RESUMEN
BACKGROUND: N-of-1 studies allow the formal assessment of a patient's treatment. A single participant receives different interventions the same number of times in a crossover, double-blind, randomized design. Using this methodology, we will investigate the effectiveness and safety of a standardized homeopathy protocol in treating 10 cases of major depression. METHODS: The method is described below: Design: crossover double-blind placebo-controlled randomized N-of-1 studies, with at most 28 weeks of duration per participant. PARTICIPANTS: women and men at age over 18 years with a diagnosis of a major depressive episode given by a psychiatrist, who have presented a therapeutic response, i.e., a reduction ≥50% of the baseline depressive symptoms, self-assessed by the Beck Depression Inventory - Second Edition (BDI-II), and sustained for at least 4 weeks during an open homeopathic treatment following the protocol of the sixth edition of the Organon, with or without concomitant use of psychotropic drugs. INTERVENTIONS: individualized homeopathy following the same protocol, one globule of the fifty-millesimal potency diluted in 20 mL of 30% alcohol; placebo - 20 mL of 30% alcohol, in the same posology as homeopathy. Crossover study: the participant will go through three consecutive treatment blocks, with two random and masked treatment periods (A or B), corresponding to homeopathy or placebo. Treatment periods will have 2, 4, and 8 weeks in the first, second, and third blocks, respectively. A clinically significant worsening (characterized by an augmentation in BDI-II inclusion score ≥30%) will result in the termination of study participation and resumption of the open treatment. PRIMARY MEASURE: progression of the depressive symptoms, self-assessed by the participant using the BDI-II scale at weeks 0, 2, 4, 8, 12, 16, 20, 24, 28 and analyzed throughout the study concerning homeopathy and placebo partitions. Secondary measures: score of the Clinical Global Impression Scale; mental and physical health scores assessed by the 12-Item Short-Form Health Survey; participant's blind preference for treatment A or B at each block; clinical worsening; and adverse events. DATA ANALYSIS: the participant, assistant physician, evaluator, and statistician will remain blinded for the study treatments until the completion of data analysis of each study. We will follow a 10-step procedure for analyzing N-of-1 observational data of each participant and conduct a meta-analysis of the combined results. DISCUSSION: We understand that each N-de-1 study will be a chapter with its teachings in a book of ten, allowing a broader view of the effectiveness of the homeopathy protocol of the sixth edition of the Organon in treating depression.
Asunto(s)
Trastorno Depresivo Mayor , Homeopatía , Femenino , Humanos , Masculino , Estudios Cruzados , Trastorno Depresivo Mayor/terapia , Trastorno Depresivo Mayor/etiología , Método Doble Ciego , Homeopatía/métodos , Metaanálisis como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , AdultoRESUMEN
Introdução: A Empresa Brasileira de Serviços Hospitalares (Ebserh) gere 41 hospitais universitários federais (HUFs), atualmente com 36 Núcleos de Avaliação de Tecnologias em Saúde (NATS). No contexto hospitalar, o NATS desenvolve produtos de avaliação de tecnologias em saúde (ATS) para subsidiar o gestor na tomada de decisões, sendo essencial para a sustentabilidade do Sistema Único de Saúde. A implantação efetiva dos NATS ainda é desafiadora, devido à insuficiência de diretrizes específicas para ATS hospitalar. Objetivo: Relatar atuação do Grupo de Trabalho em ATS (GT-ATS) da Ebserh na elaboração de guia para orientar a estruturação e fortalecimento dos NATS dos HUFs.Relato de Experiência: O GT-ATS foi instituído por portaria, composto por representantes de NATS dos HUFs e da administração central da Ebserh. Inicialmente, fez-se levantamento dos processos envolvendo os NATS, da prática de ATS na Ebserh e foi realizado diagnóstico situacional dos NATS. Em seguida, elaborou-se o guia a partir da expertise dos membros do GT-ATS e das melhores práticas e recomendações sobre ATS hospitalar, identificadas em revisão da literatura. O "Guia para organização e funcionamento dos NATS na Rede Ebserh" foi publicado em março de 2023 no portal eletrônico da Ebserh e inclui contextualização da ATS hospitalar no Brasil, objetivos e escopo de atuação dos NATS da Ebserh, orientações para organização e funcionamento dos núcleos e modelo de regulamento interno. Também foram elaborados modelos de nota técnica, declaração de conflito de interesses, formulário de solicitação e termo de compromisso de confidencialidade. Conclusão: O GT-ATS, por meio do Guia e dos documentos elaborados, contribuiu para institucionalização, harmonização e implementação dos processos de ATS nos hospitais da Ebserh, respeitando a heterogeneidade dos contextos e níveis de maturidade dos NATS. O trabalho colaborativo dentro do GT-ATS permitiu articulação de saberes interdisciplinares e práticas interinstitucionais, ampliando a dimensão, alcance e efetividade das ações de ATS.
Introduction: The Brazilian Hospital Services Company (Ebserh) manages 41 federal university hospitals (HUFs), currently with 36 Health Technology Assessment Centers (NATS). In the hospital context, NATS develop health technology assessment (HTA) products to help managers make decisions and are essential for the sustainability of the Unified Health System. The effective implementation of NATS is still a challenge, due to the lack of specific guidelines for hospital HTA. Objective: To report on the work of Ebserh's HTA Working Group (GT-ATS) in drawing up a guide for structuring and strengthening NATS HUFs. Experience Report: The GT-ATS was set up by ordinance, made up of representatives from NATS of HUFs and from Ebserh's central administration. Initially, a survey about the processes involving the NATS and the practice of HTA at Ebserh was carried out to make a situational diagnosis. The guide was then drawn up based on the expertise of the GT-ATS members and the best practices and recommendations on hospital HTA identified in literature review. The "Guide for the organization and operation of NATS in the Ebserh network" was published in March 2023 on Ebserh's electronic portal and includes a contextualization of hospital HTA in Brazil, the objectives and scope of action of Ebserh's NATS, guidelines for the organization and operation of the centers and a model of internal regulations. Templates have also been drawn up for technical note, declaration of conflict of interests, application form and confidentiality agreement. Conclusion: Through the Guide and the documents produced, the GT-ATS contributed to the institutionalization, harmonization and implementation of HTA processes in Ebserh hospitals, while respecting the heterogeneous contexts and maturity levels of the NATS. The collaborative work within the GT-ATS has allowed interdisciplinary knowledge and inter-institutional practices to be brought together, expanding the dimension, scope and effectiveness of HTA actions.
Asunto(s)
Evaluación de la Tecnología Biomédica , Sistema Único de Salud , Redes de Información de Ciencia y Tecnología , Promoción de la Salud , Hospitales Universitarios/organización & administración , InstitucionalizaciónRESUMEN
AIMS: Ischemia/reperfusion (I/R) injury and metabolic acidosis (MA) are two critical conditions that may simultaneously occur in clinical practice. The result of this combination can be harmful to the kidneys, but this issue has not been thoroughly investigated. The present study evaluated the influence of low systemic pH on various parameters of kidney function in rats that were subjected to an experimental model of renal I/R injury. MAIN METHODS: Metabolic acidosis was induced in male Wistar rats by ingesting ammonium chloride (NH4Cl) in tap water, beginning 2 days before ischemic insult and maintained during the entire study. Ischemia/reperfusion was induced by clamping both renal arteries for 45 min, followed by 48 h of reperfusion. Four groups were studied: control (subjected to sham surgery, n=8), I/R (n=8), metabolic acidosis (MA; 0.28 M NH4Cl solution and sham surgery, n=6), and MA+I/R (0.28 M NH4Cl solution plus I/R, n=9). KEY FINDINGS: Compared with I/R rats, MA+I/R rats exhibited higher mortality (50 vs. 11%, p=0.03), significant reductions of blood pH, plasma bicarbonate (pBic), and standard base excess (SBE), with a severe decline in the glomerular filtration rate and tubular function. Microscopic tubular injury signals were detected. Immunofluorescence revealed that the combination of MA and I/R markedly increased nuclear factor κB (NF-κB) and heme-oxygenase 1 (HO-1), but it did not interfere with the decrease in endothelial nitric oxide synthase (eNOS) expression that was caused by I/R injury. SIGNIFICANCE: Acute ischemic kidney injury is exacerbated by acidic conditions.
