Full title: “Clinically Investigating Chinese Medicine Within the Evidence-Based Western Medical Paradigm”
Western and Chinese medical paradigms have evolved completely independent of one another. Presently, there remain fundamental differences in the theory and philosophy, anatomy and physiology, pathophysiology and diagnosis, and treatment methods of each, making it difficult to envision a lone system of clinical investigation equipped to justly evaluate both.
Critical clinical investigation is the driving force behind policy development. Evidence-based medicine advocates using current best evidence, gathered from the perceived gold standard, the double-blind randomized controlled trial, in making decisions about the care of individual patients. These guidelines were developed to investigate the therapeutic practices of allopathic medicine, and are incompatible with the fully-developed, time-tested methodology of Chinese medical practice.
The inability to investigate Chinese medicine within a Western medical paradigm in no way takes away from its efficacy, but rather reflects the bias of the system, further illustrating the need to develop a model that more accurately represents the modality.
The term Evidence-Based Medicine (EBM) first appeared in publication in a 1991 editorial of the American College of Physicians Journal Club as the evolution of a concept proffered the year before by Dr. Gordon Guyatt of McMaster University that he had termed ‘Scientific Medicine’.1 Scientific Medicine was a new approach of teaching medicine at the bedside, building on previous work by Dr. David Sackett to refine critical appraisal techniques applicable to clinical practice. EBM does not describe a single medical discipline but rather a range of topics, including epidemiology, bioinformatics and evidence-based guidelines. An increasing awareness of the deficiencies in standardized clinical practices and their impact on both quality and cost of patient care were the impetus for developing this new concept.2
EBM was defined by Sackett et al. as,
“the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice.”.3
Before the advent of EBM, clinical practice was viewed as much an art as a science, decision making and the collection of evidence being guided by expert opinions, years of experience and authoritarian judgement.1 A paradigm shift occurred away from lesser objective information gathering in cohort, observational, descriptive and anecdotal studies towards what is now held as the gold standard: purely objective, double-blind, randomized controlled trials (RCT).4 RCTs analyze reality by dividing it into two parts, true or false, excluding any other possibilities.5 This model excludes everything that cannot be measured or standardized as unjustifiable and deprives the practice of medicine of any vision that does not fit into the prevailing conventional, allopathic medical model.6
The goal of EBM, in simplest terms, is to improve patient outcomes, provide more cost-efficient medical care, and bring more certainty to clinical decision making.7 The use by physicians of protocols designed based on reviews of the latest scientific, evidence-based information is becoming the recommended course of action. These guidelines are being challenged by increasingly skeptical physicians, especially within the Chinese medical community, who have valid reasons to resist its application.8 There is a general feeling that the process is more of an appropriation of Chinese medicine by biomedicine, whose only goal is to restrict its practice. There is further concern about ‘testing’ the efficacy of Chinese medicine according to its effect on a biomedically defined condition, which denies the holistic nature of Chinese medicine.9 Practitioners have misgivings that EBM transforms the process of clinical decision making into an algorithmic exercise that is not individualized for specific clinical situations, and practitioners who rely exclusively on these predetermined protocols become inflexible to change and forego intuition. Western medical science does not hold a monopoly on knowledge and should not be the sole arbiter of what constitutes ‘best evidence’. Along these lines there must be an acknowledgment that altruism and compassion may not be the driving forces behind some clinical investigation and there exists a need to scrutinize the motivation of those who may exploit this concept to dictate policy or justify reimbursement while simultaneously working to marginalize practice that does not support their objective.10
Western and Eastern medicine developed over time within the context of vastly different histories, cultures and perspectives of the natural world. When considering an appropriate system of evidence-gathering in medicine it would seem imperative to understand clearly the underlying theories in which the modality was rooted. Thanks to a legacy of
recording written texts, we have a very detailed account of the conceptual thoughts and therapeutic practices of Chinese medical practitioners dating back more than 2000 years. Chinese medicine is an empirically based discipline that utilizes many different ‘scientific’ methods while remaining inseparably linked to its cultural and philosophical origins, relying on models drawn from ancient texts which have now become subject to modern interpretation.11
Differing socio-political-cultural views of Western and Chinese medicine remain problematic for integration. Chinese medicine in Asia is practiced with a maturity not yet developed in the West, and language remains an indisputable barrier for Western practitioners looking to gain a deeper understanding of the world’s oldest recorded and continuously practiced medicine. Chinese medicine is derived from the philosophical musings of East Asia, Buddhism, Taoism, and Confucianism, that are embedded in the language and culture, and it is often easier for Eastern people to relate to some of the esoteric explanations
of these phenomena having this background.12 Gaining a sense of the historical and cultural context from which Chinese medicine derived its core theoretical framework can aid non-Chinese speaking researchers to gain a better perspective.13 A deeper investigation into classic texts will offer a more accurate, yet contrary picture of Chinese medicine than that being portrayed by the Western leaning conventional healthcare system, and prove worthy of investigation on its own accord without the biomedical interpretation.14
It is only within the last 100 years that Western medicine has become so technologically and evidence based. Chinese medicine is only new in the West, and the biomedical standards now being placed on it to justify its integration are forcing a reinterpretation of Chinese medicine that does not accurately or fairly represent the modality. The theories and concepts that guide the practice of Chinese medicine, with their basis in Chinese philosophy, have yet to be mapped by a scientific equivalent or clearly defined in scientific terms.15 Some of the long-standing obstacles for its integration into the conventional healthcare system lies with the difficulty in defining acupoints, the meridian system, qi, and their connections to anatomical structures and biochemical pathways. Biomedicine finds its legitimization in scientific rationality, anchored in formal knowledge, and EBM is an extension of this.9 EBM has become generally accepted and taken as reliable, objective and not open to non-science critique.16 Chinese medicine has been time-tested by systematic observation with recorded, repeatable results over thousands of years, but this type of proof is no longer regarded as valid evidence of efficacy or safety.17,18 Chinese medicine now finds itself in the untenable position of trying to fit into the EBM paradigm or risk being left out of the prevailing medical system, while simultaneously trying to stay true to its own mandate, though the two positions seem to be fundamentally at odds.
Chinese medicine has a sound theoretical basis and fully-developed therapeutic treatment model, used correctly and effectively with a good degree of flexibility, that was developed over time and experience with over 2000 years of peer review, but still explanations of therapeutic indications within the EBM framework remain problematic. Despite its expanding use globally and Western medicine’s increasing interest and recognition of its therapeutic benefits, lack of rigorous research to demonstrate efficacy and safety from the EBM perspective still remains the biggest hindrance to the integration of Chinese medicine into the conventional Western medical healthcare system. As such, the modality finds itself under increasing pressure to submit more of its therapeutic methods to the scrutiny of the RCT.
Trials that have been performed to date adhering to these guidelines have not bolstered Chinese medicine’s argument for inclusion, but rather have been met with criticism, citing, ‘little evidence due to paucity of research studies and fundamental methodological flaws in those that have been published’.19 Criticisms include unclear randomization methods, frequent statistical errors, increased risk of bias, insufficient subject numbers to perform sub-group analysis, selective publication of positive results, and editors and peer reviewers ignoring reporting criteria. The situation for Chinese medicine becomes even more tenuous when negative results of these investigations are evaluated by decision makers in healthcare and translated into policy, or are used to direct practitioners as to the style they are permitted to practice.
The inability to investigate Chinese medicine within a Western medical paradigm, which totally ignores the very fundamentals of the therapeutic method it hopes to examine, through a model developed to fit an allopathic, reductionist perspective, in no way takes away from its efficacy, but rather reflects the bias of the system. The argument that any and all medical modalities should be subjected to this type of objective scientific scrutiny or be dismissed as ineffective is misleading.20 There is a false narrative that EBM is constructed on a level playing field where different modalities’ therapeutic interventions could be investigated in context and come to valid conclusions of efficacy.9 The adaptations imposed by biomedicine that acupuncture and other Chinese medical therapeutic interventions be validated only through proof according to its rules demonstrates a lack of respect for the history or the context from which Chinese medicine originated, and discredits what is a highly complex healthcare system.21
Of the numerous issues faced by Chinese medicine within the Western medical EBM paradigm, perhaps the most insurmountable is the core requirement of RCT that all subjects be treated identically (within their randomly allocated group). EBM attempts to investigate complex clinical phenomena systematically by isolating individual conditions and testing them as stand-alone entities. At the very core of Chinese medical theory is the approach to every clinical interaction as its own distinct encounter, with a unique set of features, circumstances, relationships and ultimately treatment.14 Western medicine takes a reductionist view of medicine, looking at it from the bottom up, reducing the body and disease to the microscopic level. Chinese medicine on the other hand takes a holistic approach, looking at it from the top down, illness being discernable by its unique external presentation. Western medicine focuses on the manipulation of disease, while Chinese medicine focuses on pattern differentiation, bian zheng lun zhi 辨证論治 (determining treatment by patterns identified),22 built around the dynamic process of illness development.23
One proposal on how to replicate Chinese medicine pattern differentiation in RCT suggests a systematic approach to assessing signs and symptoms of a group of study subjects with the same Western medical diagnosis. By quantifying a syndrome, the signs and symptoms can be tabulated and matched against those that characterize a specific Chinese medical pattern. A percentage match between the two could then serve as a score for a certain syndrome and corresponding treatment protocol. Post treatment changes in scores could then be used as a method of assessing intervention effects, while allowing a quasi-individualized treatment in a standardized, reproducible way.24 While this system of quantification does not 100% reflect the practice of Chinese medicine, it is a step in the right direction.
The blinding aspects of RCT pose unique challenges for Chinese medicine. Double blinding in a clinical trial requires that neither the investigator nor the subject knows the therapeutic technique being investigated. In the investigation of acupuncture this is an obstacle that requires transcendence of both the practical and theoretical. The rationale for the point location, depth, angle, and retention time would be familiar to a Chinese medical practitioner; he would be unable to remove this knowledge from influencing his intervention. If the protocol called for a specific needle manipulation, that would further lead the practitioner, unavoidably, to draw well-informed conclusions towards strategy. Lastly, falling into the category of ‘unmeasurable’ is the intention of the practitioner. Needling is more than just a technical procedure of inserting filiform needles into the human body; there is an essential transfer of energy between practitioner and patient, driven by the practitioner’s intention to heal and the patient’s openness to accept the help. A purely mechanical evaluation of this procedure once again totally excludes a fundamental theory of Chinese medicine. The use of so-called non-acupuncture, placebo acupuncture, sham acupuncture or decoy acupuncture, does not adequately address these issues, rendering any results ambiguous.
In the case of herbs, it is difficult to establish an appropriate placebo due to the unique smell, taste and observable characteristics of the multi-herb decocted formula. However, the increased use of pills, capsules, tablets or granules are a way to overcome this issue, as they can be produced to look and smell the same, with the control group formulated to have no pharmacological activity. The issues presented by clinically investigating the poly-pharmaceutical nature of Chinese herbal formulations is a hurdle yet to find a feasible solution.
In the investigation of any medical paradigm, it must be a consensus of the community involved that determines credibility, rather than solely an objective criterion. Scientific investigation must account for subjective perspectives, in addition to objective, as all objective conclusions are based upon subjective conditioning of the researchers and participants.12 One of the primary goals of RCT is to remove subjectivity from the process. Modern medical clinical investigation relies heavily on this assumption in its gathering of evidence, and the results need to be assessed with the realization that there is an implicit, unavoidable bias. The belief that subjectivity can be removed from any observational study, even in ideal conditions and under the most rigorous controls, is a false assumption.20 The observer inevitably influences what is observed and, whether conscious or unconscious, will skew their results to a pre-existing bias.25 To not acknowledge subjectivity does not eliminate the bias but rather creates more skewed results as it goes unaccounted for in evaluation of data.
Illness itself is a subjective experience. A person’s relationship to his or her condition, at a specific moment in time, wholly shapes the condition itself. In the age of measurable, objective data, derived from highly sophisticated biomedical diagnostic techniques, the process and outcomes have become devoid of a physician’s subjective input. This practice removes all aspects of the physician-patient relationship, reducing medicine down to an objective discipline, dismissing any of the art that is an inherent and critical part of good medicine, and is an indispensable, fundamental aspect of effective Chinese medical clinical practice. The integration of both, the best available scientific evidence and years of clinical experience, can best insure the most positive patient outcomes. A concept that was put forth by Sackett et al,
“Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannized by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient”.3
Strictly objective research reflects only the most superficial of outcomes. The reality of a clinical setting is that most patients do not simply present a single complaint with an easily discernible cause. Most diagnostic situations are multifaceted, and the use of data gathered in investigation under relatively well-defined conditions becomes less useful as it reflects only the narrow clinical situation from which it was gleaned.20
When trying to discern the root cause of disease it is sometimes necessary to go to a place that is taboo to speak of in terms of modern medicine: the existence of a connection between the body, mind and soul of a human being. These concepts are usually left for theological and philosophical discussions, contradicting the mechanistic paradigm and, according to conventional medicine, have no place in diagnostics.20 Chinese medicine not only recognizes this connection but considers it indispensable in diagnostics. True, there may be no way to clinically evaluate these concepts, no diagnostic tools other than subjective observation by the practitioner, but ignoring these concepts compromises a fundamental principle of Chinese medicine.
Chinese medicine is an energetic modality. The interconnectedness of the human being’s mind, body and soul does not simply end at the boundaries of the physical body but extends to the surrounding socio-political-cultural environment, all combining to exert a profound impact on one’s state of being. Chinese medical theory purports that illness occurs as a result of a disturbance of this wholeness and has a much better model of health regarding this inseparable relationship. Researchers hoping to understand a specific condition, who exclude consideration of these dynamics in their investigation, undercut an essential component of Chinese medical diagnostics. Patients cannot believe that they are separate from or bear no responsibility for their condition, and similarly researchers cannot separate themselves from the parameters they have dictated in developing a protocol. Neither can be under the illusion that the condition under investigation is simply foreign to the body and not a part of the natural, holistic whole. This makes the application and results of strictly objective EBM research difficult, if not impossible, to apply to a medicine based in energetics.
Both Western and Eastern medicine have undergone dramatic shifts in thought since their inception, evolving completely separate from one another. Medicine is a science that can be paradoxical even within similar paradigms, and finding consensus across paradigmatic lines is sometimes nearly impossible. Though contrasting medical paradigms might be based in diametrically opposed logic, theory and principles, they both can coexist within a healthcare system whose ultimate goal should be the promotion of global health.
The fully developed methodologies of Chinese medicine, though not synonymous with those of Western medicine, present their own unique diagnostic and therapeutic methods, and it is from these perspectives that any guidelines for investigation and research design should be governed.14 Best results in clinical practice are reached when multiple resources and strategies are employed, including clinical research data, public opinion, legal authority, financial parameters and improved leadership.26 There is clearly a need for another shift in the methods used in the investigation of Chinese medicine to take on a more pragmatic approach, towards efficacy-driven instead of the conventional mechanism-based approach.27 EBM should not be rigidly imposed on Chinese medicine but rather flexibly adapted, taking into consideration its unique characteristics.15 There is a need to develop a new outlook on what constitutes health and illness apart from conventional medical wisdom, which places such heavy emphasis simply on decrease in signs and symptoms to evaluate efficacy. A recognition of the holistic and interconnected nature of the surrounding environment and its influence on our state of wellness can lead to the creation of a new, modern, co-operative paradigm in medicine.
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