Modulation of the gut microbiome and Firmicutes phylum reduction by a nutraceutical blend in the obesity mouse model and overweight humans: A double-blind clinical trial.

Overweight and obesity are closely linked to gut dysbiosis/dysmetabolism and disrupted De-Ritis ratio [aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio], which may contribute to chronic noncommunicable diseases onset. Concurrently, extensive research explores nutraceuticals, and health-enhancing supplements, for disease prevention or treatment. Thus, sedentary overweight volunteers were double-blind randomized into two groups: Novel Nutraceutical_(S) (without silymarin) and Novel Nutraceutical (with silymarin). Experimental formulations were orally administered twice daily over 180 consecutive days. We evaluated fecal gut microbiota, based on partial 16S rRNA sequences, biochemistry and endocrine markers, steatosis biomarker (AST/ALT ratio), and anthropometric parameters. Post-supplementation, only the Novel Nutraceutical group reduced Clostridium clostridioforme (Firmicutes), Firmicutes/Bacteroidetes ratio (F/B ratio), and De-Ritis ratio, while elevating Bacteroides caccae and Bacteroides uniformis (Bacteroidetes) in Brazilian sedentary overweight volunteers after 180 days. In summary, the results presented here allow us to suggest the gut microbiota as the action mechanism of the Novel Nutraceutical promoting metabolic hepatic recovery in obesity/overweight non-drug interventions.

Influence of Phenotypes on the Metabolic Syndrome of Women with Polycystic Ovary Syndrome over a Six-Year Follow-Up in Brazil.

BACKGROUND: We followed polycystic ovary syndrome (PCOS) women with metabolic syndrome (MS) over a six-year treatment period and evaluated the influence of PCOS phenotypes on MS and on the risk for type 2 diabetes mellitus (T2DM). METHODS: This was an observational study of 457 PCOS women, whose demographic, clinical, hormonal, and metabolic data underwent analysis. The PCOS women were divided into four groups per NIH recommendations. RESULTS: After a follow-up of a mean of six years (1-20 years), 310 patients were selected to assess the development of T2DM and MS. The clinical and biochemical parameters, along with the Rotterdam phenotypes, were evaluated. Data were analyzed using Student's t- and the Pearson chi-square tests for data variation and group proportions, respectively. Additionally, multivariate analysis was applied to evaluate the effect of PCOS phenotypes on the risk for MS and T2DM. Patients of the four PCOS phenotypes did not differ in age, body mass index, total testosterone, insulin resistance, and dyslipidemia, but phenotype A patients showed the highest risk for T2DM. A decrease in androgen levels was not followed by an improved metabolic profile; instead, there was a significant increase in the number of T2DM cases. CONCLUSION: Phenotype A women are at the highest risk for type 2 diabetes mellitus.

Changes in Food Consumption in Postmenopausal Women during the COVID-19 Pandemic: A Longitudinal Study.

Studying the dietary habits and symptoms of postmenopausal women during situations such as the COVID-19 pandemic is important to mitigate long-term post-pandemic health problems. We compared the menopausal symptoms and food consumption in postmenopausal women before and during the COVID-19 pandemic. A longitudinal survey was conducted on postmenopausal Brazilian women between 2018 and 2021. The Kupperman-Blatt Menopausal Index, Women's Health Questionnaire, and 24 h food recall were used. Of 274 women, 78 (28.5%) participated in the study during the COVID-19 pandemic. The intensity of the symptoms was lower during the pandemic than during the previous period (p < 0.05). Energy and processed food consumption were lower during the pandemic than before (p = 0.003 and p = 0.003, respectively). Milk and plain yogurt consumption were also lower (p = 0.043), while the consumption of sugar-sweetened beverages and sweet foods was higher (p = 0.007 and p = 0.001, respectively) during the pandemic. There was also a decrease in the consumption of proteins and lipids (p = 0.001 and p = 0.004, respectively). In conclusion, we found that postmenopausal women consumed sweet foods and sugar-sweetened beverages in higher quantities and had a lower consumption of milk and plain yogurt and processed foods during the pandemic than during the pre-pandemic period. Furthermore, decreases in energy and macronutrient consumption were observed.

Non-oncological gynecological diagnoses in a women's health care service during the pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2.

