DRUG-TREATMENT OF FUNCTIONAL DYSPEPSIA - A SYSTEMATIC ANALYSIS OF TRIAL METHODOLOGY WITH RECOMMENDATIONS FOR DESIGN OF FUTURE TRIALS

Objectives: To evaluate drug treatment of functional dyspepsia (includ ing Helicobacter pylori) and provide guidelines for future trials base d on a critical systematic overview of published studies. Methods: Dat a sources were a Medline search for articles published in English goin g back to 1966 and a manual search of four GI journals going back to 1 980. Original randomized, double-blind, placebo-controlled trials were selected that enrolled at least 20 patients. Using a standardized, pr etested data extraction form, studies were evaluated independently by two observers for study design, outcome measures, and results. Results : Fifty two eligible studies were evaluated. Many studies suffered fro m important weaknesses in study design and execution. Only five studie s used previously validated outcome measures. Conclusions: Because of suboptimal design and/or unclear presentation of the data, none of the trials provided unequivocal evidence that there is efficacious therap y for the treatment of functional dyspepsia.