title: Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: a single-blind randomized controlled trial.
abstract: OBJECTIVE
  Therapy for active ulcerative colitis (UC) usually involves rectal formulations of corticosteroids (CS), which are characterized by the risk of systemic steroid-related adverse effects.
  
  
  BACKGROUND
  To compare the efficacy and safety of the topically acting CS beclomethasone dipropionate (BDP) versus mesalamine (5-ASA) in the treatment of active UC.
  
  
  METHODS
  Patients with mild to moderate distal active UC were randomized to a 6-week treatment with BDP 3 mg enema o.d. or 5-ASA 1 g enema daily in a single-blind, multicenter, parallel-group, controlled study. The primary efficacy variable was the decrease in Disease Activity Index (DAI) score. Safety variables were adrenal function, monitoring of adverse events, vital signs, and laboratory parameters.
  
  
  RESULTS
  A total of 217 patients were enrolled and treated with BDP (n = 111) or 5-ASA (n = 106). A significant decrease in the DAI score (P < 0.05) was observed in both treatment groups, with a clinical remission rate of 36.7% in the BDP group and of 29.2% in the 5-ASA group. Both treatments were well tolerated. No changes from baseline in morning cortisol levels were observed in the BDP group.
  
  
  CONCLUSIONS
  BDP administered as a rectal enema over a 6-week treatment period was efficacious and safe in patients with active UC, without interference with pituitary adrenal axis.
authors.affiliation: Institute of Clinical Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Gionchetti
authors.forename: Agesilao
authors.initials: A
authors.lastname: D'Arienzo
authors.forename: Fernando
authors.initials: F
authors.lastname: Rizzello
authors.forename: Francesco
authors.initials: F
authors.lastname: Manguso
authors.forename: Roberto
authors.initials: R
authors.lastname: Maieron
authors.forename: Pier Enrico
authors.initials: PE
authors.lastname: Lecis
authors.forename: Daniela
authors.initials: D
authors.lastname: Valpiani
authors.forename: Gaetano
authors.initials: G
authors.lastname: Iaquinto
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
authors.forename: Antonio
authors.initials: A
authors.lastname: Balzano
authors.forename: Guido
authors.initials: G
authors.lastname: Varoli
authors.forename: Massimo
authors.initials: M
authors.lastname: Campieri
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001507:Beclomethasone / Q000008:administration & dosage*; D015415:Biomarkers / Q000097:blood; D001799:Blood Sedimentation; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D004906:Erythrocyte Count; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007413:Intestinal Mucosa / Q000473:pathology; D007958:Leukocyte Count; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage*; D008875:Middle Aged; D012074:Remission Induction; D012189:Retrospective Studies; D012449:Safety; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D015415:Biomarkers; D005938:Glucocorticoids; D019804:Mesalamine; D001507:Beclomethasone