OBJECTIVE: Analyze clinical factors and non-oncological gynecological diagnoses before and during the initial months of the COVID-19 pandemic. METHOD: Crosssectional study at an Outpatient Gynecology Clinic in Brazil involving medical consultations performed during the pre-pandemic and pandemic periods. The number of visits, prevalence of non-oncological gynecological diagnoses, and clinical-demographic data were analyzed. Parametric continuous variables were evaluated by Student's t-test and ANOVA tests, non-parametric variables were evaluated by the Mann-Whitney and Wilcoxon tests, and categorical or binary variables were evaluated by chi-square and Fisher's exact tests. Univariate logistic regression tests were performed, and variables with p ≤ 0.20 were subjected to multivariate logistic regression. Statistical significance was set at p < 0.05. RESULTS: There were 1,236 records during the pre-pandemic period and 530 during the pandemic, reflecting a significant reduction (57.88%; p = 0.001) in medical consultations. The outpatient prevalence of women older than 50 y (OR 0.85; 95%CI 0.68-1.05) reduced, and the outpatient prevalence of postmenopausal women with hot flashes (OR 1.34; 95%CI 1.09-1.65; p = 0.005) and alcohol consumption habits (OR 2.76; 95%CI 1.15-6.59; p = 0.023) increased. There was a 6% proportional increase in noninflammatory disorders of the female genital tract (p = 0.030) and a 72.4% decrease in general physical examinations, contraception, and procreation (p = 0.001). Multivariate analysis showed that there was an increased prevalence of abnormal uterine bleeding (OR, 1.7; 95% CI 1.34-2.16; p = 0.001) and endometriosis (OR 1.65; 95% CI 1.13-2.42; p = 0.01). CONCLUSION: Medical consultations for benign gynecological diseases during the pandemic prevented non-inflammatory disorders of the female genital tract, with an emphasis on abnormal uterine bleeding and endometriosis. There was an increased prevalence of women under 50 years of age, women with symptoms of hot flashes, and alcohol consumption habits and a reduction in the prevalence of general physical examinations, contraception, and procreation.

Acute Muscle Mass Loss Predicts Long-Term Fatigue, Myalgia, and Health Care Costs in COVID-19 Survivors.

OBJECTIVE: We examined the impact of loss of skeletal muscle mass in post-acute sequelae of SARS-CoV-2 infection, hospital readmission rate, self-perception of health, and health care costs in a cohort of COVID-19 survivors. DESIGN: Prospective observational study. SETTING AND PARTICIPANTS: Tertiary Clinical Hospital. Eighty COVID-19 survivors age 59 ± 14 years were prospectively assessed. METHODS: Handgrip strength and vastus lateralis muscle cross-sectional area were evaluated at hospital admission, discharge, and 6 months after discharge. Post-acute sequelae of SARS-CoV-2 were evaluated 6 months after discharge (main outcome). Also, health care costs, hospital readmission rate, and self-perception of health were evaluated 2 and 6 months after hospital discharge. To examine whether the magnitude of muscle mass loss impacts the outcomes, we ranked patients according to relative vastus lateralis muscle cross-sectional area reduction during hospital stay into either "high muscle loss" (-18 ± 11%) or "low muscle loss" (-4 ± 2%) group, based on median values. RESULTS: High muscle loss group showed greater prevalence of fatigue (76% vs 46%, P = .0337) and myalgia (66% vs 36%, P = .0388), and lower muscle mass (-8% vs 3%, P < .0001) than low muscle loss group 6 months after discharge. No between-group difference was observed for hospital readmission and self-perceived health (P > .05). High muscle loss group demonstrated greater total COVID-19-related health care costs 2 ($77,283.87 vs. $3057.14, P = .0223, respectively) and 6 months ($90,001.35 vs $12, 913.27, P = .0210, respectively) after discharge vs low muscle loss group. Muscle mass loss was shown to be a predictor of total COVID-19-related health care costs at 2 (adjusted ß = $10, 070.81, P < .0001) and 6 months after discharge (adjusted ß = $9885.63, P < .0001). CONCLUSIONS AND IMPLICATIONS: COVID-19 survivors experiencing high muscle mass loss during hospital stay fail to fully recover muscle health. In addition, greater muscle loss was associated with a higher frequency of post-acute sequelae of SARS-CoV-2 and greater total COVID-19-related health care costs 2 and 6 months after discharge. Altogether, these data suggest that the loss of muscle mass resulting from COVID-19 hospitalization may incur in an economical burden to health care systems.

