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.
- Author:
Yu-Ming GUO
1
;
Feng-Yi LI
2
;
Man GONG
3
;
Lin ZHANG
4
;
Jia-Bo WANG
1
;
Xiao-He XIAO
5
;
Jun LI
6
;
Yan-Ling ZHAO
3
;
Li-Fu WANG
3
;
Xiao-Feng ZHANG
3
Author Information
- Publication Type:Journal Article
- Keywords: Chinese medicine; Yinchen Zhufu Decoction; cold pattern; hepatitis B virus-related acute-on-chronic liver failure; mortality
- MeSH: Acute-On-Chronic Liver Failure; complications; drug therapy; mortality; virology; Adult; Ascites; complications; Demography; Drugs, Chinese Herbal; adverse effects; pharmacology; therapeutic use; Electrolytes; Female; Hepatitis B; complications; drug therapy; mortality; physiopathology; Hepatitis B virus; physiology; Humans; Integrative Medicine; Liver; drug effects; pathology; physiopathology; virology; Liver Function Tests; Male; Peritonitis; complications; Time Factors; Treatment Outcome
- From: Chinese journal of integrative medicine 2016;22(8):573-580
- CountryChina
- Language:English
-
Abstract:
OBJECTIVETo 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).
METHODSThis 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.
RESULTSThe 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.
CONCLUSIONSThe 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).