Consideraciones Éticas y Académicas sobre el Uso de Inteligencia Artificial en Cursos de Metodología de la Investigación en Rehabilitación / Ethical and Academic Reflections on the Integration of Artificial Intelligence in Research Methodology Courses in Rehabilitation Science

En el cruce entre la revolución tecnológica y la educación en ciencias de la rehabilitación y del movimiento humano, la inteligencia artificial (IA) emerge como herramienta transformadora en los cursos de metodología de investigación. Este artículo destaca su potencial para optimizar la experiencia de aprendizaje y personalizar la instrucción, pero enfatiza la necesidad crucial de abordar desafíos éticos y pedagógicos. Propone orientaciones para equilibrar la innovación educativa y la responsabilidad académica, resaltando la importancia de la implementación consciente y planificada de la IA en los equipos de investigación en ciencias de la rehabilitación y del movimiento humano, garantizando así la integridad científica y ética en este campo en constante evolución.

In the intersection between technological advancements and education in rehabilitation science, artificial intelligence (AI) emerges as a transformative tool in research methodology. This article navigates the ethical and academic considerations tied to the incorporation of AI in rehabilitation and movement science courses. While acknowledging its potential to enhance learning experiences, it critically addresses the imperative to tackle ethical and pedagogical challenges. The paper offers guidance to strike a balance between educational innovation and academic responsibility. It emphasizes the need for a conscientious and planned implementation of AI, ensuring both scientific integrity and ethical adherence in this dynamically evolving field.

Intervention of Chinese Herbal Medicine Formulas on Oxidative Stress of Chronic Obstructive Pulmonary Disease： A Review / 中国实验方剂学杂志

Chronic obstructive pulmonary disease （COPD） is a common disease in clinical practice. It is associated with obvious exposure to toxic particles or gases and has become the leading cause of death and disability worldwide. The pathogenesis of COPD is complex， and the oxidative stress involved in COPD plays a crucial role in the pathological process of the disease. Patients with COPD usually have high levels of oxidative stress in the lungs， which will affect the whole body for a long time， causing a variety of complications and accelerating the development of the disease. On the one hand， oxidative stress can directly damage the airway and lung tissue. On the other hand， it also drives other pathological mechanisms to jointly promote the development of disease， such as participating in inflammatory reactions and protease/anti-protease imbalance， promoting mucus secretion， accelerating cellular senescence， causing autoimmunity， and involving in genetic regulatory pathways. At present， western medicine treatment is mostly based on conventional drug treatment， and antioxidant-targeted oxidative stress is adopted， but there are still some challenges in efficacy and safety. Traditional Chinese medicine has a long history of preventing and treating COPD. In particular， Chinese herbal medicine formulas have great potential to interfere with the oxidative stress of COPD. Whether it is the modified classical traditional Chinese medicine or the new formulation developed by modern doctors， the research results reflect the multi-target and multi-channel advantages of traditional Chinese medicine treatment， and their efficacy and safety are gradually verified. This paper reviewed the literature in recent years， starting with the basic and clinical research on the intervention of traditional Chinese herbal medicine formulas on oxidative stress of COPD， so as to provide further ideas for related research on the prevention and treatment of oxidative stress of COPD by traditional Chinese medicine.

Enhancing medical ethics education for medical students in clinical research: considerations and strategy analysis / Mejorando la educación ética médica para los estudiantes de medicina en la investigación clínica: consideraciones y análisis de estrategias / Melhorando a educação de ética médica para estudantes de medicina em pesquisa clínica: pensamentos e análise de estratégia

In recent years, the vigorous development of clinical researches carried out by medical schools is inseparable from the effective participation of medical students. However, as the number and categories of clinical research projects that medical students participate in increase, medical ethics related issues gradually occur. This article sorts out the ethical issues that arose in clinical researches, in which medical students participated, analyzes the underlying causes, and proposes solutions for the above-mentioned ethical issues, aiming to provide reference for medical ethics education and research project management for medical schools.

La participación efectiva de los estudiantes de medicina ha contribuido en gran medida al desarrollo exitoso de la investigación clínica en las escuelas de medicina de China en los últimos años. Sin embargo, con el creciente número y tipos de proyectos de investigación clínica en los que participan estudiantes de medicina, las cuestiones éticas se exponen gradualmente. Este trabajo enumera las cuestiones éticas que han surgido en la participación de los estudiantes de medicina en la investigación clínica en los últimos años, analiza las causas subyacentes y propone soluciones a las cuestiones éticas mencionadas anteriormente, con el objetivo de proporcionar referencia para la enseñanza de la ética médica y la gestión de proyectos de investigación para las escuelas de medicina.

A participação efetiva dos estudantes de medicina tem contribuído muito para o próspero desenvolvimento da pesquisa clínica nas escolas médicas da China nos últimos anos. No entanto, com o aumento do número e tipos de projetos de pesquisa clínica dos quais os estudantes de medicina participam, questões relacionadas à ética e à alfabetização são gradualmente expostas. Este artigo lista as questões éticas que surgiram na participação de estudantes de medicina em pesquisas clínicas nos últimos anos, analisa as causas subjacentes e propõe soluções para as questões éticas acima mencionadas, com o objetivo de fornecer referência para o ensino de ética médica e gestão de projetos de pesquisa para escolas médicas.

Innovative mechanisms of pre-marketing authorization access for rare diseases in Brazil: a case study of pabinafusp-alfa for mucopolysaccharidosis type II / Mecanismos inovadores de acesso pré-comercialização a tecnologias para doenças raras no Brasil: um estudo de caso de alfapabinafuspe para mucopolissacaridose tipo II

Patients with rare diseases frequently face unmet medical needs due to the high costs, lengthy development times, and slow approval processes for new treatments. This case study discusses innovative access alternatives for rare diseases in Brazil, focusing on early access to pabinafusp-alfa for mucopolysaccharidosis type II (MPS-II), a rare genetic lysosomal storage disease characterized by a deficiency of the enzyme iduronate-2-sulfatase. From September 2018 to March 2023, 20 Brazilian MPS-II patients received pabinafusp-alfa through a clinical research protocol. This enzyme replacement therapy (ERT) crosses the blood-brain barrier to address central nervous system manifestations unmet by existing treatments. Patients' participation in the clinical study resulted in an estimated BRL 65 million in cost savings for the public healthcare system compared to conventional ERT with idursulfase-alfa and potentially better clinical outcomes. The case study underscores the importance of innovative mechanisms in addressing patients' medical needs. Early access alternatives include: a) clinical study access, with execution/development aligned with healthcare managers and linked to future access strategies; b) regulatory-level risk-sharing, considering effectiveness uncertainties and the possibility of market withdrawal and/or reimbursement in case of negative results; and c) drug pre-delivery, with payment contingent on positive phase III clinical study outcomes. Although public-private partnerships in clinical research are underused, they could benefit all stakeholders by accelerating drug development, facilitating early patient access to innovative medicines, and generating healthcare system savings, particularly for rare diseases.

Pacientes com doenças raras frequentemente enfrentam necessidades médicas não atendidas devido aos altos custos, longos tempos de desenvolvimento e processos de aprovação lentos para novos tratamentos. Este estudo de caso discute alternativas inovadoras de acesso para doenças raras no Brasil, com foco no acesso precoce ao alfapabinafuspe para mucopolissacaridose tipo II (MPS-II), uma doença lisossômica de armazenamento genético rara, caracterizada por uma deficiência da enzima iduronato-2-sulfatase. De setembro de 2018 a março de 2023, 20 pacientes brasileiros com MPS-II receberam alfapabinafuspe por meio de pesquisa clínica. Essa terapia de reposição enzimática (TRE) atravessa a barreira hematoencefálica para tratar manifestações do sistema nervoso central não atendidas pelos tratamentos existentes. A participação dos pacientes no estudo clínico resultou em uma economia estimada de 65 milhões de reais para o sistema público de saúde, em comparação com a TRE convencional com idursulfase alfa, além de potencialmente melhores resultados clínicos. O estudo de caso destaca a importância de mecanismos inovadores no atendimento das necessidades médicas dos pacientes. As alternativas de acesso precoce incluem: a) acesso por meio de estudos clínicos, com execução/desenvolvimento alinhada aos gestores de saúde e vinculada a estratégias futuras de acesso; b) compartilhamento de risco em nível regulatório, considerando as incertezas de eficácia e a possibilidade de retirada do mercado e reembolso em caso de resultados negativos; e c) pré-entrega do medicamento, com pagamento condicionado aos resultados positivos do estudo clínico de fase III. Embora as parcerias público-privadas em pesquisa clínica sejam subutilizadas, elas poderiam beneficiar todas as partes interessadas ao acelerar o desenvolvimento de medicamentos, facilitar o acesso precoce dos pacientes a medicamentos inovadores e gerar economias para o sistema de saúde, especialmente para doenças raras.

