An approach to the design of therapeutic trials in IBS.
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 (greater than 3 times a week), and long standing symptoms (greater than 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.
D002986:Clinical Trials as Topic / Q000379:methods*; D003109:Colonic Diseases, Functional / Q000175:diagnosis / Q000188:drug therapy*; D004294:Domperidone / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008139:Loperamide / Q000627:therapeutic use; D008297:Male; D008487:Medical History Taking
D004294:Domperidone; D008139:Loperamide