Skip to main content
Top
Published in: Drug Safety 2/2015

01-02-2015 | Leading Article

Safety Surveillance of Traditional Chinese Medicine: Current and Future

Authors: Shwu-Huey Liu, Wu-Chang Chuang, Wing Lam, Zaoli Jiang, Yung-Chi Cheng

Published in: Drug Safety | Issue 2/2015

Login to get access

Abstract

Herbal medicine, including traditional Chinese medicine, has been used for the prevention, treatment, and cure of disorders or diseases for centuries. In addition to being used directly as therapeutic agents, medicinal plants are also important sources for pharmacological drug research and development. With the increasing consumption of herbal products intended to promote better health, it is extremely important to assure the safety and quality of herbal preparations. However, under current regulation surveillance, herbal preparations may not meet expectations in safety, quality, and efficacy. The challenge is how to assure the safety and quality of herbal products for consumers. It is the responsibility of producers to minimize hazardous contamination and additives during cultivation, harvesting, handling, processing, storage, and distribution. This article reviews the current safety obstacles that have been involved in traditional Chinese herbal medicine preparations with examples of popular herbs. Approaches to improve the safety of traditional Chinese medicine are proposed.
Literature
1.
go back to reference Barnes PM, Bloom B, Nahin R. CDC National Health Statistics Report #12. Complementary and alternative medicine use among adults and children: United States, 2007. 10 Dec 2008. Barnes PM, Bloom B, Nahin R. CDC National Health Statistics Report #12. Complementary and alternative medicine use among adults and children: United States, 2007. 10 Dec 2008.
2.
go back to reference Nahin R, Barnes PM, Stussman BJ, et al. CDC National Health Statistics Report #18. Costs of complementary and alternative medicine (CAM) and frequency of visits to CAM practitioners: United States, 2007. 30 July 2009. Nahin R, Barnes PM, Stussman BJ, et al. CDC National Health Statistics Report #18. Costs of complementary and alternative medicine (CAM) and frequency of visits to CAM practitioners: United States, 2007. 30 July 2009.
3.
go back to reference Fouladbakhsh JM, Stommel M, Given BA, Given CW. Pedictors of use of complementary and alternative therapies among patients with cancer. Oncol Nurs Forum. 2005;32(6):1115–22.CrossRefPubMed Fouladbakhsh JM, Stommel M, Given BA, Given CW. Pedictors of use of complementary and alternative therapies among patients with cancer. Oncol Nurs Forum. 2005;32(6):1115–22.CrossRefPubMed
5.
go back to reference Luo Xiwen tr. Bencao Gangmu: compendium of materia medica. vol 6. Foreign Languages Press; 2003. Luo Xiwen tr. Bencao Gangmu: compendium of materia medica. vol 6. Foreign Languages Press; 2003.
6.
go back to reference Maoshiny N. The yellow Emperor’s Classic of Medicine: a new translation of the Neijing suwen with commentary. Shambhala Publications, Inc.; 1995. Maoshiny N. The yellow Emperor’s Classic of Medicine: a new translation of the Neijing suwen with commentary. Shambhala Publications, Inc.; 1995.
7.
go back to reference Division of Health Statistics. Statistical Annual Report of Medical Care, National Health Insurance. Taipei: The ROC Department of Health; 2009. Division of Health Statistics. Statistical Annual Report of Medical Care, National Health Insurance. Taipei: The ROC Department of Health; 2009.
9.
go back to reference Borum ML. Fulminant exacerbation of autoimmune hepatitis after the use of ma huang. Am J Gastroenterol. 2001;96(5):1654–5.CrossRefPubMed Borum ML. Fulminant exacerbation of autoimmune hepatitis after the use of ma huang. Am J Gastroenterol. 2001;96(5):1654–5.CrossRefPubMed
10.
go back to reference Powell T, Hsu FF, Turk J, Hruska K. Ma-huang strikes again: ephedrine nephrolithiasis. Am J Kidney Dis. 1998;32(1):153–9.CrossRefPubMed Powell T, Hsu FF, Turk J, Hruska K. Ma-huang strikes again: ephedrine nephrolithiasis. Am J Kidney Dis. 1998;32(1):153–9.CrossRefPubMed
11.
go back to reference Fan TP, Deal G, Koo HL, et al. Future development of global regulations of Chinese herbal products. J Ethnopharmacol. 2012;140(3):568–86.CrossRefPubMed Fan TP, Deal G, Koo HL, et al. Future development of global regulations of Chinese herbal products. J Ethnopharmacol. 2012;140(3):568–86.CrossRefPubMed
12.
go back to reference Hughes D. New EU regulations on herbal medicines come into force. BBC News. 2011. Hughes D. New EU regulations on herbal medicines come into force. BBC News. 2011.