Continue to improve the high-quality multi-center clinical research in colorectal surgery in China / 中华消化外科杂志

High-quality clinical research is an important method to improve clinical diagnosis and treatment, promote discipline construction, and expand the frontier of medicine. In recent years, multi-center clinical studies in colorectal surgery in China have increased, and the level of clinical research has gradually improved, accumulating a wealth of clinical research experience. Innovative research topics and scientific design are the foundations of high-quality clinical research. Standardization of surgical techniques and quality control at all steps of the study are key to high-quality research. At the same time, researchers should establish a data management system, select appropriate data collection systems, and conduct regular data checks and feedback to ensure the quality of research data. Fully utilizing the advantages of case resources and further enhancing clinical research capabilities will provide assistance in promoting high-quality clinical research in the field of colorectal surgery in China. The authors summarize the experience of high-quality clinical research in colorectal surgery at home and abroad, in order to further promote the development of high-quality clinical research in China.

Clinical Evidence of Oral Chinese Patent Medicines in Treatment of Chronic Kidney Disease： A Scoping Review / 中国实验方剂学杂志

ObjectiveTo review the information and clinical studies of oral Chinese patent medicines （CPMs） for chronic kidney disease （CKD）. MethodThe CPMs for treating CKD were retrieved from the Pharmacopoeia of the People's Republic of China， National Essential Drugs List， and Medicine List for National Basic Medical Insurance， Employment Injury Insurance and Maternity Insurance. China National Knowledge Infrastructure（CNKI）， VIP， Wanfang Data， SinoMed， PubMed， Embase， Cochrane， and Web of Science were searched for the clinical trials of the treatment of CKD by CPMs from their inception dates to September 25， 2022. A database was established with the collected CPMs， and then the general conditions of the clinical trials were analyzed and presented visually. ResultA total of 16 CPMs for CKD were included in this study， including 5 classical traditional Chinese medicine （TCM） prescriptions involving Rehmanniae Radix and 11 new CPMs. The indications of the TCM prescriptions did not mention the corresponding western disease names， and those of the new CPMs mainly included chronic renal insufficiency， chronic renal failure， and chronic nephritis. Four CPMs were prepared with single Chinese medicine or active components. Specifically， Bailing Preparation and Jinshuibao Preparation were mainly prepared with the powder of Cordyceps， and the main components of Haikun Shenxi capsules and Huangkui capsules were fucoidan sulfate and the flower extract of Abelmoschi Corolla， respectively. The CPMs mainly exerted tonifying and eliminating effects on the lung， spleen， and kidney. A total of 892 clinical trials were screened out， covering all the areas in China and presented an increasing trend. Bailing Preparation was the most studied， followed by Niaoduqing Preparation. Among the 892 studies， 475 focused on single CPMs without combination with other CPMs or therapies. These studies mainly compared between conventional intervention and conventional intervention + CPM， which accounted for 75.58%. The 475 studies covered different kidney diseases， such as chronic kidney disease， chronic renal failure， nephrotic syndrome， diabetic kidney disease， IgA nephropathy， and membranous nephropathy， and involved a variety of populations including the elderly and children. Thirty-six studies evaluated TCM syndromes， reflecting the characteristics and advantages of TCM treatment. ConclusionThere are abundant oral CPMs for CKD， with varied efficacy and characteristics for different kidney diseases. However， the instruction manuals of the oral CPMs are not detailed or standard. According to the clinical research evidence in this field， the research on oral CPMs for CKD is characterized by a wide scope， rich study types， and wide disease coverage， while the sample size and quality remain to be improved.

Treatment of Allergic Rhinitis with Traditional Chinese Medicine： A Review / 中国实验方剂学杂志

This article reviews the clinical studies about the treatment of allergic rhinitis （AR） with traditional Chinese medicine （TCM） in recent years. AR is a common and frequently occurring disease in the department of otolaryngology. The common manifestations of AR include nasal congestion， sneezing， runny nose， and nasal itching. AR， belonging to the category of rhinitis， is a dominant disease in the TCM treatment of otorhinolaryngologic diseases and head and neck diseases. The ancient literature has laid a solid theoretical basis on the etiology and pathogenesis of AR. According to the ancient literature， the theoretical basis， and their own experience， modern doctors classified the causes of AR into the disorders in Zang-fu organs and six meridians. Most of the explanations focus on the disorders in Zang-fu organs， especially the lung， spleen， and kidney. The clinical studies in this field mainly involve TCM treatment alone， integrated TCM and Western medicine treatment， and TCM external treatment. These therapies have good efficacy in the clinical treatment of AR. Among them， TCM treatment alone has significant advantages in alleviating the symptoms and nasal signs， declining the scores of related scales， and reducing the eosinophil count （EOS） of nasal secretions， with definite long-term efficacy. Integrated TCM and Western medicine treatment can complement with each other. The TCM external treatment methods include acupuncture， moxibustion， acupoint catgut embedding， acupoint application， and nasal irrigation with TCM， which are safe， simple， acceptable by patients and have good therapeutic effect. Finally， the clinical research status of TCM treatment of AR was summarized， and suggestions were put forward from three aspects： standardizing the clinical research protocol of TCM， encouraging pure TCM research， and exploring the mechanism of TCM treatment on the basis of frontier research achievements. This review aims to provide higher-level evidence for subsequent clinical research and promote the research on dominant AR diseases.

The Methodology and Practices of Real-world Study of Acupuncture and Moxibustion / 中山大学学报(医学科学版)

Real-world study is based on evidence in real clinical medical environments. The results of real-world study have high clinical applicability and strong extrapolation， and are more in line with the characteristics of acupuncture and moxibustion. Therefore， real-world study is receiving more and more attention from the clinical research community. In this article， we briefly analyze the compatibility between real-world study and clinical research of acupuncture and moxibustion，and discuss the implementation of real-world research methodology of acupuncture and moxibustion. In addition， the shortcomings and countermeasures of real-world study on acupuncture and moxibustion in China are also summarized. At the end， we provide an outlook on the application of real-world study in clinical research of acupuncture and moxibustion.

Clinical Researches on Chinese Patent Drug for Diabetes： A Scoping Review / 中国实验方剂学杂志

ObjectiveTo review the drug information and clinical researches on Chinese patent drug in Pharmacopoeia of the People's Republic of China，National Essential Drugs List and Medicine List for National Basic Medical Insurance，Employment Injury Insurance and Maternity Insurance. MethodSearch Chinese patent medicine，which can reduce blood sugar in the three major catalogues above. CNKI，VIP，Wanfang，Embase and PubMed were searched from their inception dates to August 14th，2021 for the clinical researches on Chinese patent drug. A database was established based on the collected Chinese patent drug for the treatment of diabetes. And then，descriptive analysis was performed to analyze the general condition of clinical researches． ResultFrom the three catalogues above，28 kinds of Chinese patent drugs were retrieved， and Supplementing Qi and Nourishing Yin was the basic effect of 22 kinds of Chinese patent drugs. A total of 1 069 clinical researches published and peaked in 2017 before August 14th，2021 were included. Clinical studies have been carried out and published in all 30 provinces and autonomous regions，and the province with the largest number of published literature was Henan.What's more，16.65% of the projects were supported by government funding. The number of research to Shenqi Jiangtang tablets/granules/capsules was the largest，among the 28 kinds of Chinese patent drugs.Besides，the most frequent type of interventions in the 958 two-arm trials was the load test，accounting for 78.91%.Most types of diabetes，including type 1 diabetes，type 2 diabetes and its complications，gestational diabetes，other types of diabetes and pre-diabetes，were covered in in this study. And the results showed that different drugs with different suitable crowd. ConclusionA summary of the current status of clinical research on Chinese patent drug by means of scoping review can provide direction for the next research.

Clinical Evidence of Oral Chinese Patent Medicines in Treatment of Cardiac Arrhythmia： A Scoping Review / 中国实验方剂学杂志

ObjectiveTo review the drug information and research progress on oral Chinese patent medicines in the treatment of cardiac arrhythmia to identify existing problems and provide references for follow-up research. MethodChinese patent medicines against cardiac arrhythmia were retrieved from the three major drug catalogues，Yaozh.com，and relevant guidelines with arrhythmia as the retrieval term. The instructions for included Chinese patent medicines were retrieved through Yaozh.com and specific information was extracted. The research articles on Chinese patent medicines included were retrieved from the five databases，and the information meeting the inclusion and exclusion criteria was extracted and displayed in the form of text description and graphs after statistical analysis. ResultSixty-five oral Chinese patent medicines were included in this study，with the main functions of activating the blood and resolving stasis. The average daily cost of medicines was 8.17 yuan，and there were 42 medicines with an average daily cost of less than 10 yuan，showing a moderate medicine cost. A total of 351 research articles on Chinese patent medicines were screened out，including 259 randomized controlled trials （RCTs），16 non-RCTs，eight non-controlled trials，62 systematic reviews，two guidelines，and two expert consensuses. Eighteen types of Chinese patent medicines were involved，whose clinical trials had been conducted in 28 provinces，cities，autonomous regions，and municipalities in China. Wenxin granules and Shensong Yangxin capsules were the top medicines under investigation，accounting for 75.21% of all research articles. Among the included studies，the most common comparison design was Chinese patent medicine combined with western medicine vs western medicine （64.25%）. The outcome evaluation was mainly based on clinical efficacy，symptom efficacy，arrhythmia efficacy，adverse reactions，and heart rate changes. ConclusionThe number of clinical studies of oral Chinese patent medicines against cardiac arrhythmia varies greatly，but traditional Chinese medicine （TCM） syndrome differentiation thinking is less considered in practical application. Due to unstandardized clinical research and low-quality literature，further advancement is required in the future.

Clinical Evidence of Chinese Patent Medicines in Treatment of Respiratory Diseases in Children： A Scoping Review / 中国实验方剂学杂志

ObjectiveThis study performed a scoping review to comprehensively analyze and report the information on the instructions of Chinese patent medicines and clinical research evidence for the treatment of respiratory diseases in children. MethodChinese patent medicines against respiratory diseases in children were obtained by searching the three major drug catalogues. The Chinese and English databases were searched for relevant literature，followed by data statistics and visualized analysis. ResultAfter screening and analysis，52 Chinese patent medicines were included，involving nine dosage forms. The main drugs were Scutellariae Radix，Armeniacae Semen Amarum，Forsythiae Fructus，etc. The main functions included clearing heat and releasing exterior syndrome，and relieving cough and dissipating phlegm. The indications mainly included common cold with wind-heat syndrome and cough in children. Adverse drug reactions and contraindications were only specified in 19.23% （10/52） of Chinese patent medicines，and the rest only displayed "unclear". A total of 279 articles were included，including 277 articles from Chinese Core Periodicals and two articles from SCIE. In terms of research type，those articles included 253 randomized controlled trials （RCTs，with six dosage form/dose comparisons involved），11 retrospective analyses based on Hospital Information System （HIS） data，one case series，13 systematic reviews/Meta-analyses （with two network Meta-analyses involved），and one economic evaluation article. Among them，72.76% （203/279） of the articles were published in the Core Journals of Chinese Science and Technology. Only 33 Chinese patent medicines were involved，and Xiaoer Feire Kechuan Oral Liquid was the top 1 under investigation，accounting for 15.71% （44/280）. The indicated diseases were mainly infantile pneumonia，bronchitis，respiratory tract infection，cough，asthma，and other western medicine diseases. Xiaoer Chiqiao Qingre Granules and Xiaoer Dingchuan Oral Liquid were used off-label. The sample size was concentrated in 51-150 cases，accounting for 67.17% （178/265）. The interventions in the experimental group were mainly Chinese patent medicine + western medicine + basic treatment or Chinese patent medicine + western medicine. The main outcomes were the effective rate and the improvement of clinical symptoms. The adverse reactions were mainly gastrointestinal reactions，drug-induced skin symptoms，etc.，and two studies have shown that drug doses were associated with adverse reactions. ConclusionIn research years，the research on Chinese patent medicines in the treatment of respiratory diseases in children has advanced rapidly. However，there are still some problems that need to be resolved in the future，such as incomplete information on drug content in the instruction，concentrated drugs to be studied，limited indications，failure to highlight the characteristics of traditional Chinese medicine （TCM） syndromes，unstandardized research design，and an incomplete reflection of Chinese patent medicine.

Evaluation methods of clinical efficacy of traditional Chinese medicine / 中国中药杂志

Clinical efficacy is the basis for the development of traditional Chinese medicine(TCM), and the evaluation of clinical efficacy of TCM has always been the focus of attention. The technical and methodological difficulties in the evaluation process often restrict the generation of high-level evidence. Therefore, methodological research should be deepened and innovative practice should be carried out to study the application of scientific research methods in the evaluation of the advantages of TCM. After more than ten years of development, the clinical efficacy evaluation of TCM, on the basis of the initially classic placebo randomized controlled trials, has successively carried out a series of meaningful attempts and explorations in N-of-1 trials, cohort studies, case-control studies, cross-sectional studies, real world studies, narrative medicine studies, systematic evaluation, and other aspects, laying the foundation for the transformation of TCM from "experience" to "evidence". This paper focused on the clinical efficacy evaluation of TCM, summarized the main connotation and development status of efficacy evaluation indicators, standards, and methods, and put forward corresponding countermeasures and suggestions for the problems of indicator selection, standard formulation, and methodology optimization in the research process. It is clear that scientific and objective evaluation of the efficacy of TCM is an urgent problem to be solved at present.

Investigation and analysis of Chinese public 's cognition for clinical research / 中南大学学报(医学版)

OBJECTIVES@#Clinical research plays a vital role in disease research and population health. The public is the main source of clinical research volunteers. Understanding the public's cognition of clinical research plays a decisive role in the development of clinical research. This study aims to understand the Chinese public's cognition for clinical research and the influencing factors.@*METHODS@#The questionnaire based on Chinese-translated Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment (PARTAKE) was used to investigate the public's cognition for clinical research.@*RESULTS@#Of the 2 513 valid respondents, 91.84% had heard of "clinical research", 91.76% of the respondents believed that clinical research was beneficial to society, 65.90% were willing to participate in clinical research, 87.50% believed that confidentiality was a very important thing, 73.70% believed that their personal information had been protected when participating in clinical research, and, 46.40% did not know whether volunteers participating in clinical research could receive adequate compensation. Educational levels, employment status, and annual income impacted in public perceptions of willingness to participate in clinical research, especially in privacy protection, informed consent, whether clinical research is intended for society, compensation for clinical research, and safety of clinical research (all P<0.01).@*CONCLUSIONS@#The Chinese public's cognition level for clinical research is acceptable, but there is still a lot of room for improvement in privacy protection, informed consent, and compensation. By designing a reasonable knowledge training program for clinical research and using the multimedia, improving access to the relevant knowledge, more public will know about clinical research recruitment information, which is of great significance for the development of clinical research in China.

Post-marketing effectiveness evaluation of traditional Chinese medicine in paradigm based on "proving efficacy, conforming standard, and exploring mechanism":a case study of Danhong Injection / 中国中药杂志

At present, new concepts, new technologies, and new methods are emerging in the field of medical research, breaking through the inherent thinking patterns and research models, and promoting the transformation of the research paradigm of traditional Chinese medicine(TCM). This paper gave a case study of clinical research in Danhong Injection in the treatment of chronic stable angina, and based on the background of the study, index evaluation model, experimental design method, blind implementation of placebo, data management system, and exploration of clinical efficacy mechanism of traditional Chinese medicine compounds under the framework of modular pharmacology, the scientific idea of "proving efficacy, conforming standard, and exploring mechanism" was used as the guideline to discuss the research model of reevaluation of the effectiveness of post-marketing TCM varieties. This paper drew a target network map of Danhong Injection in the treatment of chronic stable angina for the first time, which was composed of targeted functional modules. By combining evidence-based clinical research with modular pharmacology framework, changes in the pharmacolo-gical mechanism were finally associated with changes in clinical efficacy, and the advantages of phenotypic correlation of efficacy were explored. This study is expected to provide references for the post-marketing effectiveness evaluation and new ideas for the phenotypic pharmacological mechanism study of multi-target TCM compounds and precise treatment, thereby promoting the innovative development of TCM.

Improving acupuncture research: progress, guidance, and future directions / 中国针灸

This paper makes an interpretation of the collection Acupuncture: how to improve the evidence base published by BMJ & BMJ Open. Studies show that the quality of randomized controlled trial (RCT) of acupuncture is low, and multivariable Meta-regression analysis fails to confirm most factors commonly believed to influence the effect of acupuncture. The methodological challenges in design and conduct of RCT in acupuncture were analyzed, and a consensus on how to design high-quality acupuncture RCT was developed. The number of acupuncture systematic reviews was huge but the evidence was underused in clinical practice and health policy, and a large number of western clinical practice guidelines recommended acupuncture therapy, but the usefulness of recommendations needed to be improved. In view of the problems in clinical research on acupuncture mentioned in this collection, combined with the analysis of the purpose of clinical research on acupuncture, perspectives, study types, as well as the relationship between evidence and clinical decision-making, a five-stage study paradigm of clinical research on acupuncture is proposed.

