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

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 confirmed diagnosis—could be reached according to the length of the evidence chain acquired in the structured diagnostic workflow. 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.