Effects of proton-pump inhibitors on functional dyspepsia: a meta-analysis of randomized placebo-controlled trials.

BACKGROUND & AIMS The aim of this study was to assess systematically the efficacy of proton pump inhibitors (PPIs) in the treatment of functional dyspepsia compared with placebo and to determine if any difference in the response exists between symptom subgroups of functional dyspepsia. METHODS A literature search was performed through September 2005 in PubMed, Medline, Embase, CINAHL, and Cochrane databases to include randomized, double-blind, placebo-controlled trials evaluating the efficacy of PPIs for the treatment of functional dyspepsia. Relative risk (RR) and relative risk reduction (RRR) and 95% confidence intervals (CI) were calculated under a random-effects model. RESULTS Seven studies with a total of 3725 patients were identified. PPIs were found to be more effective than placebo for reducing symptoms in patients with functional dyspepsia (RRR, 10.3%; 95% CI, 2.7%-17.3%). The estimated number needed to treat is 14.6 (95% CI, 8.7-57.1). When stratified analyses were performed, a significant difference in the efficacy was observed only in patients with ulcer-like (RRR, 12.8%; 95% CI, 7.2%-18.1%) and reflux-like dyspepsia (RRR, 19.7%; 95% CI, 1.8%-34.3%), but not in those with dysmotility-like (RRR, 5.1%; 95% CI, -10.9% to 18.7%) and unspecified dyspepsia (RRR, -8.0%; 95% CI, -23.7% to 5.6%). The effect of H pylori on the efficacy of PPIs remains unclear. Significant heterogeneity among studies was found for the overall analysis, dysmotility-like dyspepsia, H pylori-negative subgroup, and different dose subgroups. CONCLUSIONS PPIs are more effective than placebo for the management of patients with ulcer-like and reflux-like functional dyspepsia.