Introduction
Western medicine originated from ancient Greek medicine and later developed into Roman medicine. After more than two thousand years of silence, western medicine, which had experienced the baptism of the Renaissance, realized the transition and transformation from experience medicine to experimental medicine to evidence-based medicine. Compared with western medicine, the developmental path of Chinese medicine is comparatively smooth. Based on the constant accumulation and summary of experience, Chinese medicine develops gradually in clinical practice and does not experience drastic changes. However, experience medicine has inherent limitations, such as the lack of objective scientific evidence and limited acknowledgment. Thus, although Chinese medicine has many effective treatments, these limitations have become the bottleneck hindere its development. Exploration on how to accelerate transformation of Chinese medicine from experience medicine to evidence-based medicine is the only way of developing Chinese medicine.
Experience medicine, experimental medicine, and evidence-based medicine as the three milestones of world medical history
Medical practice appeared along with the emergence of human beings. Along with human activity, people started to recognize diseases, a systematic medical knowledge formed, and then experience medicine emerged. Experience medicine emphasizes on the doctor’s experience, intuition, and theoretical reasoning when making a clinical decision[
1]. In the history of western medicine, the period from ancient Asia Minor culture to before the Renaissance in the 16th century AD belongs to the stage of experience medicine. With ancient Greece considered as the cradle of western medicine, Hippocrates, “the Father of Medicine,” is respectfully regarded as the founder of western medicine. Hippocrates proposed the humoral theory and the concepts of temperament and physique, pushed for an overall view of the body and precaution, and advocated medical ethics. After the 4th century AD, the medical center steered to Rome. Galen, the medical representative of this period, created the harbinger of experimental physiology and anatomy. After the Renaissance, western medicine formally started transforming from experience medicine to experimental medicine[
2]. Experimental medicine takes animal experiments as the main research method, and evaluates and selects drugs according to the improvement of clinical syndrome and changes in some clinical indicators[
3]. Experimental medicine contributed greatly to the development of western medicine. It led to the continuous human understanding of life activities from macro to micro, from overall shape level, then into organ level, cell level, deeply to molecular level to gene level, and formed the biomedical model on the basis of reductio-nism.
With the changes in the human disease spectrum, people gradually realized that diseases are not only related with physiologic factors, but psychological, social, and other factors also have an effect on human health. Hence, the biomedical model has gradually changed into the bio-psycho-social medical model. On the one hand, the guiding role of philosophy in experimental medicine is becoming increa-singly blurred, and it is difficult to study the human body, the unity of tangible substance and intangible consciousness, from a comprehensive point of view, which makes it difficult to carry forward the advantage of experience medicine [
3]. On the other hand, the complexity and specificity of the human body determine that the outcome of in vitro or animal experiments could only be considered as clinical trial reference; whether or not the conclusion could be confirmed still requires clinical validation. Therefore, in the late 20th century, both the gradual opening of randomized control trials (RCTs) in medical research and the application of statistical methods like meta-analysis in medical fields provided reliable scientific evidence for the clinical treatment. In the 1980s, the viewpoint of patient treatments based on clinical research was formed. Increasing practice proved it sometimes was not reliable guiding clinical behavior depending only on theoretical analysis or personal experience. The conclusion of clinical research in the experience medical model, which lacked the guaranty of rigorous scientific methods, was usually with bias. In the 1990s, evidence-based medicine, which emphasized that any medical decision should follow scientific evidence, gradually progressed. Evidence-based medicine is a kind of modern clinical model which combines the doctor’s clinical experience and the best foundation of scientific research. It is the inevitable trend of the development of clinical medicine.
Chinese medicine formed the systematic and unique theory system, but it is bound by experience medicine the same
Chinese medicine is typical of experience medicine. “Huai Nan Zi • Xiu Wu Xun” stated that “Shennong tastes herbs, ……encounters seventy kinds of poisons in one day, then the medical prescription begins to flourish.” This is a vivid portrayal of Chinese ancestors doing medical activities. In the Warring States Period (722 –221 BC?), the publication of “Huangdi’s Internal Classic” which is earliest medical classic extant in China, marked the establishment of the basic theory of Chinese medicine. From the later years of the Western Han Dynasty to the earlier years of the East Han Dynasty (1st century BC–1st century AD), the publication of “Shen Nong Ben Cao Jing,” which is the earliest Chinese medicine classic extant in China, recorded the application of Chinese herbal medicine and the basic theory of prescription compatibility. In the later years of the East Han Dynasty (200 –about 210AD), the publication of “Shang Han Za Bing Lun,” which is the earliest clinical practice book combining theory with practice in China, established the principles of treatment based on syndrome differentiation. And here, Chinese medicine has formed a systematic and unique theory system, which has been carried out for thousands of years.
The theory system of Chinese medicine possesses information thinking features regarding holism as the direction
Substance, energy, and information are the three important factors any thing in nature needs to maintain in order to exist and develop. Substance is the philosophy category that marks the objective reality and the basis that considers changes in the state of motion of matter; energy is the quantitative conversion of the motion of matter; and information is changes in the state of motion of matter and its reproduction ways. In the development of human science, substance, energy, and information represent three different kinds of scientific concepts. Correspondingly, they elicit three distinct sorts of scientific thinking models, including substance thinking, energy thinking, and information thinking. Substance thinking and energy thinking, which take reductionism as the philosophical basis, attribute the overall nature of things to the nature of basic entity in the lowest level, and solve the overall nature in the higher level by the nature in the lower level in order to reveal the nature of things. With people’s deeper understanding of nature, information thin-king, which considers holism as its philosophical foundation, flourished rapidly in the 20th century in order to adapt to the comprehensive nature of science. Information thinking, based on the direction of holism, is a kind of thinking method that advocates investigating things by systematic and overall view, regards the studied objective world as an organic whole with an objective connection, and analyzes the entity and portion of things from inside and outside, upper and lower, vertical and horizontal, and front and rear[
4]. This kind of thinking mode, which stimulates human wisdom through studying the observation and description of the overall state and variation discipline of things, has become a completely new dominant way of thinking in the 21st century.
Human body, as an open and huge system, can exist and evolve through the constant exchange of substance, energy, and information with nature. After the introduction of substance, energy, and information thinking into medical science, it was discovered that western medicine and Chinese medicine recognize the rule of human life activities separately from different thinking methods, and then form two distinct medical systems (Fig. 1).
Under the constant direction of substance thinking, the development of western medicine formed a disease prevention and resistance system that regards diseases as the center. The system begins with the form and structure of the human body, along with the orientation and route of reductionism; adopts methods of analysis, decomposition, and discretion; depends on modern equipment, and deeply understands more and more the form and structure of the human body and the changing relationship among such form and structure. The fine point of western medicine is reducing the human body into independent organs, tissues, cells, proteins, and genes by technique paths, including anatomy, histology, biochemistry, molecular biology, and so on. Western medicine believes that the occurrence of every kind of disease is caused by the abnormal transformation of a single, organic molecular, protein or gene. In addition, it hopes to find the rule affecting life motion through research on a single cell, protein, and gene, as well as to discover another relevant drug aimed at the smallest and most specific biologic and abnormal transformation that causes diseases in order to resist and cure diseases [
5]. Therefore, western medicine is a fighting medical model with the feature of negation by negation. Allopathic medicine has truly undergone a very brilliant development and has played a huge role in conquering many kinds of diseases, including infectious and epidemic diseases in the past three decades. Nevertheless, with the increasingly serious harmful effects chronic non-communicable diseases have on the human body, people find it difficult to solve human health problems using only allopathic medicine.
Chinese medicine takes the Chinese ancient traditional culture as the background, regards the patients as an object to study, and holds the rule of human body changes from both space and time aspects through observation of the state of body motion and the way of state changes. Chinese medicine also combines interventions with changes in the disciplines of the state of body motion state to construct a methodological system that drives human lives, masters changes in the discipline of human lives, and is characterized by a healthy protection system taking humans as the center. This kind of medical system brings numerous advantages for the deve-lopment of Chinese medicine from the methodological aspect. First, it is requested that the changes of the motion state and the coordination between human body and outer environment should be observed from the whole perspective, because of “the unity of heaven and human” and “the unity of body and spirit.” Second, the object of study is the motive people. Hence, from a diagnostic aspect, information is collected by referring overall to four diagnostic methods, including watching, smelling, inquiring and checking, which are constructed by ways of observation, analogy and asking rules. From the treatment aspect, differential treatments and individualization treatment are emphasized to achieve the goal of coordinating yin and yang and taking even as the common state. The research method of governing the exterior to infer the interior, and taking symbols to analogy extremely meets the overall and functional standard of research methods of information science. These features have accumulated rich experience and formed a kind of overall medical model in the development of Chinese medicine.
