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Challenges to integration: standardisation and establishing an evidence base fo Chinese Herbal Medicine-D McGechie

Challenges to integration: standardisation and establishing an evidence base fo Chinese Herbal Medicine-D McGechie



Presentation given at Green Templeton college, Oxford Universtiy at symposium- The Future of Integrative Medicine: Contexts, Standards and Challenges...

Presentation given at Green Templeton college, Oxford Universtiy at symposium- The Future of Integrative Medicine: Contexts, Standards and Challenges
Duncan McGechie



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    Challenges to integration: standardisation and establishing an evidence base fo Chinese Herbal Medicine-D McGechie Challenges to integration: standardisation and establishing an evidence base fo Chinese Herbal Medicine-D McGechie Presentation Transcript

    • Challenges to integration: Standardisation and establishing an evidence base The current regulatory framework for Chinese herbal medicine in the UK, the need for good evidence and some problems with the extant evidence base. Duncan McGechie BA MSc MBAcC MRCHM FHEA (Register of Chinese Herbal Medicine, University of East London)
    • THMPD and regulation of Herbal medicines EU Traditional Herbal medicinal Products Directive (THMPD) in force 30/04/2011 This restricts access to many products associated with traditional medicines UK govt. announced intention to statutory regulate herbal medicine by the HPC in April 2012 Statutory Regulation will constitute a derogation allowing continuing practice of herbal medicines in the UK
    • Standardisation of treatment Standardisation of individual herbs and products can only be a good thing for practice Standardisation of treatment: the application of protocols to the treatment of a biomedically defined condition, in practice or research is not in keeping with Chinese medical practice This is because treatment is always individualised
    • The evidence base examples from xiao yao san 逍 遙 散 study There is a range of different quality evidence: Some is well done and rigorous (Zhang et al. 2007) Some is fair but trial format not RCT (Yamada & Kanba 2007) Research published in not peer reviewed journals (Shi 2004) Translations available online without peer review (Rogers 2006)
    • Control/ Placebo control Generally, in biomedicine if a treatment exists for a condition, new treatments are compared to it However trials are sometimes disregarded by those biased against CM if there is no placebo arm A suitable placebo for herbal medicine is possible while still individualising treatment (Flower 2009) Why do trials and reviews continue to fail in representing CM as practiced?
    • CM practice in the UK Non Chinese-speaking practitioners have limited access to information There are difficulties in communication arising from different translations of Chinese technical terminology Research available in English is often not detailed enough to form a critical opinion The Majority of Chinese research is positive Practitioners are becoming more influenced by research than traditional sources of knowledge
    • Moving forward Work has already been done outlining necessary factors in CM research design (Chan 2005, Critchley et al. 2000, Yuan & Lin 2000) Chinese medicine is pluralistic (Hsu 1999, Scheid 2002) and has been changing, dramatically so over the last 150 years (Andrews 1996, Hsu 2008, Karchmer 2004, Scheid 2007, Taylor 2005) This opens debate as to what Chinese Medicine is if it is to be evaluated It needs to be kept alive as a practice if it is to be understood and tested, or potential treatments may be lost to medicine
    • Conclusions The research base is currently inadequate It nevertheless informs clinical practice Biomedical evidence based medicine is dominant and given primacy over traditional medical theory (McGechie 2009) Unless the traditional medicine is learned fully and research conducted with reference to actual practice, the evidence won't be useful
    • Recommendations
      • We need trials that:
      • Have methodological rigour
      • Involve individualized professional prescription
      • Or split any study population into appropriate CM pattern diagnostic groups
      • Have clearly defined indications and treatments (repeatable)
      • Controlled, preferably involve a placebo
      • Employ reproducible prescriptions- GMP quality control
      • Include good clinical and manufacturing practice
    • What the RCHM is doing
      • Database project to translate Chinese research
      • Circulates quarterly research updates
      • Provides information sheets of more robust research to members
      • Implementation of authorised supplier scheme
      • Yellow card scheme
    • References Andrews, B.J. (1996) The Making of Modern Chinese Medicine, 1895-1937, PhD. Dissertation. Gonville & Caius College, Cambridge. Chan, K (2005) Chinese medicine materials and their interface with Western medical concepts. Journal of Ethnopharmacology 96: 1-18 Critchley, J.A.J.H. Zhang, Y. Chuthamanee, Suthisisang, C. Chan, T.Y.K. And, Tomlinson, B. (2000) Alternative Therapies and Medical Science: Designing Clinical Trials of Alternative/ Complementary Medicines- Is Evidence Based Traditional Chinese Medicine Attainable? Journal of Clinical Pharmacology 40: 462-467 Flower A, Chen S, Liu JP, Lewith GT, Little P. (2009) Chinese herbs for endometriosis. Cochrane Library, 2009; issue 3 Hsu, E (1999) The Transmission of Chinese Medicine, Cambridge. Cambridge University press. Hsu, E (2008) The History of Chinese Medicine in the Peoples Republic of China and its Globalisation. East Asia Science, Technology and Society: an Internatinoal Journal 2:465-484 Karchmer, E. I. (2004) Orientalizing the Body: Postcolonial transformations in Chinese Medicine. Anthropology. Chapel Hill, University of North Carolina. McGechie, D.B. (2009) How are practitioners and students of Chinese herbal medicine in the UK informed in their clinical choices? An analysis of the use of Xiao Yao San and it modifications. MSc Dissertation, Department of Integrated Health, University of Westminster. Rogers, T., (Trans.) (2006) Xiao Yao San in the Treatment of Irritable Bowel Syndrome (IBS). Blue Poppy Press http://www.bluepoppy.com/cfwebstorefb/index.cfm?fuseaction=feature.display&feature_id=877 (Accessed 27/01/09). Scheid, V. (2002) Chinese Medicine in Contemporary China: Plurality and Synthesis, London, Duke University Press. Scheid, V. (2007) Currents of Tradition in Chinese Medicine 1626-2006. Seattle, Eastland Press. Shi, Y. (2004) The Application of Modified Xiao Yao San in the Treatment of Gynaecological Diseases. Journal of Chinese Medicine, (74) , 25. Taylor, K. (2005) Chinese Medicine in Early Communist China, 1945-63. London. RoutledgeCurzon Yamada, K., and, Kanba, S. (2007) Effectiveness of kamishoyosan for premenstrual dysphoric disorder: open labelled pilot study. Psychiatry and Clinical Neurosciences, (61) , 323. Yuan R. & Lin Y. (2000) Traditional Chinese medicine: an approach to scientific proof and clinical validation. Pharmacology & Therapeutics 86 : 191-198. Zhang, Z. J., Kang, W.H., Tan, Q.R., Li, Q., Gao, C.G., Zhang, F.G., Wang, H.H., Ma, X.C., Chen, C., Wang, W., Guo, L., Zhang, Y.H., Yang, X.B. And, Yang, G.D. (2007) Adjunctive herbal medicine with carbamazepine for bipolar disorders: A double-blind randomised, placebo controlled study. Journal of Psychiatric Research, (41) , 360.