Traditional Chinese Medicine Clinical Research Research Articles

Out-of-set association analysis of lung cancer drugs and symptoms based on clinical case data mining.

There are 1.8 million lung cancer deaths worldwide, accounting for 18% of global cancer deaths, including 710,000 in China, accounting for 23.8% of all cancer deaths in China. To explore the out-of-set association rules of lung cancer symptoms and drugs through text mining of traditional Chinese medicine (TCM) treatment of lung cancer, and form medical case analysis to analyze the experience of TCM syndrome differentiation in its treatment. The medical records of all patients diagnosed with lung cancer in Nanjing Chest Hospital from January to December 2018 were collected, and the out-of-set association analysis was performed using the MedCase v5.2 TCM clinical scientific research auxiliary platform based on the frequent pattern growth enhanced association analysis algorithm. In terms of TCM treatment of lung cancer, the clinical symptoms with high correlation included cough, expectoration, chest distress, and white phlegm; and the drugs with high correlation included Pinellia ternata, licorice root, white Atractylodes rhizome, and Radix Ophiopogonis; with the prescriptions based on Erchen and Maimendong decoctions. This analytical study of the medical cases of TCM treatment for lung cancer was performed using data mining techniques, and the out-of-set association rules between clinical symptoms and drugs were analyzed, including the understanding of lung cancer in TCM. Moreover, the essence of experience in drug use was gathered, providing significant scientific guidance for the clinical treatment of lung cancer.

Exploration and consideration on establishing a core outcome set of Traditional Chinese Medicine clinical trials in distal radius fracture

There are inconsistencies in treatment outcomes, measurement instruments, and criteria for assessing clinical effectiveness in studies related to distal radius fractures (DRF), resulting in potential biases and failing to provide high-quality clinical evidence. To address these challenges, international researchers have reached a consensus on developing the core outcome indicator set for distal radius fractures(COS-DRF). However, it's important to note that the existing COS-DRF framework could not reflect the unique characteristics of Traditional Chinese Medicine (TCM) treatment. Currently, there are no established standards for treatment outcomes and measurement instruments specific to TCM clinical research, nor has a COS-DRF been established for TCM clinical studies in China. In light of these gaps, our research team aims to construct a core set of treatment outcomes for TCM clinical research on distal radius fractures. This involves compiling a comprehensive list of treatment outcomes and measurement instruments, initially derived from a thorough literature review and expert consensus, which will then undergo further refinement and updates based on real-world clinical experiences, incorporating feedback from 2 to 3 rounds of expert consensus or Delphi questionnaire surveys. Our goal is to establish a COS-DRF or CMS-DRF that aligns with the principles and practices of TCM, and provide high-quality evidence for clinical practice.

Analysis and prospects of common problems in clinical data mining of traditional Chinese medicine prescriptions

Mining data from traditional Chinese medicine(TCM) prescriptions is one of the important methods for inheriting the experience of famous doctors and developing new drugs. However, current research work has problems such as to be optimized research plans and non-standard statistics. The main problems and corresponding solutions summarized by the research mainly include four aspects.(1)The research plan design needs to consider the efficacy and quality of individual cases.(2)The significance of the difference in confidence order of association rules needs to be further considered, and the lift should not be ignored.(3)The clustering analysis steps are complex. The selection of clustering variables should comprehensively consider factors such as the frequency of TCM, network topology parameters, and practical application significance. The selection of distance calculation and clustering methods should be improved based on the characteristics of TCM clinical data. Jaccard distance and its improvement plan should be given attention in the future. A single, unexplained clustering result should not be presented, but the final clustering plan should be selected based on a comprehensive consideration of TCM clinical characteristics and objective evaluation indicators for clustering.(4)When calculating correlation coefficients, algorithms that are only suitable for continuous variables should not be applied to binary variables. This article explained the connotations of the above problems based on the characteristics of TCM clinical research and statistical principles and proposed corresponding suggestions to provide important references for future data mining research work.

A Protocol for Digitalized Collection of Traditional Chinese Medicine(TCM) Pulse Information Using Bionic Pulse Diagnosis Equipment.

