Journal
HUMAN PSYCHOPHARMACOLOGY-CLINICAL AND EXPERIMENTAL
Volume 24, Issue 5, Pages 423-428Publisher
WILEY
DOI: 10.1002/hup.1038
Keywords
irritable bowel syndrome; IBS; duloxetine; pain
Funding
- Eli Lilly
- Beth Israel Deaconess Medical Center-Harvard/MIT Health Sciences and Technology
- Pfizer Inc
- Merck Co.
- Solvay Pharmaceuticals
- Forest Laboratories
- Ortho-McNeil Janssen Scientific Affairs
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Objective To assess the efficacy of duloxetine for irritable bowel syndrome (IBS). Methods We conducted an open-label 12-week trial of duloxetine 60 mg daily in 15 patients with IBS without concurrent major depressive disorder. The primary outcome measure was average abdominal pain. Secondary measures included IBS symptoms, Clinical Global Impression-Severity, Hamilton Anxiety Rating Scale, IBS Quality-of-Life Scale, and Sheehan Disability Scale. We analyzed changes using random regression and one-sample t-tests. Results Fourteen patients completed at least one post-baseline evaluation; eight completed the study. Duloxetine was associated with significant improvement (p < 0.05) in pain, severity of illness, quality of life, loose stool, work and family disability, and anxiety. However, duloxetine did not improve hard stool. Although we found no evidence of serious duloxetine toxicity, seven participants withdrew over the course of the study because of adverse drug events. Conclusions In this small, open-label study, duloxetine appeared to be effective for many features of IBS, but its adverse effects, most notably constipation, limited its use. Since our study excluded individuals with concurrent major depression, it appears that duloxetine may benefit IBS independently of its antidepressant effects. These encouraging but preliminary open-label findings support further investigation of duloxetine treatment in placebo-controlled trials of HIS. Copyright (C) 2009 John Wiley & Sons, Ltd.
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