Regulation and application of Chinese herbs in the US: misuse is the main cause of toxic incidents

References

[[1]] Lam WC, Lyu AP, Bian ZX, et al. ICD-11: Impact on traditional Chinese medicine and world healthcare system. Pharmaceut Med. 2019;33:373-377.

[[2]] European academic science advisory council. Traditional Chinese medicine: a statement by EASAC and FEAM. Reports and statements. Biosciences.2019. Available from: https://easac.eu/publications/details/traditional-chinese-medicine-a-statement-by-easac-and-feam. Accessed July 11, 2019.

[[3]] Fleischer T, Su YC, Lin JS. How do government regulations influence the ability to practice Chinese herbal medicine in western countries. J Ethnopharmacol. 2017;196:104-109.

[[4]] Lau Y. A brief history of traditional Chinese herbal medicine in America. Mayway.Available from: https://www.mayway.com/articles/traditional-chinese-herbal-medicine-in-america

[[5]] Finn JD. Pioneer Chinese doc was a city treasure in John Day. Offbeat Oregon History. 2014.

[[6]] Moy J.Who was Yee Fung Cheung? And what is his legacy? Linkedin, May 5, 2023.

[[7]] Chang G, Fishkin S. “Chapter 21. The Chinese and the Stanford’s: Nineteenth-century America’s fraught relationship with the China men.” The Chinese and the iron road: building the transcontinental railroad. Redwood City: Stanford University Press; 2019:346-364.

[[8]] The Associated Press. Nationwide ban on ephedra goes into effect. NBC News. 2004. Available from: https://www.nbcnews.com/id/wbna4721505.

[[9]] Kapner D. Ephedra and energy drinks on college campuses. Infofactsresources. 2008.

[[10]] Vanherweghem LJ. Misuse of herbal remedies: the case of an outbreak of terminal renal failure in Belgium (Chinese herbs nephropathy). J Altern Complement Med. 1998;4(1):9-13.

[[11]] Liu W, Sun P. The second aristolochic acid case in Belgium—why were Chinese herbs blamed? J Chin Med. 2019;120:74-76.

[[12]] Chen LL, Verpoorte R, Yen HR, et al. Effects of processing adjuvants on traditional Chinese herbs. J Food Drug Anal. 2018;26(2S):S96-S114.

[[13]] Wu X, Wang SP, Lu JR, et al. Seeing the unseen of Chinese herbal medicine processing (Paozhi): advances in new perspectives. Chin Med. 2018;13:4.

[[14]] Zhou X, Seto SW, Chang D, et al. Synergistic effects of Chinese herbal medicine: a comprehensive review of methodology and current research. Front Pharmacol. 2016;7:201.

[[15]] Gao Y, Wu X, Zhao N, et al. Scientific connotation of the compatibility of traditional Chinese medicine from the perspective of the intestinal flora. Front Pharmacol. 2023;14:1152858.

[[16]] US Food & Drug Administration. Office of Dietary Supplements, National Institutes of Health. Small entity compliance guide: final rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk. 2008.

[[17]] Yang HY, Chen PC, Wang JD. Chinese herbs containing aristolochic acid associated with renal failure and urothelial carcinoma: a review from epidemiologic observations to causal inference. Biomed Res Int. 2014;569325:1-9.

[[18]] Garcia BA. Herbal tea poisons two San Franciscans public warned to discard tea purchased at Chinatown shop. San Francisco Department of Public Health. March 10, 2017.

[[19]] National Institute of Health, Office of Dietary Supplements. Dietary supplement health and education act of 1994. 1994.

[[20]] U.S. Food and Drug Administration. Current good manufacturing practices (cGMPs) for dietary supplements. June 25, 2007.

[[21]] National Academy of Sciences, Washington, D.C. Herbal pharmacology in the People’s Republic of China, a trip report of the American herbal pharmacology delegation. 1975. Available from: https://www.swsbm.com/Ephemera/China_herbs.pdf

[[22]] Liu W. What has been overlooked on study of Chinese materia medica in the West? Chin J Integr Med. 2017;21(7):483-492.

