Guidelines for the Diagnosis and Management of Herb-Induced Liver Injury

  • Jia-bo Wang
  • Yun Zhu
  • Zhao-fang Bai
  • Fu-sheng Wang
  • Xiu-hui Li
  • Xiao-he Xiao
  • Branch Committee of Hepatobiliary Diseases and Branch Committee of Chinese Patent Medicines, China Association of Chinese Medicine
Regulation and Guideline


Herb-induced liver injury (HILI) is a type of adverse drug reactions related to using Chinese medicine (CM) or herbal medicine (HM), and is now a growing segment of drug-induced liver injury (DILI) worldwide. Owing to the complicated compositions and miscellaneous risk factors associated with the clinical usage of CM or HM, it is more challenging to diagnose and manage HILI than DILI. In the present guideline issued by the China Association of Chinese Medicine (CACM), the authors present an evidence chain-based workflow with 9 structured judgment criteria for diagnosing HILI. The 3 diagnostic ending points—suspected diagnosis, clinical diagnosis, and confifi rmed diagnosis—could be reached according to the length of the evidence chain acquired in the structured diagnostic workflfl ow. Either identifying the species of CM or HM or excluding adulterations and toxin contaminants was strongly recommended to improve the level of evidence for a clinical diagnosis of HILI. In addition, the authors report that the improper use of CM, which violates the general law of CM theory, is one of the most important factors that contributes to HILI and should be avoided. By contrast, based on syndrome differentiation, some CM can also be used to treat HILI if used in accordance with the general law of CM theory. Therefore, 9 recommendations are put forward in this guideline.


herb-induced liver injury diagnosis treatment management Chinese medicine guideline 


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The authors thank to LI Li, ZHANG Tao, LIU Cheng-hai, SUN Ke-wei, YANG Hua-sheng, and GUO Yu-ming for their drafting of guidelines. MA An-lin, LU Bing-jiu, LI Bao-sen, XU Chun-jun, GOU Chun-yan, MAO De-wen, SUN Feng-xia, LI Feng-yi, WANG Guiqiang, SONG Hai-bo, LIU Hua-bao, WANG Hua-ning, GUO Jianchun, HU Jian-hua, JIA Jian-wei, HE Jin-song, ZHANG Jun-fu, ZHANG Jun-hua, LI Jun, LIU Jin-min, WANG Li-fu, GONG Man, CHE Nian-cong, ZHANG Ping, GUO Peng, LI Qin, WANG Rongbing, WANG Rui-lin, LUO Sheng-qiang, YAO Shu-kun, ZHANG Wei, ZHAO Wen-xia, WANG Xian-bo, SUN Xiao-bo, LI Xiao-dong, WANG Xiao-jun, CHI Xiao-ling, CHEN Xiao-rong, HU Xiao-yu, GAO Xiu-mei, SUN Xue-hua, ZHAO Yan-ling, YIN Yan-yao, LI Yong, LI Yong-gang, GAO Yue, GAO Yue-qiu, ZOU Zheng-sheng, CHEN Ke-ji, ZHANG Bo-li, WANG Yong-yan, ZHOU Hong-hao, LIU Chang-xiao, LI Lianda, QIAN Ying, WANG Cheng-bai, WANG Ling-tai, and WENG Weiliang were acknowledged for their suggestions and consultation. The authors thank to HU Huang-wan-yin for her assistance in language translation. The authors also thank to Neil Kaplowitz for his review and suggestion to the manuscript.

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Copyright information

© Chinese Association of the Integration of Traditional and Western Medicine 2018

Authors and Affiliations

  • Jia-bo Wang
    • 1
  • Yun Zhu
    • 1
  • Zhao-fang Bai
    • 1
  • Fu-sheng Wang
    • 2
  • Xiu-hui Li
    • 3
  • Xiao-he Xiao
    • 1
  • Branch Committee of Hepatobiliary Diseases and Branch Committee of Chinese Patent Medicines, China Association of Chinese Medicine
  1. 1.Integrative Medical Center302 Military Hospital of ChinaBeijingChina
  2. 2.Research Center for Biological Therapy302 Military Hospital of ChinaBeijingChina
  3. 3.Integrative Medical Center, Beijing YouAn HospitalCapital Medical UniversityBeijingChina

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