A COMPARISON OF MESALAMINE SUSPENSION ENEMA AND ORAL SULFASALAZINE FOR TREATMENT OF ACTIVE DISTAL ULCERATIVE-COLITIS IN ADULTS

Objectives: To compare the efficacy and safety of mesalamine (5-ASA) s uspension enema versus oral sulfasalazine (SAS) in patients with activ e mild to moderate distal ulcerative colitis. Methods: Thirty-seven pa tients were randomly assigned to treatment with either rectal mesalami ne, 4 g at night, (n = 19) or oral sulfasalazine, 1 g four times a day , (n = 18) in a 6-wk, double-blind, double-dummy. parallel-group, mult icenter study. Patients known to be refractory to SAS or 5-ASA prepara tions were excluded. Efficacy was assessed by a physician-rated Diseas e Activity Index (DAI), which included symptom evaluations and sigmoid oscopic findings, by physician-rated Clinical Global Improvement (CGI) scores, and by Patient Global Improvement (PGI) scores. Safety was as sessed by adverse event reports, clinical laboratory tests, and physic al examination. Results: Mean DAI scores indicated significant improve ment from baseline in both treatment groups. CGI scores indicated that 94% of the 5-ASA patients were either ''Very Much Improved'' or ''Muc h Improved'' at wk 6 versus 77% of the SAS patients. PGI ratings showe d more improvement in the 5-ASA treatment group than in the SAS group at wk 2 (p = 0.02) and at wk 4 (p = 0.04). Adverse events, primarily h eadache and nausea, occurred significantly more frequently (p = 0.02) in the SAS than in the S-ASA group (83 vs 42%). Three patients were wi thdrawn from SAS treatment because of adverse events. Conclusions: Rec tally administered 5-ASA is as effective as oral SAS in treatment of a ctive distal ulcerative colitis but is associated with fewer and milde r adverse events. Patients treated with 5-ASA reported improvement ear lier than those treated with SAS.