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Controlled Trial of 4-ASA in Ulcerative Colitis

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Abstract

A six-week placebo-controlled trial of theefficacy and safety of 6 g per day of 4-aminosalicylicacid (4-ASA) was conducted in 30 subjects with mild tomoderately severe ulcerative colitis. Subjects were stratified into groups having distal (<60cm) or more extensive (>60 cm) disease. Diarrhea,bleeding, sigmoidoscopic and biopsy appearance, andphysician global assessment were scored to judgeefficacy. Safety was evaluated by monitoring untowardsymptoms and laboratory values. Median percentimprovement was significantly greater (P < 0.05) inthe 4-ASA 60-cm group (42.7%) than in the placebo 60-cmgroup (21.2%), but 4-ASA was not better than placebofor the 60-cm group or the total study group. Severedyspepsia (one subject), abnormal AST (transient infive, persistent in one) and elevated lipase without pancreatitis (six subjects) were noted. Thus 6g 4-ASA for six weeks was more effective than placebo inmild to moderate ulcerative colitis extending more than60 cm above the anus, but not in distal disease, and the drug was generally welltolerated.

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Authors
  1. W. Beeken
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  2. D. Howard
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  3. J. Bigelow
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  4. T. Trainer
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  5. M. Roy
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  6. W. Thayer
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  7. G. Wild
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Beeken, W., Howard, D., Bigelow, J. et al. Controlled Trial of 4-ASA in Ulcerative Colitis. Dig Dis Sci 42, 354–358 (1997). https://doi.org/10.1023/A:1018874120749

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  • DOI: https://doi.org/10.1023/A:1018874120749

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