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

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. [ABSTRACT FROM AUTHOR]