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Treatment of Left-Sided Ulcerative Colitis with 4-Aminosalicylic Acid Enemas: A Double-Blind, Placebo-Controlled Trial

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▸Requests for reprints should be addressed to Allen L. Ginsberg, M.D.; Division of Gastroenterology, George Washington University School of Medicine, 2150 Pennsylvania Ave., N.W.; Washington, D.C. 20037.

Washington, D.C.

© 1988 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1988;108(2):195-199. doi:10.7326/0003-4819-108-2-195
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Twenty-five patients with active left-sided ulcerative colitis were randomly assigned to receive either 2 g of 4-aminosalicylic acid (para-aminosalicylic acid) or placebo in a 60-mL volume as a nightly retention enema. The duration of treatment was 8 weeks. Disease activity was assessed by grading clinical symptoms of blood, mucus, urgency, sigmoidoscopic findings, and degree of histologic inflammation in rectal biopsies. At 8 weeks, 10 of 12 patients (83%; 95% confidence interval [Cl], 55% to 97%) who received 4-aminosalicylic acid showed improvement in clinical, sigmoidoscopic, and histologic variables. In contrast, only 2 of 13 patients (15%; 95% Cl, 4% to 38%) who had received placebo showed clinical improvement (P < 0.005). The 11 patients in the placebo group who showed no improvement were treated subsequently with open-label 4-aminosalicylic acid enemas. Of the 11, 9 showed clinical, sigmoidoscopic, and histologic improvement. No adverse effects were seen. 4-Aminosalicylic acid enemas are a safe and effective means of treating left-sided ulcerative colitis.





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