The effectiveness of psychotherapies in reducing further suicide attempts: a systematic review with meta-analysis of randomized controlled trials

There is little evidence on the effectiveness of psychotherapeutic interventions in reducing new suicide attempts. This article aims to evaluate the effectiveness of psychotherapeutic interventions in reducing suicide attempts among patients with a history of previous attempts. We selected 17 articles from four databases: PubMed, Cochrane, APA PsycInfo and LILACS, in 2023. Six studies showed statistical differences that favored psychotherapeutic intervention at some point during the follow-up period. These psychotherapies addressed: problem-solving, hope induction, skills training. When comparing psychotherapy with usual care, a meta-analysis revealed an odds ratio of 0.41 (95 % CI, 0.17-0.99, p = .05) in the analysis up to 12 months of follow-up, and an odds ratio of 0.48 (95 % CI, 0.30-0.78, p < .001) after 12 months of follow-up. The results indicate the efficacy of these interventions in reducing additional suicide attempts, but they should be analyzed with caution, given the heterogeneity of the sample, treatments, and comparators. This review supports the development of prevention strategies indicated for patients who have attempted suicide.

Hay poca evidencia sobre la eficacia de las psicoterapias para reducir los nuevos intentos de suicidio. Este artículo tiene como objetivo evaluar la efectividad de las intervenciones psicoterapéuticas en la reducción de los intentos de suicidio entre pacientes con intentos previos. Se seleccionaron 17 artículos de cuatro bases de datos: PubMed, Cochrane, APA PsycInfo y LILACS. Seis estudios mostraron diferencias estadísticas que favorecieron la intervención psicoterapéutica en algún momento durante el período de seguimiento. Estas psicoterapias abordaron: resolución de problemas, inducción de esperanza y entrenamiento de habilidades. Al comparar la psicoterapia con el tratamiento habitual, el metanálisis reveló un odds ratio de 0.41 (IC del 95 %, 0.17 a 0.99, p = .05) en el análisis hasta los 12 meses de seguimiento, y un odds ratio de 0.48 (IC del 95 %, 0.30 a 0.78, p < .001) después de 12 meses de seguimiento. Los resultados apuntan a la eficacia de estas intervenciones para reducir los intentos de suicidio adicionales, pero deben analizarse con cautela, dada la heterogeneidad de la muestra, los tratamientos y los comparadores. Esta revisión apoya el desarrollo de estrategias de prevención indicadas para pacientes que han intentado suicidarse.

Comparison of the effects of two concentrations of adrenaline (0.33 mg/l versus 1 mg/l) in the irrigation serum for arthroscopic shoulder surgery: protocol of a randomized controlled trial

Background: Controlling bleeding during arthroscopic shoulder surgery helps improve the clarity of the arthroscopic visual field. Adrenaline is considered an effective and safe method to reduce bleeding. Two doses of adrenaline (0.33 mg/l and 1 mg/l) have been evaluated in the literature, but never against each other. Methods: This prospective, double-blind, randomized controlled trial will study the clarity of the visual field using a numerical scale (NS) during rotator cuff surgery on 180 patients across 5 centres. The secondary objectives include: the duration of the operation, volume of saline used, increase in baseline pressure, number of arthropump hyperpressures, mean systolic blood pressure and heart rate, as well as sudden variability. Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p<0.001). Conclusions: This study aims to determine which of the two dosages previously studied in the literature (0.33 mg/l versus 1 mg/l) provides better clarity. Trial Registration Number: 2021-A02773-38.

Effectiveness of pilates-based exercises on the diastasis recti abdominis in climacteric women: a randomized controlled trial

INTRODUCTION: Recent studies have related the climacteric period with changes in connective tissue elasticity that may be related to diastasis recti abdominis. Mat Pilates is a method of exercise without impact that currently has more practitioners, due to its satisfactory results. However, there are no studies that evaluate the effectiveness of mat Pilates for women with diastasis recti abdominis. OBJECTIVE: To evaluate the effectiveness of the mat Pilates program in climacteric women with diastasis recti abdominis. METHODS: This randomized single-blinded clinical trial evaluated climacteric women with diastasis recti abdominis. The participants were randomized into the experimental group, which participated in 3 weekly sessions of mat Pilates for 12 weeks for a total of 36 sessions, and the control group (without exercises). The inter-rectus distance was measured with a digital caliper. The G*Power Version 3.1.9.2. software was used for the sample calculation, and the SPSS 20.0 program was used for statistical analysis. RESULTS: The study comprised 21 women, including 10 in the control group and 11 in the experimental group, with mean ages of 54.3 ± 7.1 and 55.3 ± 6.0 years and body mass index values of 28.8 ± 5.5 kg/m2 and 29.9 ± 4.48 kg/m2, respectively. In the experimental group, reductions were observed in all the measures related to diastasis recti abdominis (p<0.05) in the supraumbilical, umbilical, and infra-umbilical regions. CONCLUSION: The mat Pilates method is effective for reducing diastasis recti abdominis in the climacteric period.

Immunomodulation as a Treatment for Parkinson´s Disease in Current Trials: A Systematic Review and Meta-Analysis

ABSTRACT Background: Immunomodulatory drugs and immunotherapies are being evaluated in clinical trials for the treatment of neuroinflammation, as the latter is an essential mechanism for the development and progression of Parkinson´s disease. Objective: The objective of the study is to review recent evidence on the evaluation of immunomodulators in randomized controlled clinical trials measuring improvement of motor symptoms. Methods: A meta-analysis of Movement Disorder Society-Unified Parkinson´s disease Rating Scale (MDS-UPDRS III) scores extracted from seven articles selected after an online search of PubMed, Cochrane Library, and Clarivate's Web of Science for randomized controlled clinical trials published between 2000 and July 2023 was performed. The selected articles reported clinical trials evaluating the effects of specific immunomodulators or treatments with known effects on the immune system and inflammation. MDS-UPDRS III scores were reported in these studies, and the results of the placebo groups were compared with those of the treatment groups. Results: A total of 590 patients treated with immunomodulators and 622 patients treated with placebo were included. A test for heterogeneity yielded an I2 value > 50%. The mean standard difference for change in MDS-UPDR III score was −0.46 (CI [95%] = −0.90 - −0.02, p < 0.01). No significant differences were found in the change in mean MDS-UPDR III score between the treatment and placebo groups; however, two studies showed a trend toward separation from the mean. Conclusion: The immunomodulatory treatments included in this study showed no efficacy in improving motor symptoms in Parkinson´s disease patients. Further clinical trials with larger patient populations are needed.

Kangaroo Baby Massage: An Intervention which Improves the Perceived Maternal Self-Efficacy / El masaje al bebé canguro, una intervención que mejora la autoeficacia materna percibida / Massagem no bebê canguru, uma intervenção que melhora a autoeficácia materna percebida

Abstract Introduction: The Kangaroo Baby Massage (KBM) is a technique designed for preterm and low birth weight newborns that eliminates the need for an incubator, providing a practical and beneficial option for mothers at home. Objective: To test the effect of the KBM on perceived maternal self-efficacy favoring the mother-infant interaction at home. Materials and methods: A pragmatic, double-blind, randomized clinical trial was conducted in three phases: 1) KBM integration with Kathryn Barnard's theory, 2) study design, and 3) implementation and outcome evaluation. Two groups were defined: The intervention group (KBM) and the control group (which used the kangaroo position without massage), each group consisted of 34 mother-infant pairs. Recruitment took place within an outpatient kangaroo program in Bogota, Colombia. Implementation and follow-up were conducted via teleconsultation, using the KBM video "Diary of My Kangaroo Baby" and simulators. The perceived maternal self-efficacy questionnaire was conducted at three points in time: prior to the study and on the 7th and 14th day after the study. The questionnaire was analyzed with a statistical design of longitudinal data in F1LDF1 factorial experiments. Results: Homogeneous groups were defined based on sociodemographic variables and maternal-perinatal history. Mothers who applied the KBM technique showed higher scores in perceived maternal self-efficacy at both 7 and 14 days compared to the control group mothers [RTE (lower limit; upper limit) - day 7: control = 0.502 (0.437; 0.567) vs. KBM = 0.503 (0.426; 0.581), and day 14: control = 0.564 (0.482; 0.640) vs. KBM = 0.719 (0.650; 0.776)]. Conclusion: The KBM is a nursing intervention that enhances perceived maternal self-efficacy, fostering greater family involvement and strengthening mother-child interaction.

Resumen Introducción: El masaje al bebé canguro (MBC) es una técnica para recién nacidos pretérmino y bajo peso al nacer que no requiere incubadora y favorece a las madres en el hogar. Objetivo: Probar el efecto del MBC sobre la autoeficacia materna percibida para favorecer la interacción madre-hijo en el hogar. Materiales y métodos: Ensayo clínico aleatorizado pragmático, doble ciego, desarrollado en tres fases: 1) integración MBC y teoría de Kathryn Barnard, 2) diseño del estudio y 3) ejecución y resultados. Se definieron dos grupos: intervención (MBC) y control (posición canguro sin masaje), con 34 diadas madre-hijo en cada grupo. Reclutamiento realizado en un programa canguro ambulatorio de Bogotá, Colombia. La ejecución y el seguimiento fue hecha a través de teleconsulta, el video MBC "Diario de mi bebé canguro" y simuladores. Se aplicó el cuestionario de autoeficacia materna percibida en tres momentos: antes de iniciar el estudio y a los días 7 y 14 después del estudio. Se analizó con un diseño estadístico de datos longitudinales en experimentos factoriales F1LDF1. Resultados: Fueron definidos grupos homogéneos en las variables sociodemográficas y de antecedentes materno-perinatales. Las madres que aplicaron el MBC registraron puntajes más altos de autoeficacia materna percibida a los 7 y 14 días, en comparación con las madres del control [RTE (límite inferior; límite superior) - día 7: control = 0.502 (0.437; 0.567) vs. MBC = 0.503 (0.426; 0.581), y día 14: control = 0.564 (0.482; 0.640) vs. MBC = 0.719 (0.650; 0.776)]. Conclusión: El MBC es una intervención de enfermería que mejoró la autoeficacia materna percibida, favoreciendo la participación de la familia y la interacción madre-hijo.

Resumo Introdução: A massagem no bebê canguru (MBC) é uma técnica para bebês prematuros e de baixo peso que não necessita de incubadora e que dá apoio às mães no domicílio. Objetivo: Testar o efeito da MBC na autoeficácia materna percebida para apoiar a interação mãe-bebê em casa. Materiais e método: Ensaio clínico randomizado, pragmático, duplo-cego, desenvolvido em três fases: i) integração da MBC e da teoria de Kathryn Barnard, ii) desenho do estudo e iii) execução e resultados. Foram definidos dois grupos: intervenção (MBC) e controle (posição canguru sem massagem), com 34 díades mãe-bebê em cada grupo. O recrutamento foi realizado em um programa canguru ambulatorial em Bogotá, Colômbia. A implementação e o acompanhamento foram feitos por meio de teleconsultas, do vídeo MBC "Diário do meu bebê canguru" e de simuladores. O questionário de autoeficácia materna percebida foi aplicado em três momentos: antes do início do estudo e nos dias 7 e 14 após o estudo. Ele foi analisado com um projeto estatístico de dados longitudinais em experimentos fatoriais F1LDF1. Resultados: Foram definidos grupos homogêneos para variáveis sociodemográficas e histórico ma-terno-perinatal. As mães que aplicaram o MBC registraram pontuações mais altas de autoeficácia materna percebida aos 7 e 14 dias, em comparação com as mães do controle [RTE (limite inferior; limite superior) - dia 7: controle = 0,502 (0,437; 0,567) vs. MBC = 0,503 (0,426; 0,581), e dia 14: controle = 0,564 (0,482; 0,640) vs. MBC = 0,719 (0,650; 0,776)]. Conclusões: a MBC é uma intervenção de enfermagem que melhorou a autoeficácia materna percebida, favorecendo o envolvimento familiar e a interação entre mãe e filho.

