Objective To investigate the current application of the EQ-5D in health economics research in the field of traditional Chinese medicine(TCM).Methods PubMed,Embase,CNKI,CBM and Wanfang databases were systematically searched.The clinical research literature in the field of TCM such as'Chinese medicine','tuina'and'acupuncture'containing EQ-5D analysis was included.The Excel spreadsheet was used for data extraction,and the extracted information including title,publication year,author,institution,country,conflicts of interest(declaration or involvement of enterprise),study type,participants,interventions,outcomes,research perspectives and measurement methods.The Quality of Health Economic Studies(QHES)was used to evaluate the methodological quality of the included literature.SPSS 18.0 software was used for descriptive analysis of the extracted data.Results A total of 52 articles were included,and the study design was mainly based on randomized controlled trials.The application of EQ-5D-5L was less than that of EQ-5D-3L.Most of the literature used utility value and quality-adjusted life years(QALYs)for cost-utility analysis(CUA).EQ-5D was widely used in the study of musculoskeletal diseases,and Chinese patent medicine and acupuncture were the most commonly used interventions.Chinese patent medicine was used in most systemic diseases,but it was mainly used in musculoskeletal system diseases,which was equivalent to the proportion of massage application.Acupuncture was the most widely used intervention in musculoskeletal diseases,followed by the application of pain diseases.According to the QHES evaluation criteria,the average score of the 37 articles with full text was 73.49.Among them,20 articles were of high quality,14 articles were of general quality,and 3 articles were of low quality.The quality of the research was generally acceptable,but there were problems such as unreasonable or unreported research time limit selection,research result interpretation,conflict of interest,research perspective,utility value and QALYs evaluation.No conflict of interest statement was made in all the studies involving enterprises.Conclusion The application of EQ-5D in the evaluation of health economics in TCM is less,and the quality of literature still needs to be improved.There is still much room for research and application of EQ-5D in this field.

The methodological framework for interventional clinical research of Chinese medicine （CM） under the research mode of syndrome dominating disease provides a set of technical principles and methods to design， evaluate， and implement of this kind. It consists of three main parts including general principles， research points and key design elements， with a total of 25 items. This methodological framework proposes implementing requirements and recommendations in a variety of aspects， including basic norms to be followed in relevant studies， perspectives for selecting research topics， as well as the technological details on study population （P）， intervention （I） and comparison（C）， outcome measurement （O）， time frame （T） of treatment and follow-up， sample orientation （prospective versus retrospective）， study design （S） format and type. To provide practical guidance for future studies， this article clearly explains each items of the methodological framework through some supportive cases.

In order to better promote the standardization of clinical research data,the Clinical Data Interchange Standards Consortium(CDISC)has established a series of clinical research data standards,and issued the Therapeutic Area(TA)standard for chronic obstructive pulmonary disease(COPD)in January 2016.This treatment domain standard is used to identify common data standards for clinical research protocols for COPD,to support the integration of clinical trial data from different sources and at different times,thus to promote the secondary analysis of cohort data.This article introduces the structure and content of the standard user guide for the treatment of COPD,in order to help researchers better understand and use the standard in the field of COPD treatment in research design.It is proposed to apply the standard in the field of treatment to standardize the design of clinical trials of traditional Chinese medicine for COPD,so as to promote the integration of research data and improve the efficiency of clinical trials.

The grading of evidence is an important factor in clinical decision-making. The current evidence grading system based on western medicine is limited in the clinical practice of traditional Chinese medicine （TCM）， therefore we propose the solutions to the development of grading system for TCM interventional evidence， following the international evidence grading standards， taking into considerations of the unique characteristics of TCM practice， based on the Grades of recommendation， assessment， development and evaluation （GARDE） evaluation system， and integrating with grading system regarding TCM classical literature and empirical evidence from modern famous doctors. The evidence from classical literature is suggested to be evaluated from three aspects including source of ancient medical records， comprehensive of treatment details， and the inheritance. The qualification of famous doctors， content integrity， and inheritance of experiences will be used to evaluate the evidence from famous doctors' experience. The multi-sourced evidence such as TCM classical literature， experience of modern famous doctors， and modern researches is mainly integrated in a qualitative way， and the overall level of evidence of TCM interventions will be graded consistently with the GRADE system based on modern research. The evidence from classical literature and modern famous doctors' experience will be assessed and considered as supplementary evidence， which will make the evaluation of clinical evidence more objectively and comprehensively， thereby guiding clinical practice further.

