ALLEN L. GINSBERG, M.D.; LUCY S. BECK, M.D.; THERESA M. McINTOSH, P.A.; LUCIEN E. NOCHOMOVITZ, M.D.
GINSBERG AL, BECK LS, McINTOSH TM, NOCHOMOVITZ LE. Treatment of Left-Sided Ulcerative Colitis with 4-Aminosalicylic Acid Enemas: A Double-Blind, Placebo-Controlled Trial. Ann Intern Med. 1988;108:195-199. doi: 10.7326/0003-4819-108-2-195
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Published: Ann Intern Med. 1988;108(2):195-199.
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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Gastroenterology/Hepatology, Inflammatory Bowel Disease.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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