Individualized Homeopathy for Depression in Climacteric Women: Comments on the Retraction by PLoS ONE.

In April 2020 PLoS ONE retracted an original clinical research article, published in 2015, in which we demonstrated that individualized homeopathic treatment improves depression symptoms in climacteric women. The original assessment of this study was carried out by an expert in psychiatry (depression research) with close to 35 years' experience in the field of mental health. During post-publication discussions, no serious breaches of scientific procedure or misconduct were even insinuated. Our team answered all "points of concern", raised by the current PLoS ONE editors, in extensive detail. All these were potential limitations of our study, which would usually be addressed by one of several appropriate post-publication actions, ranging from discussion of the concern within a systematic review, through to correcting the study itself by adding a correction notice. Therefore, in the interests of transparency and accuracy, a summary of the most relevant points is provided, so that a fair-minded reader can objectively form a clear opinion.

Diagnostic accuracy of the Edinburgh Postnatal Depression Scale: consequences of screening in Mexican women.

INTRODUCTION: Postpartum depression is a non-psychotic depressive episode with serious repercussions on the bond between the mother and her child, hence the importance of detecting it in a timely manner. OBJECTIVE: To determine the accuracy of the Edinburgh Postnatal Depression Scale as a diagnostic test and to analyze the consequences of screening and the probability of depression after applying the test. METHOD: Screening of 411 women with the Edinburgh Postnatal Depression Scale during the postpartum period; Beck's Depression Inventory was used as reference. RESULTS: At a cutoff point of 12, a sensitivity of 70.4 %, specificity of 72.2 %, positive predictive value of 36.9 % and negative predictive value of 91.4 % were obtained with Edinburgh Postnatal Depression Scale, as well as an area under the curve of 0.729 and a p-value of 0.0003. Out of 49 women without treatment for postpartum depression, five were identified to require it. CONCLUSIONS: The Edinburgh Postnatal Depression Scale has moderate accuracy; its application is simple, accessible and should be routine. It is necessary for strategies to detect and treat postpartum depression to be implemented in Mexico.

INTRODUCCIÓN: La depresión posparto es un episodio depresivo no psicótico con repercusiones graves en el vínculo de la madre con su hijo, de ahí la importancia de detectarla oportunamente. OBJETIVO: Determinar la exactitud de la Escala de Depresión Posnatal de Edimburgo como prueba diagnóstica y analizar las consecuencias del tamizaje y la probabilidad de depresión después de aplicar la prueba. MÉTODO: Tamizaje con la Escala de Depresión Posnatal de Edimburgo a 411 mujeres durante el posparto; se utilizó el Inventario de Depresión de Beck como referencia. RESULTADOS: En un punto de corte de 12, con la Escala de Depresión Posnatal de Edimburgo se obtuvo sensibilidad de 70.4 %, especificidad de 72.2 %, valor predictivo positivo de 36.9 % y valor predictivo negativo de 91.4 %, así como un valor del área bajo la curva de 0.729 y p = 0.0003. De 49 mujeres sin atención para depresión posparto, en cinco se identificó que la necesitaban. CONCLUSIONES: La Escala de Depresión Posnatal de Edimburgo tiene una exactitud moderada; su aplicación es sencilla, accesible y debería ser rutinaria. Es necesario que en México se implementen estrategias para detectar y tratar la depresión posparto.

Exactitud diagnóstica de la Escala de Depresión Posnatal de Edimburgo: consecuencias del tamizaje en mujeres mexicanas / Diagnostic accuracy of the Edinburgh Postnatal Depression Scale: consequences of screening in Mexican women

Resumen Introducción: La depresión posparto es un episodio depresivo no psicótico con repercusiones graves en el vínculo de la madre con su hijo, de ahí la importancia de detectarla oportunamente. Objetivo: Determinar la exactitud de la Escala de Depresión Posnatal de Edimburgo como prueba diagnóstica y analizar las consecuencias del tamizaje y la probabilidad de depresión después de aplicar la prueba. Método: Tamizaje con la Escala de Depresión Posnatal de Edimburgo a 411 mujeres durante el posparto; se utilizó el Inventario de Depresión de Beck como referencia. Resultados: En un punto de corte de 12, con la Escala de Depresión Posnatal de Edimburgo se obtuvo sensibilidad de 70.4 %, especificidad de 72.2 %, valor predictivo positivo de 36.9 % y valor predictivo negativo de 91.4 %, así como un valor del área bajo la curva de 0.729 y p = 0.0003. De 49 mujeres sin atención para depresión posparto, en cinco se identificó que la necesitaban. Conclusiones: La Escala de Depresión Posnatal de Edimburgo tiene una exactitud moderada; su aplicación es sencilla, accesible y debería ser rutinaria. Es necesario que en México se implementen estrategias para detectar y tratar la depresión posparto.

