A meta-analysis and overview of the literature on treatment options for left-sided ulcerative colitis and ulcerative proctitis

OBJECTIVES: Therapeutic trials in left-sided ulcerative colitis (L-UC) and ulcerative proctitis (UP) have lacked control for medication type, dose, de livery, and duration of therapy. METHODS: All published therapeutic articles and abstracts in L-UC or UP fro m 1958-1997 were reviewed. Improvement, remission rates, and adverse events were recorded for all (ALL), placebo-controlled (PC) studies, and for PC s tudies passing quality assessment (QA) scoring. Meta-analysis was used wher e appropriate. RESULTS: Left-sided UC: For active disease, 67 studies (17 PC; 10 QA) were identified. Mesalamine enemas achieved remission in a duration but not a do se response (QA), with higher remission rates than steroid enemas (ALL) and clinical improvement rates superior to oral therapies (QA, ALL). Remission maintenance: 17 (six PC, six QA) studies were identified. Mesalamine thera pies had comparable remission rates at 6 months, with a possible dose but n ot delivery effect. Mesalamine enema dosing intervals between QHS to Q3 day s maintained efficacy. Reported adverse events were most common with oral s ulfasalazine and dose-independent for mesalamine. Withdrawals from therapy were less than placebo, or less than or equal to 3%. Ulcerative proctitis: For active disease, 18 (nine PC, three QA) studies were identified. Mesalam ine suppositories achieved clinical improvement and remission in a duration but not dose response, with higher rates of remission than topical steroid s (ALL). Remission maintenance: three (three PC, two QA) studies were ident ified. Remission ranged from 75% to 90% (6 months) and 61-90% (12 months) f or mesalamine agents. Reported adverse events were most common for mesalami ne foam (8%). Withdrawals from therapy were <2%. CONCLUSIONS: In L-UC and UP, the efficacy and side-effect profile of topica l mesalamine are dose independent and superior to oral therapies and topica l steroids. Economic analysis suggests that use of these agents will also r esult in an overall decrease in patient costs. (C) 2000 by Am. Cell. of Gas troenterology.