A Randomized Open Label Parallel Clinical Study to Evaluate the Safety and Efficacy of Clevira Tablets against Influenza Viruses

Objective: The aim of the study was to compare the efficacy of Clevira tablets in Human adult patients, with Influenza A&B and Vital flu. Methods: This study was an open label, balanced, randomized, multi-dose, two-treatment, parallel, and comparative Phase III clinical trial to determine the safety and efficacy of Clevira Tablets. Twenty patients were enrolled and received Clevira Tablet along with Standard Treatment for Influenza A&B and other respiratory viral infections. Enrollment was based on the diagnosis of hematology, biochemistry, serology, RT-PCR, and chest X-ray and inclusion, and none of the exclusion criteria and included in the study. Results: All the patients demonstrated safety measures with respect to blood pressure and pulse rate. Furthermore, statistically significant (P < 0.0001) improvement showed in temperature from baseline (102.03 ± 0.64) and at the end of the study period (98.14 ± 0.70). Conclusion: The study demonstrated an expedited clinical cure with normal vital signs and hematological results which validated that Clevira is safe and efficacious in patients with Influenza A&B and Viral flu. The data further entrusted that Clevira can be used in infected patients with Influeza A&B and Viral Flu, and relieve the signs and symptoms, with a rapid recovery, without any adverse side effects.

Effects of pulsed electromagnetic field and retrowalking in patients with chronic non-specific low back pain: a pilot study / Efeitos do campo eletromagnético pulsado e do retrowalking em pacientes com dor lombar crônica inespecífica: um estudo piloto

INTRODUCTION: Chronic non-specific low back pain (CNSLBP) is a major worldwide condition that has severe emotional, social, and economic consequences. Management is difficult, requiring the development of new, effective, and safe approaches. OBJECTIVES: This study was conducted to examine the effects of Pulsed Electromagnetic Fields (PEMF) and retrowalking on pain, disability, spinal mobility, hamstring tightness, balance, and kinesiophobia in patients with chronic non-specific low back pain. MATERIALS AND METHODS: Participants (n = 48) with CNSLBP were randomised into four groups; Group A: Conventional group, Group B: PEMF group, Group C: retrowalking group, and Group D: PEMF and retrowalking group. The interventions were given three times per week for six weeks. The outcomes were pain, disability, hamstring tightness, balance, spinal mobility and kinesiophobia, measured at baseline and after 6 weeks. RESULTS: The result suggested a significant improvement in pain, disability, hamstring tightness, kinesiophobia and balance. However, no significant improvement in spinal mobility (flexion and extension ROM) was observed during the sixth week between-group comparison. The maximum improvement was seen in group D followed by group C and group B in comparison to group A. CONCLUSION: It can be concluded that PEMF and retrowalking when given in combination significantly decrease pain, disability, hamstring tightness, kinesiophobia and improve balance patients with chronic non-specific low back pain.

INTRODUÇÃO: A dor lombar crônica inespecífica (DLCI) é uma condição importante em todo o mundo que tem graves consequências emocionais, sociais e econômicas. O gerenciamento é difícil, exigindo o desenvolvimento de abordagens novas, eficazes e seguras. OBJETIVOS: Este estudo foi realizado para examinar os efeitos dos Campos Eletromagnéticos Pulsados (CEMP) e do retrowalking sobre a dor, a incapacidade, a mobilidade da coluna vertebral, a rigidez dos isquiotibiais, o equilíbrio e a cinesiofobia em pacientes com dor lombar crônica não específica. MATERIAIS E MÉTODOS: Os participantes (n = 48) com DLCI crônica foram divididos aleatoriamente em quatro grupos: Grupo A: Grupo convencional, Grupo B: Grupo CEMP, Grupo C: Grupo retrowalking e Grupo D: Grupo CEMP e retrowalking. As intervenções foram realizadas três vezes por semana durante seis semanas. Os resultados foram dor, incapacidade, tensão nos isquiotibiais, equilíbrio, mobilidade da coluna vertebral e cinesiofobia, medidos na linha de base e após seis semanas. RESULTADOS: O resultado sugeriu uma melhora significativa na dor, na incapacidade, na tensão dos isquiotibiais, na cinesiofobia e no equilíbrio. Entretanto, não foi observada melhora significativa na mobilidade da coluna vertebral (flexão e extensão da ADM) quando a comparação entre os grupos foi feita na sexta semana. A melhora máxima foi observada no grupo D, seguida pelo grupo C e pelo grupo B, em comparação com o grupo A. CONCLUSÃO: Pode-se concluir que a CEMP e o retrowalking, quando administrados em combinação, diminuem significativamente a dor, a incapacidade, a rigidez dos isquiotibiais, a cinesiofobia e melhoram o equilíbrio dos pacientes com dor crônica não espinhal.

Efficiency of pulsed electromagnetic field and neuromuscular electrical stimulation on painful shoulder following stroke / Eficiência do campo eletromagnético pulsado e da estimulação elétrica neuromuscular em ombro doloroso após acidente vascular cerebral

INTRODUCTION: Shoulder pain after stroke, a complication with a prevalence of up to 16­84% usually occurs after 2­3 months and leads to patients withdrawing from rehabilitation programs, staying in the hospital longer, having less limb function and having a great negative impact on their quality of life. The aim of the present study was to determine the effect of PEMF and NMES in reducing shoulder pain in patients with stroke. MATERIAL AND METHODS: A prospective, randomized controlled trial included 51 patients with shoulder pain following stroke. The patients were randomly assigned to three groups (17 people in each group): Pulsed Electromagnetic Field (PEMF), Neuromuscular Electrical Stimulation (NMES) and Control group. The outcome measures were Visual Analogue Scale (VAS), Modified Ashworth Scale (MAS) and Fugl Meyer Assessment­Upper Extremity (FMA-UE), Active and Passive Range of Motion (AROM/PROM) assessed at the baseline, six weeks into the intervention, and one week into the follow-up. RESULTS: VAS score for pain showed a mean change of 1.60, 1.60 and 4.94 in PEMF, NMES, and control respectively after 20 sessions. It showed pain was significantly improved in all the groups (p<0.001), but the effectiveness of the PEMF and NMES groups was superior to the control group. CONCLUSION: The current literature showed that PEMF & NMES are effective in improving post-stroke shoulder pain, spasticity, range of motion and motor function and a novel method for stroke patients undergoing rehabilitation.

INTRODUÇÃO: Dor no ombro após acidente vascular cerebral com prevalência de 16­84% geralmente ocorre após 2­3 meses e pode resultar na suspensão de programas de reabilitação, internações hospitalares mais longas e redução da função dos membros, prejudicando qualidade de vida dos pacientes com AVC. O objetivo do presente estudo foi determinar o efeito da PEMF e da EENM na redução da dor no ombro em pacientes com acidente vascular cerebral. MATERIAL E MÉTODOS: Um estudo prospectivo, randomizado e controlado incluiu 51 pacientes com dor no ombro pós-AVC. Os pacientes foram divididos aleatoriamente em três grupos (17 pessoas em cada grupo): grupo Campo Eletromagnético Pulsado (PEMF), grupo Estimulação Elétrica Neuromuscular (EENM) e grupo Controle. As medidas de resultados foram na Escala Visual Analógica (VAS), Escala de Ashworth Modificada (MAS) e Avaliação de Fugl Meyer ­ Extremidade Superior (FMA-UE), Amplitude de Movimento (AROM/PROM) foram avaliadas no início do estudo, após seis semanas de tratamento, e após um acompanhamento semanal. RESULTADOS: A pontuação VAS para dor mostrada uma alteração média de 1,60, 1,60 e 4,94 na PEMF, EENM e Controle, respectivamente, após 20 sessões. Mostrou melhora significativa entre os três grupos (p<0,001), mas a eficácia do grupo PEMF e EENM foi superior ao grupo Controle. CONCLUSÃO: O presente estudo mostrou que PEMF e EENM são eficazes na melhora da dor no ombro pós-AVC, espasticidade, amplitude de movimento e função motora e um novo método para pacientes com AVC em reabilitação. Nossas descobertas indicam que a eficácia da EENM é claramente superior à do PEMF na manutenção da analgesia a longo prazo.

Importancia del laboratorio en los ensayos clínicos

Los resultados de los exámenes que se realizan en el laboratorio clínico deben constituir una parte esencial en la evaluación de los sujetos incluidos en los ensayos clínicos para la introducción de nuevos medicamentos. En este artículo se describen los aspectos más importantes del trabajo en el laboratorio durante el desarrollo de un ensayo donde se emplean nuevas tecnologías. Los ensayos clínicos no solo mejoran los indicadores de salud de la población, sino que, además, exigen los mejores estándares de diagnóstico y evaluación del tratamiento, a través de nuevas tecnologías, donde se incluye el laboratorio clínico.

The results of the exams that are carried out in the clinical laboratory should constitute an essential part in the evaluation of people included in clinical trials for the introduction of new medications. In this article the most important aspects of work in the laboratory are described, during the development of a trial where new technologies are used. Clinical trials not only improve health indicators of the population, but also, demand the best diagnosis standards and evaluation of the treatment, through new technologies, where clinical laboratory is included.

¿Ensayos clínicos de superioridad, equivalencia o no inferioridad? / ¿Clinical trials of superiority, non-inferiority or equivalence?

La eficacia de una nueva intervención se establece generalmente a través de ensayos clínicos (EC) con asignación aleatoria (AA). Sin embargo, entre otros tantos desafíos metodológicos, el especificar la hipótesis de un EC con AA, sigue siendo un problema complejo de resolver para los investigadores clínicos. En este manuscrito discutimos las características de tres variantes de los EC con AA: EC de superioridad (ECS), EC de no-inferioridad (ECNI), y EC de equivalencia (ECE). Estos tres tipos de EC tienen supuestos diferentes sobre los efectos de una intervención, por lo que plantear hipótesis y definir objetivos requiere conocer algunos supuestos subyacentes a estos EC, incluso hasta elementos relacionados con la estimación del tamaño de muestra para cada cual. El objetivo de este manuscrito fue describir las diferencias metodológicas entre ECS, ECNI y ECE.

Efficacy and effectivity of new interventions are generally established through randomized clinical trials (RCTs). However, among many other methodological challenges, specifying the hypothesis of a RCT remains complex problem for clinical researchers. In this manuscript we discuss the characteristics of three variants of RCTs: superiority RCT (SRCT), non-inferiority RCT (NIRCT), and equivalence RCT (ERCT). These three types of RCT have different assumptions about the effects of an intervention, so setting hypotheses and defining objectives requires knowing some assumptions underlying these RCTs, including elements related to the estimation of the sample size for each one. The aim of this manuscript was to describe methodological differences between SRCT, NIRCT and ERCT.

Efficacy of convalescent plasma in hospitalized COVID-19 patients: findings from a controlled trial

The COVID-19 pandemic has driven the search for alternative therapies, including convalescent plasma, historically used in infectious diseases. Despite results in other diseases, its effectiveness against COVID-19 remains uncertain with conflicting results in clinical trials. A pragmatic, single-center, prospective, and open randomized controlled trial was carried out in a hospital in Brazil, with the aim of evaluating the impact of convalescent plasma on the clinical improvement of patients hospitalized with COVID-19. The World Health Organization (WHO) ordinal scale was used to measure clinical improvement, focusing on the reduction in disease severity by up to 2 points, while antibody and C-reactive protein levels were monitored over time. After hospital admission, participants were randomized 1:1 to receive convalescent plasma and standard treatment or to be part of the control group with standard treatment. Follow-up was carried out on days 1, 3, 7, 14 and/or at discharge. From January 14 to April 4, 2022, 38 patients were included, but 3 were excluded due to protocol deviations, resulting in a total of 35 patients: 19 in the control group and 16 in the plasma group. There was no significant difference in clinical improvement between the convalescent plasma group and the control group, nor in secondary outcomes. The study had limitations due to the small number of patients and limited representation of COVID-19 cases. Broader investigations are needed to integrate therapies into medical protocols, both for COVID-19 and other diseases. Conducting randomized studies is challenging due to the complexity of medical conditions and the variety of treatments available.

Critical points in the current construction of ethics committees at medical institutions / 现代医院

Significant advancements have been made in the establishment of ethics committees within medical institu-tions.However,in order to achieve a high-quality development it is imperative to focus on such critical points as distinguishment between biomedical research and the clinical application of medical technologies,steadfast adherence to the fundamental princi-ples of ethical review,establishment of an ethics committee with independent administrative authority,establishing independent ethics review committees in large medical institutions based on specialty,and strengthening of ethical training for medical person-nel and biomedical researchers.

