Flumecinol for the treatment of pruritus associated with primary biliary cirrhosis.
OBJECTIVE
To determine whether flumecinol (3-trifluoromethyl-alpha-ethylbenzhydrol, Zixoryn) is effective in ameliorating pruritus of cholestasis, particularly in primary bilary cirrhosis.


RESULTS
50 patients (46 with primary biliary cirrhosis, PBC) took oral flumecinol 600 mg or identical placebo once weekly for 3 weeks. Patients assessed pruritus by scoring a daily 100 mm visual analogue scale (VAS; 0 = no itch, 100 = severe, continuous, day and night intolerable itch). Quality of life was similarly measured. Patients scored the VAS daily for a 7-day baseline and for a further 21 days. Subjectively, pruritus improved in 13 of 24 on flumecinol and 10 of 26 on placebo (chi 2 = 1.24, P = 0.27). Median difference in fall in VAS pruritus score between baseline week (mean score for each individual used) and the last week was 8.0 [95% confidence interval (CI) -2.1 to 20.8] and for VAS quality of life was 5.0 (95% Cl 0.4 to 13.0) both in favour of flumecinol over placebo. Later, 19 patients (all PBC) were randomised to flumecinol 300 mg or placebo daily for 3 weeks. Subjectively, pruritus improved in 7 of 10 on flumecinol and 1 of 9 on placebo (Fisher's exact test, P = 0.02). Median difference in fall in VAS pruritus score was 19.8 mm (95% CI 3.3 to 40.7 mm) in favour of flumecinol over placebo and for quality of life was 3.5 mm (95% Cl -5.9 to 24.9 mm). Flumecinol did not significantly affect liver function tests, antipyrine clearance or serum total bile acids, and was not associated with any significant side-effects.


CONCLUSIONS
Flumecinol was safe at the above doses and short term treatment with 300 mg daily, significantly ameliorated pruritus in primary biliary cirrhosis.
Turner
I B
IB
Department of Medicine, Medical School, University of Newcastle upon Tyne, UK.
Rawlins
M D
MD
Wood
P
P
James
O F
OF
D000284:Administration, Oral; D001559:Benzhydryl Compounds / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008105:Liver Cirrhosis, Biliary / Q000150:complications*; D008297:Male; D011537:Pruritus / Q000150:complications / Q000209:etiology / Q000517:prevention & control*; D011788:Quality of Life; D012720:Severity of Illness Index
D001559:Benzhydryl Compounds; C016914:flumecinol