A Multicenter Clinical Trial of Pudilan Anti-inflammatory Oral Liquid of Different Doses in Treatment of Acute Pharyngitis/Tonsillitis Caused by Bacterial Infection in Adults / 中国实验方剂学杂志

ObjectiveThrough a randomized， double-blind， double-simulation， positive-control， multicenter design， this study aimed to analyze the relationship between the dosage， efficacy， and safety of Pudilan anti-inflammatory oral liquid in treating acute pharyngitis/tonsillitis in adults caused by bacterial infection and validate the regulatory effect of Pudilan anti-inflammatory oral liquid on inflammatory markers such as serum amyloid A （SAA）， C-reactive protein （CRP）， white blood cells （WBC）， neutrophil percentage （NE%）， and erythrocyte sedimentation rate （ESR）， thereby exploring the feasibility of using Pudilan anti-inflammatory oral liquid as a substitute for antibiotics in the treatment of infectious diseases and providing a basis for rational clinical medication. MethodUsing a stratified randomized， double-blind， double-simulation， positive-control， multicenter design， 220 participants were enrolled from nine centers. The participants were randomly divided into three groups at 1∶1∶1 — a Pudilan anti-inflammatory oral liquid 20 mL group （73 cases）， a Pudilan anti-inflammatory oral liquid 10 mL group （73 cases）， and a control group （amoxicillin group， 74 cases）. The treatment course was 7 days. The study observed parameters including the total effective rate of sore throat， onset and disappearance time of sore throat， health status score， treatment time， and inflammation markers. Result①Dataset division： The 211 cases were included in the full analysis dataset （FAS）， 208 cases were included in the per-protocol dataset （PPS）， and 218 cases were included in the safety dataset （SS）. ② Efficacy evaluation： There were statistically significant differences （P<0.05） in the comparison of the three groups regarding the total effective rate of sore throat， disappearance time of sore throat， and health status. Both the 20 mL and 10 mL groups were non-inferior to the control group， and there was a statistically significant difference between the 20 mL and 10 mL dosage groups （P<0.05）. There was no statistically significant difference in the comparison of onset time of sore throat among the groups. CRP， WBC， and NE% of patients in all three groups significantly decreased on the 7th day of treatment compared with those before treatment （P<0.01）. ③Safety evaluation： Adverse events mainly occurred in various examination indicators. There were no statistically significant differences in the comparison between groups， and no adverse reactions or serious adverse events occurred. ④Economic evaluation： The increased cost of the 10 mL and 20 mL dosage groups was entirely justified as compared with that in the control group. When comparing the 10 mL and 20 mL dosage groups， the 10 mL dosage group was deemed less advantageous. ConclusionPudilan anti-inflammatory oral liquid can be used alone as an alternative to antibiotics in the treatment of acute pharyngitis/tonsillitis caused by bacterial infection. It demonstrates good safety and can lower inflammation markers such as CRP， WBC， and NE%， suggesting its potential to reduce the body's inflammatory response. Its mechanism of action may be related to its multi-target regulatory mechanism.

Perfil dos protocolos de ensaios clínicos sobre Covid-19 com participação da Fiocruz / Profile of clinical trial protocols for Covid-19 with the participation of Fiocruz

Resumo Objetivo Identificar a atuação da Fiocruz em estudos clínicos relacionados à Covid-19. Analisar as diferentes terminologias utilizadas para se referir à participação da Fiocruz. Mapear a região desses estudos. Mensurar a quantidade dos estudos aprovados nas plataformas de registro de estudos clínicos e bases ético-regulatórias. Dentre estes, analisar as características metodológicas e de boas práticas dos protocolos dos estudos intervencionais. Métodos Foram revisadas as bases de dados da Agência Nacional de Vigilância Sanitária (ANVISA), Comissão Nacional de Ética em Pesquisa (Conep), Registro Brasileiro de Ensaios Clínicos (ReBEC), ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), US Food and Drug Administration (FDA) e Instituto Nacional de Propriedade Industrial (INPI). Resultados Foram encontrados 53 estudos clínicos sobre Covid-19 com a participação da Fiocruz em 39 destes como instituição proponente. Dentre os 53 estudos, 19 estão em plataformas de registro. Sobre os estudos intervencionais registrados, cinco são de prevenção e nove de tratamento. A intervenção mais analisada nestes estudos foi cloroquina/hidroxicloroquina. Observou-se ainda maior concentração dos estudos clínicos na Região Sudeste, com o total de 37. Conclusão Foram analisadas algumas limitações no delineamento metodológico que podem afetar o alcance dos estudos. Espera-se que os dados obtidos sejam utilizados para orientação futura de estudos clínicos sobre Covid-19 com participação da Fiocruz.

