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

Autor: Tarrerias AL; General and Digestive Surgery Unit, Foch Hospital, Suresnes, France., Abramowitz L; Medical Surgical Proctology Unit, Bichat-Claude Bernard Hospital, France., Marty MM; Nukléus, Clinical Trials Department, Paris, France. Electronic address: m.marty@nukleus.fr., Coulom P; Proctology Unit, Clinique St Jean Languedoc, Toulouse, France., Staumont G; Proctology Unit, Clinique St Jean Languedoc, Toulouse, France., Merlette C; General Medicine Unit, Fresnes, France., Berger V; Nukléus, Clinical Trials Department, Paris, France., Savarieau B; Nukléus, Clinical Trials Department, Paris, France; Hepatogastroenterology Unit, Intercommunal Hospital, Créteil, France., Ducrotté P; INSERM Unit U1073 and Gastroenterology Department, Rouen University Hospital, Rouen, France.
Jazyk: angličtina
Zdroj: Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver [Dig Liver Dis] 2014 Aug; Vol. 46 (8), pp. 682-7. Date of Electronic Publication: 2014 Jun 11.
DOI: 10.1016/j.dld.2014.04.005
Abstrakt: 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 (-34.5mm; standard error of the mean: 1.8mm) than in the placebo group (-26.2mm; 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.
(Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE