Coated Oral 5-Aminosalicylic Acid Therapy for Mildly to Moderately Active Ulcerative Colitis

TLDR

The study randomized 87 patients with mild‑to‑moderate ulcerative colitis to receive pH‑sensitive coated 5‑ASA at 4.8 g, 1.6 g, or placebo for six weeks, with disease activity monitored by endoscopy, physician assessment, and patient symptom diaries. At 4.8 g/day, 5‑ASA produced a 24 % complete and 50 % partial response rate versus 5 % complete and 13 % partial with placebo (P < 0.0001), while 1.6 g/day showed a non‑significant trend toward benefit; thus 4.8 g/day is effective short‑term for mild‑to‑moderate ulcerative colitis. Published in N Engl J Med 1987; 317:1625–9.

Abstract

We assessed oral 5-aminosalicylic acid (5-ASA) prepared with a pH-sensitive polymer coating in 87 patients with mildly to moderately active ulcerative colitis in a double-blind, placebo-controlled trial. Patients were randomly assigned to receive 5-ASA at a dosage of either 4.8 or 1.6 g per day or placebo for six weeks. The outcome was monitored by flexible proctosigmoidoscopic examinations and physicians' assessments at three-week intervals and by patients' recordings of daily symptoms. Results showed 24 percent complete and 50 percent partial responses in those receiving 4.8 g of 5-ASA per day as compared with 5 percent complete and 13 percent partial responses in those receiving placebo (P<0.0001, rank-sum test). At a dosage of 1.6 g per day, the response was twice as good as with placebo, but the difference did not reach statistical significance (P = 0.51). Age, sex, duration of disease, duration of active symptoms, or extent of disease did not affect the clinical outcome. We conclude that oral 5-ASA administered in a dosage of 4.8 g per day is effective therapy, at least in the short term, for mildly to moderately active ulcerative colitis. (N Engl J Med 1987; 317:1625–9.)