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.

Progress in clinical research on the integration of Chinese and Western medicines for treating primary liver cancer

Primary liver cancer(PLC) is one of the most common malignant tumors in China. PLC is characterized by insidious onset, rapid progress, poor quality of life, and short survival time. Notably, current treatment strategies remain unsatisfactory. Traditional Chinese medicines(TCM) have been used to treat a variety of diseases, including liver diseases, for more than 2000 years. In this study, we performed a review of the use frequency and clinical efficacy of TCM in treating PLC. Relevant literature from January 1, 2009, to January 1, 2021 was retrieved from network databases of China National Knowledge Infrastructure(CNKI), Chongqing VIP, Wanfang, PubMed, and SinoMed. The most frequently used TCM and their efficacy in PLC treatment were summarized. Based on the inclusion and exclusion criteria, 33 articles were selected. Overall, the efficacy of the combination of TCM and Western medicines in the treatment of PLC was higher than that in the control groups(i.e. treatment with Western medicines alone)(65.11% vs.44.31%, P <.05). Among the 33 selected articles, 11 were investigated for TCM preparation(marketed drugs) and 22 for TCM formulas. In total, 102 types of TCM(single herbs) were used to treat PLC. The top five most frequently used TCM were Poria(14.71%), Astragali radix(13.73%), Atractylodis Macrocephalae Rhizoma(12.75%), Bupleuri radix(12.75%), and Glycyrrhizae radix et Rhizoma(11.76%). Of the 102 types of TCM, tonics were the most frequently used categories, followed by heat-clearing medicines, blood-invigorating medicines, and stasis-resolving medicines. Of 207 papers, 174(84.06%) could not be subjected to statistical analysis due to research quality. Further high-quality research on herb sources, formula components and dosage, toxicology, and ethics of TCM is necessary. In conclusion, TCM play a promising role in the treatment and management of PLC, although further investigations are warranted.

Clinical Research progress of traditional Chinese medicine in treating esophageal cancer

Esophageal cancer is one of the most common malignant tumors in the world. In recent years, the incidence and mortality of esophageal cancer have increased year by year, which has seriously threatened human health. Surgery, chemotherapy and radiotherapy, as the primary treatments of Western medicine, have achieved specific results in the clinic, but each has its limitations, this is mainly related to their side effects. The diversified treatment methods of traditional Chinese medicine have visible clinical effects, especially in terms of reducing toxicity and increasing efficiency. This present review reviews the research progress of esophageal cancer in terms of traditional Chinese medicine treatment, including the application of Chinese medicine extract, Chinese herbal compound, Chinese patent medicine and TCM external treatment in clinical practice, may provide valuable information for the adjuvant treatment of esophageal cancer with traditional Chinese medicine.

Clinical research progress of oral administration of traditional Chinese medicine in the treatment of dry eyes

Dry eye is a common and frequently occurring ophthalmology disease with complex etiology and easy recurrence.Oral administration of traditional Chinese medicine has the characteristicsof high curative effect and little toxic and side effect in the treatment of dry eye.This paper collates the domestic reported clinical studies on the oral administration of traditional Chinese medicine in the treatment of dry eye,which are discussed from four aspects:special prescription for specific disease,addition and subtraction of main prescription,treatment based on syndrome differentiation and proprietary Chinese medicine.The curative effect and advantages of traditional Chinese medicine in the treatment of dry eye are demonstrated,providing a reference for the treatment of dry eye in the future.

Necessities and feasibilities of the establishment of traditional Chinese medicine clinical research protocol database

随着中医药国际化和现代化的进程，中医临床研究积累了丰富的研究信息资源，但这些资源往往分散在各个检索系统，这给参考和利用这些信息造成一定的困难。基于此，我们收集整理发表在国际期刊上的中医临床研究方案，建立中医临床研宄方案库，使高质量研究本地化管理，进而提高国内中医临床研究水平。本文分析中医临床研究方案现存的主要问题，阐述建立中医临床研究方案库的必要性和可行性，提出建库的基本技术思路，为实际开展方案库建设奠定理论基础。

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.

