at Chapel Hill conducted a double-blind, placebo-controlled, 6-month multinational trial in which patients were randomized to cilansetron 2 mg three times a day or placebo. They gave participants a survey of IBS specific quality of life measures (IBS-QOL), developed by Dr. Drossman, at both the outset and the end of the study. Higher scores on IBS-QOL indicate better quality of life.
The sample included 168 patients given cilansetron and 170 on placebo. At baseline, their mean overall IBS-QOL scores were 55.0 for cilansetron and 55.5 for placebo. Overall, patients on cilansetron improved 17.7 on the scale compared to 9.6 for patients on placebo (p‹0.005). Cilansetron showed statistically significant improvements for all subscales, except sexual, which showed the highest scores at baseline. The largest improvements were observed for interference with activity, food avoidance and poor mood (dysphoria), which had the lowest levels of QOL at baseline.
"These results show that cilansestron is well tolerated and efficacious in treating IBS with diarrhea in men and women," said Dr. Olden. "Cilansetron improves overall health-related quality of life and relieves specific symptoms of IBS with diarrhea."
Both Dr. Olden and Dr. Drossman serve as consultants to Solvay, and their fellow researchers included employees of Solvay.
The ACG was formed in 1932 to advance the scientific study and medical treatment of disorders of the gastrointestinal (GI) tract. The College promotes the highest standards in medical education and is guided by its commitment to meeting the needs of clinical gastroenterology practitioners. Consumers can get more information on GI diseases through the following ACG-sponsored programs:
1-800-978-7666 (free brochures on common GI disorders, including ulcer, colon cancer, gallstones and liver disease)
1-866-IBS-RELIEF and www.ibsrelief.org (free educational materials)
1-800-HRT-BURN (free brochure and video on heartburn and GERD)
www.acg.gi.org (ACG's Web site)