Evaluation of the efficacy of an antioxidant combination for the modulation of metabolic, endocrine, and clinical parameters in patients with polycystic ovary syndrome.

OBJECTIVE: To evaluate the efficacy of dietary supplementation with a combination of antioxidants (lipoic acid, N-acetylcysteine, vitamin B6, and S-adenosyl-L-methionine) for the modulation of metabolic, endocrine, and clinical parameters in comparison with oral contraception in non-diabetic women newly diagnosed with polycystic ovary syndrome (PCOS). METHODS: This was a prospective, partially randomized, multicenter study in which non-diabetic women with PCOS were recruited under routine clinical practice conditions and distributed in three groups to receive the following regimen for 6 months: 1) antioxidant combination (MN group); 2) oral contraception (OC group); or 3) oral contraception and the antioxidant combination (MN + OC group). General recommendation of healthy diet and regular exercise was given to all patients. Metabolic, endocrine, clinical, and quality of life parameters were recorded at baseline and after 6 months of therapy. RESULTS: A total of 96 women with PCOS were included in the study. After 6 months of treatment, the homeostasis model assessment-estimated insulin resistance (HOMA-IR) level was reduced only in the MN group, with a significant mean reduction of -0.92 points. Androstenedione was significantly reduced in all groups. Clinical parameters that significantly improved in all groups were hirsutism, acne, irregular menstruation, and quality of life, with no statistical differences between the groups. CONCLUSIONS: This study showed that the antioxidant combination might be a suitable therapy for patients with PCOS when oral contraceptive is not indicated, because in all groups clinical parameters, irregular menstruation as well as androstenedione and quality of life were significantly improved with no statistical difference between groups.

Effects of respiratory muscle training in soccer players: a systematic review with a meta-analysis.

Respiratory muscle training can improve strength and reduce respiratory muscle fatigue during high-intensity exercise. Little is known about the existing evidence in soccer players. A systematic review with a meta-analysis was performed to analyse the existing evidence on the effects of respiratory muscle training in soccer players. Two independent researchers reviewed 17 databases until July 2019. Inclusion criteria were controlled clinical trials (randomised or not), soccer players (professional or recreational), females and/or males, and respiratory muscle training compared with simulated or regular training groups. The methodological quality and quality of evidence were evaluated with the Cochrane Collaboration Tool and GRADE score, respectively. Statistical analysis was performed using the integral meta-analysis 3.3.070. Nine studies met the eligibility criteria. The meta-analysis was performed for eight variables related to respiratory muscle function, lung function and sports performance. Respiratory muscle training provided a significant improvement compared with simulated or regular training in maximal inspiratory buccal pressure (6 studies, SDM = 0.89; 95 % CI = 0.42, 1.35) and maximum consumption of oxygen (3 studies, SDM = 0.92; 95 % CI = 0.24; 1.61). No significant improvements were observed for other variables. The quality of the evidence was rated as low or very low.

Oligomeric Enteral Nutrition in Undernutrition, due to Oncology Treatment-Related Diarrhea. Systematic Review and Proposal of An Algorithm of Action.

Oncology treatment-related diarrhea and malnutrition appear together in oncological patients because of the disease itself, or the treatments that are administered for it. Therefore it is essential to carry out a nutritional treatment. Enteral nutrition formulas, containing peptides and medium chain triglycerides, can facilitate absorption in cases of malabsorption. There are few references to the use of enteral nutrition in the clinical society guidelines of patient management with oncology treatment-related diarrhea (OTRD). A bibliographic review of the studies with oligomeric enteral nutrition in OTRD found only nine studies with chemotherapy (all with the same oligomeric formula in which oral mucositis improves, while the rest of the outcomes show different results), and eight studies with radiotherapy (with different products and very heterogeneous results). We hereby present our action algorithm to supplement the diet of OTRD patients with an oligomeric enteral nutrition formula. The first step is the nutritional assessment, followed by the assessment of the functional capacity of the patient's intestine. With these two aspects evaluated, the therapeutic possibilities available vary in degrees of complexity: These will range from the usual dietary recommendations, to supplementation with oral oligomeric enteral nutrition, along with complete enteral nutrition with oligomeric formula, and up to potentially total parenteral nutrition.

AI-related BMD variation in actual practice conditions: A prospective cohort study.

The aim of the study was to evaluate the progression of bone mineral density (BMD) during 3 years of aromatase inhibitors (AI) therapy in actual practice conditions. This prospective, clinical cohort study of Barcelona-Aromatase induced Bone Loss in Early breast cancer (B-ABLE) assessed BMD changes during 3 years of AI treatment in women with breast cancer. Patients with osteoporosis (T score < -2.5 or T score ≤ -2.0) and a major risk factor and/or prevalent fragility fractures were treated with oral bisphosphonates (BPs). Of 685 women recruited, 179 (26.1%) received BP treatment. By the third year of AI therapy, this group exhibited increased BMD in the lumbar spine (LS; 2.59%) and femoral neck (FN; 2.50%), although the increase was significant only within the first year (LS: 1.99% and FN: 2.04%). Despite BP therapy, however, approximately 15% of these patients lost more than 3% of their baseline bone mass. At 3 years, patients without BP experienced BMD decreases in the LS (-3.10%) and FN (-2.79%). In this group, BMD changes occurred during the first (LS: -1.33% and FN: -1.25%), second (LS: -1.19% and FN: -0.82%), and third (LS: -0.57% and FN: -0.65%) years of AI treatment. Increased BMD (>3%) was observed in just 7.6% and 10.8% of these patients at the LS and FN, respectively. Our data confirm a clinically relevant bone loss associated with AI therapy amongst nonusers of preventative BPs. We further report on the importance of BMD monitoring as well as calcium and 25-hydroxy vitamin D supplementation in these patients.

Residual activity of cetrimide and chlorhexidine on Enterococcus faecalis-infected root canals.

Effective final irrigation regimen is an important step in order to achieve better disinfection and ensure residual antimicrobial effects after root canal preparation. The aim of this study was to compare the residual antimicrobial activity of 0.2% cetrimide, and 0.2% and 2% chlorhexidine in root canals infected with Enterococcus faecalis. Biofilms of E. faecalis were grown on uniradicular roots for 4 weeks. After root canal preparation, root canals were irrigated with 17% ethylenediaminetetraacetic acid (EDTA) to remove the smear layer. The roots were randomly divided into three experimental groups (n=26) according to the final irrigating solution: Group I, 5 mL 0.2% cetrimide; Group II, 5 mL 0.2% chlorhexidine; and Group III, 5 mL 2% chlorhexidine. Samples were collected for 50 days to denote the presence of bacterial growth. The proportion of ungrown specimens over 50 days was evaluated using the nonparametric Kaplan-Meier survival analysis. Differences among groups were tested using the log-rank test and the level of statistical significance was set at P<0.05. The highest survival value was found with 2% chlorhexidine, showing statistically significant differences from the other two groups. At 50 days, E. faecalis growth was detected in 69.23% specimens in Groups I and II, and in 34.61% specimens of Group III. There were no significant differences between 0.2% cetrimide and 0.2% chlorhexidine. Final irrigation with 2% chlorhexidine showed greater residual activity than 0.2% chlorhexidine and 0.2% cetrimide in root canals infected with E. faecalis.

Bone health in a prospective cohort of postmenopausal women receiving aromatase inhibitors for early breast cancer.

OBJECTIVE: Baseline bone health in postmenopausal women is poorly characterized in prospective series of early breast cancer (EBC) patients candidates to aromatase inhibitor (AI) therapy. Our objective is to comprehensively evaluate bone health in a prospective clinical cohort of patients recruited prior to adjuvant AI therapy, with the aim of establishing potential AI impact on bone loss and fractures. METHODS: From January 2006 to April 2010, we consecutively included 343 women with EBC who were about to start adjuvant AI therapy. Participants were assessed at baseline (before AI initiation) and at 3 months, with annual assessments thereafter. Bone mineral density (BMD), spine X-ray, bone metabolism (vitamin D [25(OH)D], bone turnover markers [BTM]), arthralgia and quality of life are measured. RESULTS: Mean age was 61.9 years; 197 (57.4%) had been previously treated with tamoxifen; 145 (42.3%) were taking exemestane, 187 (54.5%) letrozole, and 11 (3.2%) anastrozole. Analysis of baseline data shows only 59 women (17.7%) had normal BMD; 200 (60.1%) had osteopenia and 74 (22.2%) had osteoporosis; 39 women (11.4%) had a prevalent fracture, 293 (89.1%) had 25(OH)D insufficiency (<30 ng/ml), and 61 (18.5%) severe deficiency (<10 ng/ml). Low 25(OH)D concentrations were associated with lower BMD and 233 (67.9%) participants had some degree of arthralgia. CONCLUSIONS: Low bone mass, prevalent fractures and vitamin D insufficiency were highly prevalent among candidates to adjuvant AI for EBC. Therefore, it is crucial to assess BMD, prevalent fractures and 25(OH)D concentrations before starting AI therapy and during follow-up.

Vitamin D threshold to prevent aromatase inhibitor-induced arthralgia: a prospective cohort study.

Aromatase inhibitor (AI)-associated arthralgia limits adherence to therapy in breast cancer. The pathophysiology may involve vitamin D status. We wished to establish the optimal concentration of 25(OH)D that prevents or minimizes arthralgia. We used a prospective cohort of 290 women starting AI in whom baseline vitamin D was measured. All received daily vitamin D(3) (800 IU) with calcium. Women with baseline 25(OH)D concentration <30 ng/ml also received 16,000 IU of D(3) orally every 2 weeks. The primary outcome was incident or worsening joint pain derived from baseline and 3-month visual analogic scale (VAS) for joint pain. Regression models were used to analyse the association between vitamin D concentrations at 3 months and pain adjusting for age, BMI, season when the sample was drawn, aromatase inhibitor (exemestane vs. letrozole/anastrozole), prior tamoxifen therapy, baseline NTX, and previous fracture. 90% of women had a 25(OH)D <30 ng/ml at baseline. After supplementation (daily 800 IU and additional 16,000 IU every 2 weeks), 50% of them still failed to reach adequate concentrations at 3 months. In the whole cohort, there was an increase in joint pain (mean 1.16 points SD 2.66; P < 0.001) and the increase was significantly (P = 0.02) attenuated in those that reached concentrations of 25(OH)D of ≥40 ng/ml, with a lower risk of incident arthralgia (OR 0.12 ** [0.03 to 0.40]). A target concentration of 40 ng/ml 25OHD may prevent development of AI arthralgia but higher loading doses are required to attain this level in women with deficiency at baseline.

Effect of a Psidii guajavae folium extract in the treatment of primary dysmenorrhea: a randomized clinical trial.

OBJECTIVE: To assess the efficacy of two different doses of a Psidii guajavae folium extract in the management of primary dysmenorrhea. METHODOLOGY: A double-blinded randomized clinical trial was conducted in 197 women with primary dysmenorrhea. Four intervention groups were defined: two extract doses (3 and 6 mg/day); ibuprofen (1200 mg/day); placebo (3mg/day). Participants were followed-up individually for 4 months. The main outcome variable was abdominal pain intensity measured according to a visual analogue scale (VAS). RESULTS: The average age of participants was 19 years; menarche occurred around age 12 years. Participants had menstrual cycles of 28 or 29 days, with menstruation lasting 5 days and mean of pain intensity of 8.2 on the VAS. During each successive treatment cycle, participants experienced a lower pain intensity score. Multiple regression analysis, after adjusting each cycle for baseline pain, treatment compliance and other variables, showed that the group receiving 6 mg/day extract had significantly reduced pain intensity (p<0.001). This effect was maintained in cycles 2 and 3, although the reduction in the mean of pain intensity was lower. The group receiving the 3mg/day extract did not show a consistent effect throughout the three cycles. CONCLUSION: At a dose of 6 mg/day, the standardized phyto-drug (Psidii guajavae folium extract) reduced menstrual pain significantly compared with conventional treatment and placebo.

Intestinal anti-spasmodic effect of a phytodrug of Psidium guajava folia in the treatment of acute diarrheic disease.

