Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: a single-blind randomized controlled trial.
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.
Gionchetti
Paolo
P
Institute of Clinical Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Italy.
D'Arienzo
Agesilao
A
Rizzello
Fernando
F
Manguso
Francesco
F
Maieron
Roberto
R
Lecis
Pier Enrico
PE
Valpiani
Daniela
D
Iaquinto
Gaetano
G
Annese
Vito
V
Balzano
Antonio
A
Varoli
Guido
G
Campieri
Massimo
M
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
D000894:Anti-Inflammatory Agents, Non-Steroidal; D015415:Biomarkers; D005938:Glucocorticoids; D019804:Mesalamine; D001507:Beclomethasone