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Cited by 257Gastrointestinal motility and disordersPelvic floor disorders treatmentsCongenital gastrointestinal and neural anomalies

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

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Kamm, Michael A., Mueller–Lissner, Stefan, Wald, Arnold, Richter, Erika, Swallow, Ros, Gessner, Ulrika·2011·Clinical Gastroenterology and Hepatology
DOI 10.1016/j.cgh.2011.03.026
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Abstract

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.

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  • Based on meta-analyzed data from 2 studies, SPS likely leads to a large increase in CSBMs per week (MD 2.54, 95% CI 1.07-4.01) and SBMs per week (MD 4.04, 95% CI 2.37-5.71), and improved stool consistency on the Bristol Stool Form Scale (MD 2.4 points higher, 95% CI 2.07-2.73) and PAC-QOL scores (MD 0.65, 95% CI 0.50-0.80) compared with placebo.

    “Based on meta-analyzed data from 2 studies, SPS likely leads to a large increase in CSBMs per week (MD 2.54, 95% CI 1.07-4.01) and SBMs per week (MD 4.04, 95% CI 2.37-5.71) and improved the consistency of stool on the Bristol Stool Form Scale 53 (MD 2.4 points higher, 95% CI 2.07-2.73) and PAC-QOL scores (MD 0.65, 95% CI 0.50-0.80) compared with placebo.”

    From American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation (2023) · cites this paper as [51]

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  • For bisacodyl at the initial starting dose of 10 mg compared with placebo, diarrhea occurred in 53.4% vs 1.7%, and abdominal pain occurred in 24.7% vs 2.5%.

    “For bisacodyl at the initial starting dose of 10 mg compared with placebo, diarrhea occurred in 53.4% vs 1.7%, respectively, while abdominal pain occurred in 24.7% vs 2.5%, respectively. 51”

    From American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation (2023) · cites this paper as [51]

    Table 3 (page unavailable) reports exactly the stated diarrhea and abdominal-pain percentages for bisacodyl versus placebo. However, those figures cover adverse events during the four-week treatment period, not events specifically occurring at the initial 10 mg dose; the Dose reduction section reports that the mean bisacodyl dose fell after week one. (LLM, conf=0.88)

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Cites

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1 of the 19 references couldn’t be matched to a known paper.

Research works printed but not linked: 2

  1. Eoff JC, Lembo AJ. Optimal treatment of chronic constipation in managed care: review and round table discussion. J Manag Care Pharm 2008;14:1-15.
  2. Ewe K, Hoelker B. The effect of a diphenolic laxative (Bisacodyl) on water-and electrolyte transport in the human colon (author's transl) [in German]. Klin Wochenschr 1974;52:827-833.

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Authors
Kamm, M. A., Mueller–Lissner, S., Wald, A., Richter, E., Swallow, R., & Gessner, U.
Affiliations
  • The University of Melbourne (AU)
  • University of Wisconsin–Madison (US)
  • Boehringer Ingelheim (Germany) (DE)
  • Boehringer Ingelheim (United Kingdom) (GB)
Corresponding author
Gessner, Ulrika
ORCID
Venue
Clinical Gastroenterology and Hepatology
Publisher
Elsevier BV
Published
2011-07
Volume
9
Issue
7
Pages
577-583
ISSN
1542-3565 (ISSN-L)
DOI
10.1016/j.cgh.2011.03.026
OpenAlex
W2138857851
Cited by
257
References
19
Citations by year
2026: 4 · 2025: 1 · 2024: 14 · 2023: 21 · 2022: 10 · 2021: 29 · 2020: 77 · 2019: 11 · 2018: 15 · 2017: 14 · 2016: 17 · 2015: 11 · 2014: 12 · 2013: 11 · 2012: 7
FWCI
10.81
Type
journal article
Language
en
Open access
Licence
Locations
  • Clinical Gastroenterology and Hepatology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Surgery › Congenital gastrointestinal and neural anomalies
Keywords
bisacodyl, chronic constipation, stimulant laxatives, stool frequency, quality of life, drug tolerability, Rome III criteria
MeSH terms
Administration, Oral, Adult, Aged, Bisacodyl, Cathartics, Chronic Disease, Constipation, Double-Blind Method, Female, United Kingdom, Humans, Male, Middle Aged, Placebos, Treatment Outcome

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