Oral Bisacodyl Is Effective and Well-Tolerated in Patients With Chronic Constipation
Clinical Gastroenterology and Hepatology , 06/27/2011
Kamm MA et al. – Oral bisacodyl is an effective and well–tolerated treatment for patients with chronic constipation. It improves bowel function, constipation–related symptoms, and disease–related quality of life(QOL).Methods
- Randomized, double-blind, placebo-controlled, parallel-group study was conducted in 27 centers in the United Kingdom
- After a 2-week baseline period without study medication, patients were randomly assigned, in a 2:1 ratio, to groups that were given 10 mg bisacodyl (n = 247) or placebo (n=121), once daily, for 4 weeks.
- Patients used an electronic diary each day to record information relating to their constipation.
- Mean (± standard error of the mean [SEM]) number of complete spontaneous bowel movements (CSBMs) per week during the treatment period increased from 1.1 ± 0.1 in both groups to 5.2 ± 0.3 in the bisacodyl group and 1.9± 0.3 in the placebo group (P< .0001).
- All secondary end points (number of complete spontaneous bowel movements for each single week, number of spontaneous bowel movement (SBMs), and constipation-associated symptoms) differed significantly between groups, demonstrating efficacy for bisacodyl (P< .0001).
- Compared with baseline, there was a statistically significant improvement in the overall Patient Assessment of Constipation quality of life (PAC-QOL) score and all subscales (satisfaction, physical discomfort, psychosocial discomfort, worries and concerns) in the bisacodyl-treated patients, compared with those that received placebo (P≤ .0070).
- Treatment with bisacodyl was well-tolerated.