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Oral bisacodyl is effective and well-tolerated in patients with chronic constipation.

AbstractBACKGROUND & 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 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.
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.
AuthorsMichael A Kamm, Stefan Mueller-Lissner, Arnold Wald, Erika Richter, Ros Swallow, Ulrika Gessner
JournalClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 9 Issue 7 Pg. 577-83 (Jul 2011) ISSN: 1542-7714 [Electronic] United States
PMID21440672 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
Chemical References
  • Cathartics
  • Placebos
  • Bisacodyl
Topics
  • Administration, Oral
  • Adult
  • Aged
  • Bisacodyl (administration & dosage, adverse effects)
  • Cathartics (administration & dosage, adverse effects)
  • Chronic Disease
  • Constipation (drug therapy)
  • Double-Blind Method
  • Female
  • Great Britain
  • Humans
  • Male
  • Middle Aged
  • Placebos (administration & dosage)
  • Treatment Outcome

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