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BACKGROUND: There is mixed evidence on increasing rates of psychiatric disorders and symptoms during the coronavirus disease 2019 (COVID-19) pandemic in 2020. We evaluated pandemic-related psychopathology and psychiatry diagnoses and their determinants in the Brazilian Longitudinal Study of Health (ELSA-Brasil) São Paulo Research Center. METHODS: Between pre-pandemic ELSA-Brasil assessments in 2008-2010 (wave-1), 2012-2014 (wave-2), 2016-2018 (wave-3) and three pandemic assessments in 2020 (COVID-19 waves in May-July, July-September, and October-December), rates of common psychiatric symptoms, and depressive, anxiety, and common mental disorders (CMDs) were compared using the Clinical Interview Scheduled-Revised (CIS-R) and the Depression Anxiety Stress Scale-21 (DASS-21). Multivariable generalized linear models, adjusted by age, gender, educational level, and ethnicity identified variables associated with an elevated risk for mental disorders. RESULTS: In 2117 participants (mean age 62.3 years, 58.2% females), rates of CMDs and depressive disorders did not significantly change over time, oscillating from 23.5% to 21.1%, and 3.3% to 2.8%, respectively; whereas rate of anxiety disorders significantly decreased (2008-2010: 13.8%; 2016-2018: 9.8%; 2020: 8%). There was a decrease along three wave-COVID assessments for depression [ß = -0.37, 99.5% confidence interval (CI) -0.50 to -0.23], anxiety (ß = -0.37, 99.5% CI -0.48 to -0.26), and stress (ß = -0.48, 99.5% CI -0.64 to -0.33) symptoms (all ps < 0.001). Younger age, female sex, lower educational level, non-white ethnicity, and previous psychiatric disorders were associated with increased odds for psychiatric disorders, whereas self-evaluated good health and good quality of relationships with decreased risk. CONCLUSION: No consistent evidence of pandemic-related worsening psychopathology in our cohort was found. Indeed, psychiatric symptoms slightly decreased along 2020. Risk factors representing socioeconomic disadvantages were associated with increased odds of psychiatric disorders.

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Functional and structural MRI of prefrontal cortex (PFC) may provide putative biomarkers for predicting the treatment response to transcranial direct current stimulation (tDCS) in depression. A recent MRI study from ELECT-TDCS (Escitalopram versus Electrical Direct-Current Theror Depression Study) showed that depression improvement after tDCS was associated with gray matter volumes of PFC subregions. Based thereon, we investigated whether antidepressant effects of tDCS are similarly associated with baseline resting-state functional connectivity (rsFC). A subgroup of 51 patients underwent baseline rsFC-MRI. All patients of ELECT-TDCS were randomized to three treatment arms for 10 weeks (anodal-left, cathodal-right PFC tDCS plus placebo medication; escitalopram 10 mg/day for 3 weeks and 20 mg/day thereafter plus sham tDCS; and placebo medication plus sham tDCS). RsFC was calculated for various PFC regions and analyzed in relation to the individual antidepressant response. There was no significant association between baseline PFC connectivity of essential structural regions, nor any other PFC regions (after correction for multiple comparisons) and patients' individual antidepressant response. This study did not reveal an association between antidepressants effects of tDCS and baseline rsFC, unlike the gray matter volume findings. Thus, the antidepressant effects of tDCS may be differentially related to structural and functional MRI measurements.

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BACKGROUND: The management of type 2 diabetes mellitus (T2DM) requires a complex and organized care that includes patient's lifestyle change. Additionally, emotional well-being is an important part of self-management, and it may impair the individual's adherence. Therefore, equipping the patients with the necessary coping and self-care techniques may be an important step in managing diabetes. OBJECTIVE: To evaluate the effect of interventions using established mindfulness-based protocols on glycemic control of individuals with T2DM. METHODS: Data sources: Two electronic databases (PubMed and EMBASE) were searched from inception to December 2019. We limited our search to published studies in English, Spanish and Portuguese languages. STUDY SELECTION: Randomized clinical trials that assessed the effects of mindfulness in individuals with T2DM were selected. DATA EXTRACTION: Two authors independently assessed the risk of bias and extracted data from the included trials. Data were pooled using inverse-variance random-effects meta-analyses. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: Four randomized trials were included. There were no differences in blood glucose change (mean difference between groups (MD) -0.73mg/dl; 95% CI, -10.49; 9.02; I2 =0%; very low quality of evidence) or glycated hemoglobin (MD 0.05%; 95%CI -0.22 to 0.32; I2 =29%; very low quality of evidence). CONCLUSION: Although the quality of current evidence is very low, our findings suggest that established protocols involving mindfulness have no effect on blood glucose or glycated hemoglobin in individuals with T2DM. Indeed, large-scale trials are needed to evaluate the contribution of mindfulness to glycemic control in clinical practice. PROSPERO Registration ID: RD42020161940.

