The effect of music on menopausal symptoms, sleep quality,and depression: a randomized controlled trial

SUMMARY OBJECTIVE: This study aimed to determine the effect of music on menopausal symptoms, sleep quality, and depression levels in menopausal women. METHODS: This randomized controlled study was carried out between August and December 2022. The study sample consisted of 61 menopausal women (intervention: 30 and control: 31). The intervention group listened to music twice a day for 5 weeks, with a total of 70 sessions. The control group received only routine care. Menopause symptoms, depression levels, and sleep quality were evaluated at the beginning and the end of the study using the Menopausal Symptoms Rating Scale, Beck Depression Inventory, and Pittsburg Sleep Quality Index. RESULTS: The post-test Menopausal Symptoms Rating Scale, Beck Depression Inventory, and Pittsburg Sleep Quality Index scores of the menopausal women were found to be lower in the intervention group than in the control group (p=0.011, p=0.001, and p=0.006, respectively). When the pre-test and post-test mean scores were compared, the mean menopausal symptoms and depression levels decreased, and sleep quality increased significantly in the intervention group. No significant difference was observed in the control group. CONCLUSION: This study shows that music may have an effect on reducing the level of menopausal symptoms and depression levels and also increasing the sleep quality of menopausal women.

The effect of interventional program underpinned by health belief model on awareness, attitude, and performance of nurses in preventing nosocomial infections: A randomized controlled trial study / Efecto de un programa de intervención basado en el modelo de creencias en salud sobre el conocimiento, la actitud y el desempeño del personal de enfermería en la prevención de las infecciones intrahospitalarias. Ensayo controlado aleatorizado / Efeito de um programa de intervenção baseado no modelo de crenças em saúde no conhecimento, atitude e atuação da equipe de enfermagem na prevenção de infecções hospitalares. Teste controlado e aleatório

Objective. The present study examined the effect of an interventional program underpinned by the Health Belief Model (HBM) on nurses' awareness, attitude, and performance in preventing nosocomialinfections.Methods. This randomized controlled trial study was performed on 60 clinical nurses in lar, Iran. Nurses were selected using the simple random sampling method and assigned to two experimental (n=30) and control (n=30) groups. Data collection tool included the valid and reliable questionnaire was developed by Soleimani et al. The research intervention consisted of five 90-min sessions based on the health belief model in preventing hospital infection for experimental group. Before the intervention, immediately and two months after the intervention, the two groups completed the questionnaire. The control group received no intervention. Results. Data analysis showed that the differences between the two groups was statistically significant immediately and two months after the intervention (p<0.05). In experimental group the changes in the mean score of knowledge, attitude and performance of nurses before, immediately and two months after the intervention were significant (p<0.05), but in the control group, only the changes in the mean score of performance were significant (p<0.05). Conclusion. The results showed that the HBM-based intervention is effective in promoting nurses' knowledge, attitude, and performance in preventing nosocomialinfections. hence, periodical and in-service HBM-based training programs on preventing nosocomialinfections are recommended to be held for nurses.

Objetivo. El presente estudio examinó el efecto de un programa de intervención basado en el modelo de creencias en salud (Health Belief Model -HBM-, en inglés sobre el conocimiento, la actitud y el desempeño de las enfermeras en la prevención de las infecciones intrahospitalarias. Métodos. Este ensayo controlado aleatorizado se realizó en 60 enfermeras clínicas de lar, Irán. Las enfermeras fueron seleccionadas mediante el método de muestreo aleatorio simple y asignadas a dos grupos experimental (n=30) y de control (n=30). La herramienta para la recogida de datos incluyó el cuestionario válido y fiable desarrollado por Soleimani et al.La intervención consistió en cinco sesiones de 90 minutos basadas en el modelo de creencias de salud para prevenir la infección intrahospitalaria en el grupo experimental. Antes de la intervención, inmediatamente y dos meses después de la intervención, los dos grupos completaron el cuestionario. El grupo de control no recibió ninguna intervención. Resultados. El análisis de los datos mostró diferencias estadísticamente significativas entre los dos grupos en los momentos inmediatamente y dos meses después de la intervención (p<0.05). En el grupo experimental, los cambios en la puntuación media de conocimientos, actitudes y rendimiento de las enfermeras se observaron en los momentos de antes, inmediatamente y dos meses después de la intervención (p<0.05); mientras que en el grupo de control solamente los cambios en la puntuación media de desempeño fueron significativos (p<0.05). Conclusión. Los resultados mostraron que la intervención basada en HBM fue eficaz para promover el conocimiento, la actitud y el rendimiento de las enfermeras en la prevención de las infecciones intrahospitalaria, por lo que se recomienda impartir a las enfermeras programas de formación periódicos y en servicio basados en HBM sobre la prevención de las infecciones intrahospitalarias.

Objetivo. Examinar o efeito de um programa de intervenção baseado no Modelo de Crenças em Saúde (MBH) no conhecimento, atitude e desempenho dos enfermeiros na prevenção de infecções hospitalares. Métodos. Este ensaio clínico randomizado foi conduzido em 60 enfermeiras clínicas de lar, Irã. Os enfermeiros foram selecionados pelo método de amostragem aleatória simples e distribuídos em dois grupos experimental (n=30) e controle (n=30). O instrumento de coleta de dados incluiu o questionário válido e confiável desenvolvido por Soleimani et al. A intervenção consistiu em cinco sessões de 90 minutos baseadas no modelo de crenças em saúde para prevenir infecção hospitalar no grupo experimental. Antes, imediatamente e dois meses após a intervenção, ambos os grupos responderam ao questionário. O grupo controle não recebeu nenhuma intervenção. Resultados.A análise dos dados mostrou diferenças estatisticamente significativas entre os dois grupos imediatamente e dois meses após a intervenção (p<0.05). No grupo experimental foram observadas alterações na pontuação média de conhecimentos, atitudes e desempenho dos enfermeiros antes, imediatamente e dois meses após a intervenção (p<0.05); enquanto no grupo controle apenas as alterações na pontuação média de desempenho foram significativas (p<0.05). Conclusão.Os resultados demonstraram que a intervenção baseada no HBM foi eficaz na promoção do conhecimento, atitude e desempenho dos enfermeiros na prevenção de infecções hospitalares, pelo que se recomenda proporcionar aos enfermeiros este tipo de programas de formação em serviço baseados no HBM.