Traditional Chinese Medicine’s Challenge to Clinical Science and Health Policy

Traditional Chinese medicine(TCM)has been improving human health for millennia.And for that,it has gradually gained the attention of the global scientific community.TCM clinical research progresses,but slowly.I see it as being held back by perverse incentive structures in science and regulatory politics.

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.

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.

Application of evidence-based medicine methods in integrative oncology research

To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care and summarized the available evidence.Pragmatic randomized controlled trials(pRCTs)and clinical registry studies are becoming more popular as they could compensate for the limitations of RCTs.Many RCTs of TCM for cancer treatment as well as systematic reviews have been published.The most investigated therapies are based on acupuncture,Chinese herbal compounds,and Chinese patent medicines.Acupuncture has a significant advantage in relieving cancer-related symptoms.Published studies focus more on improving clinical symptoms and laboratory indicators.However,the patient's quality of life deserves more attention.

Chinese herbal medicines for prostate cancer therapy: From experimental research to clinical practice

Prostate cancer remains the second most common malignancy in men worldwide, is a global health issue,and poses a huge health burden. Precision medicine provides more treatment options for prostate cancer patients, but its popularity, drug resistance, and adverse reactions still need to be focused on. Chinese herbal medicines(CHMs) have been widely accepted as an alternative therapy for cancer, with the advantages of multiple targets, multiple pathways, and low toxicity. We searched the experimental research and clinical practice of CHMs for prostate cancer treatment published in Pub Med, Embase, and Web of Science in the last five years. We found five CHM formulas and six single CHM extracts as well as 12 CHM-derived compounds, which showed induction of apoptosis, autophagy, and cell cycle arrest, suppression of angiogenesis, proliferation, and migration of prostate cancer cells, reversal of drug resistance,and enhancement of anti-tumor immunity. The mechanisms of action include the PI3K/Akt/mTOR, AR,EGFR and Wnt/β-catenin signaling pathways, which are commonly implicated in the development of prostate cancer. We also summarized the advantages of CHMs in patients with hormone-sensitive and castration-resistant prostate cancer and provided ideas for their further experimental design and application.

Advances in Traditional Chinese Medicine for Gout

Gout has an increasing morbidity rate around the world,correlating well with hypertension,hyperlipidemia,atherosclerosis,obesity and insulin resistance,and so on.In view of Traditional Chinese Medicine(TCM),gout belongs to arthromyodynia.Keys to syndrome differentiation of TCM are in differentiation,corporeality and coated tongue(characterized to be damp).According to the dialectical characteristics of gout TCM,this paper summarized the research of gout TCM,including food-based traditional Chinese medicine,bill of lading medicine,drug extraction,optimal herbs and dosage,individual herb and compound prescription,in order to explore and elaborate the objective curative effect and exact mechanism of gout treated by TCM.

Reporting guidelines of Chinese medicine:Current situation and future development

Objective:Reporting research is as important a part of a study as its design or analysis.Reporting guidelines(RGs)provide structured advice on how to report research studies clearly and adequately.This study aimed to review the development of RGs of Chinese medicine(CM)and to provide recommen-dations for improvement.Methods:Through a systematic search of the Enhancing the QUAlity and Transparency Of health Research(EQUATOR)Network and electronic databases up to January 1,2022,we identified a total of 15 RGs of CM,and further summarized their characteristics and applications.In addition,we reviewed the development of international RGs and analyzed its impact for CM.Results:Compared with the generic RGs,the reporting standards of CM have been rapidly developed over the last 10 years,of which 57%were issued in recent 3 years(2019-2021).Currently,the system of RGs of CM has been established,especially for clinical trials,including various CM interventions and covering the guidelines from trial registration,protocol,results publication to the evidence synthesis and clinical practice guideline.However,the application of RGs of CM is suboptimal.Conclusion:It is necessary to take further measures to promote practical application,improve journals’endorsement,and establish quality monitoring procedures for RGs of CM in the future.

