The methodological quality of trials affects estimates of treatment efficacy in functional (non‐ulcer) dyspepsia

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<jats:title>Summary</jats:title><jats:p><jats:bold>Aim</jats:bold> : To evaluate treatment efficacy using objective quality criteria.</jats:p><jats:p><jats:bold>Methods</jats:bold> : A systematic review was performed of randomized controlled trials of endoscopically investigated dyspepsia (1979–2003) using the Jadad score and Rome II guidelines. The Jadad score differentiated studies as ‘high quality’ (score 4–5/5) vs. ‘poor quality’ (score 1–3/5). Three key Rome II guidelines on study design (cut‐off of 0/3 or > 0/3) were also compared with the Jadad score.</jats:p><jats:p><jats:bold>Results</jats:bold> : Poor quality trials suggested a benefit of prokinetic therapy [relative risk (RR) of remaining dyspeptic, 0.47; 95% confidence interval (CI), 0.39–0.56), which was not confirmed in high quality trials (RR, 1.0; 95% CI, 0.84–1.19). There was a marked benefit of H<jats:sub>2</jats:sub>‐receptor antagonist therapy in poor quality trials (RR, 0.68; 95% CI, 0.61–0.76), but a marginal benefit in good quality trials (RR, 0.87; 95% CI, 0.79–0.97). Trial quality did not affect the small statistically significant benefit seen with <jats:italic>Helicobacter pylori</jats:italic> eradication. Two high quality trials suggested a limited benefit with the use of proton pump inhibitors, with no poor quality trials to provide a comparison. Separation of the studies by the Rome II criteria had a similar impact on the calculated treatment estimates.</jats:p><jats:p><jats:bold>Conclusions</jats:bold> : The magnitude of benefit of prokinetic and H<jats:sub>2</jats:sub>‐receptor antagonist therapies reported in previous meta‐analyses has been over‐estimated. The quality of trials has an impact on the efficacy estimates of treatment. The Rome II criteria for study methodology may be appropriate for judging study quality.</jats:p>

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