[International standard ISO 22236 Traditional Chinese medicine-Thread-embedding acupuncture needle for single use: experience and recommendation].

The ISO 22236 Traditional Chinese medicine-Thread-embedding acupuncture needle for single use, as the first international standard (IS) in acupoint thread-embedding field, has been officially published by International Organization for Standardization (ISO) in 2020. The background of its development, difficulties and countermeasures in the process of development were reviewed, and the experience of standard development was summarized, aiming to provide methods and references for future IS development of acupuncture and moxibustion instruments. It is suggested that strengthening the discourse power in the process of IS development, increasing the compound talents cultivation for IS, valuing the importance of enterprises in the development of IS, and creating an advantageous environment for the development of IS are the keys to improve the level of standardization of acupuncture and moxibustion instruments and play a more important role in the IS development.

Optimal management of coronary artery disease in cancer patients.

Owing to early diagnosis and rapid development of treatments for cancers, the five-year survival rate of all cancer types has markedly improved worldwide. Over time, however, there has been an increase in the number of cancer patients who develop coronary artery disease (CAD) due to different causes. First, many risk factors are shared between cancer and CAD. Second, inflammation and oxidative stress are common underlying pathogeneses in both disorders. Lastly, cancer therapy can result in endothelial injury, coronary artery spasm, and coagulation, thereby increasing the risk of CAD. As more cancer patients are being diagnosed with CAD, specialized cardiac care should be established to minimize the cardiovascular mortality of cancer survivors.

Appraisal of the Quality and Contents of Clinical Practice Guidelines for Hypertension Management in Chinese Medicine: A Systematic Review.

OBJECTIVE: To evaluate the quality and consistency of recommendations in the clinical practice guidelines (CPGs) for hypertension in Chinese medicine (CM). METHODS: CM CPGs were identified from 5 electronic databases and hand searches through related handbooks published from January 1990 to December 2013. Three reviewers independently appraised the CPGs based on the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument, and compared the CPGs' recommendations on CM syndrome pattern classification and treatment. RESULTS: Five CM CPGs for hypertension were included. The quality score of the evidence-based (EB) guideline was higher than those of the consensus-based with no explicit consideration of evidence-based (CB-EB) and the consensus-based (CB) guidelines. Three out of five patterns in the CPGs were recommended by the EB guideline. Tianma Gouteng Formula () in the EB guideline was recommended mostly for hypertension patients with pattern of ascendant hyperactivity of Gan (Liver)-yang and pattern of yin deficiency with yang hyperactivity in the CPGs. Acupuncture and massage were recommended for Grade I and Grade II hypertension with severe symptoms weakening the quality of life in the EB guideline. For Grade I and Grade II hypertension, CM could be used alone, while for Grade III hypertension, they should be used in combination with Western medicines. CONCLUSION: The quality of EB guideline was higher than those of CB and CB-EB CPGs in CM for hypertension and CM should be prescribed alone or combined with Western medicines based on the grade of hypertension.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine].

To evaluate the applicability and clinical applications of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine, so as to provide the basis for the revision of the guidelines. This study was completed by the research and promotion base for traditional Chinese medicine(TCM) standard. The methods of applicability evaluation and application evaluation were used in the study. The questionnaires were filled out to evaluate applicability of the guideline, including doctor's familiarity with the guideline,the quality of the guideline, applicable conditions and clinical applications. The prospective case study analysis method was used to evaluate application of the guideline, including evaluation of clinical application compliance and application results(such as clinical effects, safety and economy). There were two parts in the guideline, which were TCM guideline and Western medicine guideline. The results of applicability evaluation showed that there were no obvious differences between TCM guideline and Western medicine guideline in doctor's familiarity with guideline(85.43%, 84.57%) and the use of the guideline(52.10%, 54.47%); the guidelines with good quality, and higher scores in the scope of application and the use of the term rationality(91.94%, 93.35%); the rationality scores of relevant contents in syndrome differentiation and treatment were more than 75%; the applicable conditions were better, and the safety score was the the highest. The comprehensive applicability evaluation showed that the proportion of the application of TCM guideline and Western medicine guideline were 77.73%, 75.46%, respectively. The results of application evaluation showed that there was high degree coincidence between the guideline with its clinical application; except for "other treatment" and "recuperation and prevention" in TCM, other items got high scores which were more than 90%; in the evaluation of application effects, safety of the guideline was best, economy of the guideline was better, and clincal effect was good. The comprehensive application evaluation showed that 75%~80% doctors were satisfied with the guideline. The Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine has been widely used in clinical practice, which is of high quality, high degree of clinical application,good safety and economy. But there were some disadvantages of the guideline such as lack of evidence-based medicine and innovation, which is need to be improved constantly in the guideline revision.

[Clinical application evaluation of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine].

Clinical application evaluation research of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine intends to evaluate the quality level and clinical application of the guideline. A questionnaire and prospective case survey methods were used to evaluate the applicability evaluation based on the clinician questionnaire and the application evaluation based on clinical case observation. The applicability evaluation, familiarity and utilization rate of doctors' guidelines were 85.06%, 62.76%; Sort by technical grade, intermediate grade doctors have a higher familiarity rate and utilization rate, while the junior grade doctor's is lower; Guide quality level of applicability evaluation, other items' rational percentage are better than 96% except the items of health preserving and prevention and other treatment is relatively low; Items' applicable percentage of applicability evaluation are more than 91% except the item of guide simplicity. Comprehensive applicability evaluation, The percentage of the guideline applicable to clinical practice accounted for 94.94%. The consistency rate of syndrome differentiation and clinical application is more than 96% in addition to prescription medication, other treatments and health preserving and prevention of the guidelines apply consistency of application evaluation. The percentage of good treatment effect accounted for 92.96% of application effect evaluation. The safety percentage is 99.89% and economy is 97.45%. The research shows that of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine quality level is good and is basically applicable to pediatric clinical practice which can be used as a standardized recommendation of pediatric common diseases' treatment specification. A small part of the guidelines are not applicable and need to be further consummated. Health preserving and prevention and other treatment of the guideline need to be revised.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine].

This study is to assess the Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine in clinical application and provide evidence for further guideline revision. The assessment was divided into applicability assessment and practicability assessment. The applicability assessment based on questionnaire survey and the traditional Chinese medicine (TCM) practitioners were asked to independently fill the Questionnaire for Applicability Assessment on the Guidelines for Diagnosis and Treatment in Traditional Chinese Medicine. The practicability assessment was based on prospective case investigation and analysis method and the TCM practitioners-in-charge filled the Case Investigation Questionnaire for Practicability Assessment on the Guidelines for Diagnosis and Treatment in Traditional Chinese Medicine. The data were analyzed in descriptive statistics. 151 questionnaires were investigated for applicability assessment and 1 016 patients were included for practicability assessment. The results showed that 88.74% of them were familiar with the guidelines and 45.70% used them. The guidelines quality and related items were similar in applicability assessment and practicability assessment, and scored highly as more than 85.00% except the "recuperating and prevention". The results suggested that the quality of Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine was high and could better guide the clinical practice. The "recuperating and prevention" part should be improved and the evidence data should be included in future guideline revision, so that the clinical utilization rate could be increased.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Coloproctology in Traditional Chinese Medicine].

To provide reference for revising the Guidelines for Diagnosis and Treatment of Common Diseases of Coloproctology in Traditional Chinese Medicine (TCM) through clinical research. 9 TCM hospitals worldwide have conducted a survey and questionnaires for 7 CPGs have been received. 263 cases clinical doctors accepted the applicability survey of guidelines. 89.35% is more familiar to the guidelines and 36.12% have been used the guidelines. In syndrome differentiation and treatment related contents, diagnostic point, treatment and syndrome differentiation are higher, accounted for 96.96%, 88.59%, 96.20%, respectively. Rationality of prevention is lower, accounted for 65.02%.88.21% clinical doctors believe that the Guidelines for Diagnosis and Treatment of Common Diseases of Coloproctology in Traditional Chinese Medicine is applicable. The application of the guidelines is evaluated by prospective observation of 1 309 cases. The higher consistency between guidelines and clinical practice is Western medicine disease diagnosis and traditional Chinese medicine disease diagnosis, accounted for 98.70%, 90.76%, respectively. The lower is rationality of prevention, accounted for 49.27%. The safety and economy of the guidelines are better, accounted for 97.02%, 95.11%, respectively. The comprehensive evaluation results showed that the overall treatment effect and technical level, satisfaction degree, applicability in clinical practice which were 7-9 points is 81.52%, 80.60%, 79.30%.The complex evaluation of diagnosis and treatment of common diseases of coloproctology in TCM guidelines is good, and suitable for clinical application with increase the content of rationality of prevention.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Cancer in Traditional Chinese Medicine].

This study aims to evaluate the adaptability and applicability of Guidelines for the Diagnosis and Treatment of Cancer in Traditional Chinese Medicine. The assessment methods included adaptability assessment and applicability assessment. The adaptability assessment was based on the questionnaire survey to evaluate the familiarity, utilization, quality, and clinical application of the Guidelines; applicability assessment was based on the prospective observation of 853 clinical cases to investigate the applicability and effect of the Guidelines, including effectiveness, economy and safety. Statistical analysis for basic description, construction of different comparison groups for cross or hierarchical statistical test, multi-factor analysis, and confounding factors were used in the study. Adaptability assessment results showed that 63.03% of TCM doctors considered guidelines as good or very good applicability and 4.24% of TCM doctors considered guidelines with very poor applicability in clinical practice. For the applicability evaluation, TCM doctors considered that the "overall efficacy and technology level", "satisfactory degree" and "adaptability in clinical practice" of the guideline were 85.46%, 80.43% and 69.40% respectively. The results showed that guideline was well known among TCM doctors, especially junior TCM doctors. Adaptability and applicability of Guidelines were totally good but the quality and adaptability of the intervention schemes were still week, so the quality of Guidelines should be improved by revision.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Gynecology in Traditional Chinese Medicine].

To evaluate the clinical applicability and application of Guidelines for Diagnosis and Treatment of Common Diseases of Gynecology in Traditional Chinese Medicine, 11 diseases from Guidelines for Diagnosis and Treatment of Common Diseases of Gynecology in Traditional Chinese Medicine were evaluated by methods of questionnaire and prospective case study at 16 construction units for traditional Chinese medicine standards research and extension. Results showed that 361 clinical doctors accepted the applicability survey of guidelines, and 87.26% of them were more familiar to the guideline and 25.21% of them used the guideline. In syndrome differentiation and treatment related contents, rationality of prescription medication and syndrome classification was higher, accounted for 91.69% and 86.98% respectively, but the rationality of recuperation prevention was lower, accounted for 44.6%. 75.62% clinical doctors believed that the Guidelines for Diagnosis and Treatment of Common Diseases of Gynecology in Traditional Chinese Medicine was applicable. The application of the guidelines is evaluated by prospective observation of 2 935 cases. The higher compliance between the guideline and clinical practice was present in TCM (traditional Chinese medicine) disease diagnosis and WM (western medicine) disease diagnosis, accounted for 98.30% and 94.11% respectively. The lower compliance was present in recuperation prevention, accounted for 59.39%. The safety and economy of the guideline was higher, accounting for 95.64%, 94.75%, respectively. The comprehensive evaluation results showed that the rate of the overall treatment effect with technical level, satisfaction degree or applicability in clinical practice which were 7-9 points is 77.38%, 74.00%, 76.90% respectively. This guideline has a high clinical compliance and can be used as a standard for common diseases of gynecology, but there are also some conditions with poor applicability, which does not conform to the actual situation, and needs to be further revised.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine].

