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


CONCLUSIONS
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.
Veldhuyzen van Zanten
S J
SJ
Division of Gastroenterology, Dalhousie University, Victoria General Hospital, Halifax Nova Scotia, Canada.
D004415:Dyspepsia / Q000188:drug therapy*; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic