Suggestions on design of evidence-based traditional Chinese medicine clinical study for new public health emergencies / 中国中药杂志

2019 novel coronavirus(2019-nCoV) has occurred for 2 months, and seriously affected the people's health in the world. Therefore, scientific prevention and control strategies and effective intervention measures are the only ways to solve the world problem. In the determination of intervention measures, not only the effectiveness evaluation, but also accessibility, treatment cost, inventory and production capacity and other relevant sociological issues shall be considered, especially in low and middle-income countries and regions. With the introduction of clinical epidemiological experiment design and evidence-based medicine evidence evaluation into the evaluation of curative effect of traditional Chinese medicine(TCM), TCM has officially entered the studies of syndrome regularity of new public health emergencies(such as SARS and influenza) clearly diagnosed by modern medicine for many years, as well as the development of relevant guidelines, consensus and paths. The results of curative effect show that TCM could significantly alleviate symptoms, control disease and tendency, reduce the occurrence of critical illness, and improve the clinical efficacy and the prognosis and quality of life of patients, which fully reflects the consciousness and self-confidence of traditional Chinese medicine workers. For the evidence-based evaluation of TCM intervention in new public health emergencies, the basic principles and general methods of clinical epidemiology and evidence-based medicine shall be followed to obtain high-quality evidence; besides, we shall also fully realize that clinical scientific study is carried out with the epidemic treatment as the primary task. The scientific hypothesis comes from the clinical problems unsolved. The scientific study conclusions aim to give feedbacks to clinical diagnosis and treatment regimens. The core elements of clinical trials are population(P), intervention(I), control(C), outcome(O), which are abbreviated as "PICO". The evaluation of intervention measures for new public health emergencies with traditional Chinese medicine shall have clear study objectives and a high quality, with a correct analysis method as the guarantee of real and reliable results. Then, the selection of patients, the de-finition of intervention measures and control measures, the development of end-point indicators, the clinical quality control under special epidemics, the data verification, and the data analysis methods to be adopted are all characteristics and key points that need special consideration. It is suggested that scientific experimental design, rigorous collection and scientific data analysis shall be conducted to reflect the therapeutic value of traditional Chinese medicine, so that the study results could be adopted and shared, and become the scientific evidence for China and even the global to republish the diagnosis and treatment regimens.

Evidence-based Chinese medicine：theory and practice / 中国中药杂志

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine.