Eficacia y seguridad del supositorio Proctokinasa® en el tratamiento de la enfermedad inflamatoria pélvica aguda

Introducción: La enfermedad inflamatoria pélvica aguda es una entidad frecuente en mujeres jóvenes en edad reproductiva, y constituye la causa principal de infertilidad. La búsqueda de un tratamiento antiinflamatorio eficaz y seguro que alivie el dolor, evite complicaciones y secuelas, es una prioridad para su tratamiento. Objetivo: Evaluar la eficacia y seguridad del tratamiento con Proctokinasa® en la enfermedad inflamatoria pélvica aguda grados I y II. Materiales y métodos: Se desarrolló un ensayo clínico, controlado, abierto, de enero de 2017 a enero de 2018, que incluyó 76 pacientes con diagnóstico de enfermedad inflamatoria pélvica aguda en la atención primaria de salud, quienes fueron asignadas aleatoriamente a dos grupos de tratamiento: grupo principal Proctokinasa®, que recibió una unidad/8 h por 2 días, y el grupo Piroxicam, un supositorio de 20 mg/24 h por 7 días. La antibioticoterapia oral recomendada se inició simultáneamente. Se evaluó la respuesta clínica y ecográfica al tratamiento. Los eventos adversos fueron evaluados. Resultados: Se constató respuesta clínica a partir de las 72 horas de tratamiento en más del 50 % de las pacientes en ambos grupos, y fue del 100 % de los casos para el grupo Proctokinasa® en las dos últimas evaluaciones realizadas (días 10 y 15). Se evidenció la remisión de las alteraciones ecográficas en el 96,9 % del grupo Proctokinasa®. Los eventos adversos fueron escasos y leves. Conclusiones: El empleo de Proctokinasa® resultó eficaz y seguro en el tratamiento de la enfermedad inflamatoria pélvica aguda grados I y II.

Introduction: Acute pelvic inflammatory disease is a common entity in young women of reproductive age and it is a leading cause of infertility. The search for an effective and safe anti-inflammatory treatment that relieves pain, avoids complications and sequels, it is priority for its treatment. Objective: To evaluate the efficacy and safety of the treatment with Proctokinasa® in acute pelvic inflammatory disease grades I and II. Materials and methods: An open, controlled clinical trial was carried out from January 2017 to January 2018 which included 76 patients diagnosed with acute pelvic inflammatory disease in primary health care; they were randomize assigned to two treatment groups: Proctokinasa® main group, who received one unity/8h for 2 days, and the Piroxican group, 1 suppository of 20 mg/24h per 7 days. The recommended oral antibiotic therapy was started simultaneously. Clinical and ultrasound response to treatment were evaluated. Adverse events were evaluated. Results: Clinical response was stated after 72 hours of treatment inmore than 50% of the patients in both groups, and it was 100% for the Proctokinasa® group in the last two evaluations (days 10 and 15). Remission of ultrasound alterations was evident in 96.9% of the Proctokinasa® group. Adverse events were few and mild. Conclusions: The use of Proctokinasa® was effective and safe in the treatment of acute pelvic inflammatory disease grades I and II.

Curative effects of Shugan Hewei Zhitong Recipe on chronic gastritis complicated by Helicobacter pylori infection / 中国基层医药

Objective:To investigate the curative effects of Shugan Hewei Zhitong Recipe on chronic gastritis complicated by Helicobacter pylori infection. Methods:Eighty-seven patients with chronic gastritis complicated by Helicobacter pylori infection who received treatment in the Huguosi Hospital of Traditional Chinese Medicine, Beijing University of Chinese Medicine, China from July 2018 to June 2020 were included in this study. They were randomly assigned to undergo treatment with either conventional Western medicine ( n = 43, control group) or Shugan Hewei Zhitong Recipe based on conventional Western medicine ( n = 44, observation group) for 2 weeks. Before and after treatment, traditional Chinese medicine syndrome scores were compared between the two groups. Curative effects of Shugan Hewei Zhitong Recipe on chronic gastritis complicated by Helicobacter pylori infection were evaluated. Results:Total response rate in the observation group was significantly higher than that in the control group [91% (40/44) vs. 72% (31/43), χ2 = 5.13, P = 0.024]. In each group, the traditional Chinese medicine symptom score post-treatment was significantly lower than the traditional Chinese medicine symptom score pre-treatment (both P < 0.001). After treatment, the traditional Chinese medicine score of the observation group was significantly lower than that of the control group ( P < 0.05). There were no adverse reactions in each group. Conclusion:Shugan Hewei Zhitong Recipe is safe and effective on chronic gastritis complicated by Helicobacter pylori infection, which is worthy of clinical promotion.

Efficacy of Curcumin on Cognitive Function Scores in Women with Premenstrual Syndrome and Dysmenorrhea: A Triple-Blind, Placebo-Controlled Clinical Trial / 中国结合医学杂志

OBJECTIVE@#To assess the efficacy of a curcumin supplementation on cognitive abilities in women suffering from premenstrual syndrome (PMS) and dysmenorrhea.@*METHODS@#A randomized, triple-blind, placebo-controlled trial was conducted from December 2019 to March 2020. A total of 124 women who had both PMS and dysmenorrhea were enrolled, and were equally and randomly assigned to the curcumin group or placebo group, 62 cases in each. Each subject received either a capsule containing 500 mg of curcuminoid, or a placebo daily, for 10 days (7 days before and until 3 days after the onset of menstrual bleeding) over 3 menstrual cycles. The cognitive abilities questionnaire was used to measures cognitive functions in 7 specific areas. Adverse reactions were monitored during and after the trial in both groups.@*RESULTS@#Administration of curcumin was associated with a significant increase in memory score (P=0.002), inhibitory control and selective attention (P=0.020), and total cognitive ability task (P=0.024). In addition, significant increments were found in scores of memory (3.5±3.1 vs. 0.4±3.8 in the curcumin and placebo groups, respectively; P=0.035), inhibitory control and selective attention (3.0±3.7 vs. 0.4±3.7; P=0.027) and total cognitive abilities (8.3±12.3 vs. 2.2±12.4; P=0.025) in the curcumin group versus placebo groups. Curcumin was safe and well-tolerable in current clinical trial.@*CONCLUSION@#Curcumin has a beneficial efficacy on cognitive function scores in women with PMS and dysmenorrhea, with improvements in memory, inhibitory control and selective attention. (Registration No. IRCT20191112045424N1, available at: https://www.irct.ir ).

