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

Publication ,  Journal Article
Masand, PS; Pae, C-U; Krulewicz, S; Peindl, K; Mannelli, P; Varia, IM; Patkar, AA
Published in: Psychosomatics
2009

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.

Duke Scholars

Published In

Psychosomatics

DOI

EISSN

1545-7206

Publication Date

2009

Volume

50

Issue

1

Start / End Page

78 / 86

Location

England

Related Subject Headings

  • Treatment Outcome
  • Psychiatry
  • Placebos
  • Paroxetine
  • Pain Measurement
  • Middle Aged
  • Male
  • Irritable Bowel Syndrome
  • Humans
  • Female
 

Citation

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MLA
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Masand, P. S., Pae, C.-U., Krulewicz, S., Peindl, K., Mannelli, P., Varia, I. M., & Patkar, A. A. (2009). A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome. Psychosomatics, 50(1), 78–86. https://doi.org/10.1176/appi.psy.50.1.78
Masand, Prakash S., Chi-Un Pae, Stan Krulewicz, Kathleen Peindl, Paolo Mannelli, Indu M. Varia, and Ashwin A. Patkar. “A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome.Psychosomatics 50, no. 1 (2009): 78–86. https://doi.org/10.1176/appi.psy.50.1.78.
Masand PS, Pae C-U, Krulewicz S, Peindl K, Mannelli P, Varia IM, et al. A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome. Psychosomatics. 2009;50(1):78–86.
Masand, Prakash S., et al. “A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome.Psychosomatics, vol. 50, no. 1, 2009, pp. 78–86. Pubmed, doi:10.1176/appi.psy.50.1.78.
Masand PS, Pae C-U, Krulewicz S, Peindl K, Mannelli P, Varia IM, Patkar AA. A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome. Psychosomatics. 2009;50(1):78–86.
Journal cover image

Published In

Psychosomatics

DOI

EISSN

1545-7206

Publication Date

2009

Volume

50

Issue

1

Start / End Page

78 / 86

Location

England

Related Subject Headings

  • Treatment Outcome
  • Psychiatry
  • Placebos
  • Paroxetine
  • Pain Measurement
  • Middle Aged
  • Male
  • Irritable Bowel Syndrome
  • Humans
  • Female