Evidence-Based Medicine in Practice: Applying Intention-to-Treat Analysis and Perprotocol Analysis

Schoenfeld, Philip S.
January 2005
American Journal of Gastroenterology;Jan2005, Vol. 100 Issue 1, p3
Academic Journal
This article presents the case report of a 36-yr-old woman with diarrhea-predominant irritable bowel syndrome (IBS) is referred for treatment by her primary care physician. She notes abdominal cramping, bloating, and intermittent loose, watery bowel movements. Over the past 3 months, the intensity and frequency of these symptoms has increased, although she has had similar symptoms intermittently for the past 3-4 yr. A 12-wk, double-blind, randomized controlled trial of 216 patients compared desipramine, a tricyclic antidepressant, versus placebo for global symptom improvement in patients with moderate to severe functional bowel disorders. This study demonstrated no significant global symptom improvement with desipramine versus placebo in the intention-to-treat analysis but did demonstrate a significant benefit with desipramine versus placebo in the perprotocol analysis.


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