title: 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: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: J
authors.initials: J
authors.lastname: Sun
authors.affiliation: Shanghai Tongji Hospital, Shanghai, China.
authors.forename: C
authors.initials: C
authors.lastname: Yang
authors.affiliation: China-Japan Friendship Hospital, Beijing, China.
authors.forename: H
authors.initials: H
authors.lastname: Zhao
authors.affiliation: Zhejiang Hospital, Hangzhou, China.
authors.forename: P
authors.initials: P
authors.lastname: Zheng
authors.affiliation: Reckitt Benckiser, Slough, UK.
authors.forename: J
authors.initials: J
authors.lastname: Wilkinson
authors.affiliation: Reckitt Benckiser, Slough, UK.
authors.forename: B
authors.initials: B
authors.lastname: Ng
authors.affiliation: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Yuan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000464:Alginates / Q000009:adverse effects / Q000627:therapeutic use*; D000536:Aluminum Hydroxide / Q000009:adverse effects / Q000627:therapeutic use*; D000863:Antacids / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China / Q000453:epidemiology; D004311:Double-Blind Method; D004338:Drug Combinations; D004415:Dyspepsia / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000453:epidemiology; D006356:Heartburn / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D057045:Laryngopharyngeal Reflux / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012824:Silicic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D017693:Sodium Bicarbonate / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D041742:Upper Gastrointestinal Tract / Q000187:drug effects* / Q000473:pathology; D055815:Young Adult
chemical_list: D000464:Alginates; D000863:Antacids; D000897:Anti-Ulcer Agents; D004338:Drug Combinations; D010919:Placebos; D012824:Silicic Acid; D000536:Aluminum Hydroxide; C007829:alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination; D017693:Sodium Bicarbonate