A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome.
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.


METHODS
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.


CONCLUSIONS
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.
Masand
Prakash S
PS
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1001 Winstead Dr., Suite 200, Cary, NC 27513, USA. pmasand@psychcme.net
Pae
Chi-Un
CU
Krulewicz
Stan
S
Peindl
Kathleen
K
Mannelli
Paolo
P
Varia
Indu M
IM
Patkar
Ashwin A
AA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D017374:Paroxetine / Q000008:administration & dosage*; D010919:Placebos; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D010919:Placebos; D017374:Paroxetine