1.Exploration of an Intelligent Evidence Achieve Mode of Evidence-Based Chinese Medicine:Take Systematic Review of Coronary Heart Disease Syndrome Research as an Example
Qianzi CHE ; Qingyang ZENG ; Tian SONG ; Lin CHEN ; Jing WAN ; Nannan SHI
Journal of Traditional Chinese Medicine 2025;66(15):1597-1603
ObjectiveTo construct an intelligent model for literature screening, retrieval, and data extraction with a systematic review of coronary heart disease syndromes as an example, so as to improve the efficiency of evidence-based Chinese medicine research. MethodsBased on China National Knowledge Infrastructure (CNKI), VIP and Wanfang Data Resource System, the articles related to coronary heart disease syndrome research published from January 1, 2000 to December 31, 2023 were retrieved. Automated tools were used to batch retrieve paper metadata. Using text similarity algorithms, papers were merged, deduplicated, and subjected to preliminary screening based on titles and abstracts. Further screening was performed using object detection and image processing technologies on the full texts and statistical tables. Natural language processing (NLP) techniques and pre-trained models were applied to extract information. ResultsThe initial search retrieved 56 255 coronary heart disease syndrome-related articles. By artificial intelligence-assisted preliminary and secondary screening, the manual verification scope was narrowed to 1075 articles. Ultimately, 646 coronary heart disease syndrome related studies were included manually. With accuracy verification showing over 90% consistency in semantic recognition and element decomposition processes, we achieved data extraction and standardization processing for both basic literature information and 38 syndrome element statistics. ConclusionBy incorporating natural language processing, pre-trained models, artificial intelligence image processing and other technologies, this study enabled efficient retrieval, screening and standardized data extraction of Chinese medicine research literature.
2.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine(Part 5): Retrieval and Synthesis of Key Information on Rational Drug Use
Ziteng HU ; Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Fuqiang ZHANG ; Yaxin CHEN ; Bin LIU ; Qianzi CHE ; Yixiang LI ; Jing GUO ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):167-171
Recommendations for Chinese patent medicine (CPM) based on key information on rational drug use are one of the important conditions for enhancing guideline enforceability as well as facilitating guideline implementation. In this study, we discussed in detail of the key information on the rational use of CPM in five aspects, which are dosage, drug discontinuation, drug-drug and drug-food interactions, safety and economy. Following the process of multi-source search, synthesis and prioritization, it is suggested to collect key information on the rational use of CPM from a multi-source search of drug instructions, policy documents, literature, and clinical experts' experiences. Then the searched information should be summarized and prioritized with the principle that taking drug instructions as the basis and other-sources information for check and supplementation. Finally, methodological recommendations for the retrieval and synthesis of key information on rational drug use in guideline recommendations has been formed.
3.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 6): Formation and Presentation of Recommendations
Yujing ZHANG ; Ning LIANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Fuqiang ZHANG ; Qianzi CHE ; Zhao CHEN ; Yuqi LIU ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):172-177
Recommendation formation is a key component of clinical practice guidelines for Chinese patent medicine (CPM), and should encompass the determination of the strength and direction of the recommendation, the rationale for the recommendation, and the methodology for implementing the recommendation. Recommendations can be formed through formal consensus and informal consensus. The strength and direction of recommendations for CPM guidelines should be determined by considering the quality of evidence for CPMs, the priority of the clinical questions, the pros and cons of efficacy and adverse effects, patient acceptance, the feasibility of the recommendation and the availability of resources, social fairness, economic benefits, and other influencing factors. In order to better guide guideline developers to consider these factors more rationally, this article provideed a detailed explanation of each factor in the context of the characteristics of TCM.
4.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 7): Introduction and Interpretation of the Guideline Reporting Checklist
Yujing ZHANG ; Fuqiang ZHANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Haili ZHANG ; Huizhen LI ; Qianzi CHE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):178-184
The systematic and comprehensive introduction and interpretation of the Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 is conducive to the presentation of high-quality clinical practice guidelines for Chinese patent medicines (CPMs), thus improving their dissemination and use. The Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 specifies the requirements for clear, complete and transparent reporting of the whole process of developing CPMs guidelines, containing 4 domains, 17 topics and 43 items, and involving the basic information, recommendations and methods of guideline development. Especially, it details the items related to the rules and regulations of the use of CPMs in the recommendations, which is helpful for improving the completeness, scientificity and practicality of the reporting of CPMs guideline.
5.Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study
Guozhen ZHAO ; Huizhen LI ; Ning LIANG ; Haili ZHANG ; Bin LIU ; Qianzi CHE ; Feng ZHOU ; He LI ; Xiaowen CHEN ; Long YE ; Jiahao LIN ; Xingyu ZONG ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):87-93
The clinical practice guidelines of traditional Chinese medicine (TCM) have problems such as limited clinical application and unclear implementation effects, which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice, this article proposes a model of combining TCM guidelines with real-world study, which includes 4 steps. Firstly, during the implementation process of the guidelines, a high-quality research database is established. Secondly, the recommendations in the guidelines are evaluated based on the established database in multiple dimensions, including applicability, effectiveness, safety, and cost-effectiveness, and thus their effectiveness in practical applications can be determined. Thirdly, based on the established database, core prescriptions are identified, and the targeted populations and medication plans are determined. That is, the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies, dosages, and duration on efficacy. Fourthly, the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions, improving their application in clinical practice. Moreover, this model can reduce research costs and improve research efficiency. When applying this model, researchers need to pay attention to the quality of real-world evidence, ensuring that it can truly reflect the situation in clinical practice. In addition, importance should be attached to the clinical application of guideline recommendations, ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally, full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion, the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.
6.Methods and Challenges for Identifying and Controlling Confounding Factors in Traditional Chinese Medicine Observational Studies
Guozhen ZHAO ; Ziheng GAO ; Chen ZHAO ; Huizhen LI ; Ning LIANG ; Bin LIU ; Qianzi CHE ; Haili ZHANG ; Yixiang LI ; Feng ZHOU ; He LI ; Bo LI ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):120-126
As a supplement to randomized controlled trials, observational studies can provide evidence for the effectiveness of traditional Chinese medicine (TCM) treatment measures. They can also study influencing factors of diseases, etiology, and prognosis. However, there is a confounding effect due to the lack of randomization, which seriously affects the causal inference between the study factors and the outcome, resulting in confounding bias. Therefore, identifying and controlling confounding factors are key issues to be addressed in TCM observational studies. According to the causal network and the characteristics of TCM theory, confounding factors can be categorized into measured and unmeasured confounding factors. In addition, attention must be paid to identifying confounding factors and intermediate variables, as well as the interaction between confounding factors and study factors. For methods of controlling confounding factors, measured confounding factors can be controlled by stratification, multifactor analysis, propensity scores, and disease risk scores. Unmeasured and unknown confounding factors can be corrected using instrumental variable methods, difference-in-difference methods, and correction for underlying event rate ratios. Correcting and controlling confounding factors can ensure a balance between groups, and confounding bias can be reduced. In addition, methods such as sensitivity analysis and determination of interactions make the control of confounding factors more comprehensive. Due to the unique characteristics of TCM, observational studies of TCM face unique challenges in identifying and controlling confounding factors, including the ever-changing TCM treatment measures received by patients, the often-overlooked confounding effects in the four diagnostic information of TCM, and the lack of objective criteria for TCM evidence-based diagnosis. Some scholars have already conducted innovative explorations to address these issues, providing a methodological basis for conducting higher-quality TCM observational studies, so as to obtain more rigorous real-world evidence of TCM and gradually develop quality evaluation criteria for OS that are consistent with the characteristics of TCM.
7.Key Techniques and Methodological Considerations for Formation of Traditional Chinese Medicine Syndrome Classification Standards
Guozhen ZHAO ; Xingyu ZONG ; Xueyao ZHAO ; Huizhen LI ; Feng ZHOU ; Xuanling ZENG ; Jiahao LIN ; Ning LIANG ; Haili ZHANG ; Qianzi CHE ; Bin LIU ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):257-261
The classification of traditional Chinese medicine (TCM) syndromes is one of the core technical elements in the industry standard of Specification of Diagnosis and Therapeutic Effect Evaluation of Diseases and Syndromes in TCM. In the past,when clinical standards for TCM were formulated,the determination of TCM syndrome classification relied heavily on textbooks and expert experience,lacking systematic research. This approach thus failed to reflect the advancement and scientificity of the standards,thereby affecting their implementation and application. This article reviewed the presentation forms and technical methods of TCM syndrome classification,including the two-tier syndrome classification model with primary and secondary symptoms,as well as the application of modern literature research,ancient literature research,Delphi method,in-depth expert interviews,consensus conferences,and real-world research. When syndrome classification standards are developed,it is necessary to build upon modern literature research,adopt a mixed approach combining qualitative research and quantitative analysis results,and reach expert consensus through consensus conferences. Through systematic research,the scientificity,applicability,and coordination of TCM syndrome classification standards can be enhanced,providing guidance for the standardization of TCM.
