Sucralfate and hydrocortisone enemas in the treatment of active ulcerative proctitis--a randomized single-blind comparative study.

Author(s): Ardizzone S, Petrillo M, Antonacci CM, Bianchi Porro G

Affiliation(s): Gastrointestinal Unit, L. Sacco Hospital, Milan, Italy.

Publication date & source: 1996-12, Aliment Pharmacol Ther., 10(6):957-60.

Publication type: Clinical Trial; Randomized Controlled Trial

BACKGROUND: Sucralfate is a non-absorbable aluminium salt of sucrose octasulphate which in recent studies has proved to be of possible use in the treatment of active distal ulcerative colitis. AIM: The aim of this randomized, single-blind, study was to compare 10 g sucralfate with 100 mg hydrocortisone enemas in the treatment of 40 patients (26 male and 14 female; mean age 36.5 years, range 18-65 years) with active ulcerative proctitis, twice daily for 4 weeks. METHODS: A clinical, sigmoidoscopic and histological assessment was performed before and 4 weeks after the start of the therapy. RESULTS: Both treatments showed significant within-treatment improvement in clinical, endoscopic and histological grades (Wilcoxon's matched pair test, P < 0.05). Between-treatment comparisons, using the Mann-Whitney test, showed that hydrocortisone is more effective than sucralfate in improving the clinical score (P < 0.05). CONCLUSIONS: Sucralfate enema treatment, which was significantly less effective than hydrocortisone enemas in this study, has very limited use in the treatment of active ulcerative proctitis.