Table of Contents Author Guidelines Submit a Manuscript
Evidence-Based Complementary and Alternative Medicine
Volume 2013, Article ID 697893, 9 pages
http://dx.doi.org/10.1155/2013/697893
Review Article

Observational Studies on Evaluating the Safety and Adverse Effects of Traditional Chinese Medicine

1Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, Taipei City 112, Taiwan
2Department of Chinese Medicine, Taipei City Hospital, Yangming Branch, Taipei City 111, Taiwan
3Center for Evidence Based Medicine, Peking University Health Science Centre, Peking University, Beijing 100871, China
4Division of Epidemiology, School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong
5Department of Public Health, College of Medicine, National Cheng Kung University, Tainan City 701, Taiwan

Received 7 April 2013; Revised 23 June 2013; Accepted 10 August 2013

Academic Editor: Lixing Lao

Copyright © 2013 Jung-Nein Lai et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. M.-S. Jong, S.-J. Hwang, Y.-C. Chen, T.-J. Chen, F.-J. Chen, and F.-P. Chen, “Prescriptions of chinese herbal medicine for constipation under the National Health Insurance in Taiwan,” Journal of the Chinese Medical Association, vol. 73, no. 7, pp. 375–383, 2010. View at Publisher · View at Google Scholar · View at Scopus
  2. C.-H. Chuang, W.-S. Hsieh, Y. L. Guo et al., “Chinese herbal medicines used in pregnancy: a population-based survey in Taiwan,” Pharmacoepidemiology and Drug Safety, vol. 16, no. 4, pp. 464–468, 2007. View at Publisher · View at Google Scholar · View at Scopus
  3. K. J. Thomas, J. P. Nicholl, and P. Coleman, “Use and expenditure on complementary medicine in England: a population based survey,” Complementary Therapies in Medicine, vol. 9, no. 1, pp. 2–11, 2001. View at Publisher · View at Google Scholar · View at Scopus
  4. D. M. Eisenberg, R. B. Davis, S. L. Ettner et al., “Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up national survey,” Journal of the American Medical Association, vol. 280, no. 18, pp. 1569–1575, 1998. View at Google Scholar · View at Scopus
  5. C. D. Hong, “Complementary and alternative medicine in Korea: current status and future prospects,” Journal of Alternative and Complementary Medicine, vol. 7, no. 1, pp. S33–S40, 2001. View at Google Scholar · View at Scopus
  6. The Committee on Chinese Medicine and Pharmacy, Department of Health Executive Yuan, Taipei City, Taiwan, List of 100 unified formulas, March 2011, http://www.ccmp.gov.tw/information/formula_type.asp?relno=549&level=C.
  7. A. Flower, C. Witt, J. P. Liu, G. Ulrich-Merzenich, H. Yu, and G. Lewith, “Guidelines for randomised controlled trials investigating Chinese herbal medicine,” Journal of Ethnopharmacology, vol. 140, no. 3, pp. 550–554, 2012. View at Publisher · View at Google Scholar · View at Scopus
  8. J.-L. Tang, “Research priorities in traditional Chinese medicine,” British Medical Journal, vol. 333, no. 7564, pp. 391–394, 2006. View at Google Scholar · View at Scopus
  9. J.-L. Tang, S.-Y. Zhan, and E. Ernst, “Review of randomised controlled trials of traditional Chinese medicine,” British Medical Journal, vol. 318, no. 7203, pp. 160–161, 1999. View at Google Scholar · View at Scopus
  10. J.-L. Tang, B.-Y. Liu, and K.-W. Ma, “Traditional Chinese medicine,” The Lancet, vol. 372, no. 9654, pp. 1938–1940, 2008. View at Publisher · View at Google Scholar · View at Scopus
  11. M. J. Verhoef, G. Lewith, C. Ritenbaugh, H. Boon, S. Fleishman, and A. Leis, “Complementary and alternative medicine whole systems research: beyond identification of inadequacies of the RCT,” Complementary Therapies in Medicine, vol. 13, no. 3, pp. 206–212, 2005. View at Publisher · View at Google Scholar · View at Scopus
