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ObjectiveTo systematically sort out the knowledge framework and conceptual logic relationship of "disease-syndrome-treatment-prescription-medicine" in the existing literature on traditional Chinese medicine（TCM） treatment of diabetic peripheral neuropathy（DPN）， to construct of the knowledge map of TCM treatment of DPN， and to promote the explicitation of the implicit knowledge in the literature on the treatment of DPN with TCM. MethodTaking the literature of China National Knowledge Infrastructure about TCM treatment of DPN as the main data source， TCM-related concepts and entities were constructed by manual citation， and the corresponding relationships between the entities were established. Structured data were formed by processing with Python 3.7， and the knowledge graph was constructed based on Neo4j 3.5.34 graph database. ResultThe resulting knowledge graph with TCM diagnosis and treatment logic， defined 12 node labels such as prescriptions， Chinese medicines and syndrome types at the schema layer， as well as 4 types of relationships， such as inclusion， correspondence， selection and composition. It could support the query and discovery of nodes（syndrome elements， syndrome types and treatment methods）， as well as the relationship between each node. ConclusionBased on the literature data， this study constructed a knowledge map for TCM treatment of DPN， which brought together various methods of TCM treatment of DPN， including internal and external treatment. The whole chain knowledge structure of syndrome differentiation and classification for DPN treatment is formed from syndrome element analysis， syndrome type composition to treatment method selection， which can provide new ideas and methods for literature data to serve clinical and scientific research work， as well as reference for visualization of TCM literature knowledge， intellectualization of TCM knowledge services and the standardization of TCM diagnosis and treatment.
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ObjectiveTo compare the differences in clinical characteristics between kidney deficiency and stasis obstruction syndrome and damp-heat stasis obstruction syndrome in patients with ankylosing spondylitis （AS）， thereby providing reference for clinical differentiation and treatment. MethodsThe clinical data of 2339 patients with AS were collected， including 1075 cases of kidney deficiency and stasis obstruction syndrome and 1264 cases of damp-heat stasis obstruction syndrome. The basic information including age， gender， course of disease， history of ophthalmia， family history and human leukocyte antigen B27 （HLA-B27） positive history， Bath ankylosing spondylitis disease activity index （BASDAI） score， Bath ankylosing spondylitis functional index （BASFI） score， Bath ankylosing spondylitis measurement index （BASMI） score， Depression Anxiety Stress Scale 21 （DASS-21） score， single symptom score in terms of spinal pain， peripheral joint pain， tendon tenderness， morning stiffness degree and morning stiffness time， patient-reported outcomes including patient global assessment （PGA） score， chronic disease therapy function-fatigue scale （FACIT-F） score and night pain visual analog scale （VAS） score， laboratory indicators including serum C-reactive protein （CRP） and erythrocyte sedimentation rate （ESR）， and CT grading of sacroiliitis were measured and compared between groups. ResultsPatients with kidney deficiency and stasis obstruction syndrome were older and had a longer course of disease （P＜0.01）. The BASDAI， BASFI and BASMI scores of the patients with kidney deficiency and stasis obstruction syndrome were 3.84±1.79， 2.78±2.00 and 3.42±2.36， respectively， while those in patients with damp-heat stasis obstruction syndrome were 4.30±1.99， 3.43±2.12， and 2.92±1.76. The BASDAI score， BASFI score， PGA score， FACIT-F score， spinal pain score， peripheral arthralgia score， tendon tenderness score， morning stiffness degree score， depression score， anxiety score， and stress score in patients with damp-heat stasis obstruction syndrome were all higher than those with kidney deficiency and stasis obstruction syndrome， with longer duration of morning stiffness and higher CRP （P＜0.05 or P＜0.01）. BASMI score and night pain VAS score were more higher in patients with kidney deficiency and stasis obstruction syndrome （P＜0.01）. There was no significant difference in the ESR level and CT grading of the sacroiliac joint between the two groups （P＞0.05）. ConclusionAS patients with kidney deficiency and stasis obstruction syndrome have poorer spinal mobility， while those with damp-heat stasis obstruction syndrome have higher disease activity， poorer physical function， and are more prone to adverse psychological reactions.
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As a kind of intervention measures of traditional Chinese medicine, acupuncture-moxibustion is highly adopted on global clinical practice. Even though the global clinical trial registration system was established more than 10 years ago, the proportion of acupuncture-moxibustion clinical trial registration is still very low; and it is very problematic on the methodological quality and report quality in the published acupuncture-moxibustion clinical trials. In order to manage particularly the acupuncture-moxibustion clinical trials, China Academy of Chinese Medical Sciences, collaborated with China Association of Acupuncture and Moxibustion and World Federation of Acupuncture Societies, established the Acupuncture-Moxibustion Clinical Trail Registry (AMCTR). AMCTR is a secondary registry platform affiliated to the Chinese Clinical Trial Registry (ChiCTR) and WHO International Clinical Trials Registry Platform (ICTRP), specifically for the acceptance and management of clinical trials in the field of acupuncture and moxibustion. It is a nonprofit academic organization, located in China Academy of Chinese Medical Sciences.
