title: Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Gastroenterology, Department of Medicine, Dalhousie University, Halifax, Canada.
authors.forename: S J
authors.initials: SJ
authors.lastname: Veldhuyzen van Zanten
authors.forename: C
authors.initials: C
authors.lastname: Cleary
authors.forename: N J
authors.initials: NJ
authors.lastname: Talley
authors.forename: T C
authors.initials: TC
authors.lastname: Peterson
authors.forename: O
authors.initials: O
authors.lastname: Nyrén
authors.forename: L A
authors.initials: LA
authors.lastname: Bradley
authors.forename: M
authors.initials: M
authors.lastname: Verlinden
authors.forename: G N
authors.initials: GN
authors.lastname: Tytgat
mesh_terms: D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy* / Q000453:epidemiology; D016481:Helicobacter Infections / Q000188:drug therapy; D016480:Helicobacter pylori; D006801:Humans; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design