Mirtazapine as Appetite Stimulant in Patients With Non-Small Cell Lung Cancer and Anorexia: A Randomized Clinical Trial.

Importance: Currently there is no standard therapy to improve cancer-related anorexia, hampering survival. Mirtazapine has been suggested as a feasible option in this context. Objectives: To assess the effect of mirtazapine on appetite and energy consumption in patients with advanced non-small cell lung cancer (NSCLC). Design, Setting, and Participants: This randomized, double-blind, placebo-controlled clinical trial including adults was performed in a tertiary cancer care center from August 2018 to May 2022 with a follow-up of 8 weeks. Overall, 134 patients were screened; 114 were assessed for eligibility and 28 were excluded. Interventions: Patients were randomized in a 1:1 ratio to receive mirtazapine, 15 mg, or placebo for 2 weeks followed by a dose escalation to 30 mg until week 8 or placebo. Both groups received nutritional assessment and dietary advice. Main outcomes and measures: Appetite was assessed by the Anorexia Cachexia Scale and energy intake. Dietary parameters were evaluated at baseline, 4 weeks, and 8 weeks, with a 24-hour dietary recall, and energy quantification based on the Mexican system of nutritional equivalents. Results: A total of 86 patients met the inclusion criteria and were randomized to the placebo (n = 43) or the mirtazapine group (n = 43). The mean (SD) age was 63.5 (11.2) years, 41 were women (57.7%) and had adenocarcinoma, Eastern Cooperative Oncology Group performance status scale score of 1, stage IV NSCLC, and were receiving first-line treatment. Baseline characteristics were similar between groups. There was no difference in appetite scores in patients who received mirtazapine or placebo after 4 and 8 weeks. After 4 weeks, mirtazapine significantly increased energy intake (379.3 kcal; 95% CI, 1382.6-576.1; P < .001) including proteins (22.5 g; 95% CI, 11.5-33.4; P = .001), carbohydrates (43.4 g; 95% CI, 13.1-73.8; P = .006), and fats (13.2 g; 95% CI, 6.0-20.4; P = .006). Fats intake was significantly higher in patients in the mirtazapine group (14.5 g vs 0.7 g; P = .02) after 8 weeks. The mirtazapine group significantly decreased the proportion of patients with sarcopenia (82.8% vs 57.1%, P = .03) at 8 weeks. Patients on mirtazapine tolerated the treatment well, but reported a higher perception of nightmares at 2 weeks based on a 10 cm VAS score (0 [25th-75th percentile, 0-1] vs 0 [25th-75th percentile, 0-0] in the control group; P = .009) but this finding was nonsignificant after 4 and 8 weeks. Conclusion and Relevance: In this randomized clinical trial of patients with advanced NSCLC, there was no difference in appetite scores in all patients who received mirtazapine or placebo, but the mirtazapine group had a significant increase in energy intake through the 4- and 8-week follow-up, mainly in fat intake, which is a better and crucial source of energy. The addition of mirtazapine in the treatment of patients with advanced NSCLC and anorexia may help these patients achieve their energy requirements and improve health-related quality of life, specifically emotional and cognitive functioning. Trial Registration: ClinicalTrials.gov Identifier: NCT04748523.

Effects of Fructans from Mexican Agave in Newborns Fed with Infant Formula: A Randomized Controlled Trial.

BACKGROUND: The importance of prebiotics consumption is increasing all over the world due to their beneficial effects on health. Production of better prebiotics from endemic plants raises possibilities to enhance nutritional effects in vulnerable population groups. Fructans derived from Agave Plant have demonstrated their safety and efficacy as prebiotics in animal models. Recently, the safety in humans of two fructans obtained from Agave tequilana (Metlin(®) and Metlos(®)) was demonstrated. METHODS: This study aimed to demonstrate the efficacy as prebiotics of Metlin(®) and Metlos(®) in newborns of a randomized, double blind, controlled trial with a pilot study design. Biological samples were taken at 20 ± 7 days, and three months of age from healthy babies. Outcomes of efficacy include impact on immune response, serum ferritin, C-reactive protein, bone metabolism, and gut bacteria changes. RESULTS: There were differences statistically significant for the groups of infants fed only with infant formula and with formula enriched with Metlin(®) and Metlos(®). CONCLUSIONS: Our results support the efficacy of Metlin(®) and Metlos(®) as prebiotics in humans, and stand the bases to recommend their consumption. TRIAL REGISTRATION: ClinicalTrials.gov, NCT 01251783.

Ventilación mecánica domiciliaria con doble nivel de presión positiva: Experiencia de un hospital de Buenos Aires / Home Mechanical Ventilation with Bilevel Positive Pressure. Experience from a Buenos Aires Hospital

