Systematic review: The methodological quality of trials affects estimates of treatment efficacy in functional (non-ulcer) dyspepsia

Neena Susan Abraham, P. Moayyedi, B. Daniels, S. J O Veldhuyzen Van Zanten

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Abstract

Aim: To evaluate treatment efficacy using objective quality criteria. Methods: 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. Results: 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 H2-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 Helicobacter pylori 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. Conclusions: The magnitude of benefit of prokinetic and H2-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.

Original languageEnglish (US)
Pages (from-to)631-641
Number of pages11
JournalAlimentary Pharmacology and Therapeutics
Volume19
Issue number6
DOIs
StatePublished - Mar 15 2004
Externally publishedYes

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Dyspepsia
Confidence Intervals
Histamine H2 Receptors
Guidelines
Proton Pump Inhibitors
Helicobacter pylori
Meta-Analysis
Therapeutics
Randomized Controlled Trials

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Systematic review : The methodological quality of trials affects estimates of treatment efficacy in functional (non-ulcer) dyspepsia. / Abraham, Neena Susan; Moayyedi, P.; Daniels, B.; Veldhuyzen Van Zanten, S. J O.

In: Alimentary Pharmacology and Therapeutics, Vol. 19, No. 6, 15.03.2004, p. 631-641.

Research output: Contribution to journalArticle

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abstract = "Aim: To evaluate treatment efficacy using objective quality criteria. Methods: 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. Results: 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 H2-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 Helicobacter pylori 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. Conclusions: The magnitude of benefit of prokinetic and H2-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.",
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