Guidelines for safe use of Polygoni Multiflori Radix

Xiaohe Xiao, Jiabo Wang, Haibo Song, Dongsheng Ouyang, Zhengsheng Zou, Ruilin Wang, Tingting He, Jing Jing, Yuming Guo, Zhaofang Bai, Xiaoyan Zhan, Ming Niu, Zhijie Ma, Chunyu Li, on Behalf of the Branch of Chinese Patent Medicine, China Association of Chinese Medicine, Branch of Hepatobiliary Diseases, China Association of Chinese Medicine, Committee of Clinical Chinese Pharmacy, Chinese Pharmaceutical Association, Subcommittee of Liver Diseases, Committee of Drug-Induced Diseases, Chinese Pharmacological Society, Committee of Clinical Toxicology, Chinese Society of Toxicology

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Acupuncture and Herbal Medicine ›› 2024, Vol. 4 ›› Issue (2) : 151-158. DOI: 10.1097/HM9.0000000000000113
Guidelines & Standards
research-article

Guidelines for safe use of Polygoni Multiflori Radix

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Abstract

Polygoni Multiflori Radix (He Shou Wu) is a Chinese medicine widely used in clinical treatment and preventive healthcare. However, recently there have been frequent reports of liver injury caused by Polygoni Multiflori Radix and its related preparations, and some patients have serious adverse outcomes, attracting wide attention worldwide. The risk of liver damage caused by preparations containing Polygoni Multiflori Radix or Polygoni Multiflori Caulis has been repeatedly reported by the Chinese Food and Drug Administration. Fortunately, substantial progress has recently been made in revealing the basic properties, main causes, material basis, and molecular mechanism of Polygoni Multiflori Radix-related liver injury. The basic characteristics and biomarkers of susceptible people have been identified, indicating that Polygoni Multiflori Radix has the risk of inducing liver injury only in a few specific populations and is safe for most populations. This study provides a scientific basis for a correct and objective understanding of liver injury caused by Polygoni Multiflori Radix, and a reasonable formulation of safe medication measures for Polygoni Multiflori Radix and related preparations. The China Association of Chinese Medicine organized experts in relevant fields across the country to draft and formulate the “Guidelines for Safe Use of Polygoni Multiflori Radix” with the aim of helping the public and relevant institutions at home and abroad to scientifically understand, evaluate, and avoid the risk of liver injury; guide the rational use; protect the health rights and interests of consumers; and promote the healthy and sustainable development of Polygoni Multiflori Radix and related preparations. These guidelines were issued by the China Association of Chinese Medicine (No. T/CACM 1328-2019).

Keywords

Drug safety / Liver injury / Polygoni Multiflori Radix / Rational use / Traditional Chinese medicine

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Xiaohe Xiao, Jiabo Wang, Haibo Song, Dongsheng Ouyang, Zhengsheng Zou, Ruilin Wang, Tingting He, Jing Jing, Yuming Guo, Zhaofang Bai, Xiaoyan Zhan, Ming Niu, Zhijie Ma, Chunyu Li, on Behalf of the Branch of Chinese Patent Medicine, China Association of Chinese Medicine, Branch of Hepatobiliary Diseases, China Association of Chinese Medicine, Committee of Clinical Chinese Pharmacy, Chinese Pharmaceutical Association, Subcommittee of Liver Diseases, Committee of Drug-Induced Diseases, Chinese Pharmacological Society, Committee of Clinical Toxicology, Chinese Society of Toxicology. Guidelines for safe use of Polygoni Multiflori Radix. Acupuncture and Herbal Medicine, 2024, 4(2): 151‒158 https://doi.org/10.1097/HM9.0000000000000113

References

[[1]]
Song HB, Du XX, Guo XX, et al. Safety and risk factor analysis on Polygoni Multiflori Radix base on ancient traditional Chinese medicine literatures. Chin J Chin Mater Med. 2015;40(5):985-988.
[[2]]
Ni ZM. Treasury of Words on the Materia Medica. Zheng Jinsheng, punctuation and collation. Beijing: Traditional Chinese Medicine Classics Press; 2006:260.
[[3]]
Chen XY. Shen Nong Ben Cao Jing Du. Beijing: People’s Medical Publishing House; 1959:97.
[[4]]
Lu YT. Leng Lu Yi Hua. Lv Zhilian, punctuation and collation. Beijing: Traditional Chinese Medicine Classics Press; 1999:150.
[[5]]
Kyoung AJ, Hyun JM, Seung SY, et al. Drug-induced liver injury: twenty five cases of acute hepatitis following ingestion of Polygonum multiflorum Thunb. Gut Liver. 2011;5:493-499.
[[6]]
Zhu Y, Li YG, Wang Y, et al. Analysis of clinical characteristics in 595 patients with herb-induced liver injury. Chin J Integr Tradit West Med. 2016;36(1):44-48.
[[7]]
Tu C, Jiang BQ, Zhao YL, et al. Comparison of processed and crude Polygoni Multiflori Radix induced rat liver injury and screening for sensitive indicators. Chin J Chin Mater Med. 2015;40(4):654-660.
[[8]]
Yu HL, Yu DM, Song HB, et al. Literature study on adverse drug reactions and analysis of risk factors of Polygonum multiflorum thunb. and its common preparations. Chin J Pharmacovigilance. 2018;15(8):470-475.
[[9]]
Park GJ, Mann SP, Ngu MC. Acute hepatitis induced by Shou-Wu-Pian, a herbal product derived from Polygonum multiflorum. J Gastroenterol Hepatol. 2001;16:115-117.
[[10]]
Mazzanti G, Batinelli L, Daniele C, et al. New case of acute hepatitis following the consumption of Shou Wu Pian, a Chinese herbal product derived from Polygonum multiflorum. Ann Intern Med. 2004;9(4):388-388.
[[11]]
Shou Wu Pian (Polygonum Multiflorum) in the LiverTox. Available from:https://www.livertox.nih.gov/ShouWuPian.htm. Accessed September 25, 2019.
[[12]]
Center for Drug Evaluation of China Food and Drug Administration. The UK MHRA warns of liver damage induced by Polygoni Multiflori Radix. Chin J Pharmacovigilance. 2006;3(5):313.
[[13]]
China Food and Drug Administration. Notice of the China Food and Drug Administration on the revision of the instructions of six oral Chinese herbal preparations containing Polygoni Multiflori Radix including Yangxueshengfa Capsule. Available from: http://samr.cfda.gov.cn/WS01/CL1706/93676.html. Accessed October 23, 2013.
[[14]]
China Food and Drug Administration. Notice of the General Office of the China Food and Drug Administration on strengthening the supervision of health food containing Polygoni Multiflori Radix. Available from: http://www.sda.gov.cn/WS01/CL0847/102806.html. Accessed July 9, 2014.
[[15]]
China Food and Drug Administration. China Food and Drug Administration warns of the risk of liver injury induced by peroral Polygoni Multiflori Radix. Available from: http://www.sda.gov.cn/WS01/CL0051/102902.html. Accessed July 16, 2014.
[[16]]
China Food and Drug Administration. Notice of the General Office of China Food and Drug Administration on matters related to the change of health food containing Polygoni Multiflori Radix. Available from: http://samr.cfda.gov.cn/WS01/CL1706/224102.html. Accessed February 5, 2018.
[[17]]
China Food and Drug Administration. Announcement of China Food and Drug Administration on revising the instructions of four varieties of drugs such as Jingwu capsule. Available from: http://samr.cfda.gov.cn/WS01/CL1706/224102.html. Accessed February 5, 2018.
