PMID- 26228097
OWN - NLM
STAT- MEDLINE
DCOM- 20160412
LR  - 20181202
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Print)
IS  - 0269-2813 (Linking)
VI  - 42
IP  - 7
DP  - 2015 Oct
TI  - 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.
PG  - 845-54
LID - 10.1111/apt.13334 [doi]
AB  - 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 (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. 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: NCT01869491.
CI  - (c) 2015 The Authors. Alimentary Pharmacology & Therapeutics Published by John 
      Wiley & Sons Ltd.
FAU - Sun, J
AU  - Sun J
AD  - Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 
      China.
FAU - Yang, C
AU  - Yang C
AD  - Shanghai Tongji Hospital, Shanghai, China.
FAU - Zhao, H
AU  - Zhao H
AD  - China-Japan Friendship Hospital, Beijing, China.
FAU - Zheng, P
AU  - Zheng P
AD  - Zhejiang Hospital, Hangzhou, China.
FAU - Wilkinson, J
AU  - Wilkinson J
AD  - Reckitt Benckiser, Slough, UK.
FAU - Ng, B
AU  - Ng B
AD  - Reckitt Benckiser, Slough, UK.
FAU - Yuan, Y
AU  - Yuan Y
AD  - Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 
      China.
LA  - eng
SI  - ClinicalTrials.gov/NCT01869491
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Retracted Publication
DEP - 20150731
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Alginates)
RN  - 0 (Antacids)
RN  - 0 (Anti-Ulcer Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Placebos)
RN  - 1343-98-2 (Silicic Acid)
RN  - 5QB0T2IUN0 (Aluminum Hydroxide)
RN  - 66220-44-8 (alginate, aluminium hydroxide, magnesium trisilicate, sodium 
      bicarbonate drug combination)
RN  - 8MDF5V39QO (Sodium Bicarbonate)
SB  - IM
CIN - Aliment Pharmacol Ther. 2015 Nov;42(10):1232. PMID: 26449861
RIN - Aliment Pharmacol Ther. 2018 Nov;48(9):1039. PMID: 30318684
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Alginates/adverse effects/*therapeutic use
MH  - Aluminum Hydroxide/adverse effects/*therapeutic use
MH  - Antacids/therapeutic use
MH  - Anti-Ulcer Agents/adverse effects/*therapeutic use
MH  - China/epidemiology
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Dyspepsia/*drug therapy/epidemiology
MH  - Female
MH  - Gastroesophageal Reflux/*drug therapy/epidemiology
MH  - Heartburn/*drug therapy/epidemiology
MH  - Humans
MH  - Laryngopharyngeal Reflux/*drug therapy/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Silicic Acid/adverse effects/*therapeutic use
MH  - Sodium Bicarbonate/adverse effects/*therapeutic use
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Upper Gastrointestinal Tract/*drug effects/pathology
MH  - Young Adult
PMC - PMC5042071
EDAT- 2015/08/01 06:00
MHDA- 2016/04/14 06:00
PMCR- 2016/09/29
CRDT- 2015/08/01 06:00
PHST- 2015/03/31 00:00 [received]
PHST- 2015/06/26 00:00 [revised]
PHST- 2015/07/06 00:00 [accepted]
PHST- 2015/08/01 06:00 [entrez]
PHST- 2015/08/01 06:00 [pubmed]
PHST- 2016/04/14 06:00 [medline]
PHST- 2016/09/29 00:00 [pmc-release]
AID - APT13334 [pii]
AID - 10.1111/apt.13334 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2015 Oct;42(7):845-54. doi: 10.1111/apt.13334. Epub 2015 
      Jul 31.