Beclomethasone dipropionate enemas versus prednisolone sodium phosphate enemas in the treatment of distal ulcerative colitis.

Abstract

AIM:

To compare beclomethasone dipropionate 3 mg/60 mL enema (BDP) and prednisolone sodium phosphate 30 mg/60 mL enema (PP) once daily in patients with active distal ulcerative colitis.

METHODS:

One hundred and fifty-seven patients were enrolled in a multicentre, 4-week, randomized, double-blind trial. Patients were assessed at baseline, 2 and 4 weeks.

RESULTS:

Both treatment groups showed statistically significant improvement of clinical activity after 2 and 4 weeks. Endoscopy and biopsy showed a reduction in the activity score at the end of the treatment period in both groups. No statistically significant difference was observed between the two treatment groups. After 4 weeks, 29% of patients in the BDP group and 25% in the PP group were considered to be in clinical remission; an improvement was observed in 40% of patients on BDP and in 47% on PP. Mean morning plasma cortisol levels showed a slight but significant reduction in the PP group, while the ACTH test showed that neither drug interfered with the hypothalamic-pituitary-adrenal (HPA) axis function. No significant changes were observed in the laboratory tests. Finally, there was a low incidence of adverse events in both groups.

CONCLUSIONS:

It is concluded that, in the topical treatment of active distal ulcerative colitis, BDP 3 mg enemas are as efficacious as PP 30 mg enemas, without interference with the HPA axis.

• Authors: M Campieri, M Cottone, F Miglio, F Manenti, M Astegiano, A D'Arienzo, F Manguso, G D'Albasio, A Bonanomi, R Galeazzi, A Orlando, G N Castiglione, P Gionchetti
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 12 Issue 4 Pg. 361-6 (Apr 1998) ISSN: 0269-2813 [Print] England
• PMID: 9690726 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents
• Glucocorticoids
• prednisolone phosphate
• Prednisolone
• Beclomethasone

Topics

• Administration, Topical
• Adult
• Anti-Inflammatory Agents (administration & dosage, therapeutic use)
• Beclomethasone (administration & dosage, therapeutic use)
• Colitis, Ulcerative (drug therapy, pathology)
• Double-Blind Method
• Enema
• Female
• Glucocorticoids (administration & dosage, therapeutic use)
• Humans
• Male
• Prednisolone (administration & dosage, analogs & derivatives, therapeutic use)
• Treatment Outcome