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A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome
Prakash S Masand1, Chi-Un Pae, Stan Krulewicz
1Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1001 Winstead Dr., Suite 200, Cary, NC 27513, USA. pmasand@psychcme.net
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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