title: Design of treatment trials for functional gastrointestinal disorders.
abstract: Until recently many clinical trials of functional gastrointestinal disorders (FGIDs) suffered from important weaknesses in trial design, study execution, and data analysis. This makes it difficult to determine whether truly efficacious therapies exist for these disorders. One of the important methodologic problems is the absence of validated outcome measures and lack of consensus among stakeholders on how to measure outcome. Currently much of the effort is being put into the development of validated outcome measures for several of the FGIDs. The randomized, controlled trial with parallel groups is the design of choice. In this report, guidelines are given for the basic architecture of intervention studies of FGIDs. Further studies on design issues are required to ensure the recommendations will become evidence based in the future.
authors.affiliation: Multinational Working Teams to Develop Diagnostic Criteria for Functional Gastrointestinal Disorders (Rome II), Division of Gastroenterology, Dalhousie University, Halifax, Nova Scotia, Canada. zanten@is.dal.ca
authors.forename: S J
authors.initials: SJ
authors.lastname: Veldhuyzen van Zanten
authors.forename: N J
authors.initials: NJ
authors.lastname: Talley
authors.forename: P
authors.initials: P
authors.lastname: Bytzer
authors.forename: K B
authors.initials: KB
authors.lastname: Klein
authors.forename: P J
authors.initials: PJ
authors.lastname: Whorwell
authors.forename: A R
authors.initials: AR
authors.lastname: Zinsmeister
mesh_terms: D018592:Cross-Over Studies; D005767:Gastrointestinal Diseases / Q000628:therapy*; D017408:Guidelines as Topic; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design / Q000592:standards*; D016896:Treatment Outcome