Quality Evaluation on Traditional Chinese Medicine Nursing Plan for Stroke in Acute and Recovery Phases

OBJECTIVE: To formulate the quality evaluation questionnaire of Traditional Chinese Medicine(TCM) nursing plan for stroke in acute and recovery phases, and to evaluate the quality of TCM nursing plan for stroke by clinical nurses. METHODS: The questionnaire was designed by referring to the Applicability Questionnaire of TCM Clinical Diagnosis and Treatment Guideline, and the expert consultation was used to assess the content validity. In addition, the results of the questionnaire were processed and analyzed with SPSS20.0 software. RESULTS: The content validity of the self-designed questionnaire was 0.94 for the S-CVI/Ave score. The results of the questionnaire demonstrated that the overall content of the plan was "better than the original routine nursing plan"(59.18%); the recognition degree of "common symptoms"(36.70%) and "syndrome classification"(36.70%) of the plan was the lowest. CONCLUSION: The plan is supposed to be further improved in the future in order to be coincident with clinical reality.

Systematic evaluation of traditional Chinese medicine for treating Parkinson's disease

BACKGROUND：To evaluate the quality of the literature addressing traditional Chinese medicine for treating Parkinson＇s disease.DATA SOURCE：A computer-based online search of Chinese publications from January 2001 to July 2008 was conducted in Chinese Biology Medical Disc Database and China National Knowledge Infrastructure. Search key words were Parkinson＇s disease, integrated traditional Chinese and Western medicine, traditional Chinese medicine therapy, and Chinese herb therapy.DATA SELECTION：Articles describing randomized, controlled trials and quasi-randomized, controlled trials were included. Literature quality was assessed using the criteria-Systematic evaluation of clinical literature related to treatment of Parkinson＇s disease with traditional Chinese medicine. This included methodology, interventions in the treatment/control group, evaluation criterion of outcomes, and frequency.MAIN OUTCOME MEASURES：Evaluation criterion of outcomes （various score methods and evaluation scales）, methodological quality, and frequency distribution were all measured.RESULTS：A total of 33 articles with randomized, controlled trials were included. Of these, six described a random method, and the remaining did not describe random allocation methods or random sequence generation methods. None of the studies estimated sample size. Case descriptions of withdrawal and loss to follow-up were unclear. Both the Unified Parkinson＇s Disease Rating Scale and Webster scale were used in the eligible studies as evaluation criteria.CONCLUSION：There are no high-quality studies that address traditional Chinese medicine therapy and integrated traditional Chinese and Western medicine for treating Parkinson＇s disease in China. Eligible studies were not performed in accordance with Consolidated Standards of Reporting Trials statement or Standards for Reporting Interventions in Controlled Trials of Acupuncture criteria, and the literature quality was low. The presently used criteria for evaluating therapeutic effects do not completely assess outcomes of traditional Chinese medicine for treating Parkinson＇s disease. The identification of precise outcomes should be verified using randomized, controlled studies with adequate controls and proper designs.

Discussion on the Quality Evaluation Method of Traditional Chinese Medicine Compound Preparations

As an important representative of the modernization of the Chinese medicine industry,traditional Chinese medicine(TCM)compound preparations are an indispensable part of the development of TCM.The complex ingredients and unclear action mechanism of TCM compound preparations restrict the development of TCM.In line with this problem,the modern TCM research has made extensive remarkable achievements.From the single indicator in the past to multiple indicator,the research on the combination of TCM fingerprints and pharmacodynamics also has made great progress.The introduction of quality evaluation methods such as the"quantitative analysis of multi-components by a single marker","dose-effect"indicator,"Bioactive Equivalent Combinatorial Components"(BECCs)and TCM quality markers have brought new ideas for quality control of TCM compound preparations.