Pulse diagnosis equipment used in Traditional Chinese Medicine (TCM) has long been developed for collecting pulse information and in TCM research. However, it is still difficult to implement pulse taking automaticallyorefficiently in clinical practice. Here, we present a digital protocol for TCM pulse information collection based on bionic pulse diagnosis equipment, which ensures high efficiency, reliability and data integrity of pulse diagnosis information. A four-degree-of-freedom pulse taking platform together with a wrist bracket can satisfy the spatial positioning and angle requirements for individually adaptive pulse acquisition. Three-dimensional reconstruction of a wrist surface and an image localization model are combined to provide coordinates of the acquisition position and detection direction automatically. Three series elastic joints can not only simulate the TCM pulse taking method that "Three fingers in a straight line, the middle finger determining the 'Guan' location and finger pulp pressing on the radial artery," but also simultaneously carry out the force-controlled multi-gradient pressing process. In terms of pulse information integrity, this proposed protocol can generate rich pulse information, including basic individual information, pulse localization distribution, multi-gradient dynamic pulse force time series, and objective pulse parameters, which can help establish the fundamental data sets that are required as the pulse phenotype for subsequent comprehensive analysis of pulse diagnosis. The implementation of this scheme is beneficial to promote the standardization of the digitalized collection of pulse information, the effectiveness of detecting abnormal health status, and the promotion of the fundamental and clinical research of TCM, such as TCM pulse phenomics.

World Health Organization survey on the level of integration of traditional Chinese medicine in Chinese health system rehabilitation services

BackgroundTo meet the growing global demand for rehabilitation services, the World Health Organization (WHO) launched Rehabilitation 2030. This study was commissioned by the WHO to investigate the integration degree of traditional Chinese medicine (TCM) in Chinese health system rehabilitation services and the demand for TCM rehabilitation in China. MethodsTwenty TCM rehabilitation experts and relevant government administrators were invited to complete the questionnaire between September 2019 and January 2022. The development of traditional, complementary, and integrative medicine (TCI) rehabilitation in China was assessed primarily based on six different health system components. Results26 policies, regulations, and national strategic plans related to TCI rehabilitation were issued by relevant government departments since 2002; notably, 14 policies related to TCI rehabilitation development were intensively introduced from 2016 to 2021. These policies cover the three main areas of financing, infrastructure development, and service delivery. The National Administration of Traditional Chinese Medicine's investment in TCM clinical capacity infrastructure and scientific research in 2019–2021 increased by 66% compared to 2010–2012, and the average number of TCM hospitals with rehabilitation departments in 2020 increased by 6.5% compared to 2018. The proportion of community health service centers providing TCM services in primary medical and health institutions has increased by 30.8% over the past 10 years. ConclusionLong-term continuous policies, substantial financial investment, and expansion of the scope of TCI rehabilitation services in primary care institutions have effectively contributed to the rapid development of TCI rehabilitation. However, human resources and financing mechanisms for TCI rehabilitation need further improvement.

Application and significance of mixed methods research in traditional Chinese medicine and narrative medicine

Since narrative medicine was introduced in China, it has been widely used in medical education and clinical practice. The research on narrative medicine in China is especially characterized by its combination with traditional Chinese medicine(TCM). At present, the research on narrative medicine in China is still in the stage of small-scale practicing and theory advocating. Besides, there is also a lack of guidance on experimental design methodology for clinical application, which leads to few high-quality studies in this field. The present study reviewed the current high-quality research on narrative medicine to discuss the value and prospects of mixed methods research in narrative medicine. In addition, the common design, application procedures, and notes of mixed methods research were explained to provide references for the extensive applications of narrative medicine in the medical field, especially TCM clinical practice, education, and scientific research.

The Challenges of Ethical Review in Clinical Research of Traditional Chinese Medicine.

The ethical review of TCM (traditional Chinese medicine) clinical research in China is highly consistent with that of Western medicine, but it lacks the characteristics and culture of TCM. Compared with modern medicine, TCM has its own characteristics, such as the theory of Yin-Yang and the five elements, the treatment of syndrome differentiation, and the compatibility of prescriptions. These characteristics determine the ethical particularity of TCM clinical research. This article discusses the challenges in the ethical review of TCM clinical research, such as scientific design, efficacy evaluation, risk assessment, informed consent, and placebo use. We propose opportunities and difficulties in the ethical review of TCM clinical research and provide some relevant suggestions.

Evidence of clinical randomized controlled trial study in treatment of acute cerebral infarction with traditional Chinese medicine in recent five years

To systematically search and sort out the clinical randomized controlled trial(RCT) on the prevention and treatment of acute cerebral infarction with traditional Chinese medicine(TCM) by using the method of evidence map, and to understand the evidence distribution of related studies. CNKI, Wanfang, VIP, CBM, PubMed, EMbase, Cochrane Library and Web of Science were retrieved from January 2016 to September 2020, and literatures related to the prevention and treatment of acute cerebral infarction with traditional Chinese medicine were included. Text description combined with table and bubble chart were used to analyze the distribution characteristics of evidence. A total of 1 102 clinical articles in recent five years were retrieved. The annual trend of clinical study publication, study size, TCM therapy category and main scheme, and study literature quality were analyzed. We find that TCM treatment of acute cerebral infarction has become a hot topic of clinical research, the number of literature showed a trend of increased year by year, various means of intervention of TCM in the treatment of the advantages of increasingly highlight. Follow-up clinical research should highlight the characteristics of TCM: in the analysis of outcome indicators; increase the neuropsychological patients after stroke and cognitive ability, and the theory of combined treatment of TCM disease when thoughts; At the same time, the quality of clinical research needs to be improved. At present, there is still a lack of unified standards for the production of evidence map. This study is the first to explore the application of evidence map to summarize and display the clinical research status of TCM treatment of acute cerebral infarction, and combine it with the setting of priority areas of TCM clinical research, so as to provide a reference basis for determining the priority topic selection of TCM treatment optimization research.

International traditional Chinese medicine guideline for diagnostic and treatment principles of diabetes.

Diabetes mellitus (DM) was one of the most severe public health problems that affected nearly 463 million adults around the world. In addition to insulin and oral hypoglycemic agents, traditional Chinese medicine (TCM) was an effective alternative therapy for diabetes and its complications, and it had been widely used in the Pan-Pacific region, especially in Southeast Asia, however, TCM lacked specialized standards of care for DM in the past, which limited the TCM clinical efficacy of diabetes. Since March 2017, the Endocrinology Committee of World Federation of Chinese Medicine Societies (WFCMS) had invited experts in diabetes, TCM, and international standard setting to work with TCM endocrinologists from the Guideline Development Committee to review the TCM clinical research evidence related to the prevention and treatment of diabetes over the previous 14 years. Over an 8-months careful revision, the international TCM guideline was finally developed under the guidance of review experts, physicians and surveyed patients, to provide standardized diagnosis and treatment advice of diabetes for global TCM doctors. This guideline clarified the TCM classification, staging, and syndromes of diabetes, gave the instructions that how to identified different stages and syndromes clearly, and accordingly recommended different TCM therapies based on the level of evidence. It's worth noting that when the guideline was being made, fewer high-quality clinical research evidence could be found, and very few researches were so outdated that need to be updated. More high-quality research evidence would be included in the updated version of guideline to continuously improve the overall level of global TCM in preventing and treating diabetes, and long-term clinical researches were advocated.

