Different from modern medicine, traditional Chinese medicine (TCM) has its unique thought patterns and decision methods. In the process of developing TCM clinical practice guidelines, not only the modern clinical researches should be included, but also the TCM ancient books which had influenced TCM for thousands of years should be included. As an important carrier of TCM, the characteristics of researches in TCM ancient books are different from modern clinical researches. In this paper, we introduced the present situation of the TCM guidelines and how to use TCM ancient books for developing TCM clinical guideline with the guidance of evidence-based method. We used the example of developing of headache TCM guideline to explain how to use TCM ancient books as evidence source for guideline development and explored the application of evidence-based research of TCM ancient books to promote TCM clinical guidelines development.
We described our understanding of EBM, the ‘three principles＇ and ‘five steps＇ to practice it. EBM is an embodiment of human moral rule and axiom in clinical medicine; it is an advanced clinical model and medical practical methodology; it results from a basis of developed and perfected clinical research methodology, best evidence database, information technology. We also discussed the relationship between EBM and traditional Chinese medicine （TCM） modernization. The definition of modernization of TCM was suggested as scientifical standardization and internationalization. TCM theory in fact is not a basic but a clinical practice theory. EBM model should become the standard model of TCM practice to accelarate the standardization of TCM diagnostic technique and therapy. The key is not try to explain TCM theories with modern medical theroies, but work out common effectiveness evaluation criteria. Only when the effectiveness is intemationally acknowledged, can TCM be internationalized.
Background As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
Based on the PRISMA 2009 checklist, the study analyzed current status and reporting quality of systematic reviews of animal experiments, and consulted experts in relevant fields to form an initial entry pool of reporting checklists for systematic reviews of animal experiments in traditional Chinese medicine (PRISMA-ATCM). Then, the initial entry pool was improved through 2 rounds of Delphi expert consultation. Finally, the items were revised through the consensus meeting, and the final PRISMA-ATCM was formed. Of the 27 items on the PRISMA checklist, 12 were revised and expanded, specifically relating to TCM interventions and animal characteristics. The publication of the PRISMA-ATCM will improve the transparency and standardization of systematic reviews of animal experiments in Chinese medicine.
The modernization and internationalization of traditional Chinese medicine (TCM) are the key issues we must face up to. The development of TCM needs to depend on the breakthrough of methods and the innovation of ideology, and the international standardization of scientific research evaluation. The clinical evidence from randomized comtrolled trials (RCT) is valuable and reliable. It has shown that the proportion of RCT identified in TCM journals was less than 30%, and the score of RCT’s quality was less than 3 using Jadad scale. However, the number of systematic reviews on TCM is increasing rapidly after the evidence-based medicine (EBM) was introduced and practiced in China. Until 2004, 43 systematic reviews of TCM were published in China, and the quality of RCT included in those reviews was elevated. It has shown that the efficacy and safety of TCM indicated some advances in treatment of certain kind of diseases. It has been realized that RCT are important in TCM, and improving the quality of RCT is the key step for modernization and internationalization of TCM.
Using the method of sample analysis, this paper showed the method of PubMed’s animal experiments retrieval strategy in system evaluations. It analyzed the literature retrieval strategy and practice of systematic evaluations of animal medicine in evidence-based medicine so as to provide reference for improving the capability of health workers, and researchers to search and construct retrieval strategies.
Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.
The traditional Chinese medicine has played an important role in the prevention and control of coronavirus disease 2019 (COVID-19). Based on the role of traditional Chinese medicine in dealing with the previous epidemics and COVID-19, this paper analyzes the problems and challenges of current situation, and focuses on improving traditional Chinese medicine scientific identification, strengthening the construction of traditional Chinese medicine system, and increasing the intensity of Chinese and Western medicine and so on. In order to improve the cooperation mechanism of Chinese and Western medicine for epidemic prevention and control, and give full play to the role of traditional Chinese medicine in the construction of national public health emergency system, this paper also gives ten corresponding suggestions.
ObjectiveTo explore the items affecting the prioritization of clinical questions and to construct an evaluation scale for prioritizing clinical question of traditional Chinese medicine (TCM) guidelines. MethodsLiterature analysis and cognitive interview were used to construct the pool of items for evaluating the prioritization of clinical questions of TCM guidelines, and Delphi methods was used to identify the items to form the evaluation scale. ResultsA total of 47 articles were included in this study, and the two rounds of Delphi questionnaires had a recovery rate of 72% and 100%, respectively. The mean value of the importance of the items in the first round ranged from 3.78 to 4.78, with a coefficient of variation ranging from 0.09 to 0.30, and the mean value in the second round ranged from 4.06 to 4.72, with a coefficient of variation ranging from 0.09 to 0.29. The evaluation scale for the prioritization of clinical questions of TCM guidelines (first edition) was constructed, which contains 13 entries in 4 dimensions. ConclusionThis study explored the items affecting the prioritization of clinical questions in TCM guidelines and developed a prioritization evaluation scale, which improved the lack of objectivity and interpretability of the current prioritization of clinical questions in TCM guidelines to a certain extent, and strengthened the transparency of the process of selecting clinical issues in TCM guidelines.
The characteristics of traditional Chinese medicine (TCM) practice include treatment based on syndrome differentiation and holism, which determines it is difficult to reflect the individualized therapeutic evaluation and overall regulation of TCM through traditional randomized controlled trials, which is based on quantitative evaluation. The implementation of N-of-1 trials will provide opportunities for quantitative evaluation of individualized therapeutic evaluation of TCM. Using mixed methods research, such as exploratory sequence design, interpretive sequence design or convergent design can provide abundant data to individualized therapeutic evaluation of TCM in different aspects, which may reflect holism and humanities characteristics of TCM in individual level.