Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine : a single-blind randomized controlled trial

GOALS: 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.

STUDY: 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.

Media Type:

Article
Cover Image
cover

Year of Publication:

2005

Contained In:

Journal of clinical gastroenterology - Vol. 39, No. 4 (2005), p. 291-7

Language:

English

Contributors:

Gionchetti, Paolo
D'Arienzo, Agesilao
Rizzello, Fernando
Manguso, Francesco
Maieron, Roberto
Lecis, Pier Enrico
Valpiani, Daniela
Iaquinto, Gaetano
Annese, Vito
Balzano, Antonio
Varoli, Guido
Campieri, Massimo
Italian BDP Study Group

Keywords:

4Q81I59GXC
Administration, Topical
Adolescent
Adult
Aged
Anti-Inflammatory Agents, Non-Steroidal
Beclomethasone
Biomarkers
Blood Sedimentation
Clinical Trial
Colitis, Ulcerative
Colonoscopy
Comparative Study
Erythrocyte Count
Female
Follow-Up Studies
Glucocorticoids
Humans
Intestinal Mucosa
Journal Article
KGZ1SLC28Z
Leukocyte Count
Male
Mesalamine
Middle Aged
Multicenter Study
Randomized Controlled Trial
Remission Induction
Research Support, Non-U.S. Gov't
Retrospective Studies
Safety
Severity of Illness Index
Single-Blind Method
Treatment Outcome

Notes:

Date Completed 18.07.2005

Date Revised 17.08.2019

published: Print

Citation Status MEDLINE

Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

PMID:

15758622

PPN (Catalogue-ID):

NLM154134112