Impacts of bariatric surgery in health outcomes and health care costs in Brazil: Interrupted time series analysis of multi-panel data.

BACKGROUND: The increasing burden of obesity generates significant socioeconomic impacts for individuals, populations, and national health systems worldwide. The literature on impacts and cost-effectiveness of obesity-related interventions for prevention and treatment of moderate to severe obesity indicate that bariatric surgery presents high costs associated with high effectiveness in improving health status referring to certain outcomes; however, there is a lack of robust evidence at an individual-level estimation of its impacts on multiple health outcomes related to obesity comorbidities. METHODS: The study encompasses a single-centre retrospective longitudinal analysis of patient-level data using micro-costing technique to estimate direct health care costs with cost-effectiveness for multiple health outcomes pre-and post-bariatric surgery. Data from 114 patients who had bariatric surgery at the Hospital of Clinics of the University of Sao Paulo during 2018 were investigated through interrupted time-series analysis with generalised estimating equations and marginal effects, including information on patients' characteristics, lifestyle, anthropometric measures, hemodynamic measures, biochemical exams, and utilisation of health care resources during screening (180 days before) and follow-up (180 days after) of bariatric surgery. RESULTS: The preliminary statistical analysis showed that health outcomes presented improvement, except cholesterol and VLDL, and overall direct health care costs increased after the intervention. However, interrupted time series analysis showed that the rise in health care costs is attributable to the high cost of bariatric surgery, followed by a statistically significant decrease in post-intervention health care costs. Changes in health outcomes were also statistically significant in general, except in cholesterol and LDL, leading to significant improvements in patients' health status after the intervention. CONCLUSIONS: Trends multiple health outcomes showed statistically significant improvements in patients' health status post-intervention compared to trends pre-intervention, resulting in reduced direct health care costs and the burden of obesity.

Análise custo-efetividade da cirurgia bariátrica para combate à obesidade moderada e severa no contexto do Sistema Único de Saúde / Cost-effectiveness analysis of bariatric surgery to tackle moderate and severe obesity in the context of the Brazilian Unified Health System

