Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS.
BACKGROUND
Patients with irritable bowel syndrome with diarrhoea (IBS-D) experience restriction in daily activities and decreased health-related quality of life (QOL).


OBJECTIVE
To investigate effects of alosetron on patient-reported health-related QOL, satisfaction and productivity in women with severe IBS-D.


METHODS
A total of 705 women (severe IBS-D, Rome II criteria) randomised to alosetron 0.5 mg QD, 1 mg QD, 1 mg BID, or placebo for 12 weeks were studied. IBSQOL, treatment satisfaction, daily activities, and lost workplace productivity (LWP) were evaluated at randomisation and Week 12.


RESULTS
One or more doses of alosetron significantly improved all IBSQOL domains except for sexual function from baseline vs. placebo. The magnitude of IBSQOL changes was consistent with a clinically meaningful effect. Alosetron 0.5 mg QD and 1 mg BID significantly reduced IBS interference with social/leisure activities and LWP from baseline vs. placebo [social/leisure (mean ±S.E.) days lost: -6.7 ± 0.8, -7.0 ± 0.9, P < 0.01; LWP (mean ± S.E.) h lost: -11.0 ± 3.3, -21.1 ± 4.1, P < 0.05 respectively]. Significantly more patients treated with alosetron reported satisfaction vs. placebo. Improvements in IBSQOL, LWP, and treatment satisfaction significantly correlated with global improvement of IBS symptoms. The incidence of adverse events with alosetron was low with constipation being the most commonly reported event. A single case of ischaemic colitis occurred, in a patient receiving alosetron 0.5 mg QD.


CONCLUSIONS
In women with severe IBS-D, alosetron treatment, including 0.5 mg QD, resulted in statistically significant and clinically relevant improvements in health-related QOL, restriction of daily activities and treatment satisfaction over placebo. IBS symptom improvement corresponded with positive changes in IBSQOL, LWP and treatment satisfaction.
Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA02215, USA. fcremoni@bidmc.harvard.edu
F
F
Cremonini
J P
JP
Nicandro
V
V
Atkinson
R
R
Shringarpure
E
E
Chuang
A
A
Lembo
D000203:Activities of Daily Living; D000328:Adult; D002243:Carbolines / Q000008:administration & dosage* / Q000009:adverse effects; D003248:Constipation / Q000139:chemically induced; D003967:Diarrhea / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D002243:Carbolines; D005765:Gastrointestinal Agents; C090840:alosetron