title: On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study.
abstract: BACKGROUND
  In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients' quality of life (QoL). A randomised, double-blind, placebo-controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief.
  
  
  OBJECTIVE
  As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on-demand ACS treatment vs. that of usual treatments.
  
  
  METHODS
  Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on-demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6.
  
  
  RESULTS
  A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p < 0.0008). The IBS-severity symptom score (IBS-SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS-SSS < 75 was more frequent in the ACS group (37.7% vs. 16.0%; p < 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on-demand ACS treatment, which was associated with both lower direct and indirect costs.
  
  
  CONCLUSIONS
  After 6 months, on-demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments.
authors.affiliation: Department of Gastroenterology, UMR 1073, Rouen University Hospital, University of Rouen, Rouen, France.
authors.forename: P
authors.initials: P
authors.lastname: Ducrotte
authors.forename: J C
authors.initials: JC
authors.lastname: Grimaud
authors.forename: M
authors.initials: M
authors.lastname: Dapoigny
authors.forename: S
authors.initials: S
authors.lastname: Personnic
authors.forename: V
authors.initials: V
authors.lastname: O'Mahony
authors.forename: M C
authors.initials: MC
authors.lastname: Andro-Delestrain
mesh_terms: D015746:Abdominal Pain / Q000517:prevention & control; D000934:Antifoaming Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011437:Propylamines / Q000627:therapeutic use*; D011788:Quality of Life; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D012841:Simethicone / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000934:Antifoaming Agents; D004338:Drug Combinations; D011437:Propylamines; D017366:Serotonin Receptor Agonists; C010846:alverine; D012841:Simethicone