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

NO BENEFICIAL EFFECTS OF TRANSDERMAL NICOTINE IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS: RESULTS OF A RANDOMIZED PLACEBO-CONTROLLED CROSS-OVER STUDY EE Vle~aark H.R. van Buuren l, G.E Van Ber~,e Hene~,ouwen 2, W.C.J. Hop 3, K.J. van Erpecum 2 IDept of Hepatogastroenterology, University Hospital Rotterdam, The Netherlands. ZDept of Hepatogastroenterology, University Hospital Utrecht, The Netherlands. 3Dept of Biostatistics, Erasmus University Rotterdam, The Netherlands. Smoking is associated with a decreased risk of primary sclerosing eholangitis. We aimed to explore the therapeutic efficacy and tolerance of transdermal nicotine treatment in this disease. Twelve patients (11 males; 37:~6 years; 6 with ulcerative colitis) without complete biochemical remission on ursodeoxycholic acid (14 mg/kg/day) were treated in a randomised cross-over trial with transdermal nicotine (15 mg/day) or a placebo, each for 8 weeks (4week washout period between treatments). One patient developed de novo ulcerative colitis and two patients did not complete the entire protocol because of intereurrent bacterial cholangitis. Baseline values (mean + range) were: bilirubin 1.3 (0.5-2.6), APt 2.5 (1.4-4.7), gGT 7.7 (0.7-38), AST 1.9 (0.5-3.2), 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 pna'itus and fatigue was noted during either period, but a small increase in body-weight was observed during placebo treatment. No significant differences were observed between the two treatment modalities after 8 weeks for bilirubin (nicotine vs placebo: +13% vs 6% change from baseline), APh (-3% vs -17%), gGT (-11% vs -13%), AST (+2% vs -10%), ALT (-1% vs -11%) or bile salts (+36% vs -3%). In conclusion, transdermal nicotine does not seem to have a clear short-term beneficial effect in primary selerosing cholangitis patients treated with ursodeoxycholic acid. Immunology, autoimmune liver disease