The assessment of subjective symptoms and patient-reported outcomes in patients with primary biliary cholangitis using PBC-40

Abstract

Patients with primary biliary cholangitis (PBC) occasionally complain of subjective symptoms including pruritus, fatigue and sicca syndrome. The aims of the study employing 180 Japanese PBC patients were1) to validate the Japanese versions of PBC-40, a disease-specific questionnaire for the quality of life, and 2) to assess subjective symptoms in Japanese patients with PBC. Statistical analyses confirmed validity of the Japanese version of PBC-40. Among all Japanese PBC patients, 26%, 31% and 54% reported fatigue, pruritus and sicca, respectively as more than “moderate” and 32% of patients assessed “absent” or “mild” in all three symptoms. The association was observed between pruritus and presence of cirrhosis, and between sicca and age. Regarding general health-related QOL assessment with SF-36, QOL was impaired in “general health perceptions”, “physical role functioning”, “vitality”, and “mental health”.