As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials. Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528-536.
Drugs, Chinese Herbal/therapeutic use* ; Medicine, Chinese Traditional/methods* ; Outcome Assessment, Health Care ; Reference Standards ; Reproducibility of Results ; Research Design ; Clinical Trials as Topic

The research on the processing mechanism of Chinese medicine is the key and core foundation to improve processing technologies of Chinese medicine, formulate the quality standards of Chinese medicinal pieces, enhance the clinical efficacy of Chinese medicine, enrich Chinese medicine processing theories, and promote the development of Chinese medicine processing. Many researc-hers have conducted in-depth exploration on the processing mechanism of Chinese medicine in the 20 years in the 21 st century. Significant progress has been made in the transformation of chemical components during the processing, the change of active components in the body, the law of toxicity attenuation in the processing of toxic Chinese medicine, the mechanism of efficacy enhancement and toxicity attenuation of processing with auxiliary materials, and the application of new biomedical technologies. At present, the processing mechanism of multiple Chinese medicines has been preliminarily clarified, which has greatly promoted the development of Chinese me-dicine processing. The development of the processing mechanism of Chinese medicine reveals that the in vitro transformation of chemical components is combined with the in vivo absorption, transport, and metabolism, and the macroscopic biological effects of the organism are combined with the cells, molecules, targets, and pathways in the study of the processing mechanism of Chinese medicine. More attention has been paid to exploring the processing mechanism from the overall level, and a modern systematic research system on the processing mechanism of Chinese medicine has been initially formed. To further promote the scientific development of Chinese me-dicine processing, the present study proposed that the research on the processing mechanism of Chinese medicine should take Chinese medicine properties into account, focus on the influence of disease condition on the mode of action and effect strength of the drugs, comply with the characteristics of clinical compound compatibility of Chinese medicine, use the holistic view research strategies of systems bio-logy, and deeply explore the processing mechanism of Chinese medicine from traditional Chinese medicine theories and the characteristics of clinical medication of Chinese medicine.
Drugs, Chinese Herbal/pharmacology* ; Medicine, Chinese Traditional ; Reference Standards ; Research Design ; Technology

By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
Clinical Trials as Topic ; Equipment and Supplies/standards* ; Indicators and Reagents/standards* ; Reproducibility of Results ; Research Design/standards*

With the development of society, more and more foreign natural medicines have entered China, but they are faced with the problem that they are not given with the traditional Chinese medicine(TCM) properties when they are used with other TCM. When we carried out the research on introducing foreign natural plant resources to TCM, gradually, a new research model and field with original characteristics of TCM--the study of new foreign introducing TCM had been formed. In the process of it, we explored and summarized research rules to form the research paradigm, which will be conducive to the standardization and scientization of new foreign introducing TCM research. For the research of foreign introducing TCM, we analyzed the research background, reviewed the application history, sorted out the research status, elaborated the concept and summarized the research achievements. On this basis, we put forward the concept and system of the modern research paradigm of new foreign introducing TCM, studied and clarified the core elements, properties and research principles of this paradigm, and summarized the research contents and methods of new foreign introducing TCM. We interpreted the foundation of paradigm construction from multiple perspectives. The paradigm was the practical application of theoretical innovation of TCM. Under the guidance of it, more and more varieties of new foreign introducing TCM will be studied, the study will be more standardized, the conclusions will be more scientific and reliable, which will inspire and guide more researchers to focus on the research of new foreign introducing TCM, and the paradigm itself will be constantly improved. The construction and application of the paradigm will certainly accelerate the innovative research of foreign introducing TCM and play a historic role in promoting the enrichment of traditional Chinese medicine varieties.
China ; Drugs, Chinese Herbal ; Internationality ; Medicine, Chinese Traditional ; Plant Preparations/standards* ; Research Design