[[18]]
Zhu Y, Liu SH, Wang JB, et al. Clinical analysis of drug-induced liver injury caused by Polygonum multiflorum and its preparations. Chin J Integr Tradit West Med. 2015;35(12):1442-1447.
[[19]]
Li CY, Li XF, Tu C, et al. The idiosyncratic hepatotoxicity of Polygonum multiflorum based on endotoxin model. Acta Pharm Sin. 2015;50(1):28-33.
[[20]]
Jing J, Wang R, Zhao X, et al. Association between the concurrence of pre-existing chronic liver disease and worse prognosis in patients with an herb-Polygonum multiflorum thunb. induced liver injury: a case-control study from a specialised liver disease center in China. BMJ Open. 2019;9(1):e023567.
[[21]]
Pang JY, Bai ZF, Niu M, et al. The toxic and protective effects of Polygonum multiflorum on normal and liver injured rats based on the symptom-based prescription theory. Acta Pharm Sin. 2015;50(8):973-979.
[[22]]
Tu C, Xiao XH, Wang JB, et al. Network pharmacology-oriented study reveals inflammatory state- dependent dietary supplement hepatotoxicity responses in normal and diseased rats. Food Funct. 2019;10:3477-3490.
[[23]]
Wang JB, Li CY, Zhu Y, et al. Integrated evidence chain-based identification of Chinese herbal medicine- induced hepatotoxicity and rational usage: exemplification by Polygonum Multiflorum (He shou wu). Chin Sci Bull. 2016;61:971-980.
[[24]]
Gao D, Xiao XH, Wang JB, et al. Poria attenuates idiosyncratic liver injury induced by Polygoni Multiflori Radix praeparata. Front Pharmacol. 2016;7:386.
[[25]]
Li CP, Wang JB, Xiao XH, et al. HLA-B*35:01 allele is a potential biomarker for predicting Polygonum multiflorum-induced liver injury in humans. Hepatology. 2019;70:346-357.
[[26]]
Meng YK, Li CY, Li RY, et al. Cis-stilbene glucoside in Polygonum multiflorum induces immunological idiosyncratic hepatotoxicity in LPS-treated rats by suppressing PPAR-γ. Acta Pharmacol Sin. 2017;38(10):1340-1352.
[[27]]
He LZ, Yin P, Meng YK, et al. Immunological synergistic mechanisms of trans-/cis-stilbene glycosides in Heshouwu related idiosyncratic liver injury. Sci Bull (Beijing). 2017;62(11):748-751.
[[28]]
Lin L, Lin H, Zhang M, et al. A novel method to analyze hepatotoxic components in Polygonum multiflorum using ultra-performance liquid Chromatography-quadrupole time-of-flight mass spectrometry. J Hazard Mater. 2015;299:249-259.
[[29]]
Li CY, Niu M, Bai ZF, et al. Screening for main components associated with the idiosyncratic hepatotoxicity of a tonic herb, Polygonum multiflorum. Front Med. 2017;11(2):253-265.
[[30]]
Li CY, He Q, Tang JF, et al. Metabolomic study on immunological stress-mediated hepatotoxicity of polygonum multiflorum and its processed products of nine times steaming and nine times sunning. Acta Pharm Sin. 2017;52(7):1069-1076.
[[31]]
Bai ZF, Gao Y, Zuo XB, et al. Progress in research on the pathogenesis of immune regulation and idiosyncratic drug-induced liver injury. Acta Pharm Sin. 2017;52(7):1019-1026.
[[32]]
Li N, Song J, Li XF, et al. Influence of drug metabolizing enzyme inhibitors on liver injury susceptibility to trans-2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucoside. Acta Pharm Sin. 2017;52(7):1063-1068.
[[33]]
Wang Y, Wang L, Saxena R, et al. Clinicopathological features of He Shou Wu-induced liver injury: this ancient anti-aging therapy is not liver-friendly. Liver Int. 2019;39(2):389-400.
[[34]]