Prospects for the future of clinical efficacy evaluation of traditional Chinese medicine——Emphasis on original theory and clinical practice

Traditional Chinese medicine(TCM)clinical efficacy evaluation runs through the development of TCM and has been progressing so far.With the introduction of evidence-based medicine(EBM)in recent 20 years,TCM clinical efficacy evaluation has developed rapidly,accumulated research and experience,improved the quality and standardization of research,but also gradually found deep-seated deficiencies.In 2019,the China Center for Evidence-based Traditional Chinese Medicine(CCEBTCM)was established,and TCM was included in the 11th revision of the International Statistical Classification of Diseases(ICD-11).In above opportunities for TCM clinical efficacy evaluation,it is necessary to face up to the previous deficiencies,so that the TCM clinical efficacy evaluation can truly reflect the actual clinical practice characteristics,including TCM clinical problems,TCM thinking and TCM diagnosis&treatment mode.Based on the summary and analysis of past research,development concepts are proposed in this article.On the one hand,original concepts of TCM should be confidently paid more attention to the design and implementation of TCM clinical efficacy evaluation to be close to TCM clinical practice.On the other hand,it is necessary to consolidate the foundation of TCM clinical practice before evaluating efficacy.Evaluated object built on TCM ontology knowledge should be demonstrated based on clinical practice,and unknown evaluated object combined with new methods,technologies and concepts should be maturely integrated in clinical practice firstly.

Status and Development Trend of Evaluation of Post-Marketing Traditional Chinese Medicines in China

Evaluation of traditional Chinese medicines after the market has achieved fruitful results after years of development.The real-world research concept has been first proposed by Chief Researcher Xie Yanming in 2010 and to 2020 with the approval of the National Medical Products Administration to use real-world evidence to support drug development and review in 2020.Real-world data application and transformation continue to cause heated discussions in the industry.Real-world research concepts have been added new motivation into the evaluation of Chinese medicines after they are marketed.The development of the Chinese patent medicine industry is facing unprecedented opportunities and challenges.

Analysis of the TCM theory of traditional Chinese health exercise

The traditional Chinese medicine(TCM)theory of traditional Chinese health exercise(TCHE)is analyzed.The effect of meridians and acupoints contained in TCHE is summarized,the treatment methods of tonifying deficiencies and reducing excesses applied in TCHE are discussed,the regulation of Zang-fu organs are emphasized,and the leading role of Qi is introduced.The exercise prescription and proper timing of TCHE are described and reported.TCHEs,such as Baduanjin,Liuzijue,and Tai Chi,possess strong TCM characteristics.

An ultra-robust fingerprinting method for quality assessment of traditional Chinese medicine using multiple reaction monitoring mass spectrometry

Chromatographic fingerprinting has been perceived as an essential tool for assessing quality and chemical equivalence of traditional Chinese medicine.However,this pattern-oriented approach still has some weak points in terms of chemical coverage and robustness.In this work,we proposed a multiple reaction monitoring(MRM)-based fingerprinting method in which approximately 100 constituents were simultaneously detected for quality assessment.The derivative MRM approach was employed to rapidly design MRM transitions independent of chemical standards,based on which the large-scale fingerprinting method was efficiently established.This approach was exemplified on QiShenYiQi Pill(QSYQ),a traditional Chinese medicine-derived drug product,and its robustness was systematically evaluated by four indices:clustering analysis by principal component analysis,similarity analysis by the congruence coefficient,the number of separated peaks,and the peak area proportion of separated peaks.Compared with conventional ultraviolet-based fingerprints,the MRM fingerprints provided not only better discriminatory capacity for the tested normal/abnormal QSYQ samples,but also higher robustness under different chromatographic conditions(i.e.,flow rate,apparent pH,column temperature,and column).The result also showed for such large-scale fingerprints including a large number of peaks,the angle cosine measure after min-max normalization was more suitable for setting a decision criterion than the unnormalized algorithm.This proof-of-concept application gives evidence that combining MRM technique with proper similarity analysis metrices can provide a highly sensitive,robust and comprehensive analytical approach for quality assessment of traditional Chinese medicine.

The theory development of traditional Chinese medicine constitution: a review

Traditional Chinese medicine constitution (TCMC),as one of the most important parts of Chinese medicine theory,attracted the attention of more and more researchers and many research projects were conducted during past several decades in China's Mainland.This review provided a historic overview of TCMC theory and research progress in its classification,evaluation criteria and epidemiology,so as to give people through a different lens to understand human health.

Biological Evaluation of ChuangYuLing Dressing—A Multifunctional Medicine Carrying Biomaterial

The safety of Chuangyuling (CYL) dressing—a multifunctional medicine carrying biomaterial was evaluated in order to provide foundation for the application of CYL as material used in the wound healing. The traditional Chinese medicine (TCM) extract solution was compounded with scaffolds (gelatin and Bletilla hyacinthine gum), and then frozen and dried to form spongy and porous material CYL. According to the standard of biological evaluation of medical devices that was instituted by the ministry of health of China \, the biological evaluation of CYL dressing was conducted. The results showed that all the contents of biological evaluation test consisting of acute toxicity, skin irritation, sensitization and cytotoxicity met the requirement of standards. It was concluded that the biomaterial carrying TCM (CYL dressing) is safe for application of wound healing.

A comprehensive review of research progress in Chinese medicines for primary liver cancer treatment

Primary liver cancer seriously threatens human health,affects the quality of life,and has a high mortality rate.Traditional Chinese medicine(TCM)has long been used in the prevention,treatment,and adjuvant treatment of primary liver cancer.Clinical trials were conducted in recent years to evaluate the efficacy and safety of TCM.The mechanism of action of TCM in primary liver cancer treatment also received extensive attention.This study summarizes the common monomial Chinese herbal medicines and their components,formulae,and the proprietary Chinese medicines used to treat primary liver cancer.Common medicines include Chansu(Bufonis venenum),Kushen(Sophorae flavescentis radix),Renshen(Ginseng radix et rhizoma),and Jianghuang(Curcumae longae rhizoma).This study also reviewed the literature on liver cancer treatment using TCM.The results confirmed the safety and efficacy of TCM in liver cancer treatment.The possible mechanisms involved are also listed,including influencing the cell cycle,inducing cancer cell apoptosis and autophagy,inhibiting cancer cell angiogenesis and metastasis,regenerating the microenvironment and DNA methylation,and regulating the innate immune response.For primary liver cancer patients who often have a long disease course,Chinese herbal medicine often plays a role in protecting and conditioning the body.Research aimed at finding more traditional Chinese herbal medicines and their mechanisms of action should be promoted.This study aimed to provide a scientific reference for further research and the rational clinical application of TCM for primary liver cancer treatment.

Chinese medicine formulas for nonalcoholic fatty liver disease: Overview of systematic reviews

BACKGROUND Nonalcoholic fatty liver disease(NAFLD)affects more than one-quarter of the global population.Due to the lack of approved chemical agents,many patients seek treatment from traditional Chinese medicine(TCM)formulas.A variety of systematic reviews have been published regarding the effectiveness and safety of TCM formulas for NAFLD.AIM To critically appraise available systematic reviews and sort out the high-quality evidence on TCM formulas for the management of NAFLD.METHODS Seven databases were systematically searched from their inception to 28 February 2020.The search terms included“non-alcoholic fatty liver disease,”“Chinese medicines,”“systematic review,”and their synonyms.Systematic reviews involving TCM formulas alone or in combination with conventional medications were included.The methodological quality and risk of bias of eligible systematic reviews were evaluated by using A Measure Tool to Assess Systematic Reviews 2(AMSTAR 2)and Risk of Bias in Systematic Review(ROBIS).The quality of outcomes was assessed by the Grading of Recommendations Assessment,Development and Evaluation(GRADE)system.RESULTS Seven systematic reviews were ultimately included.All systematic reviews were conducted based on randomized controlled trials and published in the last decade.According to the AMSTAR 2 tool,one systematic review was judged as having a moderate confidence level,whereas the other studies were rated as having a low or extremely low level of confidence.The ROBIS tool showed that the included systematic reviews all had a high risk of bias due to insufficient consideration of identified concerns.According to the GRADE system,only two outcomes were determined as high quality;namely,TCM formulas with the HuoXueHuaYu principle were better than conventional medications in ultrasound improvement,and TCM formulas were superior to antioxidants in alanine aminotransferase normalization.Other outcomes were downgraded to lower levels,mainly because of heterogeneity among studies,not meeting optimal information sample size,and inclusion of excessive numbers of small sample studies.Nevertheless,the evidence quality of extracted outcomes should be further downgraded when applying to clinical practice due to indirectness.CONCLUSION The quality of available systematic reviews was not satisfactory.Researchers should avoid repeatedly conducting systematic reviews in this area and focus on designing rigorous randomized controlled trials to support TCM formula applications.

