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

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


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.

Publication types

  • Meta-Analysis
  • Research Support, N.I.H., Extramural

MeSH terms

  • Gastroesophageal Reflux / drug therapy*
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Placebo Effect
  • Placebos / therapeutic use
  • Randomized Controlled Trials as Topic
  • Statistics as Topic
  • Treatment Outcome


  • Gastrointestinal Agents
  • Placebos