Original article—alimentary tract
Oral Bisacodyl Is Effective and Well-Tolerated in Patients With Chronic Constipation

https://doi.org/10.1016/j.cgh.2011.03.026Get rights and content

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.

Section snippets

Study Design

This multicenter, randomized, double-blind, placebo-controlled, parallel group study was undertaken from September 2007 to June 2009. Eligible patients entered a 2-week baseline period without study treatment during which rescue medication was allowed and baseline data were collected. Patients were then randomized to active treatment or placebo to be taken during a 4-week, double-blind treatment phase. Follow-up visits after baseline visit were at days 16 and 30.

Ethics

The study protocol was

Patient Disposition

The disposition of patients is shown in Figure 1. In total, 368 patients were randomized: 247 to bisacodyl and 121 to placebo. Demographic data are given in Table 1. The mean age was 55 years and 75% of patients were female.

Primary End Point

For the FAS, the baseline mean (± standard error of the mean [SEM]) number of CSBMs per week was 1.1 ± 0.1 in both groups. The adjusted (for center effect and baseline value) mean number of CSBMs per week during the 4 weeks of treatment was markedly higher in the bisacodyl

Discussion

The results of this 4-week double-blind, randomized placebo-controlled study indicate that oral bisacodyl is effective in the treatment of chronic constipation and constipation-related symptoms, and improves disease-related QOL.

A majority of patients in this study were female, consistent with the observation that chronic constipation occurs more frequently in women than men.13 The primary end point, an increase in the number of CSBMs per week during the 4-week treatment phase of the study, was

Acknowledgments

The authors are grateful to Ismar Healthcare NV for their assistance in writing the manuscript. This was supported by Boehringer Ingelheim International GmbH.

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Conflicts of interest The authors disclose the following: S. Mueller-Lissner, M.A. Kamm, and A. Wald are consultants to Boehringer Ingelheim, and U. Gessner, R. Swallow, and E. Richter are employees of Boehringer Ingelheim.

Funding Grant support: Boehringer Ingelheim International GmbH.

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