To assess the quality and application effect of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine(Guidelines) through the applicability and applicability evaluation respectively. The questionnaire survey was adopted to evaluate the applicability of the Guidelines, including the utilization, quality, and clinical application conditions. The results showed that the familiarity rate and utilization rate of the Guidelines were 85.37%, 48.78%, respectively. The data showed that the familiarity and the utilization rates were different in the working staff with different professional titles. The evaluation level was the lowest given by the staff with junior professional title (70.97%, 29.03%) in comparison. The assessment showed the overall quality of the Guideline was good and slightly low level for the rationality scores of the other therapeutic methods as well as for the recuperation and prevention (80.49%, 85.37%), which was in line with the clinical compliance of the Guideline. The perspective observation of clinical cases was used for the applicability evaluation, including clinical compliance of the Guideline, effect evaluation, and comprehensive assessment, et al. The results showed that the safety score was the highest, followed by the economic issue and efficacy. For the comprehensive evaluation of the applicability, complete applicability accounted for 29.27%, and the general applicability accounted for 87.80%. It was showed in the three index scores of the applicability evaluation that the accumulative score 7-9 scores were 75.65%, 73.89%, 71.12%. Through the applicability and applicability evaluation, the Guideline was satisfactory in the overall quality, high in the safety of clinical application and good in efficacy and economic issues. There are some limits on the development method and technical issues in the Guideline, which is required to be supplemented in the revision. Additionally, the strategy study on the promotion of the Guideline should be enhanced so as to expedite the recognition and utilization of the Guideline.

Current situation of International Organization for Standardization/Technical Committee 249 international standards of traditional Chinese medicine.

OBJECTIVE: To review the current situation and progress of traditional Chinese medicine (TCM) international standards, standard projects and proposals in International Organization for Standardization (ISO)/ technical committee (TC) 249. METHODS: ISO/TC 249 standards and standard projects on the ISO website were searched and new standard proposals information were collected from ISO/TC 249 National Mirror Committee in China. Then all the available data were summarized in 5 closely related items, including proposed time, proposed country, assigned working group (WG), current stage and classifification. RESULTS: In ISO/TC 249, there were 2 international standards, 18 standard projects and 24 new standard proposals proposed in 2014. These 44 standard subjects increased year by year since 2011. Twenty-nine of them were proposed by China, 15 were assigned to WG 4, 36 were in preliminary and preparatory stage and 8 were categorized into 4 fifields, 7 groups and sub-groups based on International Classifification Standards. CONCLUSION: A rapid and steady development of international standardization in TCM can be observed in ISO/TC 249.

The add-on effect of a Chinese herbal formula for patients with resistant hypertension: study protocol for a pilot cohort study.

BACKGROUND: Despite a recent American Heart Association (AHA) consensus statement emphasizing the importance of resistant hypertension (RH), its control is still a challenge for conventional medicine. The Chinese herbal formula, Qutan Huayu Fang, has been used effectively to assist antihypertensive agents in blood pressure control, but its effect for RH patients is still unclear. This pilot study aims to explore the effects of taking the formula in addition to antihypertensive medication in the management of RH. METHODS/DESIGN: A prospective cohort study will be conducted in two first-class hospitals of traditional Chinese medicine (TCM). Eligible RH patients will be classified as the experimental group (n = 100) and the control group (n = 100) based on the interventions they receive. Participants taking antihypertensive agents and the Chinese herbal formula will be in the experimental group and those taking antihypertensive agents alone will be in the control group. The whole study will last 24 weeks, including an 8-week observation and follow-up at 24 weeks. The primary outcomes, assessed against patient baseline conditions, will be the reduction of systolic blood pressure and diastolic blood pressure as well as changes in TCM symptoms and signs. These outcomes will be assessed at weeks 2, 4, 6, and 8. The reductions of blood pressure will also be assessed at week 24. Cardiac events and mortality rate will be secondary outcomes and will be assessed at weeks 8 and 24. Any adverse reactions will be recorded during the study. The causal inference method will be used to assess the effectiveness of the inclusion of TCM herbal medicine in the management of patients with RH. DISCUSSION: This study will determine whether the Chinese herbal formula is helpful for RH patients treated with antihypertensive agents and the findings will provide a basis for further confirmatory studies.