With the development of the methodology of clinical trials and the appearance of medical big data, the real-world study (RWS) presents its unique advantages, plays a role in clinical practice and research, and its importance is more and more recognized by scholars in recent years. In surgical research field, due to the specificity of surgical diseases and operational procedures, confounding factors and risk of bias are greatly higher than those of traditional medications. Therefore, using unique advantages of the RWS to solve the actual clinical problem in surgical field is the main goal of performing surgical RWS. This article will systematically elucidate how to perform the surgical RWS and the special matters of concern in carrying out surgical RWS.
Clinical Studies as Topic ; methods ; standards ; General Surgery ; standards ; Humans ; Research Design ; standards ; Surgical Procedures, Operative ; standards

Health food containing Chinese materia medica has many advantages in health preservation and reducing the risk of disease occurrence,which meets people's demands for " great health" and " preventive treatment of disease". However,due to its complex ingredients,diverse quality of raw materials,as well as the vagueness and lack of integrity for existing quality standards,chaos is caused in the health food market,which restricts its healthy development and also poses new challenges to the quality control of healthy food. At present,the total component content or single component content is determined in most functional/marker component examinations. Safety and microbial detection methods fail to cover the contamination range of the raw materials of Chinese materia medica.Therefore,it is impossible to meet the purpose of ensuring authenticity,safety and efficacy. In recent years,a lot of Chinese materia medica extracts have been used as raw materials for food products,but many extracts lack standards. The author believes that the quality control of health food containing Chinese materia medicas should start with the quality control of Chinese materia medica extracts. In this way,product quality is controlled from source to ensure product consistency; secondly,the overall quality control should be strengthened to ensure the authenticity of the products; the scope of safety inspection shall be expanded to fundamentally ensure the safety of products. At the same time,we should strengthen the quality control of whole process and strengthen the overall quality control of raw materials to produce health food of high quality.
Food ; standards ; Materia Medica ; standards ; Medicine, Chinese Traditional ; Quality Control ; Research Design

Temporary prescription preparation is the preparation processed into different dosage forms by relevant pharmacist according to the temporary preparation requirement and the personalized prescription made by the doctor in accordance with the syndrome differentiation and drug performance.It is an important part in personalized pharmaceutical services.Rational design of process route,production equipment and quality control method for the temporary prescription preparation,and establishment of technology research strategy and mode in accordance with the characteristics of traditional Chinese medicine temporary prescription preparations play an important role in promoting the development of the temporary prescription preparations.To promote the normalization,standardization and intelligent development of temporary prescription preparations,we would comprehensively summarize the significance,policy,technology characteristics,technology research status quo and existing problems in this paper,and put forward the research direction of temporary prescription preparation technology based on the physical properties of raw materials,equipment research strategy,and intelligent manufacturing technology.Thus it will push the inheritance and innovation of temporary prescription preparation.
Medicine, Chinese Traditional ; Prescriptions ; standards ; Quality Control ; Research Design

In 1952, the Japanese Society for Hygiene had once passed a resolution at its 22nd symposium on population control, recommending the suppression of population growth based on the idea of cultivating a healthier population in the area of eugenics. Over half a century has now passed since this recommendation; Japan is witnessing an aging of the population (it is estimated that over 65-year-olds made up 27.7% of the population in 2017) and a decline in the birth rate (total fertility rate 1.43 births per woman in 2017) at a rate that is unparalleled in the world; Japan is faced with a "super-aging" society with low birth rate. In 2017, the Society passed a resolution to encourage all scientists to engage in academic researches to address the issue of the declining birth rate that Japan is currently facing. In this commentary, the Society hereby declares that the entire text of the 1952 proposal is revoked and the ideas relating to eugenics is rejected. Since the Society has set up a working group on the issue in 2016, there have been three symposiums, and working group committee members began publishing a series of articles in the Society's Japanese language journal. This commentary primarily provides an overview of the findings from the published articles, which will form the scientific basis for the Society's declaration. The areas we covered here included the following: (1) improving the social and work environment to balance between the personal and professional life; (2) proactive education on reproductive health; (3) children's health begins with nutritional management in women of reproductive age; (4) workplace environment and occupational health; (5) workplace measures to counter the declining birth rate; (6) research into the effect of environmental chemicals on sexual maturity, reproductive function, and the children of next generation; and (7) comprehensive research into the relationship among contemporary society, parental stress, and healthy child-rearing. Based on the seven topics, we will set out a declaration to address Japan's aging society with low birth rate.
Aging ; Birth Rate ; trends ; Child ; Child Health ; Environmental Exposure ; adverse effects ; prevention & control ; Female ; Health Planning Guidelines ; Humans ; Japan ; epidemiology ; Male ; Occupational Health ; Reproductive Health ; education ; Research Design ; standards ; Societies, Scientific ; organization & administration ; Stress, Psychological ; prevention & control ; Women's Health

