[5-aminosalicylic acid enema (Pentasa) versus hydrocortisone acetate foam (Proctocort) for the treatment of outbreaks of proctitis and cryptogenetic proctosigmoiditis. A comparative randomized multicenter trial]

Abstract

The therapeutic efficacy of 1 g 5-aminosalicylic acid enema was compared with that of 90 mg hydrocortisone acetate foam following daily rectal administration to patients with idiopathic proctitis or proctosigmoiditis during two weeks. A total of 199 patients (103 5-aminosalicylic acid, 96 hydrocortisone acetate) were included in a randomized, multicenter trial. Endoscopic and clinical remission was seen in 67 and 69 percent of the 5-aminosalicylic acid-treated and in 50 and 45 percent of the hydrocortisone acetate-treated patients (P less than 0.05), respectively. Mild side effects were seen in 10.7 percent of the 5-aminosalicylic acid-treated patients and in 3.1 percent of the hydrocortisone acetate-treated patients (P = 0.05). After 2 weeks, 5-aminosalicylic acid enemas are more effective than hydrocortisone foam for topical treatment of patients with idiopathic proctitis or proctosigmoiditis.