Ultrasonic Bone Scalpel versus Conventional Technique for Thoracolumbar Spinal Decompression: A Prospective Randomized Controlled Trial / Bisturi ósseo ultrassônico versus técnica convencional para descompressão espinhal torácica: Um teste controlado randomizado prospectivo

Abstract Objective The purpose of the present study is to compare intraoperative blood loss, operating time, laminectomy time, hospital length of stay, and complications in thoracolumbar spinal decompression using ultrasonic bone scalpels (UBSs) with conventional procedures. Methods Forty-two patients who underwent decompressive laminectomy and pedicular screw fusion with a surgical level of 1-5 levels between February 1, 2020, and June 30, 2022, in a single institution were evaluated for eligibility, and 11 were excluded due to a history of spinal surgery (n= 3), spinal tumor (n= 3), and spinal infection (n= 5). A total of 31 patients were randomly divided into the UBS group (n =15) and the conventional group (n =16). Intraoperative blood loss, operating time, laminectomy time, hospital length of stay, and complications were recorded. Results Intraoperative blood loss and laminectomy time were significantly lower in the UBS group (656.0 ± 167.6 ml, 54.5 ± 27.4 minutes, respectively) than in the conventional group (936.9 ± 413.2 ml, 73.4 ± 28.1 minutes, respectively). Overall operation time, hospital length of stay, and complications were all similar between the groups. Conclusion The UBS is a useful instrument for procedures performed near the dura mater or other neural tissue without excessive heat or mechanical injury. This device is recommended for various spinal surgeries in addition to high-speed burrs and Kerrison rongeurs.

Resumo Objetivo O objetivo do presente estudo é comparar perda de sangue intraoperatória, tempo de operação, tempo de laminectomia, tempo de internação hospitalar e complicações na descompressão espinhal torácica utilizando bisturis ósseos ultrassônicos (BOUs) em relação aos procedimentos convencionais. Métodos Quarenta e dois pacientes submetidos a laminectomia descompressiva e fusão pedicular do parafuso com um nível cirúrgico de 1 a 5, entre 1° de fevereiro de 2020 e 30 de junho de 2022 em uma única instituição, foram avaliados para elegibilidade e 11 foram excluídos devido ao histórico de cirurgia espinhal (n= 3), tumor espinhal (n= 3) e infecção espinhal (n= 5). Perda de sangue intraoperatória, tempo de operação, tempo de laminectomia, tempo de internação e complicações foram registradas. Resultados A perda de sangue intraoperatória e o tempo de laminectomia foram significativamente menores no grupo BOU (656,0 ± 167,6 ml, 54,5 ± 27,4 min, respectivamente) do que no grupo convencional (936,9 ± 413,2 ml, 73,4 ± 28,1 min, respectivamente). O tempo de funcionamento total, o tempo de internação e as complicações foram todos semelhantes entre os grupos. Conclusão O bisturi ósseo ultrassônico é um instrumento útil para procedimentos realizados próximos à dura-máter ou outro tecido neural sem calor excessivo ou lesão mecânica. Este dispositivo é recomendado para várias cirurgias de coluna vertebral, juntamente com rebarbas de alta velocidade e pinça Kerrison.

Impact of Telemedicine use on clinical care indicators of pediatric intensive care units: protocol for a cluster randomized clinical trial / Impacto do uso da Telemedicina nos indicadores clínicos assistenciais de unidades de terapia intensiva pediátricas: protocolo para um ensaio clínico randomizado em cluster

ABSTRACT The objective of this study is to present the protocol of a cluster randomized clinical trial to be conducted through the TeleICU project - Qualification of Intensive Care by Telemedicine. The study will consist of a cluster randomized clinical trial, open label, in pediatric intensive care units, with an allocation ratio of 1:1, to compare the intervention group (support of Telemedicine for patients admitted to the pediatric intensive care unit) with a control group (pediatric intensive care unit usual care). The study proposed to select 16 pediatric intensive care units, including 100 participants per site, with a total of 1,600 participants. The intervention group will receive telerounds from Monday to Friday and will have specialists and continuing education activities available. The primary outcome measure will be the length of stay in the pediatric intensive care unit, defined as the difference between the date of discharge of the participant and the date of admission to the intensive care unit. The secondary outcomes will be mortality rate, invasive mechanical ventilation-free days, days using antibiotics, days using vasoactive drugs and days using sedoanalgesia. This study will be conducted in accordance with Resolution 466/12 of the National Health Council, with approval by the Research Ethics Committee of the institutions involved. The present study has the potential to reproduce studies on Telemedicine in intensive care and may make important contributions to care in intensive care units in Brazil and other settings. If Telemedicine shows positive clinical care results compared to conventional treatment, more pediatric patients may benefit. ClinicalTrials.gov registry: NCT05260710

RESUMO O objetivo deste estudo será apresentar o protocolo de um ensaio clínico randomizado em cluster a ser realizado por meio do projeto TeleUTI - Qualificação da Assistência em Terapia Intensiva por Telemedicina. O estudo consistirá em um ensaio clínico randomizado por cluster, open label, em unidades de terapia intensiva pediátricas, com proporção de alocação de 1:1, com o intuito de comparar o grupo de intervenção (apoio da telemedicina para os pacientes internados na unidade de terapia intensiva pediátrica) com um grupo controle (cuidados habituais da unidade de terapia intensiva pediátrica). O estudo se propõe a selecionar 16 unidades de terapia intensiva pediátricas, incluindo 100 participantes por local, com o total de 1.600 participantes. O grupo intervenção receberá telerounds de segunda-feira a sexta-feira e terá à disposição especialistas e atividades de educação continuada. O desfecho primário a ser avaliado será o tempo de permanência nas unidades de terapia intensiva pediátricas, definido pela diferença entre a data de alta do participante com a data de admissão na unidade de terapia intensiva. Os desfechos secundários serão: taxa de mortalidade; dias livres de ventilação mecânica, dias de uso de antibióticos, dias de uso de drogas vasoativas e dias de uso de sedoanalgesia. Este estudo será conduzido em conformidade com a resolução 466/12 do Conselho Nacional de Saúde, com aprovação pelo Comitê de Ética em Pesquisa das instituições hospitalares envolvidas. O trabalho tem o potencial de reproduzir estudos sobre Telemedicina em cuidados intensivos, podendo trazer contribuições importantes ao atendimento em unidades de terapia intensiva no Brasil e em outras realidades. Se a Telemedicina mostrar resultados clínicos assistenciais positivos em relação ao tratamento convencional, mais pacientes pediátricos poderão ser beneficiados. Registro ClinicalTrials.gov: NCT05260710

Efectividad de la Rehabilitación basada en Ejercicio Físico sobre la Sintomatología Prolongada de COVID-19 en Personas Mayores: Una Revisión Sistemática / Effectiveness of Rehabilitation based on Physical Exercise on Prolonged Symptoms of COVID-19 in Older People: A Systematic Review

Propósito. Sistematizar la evidencia respecto a la efectividad de los programas de rehabilitación, basados en la prescripción del ejercicio físico, aplicados en personas mayores con síntomas prolongados de COVID-19. Métodos. Se revisaron las bases de datos PubMed, Science Direct, SPORTDiscus, MEDLINE Complete y Web of Science. Se buscaron estudios de tipo ensayo controlado aleatorizado con fecha de publicación desde el año 2020 hasta octubre de 2022 centrados en programas de rehabilitación, o intervención terapéutica, basados en ejercicio físico en individuos mayores o igual de 60 años que manifiesten síntomas persistentes de COVID-19 posterior a la fase aguda. Resultados. Dos ensayos controlados aleatorizados, que midieron la eficacia de la rehabilitación con ejercicio físico en personas de edad avanzada (mayores o iguales a 60 años), fueron identificados. Los resultados mostraron mejoría de la tolerancia al esfuerzo, la función respiratoria y el bienestar psicológico en los adultos mayores con síntomas post-COVID-19. Sin embargo, la cantidad de estudios es baja y la representación de este grupo etario, también. Conclusión. Los programas de rehabilitación, en personas mayores, basados en ejercicio, son efectivos para tratar los síntomas post-COVID-19. Se necesitan más estudios comparativos de alta calidad, en personas mayores, para desarrollar programas de rehabilitación que permitan afrontar la fase prolongada de la enfermedad.

Purpose. To systematize the evidence regarding the effectiveness of rehabilitation programs, based on the prescription of physical exercise, applied in older people with persistent symptoms of COVID-19. Methods. The PubMed, Science Direct, SPORTDiscus, MEDLINE Complete and Web of Science databases were reviewed. Randomized controlled trial-type studies with a publication date from 2020 to October 2022 and that were focused on physical exercise-based rehabilitation programs that were applied to individuals over or equal to 60 years of age who manifest persistent COVID-19 symptoms post-acute phase. Results. Two randomized controlled trials, which measured the effectiveness of physical exercise-based rehabilitation in elderly people (over or equal to 60 years), were identified. The results showed improvement in exercise tolerance, respiratory function, and psychological well-being in older adults with post-COVID-19 symptoms. However, the number of studies is low and the representation of this age group, too. Conclusion. Physical exercise-based rehabilitation programs in older people are effective in treating post-COVID-19 symptoms. More high-quality comparative studies are needed, in older people, to develop rehabilitation programs that allow coping with the prolonged phase of the disease.

From awareness to action: Effects of a school-based intervention on TV viewing behavior stages and screen time guidelines knowledge in Brazilian adolescents / Da conscientização à ação: Efeitos de uma intervenção escolar nos estágios de mudança de comportamento para assistir TV e no conhecimento das diretrizes de tempo de tela em adolescentes brasileiros

The aims of the study were to verify the effect of an intervention on the stage of behavior change for TV viewing and to identify the possible mediating role of knowledge on screen time guidelines among Brazilian students. This study is a multicomponent school-based intervention conducted with 727 students (54.3% female, 13 years; 427 in the intervention group and 300 in the control group). The intervention was performed in 2017 with baseline and post-intervention assessments (over one academic year). Teacher training was carried out at the beginning of the intervention along with en-vironmental improvements, while educational curriculum such as the delivery of folders and posters were performed throughout the year. The stages of behavior change for TV viewing and knowledge of screen time guidelines were measured by a self-reported questionnaire and the structural equation modeling approach was performed. The intervention had no significant effects on stages of behavior change for TV (p = 0.744) nor did it result in significant changes on knowledge of screen time guide-lines (p = 0.741). While there was no mediation between knowledge of screen time guidelines and the effect of the intervention on stages of behavior change for TV (95%CI: -0.45;0.63), an associa-tion was found between knowledge of screen time guidelines and stages of behavior change for TV (p<0.001). In conclusion, intervention had no significant effect on the stages of behavior change for TV and no mediating effect was observed. However, enhancing awareness on screen time guidelines may positively impact the adolescent's intention to reduce TV time

Os objetivos do estudo foram verificar o efeito de uma intervenção nos estágios de mudança de comporta-mento para assistir TV e identificar o papel mediador do conhecimento sobre as recomendações de tempo de tela. A intervenção multicomponente, randomizada e controlada obteve a participação de 727 alunos em 2017 (54,3% meninas, 13 anos; 427 no grupo intervenção e 300 no grupo controle). A formação dos pro-fessores foi realizada no início da intervenção juntamente com as melhorias ambientais, enquanto as ações educativas foram realizadas ao longo do ano. Os estágios de mudança de comportamento para assistir TV e o conhecimento sobre as recomendações do tempo de tela foram mensurados por questionário auto reportado, pré e pós-intervenção (um ano letivo). Para análise dos dados foi realizada uma modelagem de equações estru-turais. Não houve efeito da intervenção nos estágios de mudança de comportamento para TV (p = 0,744) e também não houve mudanças significativas no conhecimento dos estudantes sobre as recomendações do tempo de tela (p = 0,741). Embora não tenha havido mediação entre conhecimento das recomendações do tempo de tela e o efeito da intervenção nos estágios de mudança de comportamento para TV (IC95%: -0,45;0,63), foi encontrada associação entre o conhecimento das recomendações e os estágios de mudança de comportamento para TV (p < 0,001). Conclui-se que a intervenção não teve efeito significativo nos estágios de mudança de comportamento para TV e efeito mediador. No entanto, aumentar a conscientização sobre as recomendações de tempo de tela pode impactar positivamente na intenção do adolescente de reduzir o tempo de TV

Treinamento de força com e sem instabilidade não melhora os níveis gerais de capacidade intrínseca em idosos com queixas cognitivas / Resistance training with and without instability does not improve overall levels of intrinsic capacity in older adults with cognitive complaints

INTRODUÇÃO: Capacidade intrínseca (CI) é um construto que engloba capacidades físicas e mentais para o autocuidado e envelhecimento saudável. A compreensão do papel potencial do treinamento resistido, com e sem instabilidade, para promover o CI precisa ser esclarecida. OBJETIVO: Avaliar o impacto do treinamento de força sobre os níveis de capacidade intrínseca em idosos com queixas cognitivas. MÉTODOS: Idosos com queixas cognitivas (n=67) foram aleatoriamente designados para 12 semanas de TF tradicional (n=23), TF com dispositivos de instabilidade (TFI) (n=22) ou controle (n=22). Ambos os grupos de treinamento realizaram três séries de 10- 15 repetições. O grupo TFI realizou exercícios utilizando dispositivos de instabilidade. O grupo controle recebeu aulas semanais de educação em saúde. Os domínios da CI foram de mobilidade e velocidade da marcha (locomotora), função global e executiva (cognitivo), força de preensão e teste de caminhada de seis minutos (vitalidade), e sintomas depressivos e autoeficácia (psicológicos) por meio de escores-z compostos. Calculamos os níveis globais de CI pela soma de cada pontuação composta. RESULTADOS: Diferença significativa intragrupo nos níveis gerais de CI (∆TFI = +1.69, ∆TF = +1.30) e seus respectivos domínios (Locomoção: ∆TFI = +2.32, ∆TF = +3.21; Cognição: ∆TFI = +2.31; Vitalidade: ∆TFI = +1.23, ∆TF = +1.42; e Psicológico: ∆TFI = -0.65, ∆TF = -0.62). Contudo, não houve diferenças entre os grupos. Análise de sensibilidade mesclando os grupos de treinamento revelou diferença significativa para o domínio locomotor após 12 semanas (+1.97, p=0.045). CONCLUSÃO: Treinamento de força com e sem dispositivos de instabilidade não melhorou os níveis de CI em idosos com queixas cognitivas.

INTRODUCTION: Intrinsic capacity (IC) is a construct that encompasses physical and mental capacities important for self-care and healthy aging. Understanding the potential role of resistance training with and without instability to promote IC needs to be clarified. OBJECTIVE: To assess the impact of resistance training on intrinsic capacity levels in older adults with cognitive complaints. METHODS: Older adults with cognitive complaints (n=67) were randomly assigned to either 12 weeks of traditional RE (n=23), RE with instability devices (REI) (n=22), or control (n=22). Both training groups performed three sets of 10-15 repetitions. REI group performed each exercise using instability devices. The control group received weekly health education classes. IC domains were analyzed using mobility and gait velocity (locomotor), global and executive functioning (cognitive), grip strength and six-minute walking test (vitality), and depressive symptoms and self-efficacy (psychological) through z-composite scores. We computed global levels of IC by the sum of each composite score. RESULTS: A significant within-group difference (improvement) in overall levels of IC (∆REI = +1.69, ∆RE = +1.30) and all their domains (Locomotion: ∆REI = +2.32, ∆RE = +3.21; Cognition: ∆REI = +2.31; Vitality: ∆REI = +1.23, ∆RE = +1.42; and Psychological: ∆REI = -0.65, ∆RE = -0.62). However, no between-group differences were observed at the completion of the trial. Sensitivity analysis merging training groups revealed a between-group difference for the locomotor domain (+1.97, p=0.045). CONCLUSION: Resistance training with and without instability devices did not improve IC levels among older adults with cognitive complaints.

Estudio aleatorizado, doble ciego, sobre la eficacia del tratamiento homeopático en niños con amigdalitis recurrente / Randomized, double-blind study on the efficacy of homeopathic treatment in children with recurrent tonsillitis

La eficacia y seguridad del tratamiento homeopático fueron investigadas en niños con amigdalitis recurrente para la que se indicaba cirugía. Métodos: Estudio clínico prospectivo, aleatorizado, doble ciego, que incluyó 40 niños de entre 3 y 7 años de edad; 20 niños fueron tratados con medicación homeopática y otros 20 niños, con placebo. El seguimiento fue de 4 meses por niño. La evaluación de los resultados fue clínica mediante un cuestionario estándar y examen clínico el primer y último día de tratamiento. La amigdalitis recurrente se definió como ocurrencia de 5 a 7 episodios de amigdalitis bacteriana aguda al año. Resultados: Del grupo de 18 niños que completó el tratamiento homeopático, 14 no presentó episodio alguno de amigdalitis bacteriana aguda; del grupo de 15 niños que recibió placebo, 5 pacientes no presentaron amigdalitis. Esta diferencia fue estadísticamente significativa (p = 0,015). Ninguno de los pacientes presentó efectos secundarios. Conclusiones: El tratamiento homeopático fue efectivo en niños con amigdalitis recurrente, en comparación con el placebo; a 14 niños (78%) ya no se les indicó cirugía. El tratamiento homeopático no se asoció con eventos adversos.

The efficacy and safety of homeopathic treatment was investigated on children with recurrent tonsillitis justifying surgery. Methods: Prospective, randomized,double-blind clinical trial that included 40 children between ages of 3 to 7 years old;20 children were treated with homeopathic medication and 20 children with placebo. Follow up was 4 months per child. Assessment of results was clinical by means of a standard questionnaire and clinical examination on the first and last day of treatment.Recurrent tonsillitis was defined as 5 to 7 episodes of bacterial acute tonsillitis per year. Results: From the group of 18 children who completed homeopathic treatment, 14 did not present any episode of acute bacterial tonsillitis; from the group of 15 children whoreceived placebo 5 patients did not present tonsillitis; this difference was statistically significant (p= 0,015). None of the patient exhibited side effects. Conclusions: Homeopathic treatment was effective in children with recurrent tonsillitis compared to placebo, 14 children (78%) were no longer indicated surgery. Homeopathic treatment was not associated with adverse events.

Estrógeno potenciado en el tratamiento homeopático del dolor pélvico asociado a endometriosis: un estudio aleatorizado, doble ciego, controlado con placebo, de 24 semanas / Potentiated estrogen in the homeopathic treatment of pelvic pain associated with endometriosis: a 24-week randomized, double-blind, placebo-controlled study

Evaluar la eficacia y seguridad del estrógeno potenciado en comparación con el placebo en el tratamiento homeopático del dolor pélvico asociado a endometriosis (EAPP, por sus siglas en inglés). Diseño del estudio: El presente fue un estudio clínico aleatorizado, doble ciego, controlado con placebo, de 24 semanas, el cual incluyó a 50 mujeres de entre 18 y 45 años de edad con diagnóstico de endometriosis infiltrante profunda con base en ultrasonido transvaginal o imágenes de resonancia magnética después de preparación intestinal, así como puntaje ≥ 5 en una escala visual analógica (VAS: rango de 0 a 10 puntos) para el dolor pélvico asociado con la endometriosis. Se administró estrógeno potenciado (12cH, 18cH y 24cH) o placebo dos veces al día por vía oral. La medida principal de resultado fue el cambio en la severidad de los puntajes parcial y global de EAPP (VAS) de la línea basal a la semana 24, determinada como la diferencia en el puntaje medio de cinco modalidades de dolor pélvico crónico (dismenorrea, dispareunia profunda, dolor pélvico no cíclico, dolor intestinal cíclico y/o dolor urinario cíclico). Las medidas secundarias de resultado fueron la diferencia media de puntaje para la calidad de vida evaluada con el Cuestionario de Salud SF-36, los síntomas de depresión en el Inventario de la Depresión de Beck (BDI) y los síntomas de ansiedad en el Inventario de Ansiedad de Beck (BAI). Resultados: El puntaje global de EAPP (VAS: rango de 0 a 50 puntos) se redujo en 12.82 (p < 0.001) en el grupo tratado con estrógeno potenciado de la línea basal a la semana 24. El grupo que utilizó estrógeno potenciado también presentó una reducción en el puntaje parcial (VAS: rango de 0 a 10 puntos) en tres modalidades de EAPP: dismenorrea (3.28; p < 0.001), dolor pélvico no cíclico (2.71; p = 0.009) y dolor intestinal cíclico (3.40; p < 0.001). El grupo de placebo no mostró cambio significativo alguno en los puntajes global o parcial de EAPP. Además, el grupo de estrógeno potenciado mostró un mejoramiento significativo en tres de ocho ámbitos de SF-36 (dolor de cuerpo, vitalidad y salud mental) y síntomas de depresión (BDI). El grupo de placebo no mostró un mejoramiento significativo a este respecto. Estos resultados demuestran la superioridad del estrógeno potenciado sobre el placebo. Se asociaron pocos eventos adversos con el estrógeno potenciado. Conclusiones: El estrógeno potenciado (12cH, 18cH y 24cH) en dosis de 3 gotas dos veces al día durante 24 semanas fue significativamente más efectivo que el placebo para reducir el dolor pélvico asociado con la endometriosis. Registro del estudio clínico: ClinicalTrials.gov Identificador: https://clinicaltrials.gov/show/NCT02427386.

To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, doubleblind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p < 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p < 0.001), non-cyclic pelvic pain (2.71; p = 0.009), and cyclic bowel pain (3.40; p < 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.

Universal mental intervention for children in school based on mental resilience forced enhancement:a randomized controlled trial study protocol / 中国学校卫生

Abstract@#Mental disorders represent 45% of the global disease burden among children and adolescents aged 10-24 years old. It is crucial to develop effective interventions that can be integrated into daily school activities in order to provide convenient and accessible mental health services for students and faculty members. The study conducts a randomized controlled trial to examine universal mental health promotion among children. The current protocol aims to develop a universal resilience focused program, which focuses on emotional regulation, coping, and problem solving. A total of 20 classes from two primary schools in grades 4-5 in Anhui, Tianchang were randomly assigned to either the intervention or waitlist group. This training consisted of 14 weekly 40 minute sessions of manualized interventions that were compatible with regular curricular activities. It is expected that this current intervention will enhance the psychological resilience of children and evaluate the effectiveness of promoting mental health among children followed up on indicators of depressive and anxiety symptoms, psychological resilience, oppositional defiant and conduct problems by questionnaires at baseline and after the intervention.

Meta-analysis of randomized controlled trials of exposure and response prevention for obsessive compulsive disorder / 中华行为医学与脑科学杂志

Objective:To systematically evaluate the intervention effect of exposure and response prevention (ERP) on obsessive compulsive disorder (OCD).Methods:PubMed, Web of Science Core Collection, EBSCO, Cochrane Library, Embase, Science Direct, Wanfang Data, China National Knowledge Infrastructure and VIP-CSTJ were used to collect randomized controlled studies related to ERP for OCD.Randomized controlled studies that met the criteria were included, with the score of Yale-Brown obsessive-compulsive scale as the primary outcome indicator and the scores of anxiety and depression scale as secondary outcome indicators, while the included literatures were evaluated for literature quality and data extraction.Review Manager 5.3 and Stata 16.0 softwares were used to conduct Meta-analysis on the extracted data.Results:Twenty-seven studies with a total of 1 239 patients were included, and 599 cases in the ERP group and 640 cases in the control group.Meta-analysis results showed that the efficacy of ERP group was significantly better than that of blank control group(MD=-6.55, 95% CI: -8.75--4.35, P<0.001) and significantly better than chlorpromazine control group treatment (MD=-5.88, 95% CI: -8.20--3.56, P<0.001) for improving patients' obsessive-compulsive symptoms, but not significantly different from CBT intervention (MD=0.21, 95% CI: -1.62-2.04, P=0.82), and the efficacy of ERP and CBT had no significant during the post-intervention follow-up period (MD=0.41, 95% CI: -2.45-3.27, P=0.78). For improving patients' depressed mood, ERP was effective in improving patients' depressed mood (SMD=-0.45, 95% CI: -0.74--0.17, P=0.002), but not significantly different from CBT (SMD=-0.05, 95% CI: -0.27-0.16, P=0.62). For improving anxiety, the efficacy of ERP group was not different from that of control group (SMD=-0.17, 95% CI: -0.56-0.23, P=0.41). Conclusion:ERP has good feasibility in improving obsessive-compulsive symptoms and depression in patients with OCD.However, long-term efficacy was not verified for improving anxiety and maintaining long-term efficacy during the follow-up period.