To introduce the application status of network Meta-analysis( NMA) in the field of traditional Chinese medicine,and to discuss the application value of NMA in the field of traditional Chinese medicine,this study comprehensively reviewed the systematic reviews with application of NMA in the field of traditional Chinese medicine. CNKI,Wan Fang,Sino Med,VIP,Embase,PubMed and Cochrane Library and the reference list of previous studies were searched. The AMSTAR scale was used to evaluate the quality of literature methodology,and PRISMA-NMA checklist was used to measure the degree of report specification. Overall,122 articles were included,including 80 in Chinese and 42 in English. The included studies centered on cancer,bone and joint disease,cardiovascular disease,respiratory disease,mental disease and digestive disease. Additionally,the intervention can be categorized into three groups,traditional Chinese medicine injection,oral Chinese medicine or prescription,and traditional physical therapy including acupuncture.Nearly one-third of the researches' intervention program is aimed at comparing the effect of Chinese and Western combined therapy and monotherapy. The overall methodology quality grade is medium and the report quality is average,with methodology reporting and result reporting especially need to be improved. The subgroup analysis shows that the methodology quality of the English literatures is evidently higher than Chinese literatures,and the quality of the literatures published after 2015 is higher than those published in or before 2015.This study indicates that the NMA can compare multiple treatments simultaneously,which accords with characteristics of the clinical practice in traditional Chinese medicine that is complex and individual. NMA in the field of traditional Chinese medicine is still in the process of development. With higher level of quality control and reporting as well as the improvement of the statistical methodology and the accumulation of original researches,NMA application in the field of traditional Chinese medicine will be promising.
Administration, Oral ; Humans ; Injections ; Medicine, Chinese Traditional ; Network Meta-Analysis ; Physical Therapy Modalities ; Quality Control ; Research Design/standards* ; Systematic Reviews as Topic

Our study aimed to amplify and explain the items of statistical reporting requirements proposed by medical journals, and to improve the statistical reporting quality of medical articles. Statistical reporting requirements were obtained from the reporting standards published by the International Committee of Medical Journal Editors (ICMJE), the Enhancing the QUAlity and Transparency of Health Research (EQUATOR) network, and the editorial board of Chinese Medical Journal, etc. The items involved in statistical reporting requirements were summarized as issues of study design, statistical analysis, and interpretation of results. Each item was amplified based on cases of original articles. It is noticeable that the statistical reporting requirements of English medical journals generally referring to guidance documents, including "Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals" proposed by the ICMJE, or the statements for different study types published by the EQUATOR network, where the statistical reporting of medical articles had been detailed specified. The statistical reporting requirements of Chinese medical journals, however, were usually stated by the editorial boards. Although the formats and contents of statistical analysis had been regulated, the requirements of Chinese medical journals were to some extent insufficient and should be enhanced in accordance with the international standards. In conclusion, the amplification and explanation of statistical reporting requirements were expected to help investigators understand the requirements for statistical reporting in medical researches, so as to effectively improve the quality of medical articles.
Biomedical Research ; Editorial Policies ; Humans ; Periodicals as Topic/standards* ; Publishing/standards* ; Reference Standards ; Research Design