Efficacy and safety of a chinese herbal formula (invigorating kidney and strengthening spleen) in chronic hepatitis B virus carrier: results from a multicenter, randomized, double-blind, and placebo-controlled trial.
A Chinese Herbal Formula (CHF) has acquired a certain therapeutic effect on chronic HBV infection. To assess the efficacy and safety of CHF on HBV replication in chronic HBV carriers, we performed a randomized, double-blind, and placebo-controlled trial involving patients from 16 centers. A total of 300 confirmed chronic HBV carriers were randomized at baseline in a ratio of 2 : 1 to receive either CHF or placebo for 52 weeks. The results showed that a greater proportion of CHF than placebo treated patients achieved virological response at week 52; the mean decline of serum HBsAg levels in the CHF group dropped more obviously than that in the control group at all stages of the treatment; however, the rates of HBeAg loss and seroconversion had no difference between the two groups. Meanwhile, were presented significant increases in IFN- γ ; IL-2 levels and reductions in IL-4 and IL-10 levels in the treatment group compared to the control group at week 52. There were no drug-related serious adverse events. In conclusion, the treatment with 52-week CHF is safe and effective in inhibiting HBV replication in chronic HBV carriers. The ability of the compound to modulate host immune function probably contributed to this effect.
Department of Hepatology, National Key Clinical Specialty of Liver Disease of Traditional Chinese Medicine, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, No. 1 Fuhua Road, Futian District, Shenzhen 518033, China ; Institute of Liver Disease, Shenzhen Hospital Affiliated to Guangzhou University of Chinese Medicine, Shenzhen 518033, China.
Jinsong
J
He
Daqiao
D
Zhou
Guangdong
G
Tong
Yufeng
Y
Xing
Yingjie
Y
Chen
Xiaohui
X
Zhang
Bolin
B
Zhan
Hui
H
Gao
Xiaozhou
X
Zhou
Yiqun
Y
Xiong
Xinliang
X
Liu
Lisheng
L
Peng
Mei
M
Qiu
Yingjun
Y
Zheng