title: Clinical trial with traditional Chinese medicine intervention ''tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment'' for chronic hepatitis B-associated liver failure.
abstract: OBJECTIVE
  To study the clinical efficacy of traditional Chinese medicine (TCM) intervention "tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment" ("TTK") for treating liver failure due to chronic hepatitis B.
  
  
  METHODS
  We designed the study as a randomized controlled clinical trial. Registration number of Chinese Clinical Trial Registry is ChiCTR-TRC-12002961. A total of 144 patients with liver failure due to infection with chronic hepatitis B virus were enrolled in this randomized controlled clinical study. Participants were randomly assigned to the following three groups: (1) a modern medicine control group (MMC group, 36 patients); (2) a "tonifying qi and detoxification" ("TQD") group (72 patients); and (3) a "tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment" ("TTK") group (36 patients). Patients in the MMC group received general internal medicine treatment; patients in the "TQD" group were given a TCM formula "tonifying qi and detoxification" and general internal medicine treatment; patients in the "TTK" group were given a TCM formula of "TTK" and general internal medicine treatment. All participants were treated for 8 wk and then followed at 48 wk following their final treatment. The primary efficacy end point was the patient fatality rate in each group. Measurements of various virological and biochemical indicators served as secondary endpoints. The one-way analysis of variance and the t-test were used to compare patient outcomes in the different treatment groups.
  
  
  RESULTS
  At the 48-wk post-treatment time point, the patient fatality rates in the MMC, "TQD", and "TTK" groups were 51.61%, 35.38%, and 16.67%, respectively, and the differences between groups were statistically significant (P < 0.05). However, there were no significant differences in the levels of hepatitis B virus DNA or prothrombin activity among the three groups (P > 0.05). Patients in the "TTK" group had significantly higher levels of serum total bilirubin compared to MMC subjects (339.40 μmol/L ± 270.09 μmol/L vs 176.13 μmol/L ± 185.70 μmol/L, P = 0.014). Serum albumin levels were significantly increased in both the "TQD" group and "TTK" group as compared with the MMC group (31.30 g/L ± 4.77 g/L, 30.72 g/L ± 2.89 g/L vs 28.57 g/L ± 4.56 g/L, P < 0.05). There were no significant differences in levels of alanine transaminase among the three groups (P > 0.05). Safety data showed that there was one case of stomachache in the "TQD" group and one case of gastrointestinal side effect in the "TTK" group.
  
  
  CONCLUSIONS
  Treatment with "TTK" improved the survival rates of patients with liver failure due to chronic hepatitis B. Additionally, liver tissue was regenerated and liver function was restored.
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Han-Min
authors.initials: HM
authors.lastname: Li
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Zhi-Hua
authors.initials: ZH
authors.lastname: Ye
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Xiang
authors.initials: X
authors.lastname: Gao
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Yan-Ming
authors.initials: YM
authors.lastname: Chen
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Yao
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Jian-Xun
authors.initials: JX
authors.lastname: Gu
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhan
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Ji
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Jian-Liang
authors.initials: JL
authors.lastname: Xu
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Ying-He
authors.initials: YH
authors.lastname: Zeng
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Fan
authors.initials: F
authors.lastname: Yang
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Xiao
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Guo-Guang
authors.initials: GG
authors.lastname: Sheng
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Xin
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Qi
authors.initials: Q
authors.lastname: Long
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Qing-Jing
authors.initials: QJ
authors.lastname: Zhu
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Zhao-Hong
authors.initials: ZH
authors.lastname: Shi
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Lian-Guo
authors.initials: LG
authors.lastname: Ruan
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Jia-Yao
authors.initials: JY
authors.lastname: Yang
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Chang-Chun
authors.initials: CC
authors.lastname: Li
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Hong-Bin
authors.initials: HB
authors.lastname: Wu
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Sheng-Duo
authors.initials: SD
authors.lastname: Chen
authors.affiliation: Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China.
authors.forename: Xin-La
authors.initials: XL
authors.lastname: Luo
mesh_terms: D000328:Adult; D049109:Cell Proliferation / Q000187:drug effects; D002681:China; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D019694:Hepatitis B, Chronic / Q000150:complications* / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology; D006801:Humans; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology; D008099:Liver / Q000187:drug effects* / Q000503:physiopathology / Q000821:virology; D017093:Liver Failure / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology / Q000821:virology; D008111:Liver Function Tests; D008115:Liver Regeneration / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D055153:Stem Cell Niche / Q000187:drug effects*; D013234:Stem Cells / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal
keywords: Chronic hepatitis B-associated liver failure; Clinical study; Liver regeneration; Treatment with integrated traditional and Western medicine; “Tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment” (“TTK”)