviscon plus Carobel for one month in a randomised, parallel group study. Parental evaluations, diary scores, and 24 hour lower oesophageal pH recordings before and at the end of each treatment were compared. In the cisapride group 14/26 (53%) were considered better by their parents compared with 19/24 (79%) of those who received Gaviscon plus Carobel. Diary scores, range (0.00-1.00), improved in both groups with the median change being greater in the Gaviscon plus Carobel group (-0.21) than the cisapride group (-0.15). Five of 17 pH variables had significantly improved from baseline in infants who had received cisapride compared with 11/17 in those receiving Gaviscon plus Carobel. However, unpaired analysis of diary and pH data showed no significant differences between the two groups. We conclude that first line treatment of GOR with cisapride is no more effective than conventional treatment with Gaviscon plus Carobel.

Topics: Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Cisapride; Drug Combinations; Drug Therapy, Combination; Galactans; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Infant; Mannans; Piperidines; Plant Gums; Polysaccharides; Serotonin Antagonists; Silicic Acid; Sodium Bicarbonate

The comparative efficacy of two alginate-containing anti-reflux preparations (Gaviscon, Algicon) was assessed in a single blind crossover study of 20 patients with gastro-oesophageal reflux disease. The clinical efficacy study was preceded by two studies in healthy volunteers to assess the intragastric effects of Algicon and Gaviscon by pH measurement, endoscopic visualization and gamma scintigraphy. Algicon and Gaviscon were shown to form a raft in the fasting and fed human stomach, with Algicon alone having a potent antacid effect below and within the raft. Both Algicon and Gaviscon liquids significantly reduced the frequency and severity of reflux symptoms from baseline when given at their recommended doses (10 ml and 20 ml four times daily, respectively). There were no significant differences between Algicon and Gaviscon, although 12 patients preferred Algicon (vs 5 for Gaviscon) for control of reflux symptoms. It was concluded that both Algicon and Gaviscon were effective for the symptomatic control of gastro-oesophageal reflux disease.

Topics: Adult; Aged; Aged, 80 and over; Alginates; Aluminum Hydroxide; Bicarbonates; Carbonates; Drug Combinations; Endoscopy, Gastrointestinal; Female; Gastric Acid; Gastric Emptying; Gastroesophageal Reflux; Gastrointestinal Contents; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Silicic Acid; Single-Blind Method; Sodium Bicarbonate

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Carbonates; Drug Combinations; England; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Carbonates; Drug Combinations; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate

This randomised double-blind study compared the effects of cimetidine 400 mg four times daily (q.d.s.), Gastrocote (alginic acid, aluminium hydroxide gel, magnesium trisilicate, sodium bicarbonate) two tablets q.d.s. and a combination of both on ambulatory 24-hour oesophageal pH, endoscopic findings and symptoms in patients with reflux oesophagitis. Patients were treated for ten weeks with assessments at entry, after four weeks and at the end of the study. Before treatment, oesophageal pH was less than 5.0 for 25% overall of the 24 hours monitoring in all three treatment groups. After ten weeks, the percentage of time with an oesophageal pH less than 5.0 was 26% on Gastrocote, 26% on cimetidine and 14% on the combination (P less than 0.05, combined therapy versus cimetidine alone). The severity of the heartburn was reduced on all three treatments. The average number of days with heartburn per week was 5.0, 3.6 and 3.4 in the Gastrocote, cimetidine and combined groups respectively. The difference between Gastrocote and the combination was statistically significant (P less than 0.05). There was a clear trend towards improvement of endoscopic oesophagitis at ten weeks in the combined therapy group when compared to single agent treatment with cimetidine or Gastrocote although the difference was not significant due to inadequate numbers. This study indicates that combined cimetidine and Gastrocote is a more effective treatment for reflux oesophagitis than single agent therapy with either drug.

