Bisacodyl and Sodium Picosulfate Improve Bowel Function and Quality of Life in Patients with Chronic Constipation—Analysis of Pooled Data from Two Randomized Controlled Trials

Abstract

Background: Quality of life (QoL) is impaired in chronic constipation. Among nonprescription laxatives QoL data out of randomized controlled trials are available only for bisacodyl and sodium picosulfate (SPS). Methods: In two ran-domized, double-blind, placebo-controlled, parallel-group trials, the efficacy and safety of treatment with either bisacodyl or SPS, respectively, were assessed. After a 2-week baseline period patients with functional constipation were randomized to a 4-week treatment with either bisacodyl (2 tablets = 10 mg), SPS (18 drops = 10 mg), or matching placebo in a ratio of active drug to placebo of 2:1. Dose re-duction as well as resuming the original dose was permitted. Patients who did not experience a bowel movement for more than 72 h were allowed to use a bi-sacodyl suppository. The primary endpoint was the mean number of Complete Spontaneous Bowel Movements (CSBMs) per week during the trial. QoL was as-sessed using the Patient Assessment of Constipation (PAC)-QoL questionnaire. Results: Active treatment led to a greater improvement of PAC-QoL scores for every domain. Active treatment was also superior to placebo for all individual questions of the questionnaire. Of note, SPS or bisacodyl not only improved sa-tisfaction with stool patterns (" quite a bit/extremely satisfied " in 12.8% of pa-tients on placebo and 50.3% on active treatment) but bloating was also consider-ably ameliorated (" not at all feeling bloated " in 24.5% on placebo and 41.4% on active treatment). Conclusion: Bisacodyl and SPS not only improve stool va-riables but also quality of life in patients with chronic functional constipation. (EudraCT Nos. 2007-001991-34 and 2007-002087-10). How to cite this paper: Müller-Lissner, S., Richter, E., Eberlin, M., Weigmann, H., Mück, T. and Kamm, M.A. (2017) Bisa-codyl and Sodium Picosulfate Improve Bowel Function and Quality of Life in Pa-tients with Chronic Constipation—Analysis of Pooled Data from Two Randomized Controlled Trials. Open Journal of Gastro-enterology, 7, 32-43.