Introdução: O excesso de peso é um dos principais fatores de risco para mortalidade e carga global de doenças no mundo. No Brasil, o incremento na prevalência de sobrepeso e obesidade constitui um desafio em saúde pública ao longo das últimas três décadas, acarretando uma grande e crescente pressão nos custos em saúde para seu tratamento. Objetivos: O objetivo da tese foi conduzir uma revisão sistemática com meta-análise da literatura científica sobre avaliação econômica da cirurgia bariátrica em diferentes países, destacando custos e desfechos em saúde da intervenção em curto, médio e longo prazo; assim como investigar custo e efetividade de diferentes estratégias de abordagem da cirurgia bariátrica como intervenção para combate à obesidade moderada a severa em uma coorte de pacientes do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP). Metodologia: O estudo foi conduzido em duas etapas: revisão sistemática e meta-análise da literatura e avaliação dos custos e da efetividade do tratamento de obesidade moderada a severa por meio de cirurgia bariátrica. A revisão sistemática com meta-análise buscou estabelecer nível de qualidade das evidências científicas sobre associação entre custos do tratamento da obesidade por meio de cirurgia bariátrica e desfechos em saúde relacionados à prevalência de doenças crônicas não transmissíveis (DCNT). A avaliação dos custos e da efetividade da cirurgia bariátrica foi baseada em coleta de dados clínicos e sociodemográficos junto aos bancos de dados de prontuários eletrônicos dos pacientes do Departamento de Gastroenterologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP). Foi utilizada análise de séries temporais para verificação de diferenças entre custos e desfechos em saúde pré- e pós-cirurgia bariátrica, assim como tendência ao longo do período de acompanhamento pré- e pós-cirurgia bariátrica. Resultados: A etapa de revisão sistemática e meta-análise identificou 697 artigos, sendo incluídos 50 estudos na extração e análise de dados, totalizando 15.548.697 pacientes. Dos estudos incluídos, 27 (54%) realizaram avaliação econômica completa, sendo 20 estudos de análise custo-efetividade (40%) e 7 estudos de análise custo-utilidade (14%), assim como 23 estudos de avaliações econômicas parciais com custos ou desfechos (46%). Somente 6 estudos avaliaram custo e efetividade da cirurgia bariátrica comparados ao tratamento tradicional de doenças relacionadas à obesidade e 3 estudos apresentaram comparação entre custo da cirurgia bariátrica e custo da obesidade. O custo da cirurgia bariátrica sem especificação da técnica foi apresentado em 19 estudos, correspondendo a US$ 49,419.63 ± 96,707.49 (mediana = US$ 12,661.96). O resultado da meta-análise de estudos que avaliaram custos pré- e pós-cirurgia bariátrica apontou redução de aproximadamente 70% nos custos pós-intervenção (diferença média padronizada, SMD = 1,691; p = 0,01). A análise do custo e da efetividade da cirurgia bariátrica na coorte do ICHC-FMUSP incluiu 318 pacientes que foram submetidos a cirurgia bariátrica entre 2017 e 2018 (267 mulheres = 83,9% e 51 homens = 16,1%), sendo incluídos indivíduos com dados completos de acompanhamento de 240 meses pré-cirurgia bariátrica e 24 meses pós-cirurgia bariátrica. O custo total antes da cirurgia bariátrica foi US$ 7,915.35 ± 15,426.70 e o custo total após a cirurgia bariátrica foi US$ 7,347.97 ± 23,105.05 (p = 0,326). O custo total dos procedimentos realizados por via aberta (laparotômica) foi de US$ 15,806.01 ± 17,167.89, US$ 8,477.10 ± 3,929.73 e US$ 10,054.58 ± 7,834.89 nas cirurgias gastrectomia vertical, BGA e BGYR, respectivamente (p = 0,0195 entre gastrectomia vertical e BGA). O custo total dos procedimentos realizados por via laparoscópica foi de US$ 5,589.11 ± 0.00, US$ 4,759.14 ± 0.00 e US$ 7,027.38 ± 7,719.15 nas cirurgias gastrectomia vertical, BGA e BGYR, respectivamente (p = 0,093). Após a cirurgia bariátrica, houve redução estatisticamente significativa no peso corporal e IMC (p<0,001). Conclusão: A cirurgia bariátrica apresenta elevada razão de custo-efetividade, com reversão da maioria dos marcadores de risco para doenças crônicas não transmissíveis relacionadas à obesidade no paciente adulto, contribuindo à diminuição dos custos do atendimento de pacientes no âmbito do sistema público de saúde em médio e longo prazos.

