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.

Factors and Their Impact on Treatment Effect of Acupuncture in Different Outcomes: A Meta-Regression of Acupuncture Randomized Controlled Trials / 中国结合医学杂志

BACKGROUND@#The effects of acupuncture have varied in different randomized controlled trials (RCTs), and there are many factors that influence treatment effect of acupuncture in different outcomes, with conflicting results.@*OBJECTIVE@#To identify factors and their impact on the treatment effect of acupuncture in different outcomes.@*METHODS@#Acupuncture RCTs were searched from 7 databases including Medline (PubMed), Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc between January 1st, 2015 and December 31st, 2019. Eligible studies must compare acupuncture to no acupuncture, sham acupuncture, or waiting lists, and report at least 1 patient-important outcome. A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables, even those excluded from the multivariable model due to collinearities. We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences (SMDs), categorising them as small (<0.2), moderate (0.2-0.4), or large (>0.4) effects.@*RESULTS@#The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables. High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude, the difference of adjusted SMDs 0.46, 95% confidence interval (CI) 0.07 to 0.84; P=0.02]. The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables. Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture (0.30, 95% CI 0.06 to 0.53; P=0.01). The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables. Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects, compared to non-penetrating acupuncture and fixed regimen, respectively (0.40, 95% CI 0 to 0.80; P=0.05; 0.29, 95% CI 0.06 to 0.53; P=0.01).@*CONCLUSIONS@#High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms. Penetrating acupuncture demonstrated greater effect in relieving non-painful symptoms. Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes. Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes.

Effect of Acupuncture on Endometrial Blood Flow in Women Undergoing in vitro Fertilization Embryo Transfer: A Single Blind, Randomized Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the effect of manual acupuncture on endometrial blood flow parameters by three-dimensional (3D) power Doppler ultrasound in women undergoing in vitro fertilization embryo transfer (IVF-ET).@*METHODS@#Seventy patients undergoing IVF-ET were equally randomized into traditional or sham acupuncture treatment group for totally 4 days (from the day of oocyte aspiration to the day of embryo transfer) of treatment by random envelope method at the Reproductive Medicine Center and Outpatient Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology from January 2013 to December 2015. Patients in the traditional acupuncture group accepted traditional acupuncture methods with manual acupuncture, and Zhongji (CV3), Qihai (CV 6), Sanyinjiao (SP6), Taichong (LR 3), Tianshu (ST 25), Guilai (ST 29) and Zusanli (ST 36) were chosen. Patients at the sham acupuncture group accepted shallow acupuncture methods at 4 non-meridian points at each shoulder and upper arm. Outcome measures included endometrial ultrasonic indices such as vascularization index (VI), flow index (FI) and vascularization flow index (VFI), endometrial thickness and volume, subendometrial VI (sVI), subendometrial FI (sFI), subendometrial VFI (sVFI), implantation rate, clinical pregnancy rate, abortion rate, live birth rate and number of live births.@*RESULTS@#Finally, 34 patients in the traditional acupuncture group and 35 in the sham acupuncture group completed this trial. VI, FI and VFI of the traditional acupuncture group were significantly higher than those in the sham acupuncture group (P<0.05). No significant differences were found in endometrial thickness, endometrial volume, sVI, sFI, sVFI, implantation rate, clinical pregnancy rate, abortion rate, live birth rate and number of live births (P>0.05).@*CONCLUSIONS@#Manual acupuncture performed after oocyte aspiration and before transplantation improved the endometrial blood flow parameters VI, RI and VFI in women who underwent IVF-ET, instead of sVI, sFI and sVFI. Therefore, acupuncture might be beneficial in women undergoing IVF-ET by increasing endometrial blood flow and endometrial receptivity. (Registration No. ChiCTR2100053354).

Clinical Evidence Mapping of Chinese Patent Medicines Combined with Western Medicine in Treatment of Hypertension / 中国实验方剂学杂志

