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Oral Bisacodyl Is Effective and Well-Tolerated in Patients With Chronic Constipation
Open accessAbstract
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 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%, 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]
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Cites
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Self-citationEfficacy and Safety of Traditional Medical Therapies for Chronic Constipation: Systematic Review
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Systematic Review on the Management of Chronic Constipation in North America
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An Evidence-Based Approach to the Management of Chronic Constipation in North America
American College of Gastroenterology Chronic Constipation Task Force (2005) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2005.50613_1.x · Cited by 247
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Self-citationKamm, M. A., Müller-Lissner, S. A., Talley, N. J., Tack, J. F., Boeckxstaens, G. E., Minushkin, O. N., Калинин, А. А., Dzieniszewski, J., van der Haeck, P. W. E., Fordham, F., et al. (2005) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2005.40749.x · Cited by 193
Self-citationLactulose syrup assessed in a double-blind study of elderly constipated patients
SANDERS, J. F. (1978) · Journal of the American Geriatrics Society · doi:10.1111/j.1532-5415.1978.tb01967.x · Cited by 109
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Metadata
- 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
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2011-07
- Volume
- 9
- Issue
- 7
- Pages
- 577-583
- ISSN
- 1542-3565 (ISSN-L)
- 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
- bronze
- doi.org
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Medicine › Urology › 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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