Effects of dexmedetomidine on vital signs during postoperative anesthesia recovery period in gynecological patients undergoing general anesthesia surgery and analysis on risk factors for complications / 中国基层医药

Objective:To investigate the effects of dexmedetomidine on vital signs during recovery from general anesthesia in gynecological patients undergoing general anesthesia surgery and analysis of risk factors for complications.Methods:A total of 80 gynecological patients undergoing general anesthesia surgery who received treatment in Lishui People's Hospital from March 2021 to March 2022 were included in this study. They were randomly divided into an observation group and a control group ( n = 40/group). All patients were subjected to general anesthesia. The observation group was infused with 0.5 μg/kg dexmedetomidine intravenously 15 minutes before induction of anesthesia and then infused with dexmedetomidine at a rate of 0.2 μg/kg per hour until 20-30 minutes before the end of the operation. The control group was identically given 0.9% normal saline. The recovery quality, vital signs before surgery and during recovery from general anesthesia (systolic blood pressure, diastolic blood pressure, heart rate, body temperature), and complications during recovery from general anesthesia were compared between the two groups. These patients were divided into a complication group and a non-complication group according to whether there were complications during recovery from general anesthesia. Univariate and multivariate Logistic regression analyses were performed to analyze the high-risk factors for complications occurring during recovery from general anesthesia in gynecological patients undergoing general anesthesia surgery. Results:The time to awaken, time to recover spontaneous respiration, and time to extubation in the observation group were significantly shorter than those in the control group ( t = 3.74, 2.97, 2.56, all P < 0.05). Systolic blood pressure, diastolic blood pressure, and heart rate measured during recovery from general anesthesia were significantly lower in the observation group compared with the control group ( t = 5.71, 4.53, 4.53, all P < 0.001). Body temperature ( t = 4.40, P < 0.001) and the incidence of complications ( χ2 = 5.69, P < 0.05) were significantly lower in the observation group compared with the control group. These patients were divided into complication ( n = 22) and non-complication ( n = 58) groups according to whether they had complications during recovery from general anesthesia. Univariate and multivariate logistic regression analyses showed that American Association of Anesthesiologists grade II, presence of underlying diseases, abnormal leukocyte count, and no use of dexmedetomidine were the risk factors for postoperative complications in gynecological patients undergoing general anesthesia surgery ( OR = 2.38, 2.86, 2.17, 3.60, all P < 0.05). Conclusion:Dexmedetomidine can improve awakening quality and vital signs and reduce complications during recovery from general anesthesia. American Association of Anesthesiologists grade, underlying disease, abnormal white blood cell count, and no use of dexmedetomidine are the risk factors for complications occurring during recovery from general anesthesia in gynecological patients undergoing general anesthesia surgery.

Outcome Indexes in Randomized Controlled Trials of Chinese Medicine for Diabetic Kidney Disease / 中国实验方剂学杂志

ObjectiveTo analyze the utilization of outcome indexes and other trial design elements in randomized controlled trials （RCTs） of Chinese medicine for diabetic kidney disease （DKD） and provide a basis for the design of clinical trials and the development of core outcome index sets for Chinese medicine treatment of DKD. MethodSeven medical databases （CNKI， Wanfang Data， VIP， SinoMed， etc.） and two clinical trial registration centers （clinicaltrials.gov and chinadrugtrials.org.cn） were searched for RCTs of Chinese medicine for DKD published in the past 5 years. The included studies were assessed for risk of bias using the Cochrane Handbook for Systematic Reviews of Interventions， and the outcome indexes and other trial design elements were statistically analyzed. ResultNinety-seven RCTs were enrolled， including five trial registration protocols. The overall risk of bias was found to be high in the included studies. Stage Ⅲ DKD （36 studies， 41.38%） and the Qi-Yin deficiency with blood stasis syndrome （16 studies， 26.23%） were the top DKD stage and traditional Chinese medicine （TCM） syndrome， respectively. The treatment duration ranged from 2 weeks to 96 weeks， with 12 weeks being the most common duration （52 studies， 56.52%）. A total of 152 outcome indexes were used in 92 RCTs and five registered trials， with a frequency of 1 040 times. These indexes were classified into eight categories： Laboratory tests （blood）， laboratory tests （urine）， clinical efficacy， TCM syndrome score， quality of life scales， vital signs， other indexes， and other events. The most frequently used outcome indexes were serum creatinine （68 times， 70.10%）， clinical response rate （55 times， 56.70%）， fasting blood glucose （51 times， 52.58%）， blood urea nitrogen （48 times， 49.48%）， total cholesterol （47 times， 48.45%）， and 24-hour urinary protein excretion （43 times， 44.33%）. Safety indexes were used in 56 RCTs and two registered trials， with 53 different indexes and a frequency of 227 times. The most frequently used safety indexes were adverse reactions （49 times， 84.48%）， liver function （28 times， 48.28%）， complete blood count （24 times， 41.38%）， electrocardiogram （17 times， 29.31%）， and urinalysis （14 times， 24.14%）. Ten RCTs and five registered trials reported primary outcome indexes， and 54 RCTs reported clinical response rates. ConclusionThe current design of outcome indexes in RCTs of Chinese medicine for DKD is not standardized. In the future， efforts should be made to develop core outcome index sets that highlight the characteristics of TCM， improve the quality of clinical research， and enhance the applicability of trial results.

