A double-blind comparison of oral versus rectal mesalamine versus combination therapy in the treatment of distal ulcerative colitis

A 6-week, multieanter, randomized, double-blind trial was performed in 60 patients with active, histologically confirmed, mild to moderate distal (~ 50 era) ulcerative colitis (UC) to evaluate the efficacy and safety of oral (O) mesalamine tablets 800rag tid (n=22) vs. a 4g rectal (R) mesalamine enema qhs (n= 18) vs. the combination (C) of oral and rectal therapy (n=20).After baseline, patients were evaluated at weeks 1, 2, 3 and 6 with endoscopic evaluations at weeks 3 and 6.Efficacy evaluations included a disease activity index (DAD and a 7-point physician and patient clinical global impression (CGI) rating.The DAI represents a composite score of four subscales: evacuation frequency, rectal bleeding, mucosal appearance and physician's overall assessment of disease severity.Patient demographics, including UC history, did not differ significantly among treatment groups.Improvement in total DAI score was greater for C (-5.3 points) followed by R (-3.9) and O (-3.4) but this trend did not reach statistical significance.The subscale measuring rectal bleeding status was significantly different among treatments at weeks I, 2 and 6 (see table): Treatment % Patients Without Physician mean CGI scores revealed greater Period Rectal Bleeding improvement (p < 0.05) with C compared to O at all visits and R compared to O at weeks 2, 3 o R c and 6.At final assessment the percentage of Week 1 9 33* 40* patients rated by their physician as much or very much improved was 45, 78 and 89 for O, Week 2 lS 35 70* R and C, respectively.Greater improvement Week 3 43 5# 75 (P < 0.05) in patient CGI scores was observed for R compared to 0 and C compared to 0 at Week 6 36 56 95** weeks 2, 3 and 6.The percentage of patients * p