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BACKGROUND: Transcranial direct current stimulation (tDCS) is a promising intervention for major depression. However, its clinical effects are heterogeneous. We investigated, in a subsample of the randomized, clinical trial Escitalopram versus Electrical Direct Current Therapy for Depression Study (ELECT-TDCS), whether the volumes of left and right prefrontal cortex (PFC) and anterior cingulate cortex (ACC) were associated with prefrontal tDCS response. METHODS: Baseline structural T1 weighted MRI data were analyzed from 52 patients (15 males). Patients were randomized to the following conditions: escitalopram 20 mg/day, bifrontal tDCS (2 mA, 30min, 22 sessions), or placebo. Antidepressant outcomes were assessed over a treatment period of 10 weeks. Voxel-based gray matter volumes of PFC and ACC were determined using state-of-the-art parcellation approaches. RESULTS: According to our a priori hypothesis, in the left dorsal PFC, larger gray matter volumes were associated with depression improvement in the tDCS group (n = 15) compared to sham (n = 21) (Cohen's d = 0.3, 95% confidence interval [0.01; 0.6], p = 0.04). Neither right PFC nor ACC volumes were associated with depression improvement. Exploratory analyses of distinct PFC subregions were performed, but no area was associated with tDCS response after correction for multiple comparisons. CONCLUSION: Left PFC baseline gray matter volume was associated with tDCS antidepressant effects. This brain region and its subdivisions should be investigated further as a potential neurobiological predictor for prefrontal tDCS treatment in depression and might be correlated with tDCS antidepressant mechanisms of action.

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IMPORTANCE: Translating evidence into clinical practice in the management of acute ischemic stroke (AIS) and transient ischemic attack (TIA) is challenging, especially in low- and middle-income countries. OBJECTIVE: To assess the effect of a multifaceted quality improvement intervention on adherence to evidence-based therapies for care of patients with AIS and TIA. DESIGN, SETTING AND PARTICIPANTS: This 2-arm cluster-randomized clinical trial assessed 45 hospitals and 2336 patients with AIS and TIA for eligibility before randomization. Eligible hospitals were able to provide care for patients with AIS and TIA in Brazil, Argentina, and Peru. Recruitment started September 12, 2016, and ended February 26, 2018; follow-up ended June 29, 2018. Data were analyzed using the intention-to-treat principle. INTERVENTIONS: The multifaceted quality improvement intervention included case management, reminders, a roadmap and checklist for the therapeutic plan, educational materials, and periodic audit and feedback reports to each intervention cluster. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite adherence score for AIS and TIA performance measures. Secondary outcomes included an all-or-none composite end point of performance measures, the individual process measure components of the composite end points, and clinical outcomes at 90 days after admission (stroke recurrence, death, and disability measured by the modified Rankin scale). RESULTS: A total of 36 hospitals and 1624 patients underwent randomization. Nineteen hospitals were randomized to the quality improvement intervention and 17 to routine care. The overall mean (SD) age of patients enrolled in the study was 69.4 (13.5) years, and 913 (56.2%) were men. Overall mean (SD) composite adherence score for the 10 performance measures in the intervention group hospitals compared with control group hospitals was 85.3% (20.1%) vs 77.8% (18.4%) (mean difference, 4.2%; 95% CI, -3.8% to 12.2%). As a secondary end point, 402 of 817 patients (49.2%) at intervention hospitals received all the therapies that they were eligible for vs 203 of 807 (25.2%) in the control hospitals (odds ratio, 2.59; 95% CI, 1.22-5.53; P = .01). CONCLUSIONS AND RELEVANCE: A multifaceted quality improvement intervention did not result in a significant increase in composite adherence score for evidence-based therapies in patients with AIS or TIA. However, when using an all-or-none approach, the intervention resulted in improved adherence to evidence-based therapies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02223273.

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Bariatric surgery is an effective strategy for blood pressure (BP) reduction, but most of the evidence relies on office BP measurements. In this study, we evaluated the impact of bariatric surgery on 24-hour BP profile, BP variability, and resistant hypertension prevalence. This is a randomized trial including obese patients with grade 1 and 2 using at least 2 antihypertensive drugs at maximal doses or >2 at moderate doses. Patients were allocated to either Roux-en-Y Gastric Bypass (RYGB) combined with medical therapy or medical therapy alone for 12 months. The primary outcome was the 24-hour BP profile and variability (average real variability of daytime and night time BP). We evaluated the nondipping status and prevalence of resistant hypertension as secondary end points. We included 100 patients (76% female, body mass index, 36.9±2.7 kg/m2). The 24-hour BP profile (including nondipping status) was similar after 12 months, but the RYGB group required less antihypertensive classes as compared to the medical therapy alone (0 [0­1] versus 3 [2.5­4] classes; P<0.01). The average real variability of systolic nighttime BP was lower after RYGB as compared to medical therapy (between-group difference, −1.63; 95% CI, −2.91 to −0.36; P=0.01). Prevalence of resistant hypertension was similar at baseline (RYGB, 10% versus MT, 16%; P=0.38), but it was significantly lower in the RYGB at 12 months (0% versus 14.9%; P<0.001). In conclusion, RYGB significantly reduced antihypertensive medications while promoting similar 24-hour BP profile and nondipping status. Interestingly, bariatric surgery improved BP variability and may decrease the burden of resistant hypertension associated with obesity. (AU)

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Bariatric surgery is an effective strategy for blood pressure (BP) reduction, but most of the evidence relies on office BP measurements. In this study, we evaluated the impact of bariatric surgery on 24-hour BP profile, BP variability, and resistant hypertension prevalence. This is a randomized trial including obese patients with grade 1 and 2 using at least 2 antihypertensive drugs at maximal doses or >2 at moderate doses. Patients were allocated to either Roux-en-Y Gastric Bypass (RYGB) combined with medical therapy or medical therapy alone for 12 months. The primary outcome was the 24-hour BP profile and variability (average real variability of daytime and night time BP). We evaluated the nondipping status and prevalence of resistant hypertension as secondary end points. We included 100 patients (76% female, body mass index, 36.9±2.7 kg/m2). The 24-hour BP profile (including nondipping status) was similar after 12 months, but the RYGB group required less antihypertensive classes as compared to the medical therapy alone (0 [0-1] versus 3 [2.5-4] classes; P<0.01). The average real variability of systolic nighttime BP was lower after RYGB as compared to medical therapy (between-group difference, -1.63; 95% CI, -2.91 to -0.36; P=0.01). Prevalence of resistant hypertension was similar at baseline (RYGB, 10% versus MT, 16%; P=0.38), but it was significantly lower in the RYGB at 12 months (0% versus 14.9%; P<0.001). In conclusion, RYGB significantly reduced antihypertensive medications while promoting similar 24-hour BP profile and nondipping status. Interestingly, bariatric surgery improved BP variability and may decrease the burden of resistant hypertension associated with obesity. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT01784848.

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BACKGROUND: Translating evidence into clinical practice in the management of acute ischemic stroke (AIS) and transient ischemic attack (TIA) is challenging especially in low- and middle-income countries. OBJECTIVES: The aim of this study is to assess the effect of a multifaceted quality improvement intervention on adherence to evidence-based therapies for AIS and TIA patients care. DESIGN: We designed a pragmatic, 2-arm cluster-randomized trial involving 36 clusters and 1624 patients from Brazil, Argentina, and Peru. Hospitals are randomized to receive a multifaceted quality improvement intervention (intervention group) or to routine care (control group). The BRIDGE Stroke multifaceted quality improvement intervention includes case management, reminders, health care providers' educational materials (including treatment algorithms), interactive workshops, and audit and feedback reports. Primary outcome is a composite adherence score to AIS and TIA performance measures. Secondary outcomes include an "all or none" composite end point to performance measures, the individual components of the composite end points, and clinical outcomes at 90 days following admission (stroke recurrence, death, and disability measured by the modified Rankin scale). SUMMARY: The BRIDGE Stroke Trial is an international pragmatic evaluation of a multifaceted quality improvement intervention. If effective, this intervention could be potentially extended widely to improve the quality of care and outcomes of patients with AIS or TIA.

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BACKGROUND: More than 30% of major depressive disorder patients fail to respond to adequate trials of medications and psychotherapy. While modern neuromodulation approaches (ie, vagal nerve stimulation, deep brain stimulation) are yet to prove their efficacy for such cases in large randomized controlled trials, trigeminal nerve stimulation (TNS) has emerged as an alternative with promising effects on mood disorders. OBJECTIVE: To assess efficacy, safety, tolerability, and placebo effect duration of continuous subcutaneous TNS (sTNS) in treatment-resistant depression (TRD). METHODS: The TREND study is a single-center, double-blind, randomized, controlled, phase II clinical trial. Twenty unipolar TRD patients will receive V1 sTNS as adjuvant to medical therapy and randomized to active vs sham stimulation throughout a 24-wk period. An additional 24-wk open-label phase will follow. Data concerning efficacy, placebo response, relapse, and side effects related to surgery or electrical stimulation will be recorded. We will use the HDRS-17, BDI-SR, IDS_SR30, and UKU scales. EXPECTED OUTCOMES: The main outcome measure is improvement in depression scores using HAM-17 under continuous sTNS as adjuvant to antidepressants. Active stimulation is expected to significantly impact response and remission rates. Minor side effects are expected due to the surgical procedure and electrical stimulation. The open-label phase should further confirm efficacy and tolerability. DISCUSSION: This study protocol is designed to define efficacy of a novel adjuvant therapy for TRD. We must strive to develop safe, reproducible, predictable, and well-tolerated neuromodulation approaches for TRD patients impaired to manage their lives and contribute with society.

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BACKGROUND: Human morbid obesity is increasing worldwide in an alarming way. The hypothalamus is known to mediate its mechanisms. Deep brain stimulation (DBS) of the ventromedial hypothalamus (VMH) may be an alternative to treat patients refractory to standard medical and surgical therapies. OBJECTIVE: To assess the safety, identify possible side effects, and to optimize stimulation parameters of continuous VMH-DBS. Additionally, this study aims to determine if continuous VMH-DBS will lead to weight loss by causing changes in body composition, basal metabolism, or food intake control. METHODS: The BLESS study is a feasibility study, single-center open-label trial. Six patients (body mass index > 40) will undergo low-frequency VMH-DBS. Data concerning timing, duration, frequency, severity, causal relationships, and associated electrical stimulation patterns regarding side effects or weight changes will be recorded. EXPECTED OUTCOMES: We expect to demonstrate the safety, identify possible side effects, and to optimize electrophysiological parameters related to VMH-DBS. No clinical or behavioral adverse changes are expected. Weight loss ≥ 3% of the basal weight after 3 mo of electrical stimulation will be considered adequate. Changes in body composition and increase in basal metabolism are expected. The amount of food intake is likely to remain unchanged. DISCUSSION: The design of this study protocol is to define the safety of the procedure, the surgical parameters important for target localization, and additionally the safety of long-term stimulation of the VMH in morbidly obese patients. Novel neurosurgical approaches to treat metabolic and autonomic diseases can be developed based on the data made available by this investigation.

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BACKGROUND: Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the impact of bariatric surgery in patients with obesity and hypertension are needed. METHODS: In this randomized, single-center, nonblinded trial, we included patients with hypertension (using ≥2 medications at maximum doses or >2 at moderate doses) and a body mass index between 30.0 and 39.9 kg/m2. Patients were randomized to Roux-en-Y gastric bypass plus medical therapy or medical therapy alone. The primary end point was reduction of ≥30% of the total number of antihypertensive medications while maintaining systolic and diastolic blood pressure <140 mm Hg and 90 mm Hg, respectively, at 12 months. RESULTS: We included 100 patients (70% female, mean age 43.8±9.2 years, mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up. Reduction of ≥30% of the total number of antihypertensive medications while maintaining controlled blood pressure occurred in 41 of 49 patients from the gastric bypass group (83.7%) compared with 6 of 47 patients (12.8%) from the control group with a rate ratio of 6.6 (95% confidence interval, 3.1-14.0; P<0.001). Remission of hypertension was present in 25 of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass, considering office and 24-hour ambulatory blood pressure monitoring, respectively, whereas no patient submitted to medical therapy was free of antihypertensive drugs at 12 months. A post hoc analysis for the primary end point considering the SPRINT (Systolic Blood Pressure Intervention Trial) target reached consistent results, with a rate ratio of 3.8 (95% confidence interval, 1.4-10.6; P=0.005). Eleven patients (22.4%) from the gastric bypass group and none in the control group were able to achieve SPRINT levels without antihypertensives. Waist circumference, body mass index, fasting plasma glucose, glycohemoglobin, low-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group. CONCLUSIONS: Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01784848.

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BACKGROUND: Recent research efforts on bariatric surgery have focusedon metabolic and diabetes mellitus resolution. Randomized trials designedto assess the impact of bariatric surgery in patients with obesity andhypertension are needed.METHODS: In this randomized, single-center, nonblinded trial, we includedpatients with hypertension (using ≥2 medications at maximum doses or >2 atmoderate doses) and a body mass index between 30.0 and 39.9 kg/m2. Patientswere randomized to Roux-en-Y gastric bypass plus medical therapy or medicaltherapy alone. The primary end point was reduction of ≥30% of the totalnumber of antihypertensive medications while maintaining systolic and diastolicblood pressure <140 mmHg and 90 mmHg, respectively, at 12 months. RESULTS: We included 100 patients (70% female, mean age 43.8±9.2 years,mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up.Reduction of ≥30% of the total number of antihypertensive medicationswhile maintaining controlled blood pressure occurred in 41 of 49 patientsfrom the gastric bypass group (83.7%) compared with 6 of 47 patients(12.8%) from the control group with a rate ratio of 6.6 (95% confidenceinterval, 3.1–14.0; P<0.001). Remission of hypertension was present in 25of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass,considering office and 24-hour ambulatory blood pressure monitoring...

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This article aims to contribute to a reflection on pesticides, based on the Brazilian legal framework, from the perspective of protecting human health and the environment. This initiative is due to successive attempts to flexibilize the regulation of pesticides in Brazil, through bills of law in progress in the Brazilian National Congress. An analysis of Bill of Law 3,200/2015 was carried out. This bill of law represents a major setback to the legislative achievements for the regulation of pesticides, in order to alert to the risks to human health from exposure to these products and aggravated by other similar proposals.

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Resumo: O presente artigo busca contribuir para uma reflexão sobre a temática dos agrotóxicos, à luz do arcabouço legal brasileiro, na perspectiva da proteção à saúde humana e ao meio ambiente. Tal iniciativa deve-se a sucessivas tentativas de flexibilização das normas de regulação de agrotóxicos no Brasil, por meio de projetos de lei em curso no Congresso Nacional. Para tanto, fez-se uma análise do Projeto de Lei nº 3.200/2015, que representa um dos maiores retrocessos às conquistas legislativas para a regulamentação dos agrotóxicos, de modo a alertar para os riscos à saúde humana frente à exposição a esses produtos e ao agravamento por outras propostas similares.

Abstract: This article aims to contribute to a reflection on pesticides, based on the Brazilian legal framework, from the perspective of protecting human health and the environment. This initiative is due to successive attempts to flexibilize the regulation of pesticides in Brazil, through bills of law in progress in the Brazilian National Congress. An analysis of Bill of Law 3,200/2015 was carried out. This bill of law represents a major setback to the legislative achievements for the regulation of pesticides, in order to alert to the risks to human health from exposure to these products and aggravated by other similar proposals.

Resumen: El presente artículo busca contribuir a una reflexión sobre la temática de los agrotóxicos, a la luz del marco legal brasileño, desde la perspectiva de proteger la salud humana y el medio ambiente. Esta iniciativa se debe a sucesivos intentos de flexibilización de las normas de regulación de agrotóxicos en Brasil, a través de proyectos de ley en curso en el Congreso Nacional. Se llevó a cabo un análisis del Proyecto de Ley 3.200/2015, que representa uno de los mayores retrocesos a las conquistas legislativas para la normativa de los agrotóxicos, para alertar sobre los riesgos a la salud humana frente a la exposición a esos productos y al agravamiento por otras propuestas similares.

