Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID): A Randomised Clinical Trial.

We evaluated in this randomised, double-blind clinical trial the efficacy of melatonin as a prophylactic treatment for prevention of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure. Healthcare workers fulfilling inclusion criteria were recruited in five hospitals in Spain and were randomised 1:1 to receive melatonin 2 mg administered orally for 12 weeks or placebo. The main outcome was the number of SARS-CoV-2 infections. A total of 344 volunteers were screened, and 314 were randomised: 151 to placebo and 163 to melatonin; 308 received the study treatment (148 placebo; 160 melatonin). We detected 13 SARS-CoV-2 infections, 2.6% in the placebo arm and 5.5% in the melatonin arm (p = 0.200). A total of 294 adverse events were detected in 127 participants (139 in placebo; 155 in melatonin). We found a statistically significant difference in the incidence of adverse events related to treatment: 43 in the placebo arm and 67 in the melatonin arm (p = 0.040), and in the number of participants suffering from somnolence related to treatment: 8.8% (n = 14) in the melatonin versus 1.4% (n = 2) in the placebo arm (p = 0.008). No severe adverse events related to treatment were reported. We cannot confirm our hypothesis that administration of melatonin prevents the development of SARS-CoV-2 infection in healthcare workers.

Cirugía endoscópica endonasal en adenomas hipofisarios: resultados quirúrgicos en una serie de 86 pacientes consecutivos / Endonasal endoscopic surgery in pituitary adenomas: Surgical results in a series of 86 consecutive patients

Introducción: El abordaje endoscópico endonasal se ha convertido en la técnica quirúrgica de elección para el tratamiento de los adenomas hipofisarios. Objetivos: El objetivo de este trabajo es presentar los resultados obtenidos en nuestro hospital en cirugía puramente endoscópica de los adenomas hipofisarios. Métodos: Hemos realizado un estudio prospectivo, recogiendo a los pacientes intervenidos de adenoma hipofisario mediante un abordaje endonasal puramente endoscópico, desde febrero de 2011 hasta agosto de 2016, obteniendo una muestra total de 86 pacientes. Todos los pacientes fueron intervenidos conjuntamente por un ORL y un neurocirujano con la técnica de four hands-two nostrils. El seguimiento medio postoperatorio fue de 32 meses. Todos los pacientes fueron evaluados según criterios clínicos, radiológicos y endocrinológicos. Resultados: En nuestra serie un 53% eran mujeres y un 47% hombres; el rango de edad variaba desde los 14 hasta los 84 años, siendo la media de 54 años. El síntoma inicial más habitual fue el déficit visual (42%), seguido por la hiperfunción hormonal (21%), siendo la acromegalia el síndrome clínico observado con más frecuencia. Los tumores más frecuentes fueron los no funcionantes (73%), y de entre los adenomas funcionantes el más frecuente fue el productor de GH (65%). En cuanto a tamaño tumoral, un 76% eran macroadenomas, un 11% microadenomas y un 13% gigantes. Un 63% presentaban extensión supraselar y un 37% invasión de seno cavernoso (grado de Knosp ≥3). Se consiguió una exéresis total en un 77% de los casos. Tras la intervención se consiguió en un 91% mejoría visual y hasta en un 73% remisión de la hiperfunción endocrina. En cuanto a las complicaciones, la más frecuente fue la insuficiencia de al menos un eje de la hipófisis anterior (9%), sin presentar casos de fístula de LCR posquirúrgica. Conclusiones: Nuestros resultados, en términos de calidad quirúrgica, se asemejan a las series publicadas y avalan la eficacia y seguridad del abordaje endoscópico endonasal como técnica de elección en el manejo quirúrgico de la glándula hipofisaria. Sin embargo, es necesario un estudio con mayor número de casos para obtener resultados con significación clínica

Introduction: The endoscopic endonasal approach has become the gold standard for the surgical treatment of pituitary adenomas. Objectives: The aim of this study is to present the results obtained in our hospital in purely endoscopic surgery of pituitary adenomas. Methods: From February 2011 to August 2016, we conducted a prospective study on a series of 86 patients with pituitary adenoma, all of whom underwent surgery with a purely endoscopic endonasal approach. The ‘four hands-two nostrils’ technique was performed in all cases by a surgical team composed of an ENT surgeon and a neurosurgeon. Mean follow-up was 32 months. All patients were evaluated according to clinical, radiological and endocrinological criteria. Results: In our series, 53% were women and 47% men. The age ranged from 14 to 84 years of age, with a mean of 54 years of age. The most common initial symptom was visual deficit (42%), followed by hormonal hyperfunction (21%), with acromegaly being the most common clinical syndrome. The most common tumours were non-functioning tumours (73%), while GH-secreting tumours (65%) were the most common functioning adenoma. Regarding tumour size, 76% were macroadenomas, 11% microadenomas and 13% giant adenomas. Approximately 63% of the adenomas exhibited suprasellar extension and 37% involved invasion of the cavernous sinus (Knosp grade ≥3). Total excision was achieved in 77% of the cases. After the intervention, visual improvement was achieved in 91% and remission of endocrine hyperfunction in up to a 73% of cases. The most common complication was anterior pituitary insufficiency of at least one axis (9%). There were no cases of postoperative cerebrospinal fluid fistula. Conclusions: In terms of surgical quality, our results are similar to those of published series, and demonstrate the efficacy and safety of the endoscopic endonasal approach as the surgical treatment of choice for pituitary adenomas. However, further studies with a higher sample size are necessary to obtain clinically significant results

[Endonasal endoscopic surgery in pituitary adenomas: Surgical results in a series of 86 consecutive patients]. / Cirugía endoscópica endonasal en adenomas hipofisarios: resultados quirúrgicos en una serie de 86 pacientes consecutivos.

