A Randomized Controlled Clinical Trial of the Serotonin Type 3 Receptor Antagonist Alosetron in Women With Diarrhea-Predominant Irritable Bowel Syndrome

Michael Camilleri, William Y. Chey, Emeran A. Mayer, Allison R. Northcutt, Amy Heath, George E. Dukes, David McSorley, Allen M. Mangel
2001 Archives of Internal Medicine  
Irritable bowel syndrome (IBS) is a common gastrointestinal disorder seen in primary care practice. The symptoms of IBS, including abdominal pain, discomfort, and abnormal bowel function, may be modulated by activity of the serotonin type 3 receptor (5-HT 3 ). The efficacy and tolerability of the 5-HT 3 receptor antagonist alosetron hydrochloride in nonconstipated female patients with IBS were evaluated in a double-blind, randomized, placebo-controlled trial. Methods: Patients received either 1
more » ... s received either 1 mg of alosetron hydrochloride (n=309) or placebo (n=317) twice daily for 12 weeks, followed by a 4-week posttreatment period. Adequate relief of IBS pain and discomfort was the primary end point. Secondary end points included improvements in urgency, stool frequency, stool consistency, incomplete evacuation, and bloating. Results: Seventy-one percent of patients were classified as having diarrhea-predominant IBS. Forty-three percent of alosetron-treated patients with diarrhea-predominant IBS (REPRINTED) ARCH INTERN MED
doi:10.1001/archinte.161.14.1733 pmid:11485506 fatcat:stsmbnhexnf3li4bofedz3gw74