Information thinking, which is directed by holism, creates the developing path of inheritance and innovation of Chinese medicine. The clinical prescription given by Chinese medical doctors comes from inheritance and modifies the prescription according to the actual situation. This is innovation. “Reading classical books, visiting famous teachers and practicing in clinic” has become a very important model in the inheritance, innovation, and development of Chinese medicine. This kind of model has produced a group of celebrated doctors and laid a great foundation for the follow-up development of Chinese medicine.
Today, the concepts and methods advocated by Chinese medicine could play equally very good roles, especially in confronting situations of new and sudden infectious diseases. For instance, when SARS suddenly occurred in 2003, the China Academy of Chinese Medical Sciences led and organized a dozen of hospitals in Beijing to carry out emergency treatment. Scientific data also demonstrated the effect of combining Chinese medicine and western medicine in treating SARS. Under the premise of a united diagnostic and evaluation standard, the effect and role of treatment based on syndrome differentiation need to be thoroughly played in order to assess the treatment results of such combination, a kind of holistic therapy compared with the single western therapy. In a press conference held in October 2003, WHO experts said that treating SARS by combining Chinese medicine and western medicine is safe and has potential positive effects. The early intervention of Chinese medicine could directly and obviously release inflammation in the lungs of patients suffering from SARS, lower the amount of western medicine containing hormones, and reduce damage on the organs[
6]. Chinese medicine, which has been experience-based for thousands of years, has been proven to have made great contributions to human health.
The research methods of clinical observation and experience summary constrains the modern development of Chinese medicine
Under the direction of holism, the theory system of Chinese medicine, which formed on the basis of long-term accumulated experience, inheritance, and innovation, is the product of the combination of knowledge experience and philosophy. During the long period of experience medicine, Chinese medicine has accumulated plentiful knowledge on precaution and treatment. However, that period is still the primary stage in medical development history, and the research methods are only limited to clinical observation and experience summary. Clinical observation is a process of acquiring relevant information through direct observation of individual patients by senses. It could also directly obtain vivid, specific, natural, and comparatively reliable perceptual information and does not need another middle link. Experience summary is generalizing and analyzing the acquired information, making it systematic and theoretical, and increasing the knowledge and skills to direct clinical practice. Although the method has contributed greatly toward promoting the development of Chinese medicine through thousands of years, its limitations have been gradually revealed with the rapid development of modern science and technique. First, the human senses have some threshold. If the threshold is exceeded, some properties of the observed object cannot be felt directly. Therefore, the observed scope is limited. Second, human observation is affected by subjective consciousness for different people with different observations, and it is sometimes limited by the knowledge and the skills of observers. Observations will inevitably have subjectivity and one-sidedness; it would be difficult to maintain objectivity. Third, because of the lack of control, natural observation is easily disturbed by a variety of complicated and occasional factors. Additionally, under the control of clinical experience, people easily form habitual and tendency thinking, overlook complex and individual distinctions, and then usually make subjective mistakes. These limitations immediately lead to the fact that it is difficult to answer the questions of “why,” only to explain the questions of “what” and “which.” Because of the individual complexity, trivial information and limited time, it is difficult for the results from observation to be popularized and applied in the group of patients. Now, it has not been widely accepted about the mechanism of Chinese herbs and the effect evaluation of Chinese medicine.
Since 1992, the concept of evidence-based medicine has been put forward, from the experience of medical and laboratory medicine to evidence-based medicine transformation, and has become the tendency for medicine as a whole. People are not limited to individual experience, textbook knowledge, and some reasonable decision-making, but advocate individual experience and patients’ will, and present the best evidence combination. Traditional Chinese medicine also faces the same development demand. Although Ex Post Facto clinical research of traditional Chinese medicine pays considerable attention to doctors’ clinical experience, expert experience guidance, it also really requires scientific, recognized evidence to support the obtained research results in order to make better and more effective clinical decision making. Therefore, some experts suggested that, Chinese medicine has many good treatments, but the effect is lack of medical evidence which is essential for it. The development of traditional Chinese medicine to pinpoint the necessary breakthrough, turning experience medicine into evidence-based medicine being one of the most important breakthroughs, is the only possible way to scientifically evaluate the curative effect of traditional Chinese medicine, adapt it to international standards, and identify the mechanism study upon which Chinese herbal medicine will be based on.
The transition and transformation from experience medicine to evidence-based medicine have become important content in the development of Chinese medicine
A considerable amount of practice have been conducted relying on the concepts and methods of evidence-based medicine in the field of Chinese medicine
Chinese medicine is not only pure medicine, but also contains knowledge in multiple subjects, including philosophy, literature, history, geography, astronomy, and possesses humanities features. During the long-term feudal period with the backwardness of science and technique, the progress in medical science was restricted. Chinese medicine has not moved toward experimental medicine, but wandered forward in the way of experience [
7], because it is affected by many kinds of factors in the development process. However, evidence-based medicine, which appeared when medical theory and practice developed to some extent, is the inheritance and development of experience medicine [
1]. Therefore, Chinese medicine totally has conditions to transit and transform from experience to evidence-based medicine.
Evidence is the most basic feature of evidence-based medicine. “Making use of the good clinical evidence carefully, accurately and wisely, combining with specific skills and clinical experience of the doctors, and thinking about the patients’ rights, value and expectation, we can work out measures for patients.” [
8] Today, the idea of pursuing the best evidence has been widely accepted by domestic scholars. Previously, evidence-based medicine graded valued evidence according to science and reliability. Now, it is internationally acknowledged on treatment that the outcome of a large sample of RCT and SR or meta-analysis is the most trustworthy evidence to prove the effect and safety of some kind of therapy—this is the golden standard [
9]. Chinese medicine also pays special attention to the concepts and methods of evidence-based medicine. Recently, domestic scholars have also carried out a large number of evidence-based research on the effects of Chinese medicine. The number of publicized RCTs is constantly increasing (Fig. 2) [
10]. Furthermore, numerous international research which adopt RCT designation have proven the function of acupuncture [
11].
Depending on evidence-based methods of modern medicine cannot completely solve the evaluation concerns of the effect of Chinese medicine
Although evidence-based research on the clinical effects of Chinese medicine has now made some achievements, it still cannot solve a series of problems, including the appearance of new therapy in Chinese medicine, optimization of modern therapy, and the rising effect. The essential reason is that research methods like RCT formed on the basis of the subject feature of western medicine, and are not completely fit for the clinical character, diagnosis, and treatment acquirement of Chinese medicine. Western medicine has experienced the transition from experience medicine to experimental medicine. Thus, the clinical research model of western medicine begins with the basic study of laboratory parameters, tests the studied results by its application in ideal clinical conditions, and then spreads it to clinical practice. However, the new methods and techniques of Chinese medicine do not start from the laboratory, but from clinical practice. These methods and techniques come from the experience accumulation of clinical practice and are then further promoted to clinical practice application after continuous study and re-testing. Hence, we summarize the clinical research model of Chinese model as “from clinical, to clinical”[
12]. The reason that two different medical models bring up two different research models, results in two different problems that should be solved quickly confronted by western medicine and Chinese medicine. Western medicine now faces the challenges of making up the divide between basic experimental research and clinical application, speedily transforming the research achievement acquired by basic research into new clinical therapy, and proposing the concept of Translational Medicine and problem of B to B (i.e. Bench to Bedside)[
13]. The challenges Chinese medicine confronts, however, are constantly finding new ways and techniques, constantly optimizing and completing the existent ways and techniques, constantly promoting the treatment therapy of Chinese medicine, which should be proven by scientific data, which is very essential.
The research methods of western medicine come from the laboratory, and have clear targets and application paths in the filtering process. Therefore, western medicine is usually fixed and carries out research aiming at the group with the same quality. Chinese medicine is different. It faces individualized patients. Patients may possess the same quality from the diseases they are suffering from, but the persons who suffer the diseases are different. Therefore, Chinese medicine usually adopts different interventions to carry out treatment aimed at a specific patient. Western medicine pays attention to the disease, whereas Chinese medicine pays more attention to the patient who suffers the disease. The theoretical foundation distinguishing the evaluation of clinical effects is shown in Table 1. Western medicine takes the diseases as standards, regards the horizontal repeated comparison of people with the same quality as the basis, and eases the differences among individuals by randomized controlled methods. In contrast, Chinese medicine takes the patients as the center, considers the intervention object as the evaluation original, and carries out vertical repeated comparative research at the same time to maintain the individual treatment based on syndrome differentiation.
According to the concept of evidence-based medicine, the elements of clinical treatment evaluation of Chinese medicine and western medicine should be the same. However, because the theoretical basis of clinical treatment evaluation is distinct, the content of the elements of clinical treatment evaluation is greatly distinct (Table 2).
In summary, the different thinking model and philosophical basis in Chinese medicine and western medicine result in different theoretical systems; different subject features and development paths lead to different clinical research models and challenges faced. Additionally, the theoretical basis of clinical treatment evaluation and the content of the elements of clinical treatment evaluation are different. The series of differences bring different requirements for us to carry out evidence-based research methods of Chinese medicine. If we completely adopt evidence-based research methods of western medicine, it is clearly impossible to solve the problems of clinical effect evaluation of Chinese medicine completely.
Taking two ways simultaneously and valuing the research on real world is helpful to transform and develop Chinese medicine to evidence-based medicine
According to the features of Chinese medicine, we propose the research idea of “Taking two ways simultaneously.” One way is that adopting clinical evaluation methods of western medicine and carrying out testing research on existent and comparatively mature therapy in ideal situations. Many ways and techniques have been proved by the “one way” in ideal situations, and their effects have been confirmed and accepted. However, there are plenty of content in Chinese medicine which needs to be studied in clinical practical situations; in the real world, that is another way. For the “one way” in ideal situations, its theoretical basis and methodology have been mature, and we should focus on promoting the study quality of the “one way.” However, for the “another way,” we should analyze and construct the theoretical basis and methodology of clinical research in the real world and build the stage for research technique; this is the key to the effective clinical research of Chinese medicine. Only by gradually maturing and completing the clinical research methods of the real world could we realize “taking two ways simultaneously” and complementing each other, continuously produce scientific and reliable evidence of Chinese medicine, and transform and develop Chinese medicine from experience medicine to evidence-based medicine.
In clinical practical situations, how to collect, manage, and apply clinical data are the primary problem in solving clinical research in the real world. This process could be carried out in three steps. First, establish clinical terms with standardization of Chinese medicine; second, build a data-collecting system with a high structure; and third, when there are a number of clinical data, build a data warehouse and excavate those data to find the rule contained in the data. We have constructed the integrated technique system of clinical research information comprised of a medical business platform, a data management platform, and a clinical research platform (Fig. 3). Every platform is supported by different tools and forms a methodology system, which could collect, manage, and apply data well in the real world to analyze the constantly produced data and evidence, as well as enhance the evidence in our clinical practice.
The appearance of evidence-based medicine leads to a huge transformation in clinical medical research and clinical practical concepts. We hope to establish clinical research methods in the real world on the basis of the advantages of Chinese medicine. These advantages include respecting the development rule of Chinese medicine itself, thoroughly relying on modern science and technique, combining multi-subject research energy at home and abroad, and “taking two ways simultaneously” in order to form and share a large number of clinical data resources, integrate data about various kinds of genomics, improve the clinical effect, uncover the scientific mechanism, and create new situations for the development of Chinese medicine. If we effectively and normatively collect a large number of clinical real data and various kinds of genomics data, and combine literature research data with those data, the evidence for clinical research of Chinese medicine will appear continuously, greatly promote the transition and transformation of Chinese medicine from experience medicine to evidence-based medicine, and achieve the goal of a healthy, rapid, and leaping development of Chinese medicine.
Higher Education Press and Springer-Verlag Berlin Heidelberg
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