The System Methodology of Chinese Medicine – Inheritance and Innovation 中医系统方法论-继承与创新

This paper is delivered at the 5th Guangzhou International Chinese Medicine Conference, Guangzhou, China, November 17-18 2011 held to commemorate the 55th anniversary of the founding of the Guangzhou University of Chinese Medicine.

广州中医药大学建校55周年庆祝大会 暨第五届中国广州国际中医药研讨会

Abstract

This paper describes the global background against which Chinese Medicine is playing an important role. The potential of Chinese Medicine to be part of the global medicine of the future lies in her unique system methodology which differs from Western Evidence Based Medicine. By analysing the essence of this 5,000 year-old medical system we can make it indisputably relevant to the modern world. Concepts such as Syndrome Differentiation and the theory of Zang Fu organs based on the theoretical principle of Yin and Yang are important ingredients for a new individualised integrative medicine. The theories of Qi and Meridians are also discussed in the context of the discoveries made in particle physics. By properly inheriting the essence of this medical system we can begin the process of innovation. We must also address the critical judgements from the EBM circles, by evaluating RCT, Systematic Review and Meta Analysis in their suitability as part of the medical methodology of the future. This paper concludes with an analysis of the convergence and divergence of East-West medical discourse, and a look into a patient-centred future medicine.

Keywords

Medical system methodology, Syndrome Differentiation, Zang Fu, Qi, Evidence Based Medicine, RCT, Systematic Review, Meta Analysis, individualised medicine

概述

本文描述了中医药在全球化大环境下正担当着的重要角色。中医药有着与西方循证医学不同的独特系统方法论,可发挥它在未来全球医学中的重要作用。通过本质分析,这一有着五千年历史的医药系统将可以无可争议的立足于现代世界。对于个体化治疗的新结合医学来说,建立于阴阳理论基础上的辨证论治概念和中医脏腑理论是重要组成部分。关于在新发现的粒子物理学背景之下的气和经络理论,本文中也进行了讨论。通过正确继承中医药系统的精髓来开展创新的路程。同时也必须通过对随机对照试验,系统评估和元分析来解决循证医学界的一些主要评判,找出它在未来医药系统方法论中的适当地位。这篇文章总结了对中西医药论述共性和差异的分析,以及对以人为本的未来医学作出一个观察。

关键词

Medical system methodology( 医学系统方法论), Syndrome Differentiation(辨证论治), Zang Fu(脏腑), Qi(气), Evidence Based Medicine(论证医学), RCT(随机对照试验), Systematic review(系统评估), Meta Analysis(元分析), individualised medicine(个体化医学)。

Introduction – The Global Background

Chinese Medicine, in the current global context, is a medicine that is a timely ingredient for a new medical paradigmi (新型医学模式). It has a unique system of methodology and a long history of clinical practice that can complement the conventional medicine and address its inadequacies. Patients are becoming increasingly aware of the negative side effects of Western drug-based medicine and the complications that can result from a surgery. More than ever, patients are demanding a qualitative change in the system of medicine and healthcare. The patients’ knowledge of their own bodies is now becoming more sophisticated and they know better than blindly following the treatment from their doctors without questioning the benefits and the risk factors. They are taking their health into their own hands and are no longer passively accepting doctors’ advice. This change in attitude over the past decades has spurred the development of – and the necessity for – a more patient-centred integrative approach to medicine (以人为本的结合医学).

The rise in popularity of complementary medicine, due to it being less invasive and more natural, is a global phenomenon. This also explains the spread of Chinese Medicine to different countries outside China.

At the same time, there is an opposing reaction to Chinese Medicine from the conventional medical establishment who cite safety concerns and evidence. These medical polemics also spread into the economic sphere of the East-West competition in the bio-medicine market; while the licensing and legislative regulations are also inextricably involved. However, the central theme is a discourse between the system methodologies of Chinese Medicine and Western medicine.

The Value and Potential of Chinese Medical System Methodology

Over the many thousand years, Chinese Medicine has evolved into a complex medical system that links clinical experience of brilliant physicians in a web that has no individual weaver. You can see in thousands of volumes of written work and documented clinical case studies of herbal medicine, acupuncture and other modalities of treatment how Chinese physicians of the past were true to the core thinking of the Chinese civilisation. The intellectual thought inherited by the Chinese since the early philosophical attainment of thinkers that culminated in the works like the I Ching (易经), Dao De Jingii (道德经), The Four Booksiii (四书) and countless others has also influenced the system methodology of Chinese Medicine.

Right at the beginning of the Chinese civilisation, from the Stone Age to the Bronze Age, the Chinese understood that the dynamics of the universe begun with the expansion of Qi () which is both a functional dynamic as well as material formation. This concept is very much accepted in science as the beginning of our universe that has been expanding since the Big Bang that resulted from accidental imbalances in the void of nothingness. Hence the concept of Dao (), being The Way, was conceived by early Chinese metaphysicists. The physical formation of all things in our universe was understood as interaction of Yin and Yang dynamics (阴阳学说) that moved from balance to imbalance and back to balance in a process of creation. The concept of harmonising Yin and Yang in order to sustain stability is a universal principle that applies to every process of existence.

This is the very principle that created Chinese Medicine as a system methodology. The human body, from health to disease, goes through the same process of the interaction of Yin and Yang. Balancing Yin and Yang elements of the body in terms of its physical, mental and emotional aspects is the Chinese Medical approach to achieving a state of harmony within the human being. Imbalances in the Yin and Yang forces of the body will result in illness. Chinese Herbal Medicine and Acupuncture are used to return the body to relative balance and achieve harmony between the Zang Fu organs ( 脏腑 ), Qi, Blood and Body Fluid(气血津液) in order to regain health. This is why Chinese Medicine is a holistic system of medicine (整体观念的医学).

The essence of Chinese Medicine lies in the unique way in which the physician analyses the imbalances that developed into diseases by employing Syndrome Differentiation (辨证论治). Methodologies such as the Eight Principles of Differentiation ( 八纲辨证 ), Zang Fu and Meridian Differentiation (脏腑与经络辨证), etc. were developed by brilliant physicians in the course of the theoretical and clinical evolution of Chinese Medicine. With these methodologies, together with the enormous understanding of Chinese herbal materia medica and acupuncture energetics, Chinese physicians are able to formulate individualised treatment for their patients. This unique methodology is becoming a solution needed by the modern disease-based medicine which applies the same medical treatment to all patients according to categorisation of diseases which lack the individualised essence.

Another part of the essence of Chinese Medicine lies in the wealth of knowledge about the relationship between the psycho-emotional aspect and the organs. It has been recorded in numerous case studies during one of the longest histories of any civilisation which has always been the most populated in the world. The Five Element theory (五行理论) and the Meridian theory (经络理论) of the interlinked organ relationships accumulated in clinical practice can contribute to the development of the future medicine.

In the modernisation of Chinese Medicine we need to look at the dynamics of Yin and Yang and Qi in the modern context by finding parallels in the particle physics (粒子物理), quantum mechanics (量子力学) and the Standard Modeliv (物理中的标准模型) that begun exploring the hidden dimensions in the dynamics of our universe and our existence. The human body exhibits the physical, conscious and unconscious qualities within its process of birth and death. The Chinese understanding of Qi within the Yin and Yang dynamics that apply to medicine will be substantiated by innovative research that links this intellectual tradition with the discoveries in new physics.

Western medicine, at present, remains at the level of cell and molecular biology whereas future medicine may carry the Chinese concepts of Qi and Yin and Yang further through medical investigations that advance deeper into the atomic and particle levels. The post-Genome researchers in System Biology (后遗传学系统生物学研究) may carry us further in defining the Chinese Medical concept of Syndrome Differentiation in relation to complex herbal prescriptions (中药复方). The wisdom of the classical formulations in Chinese herbal medicine will also be revealed by the advances of modern science. When this moment arrives the philosophy and the science of medicine will converge.

Chinese and Western Medical Methodologies – a Comparison

If Chinese Medical methodology is to become an integral part of a new global medicine then a structured analysis is necessary, between its own system and that of Evidence Based Medicine (循证医学) which is the dominant mainstream methodology representing Western medicine. Let us take a look at RCT (随机对照试验) as the gold standard and take a review of the Systematic Review (系统评估法) as well as an open analysis of the Meta Analysis (元分析法). This requires a greater analysis and although here we cannot deal with these subjects as a detailed treatise on the two methodologies, we should still discuss these issues and outline the arguments.

