Duloxetine in the treatment of irritable bowel syndrome: an open-label pilot study.
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 IBS.
Brennan
Brian P
BP
Biological Psychiatry Laboratory, McLean Hospital, Belmont, Massachusetts 02478, USA. bbrennan@partners.org
Fogarty
Kate V
KV
Roberts
Jacqueline L
JL
Reynolds
Karina A
KA
Pope
Harrison G
HG
Hudson
James I
JI
D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000627:therapeutic use*; D004185:Disability Evaluation; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D011788:Quality of Life; D012720:Severity of Illness Index; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D000700:Analgesics; D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride