Efficacy and safety of bisacodyl in the acute treatment of constipation: a double-blind, randomized, placebo-controlled study.

Abstract

BACKGROUND:

Although laxatives are a first-line treatment for constipation, there are few randomized placebo-controlled trials assessing their efficacy.

AIM:

To determine the effect and safety of oral bisacodyl on stool frequency and consistency in patients with idiopathic constipation.

METHODS:

55 patients (age 19-89 years) with idiopathic constipation were recruited from eight primary care practices and randomized to receive bisacodyl, 10 mg once daily, or placebo, on three successive days following a 3-day run-in period. Patients recorded stool frequency and consistency and adverse events. RESULTS; In each treatment group, 27 patients were evaluable for efficacy. The mean number of stools per day was significantly greater in the bisacodyl-treated group (1.8/day) compared with placebo (0.95/day) over the treatment phase (P=0.0061). Mean stool consistency score improved from 'hard' (run-in) to between 'soft' and 'well-formed' during bisacodyl treatment, remaining between 'moderately hard' and 'hard' for placebo treatment (P<0.0001). The investigator's global efficacy score was superior for the bisacodyl group compared with placebo. Both treatments were well tolerated. Serum electrolyte levels and incidence of adverse events were comparable between treatment groups.

CONCLUSIONS:

Bisacodyl is effective and safe in improving stool frequency and consistency in acute treatment of idiopathic constipation.

• Authors: S Kienzle-Horn, J-M Vix, C Schuijt, H Peil, C C Jordan, M A Kamm
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 23 Issue 10 Pg. 1479-88 (May 15 2006) ISSN: 0269-2813 [Print] England
• PMID: 16669963 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cathartics
• Bisacodyl

Topics

• Acute Disease
• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Bisacodyl (administration & dosage, adverse effects)
• Blood Cell Count
• Cathartics (administration & dosage, adverse effects)
• Constipation (drug therapy)
• Defecation (drug effects)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Treatment Outcome