Developments in the study of Chinese herbal medicine's assessment index and action mechanism for diabetes mellitus

In traditional Chinese medicine(TCM),based on various pathogenic symptoms and the‘golden chamber’medical text,Huangdi Neijing,diabetes mellitus falls under the category‘collateral disease’.TCM,with its wealth of experience,has been treating diabetes for over two millennia.Different antidiabetic Chinese herbal medicines re-duce blood sugar,with their effective ingredients exerting unique advantages.As well as a glucose lowering effect,TCM also regulates bodily functions to prevent diabetes associated complications,with reduced side effects compared to western synthetic drugs.Chinese herbal medicine is usually composed of polysaccharides,saponins,al-kaloids,flavonoids,and terpenoids.These active ingredients reduce blood sugar via various mechanism of actions that include boosting endogenous insulin secretion,enhancing insulin sensitivity and adjusting key enzyme activity and scavenging free radicals.These actions regulate glycolipid metabolism in the body,eventually achiev-ing the goal of normalizing blood glucose.Using different animal models,a number of molecular markers are available for the detection of diabetes induction and the molecular pathology of the disease is becoming clearer.Nonetheless,there is a dearth of scientific data about the pharmacology,dose-effect relationship,and structure-activity relationship of TCM and its constituents.Further research into the efficacy,toxicity and mode of action of TCM,using different metabolic and molecular markers,is key to developing novel TCM antidiabetic formulations.

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.

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.

How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern.The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine.In this paper,we propose a reappraisal protocol called“precise proprietary Chinese medicine”to precisely i)define the therapeutic aim;ii)design the protocol;iii)control the quality of proprietary Chinese medicine;iv)implement the protocol in the trial;v)study the mechanism-of-action of the proprietary Chinese medicine and vi)describe the indications of the proprietary Chinese medicine.We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

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.

Patient-reported Outcomes (PROs): An Approach to Evaluate Treatment Efficacy of Chinese Medicine or Integrative Medicine

Chinese medicine (CM) has been an experience based practice over the past three thousand years. The safety and efficacy of CM has been practised through experience, rather than nowadays’ modern scientific measurements. In this way, the development of CM has not been keeping pace with the advance in science and technology and the progress in orthodox medicine. In order to meet the requirements of modern science and technology, an evidence based approach must be adopted. Reassurance is needed to convince people for safety and efficacy of CM and give confidence to the evidence based demands ——“Tradition is confirmed by Modern Science” (1) .

Comparative Evaluation of Antitumor Chinese Patent Medicine Injections Based on Evidence-Based Medicine and Markov Model

Objective: The objective of this study was to explore the safety, efficacy, economy, and other aspects of frequently-used antitumor Chinese patent medicine injections through a comprehensive evaluation of evidence-based medical research to provide scientific information and decision-making basis for drug selection, rational drug use, public awareness of safe drug use, and medical insurance. Materials and Methods: The names of five frequently used antitumor Chinese patent medicine injections were used as search terms, including the compound Sophora flavescens injection, Kangai injection, Aidi injection, Kanglaite injection, and Brucea javanica oil emulsion injection. Relevant evidence-based medical research was extracted from the databases. A descriptive evaluation was conducted, and the Markov model was used for the cost-benefit analysis. Finally, the above injections are ranked by comprehensive scores using the multi-criteria decision analysis and Delphi method. Results: The five injections had their own advantages in enhancing the effectiveness of anti-tumor treatments, improving the quality of life for cancer patients, and reducing the incidence of adverse reactions. From the perspective of economy and other attributes, compound S. flavescens was superior to B. javanica oil, Aidi, Kangai, and Kanglaite. After a comprehensive evaluation of the above five injections, the compound S. flavescens injection received the highest score. Conclusions: Compound S. flavescens, Kangai, Aidi, B. javanica oil, and Kanglaite have their own advantages in effectiveness and no significant difference in safety. Compound S. flavescens injection has the highest comprehensive score. Clinical attention should be paid to monitoring the initial stage of medication and special groups.

On the Reform of ESP Curriculum for New Medicine Discipline

This paper discusses the reform of ESP(English for special purpose)curriculum in Chinese medicine universities for new medicine discipline.The reconstruction of ESP curriculum and evaluation system can better meet different students’needs,broaden their horizons,and cultivate compound talents of Chinese medicine with more competitiveness and international vision.

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.

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.

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.

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.

Effect of Western medicine therapy assisted by Ginkgo biloba tablet on vascular cognitive impairment of none dementia

Objective:To discuss the clinical effects of Western medicine therapy assisted by Ginkgo biloba tablet(GBT) on patients with vascular cognitive impairment of none dementia(VCIND).Methods: A total of 80 patients with VCIND were divided into two groups randomly:Conventional treatment group(control group) and combined treatment group.Conventional treatment group was given conventional treatment with anti-platelet aggregation.In this group,75 mg aspirin was given three times a day for 3 months.While in combined treatment group,19.2 mg CRT was given three times a day for 3 months together with conventional treatment(anti-platelet aggregation drugs). Montreal cognitive assessment(MoCA) and transcranial Doppler(TCD) were used to observe changes of cognitive ability and cerebral blood flow in VCIND patients before and after treatment in both groups.Then the clinical data were analyzed so as to compare the efficacy in two groups. Results:After 3 month-treatment in combined treatment group,the scores of executive ability, attention,abstract,delayed memory,orientation in the MoCA were significantly increased compared with those before treatment and those in control group after treatment.Besides,blood flow velocity of anterior cerebral artery increased significandy than that before treatment and that in control group after treatment.Conclusions:CBT tablet can improve the therapeutic efficacy as well improve cognitive ability and cerebral blood flow supply of patients with VCIND.

Methodological Approaches to Developing and Establishing the Body of Evidence on Post-marketing Chinese Medicine Safety

ABSTRACT Evidence based medicine demands the highest form of scientific evidence to demonstrate the efficacy and clinical effectiveness for any therapeutic intervention in order to provide best care. It is however accepted that in the absence of scientific evidence, personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety, post- marketing surveillance （PMS） has focussed on follow up of observational cohorts exposed to a particular drug in order to estimate the incidence of adverse drug reactions （ADRs）. Evidence on PMS of Chinese herbal products is still limited, in particular for herbal injections. The aim of this article is to suggest a new model of ascertaining the safety of Chinese medicine using a more comprehensive approach for collecting data. To collect safety data on the Chinese herbal injection, Kudiezi, a mixed methods approach is proposed using 18 hospital information systems to detectADRs in order to prospectively observe 30,000 patients over 3 years. Evidence will also be collected using a questionnaire survey and through a sample of semi structured interviews. This information based on the expert opinion and the experience of clinicians will produce additional data on the frequency and types of side effects in clinical practice. Furthermore semi structured interviews with a random sample of patients receiving the injection will be carried out to ascertain any potential side effects missed. It is hoped that this comprehensive approach to data collection will accumulate wider evidence based on individual traditional Chinese medicine care and treatment and provide important feedback to the national data collection system to ensure completeness of ADR data recording, monitoring and any potential wider effects through developing improved ADR guidelines.

Screening and evaluation of commonly-used anti-influenza Chinese herbal medicines based on anti-neuraminidase activity

Anti-influenza Chinese herbal medicines(anti-flu CHMs) have advantages in preventing and treating influenza virus infection. Despite various data on antiviral activities of some anti-flu CHMs have been reported, most of them could not be compared using the standard evaluation methods for antiviral activity. This situation poses an obstacle to a wide application of anti-flu CHMs. Thus, it was necessary to develop an evaluation method to estimate antiviral activities of anti-flu CHMs. In the present study, we searched for anti-flu CHMs, based on clinic usage, to select study objects from commonly-used patented anti-flu Chinese medicines. Then, a neuraminidase-based bioassay, optimized and verified by HPLC method by our research group, was adopted to detect antiviral activities of selected 26 anti-flu CHMs. Finally, eight of these herbs, including Coptidis Rhizoma, Isatidis Folium, Lonicerae Flos, Scutellaria Radix, Cyrtomium Rhizome, Houttuynia Cordata, Gardeniae Fructus, and Chrysanthemi Indici Flos, were shown to have strong antiviral activities with half maximal inhibitory concentration(IC_(50)) values being 2.02 to 6.78 mg·m L^(–1)(expressed as raw materials). In contrast, the IC_(50) value of positive control peramivir was 0.38 mg·m L^(–1). Considering the extract yields of CHMs, the active component in these herbs may have a stronger antiviral activity than peramivir, suggesting that these herbs could be further researched for active compounds. Moreover, the proposed neuraminidase-based bioassay was high-throughput and simple and could be used for evaluation and screening of anti-flu CHMs as well as for their quality control.

Establishing Chinese Medicine Characteristic Tumor Response Evaluation System Is the Key to Promote Internationalization of Chinese Medicine Oncology

The features and advantages of Chinese medicine （CM） in cancer comprehensive treatment have been in the spotlight of experts both at home and abroad. However, how to evaluate the effect of CM more objectively, scientifically and systematically is still the key problem of clinical trial, and also a limitation to the development and internationalization of CM oncology. The change of tumor response evaluation system in conventional medicine is gradually consistent with the features of CM clinical effect, such as they both focus on a combination of soft endpoints （i.e. quality of life, clinical benefit, etc.） and hard endpoints （i.e. tumor remission rate, time to progress, etc.）. Although experts have proposed protocols of CM tumor response evaluation criteria and come to an agreement in general, divergences still exist in the importance, quantification and CM feature of the potential endpoints.Thus, establishing a CM characteristic and wildly accepted tumor response evaluation system is the key to promote internationalization of CM oncology, and also provides a more convenient and scientific platform for CM international cooperation and communication.