alginate--aluminium-hydroxide--magnesium-trisilicate--sodium-bicarbonate-drug-combination and Dyspepsia

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

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