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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.
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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.
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Humans , Male , Female , Cross Infection , Control Groups , Randomized Controlled Trial , Health Belief Model , NursesABSTRACT
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.
Subject(s)
Humans , Male , Female , Thoracic Vertebrae/diagnostic imaging , Decompression, Surgical , LaminectomyABSTRACT
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
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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.
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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
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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.
Subject(s)
Resistance Training , Aging , ExerciseABSTRACT
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.
Subject(s)
Humans , Child, Preschool , Child , Tonsillitis/drug therapy , Homeopathic Remedy , Double-Blind MethodABSTRACT
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.
Subject(s)
Humans , Female , Adolescent , Adult , Middle Aged , Homeopathic Therapeutics , Pelvic Pain/therapy , Endometriosis/complications , Estrogens/therapeutic use , Placebos , Double-Blind MethodABSTRACT
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.
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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.
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ObjectiveTo evaluate the efficacy and safety of topical Bisaitong （鼻塞通） in treating moderate-to-severe allergic rhinitis （AR）. MethodsA randomized， positive-controlled， non-inferiority clinical trial design was adopted. Totally， 108 cases of moderate-to-severe AR were randomly divided into Bisaitong group and mometasone furoate group，with 54 cases in each group. The Bisaitong group was treated with Bisaitong smeared at the nasal cavity twice a day， and the mometasone furoate group received inhalation of mometasone furoate nasal spray 100 μg in each nostril， once a day. Both groups were treated for 4 weeks and followed up after additional 4 weeks. Both groups were compared on the rhinoconjunctivitis quality of life questionnaire （RQLQ）， rhinoconjunctivitis total symptom score （RTSS）， visual analogue score （VAS） of sneezing， runny nose， nasal itching， nasal congestion degree， days of AR episodes at enrollment， after 2- and 4-week， and at follow-up. The peripheral blood eosinophil （EOS） count and percentage （EOS%）， serum eosinophil cationic protein （ECP）， serum dust mite， dermatophagoides farinae， and cockroach allergen-specific IgE （sIgE） levels were compared between groups at enrollment and after 4-week treatment. Drug overuse rate was calculated， and the safety was evaluated. The analysis of all efficacy outcomes was based on both full analysis set （FAS） and per-protocol set （PPS）. ResultsThe lower limit of the 95% confidence interval for the differences in RQLQ scores were greater than -0.6 measured after 2- and 4-week treatment and at follow-up compared to that measured at the enrollment in both groups， indicating of the Bisaitong group being non-inferior to the mometasone furoate group. There was no statistically significant difference between groups on RTSS score， VAS scores of sneezing， runny nose， nasal itching， nasal congestion degree and days of episodes at all timepoints （P＞0.05）， but each outcome changed significantly over time in both groups （P＜0.01）. The differences between groups in EOS count， EOS%， ECP levels， serum dust mite， dermatophagoides farinae， cockroach sIgE levels， and drug overuse rate were not statistically significant at enrollment and after 4-week treatment （P＞0.05）. Adverse events occurred in eight cases （15.10%） in the Bisaitong group and five cases （9.30%） in the mometasone furoate group， showing no significant difference between groups （P＞0.05）. ConclusionTopical Bisaitong is non-inferior to mometasone furoate nasal spray in the treatment of moderate to severe AR in terms of clinical symptom relief，reduction in the episodes， improvement of quality of life， and sound safety.
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Target trial emulation， using observational data to emulate a target trial， applies the study design principles of randomized controlled trials to observational studies that aim to estimate the effect of an intervention. The advantage of target trial emulation is that observational data is used to emulate a target trial when it is not appropriate to conduct randomized controlled trials. Target trial emulation can control bias caused by the design of observational studies， and improve the effectiveness of causal inference from observational data. This paper introduced the methodological framework and key points in terms of eligibility criteria， treatment strategies， assignment procedures， grace period， outcomes， follow-up period， effect contrasts， and statistical plan for implementing target trial emulation. This article elucidated the feasibility and necessity of applying target trail emulation in the realm of traditional Chinese medicine researches， and highlighted the challenges encountered in its implementation， such as the need for specialized personnel， data collection and integration， and the control of confounding factors.
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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.
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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.
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OBJECTIVE@#To evaluate the efficacy of Chinese plaster containing rhubarb and mirabilite on surgical site infection (SSI) in patients with cesarean delivery (CD) by performing a randomized controlled trial.@*METHODS@#This randomized controlled trial included 560 patients with CD due to fetal head descent enrolled at a tertiary teaching center between December 31, 2018 and October 31, 2021. Eligible patients were randomly assigned to a Chinese medicine (CM) group (280 cases) or a placebo group (280 cases) by a random number table, and were treated with CM plaster (made by rhubarb and mirabilite) or a placebo plaster, respectively. Both courses of treatment lasted from the day 1 of CD, followed day 2 until discharge. The primary outcome was the total number of patients with superficial, deep and organ/space SSI. The secondary outcome was duration of postoperative hospital stay, antibiotic intake, and unplanned readmission or reoperation due to SSI. All reported efficacy and safety outcomes were confirmed by a central adjudication committee that was unaware of the study-group assignments.@*RESULTS@#During the recovery process after CD, the rates of localized swelling, redness and heat were significantly lower in the CM group than in the placebo group [7.55% (20/265) vs. 17.21% (47/274), P<0.01]. The durution of postoperative antibiotic intake was shorter in the CM group than in the placebo group (P<0.01). The duration of postoperative hospital stay was significantly shorter in the CM group than in the placebo group (5.49 ± 2.68 days vs. 8.96 ± 2.35 days, P<0.01). The rate of postoperative C-reactive protein elevation (≽100 mg/L) was lower in the CM group than in the placebo group [27.6% (73/265) vs. 43.8% (120/274), P<0.01]. However, there was no difference in purulent drainage rate from incision and superficial opening of incision between the two groups. No intestinal reactions and skin allergies were found in the CM group.@*CONCLUSIONS@#CM plaster containing rhubarb and mirabilite had an effect on SSI. It is safe for mothers and imposes lower economic and mental burdens on patients undergoing CD. (Registration No. ChiCTR2100054626).