Analysis on the Registration of Clinical Trials of Headache Treated by TCM / 中国中医药信息杂志

Objective To analyze the registered clinical trials of headache treated by TCM;To discuss the current research status;To provide reference for the optimization of subsequent clinical trial research plans.Methods All clinical trials of headache treated by TCM were retrieved from the ChiCTR and the ClinicalTrials.The retrieval time was from the database establishment to May 22,2023.The general characteristics,study types,intervention measures and outcome indicators of the trials were analyzed respectively.Results A total of 104 registered studies were included,with the number of registered studies increasing since 2004 and reaching a peak in 2020,involving 25 provincial administrative regions or countries and 69 clinical trial institutions;the funding sources were mainly scientific research funds of universities,national finance and local finance.The research type was mainly intervention research;the designing scheme was mainly randomized parallel control study;the high frequency random method was simple random method;45 registered studies used blind methods.Exploratory studies/pre-trials were the most commonly used in the phases of clinical researches.Most of the registered studies were single-center clinical trials with a total sample size of 9 648 patients.The main interventions were acupuncture and oral Chinese medicines.The high frequency outcome indicators included life quality of score,headache attack frequency,headache attack days and headache severity,etc.There were some problems in outcome indicators,such as non-standard,lack of TCM characteristic advantages,and insufficient patient participation.Conclusion The number of registered studies of headache treated by TCM has increased by year,but there are some problems in design elements,such as random method,blind method,number of research centers,sample size and the setting of outcome indicator.

Progress of interventional researches on peritoneal function protection / 中华肾脏病杂志

With the prolongation of peritoneal dialysis time, the peritoneum probably confronts structural and functional deterioration due to multiple factors, which will affect the efficiency of peritoneal dialysis. Clinically effective measures to protect peritoneal function are still lacking. This article reviewed studies in the last decade on protection of peritoneal function, which included strategies on dialysis prescription, medicine treatments for protection of peritoneal function, and non-medicine treatments such as far-infrared therapy and stem cell transplantation, to provide guidances for subsequent researches.

Analysis of issues and exploration of key review points in clinical trial establishment review / 中华医学科研管理杂志

Objective:As China′s new drug review and approval system continues to evolve, clinical trial management procedures are being continuously promoted and refined. This article aims to identify key review points for clinical trial establishment reviews and offer recommendations for optimizing the review process.Methods:By combining the regulatory requirements for clinical trial establishment management and the unique situation of our institution, the status of establishment approval applications upon initial submission and challenges encountered during establishment approval reviews were analyzed. The factors that may affect the likelihood of initial approval for establishment applications, and the elements and standards involved in clinical trial establishment approval reviews were studied.Results:From 2020 to 2022, the hospital received a total of 514 clinical trial establishment applications for registration purposes, with a first-time approval rate of 30.2%.Whether an application served as a team leader unit or a single-center clinical trial significantly impacted its likelihood of initial approval ( P<0.05). In clinical trial establishment reviews, drug clinical trials were most commonly associated with issues regarding sponsor qualifications, drug labeling, CRA qualifications, and drug testing reports. For medical device clinical trials, the most common issues were related to PI GCP certificate expiration dates, CRA qualifications, sponsor qualifications, and inspection reports. Conclusions:To enhance the quality and efficiency of clinical trial establishment reviews, it is recommended that trade organizations publish guidance documents on key points for clinical trial establishment reviews. Additionally, it is essential to enhance communication and collaboration among institutions, sponsors, and CROs and provide more training for relevant personnel, to jointly promote a more streamlined and effective clinical trial establishment review process.

Hepatitis B vaccine： From prevention to treatment / 临床肝胆病杂志

Hepatitis B vaccination is the most economical and effective way to prevent HBV infection. The advances in molecular biology and genetic engineering have continuously improved the manufacturing process of vaccines， and hepatitis B vaccine has gradually developed from the initial plasma-derived vaccine to the currently used recombinant vaccine. Preventive hepatitis B vaccine has been clinically tested in patients with HBsAg seroclearance to increase the level of anti-HBs， with certain safety and efficacy. As one of the multiple targets for new drugs in the treatment of chronic hepatitis B， a therapeutic hepatitis B vaccine based on HBsAg is already in the stages of research and development and clinical trial.

