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.