Medline ® Abstract for Reference 18
of 'Management of chronic constipation in adults'
Oral bisacodyl is effective and well-tolerated in patients with chronic constipation.
Kamm MA, Mueller-Lissner S, Wald A, Richter E, Swallow R, Gessner U
Clin Gastroenterol Hepatol. 2011;9(7):577. Epub 2011 Mar 25.
BACKGROUND&AIMS: Although stimulant laxatives have been used for many years to treat patients with constipation, their clinical value has been questioned, and there have been few high-quality trials to assess their efficacy. We tested the efficacy and safety of 4 weeks of treatment with oral bisacodyl tablets in patients with chronic constipation, defined by Rome III criteria.
METHODS: This 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.
RESULTS: The 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 endpoints (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.
CONCLUSIONS: Oral bisacodyl is an effective and well-tolerated treatment for patients with chronic constipation. It improves bowel function, constipation-related symptoms, and disease-related QOL.
St. Vincent's Hospital and University of Melbourne, Melbourne, Australia.