Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
To promote the accessibility and application of guidelines, it is necessary to establish a professional guideline database to adapt to the rapid growth of TCM clinical practice guidelines. This study described the framework design, technology module, information management, and quality control of the clinical practice guideline database of traditional Chinese medicine (G-TCM). G-TCM had included 658 TCM clinical practice guidelines, which would provide a platform for clinicians, researchers, guideline makers (revision), and evaluators to quickly query and obtain clinical guideline information, and play a supporting role in promoting the standardization and accessibility of TCM clinical practice guidelines and better guiding clinical practice.
Chinese medicine (CM) has significant clinical effects in the treatment of tracheal-bronchitis. It is of important clinical significance to formulate guidelines for the diagnosis and treatment of tracheal-bronchitis based on the characteristics of TCM syndrome differentiation. The Respiratory Disease Branch of China Association of Chinese Medicine and Respiratory Disease Branch of China Medical Association of Minorities organized and established a multi-disciplinary background working group, based on the World Health Organization Handbook for Guideline Development and the Guideline Development Handbook for Diagnosis and Therapy of Integrative Medicine to develop this guideline. It was developed through technical links such as clinical problem investigation, evidence collection and evaluation, Delphi consultation, and expert consensus meetings. Based on the current best evidence, CM intervention costs and expert experience, 25 recommendations were established to standardize the etiology and pathogenesis of tracheal-bronchitis, syndrome differentiation and treatment, prevention, and care, etc., which can be used by physicians at different levels of medical institutions.
Objective To review the current status of evidence-base medicine (EBM) research on traditional medicine in Japan. Methods Serial reports of EBM special committee of Japan Society for Oriental Medicine (JSOM) were reviewed. Results EBM special committee of JSOM was established earlier and carried out systematic reviews of Kampo treatment throughout Japan. The quality of preparations was standardized and reliable. Evidence Reports of Kampo Treatment 2009 (EKAT 2009) may be a promising promotion for Kampo treatment in Japan. Conclusion For the promotion and development of evidence-based Chinese medicine in China, we need to learn from EBM research projects of JSOM. Based on the current status of EBM research in China, special efforts should be made in validity of research data and scientific analysis and reports of non-randomized trials. According to the characteristics of traditional Chinese medicine, EBM research should be systematically carried out from simple to complex.
Clinical efficacy evaluation is important for the development of traditional Chinese medicine (TCM). In view of the existing accumulation and current situation of the TCM clinical efficacy evaluation, based on the international perspective, and taking the rational and objective evaluation of TCM clinical efficacy and safety as the foundation, in order to enhance TCM evidence level to support clinical decision-making and promote TCM industry and TCM internationalization development, the State Administration of TCM entrusted China Academy of Chinese Medical Sciences to establish China Center for Evidence Based Traditional Chinese Medicine (CCEBTCM). CCEBTCM is expected to optimize the allocation of evidence-based research resources in TCM field to further integrate advantages of evidence-based TCM research teams, promote consensus on evidence-based TCM standards, share evidence-based TCM data or information and lead cultural exchanges between Chinese and overseas. In this way, the status and influence of TCM in the world will be enhanced so that it can better serve global health.
ObjectivesTo analyze the citation of evidence in traditional Chinese medicine (TCM) clinical pathways in China, and to provide suggestions for future development and revision of TCM clinical pathways.MethodsTCM clinical pathways released on the websites of national administration of TCM and China association of Chinese medicine were obtained, with the retrieval time limit to June 2019. Two researchers separately utilized the Excel to extract data and performed a descriptive analysis.ResultsA total of 405 TCM clinical pathways were included, involving internal medicine, surgery, gynecology and pediatrics. Internal medicine accounted for the largest proportion of the TCM clinical pathways (133). All the 405 pathways cited references as evidence, among which the maximum and minimum quantities of cited references were 11 and 1, respectively, and the median was 3. More than 90% of the TCM clinical pathways cited the evidence in the parts of diagnosis and efficacy evaluation. For parts of TCM and western medicine treatment, the proportion of TCM clinical pathways which cited evidence was less than 75%; for parts of rehabilitation and nursing, the proportion of TCM clinical pathways which cited evidence was less than 2%. The types of evidence being cited were standard indicators (683), clinical practice guidelines (488), textbooks (236), consensus opinions, ancient books and clinical surveys. The released time was reported in 89.25% of the cited evidence; the largest time interval was between the release time of the standard indicators (evidence) and that of the TCM pathways. Among the evidence released more than 15 years before the release of the TCM pathways, the proportion of standard indicators was the highest (57.12%).ConclusionsThe published TCM clinical pathways are all developed based on evidence, however, the evidence citation ratio in different parts varies greatly. In some TCM clinical pathways, the cited evidences are not reported normatively, and some evidence are poor in timeliness.
ObjectiveTo evaluate the quality of protocols and reports on the core outcome set of traditional Chinese medicine (COS-TCM), and to provide some evidence for COS-TCM developers to carry out studies and improve the reporting quality and methodological quality during their studies. MethodsLiterature databases in Chinese and English were searched to collect COS-TCM protocols or study reports from inception to April 18, 2023. The Core Outcome Set-STAndards for Reporting (COS-STAR), Core Outcome Set-STAndards for Development (COS-STAD), and Core Outcome Set-STAndardised Protocol Items (COS-STAP) were used to evaluate their reporting and methodological quality. Additionally, the consistency of studies with both published protocols and results was evaluated. ResultsA total of 14 protocols and 14 reports (involving 23 COS-TCM studies) were included. The evaluation of COS-TCM protocols according to the COS-STAP found that the reporting rates of "Stakeholders" (71.4%) and "Missing data" (42.9%) were relatively low. For the reports of COS-TCM, the evaluation based on the COS-STAD found that the reporting rates of "the population (s) covered by the COS" (35.7%) and "care was taken to avoid ambiguity of language used in the list of outcomes" (28.6%) were relatively low. Based on the COS-STAR, the items with low reporting rates were "Protocol Deviation" (7.1%), "Participants" (21.4%), and "Conflicts of interest" (28.6%). Additionally, the consistency evaluation found that there were inconsistencies between protocols and their results, such as the types of research included in the systematic review, the methods of qualitative research, the way of holding consensus meetings, scoring methods, etc. Moreover, only one study reported protocol deviation and reasons for change. ConclusionCOS-TCM studies need to improve their methodological quality and report transparency. When developing COS-TCM, we should pay attention to the characteristics of TCM while basing on international standards. The quality evaluation guidelines and standards of reporting for COS-TCM study need to be developed in the future.
Research on the Chinese medicine standardized calendar is not only required for the development of evidence-based pharmacy, but it is also needed in order to adapt to, and promote, clinical rational use of Chinese medicine. The experience of the clinical calendar is summarized in this article. This may provide some significant clues and basis for the design and conduct of research when constructing a Chinese medicine standardized calendar.
This paper introduces the application and funding of evidence-based research projects on traditional Chinese medicine (TCM) of the National Natural Science Foundation of China (NSFC) in 2019 in terms of clinical research and methodology research, summarizes the primary problems existing in evidence-based research on TCM, discusses the quality of evidence-based research on TCM in clinical research, highlights the characteristics of TCM and reveals the evidence-based methodology on TCM.
Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.