Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese medicine and Western medicine

Integrated traditional Chinese medicine(TCM)and Western medicine(WM)is a new medical science grounded in the knowledge bases of both TCM and WM,which then forms a unique modern medical system in China.Integrated TCM and WM has a long history in China,and has made important achievements in the process of clinical diagnosis and treatment.However,the methodological defects in currently published clinical practice guidelines(CPGs)limit its development.The organic integration of TCM and WM is a deeper integration of TCM and WM.To realize the progression of"integration"to"organic integration",a targeted and standardized guideline development methodology is needed.Therefore,the purpose of this study is to establish a standardized development procedure for clinical practice guidelines for the organic integration of TCM and WM to promote the systematic integration of TCM and WM research results into clinical practice guidelines in order to achieve optimal results as the whole is greater than the sum of the parts.

中药配方颗粒临床应用国际专家共识

中药配方颗粒以中医药理论为指导,结合现代制剂新技术,选定最佳工艺,经现代化的制药技术提取、浓缩、干燥、制粒,精制而成。中药配方颗粒稳定、安全、便捷、有效。中药配方颗粒产业链相较于中药饮片可以实现从田间到车间的全程化、过程化控制,在药材来源、饮片炮制、加工工艺、质量检测、产品的销售流通等环节实现标准化管理。中药配方颗粒可部分替代中成药。目前中药配方颗粒仅涵盖常用的800余种中药,因此对许多临床并不常用的中药品种,中药配方颗粒并不能取代饮片。临床研究与动物实验中大量使用配方颗粒,从而使得科研人员不再对中药饮片进行提取与质量控制。应尽快从提高生产工艺、建立质量标准、完善监管制度、拓展临床应用等方面解决困扰配方颗粒发展所面临的问题。

Extending the CONSORT Statement to moxibustion

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion （STRICTOM）, in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.

International expert consensus on clinical application of traditional Chinese medicine formula granules

Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.

Under the narrative medicine theory to establish the evidence-based medical record written by doctors and patients through integrated therapy of traditional Chinese and western on digestive system diseases

Objective:The aim of this article was to discuss the theory of doctor-patient co-operated evidence-based medical record and set up the preliminary frame of the doctor-patient co-operated evidence-based medical record following the concept of narrative evidence-based medicine.Methods:The information was searched from Pubmed,Embase,CBMdisc,CNKI.A preliminary agreement was reached by referring to the principles of narrative medicine and advises given by experts of digestive system and evidence-based medicine in both Traditional Chinese Medicine and Western Medicine.Result:This research is a useful attempt to discuss the establishment of doctor-patient co-operated evidence-based medical record guided by the direction of narrative evidence-based medicine.Reflection and outlook:Doctor-patient co-operated medical record can be a key factor of the curative effect evaluation methodology system of integrated therapy of Tradition Chinese Medicine and Western Medicine on spleen and stomach diseases.

The concept of narrative evidence-based medicine and shared decision-making in traditional Chinese medical practice

For the explosive development of emerging diagnostic and therapeutic technologies brought by the advancement of precision medicine strategy, shared decision-making could improve the quality of clinical decision-making and promote the transformation of clinical research evidence in TCM. Paying attention to patients＇ narrative needs and strengthening medical humanistic concerns could improve clinical outcome and patient satisfaction. We described the origins and development of evidence-based medicine, narrative medicine and shared decision-making, and analyzed the existing problems in TCM clinical decision-making. Further, we put forward the model of shared decision-making between clinicians and patients under the guidance of narrative evidence-based medicine concepts and methods.

Patient decision aids for cardiovascular disease： the status-quo and prospects

This article introduced the development and application of patient decision aid （PtDA） for cardiovascular disease. There are many risk factors for cardiovascular disease, and the mortality rate is high. Therefore, continuous management in symptoms, risk factors and lifestyle behaviors is needed for a good prognosis. PtDA can improve the patient＇s understanding of cardiovascular disease and the potential risk of perception of cardiovascular disease, as well as improve the communication between doctors and patients. The emergence of narrative evidence-based medicine provided a new opportunity for the further development of PtDA. At present, there were demands for domestic cardiovascular decision aids, but the researches were extremely limited.

Clinical practice guidelines for traditional Chinese medicine and integrated traditional Chinese and western medicine:a cross-sectional study of data analysis from 2010 to 2020

Objective With the increasing publication of clinical practice guidelines(CPG)for Traditional Chinese Medicine(TCM)and Integrated Traditional Chinese and Western Medicine(IM),the standardization and scientifiction of its formulation have gradually attracted many people’s attention.To offer an overview of TCM and IM CPGs published over the past decade and analyze their general characteristics and methodological quality.Methods The China National Knowledge Infrastructure(CNKI)and WANFANG databases were searched for clinical practice guidelines and expert consensus papers from January 2010 to June 2021.Two researchers independently completed the literature screening and cross-checking according to the inclusion and exclusion criteria of CPGs and extracted information on general characteristics and methodological quality of CPGs.Results According to the selection criteria,231 CPGs(EB-CPGs=119,CBCPGs=112)were selected and the number of CPGs published in the 11 years showed an overall upward trend.The vast majority of CPGs used the Western naming system for the diseases,and only 11 CPGs were named of TCM diseases or symptoms.TCM treatments were recommended in 223 CPGs.There were 156 ancient Chinese Medicine literature sources cited in 231 CPGs and opinions and experiences of 62 TCM experts cited in 37 CPGs.The methodological quality of EB-CPGs for TCM and IM were significantly better than CB-CPGs in 11 items.Only 60 EB-CPGs and 7 CB-CPGs designated clear criteria for grading quality of evidence and strength of the recommendations and 74 CPGs presented both the level of evidence and the strength of recommendations.We classified all CPGs according to whether or not they used GRADE,and the results showed that the CPGs using GRADE had higher methodological quality and more standardized reports.Conclusion This research has shown that the quantity and quality of CPGs in both TCM and IM have improved over the time span,but the methodological quality,especially evidence citation,and the use of criteria for grading quality of evidence and strength of the recommendations,still needs to further improvement in the future.

Evidence-based optimization of integrated traditional Chinese and Western medicine therapies for prevention and treatment of coronary heart disease： design and implementation

As a chronic disease that seriously endangers public health, the number of coronary heart disease （CHD） patients in China has increased in recent years. There is great potentiality to integrate traditional Chinese and Western medicine therapies to prevent and treat CHD in clinical practice. However, most of the current integrated therapies still lack sufficient high-quality evidence, and the key links in how to apply are unclear. It is urgent to optimize them through evidence-based research to further improve the effectiveness. Therefore, we propose strategies to conduct evidence-based optimization of integrated traditional Chinese and Western medicine therapies in prevention and treatment of progressive cardiovascular diseases. These are integrated clinical trial design, attention to the key links of taking effect, combination of clinical and basic research. Based on the strategies, we started the national key research and development project ＂Evidence-based optimization research of TCM therapies in prevention and treatment of CHD （angina pectoris - myocardial infarction - heart failure）＂, which is expected to be a new paradigm in the field.

Prevention and treatment of traditional Chinese medicine against angiogenesis related cardiovascular diseases based on translational medicine

As a major medical and scientific problem perplexing mankind,cardiovascular disease seriously endangers human health and life safety,which is still the primary cause of death.Traditional Chinese medicine(TCM)plays an irreplaceable role in the prevention and treatment of cardiovascular diseases and has its own characteristics and definite advantages.However,the unclear mechanism hinders its further promotion,which is not conducive to the prevention and treatment of cardiovascular diseases.Translational medicine advocates interdisciplinary integration and cooperation between academic groups,to establish effective interaction between basic research and clinical application,lead more medical research to focus on the prevention and treatment of clinical diseases,as well as to accelerate the transformation from“discovery”to“realization”,and finally to benefit patients,that is,“from clinic and serve clinic”.This provides a reference mode for the development and research direction of TCM,which comes from clinical practice originally.Based on this,considering the important role of angiogenesis in the occurrence and prognosis of cardiovascular diseases,under the guidance of the concept of translational medicine,this manuscript sorts out the overview of TCM treatment on angiogenesis related cardiovascular diseases from four aspects:theoretical basis,pathogenesis and pathology,applied prescriptions and material basis,in order to summarize the translational medicine experience of TCM prevention and treatment from clinical practice to modern research,to provide a basis for basic research and clinical diagnosis and treatment of related diseases.

融入辨治逻辑点的中医辅助诊疗平台医师信任度预调查分析

中医智能化辅助诊疗技术研究取得了良好发展,而相应的转化应用情况却不容乐观,医师对辅助诊疗技术的信任度不足是其重要原因之一。为了增进临床医师对辅助诊疗系统基本原理的理解,提升其信任度进而应用相关辅助诊疗工具。同时,作为完善中医临床辅助诊疗平台搭建的一项工作,课题组在构建平台模式时融入了经调研所得的辨证论治思维逻辑点,拟验证其临床应用。本研究中,对使用过课题组自主研发的中医辅助诊疗平台的青年医师进行预调查,了解以访谈形式交流中医思维逻辑点的可行性,初步获知中医辨治逻辑点的融入对医师信任度的影响,以期助力中医临床辅助诊疗技术的应用。

Multidisciplinary integration to enhance the overall level of Chinese and Westernmedicine consensus efficacy

In recent years,Chinese and Western medicine clinical guidelines have attracted attention.But for the existing Chinese and Western medicine experts consensus or guidelines,Chinese medicine and Western medicine were split,out of touch from the form and content.How to lay equal stress on traditional Chinese medicine and Western medicine?How to form the organic unity of Chinese medicine and Western medicine in the clinical practice?they need to reach a consensus.This article explains how to improve the efficacy of Chinese and Western medicine from different aspects.

How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern.The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine.In this paper,we propose a reappraisal protocol called“precise proprietary Chinese medicine”to precisely i)define the therapeutic aim;ii)design the protocol;iii)control the quality of proprietary Chinese medicine;iv)implement the protocol in the trial;v)study the mechanism-of-action of the proprietary Chinese medicine and vi)describe the indications of the proprietary Chinese medicine.We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

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

With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often scattered in various retrieval systems, which brings some difficulties to the reference and use of this information. Therefore, we collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD）, in order to promote the localization of high-quality researches and improve the ability of TCM clinical research in China. After analyzing the major existing problems of TCM clinical research protocols, this essay describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD） and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.

Traditional Chinese Medicine in the New Era——New Year Message 2019

The past year of 2018 is destined to be extraordinary for traditional Chinese medicine(TCM)over her profound history of forming and development.It witnessed for the first time the World Heath Organization’s(WHO)move to include traditional medicine(TCM inclusive)in the list of the International Classification of Diseases(ICD-11),which is a really positive step recognizing traditional Chinese medicine.Similarly exciting is in the 2019 first issue,the National Geographic Magazine commented on how ancient remedies are changing modern medicine,and acknowledged China as one of the Nations possessing the oldest continuous accumulations of documented medical observations,which offers the biggest trove for scientists to sift through.

Go with the flow, emerge as the times require and propel the modernization of traditional Chinese medicine to a new era

As the new year begins, let us alsostart anew. After a long time ofpreparation, TMR Modern HerbalMedicine, an English internationalacademic journal specializing in theresearch of modernization of herbalmedicine （HM）, has been finallyestablished. Here, on the behalf ofTMR Modern Herbal Medicine team,I would like to acknowledge all the members of the Traditional Medicine Research （TMR）editorial board for their great support and help. Wewarmly welcome our readers and contributors to continueto pay attention to TMR Modern Herbal Medicine.

Bibliometrics and social network analysis of clinical researches on acupuncture and moxibustion

Objective:In order to explore the development trend and research hotspots of clinical researches of acupuncture and moxibustion and provide some insight into the key research direction for researchers.Methods:The clinical studies of acupuncture and moxibustion were searched in PubMed.Using the method of bibliometry,the year,country,journals,authors were analyzed.The cluster analysis was used to analyze subject terms by the social network analysis.Results:A total of 4237 literature were retrieved,published in 617 journals.The number of clinical studies on acupuncture and moxibustion has been increased substantially since 2006.The clinical researches on acupuncture and moxibustion have been conducted worldwide,specifically in China,the United States,Britain,Sweden,etc.Three major author cooperation networks(China,South Korea and European and North American countries)has been formed.The cluster analysis based on 53 high-frequency theme words indicates that the clinical researches on acupuncture and moxibustion are mainly concerned about acupoint selection associated with pain,stroke,knee osteoarthritis and other diseases in different age groups,blind,treatment outcomes,time factor of acupuncture,etc.Conclusion:Clinical researches on acupuncture and moxibustion have been widely concerned by international medicine.The research direction is clear,Thematic is concentrate,and research paradigm has been formed.However,international influence is still limited academically.The cooperation between different authors or teams is insufficient.The core research hotspots include the selection of acupoint,acupuncture and moxibustion tools,research design,treatment outcome,blind,time factor,follow-up,placebo,clinical protocol,quality of life,patient satisfaction and so on.

Blood stasis syndrome:clinical multi-omics research and related problems

Multi-omics is a biological analysis approach in which the data sets are multiple"omics",such as genomics,transcriptomics,proteomics,metabolomics.Multiomics can be used in the detection,diagnosis,treatment,and prognosis of diseases as a kind of potential biomarker.Blood stasis syndrome(BSS)is a common syndrome in traditional Chinese medicine(TCM).Multi-omics can reflect the change of BSS as a whole.Thus,the purpose of this manuscript was to fully review the clinical multi-omics research and related problems of BSS.We found that the multi-omics of BSS reflected many pathophysiological processes through regulating vascular endothelial cells,vasodilation and contraction,oxidative stress,thrombosis,angiogenesis,platelet aggregation,lipid metabolism,inflammatory response,immune and coagulation function,energy balance,amino acid metabolism,and so forth.Many potential biomarkers of BSS were found in multi-omics and some promoting blood circulation Chinese medicines(PBCCMs)could well regulate the abnormal biomarkers and make them return to the normal level.

Perspectives in application of biosensors for the modernization of traditional Chinese medicine

Biosensor is an instrument which is sensitive to biological material and converts its concentration into electrical signals.Organisms such as enzymes, antibodies, tissues, cells and so on can selectively identify specific substances. Thesemolecular recognition functions can be combined with the target, such as the binding of antibodies and antigens, and thebinding of enzymes to the substrate through the recognition process. Biosensor has the advantages of high specificity,high sensitivity, fast reaction speed, low cost and easy operation. It has wide application prospect in food, pharmacy,chemical industry, clinical examination, biomedicine, environmental monitoring and so on, especially as a newtechnology means, in the field of modern herbal medicine research influence. Studies have demonstrated that thebiosensing technology has been applied to, traditional Chinese medicine （TCM） targets, isolation and purification ofTCM, the mechanism of TCM, quality control of TCM, the active ingredients detection of TCM and other basicresearches. Biosensor technology has made an important contribution to the research of modern herbal medicine, and hasbecome a Hot-spot in future research.

Thinking and practice on clinical safety evaluation of combination of traditional Chinese medicine and western medicine

China is gradually establishing a multidisciplinary diagnosis and treatment system of traditional Chinese medicine(TCM)and western medicine.TCM-drug combination is prone to adverse reactions.Clinical feature is the appearance of adverse reactions,and target is the internal mechanism.The establishment of feature and target correlation model will contribute to the development of this field.This paper introduces the four steps of feature-target correlation method that risk identification,feature extraction,sign target correlation and experimental research.Xiyanping-Ribavirin combination is as an example to illustrate this method.It is expected that the method will be popularized and applied to protect clinical safety.