MAINTENANCE TREATMENT OF ULCERATIVE PROCTITIS WITH MESALAZINE SUPPOSITORIES - A DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

Objectives: A multicenter double-blind placebo-controlled clinical stu dy was conducted to evaluate the efficacy and tolerability of two diff erent therapeutic schedules of mesalazine suppositories in patients wi th ulcerative proctitis. Methods: From 1990 to 1993, 111 patients with ulcerative proctisis in remission, limited to the rectum (less than o r equal to 15 cm from anus), were enrolled. After obtaining informed c onsent, patients were randomized to three treatment groups: 500 mg mes alazine b.i.d (36 patients), 500 mg mesalazine u.i.d. (40 patients), a nd placebo (35 patients). The treatment lasted 1 yr. Follow-up consist ed of periodic clinical, endoscopic, and histological assessments. An endoscopic score >1 according to the Baron scale defined relapse occur ence. The three groups were homogeneous as regards main demographic, d iagnostic, and prognostic features. Results: The cumulative relapse ra tes at 12 months were 10% (95% confidence interval [CI]: 0-21) in the mesalazine b.i.d. group, 32% (95% CI: 16-49) in the mesalazine u.i.d. group, and 47% (95% CI: 29-65) in the placebo group. The comparison be tween the mesalazine b.i.d. group and the mesalazine u.i.d. group cumu lative relapse rates gave a p value of 0.0334, whereas the correspondi ng comparison between the mesalazine b.i.d. group and the placebo grou p gave a p value of 0.007 (log-rank test). The dose-response relations hip was statistically significant (p = 0.008 by Cox analysis). Two pat ients in the mesalazine b.i.d. group, two patients in the mesalazine u .i.d. group, and one patient in the placebo group withdrew from the st udy due to nonserious adverse events; four, three, and four patients p er group, respectively, dropped out because of poor compliance. Two pa tients in the mesalazine u.i.d. group and two in the placebo group wer e lost to follow-up. Conclusions: The results of this study confirm th e therapeutic efficacy of mesalazine suppositories in the maintenance treatment of ulcerative proctitis. According to our experience the mos t effective therapeutic schedule is 500 mg mesalazine b.i.d. (Am J Gas troenterol 1998;93:799-803. (C) 1998 by Am. Cell. of Gastroenterology.