Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials

Am J Gastroenterol. 1996 Apr;91(4):660-73.


Objectives: To evaluate drug treatment of functional dyspepsia (including Helicobacter pylori) and provide guidelines for future trials based on a critical systematic overview of published studies.

Methods: Data sources were a Medline search for articles published in English going back to 1966 and a manual search of four GI journals going back to 1980. Original randomized, double-blind, placebo-controlled trials were selected that enrolled at least 20 patients. Using a standardized, pretested 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 from important weaknesses in study design and execution. Only five studies 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 therapy for the treatment of functional dyspepsia.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Double-Blind Method
  • Dyspepsia / drug therapy*
  • Dyspepsia / epidemiology
  • Helicobacter Infections / drug therapy
  • Helicobacter pylori
  • Humans
  • Outcome Assessment, Health Care
  • Patient Selection
  • Randomized Controlled Trials as Topic
  • Research Design