Clinical characteristics and outcomes of traditional Chinese medicine-induced liver injury: a systematic review

ABSTRACT

Backgrounds

Traditional Chinese medicine (TCM) is becoming increasingly popular and related adverse events are often ignored or underestimated.

Aims

This systematic review aimed to evaluate the clinical characteristics and outcomes of TCM-induced liver injury (TCM-ILI) and to estimate the proportion of TCM-ILI in all drug-induced liver injuries (DILI).

Methods

China National Knowledge Infrastructure, Wanfang, VIP, PubMed, and Embase databases were searched. Demographic, clinical, and survival data were extracted and pooled. Factors associated with worse outcomes were calculated. For the proportion meta-analyses, the data were pooled by using a random-effects model.

Results

Overall, 21,027 articles were retrieved, of which 625 were finally included. There was a predominance of female and older patients. The proportion of liver transplantation was 2.18% (7/321). The mortality was 4.67% (15/321). Male, higher aspartate aminotransferase and direct bilirubin, and lower albumin were significantly associated with an increased risk of death/liver transplantation in TCM-ILI patients. The proportion of TCM-ILI in all DILI was 25.71%. The proportion was gradually increased with year.

Conclusions

Our work summarises current knowledge regarding clinical presentation, disease course, and prognosis of TCM-ILI. TCM can result in hepatotoxicity, even death or necessitate life-saving liver transplantation. Governmental regulation of TCM products should be strictly established.

KEYWORDS:

• TCM
• traditional Chinese medicine
• TCM-ILI
• TCM-induced liver injury
• CNKI
• China National Knowledge Infrastructure
• DILI
• drug-induced liver injury
• RUCAM
• Roussel Uclaf Causality Assessment Method
• ALT
• alanine aminotransferase
• ULN
• upper limit of normal
• ALP
• alkaline phosphatase
• SD
• standard deviation

Author contributions

Ran Wang: searched, identified, and reviewed the literature, collected the data, and wrote the manuscript; Xingshun Qi: conceived the study, identified and reviewed the literature, interpreted the data, and wrote the manuscript; Han Deng and Feifei Hou: collected the data; Chunping Su: searched and identified the literature; Eric M. Yoshida, Nahum Méndez-Sánchez, Rolf Teschke, Mingyu Sun, Xu Liu, Jiao Deng, and Xiaozhong Guo: interpreted the data, gave critical comments, and revised the manuscript. All authors have made an intellectual contribution to the manuscript and approved the submission.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

Supplemental data

Supplemental data for this article can be accessed here.

Additional information

Funding

This paper was not funded.