Introduction: Excess body weight comprises one of the main risk factors for mortality and global burden of disease worldwide. In Brazil, the increase in prevalence of overweight and obesity represents a challenge in public health throughout the last three decades, caucusing an increasing burden of cost on health services. Objectives: The objective of the dissertation was to conduct a systematic review with meta-analysis of scientific literature on economic assessment of bariatric surgery in diverse countries, highlighting health care costs and health outcomes of the intervention in short-, medium-, and long-term; and to investigate cost and effectiveness of diverse strategies of bariatric surgery to tackle moderate to severe obesity in a cohort of patients of the Clinics Hospital at the School of Medicine of the University of Sao Paulo (HC-FMUSP). Methodology: The study was conducted in two stages: systematic review and meta-analysis of the literature, and assessment of costs and effectiveness of treatment of moderate to severe obesity through bariatric surgery. The systematic review with meta-analysis focused on the level of scientific evidence on the association between health care costs for treatment of obesity through bariatric surgery and health outcomes related to the prevalence of chronic non communicable diseases (NCD). The assessment of costs and effectiveness of bariatric surgery was based on data collection of clinical and sociodemographic information in electronic medical records of patients from the Department of Gastroenterology of the Clinics Hospital at the School of Medicine of the University of Sao Paulo (HC-FMUSP). A time-series analysis was performed to verify differences between health care costs and health outcomes pre- and post-bariatric surgery, and trends throughout follow-up before and after the surgery. Results: The systematic review and meta-analysis stage identified 697 studies, being 50 studies included in the data extraction and analysis, corresponding to 6,034,589 patients. Among the studies included, 27 (54%) conducted a complete economic assessment, being 20 cost-effectiveness studies (40%) and 7 cost-utility studies (14%), and 23 partial economic assessment studies with costs and outcomes (46%). Only 6 studies assessed cost and effectiveness of bariatric surgery compared to traditional treatment of diseases related to obesity and 3 studies presented comparison between costs of bariatric surgery and costs due to obesity. The cost of bariatric surgery without indication of the surgical technique was presented in 19 studies, corresponding to US$ 49,419.63 ± 96,707.49 (median = US$ 12.661,96). The meta-analysis of the studies assessing costs pre- and post-bariatric surgery indicated reduction of approximately 70% in post-intervention costs (standard mean difference, SMD = 1,691; p = 0,01). The analysis of costs and effectiveness of bariatric surgery in the ICHC_FMUSP cohort included 318 patients who underwent bariatric surgery between 2017 and 2018 (267 women = 83.9% and 51 men = 16.1%), being included individuals with complete data on follow-up of 240 months pre-surgery and 24 months post-surgery. The total cost before bariatric surgery was US$ 7,915.35 ± 15,426.70 and the total cost after bariatric surgery was US$ 7,347.97 ± 23,105.05 (p = 0.326). The total cost of open procedures (laparotomy) was US$ 15,806.01 ± 17,167.89, US$ 8,477.10 ± 3,929.73 and US$ 10,054.58 ± 7,834.89 in surgeries of vertical gastrectomy, BGA and BGYR, respectively (p = 0.0195 between vertical gastrectomy and BGA). The total cost of procedures conducted through laparoscopy was US$ 5,589.11 ± 0.00, US$ 4,759.14 ± 0.00 and US$ 7,027.38 ± 7,719.15 in vertical gastrectomy, BGA and BGYR, respectively (p = 0.093). After bariatric surgery, there was statistically significant reduction in body weight and BMI (p<0.001). Conclusion: The bariatric surgery presents high cost-effectiveness ratio, with reversion in trends of the majority of risk factors for chronic non communicable diseases related to obesity in adult patients, contributing to the decrease in health care costs of patients in the public health system in the medium and long run.

Higher MELD score increases the overall cost on the waiting list for liver transplantation: a micro-costing analysis based study.

BACKGROUND:: The pre-transplant period is complex and includes lots of procedures. The severity of liver disease predisposes to a high number of hospitalizations and high costs procedures. Economic evaluation studies are important tools to handle costs on the waiting list for liver transplantation. OBJECTIVE:: The objective of the present study was to evaluate the total cost of the patient on the waiting list for liver transplantation and the main resources related to higher costs. METHODS:: A cost study in a cohort of 482 patients registered on waiting list for liver transplantation was carried out. In 24 months follow-up, we evaluated all costs of materials, medicines, consultations, procedures, hospital admissions, laboratorial tests and image exams, hemocomponents replacements, and nutrition. The total amount of each resource or component used was aggregated and multiplied by the unitary cost, and thus individual cost for each patient was obtained. RESULTS:: The total expenditure of the 482 patients was US$ 6,064,986.51. Outpatient and impatient costs correspond to 32.4% of total cost (US$ 1,965,045.52) and 67.6% (US$ 4,099,940.99) respectively. Main cost drivers in outpatient were: medicines (44.31%), laboratorial tests and image exams (31.68%). Main cost drivers regarding hospitalizations were: medicines (35.20%), bed use in ward and ICU (26.38%) and laboratorial tests (13.72%). Patients with MELD score between 25-30 were the most expensive on the waiting list (US$ 16,686.74 ± 16,105.02) and the less expensive were those with MELD below 17 (US$ 5,703.22 ± 9,318.68). CONCLUSION:: Total costs on the waiting list for liver transplantation increased according to the patient's severity. Individually, hospitalizations, hemocomponents reposition and hepatocellular carcinoma treatment were the main cost drivers to the patient on the waiting list. The longer the waiting time, the higher the total cost on list, causing greater impact on health systems.