Topics: Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Cimetidine; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Esophagoscopy; Esophagus; Female; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Prospective Studies; Random Allocation; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate

We studied the effects of an alginate compound (Gaviscon) on the frequency and the duration of gastroesophageal reflux (GOR) episodes in children. Twenty infants and children with characteristic symptoms of GOR were divided at random into two groups which were given either Gaviscon (ten patients, mean age: 21 months) or a placebo (ten patients, mean age: 35 months). A continuous pH probe monitoring of the lower oesophageal third was performed in all the patients before and after 8 days of treatment. Before the trial, sensitive pH monitoring variables of acid reflux (Euler-Byrne index, percentage of total reflux time per 24 h, mean duration and percentage of reflux time during sleep, total number of reflux episodes per 24 h and number of reflux episodes per 2 h post-cibal periods) were abnormal in all the patients tested. The oesophagram revealed a GOR in 13 of the 20 patients; none of the children who underwent an endoscopy had evidence of oesophagitis. Episodes of regurgitation reported by the parents decreased during Gaviscon therapy while no clinical improvement was noticed in the placebo group. No adverse effects were observed. After 8 days of treatment with Gaviscon, results of all the pH monitoring variables were significantly (P less than 0.05) reduced between -35% and -61% of the initial values recorded. In the placebo treated group, the mean values remained little changes (-9.5 to +8.2% of initial values). These data suggest that Gaviscon may prove useful in the medical management of GOR in infants and children.

Topics: Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Infant; Male; Monitoring, Physiologic; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate

Topics: Adolescent; Adult; Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Clinical Trials as Topic; Drug Combinations; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Esophagitis, Peptic; Gastroesophageal Reflux; Humans; Obesity; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Esophagitis, Peptic; Gastroesophageal Reflux; Humans; Obesity; Silicic Acid; Sodium Bicarbonate

Research to measure the chemical characterization of alginate rafts for good raft performance and ascertain how formulation can affect chemical parameters.. A selection of alginate formulations was investigated all claiming to be proficient raft formers with significance between products established and ranked.. Procedures were selected which demonstrated the chemical characterization allowing rafts to effectively impede the reflux into the esophagus or in severe cases to be refluxed preferentially into the esophagus and exert a demulcent effect, with focus of current research on methods which complement previous studies centered on physical properties. The alginate content was analyzed by a newly developed HPLC method. Methods were used to determine the neutralization profile and the acid neutralization within the raft determined along with how raft structure affects neutralization.. Alginate content of Gaviscon Double Action (GDA) within the raft was significantly superior (p < .0001) to all competitor products. The two products with the highest raft acid neutralization capacity were GDA and Rennie Duo, the latter product not being a raft former. Raft structure was key and GDA had the right level of porosity to allow for longer duration of neutralization.. Alginate formulations require three chemical reactions to take place simultaneously: transformation to alginic acid, sodium carbonate reacting to form carbon dioxide, calcium releasing free calcium ions to bind with alginic acid providing strength to raft formation. GDA was significantly superior (p <.0001) to all other comparators.

Topics: Alginates; Aluminum Hydroxide; Antacids; Calcium Carbonate; Carbonates; Drug Combinations; Electric Impedance; Esophagus; Gastroesophageal Reflux; Glucuronic Acid; Hexuronic Acids; Humans; Magnesium; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Calcium Carbonate; Drug Combinations; Gastroesophageal Reflux; Humans; Proton Pump Inhibitors; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Topics: Alginates; Aluminum Hydroxide; Drug Combinations; Drug Therapy, Combination; Gastroesophageal Reflux; Humans; Proton Pump Inhibitors; Silicic Acid; Sodium Bicarbonate

The possible pathophysiology of the relationship between gastro-esophageal reflux disease and apnea of prematurity has been widely investigated. Various physiological protective reflex responses provide a plausible biological link between gastro-esophageal reflux and apnea of prematurity. It is uncertain whether or not there is a causal relationship between the two diseases. PATIENT'S FINDINGS: Twins were admitted to the neonatal intensive care unit due to feeding problems. Physical examination was normal except for reticulated, blueviolet skin changes. Short apneic attacks occurred on the first day in twin 1 and on the second day in twin 2, and these were initially treated by stimulation and increased ambient O2 concentration. Then, we conducted methylxanthine and continuous positive airway pressure treatment. Laboratory and radiological analysis were normal. As gastro-esophageal reflux disease was thought to be the causes of the treatment-refractory apnea, therapy with gaviscon and domperidon was begun for both cases. Apneic attacks did not recur after gaviscon and domperidon therapy.. Pharmacological therapy for gastro-esophageal reflux disease has not definitively been shown to be effective in improving symptoms and hence, should be reserved especially for infants with treatment refractory apnea episodes suspected as being gastro-esophageal reflux in premature infants.. 背景：胃食管反流病和早产儿呼吸暂停之间可能的病理生理学机制已被广泛 研究。多种生理保护性反射应答为胃食管反流和早产儿呼吸暂停提供了一个合 理的生物学联系，但二者之间是否存在因果关系尚不确定。患者的研究结 果：双胞胎因为喂养问题被送进新生儿重症监护病房，体格检查发现除了网 状蓝紫色皮肤改变，其它正常。双胞胎1 和双胞胎2 分别在第一天和第二天发 生了短暂的呼吸暂停。最初我们采用刺激和增加环境中氧气浓度来治疗，然后 进行了甲基黄嘌呤和持续气道正压通气治疗。实验室和影像学分析均正常。因 为胃食管反流被认为是难治性呼吸暂停的原因，开始用嘉胃斯康 和 多潘立酮 治疗这两种情况，嘉胃斯康 和 多潘立酮治疗后没有再发生窒息。结论：胃食 管反流病的药物治疗没有明确被证明能有效改善症状，因此，尤其在治疗难治 性呼吸暂停疑似有胃食管反流的早产儿时应谨慎。.

Topics: Alginates; Aluminum Hydroxide; Antacids; Antiemetics; Apnea; Diseases in Twins; Domperidone; Drug Combinations; Gastroesophageal Reflux; Gestational Age; Humans; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Silicic Acid; Sodium Bicarbonate; Twins

Topics: Alginates; Aluminum Hydroxide; Amiodarone; Antacids; Anti-Arrhythmia Agents; Drug Combinations; Drug Interactions; Gastroesophageal Reflux; Humans; Infant; Male; Silicic Acid; Sodium Bicarbonate; Tachycardia, Supraventricular; Treatment Failure

To evaluate the efficacy of alginates in the treatment of postgastroresection reflux esophagitis.. Thirty-four post-Billroth II distal gastrectomy patients with reflux esophagitis and without erosive and ulcerative lesions of the gastric stump and anastomosis, who had received geviscon monotherapy for 6 weeks, were examined. Their symptoms and the data of esophagogastroduodenoscopy and impedance pH monitoring were assessed to control treatment results.. There was statistically significant relief of the subjective (heartburn and bitter taste in the mouth) and objective symptoms of the disease and the reflux esophagitis in geviscon-treated patients.. Geviscon is the drug of choice for treating reflux esophagitis in patients after partial distal gastrectomy provided that the acid-forming function of the gastric mucosa is minimally preserved.

Topics: Alginates; Aluminum Hydroxide; Drug Combinations; Endoscopy, Digestive System; Esophagitis, Peptic; Female; Gastrectomy; Gastroenterostomy; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Topics: Alginates; Aluminum Hydroxide; Animals; Drug Combinations; Gastroesophageal Reflux; Glucuronic Acid; Hexuronic Acids; Humans; Infant Formula; Infant, Newborn; Infant, Premature, Diseases; Milk; Posture; Silicic Acid; Sodium Bicarbonate

Recently, an 'acid pocket' has been described in the proximal stomach, particularly evident postprandially in GERD patients, when heartburn is common. By creating a low density gel 'raft' that floats on top of gastric contents, alginate-antacid formulations may neutralise the 'acid pocket'.. To assess the ability of a commercial high-concentration alginate-antacid formulation to neutralize and/or displace the acid pocket in GERD patients.. The 'acid pocket' was studied in ten symptomatic GERD patients. Measurements were made using concurrent stepwise pH pull-throughs, high resolution manometry and fluoroscopy in a semi-recumbent posture. Each subject was studied in three conditions: fasted, 20 min after consuming a high-fat meal and 20 min later after a 20 mL oral dose of an alginate-antacid formulation (Gaviscon Double Action Liquid, Reckitt Benckiser Healthcare, Hull, UK). The relative position of pH transition points (pH >4) to the EGJ high-pressure zone was analysed.. Most patients (8/10) exhibited an acidified segment extending from the proximal stomach into the EGJ when fasted that persisted postprandially. Gaviscon neutralised the acidified segment in six of the eight subjects shifting the pH transition point significantly away from the EGJ. The length and pressure of the EGJ high-pressure zone were minimally affected.. Gaviscon can eliminate or displace the 'acid pocket' in GERD patients. Considering that EGJ length was unchanged throughout, this effect was likely attributable to the alginate 'raft' displacing gastric contents away from the EGJ. These findings suggest the alginate-antacid formulation to be an appropriately targeted postprandial GERD therapy.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Manometry; Middle Aged; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Topics: Alginates; Aluminum Hydroxide; Antacids; Constipation; Drug Combinations; Gastroesophageal Reflux; Humans; Infant; Patient Positioning; Silicic Acid; Sodium Bicarbonate

To evaluate the diagnostic accuracy of single dose of gaviscon (the alginates test) in detecting gastroesophageal reflux disease (GERD) in patients with heartburn symptoms.. 123 patients (male 46, female 77, age 43.6 +/- 15.5 years) with symptoms suggestive of GERD were investigated. Symptom response to the alginates test compared in GERD positive and GERD negative patients according traditional diagnostic criteria of GERD (upper endoscopy, 24-hr pH-monitoring, esophageal manometry, response to treatment with PPIs).. Of 91 (78.9%) patients with positive alginates test, 87 were classified as GERD positive and 4 as GERD negative. Of 32 (26%) patients with negative alginates test, 29 were GERD negative and 3 GERD positive. The results providing a sensitivity of alginates test of 96.7% and a specificity of 87.7%.. The alginates test is sensitive and specific for diagnosing GERD in patients with typical GERD symptoms.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Biocompatible Materials; Drug Combinations; Endoscopy, Digestive System; Female; Gastroesophageal Reflux; Glucuronic Acid; Hexuronic Acids; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Monitoring, Physiologic; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Female; Gastroesophageal Reflux; Humans; Pregnancy; Pregnancy Complications; Silicic Acid; Sodium Bicarbonate

GERD Therapy at children is complicated task because of Physiological features of a children's body, which reflects on the processes of acid production, motility in upper gastro-intestinal tract and on the metabolism of pharmaceutical products. Some of these medications have age usage limitations due to lack of investigation of side effects in treatment of children. Usage of alginate contain medication in complex therapy of such pathological condition brings to not only fast and effective relief of such symptoms as heartburn, eructation and in positive endoscopy dynamics.

Topics: Adolescent; Alginates; Aluminum Hydroxide; Antacids; Child; Drug Combinations; Female; Gastric Acid; Gastroesophageal Reflux; Humans; Male; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Gastric Mucosa; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Pancreatitis, Chronic; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Gastroesophageal Reflux; Humans; Infant; Research Design; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

Alginate-based preparations act as mechanical antireflux barrier, which can reduce both acid and non-acid reflux events and limit the proximal migration of oesophageal refluxate.. To evaluate all the above features with a novel technique, multichannel electrical impedance and pH-metry.. Ten reflux patients underwent stationary impedancemetry and pH-metry after eating a refluxogenic meal. They were studied 1 h in basal conditions and 1 h after taking 10 mL of Gaviscon Advance. In both sessions, measurements were obtained in right lateral and supine decubitus.. Alginate preparation was able to decrease significantly (P < 0.05) the number of acid reflux events and the percentage time pH < 4.0 compared with baseline. There was no effect of the drug on non-acid refluxes. Gaviscon Advance was also significantly effective (P < 0.05) in reducing the height of proximal migration of reflux events compared with baseline in both decubitus positions.. Our findings explain how Gaviscon Advance controls acid reflux episodes, limits the proximal migration of refluxed material and thereby decreases symptoms in clinical practice.

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Drug Evaluation; Female; Gastric Acid; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Education, Medical, Continuing; Family Practice; Gastroenterology; Gastroesophageal Reflux; Germany; Humans; Peptic Ulcer; Silicic Acid; Sodium Bicarbonate

Sodium alginate (Gaviscon) is used in the management of gastro-oesophageal reflux in infants. No digestive disadvantages have as yet been reported with the use of the Gaviscon formula available in France, which contains neither aluminium hydroxide nor thickener. Twenty-two healthy neonates were prospectively studied before and after Gaviscon treatment in order to characterize their whole gut transit time with the use of a carmine index. The head of the marker appeared within the same time in both experiments but the appearance of the tail was earlier in the treated infants (P < 0.05), without any subsequent clinical consequences. The slight increase shown in the rate of the clearance of the marker from the gut, is likely to be related to a less proximal to distal dispersion of the marker, subsequently to physical changes occurring in the viscous alginate. Frequency and consistency of the stools were unmodified by treatment and accordingly Gaviscon can be regarded as having no deleterious effect on transit time in neonates.

Topics: Alginates; Aluminum Hydroxide; Antacids; Drug Combinations; Gastroesophageal Reflux; Gastrointestinal Transit; Glucuronic Acid; Hexuronic Acids; Humans; Infant, Low Birth Weight; Infant, Newborn; Prospective Studies; Silicic Acid; Sodium Bicarbonate

Forty-five patients with histologically proven Barrett's columnar-lined oesophagus (CLO) were treated in one unit over a 9-year period. Patients were studied prospectively as part of a surveillance programme; all initially received standard conservative treatment including high-dose H2-receptor antagonists. A satisfactory initial response was seen in 21 patients, but in 24 the symptoms were unchanged or progressed; 19 patients in the latter group were considered suitable for antireflux surgery and underwent fundoplication. Symptoms of heartburn or dysphagia persisted or recurred in 88 per cent of patients receiving medical treatment alone and complications developed in 38 per cent, including nine strictures and one adenocarcinoma. In patients undergoing antireflux surgery, symptoms persisted or recurred in 21 per cent and complications developed in 16 per cent (P < 0.01). Complete regression of Barrett's CLO occurred in two patients (11 per cent) after antireflux surgery. The results of this study suggest the superiority of antireflux surgery over pharmacological acid suppression in the control of symptoms and prevention of complications in patients with Barrett's CLO.

Topics: Adult; Aged; Aged, 80 and over; Alginates; Aluminum Hydroxide; Antacids; Barrett Esophagus; Bicarbonates; Drug Combinations; Esophagus; Female; Gastric Fundus; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Postoperative Complications; Prospective Studies; Ranitidine; Silicic Acid; Sodium Bicarbonate; Treatment Outcome

The effects of gastroesophageal mucosal coating agents could be related to a) the decrease of aggressive contents of gastric juice and/or b) the presence of a pH gradient between intraluminal (IL) contents and mucosa. Antacid capacities of Gaviscon and Topaal, containing sodium alginate or alginic acid, respectively, were measured using the "artificial stomach" model. This model, reproducing two major gastric dynamic functions, secretion and gastric emptying, allows to evaluate the pH variations in the IL contents and at its surface, by a double pH metric recording. Experiments were performed when drugs to be tested were added either to 100 ml of human gastric juice (100 mmol/l or 88 mmol/l with biliary reflux) or to 100 ml of 0.1 N HCl, without and with 1 percent meat extract. Simulated secretion was represented by a 3 ml/min flux of either 0.1 N HCl or gastric juice and "gastric emptying" fluxes varied from 1.5, 3.0 to 4.5 ml/min. When 0.1 N HCl solution was used, the pH levels at the surface of IL contents were close to pH 3.0 when intragastric pH reached pH 1.0 independently of "gastric" emptying flux variations. In the presence of proteins or biliary reflux material, these pH levels were higher, close to pH 4.5 and persisted for a longer time. Antacid activity was calculated as the resistance to acidification of the IL contents, as the amount of H+ ions consumed after addition of antacid to recover initial pH, i.e. 37 and 22 mmol in human gastric juice, between 37 and 17.5 mmol in 0.1 N HCl for Gaviscon and Topaal, according to emptying fluxes.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Chlorates; Drug Combinations; Gastric Juice; Gastric Mucosa; Gastroesophageal Reflux; Glucuronic Acid; Hexuronic Acids; Humans; Hydrogen-Ion Concentration; Models, Biological; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate; Time Factors

335 general practitioners participated in an observational study of the alginic acid-containing antacid preparation Gaviscon over a period of eight months. In this period, 2927 patients with reflux disease were treated. Some 62.3% of the patients were treated for six to eight days. Both the tablet and suspension forms of the drug were considered to be effective by both physician and patient in more than 94% of the cases. Drug toleration was also considered good in more than 95% of the cases. The taste of Gaviscon was described as good by 54.7% of the patients, and acceptable by 33.5%. Pregnant women with reflux symptoms were observed in a separate group (n = 52).

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Child; Child, Preschool; Drug Combinations; Female; Gastroesophageal Reflux; Humans; Infant; Male; Middle Aged; Pregnancy; Pregnancy Complications; Silicic Acid; Sodium Bicarbonate

Topics: Alginates; Aluminum; Aluminum Hydroxide; Antacids; Bicarbonates; Drug Combinations; Drug Evaluation; Gastroesophageal Reflux; Humans; Infant, Newborn; Intestinal Absorption; Male; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate

Forty bottle-fed babies, 4-12 weeks old, with clinical gastro-oesophageal reflux were studied. Continuous 24 h oesophageal pH monitoring in a prone position demonstrated a gastro-oesophageal reflux with all of the following parameters: reflux index, duration of the longest reflux episode, number of reflux episodes in 24 h, number of reflux episodes greater than 5 min in 24 h. Positional therapy (prone-antitrendelenburg position), applied to all infants, resulted in a normalization of these parameters in ten of them. The remaining 30 infants were treated with milk-thickening agents, as recommended by Carre. Nearly all (N = 25) showed an important clinical improvement. A third pH monitoring was performed after 10-14 days of treatment. In six infants the results were completely within normal ranges. In 24 infants a decrease in the number of reflux episodes was demonstrated, with a comparable reflux index and number of long lasting reflux episodes. The duration of the longest reflux episode however increased significantly (P less than 0.001). Drugs (domperidone, Gaviscon) added to the milk-thickening agents in these 24 children, led to normalization of pH tracings. Clinical symptoms were less severe or disappeared in all infants but one. We conclude that if positional therapy (prone-antitrendelenburg) does not correct gastro-oesophageal reflux in infants, pharmacological treatment should be applied. Milk-thickening agents alone can be effective in individual cases but should be prescribed with care as they can lead to more occult gastro-oesophageal reflux with episodes of longer duration, increasing the risk of oesophagitis or respiratory distress.