ObjectiveTo systematically collect， analyze， and evaluate the randomized controlled trials （RCT） of Chinese patent medicine combined with western medicine in the treatment of hypertension， map the evidence， and provide reference for the future clinical research and formulation of guidelines and policies. MethodThe relevant articles were retrieved from China Biology Medicine disc， China National Knowledge Infrastructure （CNKI）， VIP， Wanfang Data， PubMed， Embase， and Cochrane Library with the time interval from inception to December 31， 2022. The RCT of Chinese patent medicines combined with western medicine in the treatment of hypertension were included. The research characteristics and methodological quality were analyzed and evaluated. ResultA total of 330 RCTs of treating hypertension with Chinese patent medicines combined with Western medicine were included in this study， all of which were published in Chinese. These RCTs involved 88 Chinese patent medicines and 37 788 patients， and 46% of RCT had the sample size ≥100 patients. Eighty-seven percent of RCT showed the study period within 3 months. All the interventions in the RCTs were Chinese patent medicine + western medicine vs western medicine. Among the evaluation indicators， blood pressure， response rate， TCM syndrome score， endothelial cell function， and safety were mainly concerned. In terms of methodological quality， most articles did not mention the generation of random sequences， allocation concealment， or blinding method. The blinding evaluation of outcomes showed low risks of bias， and there was insufficient information to judge whether there was selective bias or other bias. ConclusionThere were many Chinese patent medicines used in combination with western medicine in the treatment of hypertension， and they were mainly taken orally. The existing RCT had problems such as small sample size， unclear clinical value positioning， imperfect design failing to reflect the value of Chinese patent medicines， unreasonable measurement indicators， and non-standard measurement methods. Future research should solve the above problems， improve the research quality， value， and authenticity， and enhance the reliability and extension of evidence.

Effect of the staging comprehensive treatment with acupuncture-moxibustion on Bell's facial palsy in the acute stage / 中国针灸

OBJECTIVES@#To compare the clinical effect on Bell's facial palsy in the acute stage between the staging comprehensive treatment with acupuncture-moxibustion and western medication.@*METHODS@#Sixty patients with Bell's facial palsy in the acute stage were randomly divided into an observation group and a control group, with 30 cases in each one. The patients in the control group were administered orally with prednisone acetate tablets and methylcobalamin tablets until the 28th day of illness. In the observation group, the staging comprehensive treatment with acupuncture-moxibustion was adopted. On the affected side, Qianzheng (EX-HN 16), Yifeng (TE 17), Sibai (ST 2), Yangbai (GB 14), Jiache (ST 6), Dicang (ST 4) and Touwei (ST 8), etc. were stimulated. In the acute stage (Day 1 to 7 of illness), the routine acupuncture and the point-toward-point needle insertion were delivered, no any manipulation was exerted at acupoints, and the needles were retained for 30 min. In the subacute stage (Day 8 to 14 of illness), on the base of the treatment as the acute stage, the depth of needle insertion was adjusted at a part of acupoints and the even needling technique was operated by twisting needle. Besides, electroacupuncture (EA) was attached to Qianzheng (EX-HN 16) and Dicang (ST 4), with continuous wave of low intensity and high frequency, 100 Hz, for 20 min. In the recovery stage (Day 15 to 28 of illness), on the base of the treatment as the subacute stage, the heavy stimulation of acupuncture was given, in which, the sticking and lifting needle techniques were delivered after the needles were inserted from Sibai (ST 2) toward Dicang (ST 4), and from Dicang (ST 4) toward Jiache (ST 6), separately; warm needling was operated at Yifeng (TE 17), and EA changed to stimulate the acupoints with the intermittent wave of high intensity and low frequency, 2 Hz, for 30 min. Acupuncture-moxibustion was given once every other day until the end of the 28th day of illness. The level of House-Brackmann facial nerve function rating scale (H-B grade),the score of Sunnybrook facial nerve grading system (Sunnybrook), the score of facial disability index (FDI), the temperature difference in the infrared thermal imaging facial area and electromyogram (EMG) situation of the affected muscle group were observed before and after treatment in the two groups. Using musculoskeletal ultrasound,the facial nerve diameter was detected and the clinical effect was compared between the two groups.@*RESULTS@#After treatment, the level of H-B grade, Sunnybrook score, the scores of physical function and social life function in FDI were improved when compared with those before treatment in the patients of either group (P<0.01, P<0.05), and the results of these evaluations in the observation group were better than those of the control group (P<0.05). After treatment, the temperature difference of the frontal area, the eye area, the zygomatic area and the mouth corner was declined in comparison with that before treatment in the two groups (P<0.05), and the temperature difference in each area in the observation group was lower than that of the control group (P<0.05).The root mean square (RMS) of the frontal muscle group, the zygomatic muscle group and the orbicularis muscle group on the affected side increased in comparison with that before treatment in the two groups (P<0.01), and RMS of the observation group was higher than that of the control group (P<0.05) after treatment. Before treatment, the diameter of the facial nerve on the affected side was larger than that on the healthy side (P<0.01), and after treatment, the diameter on the affected side was reduced when compared with that before treatment in the two groups (P<0.01); the diameter of the facial nerve on the affected side in the observation group was smaller than that of the control group (P<0.05), while, the diameter on the affected side was larger when compared with the healthy side in the control group (P<0.05). The total effective rate of the observation group was 93.3% (28/30), higher than that of the control group (83.3% [25/30], P<0.05).@*CONCLUSIONS@#The staging comprehensive treatment with acupuncture-moxibustion is clearly effective on Bell's facial palsy in the acute stage, which affirms the effectiveness of acupuncture-moxibustion for the acute stage of Bell's facial palsy in comparison with conventional western medication.

Randomized Controlled Trial Design Based on Patient Cohorts： Methods and Applications of Trials Within Cohorts / 中国实验方剂学杂志

Trials within cohorts （TwiCs） are design methods derived from randomized controlled trials （RCTS）. They have been widely used in chronic disease areas such as tumors and cardiovascular diseases. The basis of the TwiCs design is a prospective cohort of specific diseases. When RCTS need to be implemented， some patients meeting the inclusion and exclusion criteria are randomly sampled from the cohort to receive "trial interventions"， while the remaining patients in the cohort who meet the inclusion and exclusion criteria continue to receive conventional treatment as control groups. By comparing the efficacy differences between the intervention measures of the trial group and the control group， the efficacy of intervention measures was evaluated. Within the cohort， the same process could be repeated to carry out multiple RCTS， so as to evaluate different intervention measures or compare the efficacy of different doses or timing of interventions. Compared with classical RCTS， TwiCs make it easier to recruit patients from the cohort and have higher external validity， providing a new research paradigm for improving the efficiency and applicability of RCTS in clinical practice. However， TwiCs may also face the challenge of poor compliance of patients in the cohort. Researchers need to take effective measures to control these patients in the design and operation of TwiCs. This article focused on the methodological key points during the implementation of TwiCs， including multi-stage informed consent （patients are informed of consent at three stages： entering the cohort， entering the trial group， and after the trial）， randomization procedures （only random sampling of patients from the cohort to receive "trial interventions"）， sample size calculation， and statistical analysis methods. The article also compared the differences between TwiCs and traditional RCTS and illustrated TwiCs research design and analysis with examples， so as to provide new research ideas and methods for clinical researchers.

What is an "ongoing" clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study

ABSTRACT BACKGROUND: Although the concept of an "ongoing study" seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of "ongoing clinical trial" across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still "ongoing" during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of "ongoing clinical trials" lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

Historia de la hipertensión arterial: revisión narrativa

Introducción: La medición de la presión arterial es uno de los procedimientos más realizados en la práctica clínica. La presente revisión narrativa pretende sintetizar los aspectos relevantes que rodearon la definición de la hipertensión arterial, el recorrido histórico del tratamiento de esta y el aporte de los estudios a la disminución de la mortalidad por enfermedad cardiovascular en el tiempo. Metodología: Revisión narrativa de la historia de la hipertensión arterial, desde el reconocimiento de la presión arterial alta como un factor asociado al riesgo cardiovascular y la evolución histórica del tratamiento hasta los hallazgos significativos del estudio SPRINT, publicado en 2015. Resultados: Hasta hace aproximadamente 50 años la hipertensión arterial era conocida como una patología esencial, es decir, esta condición no siempre fue considerada como una enfermedad. El descubrimiento de la presión sanguínea ha sido atribuido a Stephen Hales, poeta, orador y sacerdote nacido en Inglaterra. La primera medición de la presión sanguínea e incidentalmente de la presión del pulso la realizó en 1733 en animales. Se describe el origen de la presión arterial, la hipertensión arterial, el camino recorrido para el reconocimiento de esta condición como enfermedad y posteriormente su tratamiento, hasta llegar al estudio SPRINT en 2015, el cual fue contundente en demostrar el beneficio de reducir la cifra de presión arterial sistólica objetivo en una población no diabética. Conclusión: Los resultados de esta revisión narrativa exponen cómo el reconocimiento de la presión arterial alta como un factor de riesgo cardiovascular permitió el avance en la investigación científica para determinar el tratamiento y las cifras de presión arterial que favorecen la reducción de la mortalidad y morbilidad por esta causa.

Background: Blood pressure measurement is one of the most performed procedures in clinical practice. This narrative review aims to expose the relevant aspects surrounding the definition of arterial hypertension, the historical path of its treatment, and the contribution of studies to the decrease in mortality due to cardiovascular disease over time. Methodology: Narrative review of the history of arterial hypertension from recognizing high blood pressure as a factor associated with cardiovascular risk to the historical evolution of treatment up to the SPRINT study published in 2015. Results: Until about 50 years ago, arterial hypertension was known as an essential pathology; this condition was not always considered a disease. The discovery of blood pressure has been attributed to Stephen Hales, a poet, orator and priest born in England. The first measurement of blood pressure and incidentally pulse pressure was made in 1733 in animals. The origin of blood pressure, arterial hypertension, and the path travelled for recognizing this condition as a disease and later its treatment until reaching the SPRINT study in 2015, which demonstrated the benefit of reducing the target systolic blood pressure figure in a non-diabetic population. Conclusion: This narrative review demonstrates that the recognition of high blood pressure as a cardiovascular risk factor allowed progress in scientific research to determine the treatment and blood pressure figures that favor the reduction of mortality and morbidity from this cause.

