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ObjectiveTo explore the current status and issues regarding the application of ancient books in clinical practice guidelines and expert consensus of traditional Chinese medicine （TCM） published in China， and to provide methodological recommendations for the incorporation of ancient books in the development of TCM guidelines. MethodsWe searched China National Knowledge Infrastructure （CNKI）， WanFang Data， VIP， SinoMed， PubMed， Embase， as well as six industry websites including China Association of Chinese Medicine， National Group Standards Information Platform， and Chinese Association of the Integration of Traditional and Western Medicine，etc. TCM clinical practice guidelines or expert consensus issued during January 1st， 2017， to November 26th， 2022 were searched. Clinical practice guidelines or expert consensus that explicitly referred to ancient books were included， and the content regarding the searching for ancient books， sources of access to ancient books， methods of evaluating the level of evidence， methods of evaluating the level of recommendation， and methods of evaluating the evidence for the ancient books were analysed. ResultsA total of 1,215 TCM clinical practice guidelines or expert consensus were retrieved， with 442 articles explicitly mentioning the application of ancient books， including 300 （67.87%） clinical practice guidelines and 142 （32.13%） expert consensus. Sixty of the 442 publications explicitly reported that ancient books searching had been conducted （13.57%）； among these 60 publications 27 （45.00%） explicitly reported ancient books searching strategies， and the most frequent method was manual searching with a total of 24 articles （40.00%）. The most popular search source was Chinese Medical Dictionary， a TCM classics database， with a total of 18 articles. 197 articles （44.57%） explicitly reported the evaluation criteria for the level of evidence， of which 141 articles （71.57%） involved the evaluation criteria for the ancient books； 413 articles （93.44%） mentioned ancient books in the recommendations， and only the source of formula name was mentioned in 409 （99.03%） of the publications. ConclusionThe current application of ancient books in TCM clinical practice guidelines and expert consensus is limited， with issues of non-standard searching and evaluation methods. Standar-dization and uniformity are needed in evidence grading and recommendation standards. Future research should clarify the scope and methods of applying ancient book， emphasize their integration with modern research evidence， and enhance their value and quality in the development of TCM clinical practice guidelines.
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ObjectiveTo explore the research status and trends of cohort studies on traditional Chinese medicine （TCM） efficacy evaluation from 2017 to 2022 and provide ideas and references for research in this field. MethodsSix databases including Pubmed， Web of Science， Embase， Scopus， Cochrane Library and CNKI were searched from January 1st， 2017 to December 31st， 2022. The total number of annual publications， journals， highly cited literatures， and keywords were quantitatively and visually analyzed by Bibliometrix. ResultsA total of 328 articles were included， which were published in 141 journals. The number of articles published in this field showed an overall upward trend， and retrospective cohort studies （282 papers， 85.98%） accounted for the largest proportion. A total of 151 cohort studies （46.04%） were conducted based on the database and showed an overall upward trend. The subjects were mainly patients with tumors （77 papers， 23.48%）， and cardiovascular and cerebrovascular diseases （64 papers， 19.51%）. The top 3 highly cited literatures mainly explore the association between TCM and survival outcome and quality of life in patients with malignant tumors. Fourteen and twenty-five high-frequency keywords were included in Chinese and English literature respectively， which formed 3 clusters such as research methods， statistical analysis and diseases. ConclusionIt was the current status to focus on retrospective cohort studies and focus on patients with tumors or cardiovascular and cerebrovascular diseases. Using observational database to conduct cohort studies of TCM efficacy evaluation could be the future research direction.
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Currently， there are many difficulties in formulating recommendations of traditional Chinese medicine （TCM） clinical practice guidelines. This paper analyzed and summarized the unique or prominent difficult issues in the formulation of recommendations faced by TCM guidelines， such as experts' professional background and experience bringing about the preferance from the academic emotion， inconsistency between different academic schools making it difficult to reach consensus， lack of guiding principles of the decision weight of different dimensions for recommendations. Therefore， methodological suggestions have been put forward， including organizing parallel TCM and western medicine consensus group， improving the method of combining TCM and western medicine paradigm， attaching great importance to the evidence-based governance of academic schools， and promoting the research on different dimensions for recommendation formulation， which may provide a methodological reference for the guideline development.