Asunto(s)
Acidosis/complicaciones , Lesión Renal Aguda/complicaciones , Acidosis/inducido químicamente , Acidosis/patología , Lesión Renal Aguda/mortalidad , Lesión Renal Aguda/patología , Cloruro de Amonio , Animales , Bicarbonatos/sangre , Hemo Oxigenasa (Desciclizante)/metabolismo , Concentración de Iones de Hidrógeno , Pruebas de Función Renal , Masculino , FN-kappa B/metabolismo , Óxido Nítrico Sintasa de Tipo III/metabolismo , Ratas , Ratas Wistar , Arteria Renal/patología , Daño por Reperfusión/mortalidad , Daño por Reperfusión/patología , Desequilibrio HidroelectrolíticoRESUMEN
Lesão renal por isquemia/reperfusão (I/R) e acidose metabólica (AM) são duascondições críticas que ocorrem frequentemente na prática clínica. O resultado dessacombinação pode ser prejudicial para os rins, mas esta questão não tem sidoexaustivamente estudada até hoje. O presente estudo avaliou em ratos a influênciado baixo pH sistêmico em vários parâmetros da função renal mediante lesão renalpor I/R. A acidose metabólica foi induzida em ratos Wistar machos através daingestão de cloreto de amônio (NH4CI) dissolvido na água de beber, iniciando 2 diasantes da indução de lesão renal por isquemia/reperfusão e mantida durante todo oestudo. Isquemia/reperfusão renal foi induzida por clampeamento bilateral dasartérias renais durante 45 min, seguido por 48 h de reperfusão. Ao final do estudo,foram obtidas amostras de sangue arterial, urina e tecido renal. Os animais foramdivididos em quatro grupos: controle (submetido à cirurgia sham, n = 8), I/R (n = 8),acidose metabólica (AM; solução de NH4CI 0,28 M + cirurgia sham, n = 6), e AM+I/R(solução de NH4CI 0,28 M + I/R, n = 9). Em comparação com grupo I/R, ratosAM+I/R apresentaram maior mortalidade (50% vs. 11%), redução significativa de pHsanguíneo (7,00 ± 0,04 vs. 7,35 ± 0,03), bicarbonato plasmático (pBic; 9,0 ± 1,4 vs.21,4 ± 0,9 mmol/L), e excesso de base (SBE; -23,8 ± 1,5 vs. -2,7 ± 0,9 mmol/L), comdeclínio no ritmo de filtração glomerular (0,05 ± 0,02 vs. 0,14 ± 0,03 mL/min/100 g) efunção tubular...
Ischemia/reperfusion (I/R) injury and metabolic acidosis (MA) are two criticalconditions that frequently occur in the clinical practice. The result of this combinationcan be harmful to the kidneys, but this issue has not been thoroughly investigatedhitherto. The present study evaluated the influence of low systemic pH on severalkidney function parameters in rats subjected to experimental model of renal I/Rinjury. Metabolic acidosis was induced in male Wistar rats by ingesting ammoniumchloride (NH4Cl) in tap water, beginning 2 days before ischemic insult and maintainedduring the entire study. Ischemia/reperfusion was induced by clamping both renalarteries for 45 min, followed by 48 h of reperfusion. At the end of the study, arterialblood samples and urine were collected and left kidneys were harvested. Fourgroups were studied: control (subjected to sham surgery, n = 8), I/R (n = 8),metabolic acidosis (MA; 0.28 M NH4Cl solution and sham surgery, n = 6), andMA+I/R (0.28 M NH4Cl solution plus I/R, n = 9). Compared with I/R rats, MA+I/R ratsexhibited higher mortality (50% vs. 11%), significant reduction of blood pH (7.00 ±0.04 vs. 7.35 ± 0.03), plasma bicarbonate (pBic; 9.0 ± 1.4 vs. 21.4 ± 0.9 mmol/L), andstandard base excess (SBE; -23.8 ± 1.5 vs. -2.7 ± 0.9 mmol/L), with a severe declinein the glomerular filtration rate (0.05 ± 0.02 vs. 0.14 ± 0.03 mL/min/100 g) and tubularfunction. In addition, tubular changes were more intense determining higher scores oftubular injury...