Randomized control study in the influence of different training methods of Tai Chi on Chinese medicine constitution of international students with depression or depression tendency

Objective： To evaluate the effect of different training methods of Tai Chi on Chinese medicine constitution of international students with depression or depression tendency. Methods： Thirty-eight Africa international students were randomly divided into the physical exercise group who receiving the simple physical exercise of simplified 24-form Tai Chi （physical exercise group） and the breathing group who receiving both deep breathing method plus simple physical exercise （breathing group）. The average scores of Chinese medicine gentleness and various biased constitutional types in the two groups were compared. Results： The average score of thirty-eight students with biased constitution in both groups decreased significantly compared with that before training （P 〈 0.05）. Compared with that before training, the average scores of biased constitutional types in the breathing group, including Qi deficiency, Yang deficiency, phlegm-dampness and Qi stagnation, were significantly decreased （P 〈 0.05）. The average scores of Yang deficiency, blood stasis and Qi stagnation constitutional types of students in simple physical group after training were also significantly decreased after training （P 〈 0.05）. Moreover, the average scores of biased constitutional types, including Qi deficiency, Yang deficiency, Yin deficiency, phlegm and dampness, Qi-stagnation, in the breathing group were significantly lower than those of the simple exercise group, suggesting the superior therapeutic effect of breathing training method （P 〈 0.01）. Conclusion： When combines with the deep breathing method, Tai Chi training achieves better effect on improving the biased constitutional types which may be related to depression or depression tendency, including Qi deficiency, Yang deficiency, Yin deficiency, phlegm and dampness, Qi-stagnation.

Blinding assessment in clinical trials of traditional Chinese medicine:Exploratory principles and protocol

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.

Clinical practice guidelines for treating headache with Traditional Chinese Medicine: quality assessment with the appraisal of guidelines for research and evaluation Ⅱ instrument

OBJECTIVE: To critically appraise the methodological quality of clinical practice guidelines for headache produced over the last two decades, including those covering specific interventions using Traditional Chinese Medicine.METHODS: The guidelines on headache disorders were obtained by searching a number of databases, including Pub Med, EMBASE, Web of Science,Chinese Biomedical Literature Database, China National Knowledge Infrastructure Database, China Science and Technology Journal Database, and Wanfang database, three guideline-related databases [Guideline-International Network, National Guideline Clearinghouse, and Medlive], and the records of organizations that develop guidelines. The publication date was limited to the period from January 1996 to June 2015. The search terms "headache", "headache disorders", "cephalalgia", "migraine", "tension-type headache", "practice guideline", "consensus ", "statement", "regulation", and "recommendation" were used in the "Me SH" and "Free-text" fields. The guidelines were independently appraised by four researchers using the Appraisal of Guidelines for Research and Evaluation Ⅱ instrument.RESULTS: A total of 23 guidelines published between 1998 and 2014 were reviewed. The overall consistency of the four appraisers was good [interclass correlation coefficient 0.84; 95% confidence interval(CI) 0.82-0.86]. The mean(standard deviation) scores for scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence were 52.1(18.0), 39.5(17.1), 33.4(21.0), 49.8(21.9),23.8(19.3), and 24.2(23.7). Only two guidelines were recommended, 12 were recommended with modification, and nine were not recommended.CONCLUSION: Physical Traditional Chinese Medicine therapies were recommended to treat headache. The overall quality of headache guidelines was low in China, but evidence-based guidelines are gradually becoming mainstream. Guideline developers should carefully consider, in particular,three domains: rigor of development, applicability,and editorial independence.

Quantitative Evaluation of the Compatibility Effects of Aidi Injection on the Treatment of Hepatocellular Carcinoma Using Targeted Metabolomics:A New Strategy on the Mechanism Study of an Anticancer Compound in Traditional Chinese Medicine

