Table of Contents Author Guidelines Submit a Manuscript
Evidence-Based Complementary and Alternative Medicine
Volume 2013, Article ID 128030, 10 pages
http://dx.doi.org/10.1155/2013/128030
Review Article

Adaption and Application of the Four Phase Trials to Traditional Chinese Medicines

1Division of Epidemiology, The JC School of Public Health and Primary Care, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
2Hong Kong Cochrane, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong

Received 8 June 2013; Accepted 16 July 2013

Academic Editor: Allan Hackshaw

Copyright © 2013 M. Y. Di and J. L. Tang. 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. E. K. Fung and J. M. Loré Jr., “Randomized controlled trials for evaluating surgical questions,” Archives of Otolaryngology—Head and Neck Surgery, vol. 128, no. 6, pp. 631–634, 2002. View at Google Scholar · View at Scopus
  2. M. Gross, “Innovations in surgery. A proposal for phased clinical trials,” Journal of Bone and Joint Surgery. British, vol. 75, no. 3, pp. 351–354, 1993. View at Google Scholar · View at Scopus
  3. R. S. McLeod, “Issues in surgical randomized controlled trials,” World Journal of Surgery, vol. 23, no. 12, pp. 1210–1214, 1999. View at Publisher · View at Google Scholar · View at Scopus
  4. F. G. Miller, “Sham surgery: an ethical analysis,” The American Journal of Bioethics, vol. 3, no. 4, pp. 41–48, 2003. View at Google Scholar · View at Scopus
  5. C. Gluud and L. L. Gluud, “Evidence based diagnostics,” British Medical Journal, vol. 330, no. 7493, pp. 724–726, 2005. View at Google Scholar · View at Scopus
  6. P. McCulloch, D. G. Altman, W. B. Campbell et al., “No surgical innovation without evaluation: the IDEAL recommendations,” The Lancet, vol. 374, no. 9695, pp. 1105–1112, 2009. View at Publisher · View at Google Scholar · View at Scopus
  7. Wikipedia Website, “Phases of clinical research,” May 2013, http://en.wikipedia.org/wiki/Phases_of_clinical_research.
  8. Wikipedia Website, “Clinical trial,” May 2013, http://en.wikipedia.org/wiki/Clinical_trial.
  9. Medicines Australia Website, “Clinical trials,” May 2013, http://medicinesaustralia.com.au/issues-information/clinical-trials/.
  10. Canada Trials Website, “What is clinical trial?” May 2013, http://www.canadatrials.com/AboutClinicalResearch.php.
  11. “Cancer research UK. Phase 1, 2, 3 and 4 trials,” May 2013, http://www.cancerresearchuk.org/cancer-help/trials/types-of-trials/phase-1-2-3-and-4-trials.
  12. World Health Organization, “International Clinical Trial Registry Platform,” May 2013, http://www.who.int/ictrp/glossary/en/.
  13. S. Weinstein, N. A. Obuchowski, and M. L. Lieber, “Clinical evaluation of diagnostic tests,” American Journal of Roentgenology, vol. 184, no. 1, pp. 14–19, 2005. View at Google Scholar · View at Scopus
  14. Igitur-archive libraty, “Evaluation of routinely used diagnostic tests,” April 2013, http://igitur-archive.library.uu.nl/dissertations/2006-0512-200050/c8.pdf.
  15. K. Boyle and F. R. Batzer, “Is a placebo-controlled surgical trial an oxymoron?” Journal of Minimally Invasive Gynecology, vol. 14, no. 3, pp. 278–283, 2007. View at Publisher · View at Google Scholar · View at Scopus
  16. C. Petrini, “Surgical experimentation and clinical trials: differences and related ethical problems,” Annali dell'Istituto Superiore di Sanità, vol. 49, no. 2, pp. 230–233, 2013. View at Google Scholar
  17. A. Flower, G. Lewith, and P. Little, “Combining rigour with relevance: a novel methodology for testing Chinese herbal medicine,” Journal of Ethnopharmacology, vol. 134, no. 2, pp. 373–378, 2011. View at Publisher · View at Google Scholar · View at Scopus
  18. 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
  19. J.-L. Tang, “Some reflections on the evaluation of clinical effectiveness of Chinese medicine in China,” Chinese Journal of Integrative Medicine, vol. 16, no. 5, pp. 390–391, 2010. View at Publisher · View at Google Scholar · View at Scopus
  20. J. L. Tang and T. W. Wong, “The need to evaluate the clinical effectiveness of traditional Chinese medicine,” Hong Kong Medical Journal, vol. 4, no. 2, pp. 208–210, 1998. View at Google Scholar
  21. L. Lao, Y. Huang, C. Feng, B. M. Berman, and M. T. Tan, “Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial,” Statistics in Medicine, vol. 31, no. 7, pp. 619–627, 2012. View at Publisher · View at Google Scholar · View at Scopus
