Low Pentasa dosage versus hydrocortisone in the topical treatment of active ulcerative colitis: a randomized, double-blind study.

Author(s): Bianchi Porro G, Ardizzone S, Petrillo M, Fasoli A, Molteni P, Imbesi V

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

Publication date & source: 1995-05, Am J Gastroenterol., 90(5):736-9.

Publication type: Clinical Trial; Randomized Controlled Trial

OBJECTIVES: To compare a low dosage (1 g/day) rectal preparation of 5-aminosalicylic acid in slightly acidic, buffered suspension (Pentasa) with a hydrocortisone 100 mg/day enema (Cortenema). METHODS: Fifty-two patients with mild to moderate distal ulcerative colitis were randomized under double-blind conditions to receive a rectal preparation of either Pentasa (1 g/day) or Cortenema (100 mg/day) for 3 wk. RESULTS: After 3 wk, both types of treatment resulted in statistically significant improvements in clinical and endoscopic activity. No significant difference was observed between the two drugs in any of the parameters considered, although a statistical trend in favor of Pentasa was evident when analysis was limited to clinical activity (p = 0.07). No side effects were reported in either group. CONCLUSIONS: Our experience confirms that short term topical treatment with a low dosage 5-aminosalicylic acid is at least as effective as 100-mg hydrocortisone enemas in treating mild to moderate distal ulcerative colitis and is generally well tolerated.