24721240
OBJECTIVE	To 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 ) .
METHODS	A 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 .
METHODS	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 .
METHODS	The generic QoL scale developed by the World Health Organization ( WHOQOL-BREF ) was used to score the patients ' perceptions of treatment outcome .
RESULTS	After 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 .
RESULTS	In addition , both groups showed significant improvements of liver function markers and in signs of liver fibrosis ( both P less than 0.05 ) .
RESULTS	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 ) .
RESULTS	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 ) .
CONCLUSIONS	When 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 .