Ancestral medicinal use of guava (Psidium guajava L. Fam. Myrtaceae) is today supported by numerous biomedical studies concerning the properties of leaf extracts. However, insufficient clinical studies are reported on the use of this plant resource in the treatment of gastrointestinal ailments. The present work reports a randomized, double-blinded, clinical study performed to evaluate the safety and efficacy of a phytodrug (QG-5) developed from guava leaves, standardized in its content of quercetin and orally administered to a group of adult patients with acute diarrheic disease. Capsules containing 500 mg of the product were administered to 50 patients every 8 h during 3 days. Results obtained showed that the used guava product decreased the duration of abdominal pain in these patients.

Validation of a prognostic index in the critically ill newborn / Validación de un índice pronóstico en el recién nacido en estado crítico

Objetivo. Elaborar y validar un modelo pronóstico para evaluar a los pacientes que ingresan a una Unidad de Cuidados Intensivos Neonatales (UCIN). Diseño. Casos y controles anidado en una cohorte. Lugar. UCIN de dos hospitales de tercer nivel y uno de segundo nivel. Pacientes. El estudio se realizó en dos fases (elaboración y validación del modelo respectivamente). En la primera fase se estudiaron 336 recién nacidos, 112 casos (pacientes fallecidos en la UCIN) y 224 controles (pacientes egresados vivos de la UCIN). En la segunda fase se incluyeron 300 pacientes, 100 casos y 200 controles. Mediciones. A cada uno de los pacientes que ingresaron al estudio se les determinaron los factores perinatales, clínicos, paraclínicos, y de co-morbilidad dentro de las primeras 12 horas de haber ingresado. Las variables que mostraron significancia estadística en el análisis bivariado se llevaron a un modelo de regresión logística. Resultados. Las variables que constituyeron el modelo pronóstico fueron edad gestacional x peso al nacer, paO2/FiO2 x saturación de O2, paro cardiaco, malformaciones congénitas mayores, septicemia y exceso de base. En la cohorte de elaboración la sensibilidad del modelo fue 70 por ciento y la especificidad 91 por ciento. En la cohorte de validación la sensibilidad fue 68 por ciento y la especificidad 92 por ciento, el valor predictivo positivo 80 por ciento, el valor predictivo negativo 85 por ciento y la frecuencia de clasificación correcta 84 por ciento. Conclusiones. El índice pronóstico de mortalidad neonatal desarrollado en este estudio demostró ser útil para la evaluación de la mortalidad hospitalaria en recién nacidos críticamente enfermos que ingresan a una UCIN.

Defunciones inesperadas en un hospital pediátrico / Mortality in a pediatrics hospital. Some considerations about unexpected deaths

Objetivo: conocer algunas características hospitalarias e identificar su asociación con las defunciones calificadas como inesperadas. Material y métodos: se trata a un estudio transversal en el que fueron evaluados los expedientes de las defunciones ocurridas entre 1994 y 1995 en un hospital pediátrico de tercer nivel, sin distinción del sexo, edad o enfermedad del paciente. Una vez valoradas, las defunciones fueron calificadas como esperadas, inesperadas o súbitas por el Subcomité de Mortalidad del hospital. El análisis se realizó con medidas de frecuencia y estimación de pruebas de hipótesis para muestras independientes con intervalo de confianza de 95 por ciento (IC 95 por ciento). Resultados: se estudiaron 411 defunciones evaluadas por el Subcomité de Mortalidad, que representaron 79.5 por ciento del total. De acuerdo con la evolución del padecimiento, 67.6 por ciento fue calificado como defunción esperada a corto plazo, 11.9 por ciento como esperada a largo plazo, 15.6 por ciento inesperada y 4.9 por ciento súbita. Los pacientes evaluados como estables al ingreso tuvieron mayor frecuencia de defunciones inesperadas que los muy graves (OR = 8.4, IC 95 por ciento = 3.9-18). La identificación de problemas en el diagnóstico (OR = 2.3, IC 95 por ciento 1.3-3.8) y en el tratamiento (OR = 3.8, IC 95 por ciento = 2.3-6.2) fueron variables que presentaron diferencias significativas. Conclusiones: la evaluación de las condiciones en que se presentaron las defunciones respecto a la atención hospitalaria permite tomar medidas que pueden prevenir problemas en la atención médica futura