OBJECTIVETo prospectively evaluate the efficacy of a traditional Chinese medicine (TCM)-based therapy for treating liver fibrosis in patients with chronic hepatitis B (CHB), and to investigate the patients' perception of the treatment's effects on quality of life (QoL).

METHODSA total of 430 patients with CHB-related liver fibrosis were randomly assigned to treatment groups for receipt of a 12-month course of the antiviral drug entecavir alone (control group) or in combination with the TCM Liuweiwuling tablets. Patients were assessed before (pre-treatment) and after therapy and the treatment-related differences in clinical manifestations, levels of liver function markers and liver fibrosis indexes, color ultrasound images, and hepatitis B virus (HBV) DNA load were compared between the two groups by statistical analysis. The generic QoL scale developed by the World Health Organization (WHOQOL-BREF) was used to score the patients' perceptions of treatment outcome.

RESULTSAfter treatment, the patients in both groups showed significant improvement in the majority of clinical manifestations (both P less than 0.05), with the exception of bloating. In addition, both groups showed significant improvements of liver function markers and in signs of liver fibrosis (both P less than 0.05). Both groups also showed significant reductions in the diameters of the portal and splenic (both P less than 0.05), as well as increases in the rate of undetectable HBV DNA (with a statistically similar outcome achieved in the two groups). Finally, both groups had higher QoL scores after treatment, with all assessed parameters except environment showing a significant improvement (all P less than 0.05).

CONCLUSIONWhen used in combination with entecavir, the TCM Liuweiwuling tablet is a safe therapy for CHB and its related liver fibrosis and may help to improve the QoL of these patients.