Topical treatment with 5-aminosalicylic in distal ulcerative colitis by using a new suppository preparation - A double-blind placebo controlled trial

Sixty-two patients with ulcerative colitis localised to the distal sigmoid colon and rectum (<20 cm) entered the trial. Thirty-two were treated with 5-ASA 500 mg suppositories (Asacol) 3 times a day for 1 month while 30 received a placebo given in the same regime. Clinical, sigmoidoscopic and histological assessment was carried out before, after 15 days and after 1 month of treatment. At the end of the study 5-ASA suppositories showed significantly better results in all the parameters recorded than placebo (p<0.01). There were no unwanted effects related to the use of suppositories. This treatment should therefore be offered as a first choice for patients with distal rectosigmoiditis. © 1990 Springer-Verlag.