  22. B. L. Zhang, J. H. Zhang, and J. Q. Hu, “Thinking about translational medicine and traditional Chinese medicine,” Journal of Translational Medicine, vol. 10, supplement 2, p. A33, 2012. View at Google Scholar
  23. T. T. Hien, N. P. J. Day, N. H. Phu et al., “A controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria,” The New England Journal of Medicine, vol. 335, no. 2, pp. 76–83, 1996. View at Publisher · View at Google Scholar · View at Scopus
  24. 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
  25. Y. Zhang, “To explore natures of diseases by combining main, accompanyting and changing syndromes in education of TCM,” Chinese Medicine Modern Distance Education of China, vol. 10, no. 11, pp. 53–54, 2012. View at Google Scholar
  26. C. H. Yang, J. M. Lin, and J. Xie, “Study on the metabolin difference of hypertension patients of gan-yang hyperactivity syndrome and yin-yang deficiency syndrome,” Zhongguo Zhong Xi Yi Jie He Za Zhi, vol. 32, no. 9, pp. 1204–1207, 2012. View at Google Scholar
  27. H. Q. Jiang, Y. L. Li, and J. Xie, “Urine metabonomic study on hypertension patients of ascendant hyperactivity of gan yang syndrome by high performance liquid chromatography coupled with time of flight mass spectrometry,” Zhongguo Zhong Xi Yi Jie He Za Zhi, vol. 32, no. 3, pp. 333–337, 2012. View at Google Scholar
  28. W.-L. Gu, Z.-X. Shi, Y.-X. Yu, Y.-W. Wu, B.-W. Lu, and K.-K. Hui, “Distribution characteristics of syndrome types in essential hypertension,” Journal of Chinese Integrative Medicine, vol. 8, no. 9, pp. 842–847, 2010. View at Publisher · View at Google Scholar · View at Scopus
  29. J. F. Bi, J. G. Duan, and Z. M. Lui, “Discussion of the effect of placebo control in randomized controlled trials(RCTs),” Pharmacology and Clinics of Chinese Materia Medica, vol. 23, no. 4, pp. 59–61, 2007. View at Google Scholar
  30. X. F. Wang, D. Dong, F. Liu et al., “Exploration on preparation of placeboes for clinical trials in traditional Chinese medicines,” Liaoning Journal of Traditional Chinese Medicine, vol. 30, no. 12, p. 966, 2003. View at Google Scholar
  31. X. D. Tang, L. Q. Bian, and R. Gao, “Exploration into the preparation of placebos used in Chinese medicinal clinical trial,” Zhongguo Zhong Xi Yi Jie He Za Zhi, vol. 29, no. 7, pp. 656–658, 2009. View at Google Scholar
  32. C.-S. Cheng and Y.-H. Zhu, “Discussion on the constructing principle of syndrome differentiation system according to meridian and collateral theories,” Zhongguo Zhen Jiu, vol. 31, no. 9, pp. 831–833, 2011. View at Google Scholar · View at Scopus
  33. M. F. Mei, “A systematic analysis of the theory and practice of syndrome differentiation,” Chinese Journal of Integrative Medicine, vol. 17, no. 11, pp. 803–810, 2011. View at Google Scholar · View at Scopus
  34. Y. Guan, Y. Yin, Y.-R. Zhu et al., “Dissection of mechanisms of a chinese medicinal formula: danhong injection therapy for myocardial ischemia/reperfusion injury in vivo and in vitro,” Evidence-Based Complementary and Alternative Medicine, vol. 2013, Article ID 972370, 13 pages, 2013. View at Publisher · View at Google Scholar
  35. Z. Xiang, T. Qiao, H. Xiao et al., “The anaphylactoid constituents in Xue-Sai-Tong injection,” Planta Medica, 2013. View at Publisher · View at Google Scholar
  36. J. P. Zhang, Y. Y. Zhang, Y. Zhang et al., “Salvia miltiorrhiza (Danshen) injection ameliorates iron overload-induced cardiac damage in mice,” Planta Medica, vol. 79, no. 9, pp. 744–752, 2013. View at Google Scholar
  37. S. Fu, J. Zhang, F. Menniti-Ippolito et al., “Huangqi injection (a traditional chinese patent medicine) for chronic heart failure: a systematic review,” PLoS ONE, vol. 6, no. 5, Article ID e19604, 2011. View at Publisher · View at Google Scholar · View at Scopus
  38. J. F. Xie, “Research and development of modern formulation of traditional Chinese medicine,” Medical Information, vol. 24, no. 3, p. 333, 2011. View at Google Scholar
  39. P. Venkatasubramanian, S. Kumar K., and V. S. N. Nair, “Cyperus rotundus, a substitute for Aconitum heterophyllum: studies on the Ayurvedic concept of Abhava Pratinidhi Dravya (drug substitution),” Journal of Ayurveda and Integrative Medicine, vol. 1, no. 1, pp. 33–39, 2010. View at Publisher · View at Google Scholar · View at Scopus
