[Therapeutic efficacy and quality of life investigation of traditional Chinese medicine-based therapy of chronic hepatitis B-related liver fibrosis].
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. 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.


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. 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).


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.
Department of Infectious, The Inner Mongolia People's Hospital, Hohhot 010017, China.
Jihong
J
An
Wen
W
Ni
Jie
J
Qiao
D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives / Q000627:therapeutic use; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D011788:Quality of Life; D016896:Treatment Outcome
D000998:Antiviral Agents; D004365:Drugs, Chinese Herbal; C413685:entecavir; D006147:Guanine