An Approach to the Design of Therapeutic Trials in IBS

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.

Key Words:

• Irritable Bowel Syndrome
• Loperamide
• Therapeutic Trials