INTERMITTENT THERAPY WITH HIGH-DOSE 5-AMINOSALICYLIC ACID ENEMAS MAINTAINS REMISSION IN ULCERATIVE PROCTITIS AND PROCTOSIGMOIDITIS

PURPOSE: The aim of this study was to compare the efficacy of intermit tent therapy with mesalazine enemas and continuous oral mesalazine to maintain remission of distal ulcerative colitis or proctitis. METHODS: Thirty eight patients with distal ulcerative colitis (n = 17) or ulce rative proctitis (n = 21) in clinical, endoscopic, and histologic remi ssion were randomly assigned to receive either oral mesalazine (0.5 g three times/day, Eudragit L coating, n = 19) or intermittent therapy w ith mesalazine enemas (4 g of 5-aminosalicylic acid enema every third night, n = 19). Both groups were comparable in regard to sex, age, age at disease onset, extent and duration of disease, number and mode of treatment of previous attacks, and time in remission. Patients were re viewed at the beginning of the study and, subsequently, at two-month i ntervals for 24 months or until a relapse occurred. At each visit, dia ries were reviewed and clinical and laboratory assessments were perfor med. Sigmoidoscopy was carried out and biopsies were obtained by a bli nded observer. Histology was assessed without knowledge of the patient 's clinical state or treatment category. RESULTS: At the end of the st udy, 6 of 19 patients on oral mesalazine (32 percent) and 14 of 19 pat ients on mesalazine enemas (74 percent) were still in full remission ( log rank test: 15.28, P < 0.001). Differences in relapse rates between groups were significant even when data were stratified by extent of d isease (P < 0.01). In the oral group, six and seven patients relapsed at 12 and 24 months, respectively. In the enema group, three and two r elapses occurred in the first and second year of the study, respective ly. All patients complied with the treatment satisfactorily and there were no dropouts. CONCLUSION: These results suggest that intermittent therapy with mesalazine enemas is more effective than continuous oral mesalazine in maintaining remission in patients with distal ulcerative colitis and proctitis.