  12. M. E. Hyland, “Methodology for the scientific evaluation of complementary and alternative medicine,” Complementary Therapies in Medicine, vol. 11, no. 3, pp. 146–153, 2003. View at Publisher · View at Google Scholar · View at Scopus
  13. F. Efficace, M. Horneber, S. Lejeune et al., “Methodological quality of patient-reported outcome research was low in complementary and alternative medicine in oncology,” Journal of Clinical Epidemiology, vol. 59, no. 12, pp. 1257–1265, 2006. View at Publisher · View at Google Scholar · View at Scopus
  14. N. Bhardwaj, K. Jain, S. Arora, and N. Bharti, “A comparison of three vasopressors for tight control of maternal blood pressure during cesarean section under spinal anesthesia: effect on maternal and fetal outcome,” Journal of Anaesthesiology Clinical Pharmacology, vol. 29, no. 1, pp. 26–31, 2013. View at Google Scholar
  15. V. I. Carrara, K. M. Lwin, A. P. Phyo et al., “Malaria burden and artemisinin resistance in the mobile and migrant population on the thai-myanmar border, 1999–2011: an observational study,” PLoS Medicine, vol. 10, no. 3, Article ID e1001398, 2013. View at Google Scholar
  16. C. Bunchorntavakul and K. R. Reddy, “Review article: herbal and dietary supplement hepatotoxicity,” Alimentary Pharmacology & Therapeutics, vol. 37, no. 1, pp. 3–17, 2013. View at Google Scholar
  17. J.-L. Vanherweghem, M. Depierreux, C. Tielemans et al., “Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs,” The Lancet, vol. 341, no. 8842, pp. 387–391, 1993. View at Publisher · View at Google Scholar · View at Scopus
  18. S.-C. Hsieh, J.-N. Lai, P.-C. Chen, H.-J. Chen, and J.-D. Wang, “Development of active safety surveillance system for traditional Chinese medicine: an empirical study in treating climatic women,” Pharmacoepidemiology and Drug Safety, vol. 15, no. 12, pp. 889–899, 2006. View at Publisher · View at Google Scholar · View at Scopus
  19. C. A. Naranjo, U. Busto, E. M. Sellers et al., “A method for estimating the probability of adverse drug reactions,” Clinical Pharmacology and Therapeutics, vol. 30, no. 2, pp. 239–245, 1981. View at Google Scholar · View at Scopus
  20. R. H. Howland, “Understanding and assessing adverse drug reactions,” Journal of Psychosocial Nursing and Mental Health Services, vol. 49, no. 10, pp. 13–15, 2011. View at Publisher · View at Google Scholar · View at Scopus
  21. J.-N. Lai, H.-J. Chen, C.-C. Chen, J.-H. Lin, J.-S. Hwang, and J.-D. Wang, “Duhuo Jisheng Tang for treating osteoarthritis of the knee: a prospective clinical observation,” Chinese Medicine, vol. 2, article 4, 2007. View at Publisher · View at Google Scholar · View at Scopus
  22. C.-H. Yeh, C. K. Arnold, Y.-H. Chen, and J.-N. Lai, “Suan Zao Ren Tang as an original treatment for sleep difficulty in climacteric women: a prospective clinical observation,” Evidence-Based Complementary and Alternative Medicine, vol. 2011, Article ID 673813, 8 pages, 2011. View at Publisher · View at Google Scholar · View at Scopus
  23. J.-N. Lai, J.-S. Hwang, H.-J. Chen, and J.-D. Wang, “Finished herbal product as an alternative treatment for menopausal symptoms in climacteric women,” Journal of Alternative and Complementary Medicine, vol. 11, no. 6, pp. 1075–1084, 2005. View at Publisher · View at Google Scholar · View at Scopus
  24. J. G. Y. Lue, Essential Prescriptions of the Golden Coffer, Paradigm Publication, 2008, http://www.paradigm-pubs.com/catalog/detail/JinGui.
