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 safet...

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Bibliographic Details
Published in:Psychosomatics (Washington, D.C.) D.C.), 2009-01, Vol.50 (1), p.78-86
Main Authors: Masand, Prakash S., M.D, Pae, Chi-Un, M.D, Krulewicz, Stan, M.D, Peindl, Kathleen, M.D, Mannelli, Paolo, M.D, Varia, Indu M., M.D, Patkar, Ashwin A., M.D
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Analysis of Variance
Biological and medical sciences
Chi-Square Distribution
Delayed-Action Preparations
Double-Blind Method
Female
Humans
Internal Medicine
Irritable Bowel Syndrome - drug therapy
Male
Medical sciences
Middle Aged
Neuropharmacology
Pain Measurement
Paroxetine - administration & dosage
Pharmacology. Drug treatments
Placebos
Psychiatry
Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer
Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease)
Psychology. Psychoanalysis. Psychiatry
Psychopharmacology
Treatment Outcome
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Summary: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.
ISSN:0033-3182
1545-7206
DOI:10.1176/appi.psy.50.1.78