INTRODUCTION: The endoscopic endonasal approach has become the gold standard for the surgical treatment of pituitary adenomas. OBJECTIVES: The aim of this study is to present the results obtained in our hospital in purely endoscopic surgery of pituitary adenomas. METHODS: From February 2011 to August 2016, we conducted a prospective study on a series of 86 patients with pituitary adenoma, all of whom underwent surgery with a purely endoscopic endonasal approach. The 'four hands-two nostrils' technique was performed in all cases by a surgical team composed of an ENT surgeon and a neurosurgeon. Mean follow-up was 32 months. All patients were evaluated according to clinical, radiological and endocrinological criteria. RESULTS: In our series, 53% were women and 47% men. The age ranged from 14 to 84 years of age, with a mean of 54 years of age. The most common initial symptom was visual deficit (42%), followed by hormonal hyperfunction (21%), with acromegaly being the most common clinical syndrome. The most common tumours were non-functioning tumours (73%), while GH-secreting tumours (65%) were the most common functioning adenoma. Regarding tumour size, 76% were macroadenomas, 11% microadenomas and 13% giant adenomas. Approximately 63% of the adenomas exhibited suprasellar extension and 37% involved invasion of the cavernous sinus (Knosp grade ≥3). Total excision was achieved in 77% of the cases. After the intervention, visual improvement was achieved in 91% and remission of endocrine hyperfunction in up to a 73% of cases. The most common complication was anterior pituitary insufficiency of at least one axis (9%). There were no cases of postoperative cerebrospinal fluid fistula. CONCLUSIONS: In terms of surgical quality, our results are similar to those of published series, and demonstrate the efficacy and safety of the endoscopic endonasal approach as the surgical treatment of choice for pituitary adenomas. However, further studies with a higher sample size are necessary to obtain clinically significant results.

Eficacia de la estimulación cognitiva en pacientes con enfermedad de Alzheimer / Cognitive stimulation efficacy in patients with Alzheimer's disease

En la actualidad, son cada vez más los profesionales que se decantan por la intervención en la enfermedad de Alzheimer (EA) con un tratamiento combinado, y la estimulación cognitiva (EC) obtiene paulatinamente un papel más relevante. El objetivo de este estudio fue comprobar que la EC muestra resultados de mantenimiento de las funciones cognitivas frente a los sujetos que no reciben este tratamiento. Pacientes y método: Participaron un total de 52 sujetos diagnosticados de EA y con Mini-Mental State Examination (MMSE) >=20, divididos en dos grupos: un grupo experimental compuesto por 31 sujetos que estuvieron expuestos a sesiones de EC durante 9 meses, y un grupo control formado por 21 pacientes que no realizaron EC. La EC se llevó a cabo en la Clínica Neurodem por al menos una neuropsicóloga en sesiones grupales de 6 personas como máximo, 2 veces a la semana y con una duración de 120 minutos por sesión, donde se trabajaron diferentes funciones cognitivas utilizando distintas técnicas. Resultados: Los que obtuvimos fueron una media de MMSE del grupo experimental antes de EC de 24,61 con una DT de 2,58, y una media después de EC de 24,61 con DT de 3,73. En el grupo control encontramos una media inicial de MMSE de 22,80 y DT de 2,27, y después de 9 meses una media de MMSE de 21,42 y DT de 1,71. Las puntuaciones en fluencia fueron, para el grupo experimental, en pretest de 13 y en postest de 13,18; para los controles, la media en fluencia fue de 10,61 y, tras 9 meses, de 8,57. Conclusiones: El grupo experimental mantiene estables sus puntaciones en ambas pruebas frente al grupo control, que tiene un descenso en ellas(AU)

Nowadays, there are more professionals who choose intervention in Alzheimer Disease (AD) with a combined treatment, this way, cognitive stimulation (CS) becomes more relevant day by day. The aim of this study was to prove that CS shows maintenance’s results of the cognitive functions in patients who received this treatment versus patients that did not recieved it. Patients and method: 52 subjects with AD and Mini-Mental State Examination (MMSE) >=20, divided in two groups: experimental group (n= 31) which executed CS during 9 months, and one control group (n= 21) which didn’t execute the task. The CS was developed in Neurodem by one of the neuropsychologist which works in the clinic. It was taken in grupal session with a maximum of 6 patients, twice a week during 120 minutes, where the neuropsychologist and the patients worked with different cognitive functions, using different tecnics. Results: before CS experimental group x MMSE was 24,61 and sigma = 2,58 and control group MMSE x = 22,80 and sigma= 2,27. After 9 months results shows that x MMSE in experimental group was 24,61 and sigma was 2,58. In control group MMSE x was 21,42 and sigma was 1,71. In experimental group fluency puntuation was 10,61 and before 9 months was 8,57. Conclusions: the experimental group keeps its scores in both tasks whereas the control group shows a reduction in these tasks(AU)