Presentation given at Green Templeton college, Oxford Universtiy at symposium- The Future of Integrative Medicine: Contexts, Standards and Challenges 13.03.2011 pdf Duncan McGechie http://www.acupuncturebodywork.co.uk/

1. 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)

2. 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

3. 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

4. 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Research published in not peer reviewed journals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)

5. 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?

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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.