Efficacy of a CO2 -releasing suppository in dyschezia: A double-blind, randomized, placebo-controlled clinical trial

• Published in: Digestive and liver disease 2014-08, Vol.46 (8), p.682-687
• Main Authors: Tarrerias, Anne Laure, Abramowitz, Laurent, Marty, Marc M.L, Coulom, Pierre, Staumont, Ghislain, Merlette, Christophe, Berger, Véronique, Savarieau, Bernard, Ducrotté, Philippe
• Format: Article
• Language: English
• Subjects: Adult; Aged; Carbon Dioxide - administration & dosage; Carbon Dioxide - adverse effects; Clinical trial; Constipation - complications; Constipation - drug therapy; Constipation - physiopathology; Double-Blind Method; Dyschezia; Female; Functional G.I. disease; Gastroenterology and Hepatology; Humans; Male; Middle Aged; Quality of Life; Severity of Illness Index; Suppositories
• ISSN: 1590-8658; 1878-3562
• DOI: 10.1016/j.dld.2014.04.005

Abstract Background Constipation has a significant impact on quality of life. Aim of this study was to evaluate the safety and the efficacy for relieving dyschezia symptoms of a CO2 -releasing suppository in a randomized, placebo-controlled, clinical trial. Methods Fifty-three office-based primary care physicians and 24 gastroenterologists conducted the study in France, between November 2010 and January 2012. Patients (aged 18–75 years) with dyschezia were eligible. Patients were randomly allocated a once-a-day suppository (CO2 -releasing suppository or placebo) for 21 days. Primary endpoint was the change, from Day 0 to Day 21, in the intensity of discomfort related to dyschezia based on a self-assessed 0–100 visual analogue scale. Results A total of 323 patients were randomized, i.e. 166 into the intervention group and 157 into the placebo group. Co-variance analysis showed a greater reduction in discomfort visual analogue scale score in the intervention group (−34.5 mm; standard error of the mean: 1.8 mm) than in the placebo group (−26.2 mm; standard error of the mean: 1.9 mm; p < 0.001). The greater efficacy of the CO2 -releasing suppository was confirmed for all secondary efficacy parameters. No significant side effects for either treatment were observed. Conclusion A CO2 -releasing suppository is more effective than a placebo for the relief of symptoms of dyschezia. This efficacy is associated with a good safety profile.