Objective:Compound traditional Chinese medicine(CTCM)with the application of compatibility from multiple active ingredients with multiple-specific targets can achieve a synergistic effect on cancer therapy.This study is aimed to observe the compatibility effects of Aidi injection on the treatment of hepatocellular carcinoma and to explore the mechanism of CTCM.Methods:Aidi injection is a clinical compound prescription containing Mylabris,Ginseng,Astragalus,and Acanthopanax,which can inhibit tumor growth and induce apoptosis.In this study,the anticancer activity of Aidi injection,as well as its disassembled and combined compositions,had been evaluated by varying levels of polyamine biomarkers on human hepatoma Hep-G2 cells detected using ultrahigh-performance liquid chromatography-tandem mass spectrometry.Results:According to the different variations in polyamine levels,it was revealed that Mylabris and Ginseng had an antitumor effect,while Astragalus acted as an assistant and Acanthopanax had weak anticancer activity.The increased level of polyamines in Hep-G2 cells had been found in HL-7702 cells.On combining Mylabris and Ginseng,polyamine levels went close to the normal level,which was even more marked when Astragalus was added.Aidi injection acted like the combination of Mylabris,Ginseng,and Astragalus.Conclusions:This study established a quantitative evaluation of the compatibility effects of Aidi injection based on polyamine biomarkers and evaluated the consistency of its anticancer effect,providing a manner to research the efficacy evaluation of CTCM.Moreover,the correlation between polyamine metabolism and anticancer activity can be used in anticancer drug screening.

Validity and reliability of the evaluation tool of TCM confidence in students with TCM learning experience

Objective:This study aimed to design an evaluation scale of traditional Chinese medicine(TCM)confidence and then evaluate its validity and reliability.Methods:Three parallel samples with TCM learning experience were included in this current study.Randomly selected 500 nursing students were included factor analysis and reliability and validity analyses.After 4 weeks,200 nursing students were recruited to retest the reliability.The evaluation tool of TCM confidence included 6 dimensions and 25 entries.Results:Cronbach's a coefficient of the evaluation scale was 0.95 and that of the 6 observed aspects were higher than 0.90,and splithalf reliability was 0.81.For the retest reliability,Cronbach's a coefficient of the evaluation scale was 0.93 and that of the 6 examined aspects was all over 0.80.The index of content validity Scale Content Validity Index(S-CVI)was 0.92 and Item Content Validity Index(I-CVI)was 0.83–1.00.Conclusions:Observed results may indicate that the designed tool can be used to assess the TCM confidence level of students with TCM studied experience and also can evaluate results of TCM education during studying TCM lectures.

Optimal exercise intensity and volume to impact rats with Traditional Chinese Medicine phlegm-dampness constitution

Objective:We aim to investigate the effects of different exercise intensities and volumes on Phlegm-dampness constitution(PDC).Methods:The rats were fed with high-fat food and lived in 75%–85%humidity for 6 weeks to establish the model of PDC.Then PDC rats were screened and intervened by varying exercise intensities for 8 weeks.Weight,constitution scores,blood and liver tissues were collected to detect the concentration of serum total cholesterol(Tch),triglyceride(TG),low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C),homocysteine(Hcy),blood glucose(GLU),alanine transaminase(ALT)and percentage of lipid droplet area in liver tissue(PLDA).Results:The weight,Tch,TG,HDL-C,LDL-C,Hcy,GLU,and ALT of rats in moderate-intensity exercise group returned to normal.The rats with high-intensity or low-intensity exercise did not recover as well as moderate-intensity.Conclusion:Different exercise intensities and volumes have different effects on PDC,moderate-intensity exercise over an 8-week intervention is most appropriate.

Considerations on Intervention Goal and Efficacy Evaluation of Traditional Chinese Medicine in the Treatment of Neurological Diseases

In the last several years, traditional Chinese medicine （TCM） has made much progress in the treatment of neurological diseases. The living space of TCM in neurological diseases lies in refractory diseases, aging and chronic diseases caused by multiple factors as well as sub-health state and chronic fatigue state. The effect model of TCM mainly consists of whole effect, self-organization, self-stable model, holographic effect and butterfly effect. The effective point of TCM in neurological diseases lies mainly in end-points and health-related events. Moreover, TCM has advantages in the evaluation of symptoms, syndrome and quality of life （QOL）. Some key indexes should be included when evaluating the efficacy of TCM in neurological diseases. Meanwhile, the advantages of TCM such as end-points, health-related events and QOL should be highlighted. Multi-subject researching methods could be adopted to make a comprehensive evaluation of subjective and objective indexes. The clinical evidence on the TCM efficacy evaluation may come from RCTs, and other types of designs can also be considered.

Opening up a Way of Evaluating Evidence-based Medicine in Traditional Chinese Medicine

Evidence-based medicine is an authoritative way of evaluating the clinical efficacy of drugs, which provides the direct evidence for clinical medication. The rise of evidence-based medical research brought about the changes in Chinese medicine from the empirical medical era into the era of evidence-based medicine. Chinese medicine, as the experience