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