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

Clin Gastroenterol Hepatol. 2011 Jul;9(7):577-83. doi: 10.1016/j.cgh.2011.03.026. 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 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Bisacodyl / administration & dosage*
  • Bisacodyl / adverse effects*
  • Cathartics / administration & dosage*
  • Cathartics / adverse effects*
  • Chronic Disease
  • Constipation / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Placebos / administration & dosage
  • Treatment Outcome
  • United Kingdom


  • Cathartics
  • Placebos
  • Bisacodyl