Randomized clinical trial: a double-blind, placebo-controlled study to assess the clinical efficacy and safety of alginate–antacid (Gaviscon Double Action) chewable tablets in patients with gastro-oesophageal reflux disease

Abstract

Background 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. Aim 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. Participants and methods 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. Results 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. Conclusion The alginate–antacid combination, Gaviscon DA, is an effective and well-tolerated treatment to reduce reflux symptoms and associated dyspepsia in symptomatic GERD patients.

An update on current treatment strategies for laryngopharyngeal reflux symptoms

“…11 Placebo-controlled trials demonstrate significant symptom improvement with alginates in patients with typical GERD symptoms. 39,40 Alginates also improve symptoms in LPR patients. In one randomized controlled trial of patients with RSI scores of >10 and RFSs of >5, the group that received Gaviscon Advance had greater symptom improvement at 2, 4, and 6 months after treatment as well as laryngoscopic improvement per the RFS at 6 months compared with the group that received no treatment.…”

“…Alginates are often used as an adjunct to PPI therapy in patients with GERD who have not symptomatically improved with acid suppression 11 . Placebo‐controlled trials demonstrate significant symptom improvement with alginates in patients with typical GERD symptoms 39,40 …”

2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease

“…[235][236][237] Alginate showed a better clinical effect in reducing reflux-related symptoms than placebo or non-alginate antiacid. 238,239 In a meta-analysis, alginate-antacid also showed 60.0% relative benefit compared to placebo. 240 A RCT in patients with NERD showed that alginate had similar clinical efficacy compared with PPI.…”

Management of upper gastrointestinal symptoms in patients with autoimmune gastritis

“…For example, the Gaviscon Advance version available in the U.K. contains 1000 mg of sodium alginate, meanwhile, the U.S. version contains only 250 mg of sodium alginate [73]. Alginates have been effective in the treatment of heartburn, regurgitation, and dyspepsia in patients with general GERD symptoms, before differentiation of nonacid vs. acid reflux on pH impedance studies [74,75]. Conversely, sucralfate has not been studied in AIG patients.…”