Ciclosporin (CyA) in Primary Biliary Cirrhosis (PBC): A Multicentre, Double-blind, Placebo-controlled Long-term Therapeutic Study. The Study Design

Abstract

Primary biliary cirrhosis (PBC) is a chronic inflammatory disease involving the intrahepatic bile ducts and progressing to cirrhosis, liver failure and variceal hemorrhage. Sjögren’s syndrome and pancreatic hyposecretion occur in up to 70% of patients with PBC, thus accounting for the “dry gland syndrome”. The incidence of PBC is approximately 50 per million population [5] and PBC is more common in females aged 40–60 years. The mean duration of survival of symptomatic patients is approximately 11.9 years [2], but symptomfree patients appear to have a similar life expectancy to age-matched and sex-matched controls from the general population of the USA [3].