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Objective To evaluate the effectiveness and safety of moxibustion for knee osteoarthritis and the methodological quality of systematic reviews(SRs).Methods SRs of moxibustion for knee osteoarthritis were retrieved from CNKI,VIP,Wanfang Data,SinoMed,PubMed,Cochrane Library,Embase and Web of Science was conducted from the establishment of the databases to February 10,2022.AMSTAR 2 was used to assess the methodological quality of SRs.The randomized controlled trials(RCTs)included in these SRs were screened and summarized according to inclusion standard.RevMan 5.4 software was used for Meta-analysis,and GRADE approach was used to assess the certainty of evidence.Results A total of 15 SRs were included.The evaluation results of the AMSTAR 2 showed that the methodological quality was very low for 14 SRs,and low for other 1 SR.A total of 36 RCTs were included.Meta-analysis results showed that compared with the non-steroidal anti-inflammatory drugs(NSAIDs),the moxibustion group had better effects on improvement of WOMAC scores[mean difference(MD)=-5.95;95%confidence interval(CI):-9.25 to-2.65;low quality],relieving pain[MD=-1.26;95%CI:-2.19 to-0.32;very low quality],and improving effective rate[risk ratio(RR)=1.16;95%CI:1.11 to 1.22;low quality].In the moxibustion group,some patients experienced blisters,and most healed in 3 days.Conclusion Moxibustion has advantages in pain reduction and improving effective rate compared with routine Western therapy for knee osteoarthritis.However,well-designed high-quality RCTs are needed for further verification.
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OBJECTIVE To analyze the research status， hotspots， and trend of the clinical comprehensive evaluation of Chinese patent medicine in China. METHODS Based on CNKI， VIP and Wanfang database， clinical comprehensive evaluation of Chinese patent medicine was used as the subject of retrieval， and the retrieval time was from the inception to October 30th， 2022. CiteSpace 6.1.R3 and VOSviewer were used to conduct a visualization analysis of the relative literature of clinical comprehensive evaluation of Chinese patent medicine in terms of annual publication quantity， authors， institutions， keywords， etc. RESULTS & CONCLUSIONS A total of 1 460 pieces of literature related to the clinical comprehensive evaluation of Chinese patent medicine were included. The overall annual publication quantity showed a growth trend. There were 714 authors in the included literature. The institutions with a large publication quantity included the Chinese Academy of Traditional Chinese Medicine， Beijing University of Chinese Medicine， Tianjin University of Traditional Chinese Medicine， etc.， and there was little cooperation among the authors and institutions. High-frequency keywords included Chinese patent medicine， safety， adverse drug reactions， rational drug use， etc. Research hotspots focused on the safety and effectiveness evaluation of Chinese patent medicine. It may be a research trend in this field to strengthen the prescription review of Chinese patent medicine， and build a multi-dimensional and multi-criteriaclinical comprehensive evaluation system for the rational use of Chinese patent medicine.
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Syndrome differentiation and treatment is a unique mode of diagnosis in traditional Chinese medicine （TCM）. The establishment of scientific and standardized syndrome diagnosis standards is an important link to evaluate the clinical efficacy of TCM objectively and systematically， and also a prerequisite for the promotion and development of TCM to obtain international recognition. This article reviewed the basic modes and existed problems of the current syndrome diagnosis criteria， and proposed to construct a multidimensional core information set integrating the minimized core symptoms， the artificial intelligence signs， the multi-modal laboratory indicators， and multi-omics specific markers， so as to present syndrome characteristics from multiple perspectives systematically. This paper also described the basic mode， constructure， as well as the process and methodology to be adopted in the establishment of the standardized diagnostic research method. The core information set of diagnostic symptoms not only took into account the specificity of the disease， but also improved the inconsistency due to the complexity and subjectivity of the syndrome differentiation， thereby providing a methodological basis for the standardization of TCM syndrome differentiation in clinical research.
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In recent years， the incidence of colorectal cancer has been rising in China， and with the promotion of early screening and early diagnosis， most colorectal cancers are able to achieve long-term survival through timely diagnosis and treatment. Nevertheless， 30%-70% of patients with early to mid-stage colorectal cancer after radical surgery still have psychological problems such as anxiety， depression， and fear of recurrence and metastasis， and they hope to seek help from traditional Chinese medicine（TCM） treatment. In order to further standardize the integrated traditional Chinese and western medicine psychological rehabilitation interventions of stage Ⅰ-Ⅲ colorectal cancer after radical surgery， and to improve the diagnosis and treatment level， under the support of the pilot project of clinical collaboration between Chinese and western medicine for major and difficult diseases of National Administration of TCM， experts in oncology， integrated Chinese and western medicine， psychology， surgery， nursing， evidence-based medicine and other disciplines from 10 units nationwide participated in the work， led by Xiyuan Hospital，China Academy of Chinese Medical Sciences and Beijing Cancer Hospital. Based on the methodology and process of guideline development of the World Health Organization Handbook for Guideline Development and the Regulations for Group Standards of China Association of Chinese Medicine， the Guidelines for Psychological Rehabilitation Intervention Combined Integrated Traditional Chinese and Western Medicine After Radical Surgery for Early and Middle Stage Colorectal Cancer have been developed according to the current best evidence， extensive consultation with clinical experts and following the situation of current clinical practice. The guideline provides the psychological characteristics， the needs and willingness to accept psychological rehabilitation， the interventions for psychological rehabilitation， evaluation of efficacy， follow-up review， educational guidance and others of patients with stage Ⅰ-Ⅲ colorectal cancer after radical surgery. It can provide guidance for TCM（integrated Chinese and western medicine） clinicians and psychologists engaged in the psychological rehabilitation of integrated Chinese and western medicine oncology， especially for doctors in primary medical institutions.
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Colorectal cancer is one of the most common malignant tumors of digestive tract. In 2020， 1.93 million new cases of colorectal cancer were diagnosed globally， ranking third in the global incidence spectrum， and 930 000 new deaths were reported， ranking second in the global cause of death spectrum. Meanwhile， the medical cost of metastatic colorectal cancer is the highest among all stages. A large number of studies have demonstrated that traditional Chinese medicine（TCM） treatment can bring clinical benefits to patients with metastatic colorectal cancer with unique efficacy. In order to further standardize the TCM diagnosis and treatment for metastatic colorectal cancer and improve the level of TCM diagnosis and treatment， Xiyuan Hospital， China Academy of Chinese Medical Sciences， together with other relevant units in China， according to the guideline development process of the World Health Organization Handbook for Guideline Development and the relevant requirements of the Clinical Evidence Grading Criteria on TCM Based on Evidence Body， the Regulations for Group Standards of China Association of Chinese Medicine and others， combined with the characteristics of TCM diagnosis and treatment and the actual situation in China， the Guidelines for TCM Diagnosis and Treatment of Metastatic Colorectal Cancer was developed in accordance with the Catalogue of TCM Diagnosis and Treatment Plans for 105 Diseases in 24 Specialties issued by Department of Medical Administration of National Administration of TCM.
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OBJECTIVE To explore the research sta tus，hotspots and frontier trends in the field of domestic evidence-based traditional Chinese medicine ，and to provide reference for the development of this field. METHODS Retrieved from CJFD ，VIP and Wanfang database ，CiteSpace software and bibliometrics method were used to statistically analyze the annual quantity of documents published ，authors，institutions，and keywords ，etc. RESULTS A total of 3 154 papers were included in this study ，and the annual number of papers presented an overall upward trend. The author with the highest number of papers was Liu Jianping ， who published 106 papers and was closely connected with other authors. China Academy of Chinese Medical Sciences ，Beijing University of Chinese Medicine and Tianjin University of Chinese Medicine were highly productive institutions ，with more than 100 articles published each and a relatively wide range of cooperation. Evidence-based medicine ，Traditional Chinese Medicine ， evaluation，evidence-based nursing ，review，medical education ，clinical research and other high-frequency keywords （frequency of more than 100 times each ）formed hot topics of research. CONCLUSIONS The research of evidence-based traditional Chinese medicine in China has been paid more and more attention ；“evidence-based medicine ”“traditional Chinese medicine ” “evidence-based nursing ”and“clinical research ”are the research hotspots.
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OBJE CTIVE To provide reference for the adjustment and optimization of the policies related to traditional Chinese medicine（TCM）injection in China. METHODS The policies related to TCM injections issued at the national level were collected from Jan. 1，1990 to May 31，2021. Based on the perspective of policy tool ，the content analysis and quantitative analysis were used to classify ，code and analyze the policy terms according to “policy serial number-chapter number-specific terms ”. RESULTS & CONCLUSIONS Totally 30 policy documents related to TCM injection were included ， with a total of 389 codes. Environment-based policy tools were the most widely used （79.95％），followed by supply-oriented policy tools ，accounting for 15.42％. Demand-based policy tools accounted for the least proportion （4.63％）. Among environment-based policy tools ，the regulatory and control policy tools （38.05％） received more attention，and the policy publicity （2.06％） received fewer applications. Among supply-oriented policy tools ，there were more applications of science and technology support （10.80％）， and fewer applications of capital investment （0.26％）. Among demand- based policy tools ，organizational coordination was the most widely used （3.34％），followed by experience demonstration （1.29％），which had not yet involved the relevant policies of international exchange. In order to promote the development of TCM injection ，it is necessary to appropriately reduce the application of environment-based policy tools ，increase the application of policies such as policy publicity ，and improve the external environment for TCM injection ；optimize the internal combination of supply-oriented policy tools ，increase the use of capital investment tools ，and effectively play the role of policy boosting；emphasize the application of demand-based policy XJY21013） tools to form an effective policy pulling force for the healthy development of TCM injection.
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OBJECTIVE To provide refere nce for the optimization and adjustment of the relevant policies in the field of pediatric drug in China. METHODS“Children”“pediatrics”and“drugs”were taken as the keywords to search the official websites of the State Council ，the National Health Commission ，the National Healthcare Security Administration ，the State Administration of Market Regulation and other relevant ministries and commissions ，and collect the relevant pediatric drug policies issued at the national level from January 1，2010 to December 31，2021. Content analysis method was used to summarize ，code and statistically analyze the policy tools used in the policy research documents. RESULTS A total of 39 policy documents and 327 policy tools were included in this study. According to statistics ，from 2011 to 2021，China issued national policy documents on pediatric drug use every year ，and in recent years ，the issuance of documents was relatively intensive. The main body of issuing pediatric drugs policy was the national health department and drug supervision and administration department （71.79％，28/39），and the number of documents issued by relevant ministries and commissions alone （76.92％，30/39）was significantly more than the number of documents jointly issued by multiple ministries and commissions （23.08％，9/39）. The environmental policy tools were the most widely used （64.83％，212/327），followed by s upply-oriented policy tools （30.28％，99/327），and demand-oriented policy tools were the least used （4.89％，16/327）. CONCLUSIONS The development of pediatric drug use in China is in its infancy. It is suggested that China should optimize supply-oriented policy tools，increase capital investment and the use of public health service tools ；adjust environmental policy tools ，accelerate the legislation of pediatric drugs ，and increase the proportion of incentive policy tool ；attach importance to demand-oriented policy tools ，strengthen international exchanges and the application of service outsourcing in the field of pediatric medication ；plan the use of various policy tools as a whole ，and coordinate the use proportion of three types of policy tool and their sub policy tools，so as to enhance the initiative of policy tools ，form policy synergy ，and jointly promote the development of pediatric drug use.
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This study was aimed to investigate the mechanism underlying the neuropsychiatric comorbidity in the process of "stress"-"inflammation"-"comorbidity",from the perspective of traditional Chinese medicine (TCM) basic theory in combination with our previous 20-year findings.Notably,the neural-psychiatric comorbidity between psychiatric disorders,including depression,schizophrenia and anxiety,and systemic diseases,such as ischemic stroke,Alzheimer's disease (AD) and asthma,have something in common in the pathophysiological mechanism.The stress-induced structural and functional changes in the brain,the stress-initiated diversely structural and neurobiological changes in neurocircuitry,and the stress-mediated neurochemical alterations in neurotransmitter are considered to be involved in the common pathophysiological mechanisms in the neural-psychiatric comorbidity,which initiates a cascade of physiological and psychological processes that contributes to the development of various types of neuropsychiatric disorders.Accordingly,it will be of great significance to investigate mechanisms underlying the neuropsychiatric comorbidity in the process of "stress"-"inflammation"-"comorbidity" under the guidance of the basic theory of "treating disease from the root" and "same treatment for different diseases" in TCM.
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Abstract] Objective To investigate the in vivo therapeutic effects of an extract of herb medi-cines, YiGanQingDuKeLi, in combination with adefovir dipivoxil (ADV) on the rebound of duck hepatitis B virus ( DHBV) multiplication after withdrawal of ADV treatment.Methods Peking ducks were infected with DHBV positive serum samples for 7 days and then screened by SYBR Green real-time PCR.The ducks positive for DHBV were randomly divided into five groups including the model control group, the ADV treat-ment group, the herb treatment group, the high-dose combination therapy group and the low-dose combina-tion therapy group.The ducks in the ADV treatment and the herb treatment groups were respectively treated with distilled water and YiGanQingDuKeLi (1.2 g/ml) for 14 days after the treatment of ADV (0.25 mg/ml) for 21 days.The ducks in the high-dose group were treated with YiGanQingDuKeLi (1.2 g/ml) for 14 days after the combined treatment with high-dose YiGanQingDuKeLi (1.2 g/ml) and ADV (0.25 mg/ml) for 21 days.The ducks in the low-dose group were treated with YiGanQingDuKeLi (0.6 g/ml) for 14 days after the combined treatment with YiGanQingDuKeLi (0.6 g/ml) and ADV (0.125 mg/ml) for 21 days.Blood samples were collected from each duck via leg vein after 0, 7, 14 and 21 days of drug adminis-tration and after 7 and 14 days of drug withdrawal.The levels of DHBV-DNA, alanine aminotransferase ( ALT) and aspartate aminotransferase ( AST) in blood serum samples were detected.Results Compared with the model group, the levels of DHBV-DNA, ALT and AST in ducks from the herb treatment group and combined treatment groups were decreased before the discontinuation of ADV treatment ( P<0.05 or P<0.01).Moreover, the titers of DHBV-DNA in ducks treated with high doses of drugs were much lower than those from ADV treatment group.The levels of DHBV-DNA, ALT and AST in ducks treated with herb medi-cine and high doses of drugs remained at relatively low levels after the cessation of ADV treatment, but re-bounded significantly in ducks with ADV treatment.The levels of DHBV-DNA and ALT rebounded slightly in ducks treated with low doses of drugs as compared with those of ADV treatment group ( P<0.01 or P<0.05).Conclusion The treatment of YiGanQingDuKeLi in combination with ADV could inhibit not only the in vivo replication of DHBV, but also the rebound of DHBV multiplication after ADV withdrawal.
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Abstract: In order to improve the quality of reporting Chinese herbal medicine (CHM) trials, an elaborated checklist was developed according to the basic characteristics of traditional Chinese medicine (TCM) and on the basis of the Reporting Randomized Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. This checklist adopted the 22 items of the Herbal CONSORT Statement with some necessary elaboration and modification in the detailed contents of 11 items, among which, the items of Participants, Intervention, Control group and Outcomes were elaborated and modified accordingly to adapt TCM characteristics. Since the design and reporting of trials on Chinese proprietary medicine and herbal decoctions are different in some aspects, the checklist provided two sets of elaborated item 4 (interventions). We hope that authors, journal editors and peer reviewers find this checklist instructive.
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Qualitative research methods are becoming more and more important in medical research area. Some qualitative researches played important roles in the exploration and the spread of core ideas of Chinese medicine. The report of qualitative research should be transparent and credible according to the standardized report criterion. On the basis of 22 criteria, the Consolidated Criteria for Reporting Qualitative Research (COREQ) was developed and published in September 2007. This introduction to COREQ will be helpful to Chinese qualitative researchers and readers in the implementation of high quality of medical qualitative research in China.