Systematic Investigation on Multi-Scale Mechanisms of Astragaloside IV in Treating Diabetic Nephropathy

Diabetic nephropathy (DN), a common complication of diabetes mellitus, is the main cause of end-stage nephropathy, and thus developing novel strategies for reversing DN remains urgent. Astragaloside IV (AS-IV), a glycoside extracted from the Astragalus membranaceus (Fisch.) Bunge, is a widely used Traditional Chinese Medicine (TCM) in China and presents diverse pharmacological properties including the protective effect on DN. However, the rudimentary mechanism of AS-IV in remedying DN remains indeterminate. Currently, we systematically explore the pharmacological mechanism of action of AS-IV for treating DN. Firstly, AS-IV was evaluated by ADME assessment, and 26 targets were screened out through target prediction. Then, we decipher the protein-protein interaction (PPI), Gene Ontology (GO) enrichment analysis, disease and pathway network analysis to obtain the specific molecular biological process and pharmacological activity of AS-IV in the treatment of DN. Meanwhile, both in vivo and in vitro experiments confirmed that AS-IV has anti-oxidative stress, anti-inflammatory, anti-epithelial-mesenchymal transition (EMT) effects, and can inhibit the Wnt/β-catenin signaling pathway, ultimately ameliorating the renal injury caused by high glucose. Additionally, we also applied molecular docking and molecular dynamics simulation to predict the specific binding sites and binding capacity of AS-IV and related targets. Overall, the comprehensive system pharmacology method and experiment validations provide an accurate explanation for the molecular mechanism of AS-IV in the treatment of DN. Moreover, it is expected to provide a brand new strategy for exploring the effective components of TCM. Funding Statement: Financial support from the second batch of scientific research projects for the construction of the national TCM clinical research base (No. JDZX2015130), the National Science Foundation for Young Scientists of China (No.81904062), and the high-level introduction of talent special support plan (No. DT19200001). Declaration of Interests: The author(s) declared that this article content has no conflicts of interest. Ethics Approval Statement: All these experimental protocols were authorized by the Animal Experimentation Ethics Committee of the Anhui University of Chinese Medicine.

Necessities and feasibilities of the establishment of traditional Chinese medicine clinical research protocol database

Necessities and feasibilities of the establishment of traditional Chinese medicine clinical research protocol database

Traditional Chinese Medicine's Challenge to Clinical Science and Health Policy

Traditional Chinese medicine (TCM) has been improving human health for millennia. And for that, it has gradually gained the attention of the global scientific community. TCM clinical research progresses, but slowly. I see it as being held back by perverse incentive structures in science and regulatory politics.

Cluster analysis for syndromes of real-world coronary heart disease with angina pectoris.

Syndromes of coronary heart disease with angina pectoris were analyzed to provide guidance for clinical practice and to improve accuracy of traditional Chinese medicine (TCM) diagnoses and efficacy of TCM treatment. A total of 860 cases with coronary heart disease with angina pectoris were selected from TCM Clinical Research Information Sharing System for TCM clinics and research. Syndromes were automatically extracted with the cluster method and were analyzed to provide objective evidence for clinical studies. Final syndrome classifications were recognized and confirmed by clinical experts. Popular syndromes included Qi and blood deficiency, blood stasis and obstruction collaterals, liver depression and spleen deficiency, and Qi stagnation and blood stasis. Syndromes Qi and blood deficiency and blood stasis and obstruction collaterals accounted for 28.61% of total syndromes, whereas liver depression and spleen deficiency and Qi stagnation and blood stasis accounted for 26.44%. The main syndrome elements comprised Qi deficiency, blood deficiency, blood stasis, and Qi stagnation.

Experience inheritance from famous specialists based on real-world clinical research paradigm of traditional Chinese medicine.

The current modes of experience inheritance from famous specialists in traditional Chinese medicine (TCM) include master and disciple, literature review, clinical-epidemiology-based clinical research observation, and analysis and data mining via computer and database technologies. Each mode has its advantages and disadvantages. However, a scientific and instructive experience inheritance mode has not been developed. The advent of the big data era as well as the formation and practice accumulation of the TCM clinical research paradigm in the real world have provided new perspectives, techniques, and methods for inheriting experience from famous TCM specialists. Through continuous exploration and practice, the research group proposes the innovation research mode based on the real-world TCM clinical research paradigm, which involves the inheritance and innovation of the existing modes. This mode is formulated in line with its own development regularity of TCM and is expected to become the main mode of experience inheritance in the clinical field.

