title: Efficacy of a CO2-releasing suppository in dyschezia: a double-blind, randomized, placebo-controlled clinical trial.
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 (-34.5mm; 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: General and Digestive Surgery Unit, Foch Hospital, Suresnes, France.
authors.forename: Anne Laure
authors.initials: AL
authors.lastname: Tarrerias
authors.affiliation: Medical Surgical Proctology Unit, Bichat-Claude Bernard Hospital, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Abramowitz
authors.affiliation: Nukléus, Clinical Trials Department, Paris, France. Electronic address: m.marty@nukleus.fr.
authors.forename: Marc M L
authors.initials: MM
authors.lastname: Marty
authors.affiliation: Proctology Unit, Clinique St Jean Languedoc, Toulouse, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Coulom
authors.affiliation: Proctology Unit, Clinique St Jean Languedoc, Toulouse, France.
authors.forename: Ghislain
authors.initials: G
authors.lastname: Staumont
authors.affiliation: General Medicine Unit, Fresnes, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Merlette
authors.affiliation: Nukléus, Clinical Trials Department, Paris, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Berger
authors.affiliation: Nukléus, Clinical Trials Department, Paris, France; Hepatogastroenterology Unit, Intercommunal Hospital, Créteil, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Savarieau
authors.affiliation: INSERM Unit U1073 and Gastroenterology Department, Rouen University Hospital, Rouen, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ducrotté
mesh_terms: D000328:Adult; D000368:Aged; D002245:Carbon Dioxide / Q000008:administration & dosage* / Q000009:adverse effects; D003248:Constipation / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D013488:Suppositories
chemical_list: D013488:Suppositories; D002245:Carbon Dioxide
keywords: Clinical trial; Dyschezia; Functional G.I. disease