Design of treatment trials for functional gastrointestinal disorders

S. J.O. Veldhuyzen Van Zanten, N. J. Talley, P. Bytzer, K. B. Klein, P. J. Whorwell, A. R. Zinsmeister

Research output: Contribution to journalReview article

198 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)II69-II77
JournalGut
Volume45
Issue numberSUPPL. 2
StatePublished - Sep 24 1999

Keywords

  • Clinical trial
  • Dyspepsia
  • Evidence based medicine
  • Functional dyspepsia
  • Functional gastrointestinal disorder(s)
  • Irritable bowel syndrome
  • Outcome measures
  • Random allocation
  • Rome II
  • Study design

ASJC Scopus subject areas

  • Gastroenterology

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    Veldhuyzen Van Zanten, S. J. O., Talley, N. J., Bytzer, P., Klein, K. B., Whorwell, P. J., & Zinsmeister, A. R. (1999). Design of treatment trials for functional gastrointestinal disorders. Gut, 45(SUPPL. 2), II69-II77.