Topics: Alginates; Aluminum Hydroxide; Bicarbonates; Domperidone; Drug Combinations; Gastric Acidity Determination; Gastroesophageal Reflux; Humans; Infant; Infant Food; Microcomputers; Posture; Silicic Acid; Sodium Bicarbonate

The medical therapy of reflux esophagitis consists of modifications of the patients's lifestyle and antacids, alginic acid or both (phase I). Phase II medications include drugs that suppress acid/peptic activity (antacid/alginate, H2-receptor blockers, cimetidine, ranitidine, famotidine), drugs that enhance motility (metoclopramide, domperidone) and drugs that coat and increase mucosal protection (sucralfate). Combinations of H2-receptor blockers and motility stimulating drugs have not been very effective. Overall the results of medical therapy of reflux esophagitis are suboptimal.

Topics: Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Combined Modality Therapy; Dilatation; Domperidone; Drug Combinations; Esophagitis, Peptic; Gastroesophageal Reflux; Histamine H2 Antagonists; Humans; Metoclopramide; Peristalsis; Silicic Acid; Sodium Bicarbonate; Sucralfate

Topics: Administration, Oral; Adult; Aged; Alginates; Aluminum Hydroxide; Bicarbonates; Drug Combinations; Gastroesophageal Reflux; Humans; Middle Aged; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate; Solutions

The technique of gastroesophageal scintigraphy was developed in order to quantitatively detect reflux from the stomach into the esophagus. The scintigraphic technique was compared to previous diagnostic tests including barium esophagography, fluoroscopy, endoscopy, esophageal biopsy, the acid perfusion test, esophageal manometry, and the acid reflux test. None of the other techniques is as sensitive as gastroesophageal scintigraphy for the detection of reflux, in comparison to the acid reflux test. Gastroesophageal scintigraphy is able to detect gastroesophageal reflux accurately, rapidly, noninvasively, and more sensitively than other diagnostic techniques. In addition, it is able to be employed to quantitate reflux and is suitable for studying the effects of various therapeutic modalities.

Topics: Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Bethanechol Compounds; Bicarbonates; Drug Combinations; Esophagogastric Junction; Esophagus; Female; Gastroesophageal Reflux; Humans; Male; Methods; Middle Aged; Posture; Radionuclide Imaging; Silicic Acid; Sodium Bicarbonate; Stomach

This study was designed to evaluate quantitatively the mode of action of alginic acid compound (AAC) in the treatment of patients with symptomatic gastroesophageal reflux. Gastroesophageal scintigraphy using an orall administered Tc-99m sulfur colloid solution was used to demonstrate that AAC decreased significantly the gastroesophageal reflux index from (9.9 +/- 1.3) % to (6.5 +/- 0.8) % (p less than 0.05). No alteration of lower esophageal sphincter pressure was observed. After ACC was suitably labeled with Sr-87m, a dual-nuclide scintigraphic technique was used to show that most (greater than 75%) of the AAC was located in the upper half of the stomach in both normal subjects and patients with gastroesophageal reflux. In those subjects in whom reflux did occur after treatment with AAC, the Sr-87m-AAC refluxed into the esophagus preferentially compared with the liquid containing Tc-99m sulfur colloid. These findings suggest that AAC dimishes gastroesophageal reflux by means of its foaming, floating, and viscous properties.

Topics: Adult; Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Drug Combinations; Esophagogastric Junction; Gastroesophageal Reflux; Humans; Middle Aged; Pressure; Radionuclide Imaging; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate; Viscosity

Topics: Alginates; Aluminum Hydroxide; Antacids; Bicarbonates; Child, Preschool; Drug Combinations; Female; Gastroesophageal Reflux; Humans; Infant; Male; Silicic Acid; Silicon Dioxide; Sodium Bicarbonate