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Aliment Pharmacol Ther. 2010 Jul;32(1):29-42. doi: 10.1111/j.1365-2036.2010.04315.x. Epub 2010 Mar 26.

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

Author information

1
Beth Israel Deaconess Medical Center, Boston, MA, USA.

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.

PMID:
20353496
PMCID:
PMC3150180
DOI:
10.1111/j.1365-2036.2010.04315.x
[Indexed for MEDLINE]
Free PMC Article
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