Appraisal of clinical practice guidelines for ischemic stroke management in Chinese medicine with appraisal of guidelines for research and evaluation instrument: A systematic review.

OBJECTIVE: To systematically review the clinical practice guidelines (CPGs) for ischemic stroke in Chinese medicine (CM) with the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. METHODS: CM CPGs for ischemic stroke were searched in 5 online databases and hand-searches in CPGrelated handbooks published from January 1990 to December 2012. The CPGs were categorized into evidence based (EB) guideline, consensus based with no explicit consideration of evidence based (CB-EB) guideline and consensus based (CB) guideline according to the development method. Three reviewers independently appraised the CPGs based on AGREE II instrument, and compared the CPGs' recommendations on CM pattern classification and treatment. RESULTS: Five CM CPGs for ischemic stroke were identified and included. Among them, one CPG was EB guideline, two were CB guidelines and two were CB-EB guidelines. The quality score of the EB guideline was higher than those of the CB-EB and CB guidelines. Five CM patterns in the CPGs were recommended in the EB CPG. The comprehensive protocol of integrative Chinese and Western medicine recommended in the EB CPG was mostly recommended for ischemic stroke in the CPGs. The recommendations varied based on the CM patterns. CONCLUSION: The quality of EB CPG was higher than those of CB and CB-EB CPGs in CM for ischemic stroke and integrative approaches were included in CPGs as major interventions.

Expert consensus on the treatment of hypertension with chinese patent medicines.

Objectives. This study was aimed to determine the therapeutic principle and identify Chinese Patent Medicine (CPM) with corresponding indications for hypertension treatment. Methods. Three rounds of Delphi survey were mailed among 40 cardiovascular integrative medicine specialists. Items with agreement of more than 80% respondents were included in the consensus. Results. According to majority of the panelists, CPM is suitable for most hypertensive patients and should be used according to traditional Chinese medicine pattern classification. CPM could be used alone for grade 1 hypertension and could be used in combination with Western biomedicine (WM) for both grade 2 and grade 3 hypertension. It is recommended that less than two CPMs are used simultaneously. For the treatment of grade 2 and 3 hypertension, CPM and WM should be taken separately. Recommended CPMs included Tianma Gouteng granule, Qiju Dihuang capsule, Jinkui Shenqi pill, Yinxingye tablet, Niuhuang Jiangya pill and Banxia Tianma pill. The indications of 4 CPMs were specified with symptoms related to TCM pattern classification by the experts. Conclusions. An expert consensus on CMP application was formed for the treatment of hypertension in the form of integrative medicine. A flow of IM hypertension management was proposed based on the results of the survey.

Feasibility analysis of the value of Q method in the classification and understanding of expert experience.

The Q method, combining qualitative and quantitative methods, refers to the qualitative analysis of Q-sorts based on quantitative techniques. It is used to research individual subjective experience, analyzing consensus and divergence to identify and categorize subjects' viewpoints. The sorting process is completely performed by the subjects, independent of study researchers. The Q method in medical research has been applied in many fields, including nursing care, clinical studies, doctor and patient's perceptions, health evaluation and decision making. The authors used the Q method to research Chinese medicine (CM) group decision making, exploring its practical feasibility in this important field. Four primary domains are addressed: (1) integration of expert opinion; (2) expert classification; (3) ascertaining the entire viewpoint orientation of a certain type of expert; and (4) comparison of expert opinion using an additional perspective. The essence of the Q method caters to the CM thinking model and should be introduced into CM and explored more deeply.

Development of clinical practice guidelines in 11 common diseases with Chinese medicine interventions in China.