[[23]] Liu W. Traditional Herbal Medicine Research Methods-Identification, Analysis, Bioassay, and Pharmacological and Clinical Studies. Hoboken, New Jersey: John Wiley & Sons; 2011.

[[24]] Changou CA, Shiah HS, Chen LT, et al. A phase II clinical trial on the combination therapy of PHY906 plus capecitabine in hepatocellular carcinoma. Oncologist. 2021;26(3):e367-e373.

[[25]] U.S. Food & Drug Administration. Facts about Dietary Supplements.Available from: https://www.fda.gov/news-events/rumor-control/facts-about-dietary-supplements.

[[26]] The American Herbal Pharmacopoeia®(AHP). Available from: https://herbal-ahp.org/. Accessed May 16, 2023.

[[27]] U.S. Pharmacopeia (USP). Dietary Supplements Compendium. Available from: https://www.usp.org/products/dietary-supplements-compendium.

[[28]] LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

[[29]] Xiao XH, Zhao X, Bai ZF, et al. New outlook on safety of traditional Chinese medicine: concept and practice. China J Chin Materia Medica. 2023;48(10):2557-2564.

[[30]] Li CP, Rao T, Chen XP, et al. HLA-B*35:01 allele is a potential biomarker for predicting Polygonum multiflorum-induced liver injury in humans. Hepatology. 2019;70:346.

[[31]] Zhao ZZ, Guo P, Brand E. A concise classification of bencao (materia medica). Chin Med. 2018;13:18.

[[32]] Pharmacopoeia of the People’s Republic of China. Pharmacopoeia of the People’s Republic of China volumes 1 & 2(English Edition). 2000.

[[33]] Zhu H, Wang X, Wang X, et al. The toxicity and safety of Chinese medicine from the bench to the bedside. J Herb Med. 2021;28(10):1-14.

[[34]] Alimoghaddam K. A review of arsenic trioxide and acute promyelocytic leukemia. Int J Hematol Oncol Stem Cell Res. 2014;8(3):44-54.

[[35]] Liu W, Li Y, Xia A, et al. Queries on the article “Maternal traditional Chinese medicine exposure and risk of congenital malformations” and suggestions for teratogenicity research. Reproduction and Breeding. 2023.

[[36]] Price S. Extract of thunder god vine root ameliorates inflammation in patients withRA. Nat Rev Rheumatol. 2009;5:526.

[[37]] Song X, Zhang Y, Dai E. Therapeutic targets of thunder god vine (Tripterygium wilfordii hook) in rheumatoid arthritis (Review). Mol Med Rep. 2020;21(6):2303-2310.

[[38]] Peng T, Yin LL, Xiong Y, et al. Maternal traditional Chinese medicine exposure and risk of congenital malformations: a multicenter prospective cohort study. Acta Obstet Gynecol Scand. 2023;102(6):735-743.

[[39]] Van Norman GA. Limitations of animal studies for predicting toxicity in clinical trials: is it time to rethink our current approach? JACC Basic Transl Sci. 2019;4(7):845-854.

[[40]] Wang CC, Li L, Tang LY, et al. Safety evaluation of commonly used Chinese herbal medicines during pregnancy in mice. Hum Reprod. 2012;27(8):2448-2456.

[[41]] Lee SW, Lai NM, Chaiyakunapruk N, et al. Adverse effects of herbal or dietary supplements in G6PD deficiency: a systematic review. Br J Clin Pharmacol. 2017;83(1):172-179.

[[42]] Gu Y, Wu T, Huang Z, et al. Development toxicities of realgar on embryo/fetal of rats and rabbits. Chin J Pharmacol Toxicol. 2013;27:1007.

RIGHTS & PERMISSIONS

2024 Acupuncture and Herbal Medicine