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[Study and opinion on toxicity of aristolochic acid]
Yue Gao1, Xiao-He Xiao2, Xiao-Xin Zhu3
1Institute of Radiation Medicine Sciences, Academy of Military Medical, Academy of Military Sciences, Beijing 100850, China.
Abstract:
On October 18th, 2017, a research article named "Aristolochic acids and their derivatives are widely implicated in liver cancers in Taiwan and throughout Asia" was published on Science Translational Medicine. This article pointed out that herbs containing aristolochic acids could cause liver cancer by inducing the specific "aristolochic acids mutational signature". The public was also suggested to avoid the intake of herbs containing aristolochic acids. Since 2000, CFDA has gradually abolished the medicinal standards for herbs containing aristolochic acids such as caulis aristolochiae manshuriensis, aristolochia heterophylla and radix aristolochiae. Related drugs have been strengthened supervision since then. Chinese Pharmacopoeia has also removed the records of a series of related herbs. State Administration of Traditional Chinese Medicine held a conference on the "toxicity" of aristolochic acids as soon as the article was published. After a discussion of the studies on the toxicity of aristolochic acids, experts attending the meeting discovered several problems, including the unclearness of exposure history, tumor-producing dose and latent period, the absence of some key factors such as hepatitis B, the small sample size, miscellaneous factors, incomplete evidence chains, the missing of analyses between data with huge differences, the insufficiency of fundamental research arguments, etc. In order to understand the toxicity of aristolochic acids and the carcinogenic risks, as well as guide clinical safe medication, the experts suggested that：①Complete the systematical evaluation of aristolochic acids carcinogenicity as soon as possible. Scientifically elucidate the relationship between aristolochic acids and the genesis of liver cancer. ②Establish medication risk warnings of aristolochic acids and strengthen the supervision. ③Make an in-depth study of the toxicity of traditional Chinese medicine. Find out the adverse effects of all traditional Chinese medicine step by step.
Insights
Aristolochic acids in herbs are linked to liver cancer through a specific mutational signature. Experts recommend avoiding these herbs and call for further research into aristolochic acid toxicity and traditional Chinese medicine safety.
Area of Science:
- Toxicology
- Oncology
- Pharmacology
Background:
- A 2017 study linked aristolochic acids in herbs to liver cancer in Asia via a specific "aristolochic acids mutational signature."
- Regulatory actions in China since 2000 have removed related herbs from medicinal standards and strengthened drug supervision.
- Concerns exist regarding the scientific evidence, including unclear exposure history, dose-response relationships, and confounding factors like hepatitis B.
Purpose of the Study:
- To address expert concerns regarding the toxicity and carcinogenicity of aristolochic acids.
- To guide clinical safe medication practices concerning traditional Chinese medicine.
- To prompt further systematic evaluation and research into aristolochic acid-related risks.
Main Methods:
- Review of existing studies on aristolochic acid toxicity and carcinogenicity.
- Expert panel discussion to identify research gaps and methodological limitations.
- Analysis of regulatory actions and pharmacopoeia revisions.
Main Results:
- The "aristolochic acids mutational signature" is implicated in liver cancer development.
- Significant gaps in fundamental research arguments, evidence chains, and data analysis were identified.
- Experts highlighted issues with exposure history, tumor-producing dose, latent period, and confounding factors.
Conclusions:
- A systematic evaluation of aristolochic acid carcinogenicity is urgently needed.
- Establishment of medication risk warnings and enhanced supervision are recommended.
- In-depth research into the toxicity of all traditional Chinese medicines is crucial for patient safety.
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