OBJECTIVE: To analyze the clinical practice guideline (CPG) development on 11 common diseases with Chinese medicine (CM) interventions in China. METHODS: The CPGs of 11 common diseases which could be treated effectively with CM had been published between 1980 and 2010 in China. The 11 diseases include coronary heart disease (angina pectoris), hypertension, chronic gastritis, rheumatoid arthritis, cerebral infarction, migraine, diabetes, primary osteoporosis, insomnia, common cold, and IgA nephropathy. The issuing organization, date of publication, development methods, and citation rate of the CPGs were analyzed. According to the development method, each guideline was categorized as consensus-based (CB), evidence-based (EB), or consensus based with no explicit consideration of evidence-based (CB-EB). RESULTS: Thirty-three CPGs on the 11 common diseases were found: 20 guidelines were classified as CB, 13 as CB-EB and none as EB. Fifteen CPGs were issued by the China Association of Chinese Medicine, 8 by professional working groups, and 4 by the State Administration of Traditional Chinese Medicine. Six guidelines were published between 1980 and 1990, 9 between 1991 and 2000, and 18 between 2001 and 2010. Fifty-eight percent of these guidelines have not been amended timely. Only 54.5% (18/33) of the 33 guidelines were cited by other researchers and 45.5% (15/33) percent had never been cited. CONCLUSIONS: Most CPGs developed for 11 common diseases with CM approaches in China are consensus, and their citation rates are relatively low. The results suggest that more EB CPG or CPG strictly based on expert consensus could be developed, and great efforts should be made for future CM CPG application.

[Exploration on syndrome differentiation standardization of Chinese medicine diagnosis and treatment].

The syndrome differentiation standardization of Chinese medicine and treatment technologies is the premise of Chinese medicine's entry into the world. But its individualized diagnosis and therapeutic features are contrary to the specification of standardization. The achievement and existent problems in syndrome differentiation standardization of Chinese medicine and treatment technologies were summarized in this paper. The thinking ways and recommendations to solve were proposed as well.

[Thinking on methods for formulating development strategy of traditional Chinese medicine standardization].

Traditional Chinese medicine (TCM) standardization serves as an important foundation of TCM modernization and internationalization, and TCM standardization strategy is the core of the subject. Recently, some developed countries and developing countries with a better economic basis have set development strategy for TCM standardization. China is at the beginning on TCM standardization strategy study. This paper explored the methods for setting TCM standardization development strategy. Firstly, strengths, weaknesses, opportunities and threats of TCM were analyzed based on SWOT method to set development tactics. On the above basis, the authors defined the total goal and stage goal under the guidance of the relevant laws and regulations. To achieve the strategic goal, priority areas were formed by literature analysis and expert inquiry method, and the safeguard measures were formulated by expert symposium. Secondly, the draft for development strategy of TCM standardization was made based on the above content. Finally, the authors revised and formed the official development strategy of TCM standardization.

Assessing the quality of the first batch of evidence-based clinical practice guidelines in traditional Chinese medicine.

OBJECTIVE: To assess the quality of the first batch of Chinese evidence-based clinical practice guidelines (CPGs) in Traditional Chinese Medicine (TCM) using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. METHODS: Evidence-based CPGs in TCM supported by the World Health Organization Western Pacific Regional Office (WHO/WPRO) and whose development was organized by the China Academy of Chinese Medical Sciences were identified and manually retrieved. CPGs were assessed using the AGREE instrument, and the data in each CPG were analyzed in terms of the six domains in the AGREE instrument: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and editorial independence. RESULTS: Twenty-eight CPGs were identified, of which 26 were included in the study. The AGREE instrument rated the 26 CPGs in terms of the six domains. The assessment results showed the following average scores: for editorial independence, 84.16%; for rigor of development, 80.95%; for scope and purpose, 79.96%; for clarity and presentation, 70.88%; for stakeholder involvement, 61.28%; for applicability, the average score was only 27.09%. In summary, nine CPGs were rated as "strongly recommended", six as "recommended with provision or alternation", and 11 as "unsure". CONCLUSION: Most of the first batch of Chinese evidence-based CPGs in TCM had significant shortcomings in applicability. It is suggested that special attention be paid to enhancing the quality of applicability when developing evidence-based CPGs in TCM.