Effect of Shuanghu Qinggan Granule () and Yigan Yiqi Jieyu Granule () plus lamivudine on chronic hepatitis B patients: A randomized double-blind placebo-controlled trial.

Abstract

OBJECTIVE:

To observe the clinical efficacy and safety of Shuanghu Qinggan Granule ( , SQG) plus Yigan Yiqi Jieyu Granule (, YYJG) combined with lamivudine (LAM) on chronic hepatitis B (CHB) patients.

METHODS:

The study was a multicenter, randomized, double-blinded and parallel controlled trial. A total of 320 patients were randomly allocated into 2 groups equally: 160 patients (treatment group) were given SQG and YYJG combined with LAM; and 160 patients (control group) were given LAM plus Chinese herb placebo, respectively. Liver functions, hepatitis B envelop antigen (HBeAg) titer levels, and hepatitis B virus DNA (HBV-DNA) load were monitored.

RESULTS:

(1) In the 48th week, the treatment group showed superior HBeAg seroconversion rate than that in the control group (38.0% vs. 24.0%, P<0.05). (2) In the 48th week, the treatment group demonstrated lower HBeAg titer than that in the control group (P<0.05). (3) In the 12th, 24th, 48th week, there was no statistical significance in HBV-DNA response rate between the two groups. (4) In the 12th week, the level of glutamyl transpeptidase (GGT) was significantly decreased in the treatment group compared with the control group (P<0.05); in the 36th week, the levels of alanine aminotransferase and aspartate transaminase were significantly lower in the treatment group than those in the control group (P<0.05).

CONCLUSION:

The protocol of SQG and YYJG combined with LAM to treat CHB showed superior efficacy than LAM monotherapy.

• Authors: Yong-An Ye, De-Lu Tian, Jian Jiang, Jun Li, Jian-Jie Chen, Zhi-Hong Li, Wei-Guo Ma, Yi-Ming Zhao, Rong-Bing Wang, Shi-Zhong Yang, Feng-Zhen Shao, Guang Ji, Da-Qiao Zhou, Tie-Jun Liu, Dong-Sheng Cheng, Wei Zhang, Ke-Wei Sun, Yu-Fen Wang, Le-Quan Min, Xiao-Ke Li
• Journal: Chinese journal of integrative medicine (Chin J Integr Med) Pg. (Dec 08 2016) ISSN: 1993-0402 [Electronic] China
• PMID: 27933509 (Publication Type: Journal Article)