13.
go back to reference Zhang L, Yan J, Liu X, et al. Pharmacovigilance practice and risk control of traditional Chinese medicine drugs in China: current status and future perspective. J Ethnopharmacol. 2012;10(140):519–25.CrossRef Zhang L, Yan J, Liu X, et al. Pharmacovigilance practice and risk control of traditional Chinese medicine drugs in China: current status and future perspective. J Ethnopharmacol. 2012;10(140):519–25.CrossRef
15.
go back to reference Liu SH, Cheng YC. Old formula, new Rx: the journey of PHY906 as cancer adjuvant therapy. J Ethnopharmacol. 2012;140(3):614–23.CrossRefPubMed Liu SH, Cheng YC. Old formula, new Rx: the journey of PHY906 as cancer adjuvant therapy. J Ethnopharmacol. 2012;140(3):614–23.CrossRefPubMed
17.
go back to reference Wu KM, Farrelly J, Birnkrant D, et al. Regulatory toxicology perspectives on the development of botanical drug products in the United Sates. Am J Ther. 2004;11:213–7.CrossRefPubMed Wu KM, Farrelly J, Birnkrant D, et al. Regulatory toxicology perspectives on the development of botanical drug products in the United Sates. Am J Ther. 2004;11:213–7.CrossRefPubMed
18.
go back to reference Veregen: a botanical for treatment of genital warts. Obstet Gynecol. 2008;112(3):691–2. Veregen: a botanical for treatment of genital warts. Obstet Gynecol. 2008;112(3):691–2.
19.
go back to reference Tradtrantip L, Namkung W, Verkman AS. Crofelemer, an antisecretory antidiarrheal proanthocyanidin oligomer extracted from Croton lechleri, targets two distinct intestinal chloride channels. Mol Pharmacol. 2010;77(1):69–78.CrossRefPubMedCentralPubMed Tradtrantip L, Namkung W, Verkman AS. Crofelemer, an antisecretory antidiarrheal proanthocyanidin oligomer extracted from Croton lechleri, targets two distinct intestinal chloride channels. Mol Pharmacol. 2010;77(1):69–78.CrossRefPubMedCentralPubMed
20.
go back to reference Teschke R, Wolff A, Frenzel C, Schulze J. Review article: herbal hepatotoxicity—an update on traditional Chinese medicine preparations. Aliment Pharmacol Ther. 2014;40(1):32–50.CrossRefPubMed Teschke R, Wolff A, Frenzel C, Schulze J. Review article: herbal hepatotoxicity—an update on traditional Chinese medicine preparations. Aliment Pharmacol Ther. 2014;40(1):32–50.CrossRefPubMed
21.
go back to reference Chen SP, Ng SW, Poon WT, Lai CK, et al. Aconite poisoning over 5 years: a case series in Hong Kong and lessons towards herbal safety. Drug Saf. 2012;35(7):575–87.CrossRefPubMed Chen SP, Ng SW, Poon WT, Lai CK, et al. Aconite poisoning over 5 years: a case series in Hong Kong and lessons towards herbal safety. Drug Saf. 2012;35(7):575–87.CrossRefPubMed
22.
go back to reference Nyirimigabo E, Xu Y, Li Y, et al. A review on phytochemistry, pharmacology and toxicology studies of Aconitum. J Pharm Pharmacol. 2014 [Epub ahead of print]. Nyirimigabo E, Xu Y, Li Y, et al. A review on phytochemistry, pharmacology and toxicology studies of Aconitum. J Pharm Pharmacol. 2014 [Epub ahead of print].
25.
go back to reference Vanherweghem JL, Depierreux M, Tielemans C, et al. Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet. 1993;341:387–91.CrossRefPubMed Vanherweghem JL, Depierreux M, Tielemans C, et al. Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet. 1993;341:387–91.CrossRefPubMed
26.
go back to reference Nortier JL, Martinez MC, Schmeiser HH, et al. Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). N Engl J Med. 2000;342(23):1686–92.CrossRefPubMed Nortier JL, Martinez MC, Schmeiser HH, et al. Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). N Engl J Med. 2000;342(23):1686–92.CrossRefPubMed
27.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
28.
go back to reference Chen CH, Dickman KG, Huang CY, et al. Aristolochic acid-induced upper tract urothelial carcinoma in Taiwan: clinical characteristics and outcomes. Int J Cancer. 2013;133(1):14–20.CrossRefPubMed Chen CH, Dickman KG, Huang CY, et al. Aristolochic acid-induced upper tract urothelial carcinoma in Taiwan: clinical characteristics and outcomes. Int J Cancer. 2013;133(1):14–20.CrossRefPubMed
29.
go back to reference Hoang ML, Chen CH, Sidorenko VS, et al. Mutational signature of aristolochic acid exposure as revealed by whole-exome sequencing. Sci Transl Med. 2013;5:197ra102.CrossRefPubMedCentralPubMed Hoang ML, Chen CH, Sidorenko VS, et al. Mutational signature of aristolochic acid exposure as revealed by whole-exome sequencing. Sci Transl Med. 2013;5:197ra102.CrossRefPubMedCentralPubMed
30.
go back to reference Drew AK, Whyte IM, Bensoussan A, et al. Chinese herbal medicine toxicology database: monograph on Herba Asari, “xi xin”. J Toxicol Clin Toxicol. 2002;40(2):169–72.CrossRefPubMed Drew AK, Whyte IM, Bensoussan A, et al. Chinese herbal medicine toxicology database: monograph on Herba Asari, “xi xin”. J Toxicol Clin Toxicol. 2002;40(2):169–72.CrossRefPubMed
31.
go back to reference Lee CH, Wang JD, Chen PC. Risk of liver injury associated with Chinese herbal products containing Radix bupleuri in 639,779 patients with Hepatitis B virus infection. PLoS One. 2011;6(1):e16064.CrossRefPubMedCentralPubMed Lee CH, Wang JD, Chen PC. Risk of liver injury associated with Chinese herbal products containing Radix bupleuri in 639,779 patients with Hepatitis B virus infection. PLoS One. 2011;6(1):e16064.CrossRefPubMedCentralPubMed
32.
go back to reference Xue X, Xiao Y, Gong L, et al. Comparative 28-day repeated oral toxicity of Longdan Xieganwan, Akebia trifoliate (Thunb.) koidz., Akebia quinata (Thunb.) Decne. and Caulis aristolochiae manshuriensis in mice. J Ethnopharmacol. 2008;119(1):87–93.CrossRefPubMed Xue X, Xiao Y, Gong L, et al. Comparative 28-day repeated oral toxicity of Longdan Xieganwan, Akebia trifoliate (Thunb.) koidz., Akebia quinata (Thunb.) Decne. and Caulis aristolochiae manshuriensis in mice. J Ethnopharmacol. 2008;119(1):87–93.CrossRefPubMed
33.
go back to reference Hsu HY, Hsu CS. Commonly used Chinese herb formulas with illustrations. Los Angeles: Oriental Healing Art Institute; 1980. Hsu HY, Hsu CS. Commonly used Chinese herb formulas with illustrations. Los Angeles: Oriental Healing Art Institute; 1980.
34.
go back to reference Pharmacopoeia of the People’s Republic of China. vol 1, 1997. Pharmacopoeia of the People’s Republic of China. vol 1, 1997.
35.
go back to reference Fu PP, Yang YC, Xia Q, et al. Pyrrolizidine alkaloids-tumorigenic components in Chinese herbal medicines and dietary supplements. J Food Drug Anal. 2002;10(4):198–211. Fu PP, Yang YC, Xia Q, et al. Pyrrolizidine alkaloids-tumorigenic components in Chinese herbal medicines and dietary supplements. J Food Drug Anal. 2002;10(4):198–211.
36.
go back to reference Cohen PA, Maller G, DeSouza R, et al. Presence of banned drugs in dietary supplements following FDA recalls. JAMA. 2014;312(16):1691–3.CrossRefPubMed Cohen PA, Maller G, DeSouza R, et al. Presence of banned drugs in dietary supplements following FDA recalls. JAMA. 2014;312(16):1691–3.CrossRefPubMed
38.
go back to reference Meharg AA. Arsenic in rice—understanding a new disaster for South-east Asia. Trends Plant Sci. 2004;9:415–7.CrossRefPubMed Meharg AA. Arsenic in rice—understanding a new disaster for South-east Asia. Trends Plant Sci. 2004;9:415–7.CrossRefPubMed
39.
go back to reference Moreno-Jiménez E, Meharg AA, Smolders E, et al. Sprinkler irrigation of rice fields reduces grain arsenic but enhances cadmium. Sci Total Environ. 2014;1(485–486):468–73.CrossRef Moreno-Jiménez E, Meharg AA, Smolders E, et al. Sprinkler irrigation of rice fields reduces grain arsenic but enhances cadmium. Sci Total Environ. 2014;1(485–486):468–73.CrossRef
40.
go back to reference Harris ESJ, Cao S, Littlefield BA, et al. Heavy metal and pesticide content in commonly prescribed individual raw Chinese herbal medicines. Sci Total Environ. 2011;409(20):4297–305.CrossRefPubMedCentralPubMed Harris ESJ, Cao S, Littlefield BA, et al. Heavy metal and pesticide content in commonly prescribed individual raw Chinese herbal medicines. Sci Total Environ. 2011;409(20):4297–305.CrossRefPubMedCentralPubMed
41.
go back to reference Genuis SJ, Schwalfenberg G, Siy A-KJ, Rodushkin I. Toxic element contamination of natural health products and pharmaceutical preparations. Sem DS, editor. PLoS One. 2012;7(11):e49676. Genuis SJ, Schwalfenberg G, Siy A-KJ, Rodushkin I. Toxic element contamination of natural health products and pharmaceutical preparations. Sem DS, editor. PLoS One. 2012;7(11):e49676.
42.
go back to reference Lee KH, Morris-Natschke SL, Yang X, et al. Recent progress of research on medicinal mushrooms, foods, and other herbal products used in traditional Chinese medicine. J Tradit Complement Med. 2012;2(2):84–95.PubMedCentralPubMed Lee KH, Morris-Natschke SL, Yang X, et al. Recent progress of research on medicinal mushrooms, foods, and other herbal products used in traditional Chinese medicine. J Tradit Complement Med. 2012;2(2):84–95.PubMedCentralPubMed
43.
go back to reference Zuo HL, Chen SJ, Zhang DL, et al. Quality evaluation of natural Cordyceps sinensis from different collecting places in China by the contents of nucleosides and heavy metals. Anal Methods. 2013;5:5450–6.CrossRef Zuo HL, Chen SJ, Zhang DL, et al. Quality evaluation of natural Cordyceps sinensis from different collecting places in China by the contents of nucleosides and heavy metals. Anal Methods. 2013;5:5450–6.CrossRef
44.
go back to reference Wu TN, Yang KC, Wang CM, et al. Lead poisoning caused by contaminated Cordyceps, a Chinese herbal medicine: two case reports. Sci Total Environ. 1996;182(1–3):193–5.CrossRefPubMed Wu TN, Yang KC, Wang CM, et al. Lead poisoning caused by contaminated Cordyceps, a Chinese herbal medicine: two case reports. Sci Total Environ. 1996;182(1–3):193–5.CrossRefPubMed
45.
go back to reference Chen LL, Zhou X, Zhang YX, et al. Chemical composition and Heavy metal content of radix of Panax notoginseng from different sources. In: Proceedings of the 13th Meeting of Consortium for Globalization of Chinese Medicine. 2014. Chen LL, Zhou X, Zhang YX, et al. Chemical composition and Heavy metal content of radix of Panax notoginseng from different sources. In: Proceedings of the 13th Meeting of Consortium for Globalization of Chinese Medicine. 2014.
46.
go back to reference Zhang MY, Xie J, Zhang TY, et al. Sinomonas notoginsengisoli sp. nov., isolated from the rhizosphere of Panax notoginseng. Antonie Van Leeuwenhoek. 2014;106(4):827–35.CrossRefPubMed Zhang MY, Xie J, Zhang TY, et al. Sinomonas notoginsengisoli sp. nov., isolated from the rhizosphere of Panax notoginseng. Antonie Van Leeuwenhoek. 2014;106(4):827–35.CrossRefPubMed
47.
go back to reference Bhattacharyya P, Jha DK. Plant growth-promoting rhizobacteria (PGPR): emergence in agriculture. World J Microbiol Biotechnol. 2012;28:1327–50.CrossRefPubMed Bhattacharyya P, Jha DK. Plant growth-promoting rhizobacteria (PGPR): emergence in agriculture. World J Microbiol Biotechnol. 2012;28:1327–50.CrossRefPubMed
51.
go back to reference Kan WL, Ma B, Lin G. Sulfur fumigation processing of traditional Chinese medicinal herbs: beneficial or detrimental? Front Pharmacol. 2011;27(2):84. Kan WL, Ma B, Lin G. Sulfur fumigation processing of traditional Chinese medicinal herbs: beneficial or detrimental? Front Pharmacol. 2011;27(2):84.
52.
go back to reference Wu J, Shen H, Xu J, et al. Detection of Sulfur-fumigated Paeoniae Alba Radix in complex preparations by high performance liquid chromatography tandem mass spectrometry. Molecules. 2012;17:8938–54.CrossRefPubMed Wu J, Shen H, Xu J, et al. Detection of Sulfur-fumigated Paeoniae Alba Radix in complex preparations by high performance liquid chromatography tandem mass spectrometry. Molecules. 2012;17:8938–54.CrossRefPubMed
53.
go back to reference Asgarpanah J, Kazemivash N. Phytochemistry, pharmacology and medicinal properties of Carthamus tinctorius L. Chin J Integr Med. 2013;19(2):153–9.CrossRefPubMed Asgarpanah J, Kazemivash N. Phytochemistry, pharmacology and medicinal properties of Carthamus tinctorius L. Chin J Integr Med. 2013;19(2):153–9.CrossRefPubMed
54.
go back to reference Rao WW, Jiang L, Zhao CY, et al. Identification of chemical industry dyes in adulteration of Chinese medicinal materials. J Pharm Anal. 2007;27(11):1742–5. Rao WW, Jiang L, Zhao CY, et al. Identification of chemical industry dyes in adulteration of Chinese medicinal materials. J Pharm Anal. 2007;27(11):1742–5.
55.
go back to reference Liu SH, Cheng YC, Saif MW. Controlling chemotherapy-related side effects with Chinese medicine. Chapter 7 of “Supportive Cancer Care with Chinese Medicine”. Springer Science; (2010). Liu SH, Cheng YC, Saif MW. Controlling chemotherapy-related side effects with Chinese medicine. Chapter 7 of “Supportive Cancer Care with Chinese Medicine”. Springer Science; (2010).
56.
go back to reference White J. PC-SPES-A Lesson for future dietary supplement research. J Natl Cancer Inst. 2002;94(17):1261–2.CrossRefPubMed White J. PC-SPES-A Lesson for future dietary supplement research. J Natl Cancer Inst. 2002;94(17):1261–2.CrossRefPubMed
58.
go back to reference Meyer JP, Gillatt DA. PC-SPES: a herbal therapy for the treatment of hormone refractory prostate cancer. Prostate Cancer Prostatic Dis. 2002;5(1):13–5.CrossRefPubMed Meyer JP, Gillatt DA. PC-SPES: a herbal therapy for the treatment of hormone refractory prostate cancer. Prostate Cancer Prostatic Dis. 2002;5(1):13–5.CrossRefPubMed
59.
go back to reference DiPaola RS, Zhang H, Lambert GH, et al. Clinical and biologic activity of an estrogenic herbal combination (PC-SPES) in prostate cancer. N Engl J Med. 1998;339(12):785–91.CrossRefPubMed DiPaola RS, Zhang H, Lambert GH, et al. Clinical and biologic activity of an estrogenic herbal combination (PC-SPES) in prostate cancer. N Engl J Med. 1998;339(12):785–91.CrossRefPubMed
60.
go back to reference Small EJ, Frohlich MW, Bok R, et al. Prospective trial of the herbal supplement PC-SPES in patients with progressive prostate cancer. J Clin Oncol. 2000;18:3595–603.PubMed Small EJ, Frohlich MW, Bok R, et al. Prospective trial of the herbal supplement PC-SPES in patients with progressive prostate cancer. J Clin Oncol. 2000;18:3595–603.PubMed
61.
go back to reference De la Taille A, Hayek OR, Burchardt M, et al. Role of herbal compounds (PC-SPES) in hormone-refractory prostate cancer: two case reports. J Altern Complement Med. 2000;6:449–51.CrossRefPubMed De la Taille A, Hayek OR, Burchardt M, et al. Role of herbal compounds (PC-SPES) in hormone-refractory prostate cancer: two case reports. J Altern Complement Med. 2000;6:449–51.CrossRefPubMed
62.
go back to reference De la Taille A, et al. Effects of a phytherapeutic agent, PC-SPES, on prostate cancer: a preliminary investigation on human cell lines and patients. BJU Int. 1999;84:845–50.CrossRefPubMed De la Taille A, et al. Effects of a phytherapeutic agent, PC-SPES, on prostate cancer: a preliminary investigation on human cell lines and patients. BJU Int. 1999;84:845–50.CrossRefPubMed
63.
go back to reference Sovak M, Seligson AL, Konas M, et al. Herbal composition PC-SPES for management of prostate cancer: identification of active principles. J Natl Cancer Inst. 2002;94(17):1275–81.CrossRefPubMed Sovak M, Seligson AL, Konas M, et al. Herbal composition PC-SPES for management of prostate cancer: identification of active principles. J Natl Cancer Inst. 2002;94(17):1275–81.CrossRefPubMed
64.
go back to reference Woolf GM, Petrovic LM, Rojter SE, Wainwright S, et al. Acute hepatitis associated with the Chinese herbal product jin bu huan. Ann Intern Med. 1994;121(10):729–35.CrossRefPubMed Woolf GM, Petrovic LM, Rojter SE, Wainwright S, et al. Acute hepatitis associated with the Chinese herbal product jin bu huan. Ann Intern Med. 1994;121(10):729–35.CrossRefPubMed
65.