Subject(s)
Pregnancy , Female , Humans , Surgical Wound Infection/etiology , Medicine, Chinese Traditional , Anti-Bacterial Agents/therapeutic use , Cesarean Section/adverse effects , Double-Blind Method , Treatment OutcomeABSTRACT
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).
Subject(s)
Male , Humans , Quality of Life , Mindfulness , Colorectal Neoplasms/therapyABSTRACT
This study aims to provide evidence for clinical practice by systematically reviewing the efficacy and safety of Gusongbao preparation in the treatment of primary osteoporosis(POP). The relevant papers were retrieved from four Chinese academic journal databases and four English academic journal databases(from inception to May 31, 2022). The randomized controlled trial(RCT) of Gusongbao preparation in the treatment of POP was included after screening according to the inclusion and exclusion criteria. The quality of articles was evaluated using risk assessment tools, and the extracted data were subjected to Meta-analysis in RevMan 5.3. A total of 657 articles were retrieved, in which 15 articles were included in this study, which involved 16 RCTs. A total of 3 292 patients(1 071 in the observation group and 2 221 in the control group) were included in this study. In the treatment of POP, Gusongbao preparation+conventional treatment was superior to conventional treatment alone in terms of increasing lumbar spine(L2-L4) bone mineral density(MD=0.03, 95%CI[0.02, 0.04], P<0.000 01) and femoral neck bone mineral density, reducing low back pain(MD=-1.69, 95%CI[-2.46,-0.92], P<0.000 1) and improving clinical efficacy(RR=1.36, 95%CI[1.21, 1.53], P<0.000 01). Gusongbao preparation was comparable to similar Chinese patent medicines in terms of improving clinical efficacy(RR=0.95, 95%CI[0.86, 1.04], P=0.23). Gusongbao preparation was inferior to similar Chinese patent medicines in reducing traditional Chinese medicine syndrome scores(MD=1.08, 95%CI[0.44, 1.71], P=0.000 9) and improving Chinese medicine syndrome efficacy(RR=0.89, 95%CI[0.83, 0.95], P=0.000 4). The incidence of adverse reactions of Gusongbao preparation alone or combined with conventio-nal treatment was comparable to that of similar Chinese patent medicines(RR=0.98, 95%CI[0.57, 1.69], P=0.94) or conventio-nal treatment(RR=0.73, 95%CI[0.38, 1.42], P=0.35), and the adverse reactions were mainly gastrointestinal discomforts. According to the available data, Gusongbao preparation combined with conventional treatment is more effective than conventional treatment alone in increasing lumbar spine(L2-L4) bone mineral density and femoral neck bone mineral density, reducing low back pain, and improving clinical efficacy. The adverse reactions of Gusongbao preparation were mainly gastrointestinal discomforts, which were mild.
Subject(s)
Humans , Bone Density , Low Back Pain , Medicine, Chinese Traditional , Osteoporosis/drug therapyABSTRACT
This study systematically evaluated the clinical efficacy and safety of Fengliao Changweikang prescription for treating acute gastroenteritis(AGE). The databases of CNKI, Wanfang, VIP, SinoMed, Medline, Cochrane Library and two clinical trial registration platforms were retrieved from inception to August 30, 2022, to collect randomized controlled trial(RCT) on Fengliao Changweikang prescription treating AGE. Two researchers independently conducted literature screening, data extraction, and risk of bias assessment according to pre-established inclusion and exclusion criteria. RevMan 5.4.1 was used for data analysis. Finally, 18 RCTs were included, involving 3 489 patients. Meta-analysis showed that compared with conventional western medicine, Fengliao Changweikang prescription improved the relief rate of abdominal pain(RR=1.27, 95%CI[1.17, 1.38],P<0.000 01); Fengliao Changweikang prescription + conventional western medicine increased the cure rate(RR=1.43, 95%CI[1.12, 1.82], P=0.004), shortened the duration of diarrhoea(RR=-1.65, 95%CI[-2.44,-0.86], P<0.000 1), abdominal pain(RR=-1.46, 95%CI[-2.00,-0.92], P<0.000 01), vomiting(RR=-2.16, 95%CI[-2.51,-1.81], P<0.000 01) and fever(RR=-2.61, 95%CI[-4.00,-1.23], P=0.000 2), down-regulated the level of interleukin-8(IL-8)(RR=-1.07, 95%CI[-1.26,-0.88], P<0.000 01), IL-6(RR=-8.24, 95%CI[-8.99,-7.49], P<0.000 01) and hypersensitive C-reactive protein(hs-CRP)(RR=-3.04, 95%CI[-3.40,-2.69], P<0.000 01) and recurrence of AGE(RR=0.20, 95%CI[0.05, 0.90], P<0.04). In conclusion, Fengliao Changweikang prescription was safe in clinical application. It was beneficial to alleviate the clinical symptoms of diarrhea, abdominal pain, vomiting, and fever, and down-regulate the levels of some serum inflammatory factors in AGE patients. However, considering that few high-quality studies have evaluated the efficacy and safety of Fengliao Changweikang prescription in treatment of AGE, further evidence is needed in the future.
Subject(s)
Humans , Drugs, Chinese Herbal/adverse effects , Treatment Outcome , Gastroenteritis/drug therapy , PrescriptionsABSTRACT
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).