  40. P. Zhang, X. Wang, S. Xiong et al., “Genome wide expression analysis of the effect of the Chinese patent medicine zilongjin tablet on four human lung carcinoma cell lines,” Phytotherapy Research, vol. 25, no. 10, pp. 1472–1479, 2011. View at Publisher · View at Google Scholar · View at Scopus
  41. S. Kuek, W.-J. Wang, and S.-Q. Gui, “Efficacy of chinese patent medicine tian gui capsule in patients with polycystic ovary syndrome: a randomized controlled trial,” Journal of Chinese Integrative Medicine, vol. 9, no. 9, pp. 965–972, 2011. View at Publisher · View at Google Scholar · View at Scopus
  42. Y.-N. Song, J.-J. Sun, Y.-Y. Lu et al., “Therapeutic efficacy of fuzheng-huayu tablet based traditional chinese medicine syndrome differentiation on hepatitis-B-caused cirrhosis: a multicenter double-blind randomized controlled trail,” Evidence-Based Complementary and Alternative Medicine, vol. 2013, Article ID 709305, 8 pages, 2013. View at Publisher · View at Google Scholar
  43. H. Cao, M. Ren, L. Guo et al., “JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial,” Trials, vol. 11, article 27, pp. 1–8, 2010. View at Publisher · View at Google Scholar · View at Scopus
  44. Y. Gao, H. Zhong, B. Ma et al., “Randomized, double-blind, parallel-controlled clinical trial on correspondence of prescriptions and traditional Chinese medicine syndrome of ischemic stroke,” Journal of Traditional Chinese Medicine, vol. 32, no. 3, pp. 335–342, 2012. View at Google Scholar
  45. G. Yang, X. Li, L. Wang et al., “Traditional chinese medicine in cancer care: a review of case series published in the chinese literature,” Evidence-Based Complementary and Alternative Medicine, vol. 2012, Article ID 751046, 8 pages, 2012. View at Publisher · View at Google Scholar
  46. S. Y. Li, J. S. Li, M. H. Wang et al., “Effects of comprehensive therapy based on traditional Chinese medicine patterns in stable chronic obstructive pulmonary disease: a four-center, open-label, randomized, controlled study,” BMC Complementary and Alternative Medicine, vol. 12, no. 197, pp. 1–11, 2012. View at Google Scholar
  47. B. Brinkhaus, D. Pach, R. Lüdtke, and S. N. Willich, “Who controls the placebo? Introducing a Placebo Quality Checklist for pharmacological trials,” Contemporary Clinical Trials, vol. 29, no. 2, pp. 149–156, 2008. View at Publisher · View at Google Scholar · View at Scopus
  48. C. Elder, C. Ritenbaugh, M. Aickin et al., “Reductions in pain medication use associated with traditional Chinese medicine for chronic pain,” The Permanente Journal, vol. 16, no. 3, pp. 18–23, 2012. View at Google Scholar
  49. F. C. Sun, “Discussion on main factors influencing quality of traditional Chinese medicines,” China Medical Herald, vol. 8, no. 15, pp. 154–155, 2011. View at Google Scholar
  50. M. T. R. Grapow, R. von Wattenwyl, U. Guller, F. Beyersdorf, and H.-R. Zerkowski, “Randomized controlled trials do not reflect reality: real-world analyses are critical for treatment guidelines!,” Journal of Thoracic and Cardiovascular Surgery, vol. 132, no. 1, pp. 5–7, 2006. View at Publisher · View at Google Scholar · View at Scopus
  51. M. Li, J. P. Shi, and H. H. Yu, “Relationship between the “Real World” research, randomized controlled trial and number of one randomized controlled trial in clinical therapeutic study,” Zhonghua Liu Xing Bing Xue Za Zhi, vol. 33, no. 3, pp. 342–345, 2012. View at Google Scholar
  52. F. Tian and Y.-M. Xie, “Real-world study: a potential new approach to effectiveness evaluation of traditional Chinese medicine interventions,” Journal of Chinese Integrative Medicine, vol. 8, no. 4, pp. 301–306, 2010. View at Publisher · View at Google Scholar · View at Scopus
  53. E. B. Larson, “Building trust in the power of “big data” research to serve the public good,” JAMA, vol. 309, no. 23, pp. 2443–2444, 2013. View at Google Scholar
  54. T. B. Murdoch and A. S. Detsky, “The inevitable application of big data to health care,” JAMA, vol. 309, no. 13, pp. 1351–1352, 2013. View at Publisher · View at Google Scholar
  55. R. Peto, R. Collins, and R. Gray, “Large-scale randomized evidence: large, simple trials and overviews of trials,” Journal of Clinical Epidemiology, vol. 48, no. 1, pp. 23–40, 1995. View at Publisher · View at Google Scholar · View at Scopus