Abstract Introduction Postpartum depression is a non-psychotic depressive episode with serious repercussions on the bond between the mother and her child, hence the importance of detecting it in a timely manner. Objective: To determine the accuracy of the Edinburgh Postnatal Depression Scale as a diagnostic test and to analyze the consequences of screening and the probability of depression after applying the test. Method: Screening of 411 women with the Edinburgh Postnatal Depression Scale during the postpartum period; Beck's Depression Inventory was used as reference. Results: At a cutoff point of 12, a sensitivity of 70.4 %, specificity of 72.2 %, positive predictive value of 36.9 % and negative predictive value of 91.4 % were obtained with Edinburgh Postnatal Depression Scale, as well as an area under the curve of 0.729 and a p-value of 0.0003. Out of 49 women without treatment for postpartum depression, five were identified to require it. Conclusions: The Edinburgh Postnatal Depression Scale has moderate accuracy; its application is simple, accessible and should be routine. It is necessary for strategies to detect and treat postpartum depression to be implemented in Mexico.

[Tratamiento nutricional hiperproteico precirugía bariátrica en obesidad mórbida]. / High-protein diet in morbidity obesity patient before bariatric surgery.

OBJETIVO: Comparar la efectividad de un plan de alimentación hipocalórico hiperproteico con otro normoproteico sobre la composición corporal, los parámetros bioquímicos y las citocinas inflamatorias en pacientes obesos precirugía bariátrica sometidos a un tratamiento integral. MÉTODO: Se estudiaron 76 pacientes con un índice de masa corporal (IMC) ≥ 40 kg/m² previamente a la cirugía bariátrica. Un grupo fue tratado con una dieta hipocalórica hiperproteica y se comparó con una dieta hipocalórica normoproteica. Se evaluaron parámetros bioquímicos, parámetros antropométricos, composición corporal y valores de citocinas inflamatorias en suero al inicio y después de 4 meses de tratamiento. RESULTADOS: En ambos grupos se observó una disminución de peso, de IMC y de masa grasa, así como un incremento de la masa muscular respecto al momento basal (p < 0.05), sin diferencias entre los grupos estudiados. No se encontraron cambios en los parámetros bioquímicos ni en las concentraciones séricas de factor de necrosis tumoral (TNF) e interleucina (IL)-6 antes y después de 4 meses de tratamiento, ni entre los grupos evaluados (p > 0.05). Las concentraciones séricas de IL-1ß disminuyeron únicamente con la dieta hipocalórica normoproteica (p = 0.02). CONCLUSIONES: La dieta hipocalórica hiperproteica no muestra ventajas en la reducción de peso y grasa corporal, ni en la ganancia de masa muscular, en comparación con la dieta hipocalórica normoproteica en pacientes con obesidad mórbida precirugia bariátrica sometidos a un tratamiento integral. OBJECTIVE: Compare the effectiveness of a hyperproteic hypocaloric feeding plan with a normoproteic on body composition, biochemical parameters and inflammatory cytokines in obese pre-bariatric surgery patients in the integral treatment. METHOD: Seventy-six pre-bariatric surgery patients with body mass index (BMI) ≥ 40 kg/m² were studied. One group was treated with a hyperproteic hypocaloric diet and compared with a normoproteic hypocaloric diet. Biochemical parameters, anthropometric parameters, body composition and levels of tumor necrosis factor (TNF), interleukin (IL)-6 and IL-1ß in serum were evaluated at the initiation of treatment and after 4 months. RESULTS: In both groups studied, a decrease in weight, BMI and fat mass was observed, as well as an increase in muscle mass compared to baseline (p < 0.05), no differences showed between the groups studied. No change was found in the biochemical parameters and serum levels of TNF and IL-6 before and after 4 months of treatment, nor among the groups evaluated (p > 0.05). Serum IL-1ß levels decreased after treatment with only a normoprotein hypocaloric diet (p = 0.02). ­. CONCLUSIONS: Hyperproteic hypocaloric diet does not show advantages in weight reduction and body fat or in muscle mass gain compared to the normoproteic hypocaloric diet in patients with morbid obesity bariatric pre-surgery in the integral treatment.

