A prospective randomized double blind trial comparing prednisolone and 4‐aminosalicylic acid enemas in acute distal ulcerative colitis

Abstract

A prospective double blind and randomized study was conducted to compare 4-aminosalicylic acid (4-ASA) and prednisolone-21-phosphate enemas in inducing remission in patients with acute distal ulcerative colitis. Patients with ulcerative colitis distal to the splenic flexure as assessed by flexible colonoscopy, barium enema and histology were included in the study. Of 40 consecutive patients, 20 were randomized to each of the two treatment groups. Clinical evaluation was done weekly; sigmoidoscopy and histology were performed at entry and at the end of 4 weeks. Therapy was discontinued in four patients treated with prednisolone enemas due to worsening of symptoms. The clinical improvement was significant in the remaining patients (P less than 0.001) and was similar in the two groups (P greater than 0.1). Sigmoidoscopic and histological improvement were better with 4-ASA than with prednisolone enemas. No adverse effects were observed in any of the patients treated. The present study suggests that 4-ASA is a safe and effective treatment for inducing remission in acute distal ulcerative colitis.

Putting Rectal 5-Aminosalicylic Acid in Its Place: The Role in Distal Ulcerative Colitis

“…Two randomized trials compared a 2 g 4-ASA (paraaminosalicylic acid) enema with a 20-mg prednisolone enema of equal volume (50 or 60 ml) in patients with distal ulcerative colitis (38,39). The pooled results favored 4ASA for inducing clinical improvement (pooled OR 3.12, 95% CI 1.01-9.70) and also showed a trend in favor of 4-ASA for inducing clinical remission (pooled OR 1.91, 95% CI 0.76 -4.86) (16).…”

Tolerance of 4-Aminosalicylic Acid Enemas in Patients with Inflammatory Bowel Disease and 5-Aminosalicylic–induced Acute Pancreatitis

“…17 4‐ASA has been tested in the treatment of ulcerative colitis or Crohn's disease, in oral form with colonic delivery formulations (1.5–6 g/day), and in topical form (2–4 g/day). 5–14 Side effects of these new formulations have also been uncommon and moderate: abdominal pain, fever, bloating, and headache. A few cases of abnormal liver function tests have been reported, but no case of symptomatic acute pancreatitis was described.…”

“…4‐aminosalicylic acid ( 4‐ASA), which differs from 5‐ASA in the position of the NH 2 group, has also been shown to be effective in inflammatory bowel disease; in enemas or in oral formulations. 5–14 The possibility of cross reactions between 4‐ASA and 5‐ASA has never been evaluated. We report three cases of patients with IBD who developed acute pancreatitis related to 5‐ASA and subsequently tolerated 4‐ASA enemas.…”