Comparison of Oral with Rectal Mesalazine in the Treatment of Ulcerative Proctitis P. Gionchetti, M.D., F. Rizzello, M.D., A. Venturi, M.D., M. Ferretti, M.D., C. Brignola, M.D., M. Miglioli, M.D., M. Campieri, M.D. From the Dipartimento di Medicina Interna e Gastroenterologia, Universit& di Bologna, Bologna, Italy PURPOSE: The aim of our study- was to compare the efficacy and safety of oral mesalazine with mesalazine suppositories ha patients with active ulcerative proctitis. PATIENTS AND METHODS: A four-week, randomized, single-blind trial was performed in 58 patients with active, histologically con- finned ulcerative proctitis (-< 15 cm) to evaluate the efficacy and safety of oral 800-mg mesalazine tablets taken three times per day (11 = 29) compared with 400 mg of mesala- zine suppositories administered three times per day- (n = 29). Patients were evaluated at study entry and after two and four weeks. Efficacy evaluations included a disease activity index, which represents a score with four variables: stools frequency, rectal bleeding, mucosal appearance, and physician's assessment of disease severity. Histologic activ- ity was also assessed at study entry and after two and four weeks in accordance with the criteria by Truelove and Richard. Safety assessment included clinical laboratory pa- ran:eters and adverse event reports. RESULTS: There were no significant differences with regard to baseline compari- sons of demographics and severity between the two treat- ment groups. Improvement in mean disease activity index score was significantly greater with suppositories compared with oral mesalazine, both at two-week and four-week visits (mean disease activity index scores at baseline, two, and four weeks: suppositories = 7.7, 2.59, and 1.48; tablets = 7.42, 5.72, and 3.48, respectively (P < 0.001)). The rate of histologic remission was significantly greater with suppos- itories compared with tablets both at two and four weeks (P < 0.01). There were no significant differences in adverse events or clinical laboratory results between treatment groups. CONCLUSIONS: Results of this study indicate that treatment with mesalazine suppositories produces earlier and significantly better results than oral mesalazine in the treatment of active ulcerative proctitis. [Key words: Mesala- zine suppositories; Mesalazine tablets; Ulcerative proctitis; Topical treatment] Gionchetti P, Rizzello F, Venturi A, Ferretti M, Brignola C, Miglioli M, Campieri M. Comparison of oral with rectal mesalazine in the treatment of ulcerative proctitis. Dis Co- lon Rectum 1998;41:93-97. T opical treatment with 5-aminosalicylic acid (5- ASA, mesalazine) has been shown to be effective for treatment of active distal ulcerative colitis when Presented at the meeting of Digestive Disease Week, San Francisco, California, May 19 to 22, 1996. Address reprint requests to Dr. Gionchetti: Dipartimento di Medi- cina Interna e Gastroenterologia, Policlinico S.Orsola, Via Massar- enti, 9, 40138 Bologna, Italy. formulated either as enemas:' 2 or suppositories. 3'4 Although enemas reach the splenic flexure 5' 6 and are potentially suitable for patients with left-sided dis- ease, suppositories, which have been shown to reach the sigmoid colon, 7 represent a more practical and suitable approach than enemas in patients with proc- titis or distal proctosigmoiditis. 8 A dose-ranging trial demonstrated that mesalazine suppositories, 500 mg twice daily, represent the optimum dose in active proctitis. 9 There are no placebo-controlled studies that spe- cifically assess the efficacy of oral aminosalicylates for the treatment of distal sigmoiditis and proctitis, and there are only two studies that directly compare the treatment of oral sulfasalazine or 5-aminosalicylic acid with topical therapy in active distal ulcerative colitis. The first study showed a similar efficacy of oral sul- fasalazine (4 g) and mesalazine enemas (4 g) after six weeks, but with an earlier improvement and fewer and milder side-effects associated with rectally admin- istered mesalazine. 1° In the second study, mesalazine enemas (4 g) alone and the combination of mesala- zine enemas (4 g) and oral mesalazine (2.4 g) were more effective than oral mesalazine alone (2.4 g).:: The aim of our stud}, was to compare the efficacy and safety of oral mesalazine (800 mg three times per day) with mesalazine suppositories (400 mg three times per day-) in active ulcerative proctitis. 93 MATERIALS AND METHODS Selection of Patients The study was performed in accordance with the Declaration of Helsinki and all amendments and was approved by the local Ethic Committee; all patients were informed of the nature and purpose of the stud}', and they gave their written consent. Eligible patients were older than 18 years, with a confirmed diagnosis of active ulcerative proctitis, not extending beyond 15