title: Oral bisacodyl is effective and well-tolerated in patients with chronic constipation.
abstract: OBJECTIVE
  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.
authors: St. Vincent's Hospital and University of Melbourne, Melbourne, Australia.
authors: Michael A
authors: MA
authors: Kamm
authors: Stefan
authors: S
authors: Mueller-Lissner
authors: Arnold
authors: A
authors: Wald
authors: Erika
authors: E
authors: Richter
authors: Ros
authors: R
authors: Swallow
authors: Ulrika
authors: U
authors: Gessner
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001726:Bisacodyl / Q000008:administration & dosage* / Q000009:adverse effects*; D002400:Cathartics / Q000008:administration & dosage* / Q000009:adverse effects*; D002908:Chronic Disease; D003248:Constipation / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D002400:Cathartics; D010919:Placebos; D001726:Bisacodyl