Treatment duration of wrist-ankle acupuncture for relieving post-thyroidectomy pain: A randomized controlled trial / 中西医结合学报

BACKGROUND@#Treatment duration of wrist-ankle acupuncture (WAA) is uncertain for post-thyroidectomy pain relief.@*OBJECTIVE@#This study evaluated the effect of different WAA treatment duration on post-operative pain relief and other discomforts associated with thyroidectomy.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTION@#This randomized controlled trial was conducted at a single research site in Guangzhou, China. A total of 132 patients receiving thyroidectomy were randomly divided into the control group (sham WAA, 30 min) and three intervention groups (group 1: WAA, 30 min; group 2: WAA, 45 min; group 3: WAA, 60 min), with group allocation ratio of 1:1:1:1. Acupuncture was administered within 1 hour of leaving the operating room.@*OUTCOMES AND MEASURES@#Primary outcome was patients' pain at the surgical site assessed by visual analogue scale (VAS) at the moment after acupuncture treatment (post-intervention). Secondary outcomes included the patients' pain VAS scores at 6, 12, 24, 48 and 72 h after the thyroidectomy, the 40-item Quality of Recovery (QoR-40) score, the grade of post-operative nausea and vomiting (PONV), and the use of additional analgesic therapy.@*RESULTS@#The adjusted mean difference (AMD) in VAS scores from baseline to post-intervention in group 1 was -0.89 (95% confidence interval [CI], -1.02 to -0.76). The decrease in VAS score at post-intervention was statistically significant in group 1 compared to the control group (AMD, -0.43; 95% CI, -0.58 to -0.28; P < 0.001), and in groups 2 and 3 compared to group 1 (group 2 vs group 1: AMD, -0.65; 95% CI, -0.81 to -0.48; P < 0.001; group 3 vs group 1: AMD, -0.66; 95% CI, -0.86 to -0.47; P < 0.001). The VAS scores in the four groups converged beyond 24 h after the operation. Fewer patients in group 2 and group 3 experienced PONV in the first 24 h after operation. No statistical differences were measured in QoR-40 score and the number of patients with additional analgesic therapy.@*CONCLUSION@#Compared with the 30 min intervention, WAA treatment with longer needle retention time (45 or 60 min) had an advantage in pain relief within 6 h after surgery. WAA's analgesic effect lasted for 6-12 h post-operatively. Please cite this article as: Han XR, Yue W, Chen HC, He W, Luo JH, Chen SX, Liu N, Yang M. Treatment duration of wrist-ankle acupuncture for relieving post-thyroidectomy pain: A randomized controlled trial. J Integr Med. 2023; 21(2): 168-175.

Laser acupuncture combined with auricular acupressure improves low-back pain and quality of life in nurses: A randomized controlled trial / 中西医结合学报

BACKGROUND@#Low-back pain (LBP) in nurses is a major health concern that affects their quality of life and ability to work, with consequences for their economic status.@*OBJECTIVE@#This study evaluates the effect of low-level laser acupuncture combined with auricular acupressure (LAA) on pain intensity, pain interference and quality of life in nurses with LBP.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS@#This randomized controlled trial recruited a convenience sample of hospital-based nurses from one teaching hospital in Taiwan, China. Participants were randomly assigned to the LAA group (n = 38) receiving low-level laser acupuncture and auricular acupressure for 4 weeks, and the control group (n = 38) receiving only sham laser acupuncture treatment without laser energy output.@*MAIN OUTCOME MEASURES@#Data were collected for the primary pain outcome using the Short Form of the Brief Pain Inventory, while the secondary outcome, quality of life, was evaluated using the Roland-Morris Disability Questionnaire. Both primary and secondary outcomes were scored before the intervention, and after 2-week and 4-week intervention. The rate of LBP recurrence was evaluated at the 4th week and 8th week after the end of intervention.@*RESULTS@#After controlling for prior pain, the result of linear mixed model analysis showed trends in significant between-group differences in the level of current pain occurring in week 4 (P < 0.001), worst pain in week 2 (P < 0.001) and week 4 (P < 0.001), least pain in week 2 (P = 0.032) and week 4 (P < 0.001), pain interference in week 2 (P = 0.009) and week 4 (P < 0.001), and in the life dysfunction in week 2 (P < 0.001) and week 4 (P < 0.001). Recurrence rates of LBP at the 4th and 8th weeks after the end of intervention were 0% and 36.89% in the LAA group, and 69.44% and 36.11% in the control group.@*CONCLUSION@#This study shows that 4-week LAA intervention reduced pain intensity and pain interference, and improved quality of life for hospital-based nurses with LBP. These effects were maintained continuously for at least 4 weeks after the intervention. The nonpharmacological intervention, LAA, may be another efficacious, feasible, noninvasive, analgesic intervention for LBP.@*TRIAL REGISTRATION@#This study is registered at Clinicaltrials.gov (registration number NCT04423445).

A Randomized Controlled Trial of Mindfulness in Recovery from Colorectal Cancer / 中国结合医学杂志

OBJECTIVE@#This study examined whether a 4-week group-based mindfulness intervention would be superior in reducing psychological distress in colorectal cancer (CRC) patients compared to a psychoeducation and cognitive behavioural skills learning support active control group.@*METHODS@#Patients with CRC were randomized via Computerised Permuted Block Randomisation to mindfulness or active control groups (2-h weekly sessions over 4 weeks). Outcomes were measured pre-intervention, and 8 weeks and 6 months post-baseline. The primary outcome was psychological distress measured by the Hospital Anxiety and Depression Scale. Secondary outcomes were generic quality of life (QoL), disease specific QoL, mindfulness, and intervention credibility and acceptability.@*RESULTS@#Sixty-eight participants were randomized to mindfulness (n=35) or active control group (n=33). Uptake of potentially eligible patients consenting was low (28.0%) and the dropout rate was 33.8%. Depression scores were reduced in both groups at week 8 (P=0.020). Control participants had greater improvement in generic mental QoL scores at week 8 than mindfulness (P=0.023). In disease specific QoL, there was reduction in impotence symptom in the mindfulness group (P=0.022) and reduction in faecal incontinence in the control group (P=0.019). The embarrassment symptom had a significantly lower increase in the mindfulness group at week 8 compared to the control group (P=0.009). Both groups rated the treatments as credible and acceptable.@*CONCLUSIONS@#Mindfulness was not superior to the active control group in terms of alleviating psychological distress but both treatments were associated with some improvements in depression. There was low uptake of both interventions. (Trial registration number: ACTRN12616001033437).

