title: Budesonide versus mesalamine for maintaining remission in patients refusing other immunomodulators for steroid-dependent Crohn's disease.
abstract: OBJECTIVE
  To compare the efficacy of controlled-release budesonide capsules with that of mesalamine for maintaining remission and improving quality of life (QOL) in patients with steroid-dependent Crohn's disease.
  
  
  METHODS
  Fifty-seven patients (25 men; mean age, 32 +/- 10.1 yr) with quiescent steroid-dependent Crohn's ileitis, ileocolitis, or colitis (Crohn's disease activity index <150) entered a prospective, investigator-blind trial. Patients were eligible for treatment with azathioprine but had not consented or had developed side effects. Patients were randomized to receive budesonide 6 mg/day (n = 29) or mesalamine 1 g 3 times/day (n = 28). Follow-up assessments were made every 2 months for up to 1 year or until relapse. At each visit, quality of life (QOL) was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ).
  
  
  RESULTS
  There were no significant differences in baseline clinical characteristics between the study groups. The 1-year relapse rate was significantly lower in the budesonide group than in the mesalamine group (55% vs. 82%; 95% confidence interval, 12.4%-41%; P = 0.045). Patients assigned to budesonide also remained in remission longer (241 +/- 114 days vs. 147 +/- 117 days; 95% confidence interval, 32.7-155.3 days; P = 0.003). Compared with mesalamine, budesonide treatment also was associated with a better QOL throughout the study (mean total IBDQ scores 165 +/- 36 vs. 182 +/- 28, respectively; 95% confidence interval, -0.4 to 34.4, P = 0.0001). This advantage was confirmed in patients' self-assessed QOL scores.
  
  
  CONCLUSIONS
  Over a 1-year period, controlled-release budesonide was significantly more effective than mesalamine for maintaining remission and improving the QOL of patients with steroid-dependent Crohn's disease.
authors.affiliation: First Department of Gastroenterology, Evangelismos Hospital, Athens, Greece. gman195@yahoo.gr
authors.forename: Gerassimos J
authors.initials: GJ
authors.lastname: Mantzaris
authors.forename: Kalliopi
authors.initials: K
authors.lastname: Petraki
authors.forename: Michael
authors.initials: M
authors.lastname: Sfakianakis
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Archavlis
authors.forename: Angeliki
authors.initials: A
authors.lastname: Christidou
authors.forename: Helen
authors.initials: H
authors.lastname: Chadio-Iordanides
authors.forename: George
authors.initials: G
authors.lastname: Triadaphyllou
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D019819:Budesonide / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012074:Remission Induction; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine; D019819:Budesonide