Global Landscape of Clinical Trials in Lung Cancer / 肿瘤防治研究

Lung cancer, the second most prevalent cancer in the world with a persistently high mortality rate, threatens the life and health of all humanity. With the development of clinical trials, the treatment options for lung cancer have been enriched, and the understanding of the timing of intervention has become more explicit than before. Thus, the prognosis of lung cancer has significantly improved. However, unmet clinical needs still exist. This review provides the global trend of clinical research in lung cancer treatment and describes the evolution of clinical trials in terms of design, implementation, and regulation. The change in study endpoints is conducive to shortening the research and development cycle and accelerating the launch of drugs. The refinement of study populations and therapeutic targets facilitates the realization of the maximum efficacy of precision treatment. The integration of comprehensive and diversified therapeutic strategies and the combination of prevention and treatment further promote the improvement of survival and the alleviation of social burden. This review also proposes a prospective direction for future development of clinical research in lung cancer.

Challenges， countermeasures and key points of ethical review for decentralized clinical trials / 中国医学伦理学

Decentralized clinical trials （DCT） are bringing new changes to clinical trials， the core concept of “patient-centered” must be adhered， and the safety and rights of research participants must be adequately safeguarded. Although DCTs have similarities with traditional clinical trials， they are not suitable for all clinical trials， and are more suitable for oral administration， stable condition of study participants， and longer duration of treatment in clinical trials. DCT， elements must be selected based on the characteristics of clinical trials， and strike a balance between improving the sense of gain， safety， and rights and dignity of research participants， as well as the quality of data collected. Currently， DCT in China face many challenges. To actively promote DCTs in China， regulatory regulations and guiding principles should be improved. Based on patient-centered design principles， the first discussion requires real-time online communication. Researchers should provide more clinical trial services， improve risk control and accessibility of medical assistance， use third-party convenient payments， ensure fair recruitment of research participants， consider compliance， validate digital health technology， remote monitoring and electronic informed consent compliance， ensure the security of data collection， transmission， and analysis， as well as strengthen multi-party training. Ethical review is one of the important means to protect the safety and rights of research participants. Ethics committees should focus on appropriate DCTs elements that are patient-centered， compliance and effectiveness of electronic informed consent， processing and reporting of security information， privacy protection of data collection， compliance of remote monitoring， family health follow-up， management of biological samples and experimental medical products， and training programs. The author believed that the complementarity and combination with traditional clinical trials will make DCTs elements implemented more easily and smoothly. By leveraging the power of scientific and technological advances， DCTs will boost the speed of China’s drug and medical device research and development， enhance international competitiveness， and benefit more patients.

Ethical reviewof cosmetic efficacy claims evaluation trails / 中国医学伦理学

The supervision of cosmetics started relatively late in China， and corresponding laws and regulations on ethical review are not yet perfect. The Cosmetics Supervision and Administration Regulations， which came into force on January 1， 2021， had stricter requirements for cosmetic efficacy claims， requiring that cosmetic efficacy claims should have a sufficient scientific basis. Cosmetic efficacy claims evaluation trials include human efficacy evaluation trials， consumer use tests， and laboratory trials. Human efficacy evaluation trials and consumer use tests should comply with the requirements of ethical principles， the necessary product safety evaluation should be completed before the tests are carried out， to ensure that there is no harm to the human health of research participants （or consumers） under normal， foreseeable circumstances. The Regulations on the Administration of Registration and Filing Materials for Cosmetics required that product test reports should include microbiological and physical-chemical tests， toxicological trials， human safety trial reports， and human efficacy trial reports. The key points of the ethics committee’s review of cosmetic efficacy claims evaluation trials include the reasonableness of the trial protocol， consumer survey and expert evaluation， selection of detection methods， study population and sample size， safety evaluation of the cosmetics， risk assessment of cosmetic raw materials， protection of privacy， and qualifications of the testing institutions and researchers. High-quality ethical review is conducive to safeguarding the safety and rights of research participants （or consumers）， and will also promote the quality of cosmetic efficacy claims evaluation trails in China.