Gut 1999;45(Suppl 2):II69-II77 ( September )

Design of treatment trials for functional gastrointestinal disorders

S J O Veldhuyzen van Zanten^a, N J Talley^b, P Bytzer^c, K B Klein^d, P J Whorwell^e, A R Zinsmeister^f

^a Chair, Committee on Design of Treatment Trials for Functional Gastrointestinal Disorders, Multinational Working Teams to Develop Diagnostic Criteria for Functional Gastrointestinal Disorders (Rome II), Division of Gastroenterology, Dalhousie University, Halifax, Canada, ^b Co-Chair, Committee on Design of Treatment Trials for Functional Gastrointestinal Disorders, Multinational Working Teams to Develop Diagnostic Criteria for Functional Gastrointestinal Disorders (Rome II), Department of Medicine, University of Sydney, Nepean Hospital, New South Wales, Australia, ^c Department of Medical Gastroenterology, Glostrup University Hospital, Glostrup, Denmark, ^d International Drug Development Consulting, Bainbridge Island, Washington, USA, ^e Department of Medicine, University Hospital of South Manchester, Manchester, UK, ^f Section of Biostatistics, Mayo Clinic, Rochester, MN, USA

Correspondence to: S J O Velduyzen van Zanten, MD, Queen Elizabeth II Health Sciences Center, Victoria General Hospital Site, Room 928, Centennial Building, 1278 Tower Road Halifax, Nova Scotia B3H 2Y9, Canada. Email: zanten{at}is.dal.ca

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.


Keywords: clinical trial; random allocation; functional gastrointestinal disorder(s); dyspepsia; functional dyspepsia; irritable bowel syndrome; evidence based medicine; study design; outcome measures; Rome II

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© 1999 by Gut
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