go back to reference Picciotto A, Campo N, Brizzolara R, et al. Chronic hepatitis induced by jin bu huan. J Hepatol. 1998;28:165–7.CrossRefPubMed Picciotto A, Campo N, Brizzolara R, et al. Chronic hepatitis induced by jin bu huan. J Hepatol. 1998;28:165–7.CrossRefPubMed
66.
go back to reference Horowitz RS, Feldhaus K, Dart RC. The clinical spectrum of Jin Bu Huan toxicity. Arch Intern Med. 1996;156(8):899–903.CrossRefPubMed Horowitz RS, Feldhaus K, Dart RC. The clinical spectrum of Jin Bu Huan toxicity. Arch Intern Med. 1996;156(8):899–903.CrossRefPubMed
67.
go back to reference FAO (Food and Agriculture Organization of United Nations). Manual on the Application of the HACCP System in Mycotoxin Prevention and Control, 73, FAO Food and Nutrition Paper, Rome. 2001. FAO (Food and Agriculture Organization of United Nations). Manual on the Application of the HACCP System in Mycotoxin Prevention and Control, 73, FAO Food and Nutrition Paper, Rome. 2001.
68.
go back to reference Zain ME. Impact of mycotoxins on humans and animals. J Saudi Chem Soc. 2011;15:129–44.CrossRef Zain ME. Impact of mycotoxins on humans and animals. J Saudi Chem Soc. 2011;15:129–44.CrossRef
69.
go back to reference Ashiq S, Hussain M, Ahmad B. Natural occurrence of mycotoxins in medicinal plants: a review. Fungal Genet Biol. 2014;66:1–10.CrossRefPubMed Ashiq S, Hussain M, Ahmad B. Natural occurrence of mycotoxins in medicinal plants: a review. Fungal Genet Biol. 2014;66:1–10.CrossRefPubMed
70.
go back to reference Kneifel W, Czech E, Kopp B. Microbial contamination of medicinal plants—a review. Planta Med. 2002;68(1):5–15.CrossRefPubMed Kneifel W, Czech E, Kopp B. Microbial contamination of medicinal plants—a review. Planta Med. 2002;68(1):5–15.CrossRefPubMed
71.
go back to reference Melchart D, Linde K, Weidenhammer W, Hager S, Shaw D, et al. Liver enzyme elevations in patients treated with traditional Chinese medicine. JAMA. 1999;282(1):28–9.CrossRefPubMed Melchart D, Linde K, Weidenhammer W, Hager S, Shaw D, et al. Liver enzyme elevations in patients treated with traditional Chinese medicine. JAMA. 1999;282(1):28–9.CrossRefPubMed
72.
go back to reference Itoh S, Marutani K, Nishijima T, Matsuo S, Itabashi M. Liver injuries induced by herbal medicine, syo-saiko-to (xiao-chai-hu-tang). Dig Dis Sci. 1995;40(8):1845–8.CrossRefPubMed Itoh S, Marutani K, Nishijima T, Matsuo S, Itabashi M. Liver injuries induced by herbal medicine, syo-saiko-to (xiao-chai-hu-tang). Dig Dis Sci. 1995;40(8):1845–8.CrossRefPubMed
73.
go back to reference Seeff L, Stickel F, Navarro VJ. Hepatotoxicity of herbals and dietary supplements. In: Kaplowitz N, DeLeve LD, editors. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier; 2013. p. 631–58.CrossRef Seeff L, Stickel F, Navarro VJ. Hepatotoxicity of herbals and dietary supplements. In: Kaplowitz N, DeLeve LD, editors. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier; 2013. p. 631–58.CrossRef
74.
go back to reference Schieman C, Rudmik LR, Dixon E, et al. Complementary and alternative medicine use among general surgery, hepatobiliary surgery and surgical oncology patients. Can J Surg. 2009;52(5):422–6.PubMedCentralPubMed Schieman C, Rudmik LR, Dixon E, et al. Complementary and alternative medicine use among general surgery, hepatobiliary surgery and surgical oncology patients. Can J Surg. 2009;52(5):422–6.PubMedCentralPubMed
75.
go back to reference Li X, Yang G, Li X, et al. Traditional Chinese medicine in cancer care: a review of controlled clinical studies published in Chinese. PLoS One. 2013;8(4):e60338.CrossRefPubMedCentralPubMed Li X, Yang G, Li X, et al. Traditional Chinese medicine in cancer care: a review of controlled clinical studies published in Chinese. PLoS One. 2013;8(4):e60338.CrossRefPubMedCentralPubMed
76.
