A systematic overview (meta-analysis) of outcome measures in Helicobacter pylori gastritis trials and functional dyspepsia.

STUDY AIM: To critically appraise the use of outcome measures in treatment trials of Helicobacter pylori positive non-ulcer dyspepsia patients.

METHODS

Meta-analysis of published randomized placebo-controlled clinical trials.

RESULTS

Significant methodological problems were detected in all seven retrieved studies. There is marked variation in measurement of: symptoms, scales used to assess severity of dyspepsia, use of global assessments and methods used to determine whether a change occurred in symptom severity.

CONCLUSION

Much more attention needs to be paid to outcome measures in non-ulcer dyspepsia trials and consensus on this should be reached by investigators in this area.