Thinking on Clinical Key Problems During Transformation of Preparations in Medical Institutions to Innovative Chinese Medicines / 中国实验方剂学杂志

Under the national policy background of traditional Chinese medicine（TCM）registration review and approval reform， TCM preparations in medical institutions（hereinafter referred to as medical institution preparations） have human use experience， conform to the characteristics of TCM clinical practice， and have advantages in the research and development of innovative Chinese medicines. Therefore， the research and development mode based on clinical experience prescription-medical institution preparations-innovative Chinese medicines has attracted widespread attention from the industry. However， in the process of development and use of medical institution preparations， there are generally clinical problems that restrict their transformation into innovative Chinese medicines， resulting in a relatively weak collection basis of human use experience and insufficient clinical evidence for supporting the research and development of new TCM medicines. In this paper， on the basis of sorting out the supporting regulations and relevant technical requirements of human use experience， and analyzing the clinical problems restricting the transformation of medical institution preparations， it provides suggestions for medical institutions to carry out high-quality research on human use experience of preparations in the process of TCM clinical practice from the aspects of continuously exploring clinical value， improving the construction of information system， focusing on the TCM clinical practice and giving full play to the advantages of discipline cooperation. By realizing the whole life cycle management of medical institution preparations based on three-combination evaluation evidence system， we can promote the transformation of medical institution preparations into innovative Chinese medicines.

Systematic review of clinical effects of enamel matrix derivative as adjunctive therapy for gingival recession / 口腔疾病防治

Objective @#To evaluate the clinical effect of enamel matrix derivative(EMD) assisted with connective tissue graft(CTG) in the treatment of gingival recession.@*Methods @#Search The Cochrane Library, PubMed, EMbase, Web of Science, Wanfang Public Database,VIP database and CNKI to search for randomized controlled trials of EMD in the treatment of gingival recession. The search period is from the establishment of the databases to October 3, 2022. The test group was treated with EMD+CTG, while the control group was treated with CTG alone. Meta-analyses were performed using Review Manager 5.4.1 and Stat12.0.@*Results@# Meta analysis results showed that only 12 months after treatment, there was a statistically significant difference in the PD and CAL outcome indicators between the EMD assisted treatment group and the control group [MDPD=-0.10, 95% CI (-0.19, -0.01), P = 0.03], [MDCAL=-0.38, 95% CI(-0.71, -0.04), P = 0.03]. There was no significant difference between the test group and the control group in other indicators.@*Conclusion @#EMD assisted CTG in the treatment of gingival recession may be beneficial to the reduction of PD and CAL.

High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary diseases with acute-moderate hypercapnic respiratory failure: a randomized controlled trial of non-inferiority / 中华急诊医学杂志

Objective:To compare the efficacy of high-flow nasal cannula oxygen therapy (HFNC) and non-invasive ventilation (NIV) in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with moderate typeⅡ respiratory failure, to clarify the feasibility of HFNC in the treatment of AECOPD, and to explore the influencing factors of HFNC failure.Methods:This study was a randomized controlled trial of non-inferiority. Patients with AECOPD with moderate type Ⅱ respiratory failure [arterial blood gas pH 7.25-7.35, partial pressure of arterial blood carbon dioxide (PaCO 2)> 50 mmHg] admitted to the Intensive Care Unit (ICU) from January 2018 to December 2021 were randomly assigned to the HFNC group and NIV group to receive respiratory support. The primary endpoint was the treatment failure rate. The secondary endpoints were blood gas analysis and vital signs at 1 h, 12 h, and 48 h, total duration of respiratory support, 28-day mortality, comfort score, ICU length of stay, and total length of stay. Multivariate logistic regression analysis was used to evaluate the failure factors of HFNC treatment. Results:Totally 228 patients were randomly divided into two groups, 108 patients in the HFNC group and 110 patients in the NIV group. The treatment failure rate was 29.6% in the HFNC group and 25.5% in the NIV group. The risk difference of failure rate between the two groups was 4.18% (95% CI: -8.27%~16.48%, P=0.490), which was lower than the non-inferiority value of 9%. The most common causes of failure in the HFNC group were carbon dioxide retention and aggravation of respiratory distress, and the most common causes of failure in the NIV group were treatment intolerance and aggravation of respiratory distress. Treatment intolerance in the HFNC group was significantly lower than that in the NIV group (-29.02%, 95% CI -49.52%~-7.49%; P=0.004). After 1 h of treatment, the pH in both groups increased significantly, PaCO 2 decreased significantly and the oxygenation index increased significantly compared with baseline (all P < 0.05). PaCO 2 in both groups decreased gradually at 1 h, 12 h and 48 h after treatment, and the pH gradually increased. The average number of daily airway care interventions and the incidence of nasal and facial lesions in the HFNC group were significantly lower than those in the NIV group ( P < 0.05), while the comfort score in the HFNC group was significantly higher than that in the NIV group ( P=0.021). There was no significant difference between the two groups in the total duration of respiratory support, dyspnea score, ICU length of stay, total length of stay and 28-day mortality (all P > 0.05). Multivariate logistic regression analysis showed that acute physiology and chronic health evaluation Ⅱ score (≥15), family NIV, history of cerebrovascular accident, PaCO 2 (≥60 mmHg) and respiratory rate (≥32 times/min) at 1 h were independent predictors of HFNC failure. Conclusions:HFNC is not inferior to NIV in the treatment of AECOPD complicated with moderate type Ⅱ respiratory failure. HFNC is an ideal choice of respiratory support for patients with NIV intolerance, but clinical application should pay attention to the influencing factors of its treatment failure.

Evaluation index research of the randomized controlled trial of infertility treated by Traditional Chinese Medicine / 国际中医中药杂志

Objective:To collect and analyze the evaluation index of infertility treated by Traditional Chinese Medicine (TCM), which will lay a foundation for the establishment of the core index and evaluation index system of TCM treating infertility.Methods:By retriving the published literatures of randomized controlled trials of infertility treated by TCM in the database of CNKI, VIP, Wanfang, SinoMed, PubMed and Cochrane Library from January 1, 2011 to December 31, 2020, and after the screening according to the creteria of inclusion and exclusion, this paper analyzed the normal indexes of infertility and the pathogenic indexes of TCM.Results:A total of 95 RCTs were included, including 9 069 patients aged between 20-39 years old. The average sample size of each RCT study was 95, involving 78 evaluation criteria. The highest frequency of use was the total effective rate, etiological-index analysis found that the general indicators of infertility such as the total effective rate, pregnancy rate, TCM syndrome scores,and common etiological factors such as LH, FSH are the characteristic indicators.Conclusion:There are many problems in the evaluation indexes of clinical trials of treating infertility by TCM, such as great differences in number and not standardized usage. It is necessary to carry out research on the construction of core indicator and evaluation indicator systems of infertility according to different etiologies.