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Through several thousand years’ inheritance and development by Chinese people, traditional Chinese medicine (TCM) has formed its unique theoretic system, whose efficacy has been widely accepted. However, because TCM theory focuses on the relationships among syndromes, treatment and efficacy, instead of the cause-and-effect relationship explored by modern natural science, the scientificity of TCM has always been questioned. In recent years, because virtual-world clinical research mode and the concept of “big data” were emphasized, increasing researchers began to put their research emphasis on the correlativity between intervening measures of diseases and outcome indicators. This change and the advancement of computer data mining and analysis technology, bring great opportunities for the further development of TCM theory and practice. This article concluded data mining technology used in TCM diagnosis and treatment in recent years, such as clustering analysis, decision tree, Bayesian network, neural network and multi-instance learning, which showed how to apply these methods to reveal rules of TCM diagnosis and treatment from a large number of TCM syndrome data, find knowledge hidden in data, and show TCM effectiveness supported by data.
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Traditional Chinese medicine (TCM) emphasizes treatment based on syndrome differentiation, which is the core technology that can embody the characteristics and advantages of TCM diagnosis and treatment. This is based on holistic view to illustrate individual diagnosis and treatment and dynamic treatment. However, RCT, which is frequently used in TCM clinical studies, can not reflect the concept of treatment based on syndrome differentiation. The use of adaptive treatment strategies in clinical researches can adjust therapy in patients according to the changes of diseases, so it can reflect individual diagnosis and treatment and dynamic treatment. From this perspective, the process of treatment based on syndrome differentiation is a process of decision-making of adaptive treatment. So the method for developing adaptive treatment strategies can effectively evaluate the efficacy of different treatment strategies in TCM clinical studies. Adaptive treatment strategies have been used in some clinical studies from some published foreign literatures. However, the use of adaptive treatment strategies in domestic clinical researches is seldom reported. This article discussed the concept of adaptive treatment strategies and their important components in detail. In addition, it presented three methods which can take the delayed effects of the current treatment action into consideration and can compare the overall effect of different adaptive treatment strategies, with a purpose to lay some foundation for future TCM researches in the development of optimal clinical pathway and provide new ideas and methods for researches.
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Traditional Chinese medicine (TCM) emphasizes treatment based on syndrome differentiation, which em-bodies the concept of individualized diagnosis and dynamic treatment on a holistic view. RCT was frequently used in TCM clinical study. However, it cannot reflect the concept of treatment based on syndrome differentiation. The use of adaptive treatment strategies (ATS) in clinical research can adjust therapy in patients according to the change of disease, so it can reflect personalized medicine and dynamic treatment. From this perspective, the process of treat-ment based on syndrome differentiation was a process of adaptive treatment decision. So the method for developing ATS can effectively evaluate the efficacy of different treatment strategies in TCM clinical study. ATS had been used in some clinical studies from published literatures abroad. However, the use of ATS in domestic clinical research was seldom been reported. This paper gave an outline of the concept of ATS. In addition, this paper focused on three methods which can take the delayed effects of current treatment action into consideration and can compare the over-all effect of different ATS. It was hoped to lay foundation for future scientific research of TCM in the implementation of SMART and provide a new idea.
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This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.
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Objective To study the scientificity and rationality in data management of the project of Chinese Chronic Disease Clinical Research System and its Achievements Application Mode;To provide evidence and reference for the improvement of follow-up work. Methods According to the relevant management regulations, guidelines, and other relevant documents of national and international clinical research data,“Questionnaire for Research Data Management Assessment of Chinese Chronic Disease Prevention” was designed. The questionnaires were used in 10 clinical topics during the on-site inspection survey, and 20 valid questionnaires were retrieved and analyzed statistically. Results 50-60 percentage of subjects in data management and statistics were performed by the third party;70 percentage of subjects were performed by their own central monitoring;50 percentage of the subjects adopted a cooperative manner with others to develop appropriate data management systems;7 centers had system and plan for data management;Data management was carried out;implementation degree of training, database, CRF tracing, and others 7 aspects was low. Conclusion Improving the quality of data management of TCM clinical research still needs to be perfected from many aspects, and quality mode of large-scale clinical trials should be improved.
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Background Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being increasingly used in other countries for the treatment of cardiovascular diseases. Although many studies have demonstrated that certain Chinese herbal products are effective and safe for the treatment of cardiovascular diseases, most of these lack sufficient quality. Therefore, large randomized clinical trials and further scientific research to determine its safety, effectiveness are necessary.QiShen YiQi Dripping Pills (QSYQDP) is a herbal preparation clinically used in the treatment and prevention of coronary artery disease. Preliminary observations have shown its safety and effectiveness. Methods/Design This randomized, controlled trial will recruit 3600 patients with a history of myocardial infarction. Patients will be randomized into two groups by a Centr-Randomized System. One group receives QSYQDP, the other group receive aspirin. This trial protocol will describe eligibility criteria, detailed information on the treatment definition, blinding, endpoints, statistical methods, sample size determination, data management, legal aspects, and the current status of the trial. Discussion This trial is one of the first randomized, controlled clinical trial to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment and secondary prevention of coronary artery disease. The results of this study should help to define the role of TCM in modern medical care, as well as to provide the management strategy for CAD patients in China and other countries.