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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
Author(s) -
Sun J.,
Yang C.,
Zhao H.,
Zheng P.,
Wilkinson J.,
Ng B.,
Yuan Y.
Publication year - 2015
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13334
Subject(s) - gerd , antacid , medicine , heartburn , placebo , reflux , gastroenterology , incidence (geometry) , regurgitation (circulation) , clinical trial , disease , pathology , physics , alternative medicine , optics
Summary 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 ( AE s). 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 AE s 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: NCT 01869491