Randomised clinical trial: the clinical efficacy and safety of an alginate-antacid (Gaviscon Double Action) versus placebo, for decreasing upper gastrointestinal symptoms in symptomatic gastroesophageal reflux disease (GERD) in China

Aliment Pharmacol Ther. 2015 Oct;42(7):845-54. doi: 10.1111/apt.13334. Epub 2015 Jul 31.

Abstract

Background: 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.

Aim: 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.

Methods: 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).

Results: 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.

Conclusion: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Retracted Publication

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Alginates / adverse effects
  • Alginates / therapeutic use*
  • Aluminum Hydroxide / adverse effects
  • Aluminum Hydroxide / therapeutic use*
  • Antacids / therapeutic use
  • Anti-Ulcer Agents / adverse effects
  • Anti-Ulcer Agents / therapeutic use*
  • China / epidemiology
  • Double-Blind Method
  • Drug Combinations
  • Dyspepsia / drug therapy*
  • Dyspepsia / epidemiology
  • Female
  • Gastroesophageal Reflux / drug therapy*
  • Gastroesophageal Reflux / epidemiology
  • Heartburn / drug therapy*
  • Heartburn / epidemiology
  • Humans
  • Laryngopharyngeal Reflux / drug therapy*
  • Laryngopharyngeal Reflux / epidemiology
  • Male
  • Middle Aged
  • Placebos
  • Silicic Acid / adverse effects
  • Silicic Acid / therapeutic use*
  • Sodium Bicarbonate / adverse effects
  • Sodium Bicarbonate / therapeutic use*
  • Surveys and Questionnaires
  • Treatment Outcome
  • Upper Gastrointestinal Tract / drug effects*
  • Upper Gastrointestinal Tract / pathology
  • Young Adult

Substances

  • Alginates
  • Antacids
  • Anti-Ulcer Agents
  • Drug Combinations
  • Placebos
  • Silicic Acid
  • Aluminum Hydroxide
  • alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
  • Sodium Bicarbonate

Associated data

  • ClinicalTrials.gov/NCT01869491