Higher MELD score increases the overall cost on the waiting list for liver transplantation: a micro-costing analysis based study / Altos valores de MELD aumentam o custo total em lista de espera para o transplante hepático. Um estudo de microcusteio

ABSTRACT BACKGROUND: The pre-transplant period is complex and includes lots of procedures. The severity of liver disease predisposes to a high number of hospitalizations and high costs procedures. Economic evaluation studies are important tools to handle costs on the waiting list for liver transplantation. OBJECTIVE: The objective of the present study was to evaluate the total cost of the patient on the waiting list for liver transplantation and the main resources related to higher costs. METHODS: A cost study in a cohort of 482 patients registered on waiting list for liver transplantation was carried out. In 24 months follow-up, we evaluated all costs of materials, medicines, consultations, procedures, hospital admissions, laboratorial tests and image exams, hemocomponents replacements, and nutrition. The total amount of each resource or component used was aggregated and multiplied by the unitary cost, and thus individual cost for each patient was obtained. RESULTS: The total expenditure of the 482 patients was US$ 6,064,986.51. Outpatient and impatient costs correspond to 32.4% of total cost (US$ 1,965,045.52) and 67.6% (US$ 4,099,940.99) respectively. Main cost drivers in outpatient were: medicines (44.31%), laboratorial tests and image exams (31.68%). Main cost drivers regarding hospitalizations were: medicines (35.20%), bed use in ward and ICU (26.38%) and laboratorial tests (13.72%). Patients with MELD score between 25-30 were the most expensive on the waiting list (US$ 16,686.74 ± 16,105.02) and the less expensive were those with MELD below 17 (US$ 5,703.22 ± 9,318.68). CONCLUSION: Total costs on the waiting list for liver transplantation increased according to the patient's severity. Individually, hospitalizations, hemocomponents reposition and hepatocellular carcinoma treatment were the main cost drivers to the patient on the waiting list. The longer the waiting time, the higher the total cost on list, causing greater impact on health systems.

RESUMO CONTEXTO: O período pré-transplante é complexo e inclui grande quantidade de procedimentos. A gravidade da doença hepática predispõe a um alto número de internações e procedimentos de alto custo. Estudos em avaliação econômica são uma importante ferramenta para o manejo dos custos em lista de espera para o transplante hepático. OBJETIVO: O objetivo do presente estudo foi avaliar o custo total do paciente em lista de espera para o transplante hepático e os principais recursos relacionados ao alto custo. MÉTODOS: Foi realizado um estudo de coorte em 482 pacientes registrados em lista de espera para o transplante hepático. Os pacientes foram acompanhados por um período de 24 meses, no qual foram avaliados todos os custos de materiais, medicamentos, consultas, procedimentos internações, exames laboratoriais e de imagem, reposição de hemocomponentes e nutrição recebida. A quantidade total de cada recurso e componente utilizado foi obtida e multiplicada pelo seu valor unitário e, desta maneira, o custo individual de cada paciente foi obtido. RESULTADOS: O total gasto pelos 482 pacientes foi de US$ 6.064.986,51. Os custos ambulatoriais corresponderam a 32,4% do total (US$ 1.965.045,52) e os custos em internação corresponderam a 67,6% do total (US$ 4.099.940,99). Os principais determinantes do custo em ambulatório foram: medicamentos (44,31%) e exames laboratoriais e de imagem (31,68%). Os principais determinantes de custo em internações foram: medicamentos (35,20%), utilização do leito em enfermaria e em UTI (26,38%) e exames laboratoriais (13,72%) Pacientes com valores de MELD entre 25-30 foram os de maiores custos em lista de espera (US$ 16.686,74 ± 16,105.02) e os de menor custo foram os pacientes com MELD abaixo de 17 (US$ 5.703,22 ± 9.318,68). CONCLUSÃO: O custo total em lista de espera para o transplante hepático aumenta de acordo com a gravidade do paciente. Individualmente, internações, reposição de hemocomponentes e o tratamento do paciente com carcinoma hepatocelular são os principais determinantes de custo para os pacientes em lista de espera para o transplante hepático. Quanto maior o tempo de espera, maiores serão os custos em lista, causando maior impacto nos sistemas de saúde.