title: A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome.
abstract: 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.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1001 Winstead Dr., Suite 200, Cary, NC 27513, USA. pmasand@psychcme.net
authors.forename: Prakash S
authors.initials: PS
authors.lastname: Masand
authors.forename: Chi-Un
authors.initials: CU
authors.lastname: Pae
authors.forename: Stan
authors.initials: S
authors.lastname: Krulewicz
authors.forename: Kathleen
authors.initials: K
authors.lastname: Peindl
authors.forename: Paolo
authors.initials: P
authors.lastname: Mannelli
authors.forename: Indu M
authors.initials: IM
authors.lastname: Varia
authors.forename: Ashwin A
authors.initials: AA
authors.lastname: Patkar
mesh_terms: 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
chemical_list: D003692:Delayed-Action Preparations; D010919:Placebos; D017374:Paroxetine