【 Objective:】 To understand subjects’ experiences and opinions on clinical trials of traditional Chinese medicine (TCM) and the process of informed consent during the process of participating in TCM clinical trials, and to provide reference for obtaining high-quality informed consent in TCM clinical trials. 【Methods:】 Using qualitative research methods, semi-structured individual in-depth interviews were conducted on 6 participants who had previously participated in TCM clinical trials. 【Results:】 Through data analysis, five major themes and several sub-themes were obtained, including the reasons why participants are willing to participate in TCM clinical trials, the concerns about unwillingness to participate, the information that they hope to be informed during the informed consent process, the specific content that they want to know in TCM clinical trials, and the evaluation of understanding and satisfaction with informed consent. 【Conclusion:】 In the process of informed consent in TCM clinical trials, attention should be paid to the explanation of adverse drug reactions of TCM, the reasonable arrangement and clear notification of the time for participants to participate in the trial, emotional humanistic care in the process of informed consent communication, and the value embodiment of subjects and their expectations for acquiring special knowledge of TCM.

Data acquisition is one of the key links that influencing the quality of clinical research.Electronic data capture system (EDC) embodies the advantages of saving time,manpower and material resources and improving efficiency and reliability by data acquisition.CDISC has established worldwide industry standards to support the electronic acquisition,exchange,submission and archiving of clinical research data.The application of CDISC standards to EDC system is favorable in ensuring the validity and standardization of clinical data.This paper takes the Oracle's OC/ RDC (Oracle Clinical / Oracle Remote Data Capture) system as an example to discuss the application of CDISC standard to EDC system from the two aspects:direct application and indirect application.We suggest that data collection should be taken into account during the design phase of a clinical trial,and the CDISC standard be applied at the CRF design stage.A design for eCRF takes time and effort by the combination of EDC system and CDISC standard,while thoughtless design may collect the wrong data.Therefore,it is suggested that a specialized personnel should be put in charge of eCRF design and maintenance during the operation of EDC system,and a set of standardized eCRFs based on CDISC standard and standard operating procedures should be built in one organization.

Objective To evaluate the efficacy and safety ofGuipi Decoction vs. antidepressants for depression. Methods Articles about the randomized controlled trials (RCTs) ofGuipi Decoction for depression were searched in the databases of CNKI, VIP, Wanfang Data, CMB, Embase, PubMed, and Cochrane Library. Two researchers independently screened the articles, extracted the data, and evaluated the methodological quality. Meta-analyses were performed by using RevMan 5.2 software.Results A total of 9 RCTs articles involving 893 cases were included. Meta-analysis results suggested that as compared with antidepressants only,Guipi Decoction together with antidepressants was associated with a significantly greater reduction in HAMD scores (MD=-4.63, 95%CI [-5.95, -3.32];P<0.001). There was no significant difference in HAMD scores betweenGuipi Decoction used alone and antidepressants (MD=-0.30, 95%CI [-4.22, 3.62];P=0.88). As compared with antidepressants,Guipi Decoction together with antidepressants increased in the rates of total effective events (RR=1.26, 95%CI [1.14, 1.38];P<0.001). No serious adverse reactions were reported. Meta-analysis results suggested that the incidence of adverse reactions of Guipi Decoction(RR=0.48, 95%CI [0.40, 0.58];P<0.001) andGuipi Decoction together with antidepressants (RR=0.51, 95%CI [0.30, 0.85];P=0.010) were lower than that of antidepressants alone.Conclusion The present evidence suggests thatGuipi Decoction is effective and relatively safe for patients with depression. However, because the quality of included research was low, more large-scale RCTs with multicenter and high quality are needed for further verification.

Due to the differences between Chinese and Western cultures, Chinese version of foreign research instruments may not be totally applicable for use in evaluating the therapeutic effect of traditional Chinese medicine (TCM). Great efforts have been made by Chinese researchers to develop scales for evaluation of the therapeutic effects of TCM. This study aims to understand the current situation of research in the development of evaluation instrument in TCM.

To evaluate the consistency of tongue manifestation and pulse condition observed by traditional Chinese medicine clinicians.

To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM).