BackgroundHepatitis B virus (HBV) infection is a significant global health problem, especially in China. Chronic liver disease affects health related quality of life (HRQOL). The intervention method to improve HRQOL in patients with hepatitis B has been one-dimensional with inconsistent results. The purpose of this study was to evaluate the effect of comprehensive intervention on health-related quality of life and provide guidance on improving HRQOL for patients with chronic hepatitis B.MethodsPatients with chronic hepatitis B eligible for our study were randomly selected in three model regions of Jiangsu Province in June 2010. 272 patients were invited and 254 took part, with a refusal rate of 6.62%. Comprehensive intervention included government support, technical guidance from the Chinese Centre for Disease Control and Prevention, standardised medical care, and community involvement. HRQOL before and 1 year after intervention was measured with the Short Form 36 and HBV-specific health surveys. Chi-square test, t-test and multiple linear regressive analyses were used.ResultsAfter comprehensive intervention, the HRQOL in patients with chronic hepatitis B showed significantly improvements in bodily pain, vitality, social functioning, and mental, as well as physical and mental component score (p < 0.05). Family and social support increased, and financial concerns decreased (p < 0.05). Marital status, duration of illness-related absence from work, education level, family financial status, and health insurance type were important factors affecting HRQOL change between the baseline and final assessment in patients with chronic hepatitis B.ConclusionThe comprehensive intervention was effective in improving the HRQOL of patients with chronic hepatitis B.Trial registrationChiCTR-OCH-12001882