Retracted: 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

Abstract

SummaryBackgroundThere 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.AimRandomised 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.MethodsParticipants 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).ResultsMean 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.ConclusionGaviscon DA tablets provide effective and safe reduction in acid reflux and dyspepsia symptoms in Chinese individuals with mild‐to‐moderate GERD. ClinicalTrials.gov: NCT01869491

Alginate antacid (Gaviscon DA) chewable tablets reduce esophageal acid exposure in Chinese patients with gastroesophageal reflux disease and heartburn symptoms

“…This was a randomized, double‐blind, placebo‐controlled study that used a validated patient‐reported outcome instrument, the reflux disease questionnaire, as the primary end‐point. Chinese GERD patients receiving DA alginate antacid tablets reported statistically significantly greater improvement in GERD symptoms (heartburn, regurgitation and dyspepsia) after 7 days of treatment . Taken together, findings from the pH monitoring and symptom relief studies support the efficacy of DA alginate antacid tablets for treating post‐prandial acid reflux and heartburn, and for short‐term symptom relief in GERD.…”

Topiramate modulates trigeminal pain processing in thalamo-cortical networks in humans after single dose administration

“…Placebo pills contained medically non-effective mannitol [15,16] (Mannitol 99.5 T, highly-dispersed silicon dioxide 0.5 T) and matched the topiramate pills in appearance. Blood samples were drawn 60 min after administration to determine the topiramate plasma concentration at its peak, shortly before the start of the MR measurement.…”

Editorial: alginate-antacid combinations in erosive oesophagitis - picking the acid pocket. Authors' reply

“…The authors' declarations of personal and financial interests are unchanged from those in the original article. 2…”