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.

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

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.

Low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction - a narrative review

ABSTRACT Objectives: To provide an overview of low-intensity extracorporeal shockwave therapy (LIEST) for erectile dysfunction (ED), pointing out which concepts are already consolidated and which paths we still need to advance. Materials and Methods: We performed a narrative review of the literature on the role of shockwave therapies in erectile dysfunction, selecting publications in PUBMED, including only relevant clinical trials, systematic reviews and meta-analyses. Results: We found 11 studies (7 clinical trials, 3 systematic review and 1 meta-analysis) that evaluated the use of LIEST for the treatment of erectile dysfunction. One clinical trial evaluated the applicability in Peyronie's Disease and one other clinical trial evaluated the applicability after radical prostatectomy. Conclusions: The literature presents little scientific evidence but suggests good results with the use of LIEST for ED. Despite a real optimism since it is a treatment modality capable of acting on the pathophysiology of ED, we must remain cautious, until a larger volume of higher quality studies allows us to establish which patient profile, type of energy and application protocol will achieve clinically satisfactory results.

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.

Photobiomodulation efficacy of major salivary glands in children with caries activity: study protocol for randomized, double-blind, placebo-controlled, parallel-group clinical trial / Efeito da fotobiomodulação das principais glândulas salivares em crianças com actividade de cárie: ensaio clínico aleatório duplo-cego

Background: Dental caries is one of the most prevalent diseases among children worldwide. Saliva plays a significant role in the demineralization/remineralization of the dental surface. Several salivary characteristics, such as flow rate, pH, and buffering capacity, provide relevant information regarding the development of carious lesions. Photobiomodulation has shown promising results in improving salivary flow rate and buffer capacity in the adult population. Purpose: of this trial was to evaluate the efficacy of photobiomodulation of the major salivary glands on salivary parameters in children with caries. Methods: This protocol details a randomized, double-blind, parallel-group, controlled trial that evaluated salivary parameters through photobiomodulation in children. Fifty 6- to 12-year-old participants will be randomly divided into two groups:1) photobiomodulation experimental group (G1) (n=25) and 2) photobiomodulation placebo group (G2) (n=25). Infrared light will be applied at 16 intra-and extraoral points and placebo, respectively. Unstimulated salivary samples will be collected before and immediately after application once a week for three consecutive weeks. Salivary samples will be analyzed for their flow rate, pH, and buffering capacity. The primary outcomes are the differences in salivary flow rates between G1 and G2. The secondary outcomes are differences in salivary pH and buffering capacity between G1 and G2. Discussion: The results of this clinical trial will offer evidence for the efficacy of photobiomodulation in salivary parameters and to support decision-making regarding non-invasive treatments to control dental caries.

Contexto: A cárie dentária é uma das doenças mais prevalentes entre as crianças em todo o mundo. A saliva desempenha um papel significativo na desmineralização/remineralização da superfície dentária. Várias características salivares, como a taxa de fluxo, o pH e a capacidade de tamponamento, fornecem informações relevantes sobre o desenvolvimento de lesões de cárie. A fotobiomodulação demonstrou resultados promissores na melhoria da taxa de fluxo salivar e da capacidade de tamponamento na população adulta. Objetivo: deste estudo foi avaliar a eficácia da fotobiomodulação das glândulas salivares principais sobre os parâmetros salivares em crianças com cárie. Métodos: Este protocolo detalha um estudo randomizado, duplo-cego, de grupos paralelos e controlado que avaliou parâmetros salivares por meio da fotobiomodulação em crianças. Cinquenta participantes de 6 a 12 anos de idade serão divididos aleatoriamente em dois grupos: 1) grupo experimental de fotobiomodulação (G1) (n=25) e 2) grupo placebo de fotobiomodulação (G2) (n=25). A luz infravermelha será aplicada em 16 pontos intra e extraorais e o placebo, respectivamente. Amostras salivares não estimuladas serão coletadas antes e imediatamente após a aplicação, uma vez por semana, durante três semanas consecutivas. As amostras salivares serão analisadas quanto à sua taxa de fluxo, pH e capacidade de tamponamento. Os resultados primários são as diferenças nas taxas de fluxo salivar entre G1 e G2. Os resultados secundários são as diferenças no pH salivar e na capacidade de tamponamento entre G1 e G2. Discussão: Os resultados desse ensaio clínico oferecerão evidências da eficácia da fotobiomodulação nos parâmetros salivares e apoiarão a tomada de decisões em relação a tratamentos não invasivos para o controle da cárie dentária.

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.

Investigación clínica en homeopatía: revisiones sistemáticas y estudios clínicos aleatorizados / Clinical research in homeopathy: systematic reviews and randomized clinical trials

Se considera que las revisiones sistemáticas y estudios clínicos aleatorizados (RCT) presentan el nivel de evidencia más alto. Objetivo: Realizar una revisión descriptiva de las revisiones sistemáticas y estudios clínicos controlados aleatorizados (RCT, por sus siglas en inglés) sobre la efectividad y eficacia de la homeopatía. Métodos: Los datos del reporte publicado por la Liga Medicorum Homeopathica Internationalis (LMHI) en 2014 fueron actualizados mediante una búsqueda en la base de datos PubMed. Resultados: Se localizaron 7 revisiones sistemáticas con meta-análisis, 6 de las cuales concluyeron que los efectos de la homeopatía no son compatibles con el efecto placebo; sólo una revisión sistemática llegó a la conclusión opuesta, aunque fue severamente criticado debido a sus errores metodológicos. Un total de 19 RCT fueron publicados a lo largo del periodo analizado. El 84.2% tuvo por lo menos un resultado positivo. Conclusiones: Con base en las evidencias disponibles del más alto nivel, no es posible afirmar que los efectos de la homeopatía son exclusivamente un efecto placebo. Por el contrario, se han detectado efectos específicos en varios estudios.

Systematic reviews and randomized clinical trials (RCT) are considered to have the highest level of evidence. Aim: To perform a descriptive review of systematic reviews and RCT on the effectiveness and efficacy of homeopathy. Methods: Data from the report published by Liga Medicorum Homeopathica Internationalis (LMHI) in 2014 were updated by means on a search conducted in database PubMed. Results: 7 systematic reviews with meta-analysis were located, 6 of them concluded that the effects of homeopathy are not compatible with placebo effect; only 1 systematic review arrived to the opposite conclusion, but was severely criticized due to methodological flaws. A total of 19 RCT were published along the analyzed period; 84.2% had at least one positive outcome. Conclusions: Based on the available evidences of the highest level it is not possible to assert that the effects of homeopathic are exclusively placebo effect. On the opposite, specific effects were detected in several studies.

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.

Role of calcium &/or vitamin D supplementation in preventing osteoporotic fracture in the elderly: A systematic review & meta-analysis

Background & objectives: Calcium and vitamin D, separately or in combination are usually prescribed to prevent fragility fractures in elderly population. However, there are conflicting results regarding the ideal dosage and overall efficacy obtained from randomized controlled trials (RCTs) conducted in the past. The objective of this study was to assess the fracture risk with the administration of calcium or vitamin D alone or in combination in elderly population (>60 yr). Methods: PubMed, Cochrane and Embase databases were searched to identify the studies from inception to February 2021 with keywords, ‘vitamin D’, ‘calcium’ and ‘fracture’ to identify RCTs. The trials with comparing vitamin D, calcium or combination with either no medication or placebo were included for final analyses. The data were extracted and the study quality was assessed by two reviewers. The principal outcome measure was fractures around hip joint and secondary outcomes assessed were vertebral and any other fracture. Results: Eighteen RCTs were considered for the final analysis. Neither calcium nor vitamin D supplementation was associated with risk of fractures around hip joint [risk ratio (RR) 1.56; 95% confidence interval (CI), 0.91 to 2.69, I2=28%; P=0.11]. In addition, the combined administration of calcium and vitamin D was also not associated with fractures around the hip joint in comparison to either no treatment or placebo. The incidence of vertebral (RR 0.95; 95% CI, 0.82 to 1.10, I2=0%; P=0.49) or any other fracture (RR 0.83; 95% CI 0.65 to 1.06, I2=0%; P=0.14) was not significantly associated with the administration of calcium and vitamin D either individually or in combination. Further subgroup analysis of the results did not vary with the dosage of calcium or vitamin D, dietary calcium intake sex, or serum 25-hydroxyvitamin D levels. Interpretation & conclusions: The present meta-analysis of RCTs on calcium, vitamin D or a combination of the two in comparison to no treatment or placebo did not support the routine administration protocol of calcium and vitamin D either alone or in combination to lower the risk of fractures in elderly population.