Chinese Medicine is often attacked by Western scientific communities as lacking in the type of evidence that equates to findings from Randomised Controlled Trials (RCT) demanded in Western medicine. Out of the 200, 000 or so RCTs collected by the Cochrane Libraryv (嘉基医学图书馆), very few were subjected to Meta Analysis or a Systematic Review. Indeed, the BMJ (英国医学杂志) report Clinical Evidence, which summarises the current state of knowledge on the effectiveness of medicine in the West, shows that only a small percentage of such medical practice is evidence-based and that only 11% is proven to be as beneficialvi. Nonetheless, we should look at the validity of RCT when judging a medical outcome in comparison with the anecdotal evidence from the patients.

Throughout the history of the theory of knowledge (认知论), Western scientific tradition differed from the Chinese philosophical tradition in its methodology for evaluating evidence. Scientific evaluation insists on repeatable physical evidence, whereas philosophical knowledge accepts, besides physical evidence, non-physical evidence measurable only by perception. When applying these methodological differences in medical trial evaluations it is not possible to eliminate subjective bias since it is inextricably linked with objective reality.

When a trial is randomised either with single blinded, double blinded or triple blinded design it is still subject to the mental interpretation that gives rise to the probability of chance. The error of chance exists even in triple blinded trials, a complex and expensive design in which the patient, the physician and the investigators are all blinded. This is because some eligible individuals may refuse to participate in the given group and choose to participate in another group and therefore the test is no longer randomised. Another reason strongly supporting this argument is that in the more complex non-drug clinical trials, such as those for Chinese medicine treatment in comparison with Western medicine treatment, the quality of medical interventions are heavily dependent on clinician’s skill which can also affect the outcome. Differences in the level of methodological rigour give rise to bias in treatment outcomes. To ensure an unbiased outcome it is impossible to make absolute equality between the receiving and the non-receiving groups.

There is another factor; the level of the placebo effect (安慰剂效应). A group of clinicians may affect a group of patients with a placebo effect while another group of patients – who may not be so sensitive to certain placebo effects – will not be affected. The RCT, therefore, can only be of a limited methodological value when evaluating the effect of Chinese Medicine treatment that used individualised Syndrome Differentiation diagnosis. When a treatment is given according to an individualised diagnosis and a pattern or syndrome that has been analysed from the clinical features identified by a Chinese physician rather than a disease classification, then not only is RCT not suitable but also the other methods in Evidence Based Medicine such as Systematic Review and Meta Analysis cannot be valid.

We cannot synthesise the findings from individualised treatments and statistically review such clinical results either qualitatively or quantitatively. The meaningfulness of statistics can only apply to a drug trial in terms of the percentage of benefits between the receiving and non-receiving group. Chinese Medicine – its complicated nature – is a different modality. According to Chinese physicians who treat the patient’s syndromes rather than the disease, percentages in statistics are fallacies. Even 1% of patients who benefited from the treatment is a validation of that particular individualised approach. Traditional reviews such as narrative review, critical review or literature review may differ from Systematic Review. Peer-review protocol in a strictly structured form is not suitable for individualised Chinese Medicine procedures. But for the patient it is still valid as a patient-centred methodological approach. Statistics, therefore, should not be a religion to be followed in medical evaluations.

When applying Meta-Analysis in a complete coverage of relevant studies and relying on the presence of heterogeneity or robustness of the main findings by using sensitivity analysis, we need to look at the rational validity of such a methodology when evaluating Chinese Medical treatment. Chinese Medicine receives accusations that it is in danger of being unsystematic in determining the effectiveness of research and is therefore deficient in objective judgement, however precision and transparency are valid only in generalised methodological terms. Chinese Medicine is a methodology of individualised treatment and therefore cannot be subjected to a structure that is too rigid when determining an outcome. The patient-centred approach in evaluation (以人为本评估法) is needed in order to determine the treatment outcomes of Chinese Medicine.