He LZ, Yin P, Meng YK, et al. Study on the mechanism of PPAR-γ dependent immunological idiosyncrasy liver injury induced by Polygonum multiflorum. Acta Pharm Sin. 2017;52(7):1027-1032.
[[35]]
Lai XX, Wu JB, Chen S, et al. Risk factors analysis and security application discussion of Polygonum multiflorum based on retrospective study. Chin J Chin Mater Med. 2018;43(15):3205-3210.
[[36]]
Wang HZ, Li XH. Clinical analysis of 33 cases of drug-induced liver injury caused by Polygonum Multiflorum Thunb. and its related preparations. J Integr Chin West Med Hepatol. 2018;28(1):25-27.
[[37]]
Rochon J, Protiva P, Seeff LB, et al. Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury. Hepatology. 2008;48(4):1175-1183.
[[38]]
Chalasani NP, Hayashi PH, Bonkovsky HL, et al. ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury. Am J Gastroenterol. 2014;109(7):950-966.
[[39]]
European Association for the Study of the Liver. EASL Clinical Practice Guidelines: drug-induced liver injury. J Hepatol. 2019;70(6):1222-1261.
[[40]]
Wang JB, Zhang L, Guo YM, et al. Causality assessment strategies and methods for Chinese medicines-induced liver injury. Acta Pharm Sin. 2018;53(6):920-928.
[[41]]
Guo YM, Tu C, He Q, et al. Study on safe drug use of Polygonum multiflorum based on cognition of drug properties. J Tradit Chin Med. 2018;59(9):721-724.
[[42]]
Zhou YY, Niu M, Tu C, et al. Metabolomic study on the susceptible factors of idiosyncratic Traditional Chinese Medicine-induced liver injury: exemplification of a Polygonum multiflorum preparation. Chin Sci Bull. 2019;64:948-962.
[[43]]
Tu C, Wang JB, Xiao XH, et al. Susceptibility-related factor and biomarkers of dietary supplements Polygonum multiflorum-induced liver injury in rats. Front Pharmacol. 2019;10:335.
[[44]]
Wang JB, Zhang L, Yang W, et al. Method of evaluating the susceptibility to Polygoni Multiflori Radix-induced liver injury based on multifactor combination model and the application. China, CN201710669561.4.
[[45]]
Li CY, Tu C, Gao D, et al. Metabolomic study on idiosyncratic liver injury induced by different extracts of Polygonum multiflorum in rats integrated with pattern recognition and enriched pathways analysis. Front Pharmacol. 2016;7:483.
[[46]]
Zhang CE, Niu M, Li Q, et al. Urine metabolomics study on the liver injury in rats induced by raw and processed Polygonum multiflorum integrated with pattern recognition and pathways analysis. J Ethnopharmacol. 2016;194:299-306.
[[47]]
Zhang L, Niu M, Wei AW, et al. Risk profiling using metabolomic characteristics for susceptible individuals of drug-induced liver injury caused by Polygonum multiflorum. Arch Toxicol. 2019;94:245-256.
[[48]]
Wang YX, Liu B, Shi RB, et al. Research on quality control method of stilbene fraction of Polygonum multiflorum Thunb. Chin J Tradit Chin Med Pharm. 2009;24(10):1277-1280.
[[49]]
Zhang L, Bai ZF, Li CY, et al. Study on idiosyncratic liver injury and content of cis-2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucoside in radix Polygoni multiflori Preparata. Acta Pharma Sin. 2017;52(7):1041-1047.
[[50]]
Zhang L, Liu X, Tu C, et al. Components synergy between stilbenes and emodin derivatives contributes to hepatotoxicity induced by Polygonum multiflorum. Xenobiotica. 2020;50(5):515-525.
[[51]]
Gao D, Li XF, Yin P, et al. Preliminary study on hepatotoxic components in Polygoni multiflori radix based on processing and toxicity-decreasing. China Tradit Herb Drugs. 2017;48(10):2044-2050.

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