Randomised clinical trial: relief of upper gastrointestinal symptoms by an acid pocket-targeting alginate-antacid (Gaviscon Double Action) - a double-blind, placebo-controlled, pilot study in gastro-oesophageal reflux disease

Aliment Pharmacol Ther. 2014 Mar;39(6):595-602. doi: 10.1111/apt.12640. Epub 2014 Jan 28.

Abstract

Background: 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.

Aim: 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.

Methods: 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).

Results: 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.

Conclusions: 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).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alginates / adverse effects
  • Alginates / therapeutic use*
  • Aluminum Hydroxide / adverse effects
  • Aluminum Hydroxide / therapeutic use*
  • Antacids / adverse effects
  • Antacids / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Dyspepsia / drug therapy
  • Female
  • Gastroesophageal Reflux / drug therapy*
  • Gastroesophageal Reflux / physiopathology
  • Heartburn / drug therapy
  • Heartburn / etiology
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Silicic Acid / adverse effects
  • Silicic Acid / therapeutic use*
  • Sodium Bicarbonate / adverse effects
  • Sodium Bicarbonate / therapeutic use*
  • Treatment Outcome

Substances

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