Abstract Objective To identify Fiocruz's performance in clinical studies related to Covid-19. Analyze the different terminologies used to refer to Fiocruz participation. Map the region of these studies. Measure the number of studies approved on clinical study registration platforms and regulatory ethical bases. Analyze the methodological characteristics and good practices of the interventional study protocols. Methods We reviewed databases of Brazilian National Research Ethics Committee, databases of Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA), Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), US Food and Drug Administration (FDA) and Brazilian National Institute of Industrial Property (Instituto Nacional de Propriedade Industrial-INPI). Results 53 clinical studies on Covid-19 were found with the participation of Fiocruz in 39 of them as a proponent institution. Among the 53 studies, 19 are on registration platforms. Of the registered interventional studies, 5 are for prevention and 9 for treatment. The intervention most frequently evaluated in these studies was chloroquine / hydroxychloroquine. There was also a greater concentration of clinical studies in the southeastern region, with a total of 37 studies. Conclusion Some limitations in the methodological design were analyzed, which may affect the scope of the studies. It is expected that the data obtained will be used to guide future clinical studies on Covid-19 with Fiocruz participation.

Fidelity in acupuncture-moxibustion clinical research: application and reflection / 中国针灸

As an indicator that measures the degree of implementation of intervention measures during the implementation process, fidelity could be used for monitoring and quality evaluation of the completion degree of intervention measures, and plays an important role in improving the degree of intervention implementation and clarifying the factors that affect intervention implementation. This article aims to introduce the connotation and significance, measurement, control, and current application status of fidelity, as well as the current application status of fidelity in acupuncture-moxibustion clinical research and its inspiration for future research. Meanwhile, based on the existing evaluation tool development methods of fidelity and the characteristics of acupuncture-moxibustion clinical research, a preliminary fidelity evaluation framework is proposed. Introducing fidelity into acupuncture-moxibustion clinical research could improve the implementation quality and compliance of acupuncture-moxibustion in clinical research, increase the credibility and effectiveness of clinical research results, and promote the transformation of acupuncture-moxibustion experience into easily learnable and promotable treatment plans.

Construction of a core outcome set in clinical research of acupuncture and moxibustion for treatment of adhesive capsulitis / 中国针灸

This study aims to construct the core outcome set for the clinical trials of adhesive capsulitis treated with acupuncture and moxibustion. Using systematic review, semi-structured interview, Delphi questionnaire survey, analytic hierarchy process and expert consensus meeting, the primary outcomes are obtained, i.e. local tenderness, pain degree during movement, range of motion, changes in range of motion, function score, and score of local symptoms of shoulder joint. The secondary outcomes are myofascial thickness, thickness of the inferior wall of the joint capsule, health status, activity of daily living, incidence of adverse events, laboratory indexes, vital signs, cost-effectiveness, total effective rate, and patient satisfaction. It is expected to provide a reference for the outcome selection in clinical trials and the generation of medical evidences in the treatment of adhesive capsulitis with acupuncture and moxibustion.

Chaihu Longgu Mulitang in Treatment of Coronary Heart Disease Complicated with Anxiety and Depression： A Review / 中国实验方剂学杂志

Coronary heart disease （CHD） with atherosclerosis is a common chronic disease worldwide， and anxiety and depression are potential and crucial risk factors for adverse prognosis in CHD. Chaihu Longgu Mulitang （CLMT）， first mentioned in the Shang Han Lun （《伤寒论》）， is a classic prescription for treating Shaoyang diseases combined with disturbance of the mind and spirit， with the effects of harmonizing Shaoyang and calming the mind. Current research on mechanisms has shown that CLMT can play a role in CHD complicated with anxiety and depression through multiple pathways， including regulating related signaling pathways， inhibiting the expression of inflammatory factors， improving oxidative stress damage， modulating neurotransmitter levels， suppressing the hypothalamic-pituitary-adrenal axis， promoting mobilization of mesenchymal stem cells from the bone marrow， and inhibiting platelet activation. Clinical studies have demonstrated that CLMT significantly improves symptoms such as angina and insomnia caused by CHD complicated with anxiety and depression， effectively reduces negative emotions， improves traditional Chinese medicine （TCM） syndrome scores， and decreases levels of inflammatory factors. Furthermore， it has fewer adverse reactions and higher safety than conventional western medicine treatments. This article provides a review of the mechanisms and clinical studies of CLMT in the treatment of CHD complicated with anxiety and depression based on a comprehensive analysis of literature from the China National Knowledge Infrastructure （CNKI）， Wanfang Data， VIP， PubMed， and other databases in the past 15 years， in order to provide references for further research on the use of CLMT in the management of CHD complicated with anxiety and depression.