Treatment of left-sided ulcerative colitis with 4-aminosalicylic acid enemas. A double-blind, placebo-controlled trial.
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 [CI], 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% CI, 4% to 38%) who had received placebo showed clinical improvement (P less than 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.
Ginsberg
A L
AL
Department of Medicine, George Washington University School of Medicine, Washington, D.C.
Beck
L S
LS
McIntosh
T M
TM
Nochomovitz
L E
LE
D000328:Adult; D010131:Aminosalicylic Acid / Q000008:administration & dosage* / Q000627:therapeutic use; D000636:Aminosalicylic Acids / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004733:Enema; D005260:Female; D006801:Humans; D008297:Male; D011897:Random Allocation; D012812:Sigmoidoscopy
D000636:Aminosalicylic Acids; D010131:Aminosalicylic Acid