5-Aminosalicylic acid (5-ASA), the presumed active moiety of
sulfasalazine, has shown clinical efficacy when administered per rectum as initial
therapy to patients with distal
ulcerative colitis. We report the results of a randomized double-blind trial comparing nightly retention of a 4-g 5-ASA
enema with continued administration of
hydrocortisone enemas in 18 patients with persistent active distal
ulcerative colitis after at least a 3-wk course of treatment with 100-mg
hydrocortisone enemas with or without oral
sulfasalazine. Continuation of
hydrocortisone enemas rather than placebo was used in the control group to reflect the realistic alternative
therapy likely to be employed in current practice. Response to
therapy was assessed after 3 wk by comparing pretreatment and posttreatment point scores of clinical, sigmoidoscopic, and histological severity. Improvement in clinical score was achieved in seven of nine 5-ASA
enema-treated patients versus one of nine
hydrocortisone enema-treated patients (p less than 0.05). Sigmoidoscopic and histological improvement generally paralleled clinical improvement. We conclude that in patients with distal
ulcerative colitis unresponsive to standard
therapy, treatment with 5-ASA
enemas results in significant short-term clinical and sigmoidoscopic improvement in a majority of cases. Moreover, a significantly greater number of refractory patients improve when switched to 5-ASA
enemas than when continued on standard
therapy.