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A Double-Blind, Randomized, Placebo-Controlled Trial of Paroxetine Controlled-Release in Irritable Bowel Syndrome

Received July 7, 2006; revised December 14, 2006; accepted January 4, 2007. From the Dept. of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC; and GlaxoSmithKline, Neurosciences Medicines Development Center, Clinical Psychiatry North America. Send correspondence and reprint requests to Prakash S. Masand, M.D., Consulting Professor of Psychiatry, Dept. of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1001 Winstead Dr., Suite 200, Cary, NC 27513. e-mail: pmasand{at}psychcme.net
© 2009 The Academy of Psychosomatic Medicine

BACKGROUND: Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disease that causes significant impairment in quality of life and accounts for $8 billion per year to the healthcare system and loss of productivity in the workplace. OBJECTIVE: The authors examined the efficacy and safety of paroxetine controlled-release (paroxetine-CR) in patients with IBS. METHOD: Seventy-two patients with IBS participated in a 12-week, double-blind, randomized, placebo-controlled study of paroxetine-CR (12.5 mg–50 mg/day). Efficacy was measured by Composite Pain Scores (primary outcome) and the Clinical Global Impression–Improvement (CGI–I) and Severity (CGI–S) ratings. RESULTS: In intent-to-treat analyses, there were no significant differences between paroxetine-CR (N=36) and placebo (N=36) on reduction in Composite Pain Scores, although the proportion of responders on CGI–I was significantly higher in the paroxetine-CR group. The treatment was well tolerated. CONCLUSION: The study did not demonstrate a statistically significant benefit for paroxetine-CR over placebo on the primary outcome measure, although there was improvement in secondary outcome measures. Overall, paroxetine-CR seems to have potential benefit in IBS. Studies with adequate samples may clarify the role of paroxetine-CR in IBS.

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