title: A concomitant treatment by CO2-releasing suppositories improves the results of anorectal biofeedback training in patients with dyschezia: results of a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Dyschezia is a defecatory disorder that places a heavy burden on a patient's quality of life. Biofeedback is the recommended treatment in most cases.
  
  
  OBJECTIVE
  The objective of our study was to test whether a CO2-releasing suppository for patients with dyschezia could be effective in improving biofeedback training results.
  
  
  METHODS
  A randomized, double-blind, multicenter, placebo-controlled study was conducted in patients (18-75 years of age) with dyschezia defined according to the modified Rome III criteria. Patients were randomly assigned to either a CO2-releasing suppository or placebo suppository once per day for 21 days.
  
  
  METHODS
  This was a multicenter trial.
  
  
  METHODS
  A total of 122 patients were randomly assigned (62 intervention group and 60 placebo group).
  
  
  METHODS
  The primary end point was the change from day 0 to day 21 in intensity of symptoms on the basis of a self-assessed dyschezia using a visual analog scale (range, 0-100). Analyses were performed using intention-to-treat principles.
  
  
  RESULTS
  A greater reduction from baseline to day 21 in symptom visual analog scale score was observed in the intervention group (-41.3 mm) than in the control group (-22.3 mm). Some secondary efficacy parameters improved more in the intervention group, including the percentage of patients who improved ≥50%, symptom intensity over 21 days, stool stains on underwear or pads, and need to practice manual maneuvers to facilitate defecation at day 21. At day 21, rectal sensitivity in the intervention group (31.4 mL) was lower than in the control group (39.1 mL).
  
  
  CONCLUSIONS
  There was a lower number of patients recruited than planned by the protocol. The sponsor stopped the trial before the inclusion of 306 participants, with no intermediate analysis. In addition, the main analysis conducted on the full analysis set population could have led to a statistical bias.
  
  
  CONCLUSIONS
  The results of this multicenter trial demonstrate the added benefits of a CO2-releasing suppository in patients with dyschezia who were treated by anorectal biofeedback training.
authors.affiliation: 1Service de Chirurgie Viscérale et Gynécologique, Groupe Hospitalier des Diaconesses Croix St Simon, Paris, France 2Cabinet de Gastro-Entérologie, Paris, France 3Methodologist, Nukléus, Clinical Trials Department, Paris, France 4Unité de Neuro-Gastroentérologie, Institut National de la Recherche Agronomique, Toulouse, France 5Centre d'Exploration et de Rééducation Périnéale, Paris, France 6Centre de Soins du Marais, Paris, France 7Service d'Hépato Gastroentérologie, Hôpital Intercommunal, Créteil, France 8Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire de Rouen, Hôpital Charles Nicolle, Rouen, France.
authors.forename: Odile
authors.initials: O
authors.lastname: Cotelle
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cargill
authors.forename: Marc M L
authors.initials: MM
authors.lastname: Marty
authors.forename: Lionel
authors.initials: L
authors.lastname: Bueno
authors.forename: Max Claude
authors.initials: MC
authors.lastname: Cappelletti
authors.forename: Hélène
authors.initials: H
authors.lastname: Colangeli-Hagège
authors.forename: Bernard
authors.initials: B
authors.lastname: Savarieau
authors.forename: Philippe
authors.initials: P
authors.lastname: Ducrotté
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002245:Carbon Dioxide / Q000008:administration & dosage* / Q000009:adverse effects; D003248:Constipation / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D056228:Feedback, Sensory; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D013488:Suppositories / Q000009:adverse effects; D055815:Young Adult
chemical_list: D013488:Suppositories; D002245:Carbon Dioxide