Thirty five adult patients with precirrhotic
primary sclerosing cholangitis were randomly allocated to treatment for at least one year with low dose (4.1 mg/kg/day)
cyclosporin or placebo in a double blind trial. Thirty patients had coexisting
ulcerative colitis, including three who had previously undergone
colectomy and one who discontinued treatment after three months. Of the remaining 26 patients, 16 received
cyclosporin and 10 received placebo. Endoscopy was performed at entry to confirm the diagnosis of
inflammatory bowel disease. The
ulcerative colitis disease activity was prospectively classified annually as remission/mild, moderate, or severe using the Truelove and Witt's criteria. Before treatment there were no differences between the
cyclosporin and placebo groups in the number of patients with remission/mild
colitis, 14/16 (88%) v 9/10 (90%), and moderate
colitis, 2/16 (12%) v 1/10 (10%). During treatment, a remission/mild disease course was present in 15/16 (94%) v 6/10 (60%), p = 0.05 and a moderate disease course in 1/16 (6%) v 4/10 (40%), p = 0.05. It is concluded that patients treated with
cyclosporin for
primary sclerosing cholangitis who have coexisting
ulcerative colitis have a more benign course of
colitis resulting both from improvement of moderately active
colitis and from fewer flares of remission/mildly active
colitis. These findings suggest that
cyclosporin may be of benefit to the colon in patients with
ulcerative colitis who are being treated with
cyclosporin for
primary sclerosing cholangitis.