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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.

作者信息

Sun J, Yang C, Zhao H, Zheng P, Wilkinson J, Ng B, Yuan Y

机构信息

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

Shanghai Tongji Hospital, Shanghai, China.

出版信息

Aliment Pharmacol Ther. 2015 Oct;42(7):845-54. doi: 10.1111/apt.13334. Epub 2015 Jul 31.


DOI:10.1111/apt.13334
PMID:26228097
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5042071/
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. 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.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d3d/5042071/93fc60bcdb76/APT-42-845-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d3d/5042071/7d0a2f67da27/APT-42-845-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d3d/5042071/93fc60bcdb76/APT-42-845-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d3d/5042071/7d0a2f67da27/APT-42-845-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d3d/5042071/93fc60bcdb76/APT-42-845-g002.jpg

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[1]
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.

Aliment Pharmacol Ther. 2015-10

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本文引用的文献

[1]
Gaviscon Double Action Liquid (antacid & alginate) is more effective than antacid in controlling post-prandial oesophageal acid exposure in GERD patients: a double-blind crossover study.

Aliment Pharmacol Ther. 2014-9

[2]
Proton pump inhibitors reduce the size and acidity of the acid pocket in the stomach.

Clin Gastroenterol Hepatol. 2014-4-12

[3]
Randomised clinical trial: relief of upper gastrointestinal symptoms by an acid pocket-targeting alginate-antacid (Gaviscon Double Action) - a double-blind, placebo-controlled, pilot study in gastro-oesophageal reflux disease.

Aliment Pharmacol Ther. 2014-1-28

[4]
Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review.

Gut. 2013-7-13

[5]
An alginate-antacid formulation localizes to the acid pocket to reduce acid reflux in patients with gastroesophageal reflux disease.

Clin Gastroenterol Hepatol. 2013-5-10

[6]
The acid pocket: a target for treatment in reflux disease?

Am J Gastroenterol. 2013-4-30

[7]
Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial.

BMC Gastroenterol. 2012-2-23

[8]
Efficacy of adding sodium alginate to omeprazole in patients with nonerosive reflux disease: a randomized clinical trial.

Dis Esophagus. 2011-11-2

[9]
An alginate-antacid formulation (Gaviscon Double Action Liquid) can eliminate or displace the postprandial 'acid pocket' in symptomatic GERD patients.

Aliment Pharmacol Ther. 2011-5-3

[10]
Epidemiology of gastroesophageal reflux disease in Asia: a systematic review.

J Neurogastroenterol Motil. 2011-1-26

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