Theory and research of dryness in traditional Chinese medicine

Dryness is the inherent performance in traditional Chinese medicine. Dryness with a specific efficacy and side effect can be reduced suitably by processing and compatibility in the clinical application. Nowadays domestic scholars have developed research of dryness in traditional Chinese medicine. However, it remains problems such as evaluation index of dryness not clear. This paper takes medical literature mining technology to analyze the historical origin and features of dryness theory. Combing the modern literatures to explicate the dryness' research status and existing problems. Putting forward the traditional Chinese medicine and research should adopt multidisciplinary knowledge and study the system of comprehensive evaluation. Dryness is expected to further application in traditional Chinese medicine clinical research.

GW24-e2961 A summary and evaluation of the current evidence for traditional Chinese medicine for myocardial infarction

ObjectivesA comprehensive summary and evaluation of the current evidence profile of the role of traditional Chinese medicine (TCM) in myocardial infarction management was conducted to provide evidence-based recommendations for clinical...

N-of-1 trials in China

The N-of-1 trial design (randomized and blinded single-patient trials) has been popular abroad for 25 years or more. Many papers using the N-of-1 trials have been published in international medical journals. However, little is known about this methodology in China. Our purpose is to describe the current status of N-of-1 trials in China, to explain why they have not been more widely used, and to suggest a roadmap for the development of N-of-1 trials, especially for the study of Traditional Chinese Medicine (TCM). An electronic search was conducted using the Chinese Biological Medicine Database (CBM) and China National Knowledge Infrastructure (CNKI) with the keywords "N-of-1 trial, single case OR individual patient AND randomized". We also searched PubMed. The Chinese Science Citation Database (CSCD) as a citation was searched at last. 23 studies were retrieved from CBM and 34 from CNKI. There were 13 papers about N-of-1 trials in CBM and 17 in CNKI. Only 3 studies were rigorously designed (i.e., using randomization, control periods and blinding). The other 8 papers were descriptive and review articles, most of which were in TCM. One review was published in SCI-E and one in MEDLINE. Three papers were found in CSCD as citations. Only one of the retrieved studies was funded. While N-of-1 trials may offer a good tool to individualize clinical care and enrich TCM clinical research, they have not been widely used to date. To spur the development of this method, we would like to suggest three points. First, the Chinese government should endorse and sponsor N-of-1 studies. Second, researchers and physicians should be systematically trained in the method. Third, thorough considerations on trials allow better research and focus on the patients' needs.

Clinical research of traditional chinese medicine needs to develop its own system of core outcome sets.

Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards.

CDISC Standards and Clinical Research Data Standardization of Traditional Chinese Medicine

Abstract More and more attention has been paid to the standardization of clinical research data. International clinical data standards mainly include four categories, which are the File Format, Exchange Standard, Analysis Standard and Terminology Standard. Clinical Data Interchange Standards Consortium (CDISC) is the main criteria of exchanging standard and analyzing standard currently. Backwardness of quality and level of the data management have become one of the most important factors that affect the sustained, rapid and healthy development of domestic clinical trials. How to apply international standards of clinical data to narrow the gap of clinical research of Chinese medicine with the international advanced level is a topic which needs to be continuously explored. This paper firstly introduced the CDISC and its two standards, then analyzed the significance of data standardization in clinical research of traditional Chinese medicine (TCM), and finally discussed problems existed in the process of TCM clinical research using CDISC standards. It was suggested that the strengthening on research of relevant TCM semantic structure and its terminology standard is the key problem. The only way to solve this problem is to use the CDISC standards.

Application of Delphi method in traditional Chinese medicine clinical research

In recent years, Delphi method has been widely applied in traditional Chinese medicine (TCM) clinical research. This article analyzed the present application situation of Delphi method in TCM clinical research, and discussed some problems presented in the choice of evaluation method, classification of observation indexes and selection of survey items. On the basis of present application of Delphi method, the author analyzed the method on questionnaire making, selection of experts, evaluation of observation indexes and selection of survey items. Furthermore, the author summarized the steps of application of Delphi method in TCM clinical research.