Ensayo controlado y aleatorizado del uso de Heberkinasa® en el derrame pleural paraneumónico en niños / Randomized Controlled Trial of the Use of Heberkinase® in Parapneumonic Pleural Effusion in Children

Introducción: El derrame pleural paraneumónico resulta la complicación más frecuente de la neumonía bacteriana, de manejo complejo y muchas veces quirúrgico. No existen publicaciones en Cuba provenientes de ensayos clínicos controlados y aleatorizados ni del uso de la estreptoquinasa recombinante (Heberkinasa®) en el derrame pleural. Objetivo: Evaluar la eficacia y la seguridad de la Heberkinasa® en el tratamiento del derrame pleural paraneumónico complicado complejo y el empiema en niños. Métodos: Ensayo clínico fase III, abierto, aleatorizado (2:1), en grupos paralelos y controlado. Se concluyó la inclusión prevista de 48 niños (1-18 años de edad), que cumplieron los criterios de selección. Los progenitores otorgaron el consentimiento informado. Los pacientes se distribuyeron en dos grupos: I- experimental: terapia estándar y administración intrapleural diaria de 200 000 UI de Heberkinasa® durante 3-5 días y II-control: tratamiento estándar. Las variables principales: necesidad de cirugía y la estadía hospitalaria. Se evaluaron los eventos adversos. Resultados: Ningún paciente del grupo I-experimental requirió cirugía, a diferencia del grupo II-control en el que 37,5 por ciento necesitó cirugía video-toracoscópica, con diferencia altamente significativa. Se redujo la estadía hospitalaria (en cuatro días), las complicaciones intratorácicas y las infecciones asociadas a la asistencia sanitaria en el grupo que recibió Heberkinasa®. No se presentaron eventos adversos graves atribuibles al producto. Conclusiones: La Heberkinasa® en el derrame pleural paraneumónico complicado complejo y empiema resultó eficaz y segura para la evacuación del foco séptico, con reducción de la necesidad de tratamiento quirúrgico, de la estadía hospitalaria y de las complicaciones, sin eventos adversos relacionados con su administración(AU)

Introduction: Paraneumonic pleural effusion is the most frequent complication of bacterial pneumonia, with complex and often surgical management. There are no publications in Cuba from randomized controlled clinical trials or the use of recombinant streptokinase (Heberkinase®) in pleural effusion. Objective: To evaluate the efficacy and safety of Heberkinase® in the treatment of complex complicated parapneumonic pleural effusion and empyema in children. Methods: Phase III, open-label, randomized (2:1), parallel-group, controlled clinical trial. The planned inclusion of 48 children (1-18 years of age), who met the selection criteria, was completed. Parents gave informed consent. The patients were divided into two groups: I-experimental: standard therapy and daily intrapleural administration of 200,000 IU of Heberkinase® for 3-5 days; and II-control: standard treatment. The main variables: need for surgery and hospital stay. Adverse events were evaluated. Results: No patient in group I-experimental required surgery, unlike group II-control in which 37.5 percent required video-assisted thoracoscopic surgery, with a highly significant difference. Hospital stay (to 4 days), intrathoracic complications and infections associated to healthcare in the group that received Heberkinase® was reduced. No serious adverse events attributable to the product occurred. Conclusions: Heberkinase® in complex complicated parapneumonic pleural effusion and empyema was effective and safe for the draining of the septic focus, with reduction of the need for surgical treatment, hospital stay and complications, with no adverse events related to its administration(AU)

Effect of the association of continuous shortwave diathermy and Pilates-based exercises on pain, depression, and anxiety in chronic non-specific low back pain: a randomized clinical trial

Chronic nonspecific low back pain (CNLBP) is the most common musculoskeletal condition, which can be influenced by nociceptive, psychosocial, cognitive, and affective aspects, causing vulnerabilities and impairing the individual's ability to manage pain. The association of continuous shortwave diathermy (CSWD) with Pilates-based exercises may contribute to reduce pain, depression, and anxiety in patients with CNLBP. A single-blind randomized clinical trial was performed in which 36 patients with CNLBP were divided into a control group that received placebo CSWD and an intervention group that received active CSWD. Both groups received 12 sessions of Pilates-based exercises. Pain, depression, and anxiety variables were evaluated using the McGill questionnaire, the Beck Depression Inventory, and the Visual Analog Anxiety Scale. Assessments were performed at baseline, after three and six weeks of treatment, and at the three-month follow-up. The Shapiro-Wilk test, Student's t-test, Mann-Whitney U test, chi-squared test, and repeated measures ANOVA, with α=0.05, were used to compare the outcomes, and indicated that active CSWD did not present additional improvement in the assessed variables in CNLBP patients compared to the placebo group. Both groups improved pain and depression at follow-up and reduced anxiety only during Pilates-based exercises. Therefore, only Pilates-based exercises seemed sufficient to manage patients with CNLBP.

Reflexiones acerca de las cambiantes narrativas sobre las vacunas contra la COVID-19

Nos propusimos discernir en qué medida las estrategias mediáticas adoptadas en torno a las vacunas contra la COVID-19, a lo largo de los primeros 15 meses desde el comienzo de su aplicación, pueden considerarse aportes legítimos y coherentes para comprender mejor su desempeño, y en qué grado las narrativas elaboradas pudieran responder a intereses económicos de las élites corporativas. Una vez recopilados los elementos más relevantes con que se configuran las narrativas predominantes desde el momento en que se concibieron las vacunas, se identificaron diversas anomalías que resultaron, en mayor o menor medida, invisibilizadas en el proceso de su aprobación y de los resultados de su aplicación. Las más significativas conciernen al manejo de las definiciones, los incumplimientos de compromisos y los conflictos de interés que comprometen la actuación de las empresas comercializadoras y los entes reguladores de las vacunas. Numerosos elementos relacionados con los intereses corporativos han gravitado en la elaboración del relato sobre las vacunas. Entre los que reclaman resignificación se hallan: su capacidad preventiva real de contagios, evoluciones graves y muertes, su eficacia ante nuevas variantes, la duración de la inmunidad que confieren, sus efectos adversos, el papel sinérgico de la inmunidad adquirida y los recursos empleados por las empresas para conseguir un predominio virtualmente monopólico en el mercado.

We set out to discern to what extent the media strategies adopted around the vaccines against covid-19 during the first 15 months since the beginning of their application can be considered as a legitimate and coherent contributions to a better understanding about their performance and to what extent the elaborated discourses could respond to the economic interests of the corporations' elites. Once the most relevant elements that have shaped the predominant narratives from the moment the vaccines were conceived were compiled, several anomalies were identified that were to a greater or lesser extent invisibilized in the process of their approval and the results of their application. The most significant of these concern the handling of definitions, non-compliance with commitments and conflicts of interest that compromise the actions of vaccine marketing companies and regulatory bodies. Many elements related to corporative interests have influenced the narrative concerning vaccines. Among those that require a resignification are: their real preventive capacity against contagions, serious diseases and deaths, their efficacy against new variants, the duration of the immunity they confer, their side effects, the synergic role of acquired immunity, and the resources used by the companies to achieve a virtually market monopolistic predominance.

Propomo-nos discernir em que medida as estratégias mediáticas adotadas em torno das vacinas covid-19, ao longo dos primeiros 15 meses desde o início da sua aplicação, podem dar contribuições legítimas e coerentes para melhor compreender o seu desempenho, e em que medida as narrativas poderiam responder aos interesses econômicos das elites corporativas. Uma vez compilados os elementos mais relevantes com os quais se configuram as narrativas predominantes desde o momento em que as vacinas foram concebidas, foram identificadas diversas anomalias que foram, em maior ou menor medida, invisibilizadas no processo de sua aprovação e nos resultados de sua aplicação . As mais significativas dizem respeito à gestão de definições, descumprimentos de compromissos e conflitos de interesse que comprometem a atuação das empresas comercializadoras e dos órgãos reguladores das vacinas. Inúmeros elementos relacionados a interesses corporativos gravitaram na elaboração da história sobre vacinas. Entre os que demandam ressignificação estão: sua real capacidade preventiva de contágios, evoluções graves e óbitos, sua eficácia contra novas variantes, a duração da imunidade que se consolidou, seus efeitos adversos, o papel sinérgico da imunidade adquirida e os recursos utilizados. empresas para alcançar o domínio do monopólio virtual no mercado.

Efficacy of Draksadi Phantam in Generalized Anxiety Disorder- An Uncontrolled Clinical Trial

Anxiety disorders are one of the most prevalent class of mental disorders in the general population. Generalized anxiety disorder (GAD) is a common anxiety disorder that comprises continuous and long-lasting worrying, tension, which making normal life problematic and relaxation impossible The prevalence rate of GAD disorder is increasing constantly in modern era. Though many different types of modern medications used currently to treat anxiety disorders provide temporary relief, they come with various side effects, Drug dependence and safety concerns. In Ayurveda the symptoms of this disease show resemblance with the condition. Cittodvega (excited state of mind) which is one among the Manovikara in Ayurveda caused by dysfunction of increased Vata and Pitta dosha. The present study was conducted as an Uncontrolled clinical trial to study the Efficacy of Drakshadi Phantam in 38 diagnosed participants of Generalized Anxiety Disorder with the age group 20–50 were administered with 100ml of Drakshadi Phantam twice daily before food continuously for a period of 45 days. Five assessments were done staring from 0th day of treatment to 60 the day of the study with a gap of 15 days, using Hamilton anxiety rating scale and Rajas Tams rating scale. The assessment scores of different intervals were statistically analysed using RM ANOVA. Effect of the therapy were statistically analysed in each domain of HAM – A rating scale in different intervals of the study. The therapy was found statistically significant in reducing the symptoms of GAD in all the 14 domains of the HAM- A Rating scale. Based on results it has been concluded that Drakshadi Phantam has statistically significant effect in reducing the symptoms of all the 14 domains of Hamilton anxiety rating scale and reducing the Rajasika and Tamasika qualities of the study participants.

Compreensão do consentimento informado em pesquisa clínica de vacina contra o Zika vírus: estudo transversal / Understanding of informed consent in clinical research for a vaccine against Zika virus: a cross-sectional study / Comprensión del consentimiento informado en la investigación clínica de una vacuna contra el virus del Zika: un estudio transversal

OBJETIVO: avaliar a compreensão das informações do Termo de Consentimento Livre e Esclarecido pelos participantes de uma pesquisa clínica de vacina contra o Zika vírus. MÉTODO: estudo transversal com amostra por conveniência e participação de 101 voluntários de uma pesquisa clínica em Belo Horizonte, Minas Gerais. Utilizou-se um questionário estruturado. A análise dos dados foi realizada no programa R, segundo a estatística descritiva e inferencial. RESULTADOS: a média de acertos dos participantes sobre as informações do documento de consentimento foi de 66,9%. A maioria dos participantes assinou o documento sem o conhecimento suficiente das informações da pesquisa. O Índice de compreensão foi maior entre os participantes que tinham se voluntariado em pesquisas prévias (p=0,039). CONCLUSÃO: verificaram-se limitações importantes na compreensão dos participantes sobre informações do termo de consentimento, o que comprometeu a decisão autônoma. São necessárias adaptações e melhorias nos processos de consentimento informado em prol da sua validade.

OBJECTIVE: to assess the understanding of the information contained in the Informed Consent Form by the participants of a clinical trial of a vaccine against the Zika virus. METHOD: cross-sectional study using intentional sampling, including a total of 101 volunteers in clinical research in Belo Horizonte, Minas Gerais. A structured questionnaire was used. Data analysis was performed using R software, according to descriptive and inferential statistics. RESULTS: the mean of correct answers of the participants regarding the information in the consent form was 66.9%. Most participants signed the document without sufficient knowledge of the research information. The comprehension index was higher among participants who had volunteered in previous research (p=0.039). CONCLUSION: there were important limitations in the participants' understanding of information in the consent form, which compromised the autonomous decision. Adaptations and improvements are necessary in the processes of informed consent for its validity.

OBJETIVO: evaluar la comprensión de las informaciones contenidas en el Término de Consentimiento Libre e Informado por los participantes de un ensayo clínico de una vacuna contra el virus del Zika. MÉTODO: estudio transversal con muestra de conveniencia y participación de 101 voluntarios en una investigación clínica en Belo Horizonte, Minas Gerais. Se utilizó un cuestionario estructurado. El análisis de datos se realizó mediante el programa R, según estadística descriptiva e inferencial. RESULTADOS: el promedio de aciertos de los participantes con respecto a las informaciones del documento de consentimiento fue de 66,9%. La mayoría de los participantes firmó el documento sin conocimiento suficiente de las informaciones de la investigación. El índice de comprensión fue mayor entre los participantes que se habían ofrecido como voluntarios en investigaciones anteriores (p=0,039). CONCLUSIÓN: hubo limitaciones importantes en la comprensión de las informaciones del formulario de consentimiento por parte de los participantes, lo que comprometió la decisión autónoma. Son necesarias adecuaciones y mejoras en los procesos de consentimiento informado para su validez.

A randomized controlled clinical study of 0.01% and 0.02% atropine eye drops on myopia development in adolescents / 中华实验眼科杂志

Objective:To compare the clinical efficacy and safety of 0.01% and 0.02% atropine eye drops on myopia development in adolescents.Methods:A randomized controlled double-blind study was carried out.Two hundred and eighty myopic adolescents (280 eyes) with spherical equivalent (SE) from -1.25 to -6.0 D were enrolled in The First Affiliated Hospital of Zhengzhou University from June 2016 to June 2017.All the subjects wore full-correction single vision spectacle lenses before topical administration of atropine eye drops.The subjects were randomly divided into 0.01% atropine group (142 eyes) and 0.02% atropine group (138 eyes) according to the random number table method.Atropine 0.01% or 0.02% eye drops was topically used in the test eye once per night according to grouping, and the related parameters of the right eyes were collected for data analysis.The subjects were followed up at the 1st, 4th, 8th and 12th month following administration.The SE was measured with an autorefractor to evaluate the refractive change.The anterior chamber depth, corneal curvature and axial length (AL) were measured with an IOLMaster.The adverse responses of atropine eye drops were investigated via a questionnaire.This study protocol adhered to the Declaration of Helsinki and was approved by an Ethics Committee of The First Affiliated Hospital of Zhengzhou University (No.2016-35). Written informed consent was obtained from subjects and their guardian prior to entering the cohort.Results:The follow-up rate of 0.01% atropine group was 83.8%, and the follow-up rate of 0.02% atropine group was 84.8% at the end of following-up.SE and AL increased by (-0.47±0.32)D and (0.37±0.20)mm in 0.01% atropine group, and (-0.38±0.35)D and (0.30±0.17)mm in 0.02% atropine groups during the following-up, respectively, showing statistically significant differences between two groups ( P=0.040, 0.004). After adjusting age, body mass index and baseline SE, the analysis by generalized additive mixed model showed that the increase rate of SE was -0.039 D/month and -0.032 D/month in 0.01% and 0.02% atropine group, respectively ( Pinteraction=0.041). After adjusting age, body mass index and baseline AL, the analysis of mixed effect model showed that the increase rate of AL was 0.031 mm/month and 0.025 mm/month in 0.01% and 0.02% atropine group, respectively ( Pinteraction=0.032). In 0.01% and 0.02% atropine groups, 32 cases (26.9%) and 33 cases (28.2%) occurred photophobia from 1st to 4th week during administration, and 7 cases (5.9%) and 7 cases (6.0%) appeared near-vision blur from 2nd to 4th week.Allergic response occurred in 0.01% atropine group at 1 month of treatment, and the symptom disappeared after interruption of the medication for two days. Conclusions:The incidence of adverse resoponses of 0.01% and 0.02% atropine eye drops is similar.Atropine 0.02% eye drops is more effective in controlling myopia progression.

Effects of Interactive Dynamic Scalp Acupuncture on Motor Function and Gait of Lower Limbs after Stroke: A Multicenter, Randomized, Controlled Clinical Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the effects of interactive dynamic scalp acupuncture (IDSA), simple combination therapy (SCT), and traditional scalp acupuncture (TSA) on motor function and gait of the lower limbs in post-stroke hemiplegia patients.@*METHODS@#A total of 231 patients with post-stroke hemiplegia was randomly divided into IDSA (78 cases), SCT (78 cases), and TSA (75 cases) groups by a random number table. Scalp acupuncture (SA) and lower-limb robot training (LLRT) were both performed in the IDSA and SCT groups. The patients in the TSA group underwent SA and did not receive LLRT. The treatment was administered once daily and 6 times weekly for 8 continuous weeks, each session lasted for 30 min. The primary outcome measures included Fugl-Meyer assessment of the lower extremity (FMA-LE), berg balance scale (BBS), modified barthel index (MBI), and 6-min walking test (6MWT). The secondary outcome measures included stride frequency (SF), stride length (SL), stride width (SW), affected side foot angle (ASFA), passive range of motion (PROM) of the affected hip (PROM-H), knee (PROM-K) and ankle (PROM-A) joints. The patients were evaluated before treatment, at 1- and 2-month treatment, and 1-, and 2-month follow-up visits, respectively. Adverse events during 2-month treatment were observed.@*RESULTS@#Nineteen patients withdrew from the trial, with 8 in the IDSA and 5 in the SCT groups, 6 in the TSA group. The FMA-LE, BBS, 6MWT and MBI scores in the IDSA group were significantly increased after 8-week treatment and 2 follow-up visits compared with the SCT and TSA groups (P<0.05 or P<0.01). Compared with pre-treatment, the grade distribution of BBS and MBI scores in the 3 groups were significantly improved at 1, 2-month treatment and 2 follow-up visits (P<0.05 or P<0.01). The SF, PROM-H, PROM-K and PROM-A in the IDSA group was significantly increased compared with the SCT and TSA groups after 8-week of treatment (P<0.05 or P<0.01). Compared with the SCT group, ASFA of the IDSA group was significantly reduced after 8-week of treatment (P<0.05). SF, SL, PROM-K and PROM-A were significantly increased at the 2nd follow-up visit whereas the ASFA was significantly reduced in the IDSA group compared with the SCT groups at 1st follow-up visit (P<0.05 or P<0.01). The SF was significantly increased in the SCT group compared with the TSA group after 8-week treatment (P<0.05). Compared with the TSA group, PROM-K, PROM-A were significantly increased at the 2nd follow-up visit (P<0.05).@*CONCLUSIONS@#The effects of IDSA on lower-limb motor function and walking ability of post-stroke patients were superior to SCT and TSA. The SCT was comparable to TSA treatment, and appeared to be superior in improving the motion range of the lower extremities. (Registration No. ChiCTR1900027206).

Effectiveness of educational intervention with manual for anxiety and stress reduction: controlled clinical trial / Efectividad de la intervención educativa con manual para reducción de la ansiedad y estrés: ensayo clínico controlado / Efetividade da intervenção educativa com manual para redução da ansiedade e estresse: ensaio clínico controlado

ABSTRACT OBJECTIVE: To evaluate the effectiveness of the educational intervention through an informative manual in reducing anxiety, stress, and changes in vital signs in patients awaiting cardiac catheterization. METHODS: Parallel, randomized, controlled, blind clinical trial. The study excluded patients waiting for cardiac catheterization; those who received the information manual were randomized to the intervention group, and those who received routine information from the unit went to the control group. The study used the State Anxiety Inventory and Perceived Stress Scale and the ANOVA test to analyze the outcomes between the groups. Clinical Trials NCT03369873. RESULTS: There was no change concerning time, first and second moment (anxiety, P=0.225; and stress, P=0.696), interaction (anxiety, P=0.183; and stress, P=0.444), or groups, control, and intervention (anxiety, P=0.341; and stress, p=0.624). CONCLUSION: Although the educational intervention performed did not have an impact on the reduction of anxiety and stress, this type of intervention should be maintained for greater comfort and safety of patients and family members.

RESUMEN OBJETIVO: Evaluar efectividad de intervención educativa mediante manual informativo en la reducción de ansiedad, estrés y alteraciones de signos vitales en pacientes que aguardaban cateterismo cardíaco. MÉTODOS: Ensayo clínico paralelo, aleatorio, controlado, ciego. Incluidos pacientes que aguardaban cateterismo cardíaco; los que recibieron el manual informativo fueron randomizados al grupo intervención; y los que recibieron informaciones rutinarias de la unidad, al grupo control. Utilizados Inventario de Ansiedad-Estado y Escala de Estrés Percibido. Realizada prueba ANOVA para análisis de desfechos entre los grupos. Clinical Trials NCT03369873. RESULTADOS: No hubo alteración en relación al tiempo, primer y segundo momento (ansiedad, p=0,225; y estrés, p=0,696), interacción (ansiedad, p=0,183; y estrés, p=0,444) o grupos, control e intervención (ansiedad, p=0,341; y estrés, p=0,624). CONCLUSIÓN: Aunque la intervención educativa realizada no tenga presentado impacto en la reducción de ansiedad y estrés, ese tipo de intervención debe ser mantenido, para mayor comodidad y seguridad de pacientes y familias.

