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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Meta-analysis: the effects of placebo treatment on gastro-oesophageal reflux disease

Review published: 2010.

Bibliographic details: Cremonini F, Ziogas DC, Chang HY, Kokkotou E, Kelley JM, Conboy L, Kaptchuk TJ, Lembo AJ.  Meta-analysis: the effects of placebo treatment on gastro-oesophageal reflux disease. Alimentary Pharmacology and Therapeutics 2010; 32(1): 29-42. [PMC free article: PMC3150180] [PubMed: 20353496]

Quality assessment

The authors concluded that the placebo response rate in controlled trials of patients with gastro-oesophageal reflux disease was substantial; it appeared to be independent of erosive/non-erosive oesophagitis, but related to the class of acid suppression treatment studied. These conclusions appeared to reflect the evidence, but incomplete review methodology reporting and differences between trials make it difficult to assess their reliability. Full critical summary

Abstract

BACKGROUND: There appears to be a significant placebo response rate in clinical trials for gastro-oesophageal reflux disease. Little is known about the determinants and the circumstances associated with placebo response in the treatment of gastro-oesophageal reflux disease (GERD).

AIMS: To estimate the magnitude of the placebo response rate in randomized controlled trials for GERD and to identify factors that influence this response.

METHODS: A meta-analysis of randomized, double-blind, placebo-controlled trials, published in English language, which included >20 patients with GERD, treated with either a proton pump inhibitor or H(2)-receptor antagonist for at least 2 weeks. Medline, Cochrane and EMBASE databases were searched, considering only studies that reported a global response for 'heartburn'.

RESULTS: A total of 24 studies included 9989 patients with GERD. The pooled odds ratio (OR) for response to active treatment vs. placebo was 3.71 (95% CI: 2.78-4.96). The pooled estimate of the overall placebo response was 18.85% (range 2.94%-47.06%). Patients with erosive oesophagitis had a non-significantly lower placebo response rate than patients without it (11.87% and 18.31%, respectively; P = 0.246). Placebo response was significantly lower in studies of PPI therapy vs. studies of H(2) RAs (14.51% vs. 24.69%, respectively; P = 0.05).

CONCLUSIONS: The placebo response rate in randomized controlled trials for GERD is substantial. A lower placebo response was associated with the testing of PPIs, but not the presence of erosive oesophagitis.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2012 University of York.

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