title: 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 (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.
mesh_terms: 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
chemical_list: D004294:Domperidone; D008139:Loperamide