8.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 2): Development Process and Key Steps during Preparation Stage
Yujing ZHANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Xiaoling LI ; Qianzi CHE ; Jingya WANG ; An LI ; Nannan SHI ; Yanping WANG ; Ning LIANG
Journal of Traditional Chinese Medicine 2024;65(3):275-280
It is necessary to develop rapid and living guidelines in order to improve the evidence translation and guidance for clinical practice in emergency situations, and to enhance the participation of traditional Chinese medicine (TCM) in management of emergencies. This paper introduced the process of developing rapid and living guidelines of TCM and divided it into three stages, that is preparation, rapid development and dynamic updating, which highlights the features of rapid development, high quality, and dynamic updating and the integration with the predominance of TCM. By comparing with general guidelines on composition, personnel number, timing to formulate and communication patterns of the guideline working groups, as well as the content and number of clinical questions, this paper mainly gave suggestions on how to formulate a concise but authoritative team during the preparation stage, how to efficiently manage the guideline team and promote the development process from conflict of interest management, working and communication mode adjustment, and how to formulate and update the important and prioritized clinical questions, all of which may provide reference for the development of TCM rapid and living guidelines.
9.Interpretation of the Guideline for Multi-dimensional and Multi-criteria Comprehensive Evaluation of Chinese Patent Medicine:weighting of evaluation indicators
Haili ZHANG ; Bin LIU ; Weili WANG ; Wenjie CAO ; Yijiu YANG ; Ziteng HU ; Yaxin CHEN ; Ning LIANG ; Huizhen LI ; Qianzi CHE ; Xingyu ZONG ; Zhao CHEN ; Yanping WANG ; Nannan SHI
China Pharmacy 2024;35(7):773-777
OBJECTIVE To provide a detailed report and interpretation of the method and results for determining the weights of the technical indicators from the “multi-dimensional and multi-criteria comprehensive evaluation index system (first edition)” stated in Guideline for Multi-dimensional and Multi-criteria Comprehensive Evaluation of Chinese Patent Medicine. METHODS Normalization calculations were performed on the comprehensive weight values calculated by the analytic hierarchy process and expert weighting method to obtain the objective weights of the indicators. RESULTS The weight results of the six primary dimensions in the current comprehensive evaluation indicator system of Chinese patent medicine showed effectiveness dimension> safety dimension>standard dimension>application dimension>scientific dimension>economic dimension, with weight values of 0.281 0, 0.268 5, 0.195 8, 0.107 3, 0.096 1 and 0.051 3 respectively, consistent with the results of most researches currently. CONCLUSIONS The process of weight determination in this indicator system is scientifically reasonable, with clear methods and clear interpretations, and is worthy of further optimization and widespread application.
10.Quality Evaluation of the Randomized Controlled Trials of Chinese Medicine Injection for Acute Cerebral Infarction in Last Five Years Based on ROB and CONSORT-CHM Formulas 2017
Ziteng HU ; Qianzi CHE ; Ning LIANG ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Weili WANG ; Haili ZHANG ; Wenjie CAO ; Yijiu YANG ; Tian SONG ; Dingyi WANG ; Xingyu ZONG ; Cuicui CHENG ; Yin JIANG ; Yanping WANG ; Nannan SHI
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(7):32-37
Objective To evaluate the risk of bias and reporting quality in randomized controlled trials(RCTs)of the Chinese medicine injection for acute cerebral infarction in the last five years.Methods RCTs literature on Chinese medicine injection in the treatment of acute cerebral infarction was systematically searched in CNKI,Wanfang Data,VIP,China Biology Medicine Database(CBM),PubMed,Embase and Cochrane Library from April 20,2018 to April 20,2023.The risk of bias and reporting quality of included RCTs were evaluated using the Cochrane Risk of Bias Tool(ROB 1.0)and CONSORT-CHM Formulas 2017,respectively.Results A total of 4 301 articles were retrieved,and 408 RCTs were included according to inclusion and exclusion criteria.The ROB evaluation results showed that the the majority of studies were rated as having an unclear risk of bias due to the lack of reporting on allocation concealment,blind method,trial registration information,and funding sources.The evaluation results of CONSORT-CHM Formulas 2017 showed that the number of reported papers of 17 items was greater than or equal to 50%,and the number of reported papers of 25 items was less than 10%,and most of the RCTs did not show the characteristics of TCM syndrome differentiation and treatment.Conclusion The quality of Chinese medicine injection in the treatment of acute cerebral infarction RCTs is generally low.It is recommended that researchers refer to the methodology design of RCTs and international reporting standards,improve the trial design,standardize the trial report,and highlight the characteristics of TCM syndrome differentiation and treatment.

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