title: 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).
  
  
  CONCLUSIONS
  The protocol of SQG and YYJG combined with LAM to treat CHB showed superior efficacy than LAM monotherapy.
authors.affiliation: Department of Gastroenterology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. Yeyongan@vip.163.com.
authors.forename: Yong-An
authors.initials: YA
authors.lastname: Ye
authors.affiliation: Department of Gastroenterology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: De-Lu
authors.initials: DL
authors.lastname: Tian
authors.affiliation: Department of Hepatology, Shanghai Shuguang Hospital, Shanghai, 201210, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Jiang
authors.affiliation: Department of Integrated Chinese and Western Medicine, 302 Military Hospital of China, Beijing, 100039, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Hepatology, Shanghai Shuguang Hospital, Shanghai, 201210, China.
authors.forename: Jian-Jie
authors.initials: JJ
authors.lastname: Chen
authors.affiliation: Department of Gastroenterology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: Zhi-Hong
authors.initials: ZH
authors.lastname: Li
authors.affiliation: Department of Gastroenterology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: Wei-Guo
authors.initials: WG
authors.lastname: Ma
authors.affiliation: Epidemic Research Center, The Third Hospital Affiliated to Peking University, Beijing, 100191, China.
authors.forename: Yi-Ming
authors.initials: YM
authors.lastname: Zhao
authors.affiliation: Department of Integrated Chinese and Western Medicine, Beijing Ditan Hospital, Beijing, 100015, China.
authors.forename: Rong-Bing
authors.initials: RB
authors.lastname: Wang
authors.affiliation: Department of Hepatology, Hospital Affiliated to Changchun University of Chinese Medicine, Changchun, 130021, China.
authors.forename: Shi-Zhong
authors.initials: SZ
authors.lastname: Yang
authors.affiliation: Department of Hepatology, The First Hospital Affiliated to Tianjin University of Chinese Medicine, Tianjin, 300193, China.
authors.forename: Feng-Zhen
authors.initials: FZ
authors.lastname: Shao
authors.affiliation: Department of Hepatology, Shanghai Longhua Hospital, Shanghai, 200032, China.
authors.forename: Guang
authors.initials: G
authors.lastname: Ji
authors.affiliation: Department of Hepatology, Shenzhen Hospital of Chinese Medicine, Shenzhen, Guangdong province, 581033, China.
authors.forename: Da-Qiao
authors.initials: DQ
authors.lastname: Zhou
authors.affiliation: Department of Hepatology, Hospital Affiliated to Changchun University of Chinese Medicine, Changchun, 130021, China.
authors.forename: Tie-Jun
authors.initials: TJ
authors.lastname: Liu
authors.affiliation: Department of Hepatology, Shaanxi Provincial Hospital of Chinese Medicine, Xi'an, 710003, China.
authors.forename: Dong-Sheng
authors.initials: DS
authors.lastname: Cheng
authors.affiliation: Department of Hepatology, Shanghai Longhua Hospital, Shanghai, 200032, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Department of Hepatology, The First Hospital Affiliated to Hunan University of Chinese Medicine, Changsha, 410007, China.
authors.forename: Ke-Wei
authors.initials: KW
authors.lastname: Sun
authors.affiliation: Department of Gastroenterology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: Yu-Fen
authors.initials: YF
authors.lastname: Wang
authors.affiliation: School of Applied Science and Information Engineering, Beijing University of Science and Technology, Beijing, 100083, China.
authors.forename: Le-Quan
authors.initials: LQ
authors.lastname: Min
authors.affiliation: Department of Gastroenterology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
authors.forename: Xiao-Ke
authors.initials: XK
authors.lastname: Li
keywords: Chinese medicine; Shuanghu Qinggan Granule; YiganYiqi Jieyu Granule; chronic hepatitis B; lamivudine; randomized controlled trial