Patient-Centred Approach in Medical Evaluation

The patient-centred approach is the core principle of individualised medicine (个体化医学). Generalised medicine relies on the elimination of such symptoms as pain, fever or infection when determining whether or not its outcome is positive and can be measured through RCT as repeatable evidence. Individualised medicine, on the other hand, determines its outcomes – in relation to the well-being of the patient – over the longer term and traces them to the root cause of the disease. Chinese Medicine is individualised medicine that seeks to return the patient to long term health and not just eliminate the symptoms. Individualised medicine uses long term health rather short term symptom elimination as a basis for judging whether or not the disease has been cured. The emphasis is on regulation and regeneration besides intervention. The patient’s subjective feelings relative to objective measurements are taken into account when evaluating his/her total well-being. Taking into account the individual patient’s needs and values should be at the basis of clinical treatment and continued care.

Patient-centred approach also takes into account the psycho-emotional factors affecting the patient’s health. In Western medicine the relationship between the body’s physiological dysfunctions and psychological disorders are separated, whereas in Chinese Medicine the treatment of psycho-emotional disorders is intrinsically linked with physical treatment. The patient-centred approach should adopt the Chinese Medicine principle of integrating medical treatment with counselling within a single system of medicine.

Therefore, patient-centred care is a medical approach that goes beyond measuring the patient’s experience in terms of care quality and delivery. There are many evaluation protocols and assessment procedures being proposed by experts around the world. This is a continuous study that the author of this paper is currently conducting.

Chinese Medicine – Inheritance and Innovation for a Future Medicine

When considering Chinese Medicine methodology and its contribution to a future medicine we need to identify the unique features of this system of medicine that have been evolving over many thousands of years and bring them to serve the needs of our modern times. Modern scientific medicine is a structured methodology, in order for Chinese Medicine to be modernised we have to bring in an innovative methodological structure that can interpret dialectical thinking of Chinese Medicine. This should enable us to systematically evaluate the validity of Syndrome Differentiation as a model for individualised medicine in a holistic form.

At the same time, we must use the latest science and technology to validate the Four Diagnostic Methods in relation to Western medical diagnosis such as MIR, CT and chemical analysis. Research should also be carried out in line with the principles of Chinese herbal medicine and its complex approach to formulation of medications. In conjunction with all this, the possibility of acupuncture being developed as the leading component of Energy Medicine (能量医学) must be pursued as we progresses from research on mechanisms and syndrome point combinations. The innovation of acupuncture from Gate Control theory (闸门控制学说) and neuro-physiological mechanisms (神经生理机制) must be continued to a new plateau of acupuncture research that will incorporate the principles of Syndrome Differentiation.

When we are considering East-West medical discourse and integration, we need to steer in the direction towards convergence rather than divergence. This will involve both sides respecting the integrity of each other. The pivotal point for establishing respect lies in the relationship between science and philosophy as methods of enquiry into knowledge. The intellectual traditions of East and West differ in their theories of knowledge. It is the duty of the modern thinkers to unravel where science ends and philosophy begins and vice versa. A famous Nobel Prize physicist Professor Yang said that “when science fails to provide the answer, philosophy begins”vii, while it is also true that philosophical enquiry may lead into mathematical enquiry and the proof of experimental science. The two intellectual activities must go side by side for us to unravel the truth of our reality. The new physics, in its relativity theories and quantum mechanics, finds parallels with the fundamental theoretical system of Chinese Medicine. A future medicine will evolve from the cutting edge scientific discoveries that are synthesising with the intellectual thoughts of the Chinese civilisation which are embodied in the system methodology of Chinese Medicine.

The Yin and Yang dynamics of East-West encounters will give rise to the answers to our unstable world by innovating a new socio-economic system based on a new intellectual and cultural paradigm that brings harmony back to the human civilisation. A new medical system will be created as a result of this process. We are living in interesting times.

Man Fong Mei

London, August 2011.

梅万方

伦敦,20118

i Thomas Kuhn, 1962, The Structure of Scientific Revolutions

ii Lao Tsu, 6th Century BC, Tao Te Ching

iii The Four Books (475 BCE – 221 BCE) are Great Learning, Doctrine of the Mean, Analects of Confucius and Mencius

iv The Standard Model developed from Einstein’s Theory of Relativity, which includes the current discoveries in the Supersymmetry Theory.

v Cochrane Library, the most authoritative medical data bank for Systematic Reviews and RCTs.

vi http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp

vii Professor Chen Ning Yang (杨振宁), with an honorary doctorate from Princeton, shared the Nobel Prize in Physics in 1957 with Professor Tsung Dao (李政道)

 

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