RESUMO OBJETIVO: Avaliar a efetividade da intervenção educativa mediante manual informativo na redução da ansiedade, estresse e alterações dos sinais vitais em pacientes que aguardavam o cateterismo cardíaco. MÉTODOS: Ensaio clínico paralelo, randômico, controlado, cego. Incluíram-se pacientes que aguardavam o cateterismo cardíaco; os que receberam o manual informativo foram randomizados para o grupo-intervenção; e os que receberam informações rotineiras da unidade, para o grupo controle. Utilizaram-se Inventário de Ansiedade-Estado e Escala de Estresse Percebido. Realizou-se teste ANOVA para análise dos desfechos entre os grupos. Clinical Trials NCT03369873. RESULTADOS: Não houve alteração em relação ao tempo, primeiro e segundo momento (ansiedade, p=0,225; e estresse, p=0,696), interação (ansiedade, p=0,183; e estresse, p=0,444) ou grupos, controle e intervenção (ansiedade, p=0,341; e estresse, p=0,624). CONCLUSÃO: Embora a intervenção educativa realizada não tenha apresentado impacto na redução da ansiedade e estresse, esse tipo de intervenção deve ser mantido, para maior conforto e segurança dos pacientes e familiares.

Efeito do biofeedback da variabilidade da frequência cardíaca sobre os níveis de ansiedade traço-estado dos profissionais de enfermagem: ensaio clínico randomizado / Effect of biofeedback on heart rate variability on the levels of state-trait anxiety of health care professionals nursing: randomized clinical trial

Introdução: No cenário de trabalho global, os profissionais de enfermagem representam aproximadamente 59% da força de trabalho em saúde, caracterizando uma profissão articuladora de diversos processos assistenciais, de gestão, educativos, preventivos, políticos e de pesquisa. A interação da ansiedade com o aumento da carga de trabalho, a exaustão física e algumas caraterísticas dos ambientes de trabalho podem ter efeitos dramáticos no bem-estar físico e mental dos trabalhadores. O biofeedback da variabilidade da frequência cardíaca pode considerar-se uma intervenção alternativa no atendimento de um risco ou condição de saúde. Objetivo: Avaliar o efeito da intervenção com o biofeedback da variabilidade da frequência cardíaca (VFC) sobre os níveis de ansiedade Traço-Estado dos profissionais da enfermagem de um hospital universitário, quando comparado com uma atividade informatizada sem auto-monitoramento. Método: Trata-se de um ensaio clínico randomizado (ECR) paralelo em 115 profissionais de enfermagem, comparando dois grupos durante 9 encontros, tendo como fatores em estudo o estresse e os níveis de ansiedade traço-estado, conduzido no período de junho 2020 a agosto de 2021. Os participantes do grupo intervenção utilizaram o software EmWave Pró Plus® na aferição do biofeedback da variabilidade da frequência cardíaca e o instrumento do desfecho principal foi auto-administrado nas fases pré e pós intervenção. Os dados foram agrupados em planilhas e analisados no programa STATA 14.0, utilizando estatísticos descritivos e inferenciais. Resultados: Existe uma correlação positiva entre os escores de ansiedade traço-estado, os escores de estresse e dimensões do estresse (rho = 0.811, p <0,001). As diferenças dos deltas da ansiedade estado (0,99, IC95%=-2,01;3,99, p=0,514) e traço (0,7, IC95%=-1,85;3,26, p=0,586) não foram estatisticamente significativas no grupo intervenção de biofeedback em comparação com o controle. As diferenças dos deltas da ansiedade estado (0,70 IC95%=-1,85;3,26, p=0,586) e traço (0,71, IC95%=-1,60;3,02, p=0,546), quando ajustados pelos níveis basais da respectiva ansiedade, também não foram significativamente diferentes entre os grupos. Conclusões: Os resultados sugerem que a intervenção com biofeedback da variabilidade da frequência cardíaca não tem efeito sobre os níveis de ansiedade em profissionais de enfermagem. Os achados sugerem que a interação entre a ansiedade e estresse ocupacional possa ser considerada um ponto de referência para novas pesquisas, bem como sugere a necessidade de novos estudos que permitam comparar o biofeedback com outras terapias complementares.

Introduction: In the global work scenario, nursing professionals represent approximately 59% of the health workforce, characterizing a profession that articulates various care, management, educational, preventive, political and research processes. The interaction of anxiety with increased workload, physical exhaustion and some characteristics of work environments can have dramatic effects on workers' physical and mental well-being. Heart rate variability biofeedback may be considered an alternative intervention in the management of a health risk or condition. Objective: To evaluate the effect of the intervention with biofeedback of heart rate variability (HRV) on the levels of Trait-State anxiety of nursing professionals at a university hospital, when compared with a computerized activity without self-monitoring. Methods: parallel randomized clinical trial with 115 nursing professionals, comparing two groups during 9 meetings, having stress and state-trait anxiety levels as study factors, conducted from June 2020 to August 2020. 2021. Participants in the intervention group used the EmWave Pro Plus® software to measure heart rate variability biofeedback and the main outcome instrument was self- administered in the pre- and post-intervention phases. Data were grouped in spreadsheets and analyzed using the STATA 14.0 program, using descriptive and inferential statistics. Results: There is a positive correlation between state trait anxiety scores, stress scores and stress dimensions (rho = 0.811, p < 0.001). The differences in state anxiety deltas (0.99, 95%CI=-2.01-3.99, p=0.514) and trait (0.7, 95%CI=-1.85-3.26, p=0.586) were not statistically significant in the biofeedback intervention group compared with the control. Likewise, the differences in state anxiety deltas (0.70, 95%CI=-1.85-3.26, p=0.586) and trait (0.71, 95%CI=-1.60-3.02, p =0.546) adjusted for the respective baseline levels of anxiety, were also not significantly different between the groups. Conclusion: The results suggest that heart rate variability biofeedback intervention has no effect on anxiety levels in nursing professionals. The findings suggest that the interaction between anxiety and occupational stress can be considered a point of reference for further research; also the need for new ones that allow comparing biofeedback with other complementary therapies.

Effect of music combined with swaddling on pain in full-term newborns: randomized clinical trial / Efecto de la música combinada com swaddling en el dolor en recién nacidos a término: ensayo clínico aleatorizado

ABSTRACT Objectives: to evaluate the effect of music applied within ten and 15 minutes, combined with swaddling, on behavioral (facial action) and physiological (heart rate) responses to pain in full-term newborns, before and during venipuncture for blood sampling. Methods: a randomized, triple-blind, clinical trial with 52 rooming in infants randomly assigned to four groups of 13: Experimental 1 (music [ten minutes] plus swaddling), Experimental 2 (music [15 minutes] plus swaddling), Control 1 (no music [ten minutes] plus swaddling), and Control 2 (no music [15 minutes] plus swaddling). Pain was measured using the Neonatal Facial Coding System in the basal and procedural moments. Results: experimental 2 group showed high pain absence (p < 0.05); low heart rate mean (p < 0.0001) in the basal and procedural (antisepsis, puncture, blood squeezing/aspiration, compression) moments. Conclusions: neonates who listened to 15 minutes of music plus swaddling showed a greater absence of facial pain actions.

