An Approach to the Design of Therapeutic Trials in IBS
- 1 January 1987
- journal article
- Published by Taylor & Francis in Scandinavian Journal of Gastroenterology
- Vol. 22 (sup130) , 67-76
- https://doi.org/10.3109/00365528709091002
Abstract
The lack of easily definable end points and the variable clinical presentation make it difficult to design appropriate therapeutic trials for the Irritable Bowel Syndrome. In this article, I have described the approach that our unit have taken. Aspects of trial design that are important include the selection of those who present with frequent (>3 times a week), and long standing symptoms (>6 months), the inclusion of a baseline as well as a placebo period so that placebo response can be assessed, a flexible dose regime, concomitant measurement of relevant physiological changes and assessment of the response of individual symptoms as well as global response so that the indications for a particular type of treatment can be determined.Keywords
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