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CONTEXT AND OBJECTIVE: Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited due to refractoriness and adverse effects. We describe the study rationale and design of ELECT-TDCS (Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study), which is investigating a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). DESIGN AND SETTING: Phase-III, randomized, non-inferiority, triple-arm, placebo-controlled study, ongoing in São Paulo, Brazil. METHODS: ELECT-TDCS compares the efficacy of active tDCS/placebo pill, sham tDCS/escitalopram 20 mg/day and sham tDCS/placebo pill, for ten weeks, randomizing 240 patients in a 3:3:2 ratio, respectively. Our primary aim is to show that tDCS is not inferior to escitalopram with a non-inferiority margin of at least 50% of the escitalopram effect, in relation to placebo. As secondary aims, we investigate several biomarkers such as genetic polymorphisms, neurotrophin serum markers, motor cortical excitability, heart rate variability and neuroimaging. RESULTS: Proving that tDCS is similarly effective to antidepressants would have a tremendous impact on clinical psychiatry, since tDCS is virtually devoid of adverse effects. Its ease of use, portability and low price are further compelling characteristics for its use in primary and secondary healthcare. Multimodal investigation of biomarkers will also contribute towards understanding the antidepressant mechanisms of action of tDCS. CONCLUSION: Our results have the potential to introduce a novel technique to the therapeutic arsenal of treatments for depression.

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The growth in the use of wireless devices, notebooks and other electronic products has led to an ever increasing demand for batteries, leading to these products being commonly found in inappropriate locations, with adverse effects on the environment and human health. Due to political pressure and according to the environmental legislation which regulates the destination of spent batteries, in several countries the application of reverse logistics to hazardous waste is required. Thus, some processes have been developed with the aim of providing an appropriate destination for these products. In this context, a method for the treatment of spent batteries using thermal plasma technology is proposed herein. The efficiency of the method was tested through the determination of parameters, such as total organic carbon, moisture content and density, as well as analysis by atomic absorption spectrometry, scanning electron microscopy and X-ray fluorescence using samples before and after inertization. The value obtained for the density was 19.15%. The TOC results indicated 8.05% of C in the batteries prior to pyrolisis and according to the XRF analysis Fe, S, Mn and Zn were the most stable elements in the samples (highest peaks). The efficiency of the paste inertization was 97% for zinc and 99.74% for manganese. The results also showed that the most efficient reactor was that with the DC transferred arc plasma torch and quartzite sand positively influenced by the vitrification during the pyrolysis of the electrolyte paste obtain from batteries.

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CONTEXT AND OBJECTIVE: Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited due to refractoriness and adverse effects. We describe the study rationale and design of ELECT-TDCS (Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study), which is investigating a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). DESIGN AND SETTING: Phase-III, randomized, non-inferiority, triple-arm, placebo-controlled study, ongoing in São Paulo, Brazil. METHODS: ELECT-TDCS compares the efficacy of active tDCS/placebo pill, sham tDCS/escitalopram 20 mg/day and sham tDCS/placebo pill, for ten weeks, randomizing 240 patients in a 3:3:2 ratio, respectively. Our primary aim is to show that tDCS is not inferior to escitalopram with a non-inferiority margin of at least 50% of the escitalopram effect, in relation to placebo. As secondary aims, we investigate several biomarkers such as genetic polymorphisms, neurotrophin serum markers, motor cortical excitability, heart rate variability and neuroimaging. RESULTS: Proving that tDCS is similarly effective to antidepressants would have a tremendous impact on clinical psychiatry, since tDCS is virtually devoid of adverse effects. Its ease of use, portability and low price are further compelling characteristics for its use in primary and secondary healthcare. Multimodal investigation of biomarkers will also contribute towards understanding the antidepressant mechanisms of action of tDCS. CONCLUSION: Our results have the potential to introduce a novel technique to the therapeutic arsenal of treatments for depression. .

CONTEXTO E OBJETIVO: O transtorno depressivo maior (TDM) é uma condição psiquiátrica comum, tratada com medicamentos antidepressivos, os quais são limitados devido à refratariedade e efeitos adversos. Descrevemos o racional e o desenho do Estudo Clínico Escitalopram versus Eletroterapia no Tratamento da Depressão (ELECT-TDCS), que investiga um tratamento não farmacológico, conhecido como estimulação transcraniana por corrente contínua (ETCC). DESENHO E LOCAL: Ensaio de fase III, randomizado, de não inferioridade, de três braços, placebo-controlado, em execução em São Paulo, Brasil. MÉTODOS: O estudo compara a eficácia da ETCC ativa/pílula placebo, ETCC simulada/escitalopram 20 mg/dia e ETCC simulada/pílula placebo durante 10 semanas, randomizando 240 pacientes em uma proporção 3:3:2, respectivamente. O objetivo principal é demostrar que a ETCC não é inferior ao escitalopram com uma margem de não inferioridade de pelo menos 50% do efeito de escitalopram em relação ao placebo. Como objetivos secundários, investigamos biomarcadores como polimorfismos genéticos, marcadores séricos, excitabilidade cortical motora, variabilidade da frequência cardíaca e neuroimagem. RESULTADOS: Provar que ETCC é igualmente eficaz a antidepressivos teria um tremendo impacto na psiquiatria clínica, uma vez que a ETCC é praticamente isenta de efeitos adversos. Sua facilidade de uso, portabilidade e preço baixo são outras características atraentes para uso na atenção primária e secundária de saúde. A investigação multimodal de biomarcadores também contribuirá para a compreensão dos mecanismos de ação antidepressivos da ETCC. CONCLUSÃO: Os nossos resultados podem introduzir uma nova técnica no arsenal terapêutico do tratamento da depressão. .

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Justificativa e objetivo: A constipação intestinal se caracteriza pela dificuldade constante ou eventual nas eliminações das fezes, as quais se tornam ressecadas. O objetivo deste estudo foi avaliar a eficácia clínica e tolerabilidade da composição Cassia fistula + Senna alexandrina Miller em pacientes diagnosticados com constipação intestinal funcional crônica (CIFC). Métodos: Estudo envolvendo 96 voluntários com diagnóstico de CIFC, conforme critérios de Rome III, randomizados em grupos ativo e placebo. A avaliação da eficácia primária foi realizada através da frequência média de evacuações (FME), consistência média das fezes (CMF) e melhora global da constipação (MGC). Foram realizadas ainda avaliações secundárias como número de dias seguidos sem evacuação, proporção de evacuações com dor, esforço, sensação de evacuação incompleta ou bloqueio, uso de manobras manuais, adesão às orientações relacionadas com a dieta, ingestão hídrica e prática de exercícios, uso da medicação de resgate e melhora da constipação, segundo avaliação subjetiva do participante. Resultados: Para os parâmetros de eficácia primária, o grupo ativo apresentou melhor desempenho do que o placebo. A proporção de participantes com MGC foi superior no grupo ativo. Para a maioria das avaliações secundárias de eficácia, o grupo ativo apresentou melhor desempenho quando comparado ao placebo. De acordo com a avaliação subjetiva dos participantes sobre a melhora da constipação, o grupo ativo apresentou melhor desempenho do que o placebo. Quanto à segurança, os dois grupos apresentaram resultados similares. Conclusão: Naturetti® na apresentação cápsulas mostrou-se seguro e eficaz comparado ao placebo, sendo alternativa para tratamento da CIFC...

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A contaminação por agrotóxicos gera discussão pelos impactos no meio ambiente e saúde. Os períodos natal e neonatal constituem janelas com susceptibilidade às consequências dos agrotóxicos. O estudo possui um desenho ecológico descritivo com o objetivo de verificar a existência de associação entre o consumo per capta dos agrotóxicos e eventos da gravidez e nascimento, através da quantidade consumida em 1997 e 2001 nos estados brasileiros. Os dados são do Instituto Brasileiro de Geografia e Estatística e do Sistema de Informações sobre Nascidos Vivos. O estudo não recebeu financiamento, utilizou bases de dados populacionais públicas sem análises individuais. Nos cálculos foi utilizado o consumo per capta de agrotóxicos classificados em três grupos com os tercis de distribuição em ordem crescente. O banco de dados do Departamento de Informática do SUS foi utilizado na análise das variáveis de desfecho de gravidez. Os resultados evidenciam associação entre praguicida e prematuridade, bem como uma relação com baixo o peso ao nascer, porém, que pode ser também um efeito confundidor.