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.

The Application of Assessment of the Quality of Life in the Clinical Efficacy Evaluation System and the Selection of Questionnaires of Chinese Medicine Treating Tumors

In China, CM has been applied to treat almost every cancer patient, especially during the observation period after surgery, routine radiotherapy and chemotherapy. Several decades of CM treatment results have shown that CM treatment could be helpful in improving patients＇ physical rehabilitation, relieving symptoms and strengthening immunity. CM also could aid in the decline of rates of recurrence and metastasis, prolong the survival time, and especially, have significant effects on relieving symptoms such as relieving fatigue, improving syndromes caused by conventional therapies （surgery, radiotherapy, chemotherapy and biological treatment）, and indescribable discomforts caused by the unknown reason. It has been found in several studies that conventional medical treatment combined with CM could significantly improve QOL, and reduce treatment-related and disease-related symptoms. Patients treated with CM and Western medicine have higher scores in the fields of psychology, society,

Some Reflections on the Evaluation of Clinical Effectiveness of Chinese Medicine in China

The randomized controlled trial （RCT） as applied to medicine started in the mid last century（1） and is now deemed as the most rigorous scientific method for evaluating the clinical effectiveness of medical interventions. The earliest RCTs in Chinese medicine （CM） appeared in the early 1980s. In the past 30 years, RCT was seen to have gradually infiltrated into and have been accepted reluctantly by CM.

Clinical research of traditional Chinese medicine in big data era

With the advent of big data era, our thinking, technology and methodology are being transformed. Data-intensive scientific discovery based on big data, named ＂The Fourth Paradigm,＂ has become a new paradigm of scientific research. Along with the development and application of the Internet information technology in the field of healthcare, individual health records, clinical data of diagnosis and treatment, and genomic data have been accumulated dramatically, which generates big data in medical field for clinical research and assessment. With the support of big data, the defects and weakness may be overcome in the methodology of the conventional clinical evaluation based on sampling. Our research target shifts from the ＂causality inference＂ to ＂correlativity analysis.＂ This not only facilitates the evaluation of individualized treatment, disease prediction, prevention and prognosis, but also is suitable for the practice of preventive healthcare and symptom pattern differentiation for treatment in terms of traditional Chinese medicine （TCM）, and for the post-marketing evaluation of Chinese patent medicines. To conduct clinical studies involved in big data in TCM domain, top level design is needed and should be performed orderly. The fundamental construction and innovation studies should be strengthened in the sections of data platform creation, data analysis technology and big-data professionals fostering and training.

Could We Use Clinical Benefit to Evaluate the Effects of Chinese Medicine on the Treatment of Cancer?

The patients, who cannot endure the chemotherapy anymore, or internal disease or present drug resistance, normally use CM for improving their physical conditions and inhibiting tumor. CM has got excellent reputation because of the effects. Nonetheless, few clinical articles of CM to treat cancer are published on major international journals up to now.

Experience inheritance from famous specialists based on real- world clinical research paradigm of traditional Chinese medicine

The current modes of experience inheritance from famous specialists in traditional Chinese medicine （TCM） include master and disciple, literature review, clinical-epidemiology-based clinical research observation, and analysis and data mining via computer and database technologies. Each mode has its advantages and disadvantages. However, a scientific and instructive experience inheritance mode has not been developed. The advent of the big data era as well as the formation and practice accumulation of the TCM clinical research paradigm in the real world have provided new perspectives, techniques, and methods for inheriting experience from famous TCM specialists. Through continuous exploration and practice, the research group proposes the innovation research mode based on the real-world TCM clinical research paradigm, which involves the inheritance and innovation of the existing modes. This mode is formulated in line with its own development regularity of TCM and is expected to become the main mode of experience inheritance in the clinical field.