go back to reference Gurley BJ, Swain A, Williams DK, et al. Gauging the clinical significance of P-glycoprotein-mediated herb-drug interactions: Comparative effects of St. John’s wort, echinacea, clarithromycin, and rifampin on digoxin pharmacokinetics. Mol Nutr Food Res. 2008;52(7):772–9.CrossRefPubMedCentralPubMed Gurley BJ, Swain A, Williams DK, et al. Gauging the clinical significance of P-glycoprotein-mediated herb-drug interactions: Comparative effects of St. John’s wort, echinacea, clarithromycin, and rifampin on digoxin pharmacokinetics. Mol Nutr Food Res. 2008;52(7):772–9.CrossRefPubMedCentralPubMed
77.
go back to reference Lou SK, Wong KL, Li M, et al. An integrated web medicinal materials DNA database: MMDBD (Medicinal Materials DNA Barcode Database). BMC Genomics. 2010;24(11):402.CrossRef Lou SK, Wong KL, Li M, et al. An integrated web medicinal materials DNA database: MMDBD (Medicinal Materials DNA Barcode Database). BMC Genomics. 2010;24(11):402.CrossRef
78.
go back to reference Song J, Yao H, Li Y, Li X, Lin Y, Liu C, Han J, Xie C, Chen S. Authentication of the family Polygonaceae in Chinese pharmacopoeia by DNA barcoding technique. J Ethnopharmacol. 2009;124:434–9.CrossRefPubMed Song J, Yao H, Li Y, Li X, Lin Y, Liu C, Han J, Xie C, Chen S. Authentication of the family Polygonaceae in Chinese pharmacopoeia by DNA barcoding technique. J Ethnopharmacol. 2009;124:434–9.CrossRefPubMed
79.
go back to reference Yan M, Chen JL, Xu LW, et al. Navigating traditional Chinese medicine network pharmacology and computational tools. Evid Based Complement Alternat Med. 2013;2013:731969. Yan M, Chen JL, Xu LW, et al. Navigating traditional Chinese medicine network pharmacology and computational tools. Evid Based Complement Alternat Med. 2013;2013:731969.
80.
go back to reference Ye M, Liu SH, Jiang Z, et al. Liquid chromatography/mass spectrometry analysis of PHY906, a Chinese medicine formulation for cancer therapy. Rapid Commun Mass Spectrom. 2007;21(22):3593–607.CrossRefPubMed Ye M, Liu SH, Jiang Z, et al. Liquid chromatography/mass spectrometry analysis of PHY906, a Chinese medicine formulation for cancer therapy. Rapid Commun Mass Spectrom. 2007;21(22):3593–607.CrossRefPubMed
81.
go back to reference Tilton R, Paiva AA, Guan JQ, et al. A comprehensive platform for quality control of botanical drugs (PhytomicsQC): a case study of Huangqin Tang (HQT) and PHY906. Chin Med. 2010;20(5):30.CrossRef Tilton R, Paiva AA, Guan JQ, et al. A comprehensive platform for quality control of botanical drugs (PhytomicsQC): a case study of Huangqin Tang (HQT) and PHY906. Chin Med. 2010;20(5):30.CrossRef
82.
go back to reference Zhang W, Saif MW, Dutschman GE, et al. Identification of chemicals and their metabolites from PHY906, a Chinese medicine formulation, in the plasma of a patient treated with irinotecan and PHY906 using liquid chromatography/tandem mass spectrometry (LC/MS/MS). J Chromatogr A. 2010;1217(37):5785–93.CrossRefPubMedCentralPubMed Zhang W, Saif MW, Dutschman GE, et al. Identification of chemicals and their metabolites from PHY906, a Chinese medicine formulation, in the plasma of a patient treated with irinotecan and PHY906 using liquid chromatography/tandem mass spectrometry (LC/MS/MS). J Chromatogr A. 2010;1217(37):5785–93.CrossRefPubMedCentralPubMed
83.
go back to reference Dunnick JK, Nyska A. The toxicity and pathology of selected dietary herbal medicines. Toxicol Pathol. 2013;41(2):374–86.CrossRefPubMed Dunnick JK, Nyska A. The toxicity and pathology of selected dietary herbal medicines. Toxicol Pathol. 2013;41(2):374–86.CrossRefPubMed
84.
go back to reference Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. Edinburgh: Churchill Livingstone; 2000. Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. Edinburgh: Churchill Livingstone; 2000.