RESUMEN Objetivos: evaluar el efecto de la música aplicada en 10 y 15 minutos, combinada con swaddling, en la respuesta comportamental al dolor (mímica facial) y fisiológica (frecuencia cardíaca) de los recién nacidos a término, antes y durante la punción venosa para la extracción de sangre. Métodos: ensayo clínico aleatorizado, triple ciego, realizado en alojamiento conjunto con 52 recién nacidos, dividido aleatoriamente en cuatro grupos de 13: Experimental 1 (música [10 minutos], swaddling), Experimental 2 (música [15 minutos], swaddling), Control 1 (sin música [10 minutos, swaddling) y Control 2 (sin música [15 minutos], swaddling,). El dolor se midió utilizando el Neonatal Facial Coding System en los momentos Basal y Procedimiento. Resultados: el grupo experimental 2 mostró alta ausencia de dolor (p <0.05); media de frecuencia cardíaca baja (p<0,0001) en los momentos Basal y Procedimiento (antisepsia, punción, ordeño/aspiración de sangre, compresión). Conclusiones: recién nacidos que escucharon 15 minutos de música más swaddling mostraron una mayor ausencia de reacciones faciales de dolor.

Percepção positiva e eficácia das meias de compressão na prevenção de edema em membros inferiores de gestantes / Positive perception and efficacy of compression stockings for prevention of lower limb edema in pregnant women

Resumo Contexto A gravidez é caracterizada por mudanças fisiológicas que podem contribuir para o desenvolvimento de varizes, insuficiência venosa e edema das pernas. Objetivos Avaliar o efeito das meias de compressão em edema de membros inferiores e a percepção sobre o uso por gestantes. Métodos Trata-se de um ensaio clínico randomizado, controlado, prospectivo, paralelo e cego realizado com 60 mulheres grávidas distribuídas aleatoriamente em dois grupos: grupo intervenção (n = 30), que usou meias de compressão, e grupo controle (n = 30). Foram realizadas medições padronizadas de tornozelo e panturrilha, empregando-se fita métrica, em todos os 120 membros inferiores. No final do estudo, foi aplicado também um questionário para verificação das dificuldades e vantagens percebidas com relação ao uso das meias de compressão. Resultados As gestantes do grupo intervenção apresentaram aumento significativamente menor (p < 0,05) nos diâmetros de panturrilha e tornozelo em relação ao grupo controle. As diferenças médias, no início e no final da gestação, nos diâmetros de panturrilha direita, panturrilha esquerda, tornozelo direito e tornozelo esquerdo foram de, respectivamente, 0,30 cm, 0,30 cm, 0,15 cm e 0,15 cm no grupo intervenção e 1,95 cm, 1,95 cm, 1,73 cm e 1,87 cm no grupo controle. A maioria das gestantes não teve dificuldade para utilizar as meias de compressão, e todas relataram que sentiram diferença nos sintomas das pernas e que usariam as meias novamente. Conclusões As meias de compressão foram eficazes na prevenção de edema em membros inferiores de gestantes, as quais apresentaram percepção positiva quanto à sua utilização.

Abstract Background Pregnancy is characterized by physiological changes that can contribute to development of varicose veins, venous insufficiency, and leg edema. Objectives To evaluate the effect of compression stocking on lower limb edema in pregnant women and their perceptions of wearing them. Methods This was a randomized, controlled, prospective, parallel, blinded clinical trial conducted with 60 pregnant women randomly distributed into two groups: an intervention group (n = 30) wearing compression stockings and a control group (n = 30). Standardized ankle and calf measurements were taken of all 120 lower limbs using a tape measure. At the end of the study, a questionnaire was administered to identify perceived difficulties and advantages related to wearing compression stockings. Results Pregnant women in the intervention group had a significantly smaller increase (p < 0.05) in calf and ankle diameters compared to those in the control group. The mean differences from the beginning to the end of gestation in the diameters of the right calf, left calf, right ankle, and left ankle respectively were 0.30 cm, 0.30 cm, 0.15, cm and 0.15 cm in the intervention group and 1.95 cm, 1.95 cm, 1.73 cm, and 1.87 cm in the control group. Most of the pregnant women had no difficulty wearing the compression stockings and all reported that they felt a difference in leg symptoms and would wear stockings again. Conclusions Compression stockings were effective for preventing lower limb edema in pregnant women, who had a positive perception of wearing them.

Assertividade da punção venosa periférica orientada por ultrassom versus punção venosa periférica convencional: ensaio clínico randomizado / Assertiveness of ultrasound-guided peripheral venipuncture versus conventional peripheral venipuncture: randomized clinical trial

A punção de um acesso venoso é o procedimento invasivo mais comum no ambiente hospitalar. O uso da ultrassonografia para orientação do cateterismo venoso periférico em populações e ambientes específicos têm demonstrado benefícios assistenciais aos pacientes submetidos ao seu uso. Resultados da aplicação desta tecnologia em pacientes clínicos fora de áreas críticas, com amostra estratificada por faixa etária são inexistentes. O objetivo geral do estudo foi comparar a assertividade na primeira tentativa de inserção de cateteres venosos periféricos orientados por ultrassom realizada por enfermeiros especialistas com a punção venosa periférica convencional (sem ultrassonografia) realizada por enfermeiros assistenciais. Trata-se de um ensaio clínico randomizado (ECR) tipo PROBE (Prospective Randomized Open Blinded End Point), paralelo, controlado e de centro único, registrado na plataforma ClinicalTrials.gov sob o registro NTC04853264, conduzido em um hospital público universitário, entre 22 de junho e 24 de setembro de 2021. Foram incluídos pacientes adultos hospitalizados em unidades de internação clínica, com indicação de terapia intravenosa compatível com rede venosa periférica. Os participantes foram divididos em grupo intervenção (GI) ­ inserção de cateter venoso periférico orientado por ultrassonografia executada por enfermeiros especializados de um programa de acesso vascular; e grupo controle (GC) ­ cateterismo venoso periférico por técnica convencional executada por enfermeiros da prática clínica. A randomização foi realizada em blocos de diferentes tamanhos e estratificados por idade, através de uma ferramenta própria do software Research Electronic Data Capture (REDCap). O desfecho primário incluiu a assertividade de punção/inserção do cateter venoso periférico. Desfechos secundários incluíram o tempo em minutos despendido para a inserção do cateter venoso periférico, classificação das condições da rede venosa periférica, tempo de permanência do cateter venoso periférico e os desfechos compostos durante o seguimento. Foram incluídos um total de 166 pacientes: GI (n = 82) e GC (n = 84), sexo feminino (62,7%), predomínio de etnia branca (81,9%) e média de idade 59,5 ± 16,5 anos. A assertividade na primeira tentativa de punção venosa periférica no GI foi de 90,2% e no GC foi de 35,7% (P < 0,001), com 2,5 (IC 95% 1,88-3,40] entre os grupos. A taxa geral de assertividade foi de 100% no GI e 71,4 % no GC. Quanto ao tempo de realização do procedimento a mediana no GI foi de 5 (4-7) minutos versus 10 (6-27,5) minutos no GC, (P < 0,001). Referente às condições da rede venosa periférica dos pacientes foi evidenciado que 58,5% do GI e 41,7 GC (P = 0,053) apresentavam alto risco de falha na primeira tentativa de punção, conforme a classificação utilizada. A mediana relativa ao tempo de permanência do acesso venoso não teve diferença significativa entre os grupos 4 (2-6) versus 2 (2- 6) dias no GI e GC, respectivamente (P = 0,256). Para os desfechos compostos, os dispositivos intravenosos periféricos do GI apresentaram menor incidência de desfechos negativos, GI com 39% versus GC com 66,7% (P < 0,001), gerando uma probabilidade 42% menor de desfechos negativos no GI, 0,58 (IC 95% 0,43-0,80). Os resultados deste ECR permitem concluir que a assertividade na primeira tentativa de inserção de um cateter venoso periférico foi superior para o grupo em que foi utilizada a ultrassonografia por enfermeiros com expertise nesse procedimento, sem falhas, com menor tempo de inserção e menos incidência de desfechos desfavoráveis.

Venipuncture is the most common invasive procedure in the hospital environment. Using ultrasound to guide peripheral venipuncture in specific populations and environments has proved beneficial to patients subjected to its use. Results on the application of this technology in clinical practices outside critical areas, with sample stratifies by age group are nonexistent. Overall, this study sought to compare the assertiveness of ultrasound-guided peripheral venipuncture performed by specialist nurses with conventional peripheral venipuncture performed by care nurses. This is a parallel, controlled, single center, PROBE (Prospective Randomized Open Blinded End Point) clinical trial registered on the ClinicalTrials.gov platform under registration NTC04853264 carries out at a public university hospital, between June 22 and September 24, 2021. Adult patients admitted to clinical inpatient units, with indication for intravenous therapy compatible with peripheral venous network were included. Participants were divided into intervention group (IG) ­ ultrasound-guided peripheral venipuncture performed by specialist nurses from a vascular access program; and control group (CG) ­ conventional peripheral venipuncture performed by clinical nurses. Randomization was performed in bloc of different sizes and stratified by age group using Research Electronic Data Capture (REDCap) software. Primary outcome included the assertiveness of peripheral venipuncture. Secondary outcomes comprised time in minutes spent for peripheral venipuncture, classification of peripheral venous network condition, peripheral venous catheter length of stay, and composite outcomes during follow-up. A total of 166 patients were included: IG (n = 82) and CG (n = 84), women (62.7%), white (81.9%) and mean age 59.5 ± 16.5 years. Assertiveness on the first attempt of peripheral venipuncture in the IG was 90.2% and in the CG was 35.7% (P < 0.001), with 2.5 (95%CI 1.88-3.40] between groups. Median time of the procedure was 5 (4-7) minutes in the IG versus 10 (6-27.5) minutes in the CG, (P < 0.001). Overall assertiveness rate was 100% in the IG and 7.4 % in the CG. Regarding the patients' peripheral venous network condition, 58.5% of the IG and 41.7% of the CG (P = 0.053) showed high risk of failure in the first attempt, according to the classification used. Median duration of venous access had no significant difference between groups: 4 (2-6) versus 2 (2-6) days in the IG and CG, respectively (P = 0.256). For the composite outcomes, the IG peripheral intravenous devices had a lower incidence of negative outcomes, with 39% versus CG with 66.7% (P < 0.001), generating a 42% lower probability of negative outcomes in the IG, 0.58 (95%CI 0.3-0.80). The results allow us to conclude that assertiveness in the first attempt of peripheral venipuncture was superior for the ultrasound-guided group, with no failures, shorter insertion time, and less incidence of unfavorable outcomes.

Effects of carbohydrate use on preoperative thirst: a randomized clinical trial / Efectos de la utilización del carbohidrato sobre la sed en el preoperatorio: ensayo clínico randomizado / Efeitos da utilização do carboidrato sobre a sede no pré-operatório: ensaio clínico randomizado

ABSTRACT Objectives: to evaluate the effectiveness of carbohydrate popsicles, carbohydrate solution, and usual care (fasting) on the intensity and discomfort of preoperative thirst. Methods: a randomized clinical trial with 60 preoperative patients aged between 18 and 60 years, randomized into three groups: control (fasting), carbohydrate solution (100 ml), and carbohydrate popsicle (100 ml). The outcomes were thirst intensity and discomfort. Results: there was a difference between groups for final thirst intensity (p = 0.01) and final thirst discomfort (p = 0.001). The effect size for both the Solution Group and the Popsicle Group was robust: 0.99 and 1.14, respectively. Conclusions: the groups that received the carbohydrate fasting abbreviation showed a reduction in thirst discomfort compared to the control group. The carbohydrate popsicle proved more effective in reducing the intensity of thirst. NCT: 3.209.283

RESUMEN Objetivos: evaluar efectividad del polo de carbohidrato, solución de carbohidrato y cuidado usual (ayuno) sobre la intensidad e incomodidad de sed en el preoperatorio. Métodos: ensayo clínico randomizado, con 60 pacientes en el preoperatorio, edad entre 18 y 60 años, randomizados en tres grupos: control (ayuno); solución de carbohidrato (100 ml); polo de carbohidrato (100 ml). Los desfechos fueron la intensidad e incomodidad de sed. Resultados: hubo diferencia entre los grupos cuanto a la intensidad final de sed (p = 0,01) e incomodidad final de sed (p = 0,001). El tamaño del efecto tanto para el Grupo Solución cuanto para el Grupo Polo fue fuerte: 0,99 y 1,14, respectivamente. Conclusiones: los grupos que recibieron la abreviación del ayuno con carbohidrato presentaron reducción en la incomodidad de sed cuando comparados al grupo-control. El polo de carbohidrato se mostró más efectivo en la reducción de la intensidad de la sed. NCT: 3.209.283

RESUMO Objetivos: avaliar a efetividade do picolé de carboidrato, solução de carboidrato e cuidado usual (jejum) sobre a intensidade e desconforto da sede no pré-operatório. Métodos: ensaio clínico randomizado, com 60 pacientes no pré-operatório, idade entre 18 e 60 anos, aleatorizados em três grupos: controle (jejum); solução de carboidrato (100 ml); picolé de carboidrato (100 ml). Os desfechos foram a intensidade e o desconforto da sede. Resultados: houve diferença entre os grupos quanto à intensidade final da sede (p = 0,01) e ao desconforto final da sede (p = 0,001). O tamanho do efeito tanto para o Grupo Solução quanto para o Grupo Picolé foi forte: 0,99 e 1,14, respectivamente. Conclusões: os grupos que receberam a abreviação do jejum com carboidrato apresentaram redução no desconforto da sede quando comparados ao grupo-controle. O picolé de carboidrato mostrou-se mais efetivo na redução da intensidade da sede. NCT: 3.209.283

Systematic review and Meta-analysis of 26 randomized controlled clinical trials of Compound Danshen Dripping Pill for non-proliferating diabetic retinopathy / 中草药·英文版

Objective: Diabetic retinopathy (DR) is the retinal consequence of chronic progressive diabetic microvascular leakage and occlusion. Non-proliferating diabetic retinopathy (NPDR) is the early stage of DR. It eventually occurs to some degree in all patients with diabetes mellitus. In recent years, many clinical trials have shown that Compound Danshen Dripping Pill (CDDP) may be associated with the improvement of NPDR symptoms. The aim of this study was to quantitatively summarize the association between CDDP and the therapeutic effects of NPDR. Methods: It was conducted that a systematic literature search of PubMed, Web of Science, CNKI, VIP and Wanfang Data updated in June 2020 with the following search terms: “diabetic retinopathy” or “retinopathy” or “DR” or “NPDR”, in combination with “Compound Danshen Dripping Pill” or “Salvia miltiorrhiza” or “Danshen”. Risk ratio (RR) and weighted mean difference (WMD) with their 95% confidence interval (CI) was calculated between treatment and control groups. The sensitivity analyses were undertaken by removing each individual study when high heterogeneity appeared. Subgroup analysis, Meta-regression, and publication bias analysis were also conducted. The strength of evidence was evaluated with the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) method. Results: Twenty-six RCTs involving 2047 subjects were included to conduct a Meta-analysis after screening the studies, extracting the data, and assessing the study quality. The Stata15.0 software was utilized for processing. Meta-analysis indicated that curative effects of treatment group with CDDP was significantly better than control [RR = 0.54, 95% CI (0.40, 0.73); moderate-quality evidence]. In addition, the results showed that CDDP was significantly associated with improving retinal hemorrhages [WMD = −0.62, 95% CI (−0.78, −0.46); low-quality evidence], the vision [WMD = 0.14, and 95% CI (0.09, 0.19), low-quality evidence], fundus fluorescence angiography [RR = 0.37 and 95% CI (0.23, 0.60); low-quality evidence], reduction of retinal microaneurysm [WMD = −3.74 and 95% CI (−4.38, −3.11); moderate-quality evidence], hemangioma volume [WMD = −3.15, 95%CI (−3.45, −2.85); moderate-quality evidence], macular thickness [WMD = −5.52, 95%CI = (−64.27, −48.78); low-quality evidence], mean defect [WMD = −1.65 and 95% CI (−1.95, −1.34); very low-quality evidence], fasting blooding glucose [WMD = −0.95, 95% CI (−1.19, −0.70); low-quality evidence), hemoglobin A1c [WMD = −0.62, 95% CI (−0.93, −0.30); low-quality evidence], high sensitive C reaction protein [WMD = −5.66, 95% CI (−8.01, −3.31); low-quality evidence]. Sensitivity, subgroup, and Meta-regression analyses were also assessed. Conclusion: The study demonstrated that CDDP has beneficial clinical effects for treating NPDR and improve the vision. Moreover, it indicated that oral CDDP in NPDR patients led to significant regulation of serum level of fasting blooding glucose, hemoglobin A1c and high sensitive C reaction protein, which was associated with the pathogenesis of NPDR. However, high-quality and large randomized clinical trials will be needed to prove the consequence in future.

Clinical Efficacy of Zishui Bugan Decoction on Perimenopausal Insomnia Patients with Liver-kidney Deficiency / 中国实验方剂学杂志

ObjectiveTo evaluate the efficacy of Zishui Bugan decoction on perimenopausal insomnia of liver-kidney deficiency type and the safety. MethodA randomized， double-blind， placebo-controlled trial was designed. To be specific， 72 patients of perimenopausal insomnia with Liver-kidney deficiency were randomized into the treatment group and the control group at the ratio of 1∶1 and they were respectively treated with Zishui Bugan decoction and placebo for 3 weeks. The Pittsburgh sleep quality index （PSQI）， modified Kupperman index， traditional Chinese medicine （TCM） syndrome score， self-rating anxiety scale （SAS） score， and self-rating depression scale （SDS） score， were compared before and after treatment to determine the clinical efficacy， with adverse effects recorded. ResultThe total effective rate for insomnia was 85.3%（29/34） in treatment group and 17.6%（6/34） in control group（Z=-5.582，P<0.01）. After treatment， PSQI score， modified Kupperman index， TCM syndrome score， and SAS score were improved in both groups （P<0.05， P<0.01）， particularly the treatment group which showed significant difference from the control group （P<0.05，P<0.01）. The safety indicators were insignificantly different between two groups before and after treatment. No related adverse effects were reported in both groups during the treatment. ConclusionZishui Bugan decoction can improve the sleep quality and alleviate the menopausal symptoms， such as depression and anxiety， which shows ideal efficacy and safety for the perimenopausal insomnia with liver-kidney deficiency type.

Taxa de cicatrização em úlceras do pé diabético tratadas com biomembrana e hidrocoloide em pó: ensaio clínico randomizado / Healing rate in diabetic foot ulcers treated with biomembrane and hydrocolloid powder: randomized clinical trial / Tasa de curación en la úlceras de pie diabético tratados con biomembrana e hidrocoloide en polvo: ensayo clínico aleatorizado

Objetivo:avaliar taxa de cicatrização em úlceras do pé diabético tratadas com biomembrana de proteínas do látex de Calotropis procera (BioMem CpLP) quando comparada ao hidrocoloide em pó. Método: ensaio clínico randomizado controlado, registrado pelo Registro Brasileiro de Ensaio Clínico (REBEC), conforme protocolo RBR-98f3j9, realizado junto a oito pessoas com pé diabético, em ambulatório de pé diabético, de março a julho de 2019. No grupo experimental (n=04), realizou-se a aplicação de biomembrana; no grupo controle (n=04), utilizou-se o pó de hidrocoloide. A taxa de cicatrização foi avaliada com 30 e 60 dias após início do tratamento. Resultados: não se constataram diferenças estatísticas entre taxas de cicatrização do grupo controle e do grupo experimental na análise temporal dos 30 dias iniciais (p=0,726) e nos 60 dias subsequentes ao início do tratamento (p=0,562). Conclusão: a BioMem CpLP apresentou taxas de cicatrização semelhantes ao produto convencional, configurando-se como alternativa eficaz e de baixo custo para o tratamento de pés diabéticos.

Objective:to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.

Efficacy of intravaginal electrical stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial

ABSTRACT Purpose: To evaluate the efficacy of intravaginal electrical stimulation (IVES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB). Materials and Methods: Sixty-two women with idiopathic OAB were randomized into two groups using the random numbers generator as follows: Group 1 received BT alone (n:31), and Group 2 received BT+IVES (n:31). IVES was performed for twenty minutes three days a week over a course of eight weeks for a total of 24 sessions. Patients were evaluated in terms of incontinence severity (24-hour pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes and number of pads), symptom severity (OAB-V8), incontinence-related QoL (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale). Results: A statistically significant improvement was found in all parameters for all groups at the end of the treatment compared to the baseline values except pelvic floor muscles strength in Group 1 (p <0.05). At the end of treatment, incontinence severity, frequency of voiding, nocturia, incontinence episodes, number of pads, symptom severity, and QoL were significantly improved in Group 2 compared to Group 1 (p <0.05). Treatment satisfaction, cure/improvement, and positive response rates were significantly higher in group 2 compared to Group 1 (p <0.05). Conclusion: We conclude that BT+IVES were more effective than BT alone on both incontinence-related QoL and clinical parameters in women with idiopathic OAB.