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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

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Abstract

Objective

To evaluate the clinical efficacy and safety of Yinchen Zhufu Decoction (茵陈术附汤, 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 (χ2 =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 (χ2=9.033, P=0.003) and spontaneous bacteria peritonitis (χ2=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)

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Author information

Authors and Affiliations

  1. China Military Institute of Chinese Materia Medica, 302 Military Hospital, Beijing, 100039, China

    Yu-ming Guo  (郭玉明), Jia-bo Wang  (王伽伯) & Xiao-he Xiao  (肖小河)

  2. Treatment and Research Center for Infectious Diseases, 302 Military Hospital, Beijing, 100039, China

    Feng-yi Li  (李丰衣)

  3. Integrative Medical Center for Liver Diseases, 302 Military Hospital, Beijing, 100039, China

    Man Gong  (宫 嫚), Jun Li  (李 筠), Yan-ling Zhao  (赵艳玲), Li-fu Wang  (王立福) & Xiao-feng Zhang  (张晓锋)

  4. Medical Affairs, Novartis Pharma China, Beijing, 100004, China

    Lin Zhang  (张 琳)

Authors
  1. Yu-ming Guo  (郭玉明)
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  6. Xiao-he Xiao  (肖小河)
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  7. Jun Li  (李 筠)
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  8. Yan-ling Zhao  (赵艳玲)
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  9. Li-fu Wang  (王立福)
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Corresponding authors

Correspondence to Xiao-he Xiao  (肖小河) or Jun Li  (李 筠).

Additional information

Supported by the Ministry of Science and Technology of China, through its National Key Projects for Basic Research (No. 2007CB512607), and National Eleventh Five-year Great Science and Technology Project (No. 2008ZX10005-007)

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Guo, Ym., Li, Fy., Gong, M. et al. 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. Chin. J. Integr. Med. 22, 573–580 (2016). https://doi.org/10.1007/s11655-016-2582-2

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  • DOI: https://doi.org/10.1007/s11655-016-2582-2

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