Introducción: La ventilación domiciliaria con equipos de doble nivel de presión positiva (DNPP) es un tratamiento de uso cada vez más frecuente en nuestro medio. Objetivo: Analizar la situación actual de los pacientes con ventilación domiciliaria del Hospital Churruca. Sus características demográficas, clínicas, de uso del ventilador y relacionadas con la prestación del servicio en domicilio. Materiales y métodos: Se localizó a los pacientes a los que se les prescribió un equipo entre el 2000 y 2013. Se citaron a control para completar y actualizar datos referidos al uso de la ventilación. Para la clasificación de patologías respiratorias se utilizó la metodología del estudio Eurovent. Se entregó un cuestionario para valorar aspectos relacionados con el acceso al servicio técnico y controles domiciliarios. Resultados: Se analizaron 43 pacientes. Sexo femenino 58%, índice masa corporal 37,52 ±11,5 kg/m2. Dentro de las patologías el 58% causas pulmonares, 26% torácicas, 14% neuromusculares. El 79% fueron localizados y el 21% fueron considerados perdidos. Se objetivó uso actual en 62%, abandono en el 26% y 12% fallecimientos. En el grupo Torácicas el abandono fue del 50%.El 56% de los encuestados refirió conocer la manera de acceder al servicio técnico. Al 50% nunca se le realizó un control del equipo. Conclusiones: Existe una mayoría de sexo femenino y una prevalencia alta de obesidad. La mayor parte de los pacientes ventilados fueron por causas pulmonares y con elevada tasa de abandono global, sobretodo en el grupo torácicas. Quedó en evidencia un escaso control de los equipos en el domicilio.

Introduction: Mechanical ventilation equipment for home use is an increasingly common treatment in clinical practice. Objective: Analyze the current situation of patients attending Churruca Hospital with home mechanical ventilation. Describe demographic and clinical characteristics, related to ventilator use and to provision of the home technical services. Materials and Methods: We identified the patients who were prescribed mechanical ventilation from 2000 to 2013. We invited them to come to the hospital to complete and update data about the ventilator use. The Eurovent methodology was used for the classification of respiratory diseases. A questionnaire was delivered to evaluate aspects related to health service access and home control. Results: 43 patients were analyzed; 58% were females, the body mass index was 37.52 ± 11.5 kg/m2. Respiratory diseases: Lung pathologies, 58%; Thoracic pathologies, 26%; Neuromuscular diseases, 14%. 79% of patients were located and 21% were considered lost of sight. 62% currently used the equipment, 26% had stopped using the ventilator and 12% of patients had died. Dropout was registered in 50% of the thoracic group. Among all located patients, 56% reported knowing how to access to home technical service and 50% had never had an equipment control at home. Conclusions: We observed both a female predominance and a high prevalence of obesity among the patients included in the study. Pulmonary diseases were the major reason for prescription of mechanical ventilation at home .We observed a high default rate, especially in the thoracic pathology group. There were few equipment controls at home.

Ventilación mecánica domiciliaria con doble nivel de presión positiva: Experiencia de un hospital de Buenos Aires

Introducción: La ventilación domiciliaria con equipos de doble nivel de presión positiva (DNPP) es un tratamiento de uso cada vez más frecuente en nuestro medio. Objetivo: Analizar la situación actual de los pacientes con ventilación domiciliaria del Hospital Churruca. Sus características demográficas, clínicas, de uso del ventilador y relacionadas con la prestación del servicio en domicilio. Materiales y métodos: Se localizó a los pacientes a los que se les prescribió un equipo entre el 2000 y 2013. Se citaron a control para completar y actualizar datos referidos al uso de la ventilación. Para la clasificación de patologías respiratorias se utilizó la metodología del estudio Eurovent. Se entregó un cuestionario para valorar aspectos relacionados con el acceso al servicio técnico y controles domiciliarios. Resultados: Se analizaron 43 pacientes. Sexo femenino 58%, índice masa corporal 37,52 ±11,5 kg/m2. Dentro de las patologías el 58% causas pulmonares, 26% torácicas, 14% neuromusculares. El 79% fueron localizados y el 21% fueron considerados perdidos. Se objetivó uso actual en 62%, abandono en el 26% y 12% fallecimientos. En el grupo Torácicas el abandono fue del 50%.El 56% de los encuestados refirió conocer la manera de acceder al servicio técnico. Al 50% nunca se le realizó un control del equipo. Conclusiones: Existe una mayoría de sexo femenino y una prevalencia alta de obesidad. La mayor parte de los pacientes ventilados fueron por causas pulmonares y con elevada tasa de abandono global, sobretodo en el grupo torácicas. Quedó en evidencia un escaso control de los equipos en el domicilio.(AU)

Introduction: Mechanical ventilation equipment for home use is an increasingly common treatment in clinical practice. Objective: Analyze the current situation of patients attending Churruca Hospital with home mechanical ventilation. Describe demographic and clinical characteristics, related to ventilator use and to provision of the home technical services. Materials and Methods: We identified the patients who were prescribed mechanical ventilation from 2000 to 2013. We invited them to come to the hospital to complete and update data about the ventilator use. The Eurovent methodology was used for the classification of respiratory diseases. A questionnaire was delivered to evaluate aspects related to health service access and home control. Results: 43 patients were analyzed; 58% were females, the body mass index was 37.52 ± 11.5 kg/m2. Respiratory diseases: Lung pathologies, 58%; Thoracic pathologies, 26%; Neuromuscular diseases, 14%. 79% of patients were located and 21% were considered lost of sight. 62% currently used the equipment, 26% had stopped using the ventilator and 12% of patients had died. Dropout was registered in 50% of the thoracic group. Among all located patients, 56% reported knowing how to access to home technical service and 50% had never had an equipment control at home. Conclusions: We observed both a female predominance and a high prevalence of obesity among the patients included in the study. Pulmonary diseases were the major reason for prescription of mechanical ventilation at home .We observed a high default rate, especially in the thoracic pathology group. There were few equipment controls at home.(AU)