  25. A. K. Drew, I. M. Whyte, A. Bensoussan, A. H. Dawson, X. Zhu, and S. P. Myers, “Chinese herbal medicine toxicology database: monograph on herba asari, ‘Xi Xin’,” Journal of Toxicology—Clinical Toxicology, vol. 40, no. 2, pp. 169–172, 2002. View at Publisher · View at Google Scholar · View at Scopus
  26. The Committee on Chinese Medicine and Pharmacy Department of Health, Executive Yuan, Analysis and Specification of Aristolochic Acid in Xixin, Taipei City, Taiwan, 2008, http://www.ccmp.gov.tw/public/public.asp?selno=601&relno=601&level=C.
  27. K. Hashimoto, M. Higuchi, B. Makino et al., “Quantitative analysis of aristolochic acids, toxic compounds, contained in some medicinal plants,” Journal of Ethnopharmacology, vol. 64, no. 2, pp. 185–189, 1999. View at Publisher · View at Google Scholar · View at Scopus
  28. The Committee on Chinese Medicine and Pharmacy, Department of Health, Executive Yuan, Reference list of registered Chinese herbal medicines, Taipei City, Taiwan, Nomember 2008, http://www.ccmp.gov.tw/public/public.asp?selno=492&relno=492&level=C.
  29. S.-C. Hsieh, I.-H. Lin, W.-L. Tseng, C.-H. Lee, and J.-D. Wang, “Prescription profile of potentially aristolochic acid containing Chinese herbal products: an analysis of National Health Insurance data in Taiwan between 1997 and 2003,” Chinese Medicine, vol. 3, article 13, 2008. View at Publisher · View at Google Scholar · View at Scopus
  30. The Committee on Chinese Medicine and Pharmacy, Department of Health, Executive Yuan, Drug Registration-Related Regulations-Xixin Herbs and Products, Taipei City, Taiwan, 2008, http://www.ccmp.gov.tw/public/public.asp?selno=601&relno=601&level=C.
  31. S. Sun, Qianjin Yaofang (Invaluable Prescriptions for Ready Reference), National Palace Museum, Taipei, Taiwan, 2008, http://www.npm.gov.tw/exh92/medicinal9207/english/content/m4.htm.
  32. H.-Y. Yang, J.-L. Lin, K.-H. Chen, C.-C. Yu, P.-Y. Hsu, and C.-L. Lin, “Aristolochic acid-related nephropathy associated with the popular Chinese herb Xi Xin,” Journal of Nephrology, vol. 19, no. 1, pp. 111–114, 2006. View at Google Scholar · View at Scopus
  33. P. H. Hsieh, F. Y. Hsiao, S. S. Gau, and C. S. Gau, “Use of antipsychotics and risk of cerebrovascular events in schizophrenic patients: a nested case-control study,” Journal of Clinical Psychopharmacology, vol. 33, no. 3, pp. 299–305, 2013. View at Google Scholar
  34. V. Y. Su, Y. W. Hu, K. T. Chou et al., “Amiodarone and the risk of cancer: a nationwide population-based study,” The Cancer Journal, vol. 119, no. 9, pp. 1669–1705, 2013. View at Google Scholar
  35. W. S. Huang, C. H. Tsai, C. C. Lin et al., “Relationship between zolpidem use and stroke risk: a Taiwanese population-based case-control study,” Journal of Clinical Psychiatry, vol. 74, no. 5, pp. e433–e438, 2012. View at Google Scholar
  36. Y. T. Lin, C. J. Liu, Y. C. Yeh, T. J. Chen, and C. P. Fung, “Ampicillin and amoxicillin use and the risk of Klebsiella pneumoniae liver abscess in Taiwan,” The Journal of Infectious Diseases, vol. 208, no. 2, pp. 211–217, 2013. View at Google Scholar
  37. R. G. Price, “The role of NAG (N-acetyl-β-D-glucosaminidase) in the diagnosis of kidney disease including the monitoring of nephrotoxicity,” Clinical Nephrology, vol. 38, no. 1, pp. S14–S19, 1992. View at Google Scholar · View at Scopus
