No beneficial effects of transdermal nicotine in patients with primary sclerosing cholangitis: results of a randomized double-blind placebo-controlled cross-over study

Background/aims Smoking is associated with a decreased risk of primary scle rosing cholangitis. We aimed to explore the therapeutic efficacy of and tol erance for transdermal nicotine treatment in this disease. Methods Twelve patients (11 males; 37 +/- 6 years; six with ulcerative coli tis) who did not achieve complete biochemical remission on ursodeoxycholic acid (14 mg/kg/day) were treated in a randomized cross-over trial with tran sdermal nicotine (15 mg/day) or a placebo, each for 8 weeks (4-week washout period between treatments). Results One patient developed de novo ulcerative colitis and two did not co mplete the entire protocol because of intercurrent bacterial cholangitis. B aseline values [mean (range)] were: bilirubin, 1.3 (0.5-2.6); alkaline phos phatase (APh), 2.5 (1.4-4.7); gamma -glutamyl transpeptidase ( IGT), 7.7 (0 .7-38); aspartate aminotransferase (AST), 1.9 (0.5-3.2); alanine aminotrans ferase (ALT), 2.4 (0.4-7.3); and bile salts, 10.9 (2.1-39) times the upper limit of normal. No significant effect on pruritus or fatigue was noted dur ing either period, but a small increase in bodyweight was observed during p lacebo treatment. No significant differences were observed between the two treatment modalities after 8 weeks in bilirubin (nicotine versus placebo, 13% versus -6% change from baseline), APh (-3% versus -17%), gamma GT (-11% versus -13%), AST (+2% versus -10%), ALT (-1% versus -11%) or bile salts ( +36% versus -3%). Conclusion Transdermal nicotine does not seem to have a clear short-term be neficial effect in primary sclerosing cholangitis treated with ursodeoxycho lic acid. Eur J Gastroenterol Hepatol 13:171-175 (C) 2001 Lippincott Willia ms & Wilkins.