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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.
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