Contamination with pesticides has generated discussion about their impacts on the environment and health. Natal and neonatal periods represent windows of susceptibility to the effects of pesticides. In this study we used a descriptive ecological design with the aim of verifying a possible association between the per capita consumption of pesticides and events of pregnancy and birth, using the amount of pesticides consumed in 1997 and 2001 in Brazilian states. The data was obtained from the Brazilian Institute of Geography and Statistics and the Live Birth Information System. The study received no funding, and thus employed public databases of populations without individual analysis. For the calculations we used the per capita consumption of pesticides classified into three groups with the distribution of the tertiles in ascending order. The database of the Information Department at the SUS (Unified Health System) was used to analyze the pregnancy outcome variables. The results show an association between pesticide consumption and premature births, and pesticide consumption and low birth weight, although the latter could also be a confounding effect.

RESUMEN

JUSTIFICATIVA E OBJETIVO: A constipação intestinal é um problema crônico, frequente, que afeta a Qualidade de Vida dos indivíduos. O objetivo deste estudo foi avaliar a eficácia clínica e a tolerabilidade da composição Cassia fistula e Senna alexandrina Miller, na apresentação geleia sem açúcar, em pacientes diagnosticados com constipação intestinal funcional crônica. MÉTODOS: Estudo envolvendo 96 voluntários com diagnóstico de constipação intestinal funcional crônica, conforme Critérios de Roma III, randomizados em grupos ativo e placebo. A avaliação da eficácia primária foi realizada por meio da frequência média de evacuações, consistência média das fezes e melhora global da constipação. Foram realizadas ainda avaliações secundárias, como número de dias seguidos sem evacuação, proporção de evacuações com dor, esforço, sensação de evacuação incompleta ou bloqueio, uso de manobras manuais, sujeitos de pesquisa que aderiram às recomendações de hábitos de vida, uso de fármacos de resgate e melhora da constipação segundo avaliação do sujeito de pesquisa. RESULTADOS: A proporção de sujeitos da pesquisa que apresentou melhora global da constipação foi de 65,1% no grupo ativo e de 22,0% grupo placebo (p<0,0001). Para a maioria das avaliações secundárias de eficácia, o grupo ativo apresentou melhor desempenho quando comparado ao grupo pesquisa. De acordo com a avaliação dos sujeitos de pesquisa sobre a melhora da constipação, o grupo ativo apresentou melhor desempenho do que o grupo pesquisa. Quanto à segurança, os dois grupos apresentaram resultados similares. CONCLUSÃO: A geleia sem açúcar composta de Cassia fistula e Senna alexandrina Miller apresentou um comportamento seguro e eficaz, sendo uma alternativa para tratamento da constipação intestinal funcional crônica.

BACKGROUND AND OBJECTIVE: Intestinal constipation is a chronic and frequent problem that affects Quality of Life. The aim of this study was to evaluate the efficacy and tolerability of the composition Cassia fistula and Senna alexandrina Miller, as sugar free jelly, in patients diagnosed with chronic functional constipation. METHODS: We evaluated 96 volunteers diagnosed with functional constipation according to Rome III criteria. Volunteers were randomized into active and placebo groups. Primary efficacy endpoint was evaluated by mean frequency of bowel movements, consistency of stools and global improvement of constipation. Secondary endpoints were evaluated, such as number of days without bowel movements, proportion of bowel movements with pain, with strain, sensation of incomplete or blocked bowel movement, use of, manual maneuvers to facilitate defecation, subjects who adhered to the diet recommendation, use of rescue medication, and level of constipation improvement, according to subject evaluation. RESULTS: Global improvement of constipationwas observed in 65.1% of subjects enrolled in active group versus 22% in placebo group (p<0.0001). For most secondary efficacy evaluations, the active group performed better when compared to placebo group. According to the evaluation of the subjects on the improvement of constipation, the active group performed better than the placebo group. As for security, the two groups showed similar results. CONCLUSION: Cassia fistula and Senna alexandrina Miller sugar free jelly demonstrated to be safe and effective and it can be used as an alternative for the treatment of functional constipation.

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