title: Short-term efficacy of treating hepatitis B virus-related acute-on-chronic liver failure based on cold pattern differentiation with hot herbs: A randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the clinical efficacy and safety of Yinchen Zhufu Decoction (, YCZFD) in the treatment of acute-on-chronic liver failure caused by hepatitis B virus (HBV-ACLF) with cold pattern in Chinese medicine (CM).
  
  
  METHODS
  This is a multi-center randomized controlled trial of integrative treatment of CM and Western medicine (WM) for the management of HBV-ACLF patients. A total of 200 HBV-ACLF patients with cold pattern were equally randomly assigned to receive YCZFD and WM (integrative treatment) or WM conventional therapy alone respectively for 4 weeks. The primary end point was the mortality for HBV-ACLF patients. Secondary outcome measures included Model for End-Stage Liver disease (MELD) score, liver biochemical function, coagulation function and complications. Adverse events during treatment were reported.
  
  
  RESULTS
  The mortality was decreased 14.28% in the integrative treatment group compared with WM group (χ(2) =6.156, P=0.013). The integrative treatment was found to signifificantly improve the MELD score (t=2.353, P=0.020). There were statistically signifificant differences in aspartate transaminase, total bilirubin, indirect bilirubin, direct bilirubin and prothrombin time between the two groups (P<0.05 or P<0.01). The complications of ascites (χ(2)=9.033, P=0.003) and spontaneous bacteria peritonitis (χ(2)=4.194, P=0.041) were improved signifificantly in the integrative treatment group. No serious adverse event was reported.
  
  
  CONCLUSIONS
  The integrative treatment of CM and WM was effective and safe for HBV-ACLF patients with cold pattern in CM. The Chinese therapeutic principle "treating cold pattern with hot herbs" remains valuable to the clinical therapy. (Trial registration No. ChiCTR-TRC-10000766).
authors.affiliation: China Military Institute of Chinese Materia Medica, 302 Military Hospital, Beijing, 100039, China.
authors.forename: Yu-Ming
authors.initials: YM
authors.lastname: Guo
authors.affiliation: Treatment and Research Center for Infectious Diseases, 302 Military Hospital, Beijing, 100039, China.
authors.forename: Feng-Yi
authors.initials: FY
authors.lastname: Li
authors.affiliation: Integrative Medical Center for Liver Diseases, 302 Military Hospital, Beijing, 100039, China.
authors.forename: Man
authors.initials: M
authors.lastname: Gong
authors.affiliation: Medical Affairs, Novartis Pharma China, Beijing, 100004, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Zhang
authors.affiliation: China Military Institute of Chinese Materia Medica, 302 Military Hospital, Beijing, 100039, China.
authors.forename: Jia-Bo
authors.initials: JB
authors.lastname: Wang
authors.affiliation: China Military Institute of Chinese Materia Medica, 302 Military Hospital, Beijing, 100039, China. pharmacy302@126.com.
authors.forename: Xiao-He
authors.initials: XH
authors.lastname: Xiao
authors.affiliation: Integrative Medical Center for Liver Diseases, 302 Military Hospital, Beijing, 100039, China. liju100039@163.com.
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.affiliation: Integrative Medical Center for Liver Diseases, 302 Military Hospital, Beijing, 100039, China.
authors.forename: Yan-Ling
authors.initials: YL
authors.lastname: Zhao
authors.affiliation: Integrative Medical Center for Liver Diseases, 302 Military Hospital, Beijing, 100039, China.
authors.forename: Li-Fu
authors.initials: LF
authors.lastname: Wang
authors.affiliation: Integrative Medical Center for Liver Diseases, 302 Military Hospital, Beijing, 100039, China.
authors.forename: Xiao-Feng
authors.initials: XF
authors.lastname: Zhang
mesh_terms: D065290:Acute-On-Chronic Liver Failure / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000821:virology*; D000328:Adult; D001201:Ascites / Q000150:complications; D003710:Demography; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004573:Electrolytes; D005260:Female; D006509:Hepatitis B / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D006515:Hepatitis B virus / Q000502:physiology*; D006801:Humans; D055048:Integrative Medicine; D008099:Liver / Q000187:drug effects / Q000473:pathology / Q000503:physiopathology / Q000821:virology; D008111:Liver Function Tests; D008297:Male; D010538:Peritonitis / Q000150:complications; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D004573:Electrolytes
keywords: Chinese medicine; Yinchen Zhufu Decoction; cold pattern; hepatitis B virus-related acute-on-chronic liver failure; mortality