85.
go back to reference Pelkonen O, Xu Q, Fan TP. Why is research on herbal medicinal products important and how can we improve its quality. J Tradit Complement Med. 2014;4(1):1–7.CrossRefPubMedCentralPubMed Pelkonen O, Xu Q, Fan TP. Why is research on herbal medicinal products important and how can we improve its quality. J Tradit Complement Med. 2014;4(1):1–7.CrossRefPubMedCentralPubMed
86.
go back to reference O’Brien KA, Ling S, Abbas E, et al. A chinese herbal preparation containing radix salviae miltiorrhizae, radix notoginseng and borneolum syntheticum reduces circulating adhesion molecules. Evid Based Complement Alternat Med. 2011;2011:790784.PubMedCentralPubMed O’Brien KA, Ling S, Abbas E, et al. A chinese herbal preparation containing radix salviae miltiorrhizae, radix notoginseng and borneolum syntheticum reduces circulating adhesion molecules. Evid Based Complement Alternat Med. 2011;2011:790784.PubMedCentralPubMed
87.
go back to reference Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina (CAESA) ClinicalTrials.gov Identifier: NCT01659580. Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina (CAESA) ClinicalTrials.gov Identifier: NCT01659580.
88.
go back to reference Lam W, Bussom S, Guan F, et al. PHY906, a four-herb Chinese medicine formula first described 1,800 years ago, reduces irinotecan-induced intestinal damage through anti-inflammatory effects and by promotion of the repopulation of intestinal progenitor cells. Sci Transl Med. 2010;2(45):45ra59.CrossRefPubMed Lam W, Bussom S, Guan F, et al. PHY906, a four-herb Chinese medicine formula first described 1,800 years ago, reduces irinotecan-induced intestinal damage through anti-inflammatory effects and by promotion of the repopulation of intestinal progenitor cells. Sci Transl Med. 2010;2(45):45ra59.CrossRefPubMed
89.
go back to reference Wang E, Bussom S, Chen J, et al. Interaction of a traditional chinese medicine (PHY906) and CPT-11 on the inflammatory process in the tumor microenvironement. BMC Med Genomics. 2011;4:38.CrossRefPubMedCentralPubMed Wang E, Bussom S, Chen J, et al. Interaction of a traditional chinese medicine (PHY906) and CPT-11 on the inflammatory process in the tumor microenvironement. BMC Med Genomics. 2011;4:38.CrossRefPubMedCentralPubMed
90.
go back to reference Yen Y, So S, Rose M, et al. Phase I/II study of PHY906/capecitabine in advanced hepatocellular carcinoma. Anticancer Res. 2009;29(10):4083–92.PubMed Yen Y, So S, Rose M, et al. Phase I/II study of PHY906/capecitabine in advanced hepatocellular carcinoma. Anticancer Res. 2009;29(10):4083–92.PubMed
91.
go back to reference Saif MW, Lansigan F, Ruta S, et al. Phase I study of the botanical formulation PHY906 with capecitabine in advanced pancreatic and gastrointestinal malignancies. Phytomedicine. 2010;17(3–4):161–9.CrossRefPubMed Saif MW, Lansigan F, Ruta S, et al. Phase I study of the botanical formulation PHY906 with capecitabine in advanced pancreatic and gastrointestinal malignancies. Phytomedicine. 2010;17(3–4):161–9.CrossRefPubMed
92.
go back to reference Kummar S, Copur MS, Rose M, et al. A phase I study of the Chinese herbal medicine PHY906 as a modulator of irinotecan-based chemotherapy in patients with advanced colorectal cancer. Clin Colorectal Cancer. 2011;10(2):85–96.CrossRefPubMed Kummar S, Copur MS, Rose M, et al. A phase I study of the Chinese herbal medicine PHY906 as a modulator of irinotecan-based chemotherapy in patients with advanced colorectal cancer. Clin Colorectal Cancer. 2011;10(2):85–96.CrossRefPubMed
93.
go back to reference Saif MW, Li J, Lamb L, et al. First-in-human phase II trial of the botanical formulation PHY906 with capecitabine as second-line therapy in patients with advanced pancreatic cancer. Cancer Chemother Pharmacol. 2014;73(2):373–80.CrossRefPubMedCentralPubMed Saif MW, Li J, Lamb L, et al. First-in-human phase II trial of the botanical formulation PHY906 with capecitabine as second-line therapy in patients with advanced pancreatic cancer. Cancer Chemother Pharmacol. 2014;73(2):373–80.CrossRefPubMedCentralPubMed
94.
95.
Metadata
Title
Safety Surveillance of Traditional Chinese Medicine: Current and Future
Authors
Shwu-Huey Liu
Wu-Chang Chuang
Wing Lam
Zaoli Jiang
Yung-Chi Cheng
Publication date
01-02-2015
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 2/2015
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-014-0250-z

Other articles of this Issue 2/2015

Drug Safety 2/2015 Go to the issue