  38. J.-N. Lai, S.-C. Hsieh, P.-C. Chen, H.-J. Chen, and J.-D. Wang, “Should herbs take all the blame? Causality assessment of a serious thrombocytopenia event,” Journal of Alternative and Complementary Medicine, vol. 16, no. 11, pp. 1221–1224, 2010. View at Publisher · View at Google Scholar · View at Scopus
  39. M.-N. Lai, J.-N. Lai, P.-C. Chen, S.-C. Hsieh, F.-C. Hu, and J.-D. Wang, “Risks of kidney failure associated with consumption of herbal products containing Mu Tong or Fangchi: a population-based case-control study,” American Journal of Kidney Diseases, vol. 55, no. 3, pp. 507–518, 2010. View at Publisher · View at Google Scholar · View at Scopus
  40. M.-N. Lai, J.-N. Lai, P.-C. Chen et al., “Increased risks of chronic kidney disease associated with prescribed Chinese herbal products suspected to contain aristolochic acid,” Nephrology, vol. 14, no. 2, pp. 227–234, 2009. View at Publisher · View at Google Scholar · View at Scopus
  41. M.-N. Lai, S.-M. Wang, P.-C. Chen, Y.-Y. Chen, and J.-D. Wang, “Population-based case-control study of chinese herbal products containing aristolochic acid and urinary tract cancer risk,” Journal of the National Cancer Institute, vol. 102, no. 3, pp. 179–186, 2010. View at Publisher · View at Google Scholar · View at Scopus
  42. V. S. Stel, K. J. Jager, C. Zoccali, C. Wanner, and F. W. Dekker, “The randomized clinical trial: an unbeatable standard in clinical research?” Kidney International, vol. 72, no. 5, pp. 539–542, 2007. View at Publisher · View at Google Scholar · View at Scopus
  43. S.-C. Hsieh, J.-N. Lai, P.-C. Chen, C.-C. Chen, H.-J. Chen, and J.-D. Wang, “Is Duhuo Jisheng Tang containing Xixin safe? A four-week safety study,” Chinese Medicine, vol. 5, article 6, 2010. View at Publisher · View at Google Scholar · View at Scopus
  44. H. Y. Yang, J. D. Wang, T. C. Lo, and P. C. Chen, “Occupational exposure to herbs containing aristolochic acids increases the risk of urothelial carcinoma in Chinese herbalists,” Journal of Urology, vol. 189, no. 1, pp. 48–52, 2013. View at Google Scholar
  45. H.-Y. Yang, J.-D. Wang, T.-C. Lo, and P.-C. Chen, “Occupational kidney disease among Chinese herbalists exposed to herbs containing aristolochic acids,” Occupational and Environmental Medicine, vol. 68, no. 4, pp. 286–290, 2011. View at Publisher · View at Google Scholar · View at Scopus
  46. J. P. Vandenbroucke, “When are observational studies as credible as randomised trials?” The Lancet, vol. 363, no. 9422, pp. 1728–1731, 2004. View at Publisher · View at Google Scholar · View at Scopus
  47. O. H. Klungel, E. P. Martens, B. M. Psaty et al., “Methods to assess intended effects of drug treatment in observational studies are reviewed,” Journal of Clinical Epidemiology, vol. 57, no. 12, pp. 1223–1231, 2004. View at Publisher · View at Google Scholar · View at Scopus
  48. M. Vray, B. Hamelin, and P. Jaillon, “The respective roles of controlled clinical trials and cohort monitoring studies in the pre- and postmarketing assessment of drugs,” Therapie, vol. 60, no. 4, pp. 339–349, 2005. View at Publisher · View at Google Scholar · View at Scopus
  49. L. C. Winslow and H. Shapiro, “Physicians want education about complementary and alternative medicine to enhance communication with their patients,” Archives of Internal Medicine, vol. 162, no. 10, pp. 1176–1181, 2002. View at Google Scholar · View at Scopus