Drug Therapies for Ulcerative Proctitis: Systematic Review and Meta-analysis

Background: Patients with ulcerative colitis limited to the proctum are considered to have ulcerative proctitis (UP). In patients with more extensive ulcerative colitis, treatment occurs in a step-up fashion (5-ASA, corticosteroids, thiopurines, anti-TNF-alpha agents), a strategy which has proven effective. Although treatment of UP occurs using the same step-up design, the efficacy of these therapies in UP is scarcely studied. The objectives were to systematically review the literature for randomized controlled trials studying drug therapies for induction and maintenance of remission in patients with UP. Methods: Electronic databases and reference lists of review articles were searched. The primary outcomes were clinical remission induction rate and the maintained clinical remission rate. Secondary outcomes were induction and maintenance of endoscopic and histological remission. Relative risks (RR) and 95% confidence intervals (CI) for were calculated. Results: Twenty-three studies (1834 patients) were included. Eighteen trials investigated induction and 5 studied maintenance of remission. Topical 5-ASA was significantly superior to placebo for induction (RR, 2.39; 95% CI, 1.63-3.51) and maintenance (RR, 2.80; 95% CI, 1.21-6.45) of clinical remission, regardless of dose or formulation. Subgroup analysis of 5-ASA suppositories also showed superiority over placebo for induction of clinical (RR, 3.07; 95% CI, 1.70-5.55) and endoscopic remission (RR, 2.64; 95% CI, 1.85-3.77). Conclusions: Topical 5-ASA is superior to placebo for the induction and maintenance of clinical remission and for the induction of endoscopic remission. The efficacy of corticosteroids, thiopurines, and anti-TNF alpha has been insufficiently studied in patients with UP.