TITLE:
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
AUTHORS:
Stefan Müller-Lissner, Erika Richter, Marion Eberlin, Harald Weigmann, Tobias Mück, Michael A. Kamm
KEYWORDS:
Constipation, Laxative, Bisacodyl, Sodium Picosulfate, Quality of Life
JOURNAL NAME:
Open Journal of Gastroenterology,
Vol.7 No.1,
January
23,
2017
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 randomized, 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 reduction 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 bisacodyl suppository. The primary
endpoint was the mean number of Complete Spontaneous Bowel Movements (CSBMs)
per week during the trial. QoL was assessed 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 satisfaction with stool patterns (“quite a bit/extremely satisfied” in 12.8% of patients on
placebo and 50.3% on active treatment) but bloating was also considerably
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 variables but also quality of life in patients with
chronic functional constipation. (EudraCT Nos. 2007-001991-34 and
2007-002087-10).