Response to Individualized Homeopathic Treatment for Depression in Climacteric Women with History of Domestic Violence, Marital Dissatisfaction or Sexual Abuse: Results from the HOMDEP-MENOP Study.

BACKGROUND: Although individualized homeopathic treatment is effective for depression in climacteric women, there is a lack of well-designed studies of its efficacy for depression in battered women or in post-traumatic stress disorder. The aim of this study was to assess the association between individualized homeopathic treatment or fluoxetine and response to depression treatment in climacteric women with high levels of domestic violence, sexual abuse or marital dissatisfaction. MATERIALS AND METHODS: One hundred and thirty-three Mexican climacteric women with moderate-to-severe depression enrolled in the HOMDEP-MENOP Study (a randomized, placebo-controlled, double-blind, double-dummy, three-arm trial, with a 6-week follow-up study) were evaluated. Domestic violence, marital dissatisfaction and sexual abuse were assessed at baseline. Response to depression treatment was defined by a decrease of 50% or more from baseline score of Hamilton scale. Association between domestic violence, sexual abuse, and marital dissatisfaction and response to depression treatment was analyzed with bivariate analysis in the three groups. Odds ratio (OR) and 95% confidence interval (CI) were calculated. RESULTS: Homeopathy versus placebo had a statistically significant association with response to depression treatment after adjusting for sexual abuse (OR [95% CI]: 11.07 [3.22 to 37.96]), domestic violence (OR [95% CI]: 10.30 [3.24 to 32.76]) and marital dissatisfaction (OR [95% CI]: 8.61 [2.85 to 25.99]). CONCLUSIONS: Individualized homeopathic treatment is associated with response to depression treatment in climacteric women with high levels of domestic violence, sexual abuse or marital dissatisfaction. Further studies should be conducted to evaluate its efficacy specifically for post-traumatic stress disorder in battered women. CLINICALTRIALS. GOV IDENTIFIER: NCT01635218,: URL: http://clinicaltrials.gov/ct2/show/NCT01635218?term=depression+homeopathy&rank=1.

Correlation of the expression of YY1 and Fas cell surface death receptor with apoptosis of peripheral blood mononuclear cells, and the development of multiple organ dysfunction in children with sepsis.

Multiple organ dysfunction (MOD) is a lethal complication in children with sepsis. Apoptosis of several cell types is involved in this process, and it is associated with increased Fas cell surface death receptor (Fas) expression. As YY1 transcription factor (YY1) negatively regulates the expression of Fas in cancer models, and is associated with the clinical outcome, it may be important in MOD. The present study aimed to determine the association between the expression of Fas, YY1 and apoptosis in children with sepsis, and its association with MOD, these factors were analyzed in 30 pediatric patients that had been diagnosed with sepsis. Peripheral blood mononuclear cells were purified from patients, and YY1 and Fas protein expression was assessed by immunocytochemistry. Apoptosis was determined by terminal deoxynucleotidyl transferase dUTP nick­end labeling. Sepsis was monitored using clinical parameters, pediatric logistic organ dysfunction (PELOD) score and the pediatric mortality index. The results demonstrated that Fas expression was directly correlated with apoptosis levels and the expression of YY1 was inversely correlated with apoptosis levels. Patients with high levels of apoptosis exhibited increased disease severity and poor clinical outcome. Notably, the findings of the present study demonstrated that there were higher survival rates in patients with high YY1 expression, compared with those with low YY1 expression. Additionally, patients with MOD exhibited lower proportions of apoptotic cells compared with sepsis patients without MOD. Furthermore, the PELOD score was positively correlated with Fas and inversely correlated with YY1 expression. Finally, high apoptosis and low YY1 expression were prognostic factors associated with poor survival rates. These data suggested that YY1 may be important for apoptosis induction via the regulation of Fas during sepsis. Therefore, Fas may be a potential therapeutic target to prevent MOD through regulation of YY1 expression. Furthermore, YY1 and Fas expression in PBMCs may be used to as prognostic markers.

Is metabolic dysregulation associated with antidepressant response in depressed women in climacteric treated with individualized homeopathic medicines or fluoxetine? The HOMDEP-MENOP Study.

BACKGROUND: Climacteric is associated with both depression and metabolic dysregulation. Scarce evidence suggests that metabolic dysregulation may predict poor response to conventional antidepressants. Response to depression treatment has not been studied in homeopathic medicine. The aim of this study was to investigate the prevalence of metabolic disorders in depressed climacteric women treated with homeopathic medicines, fluoxetine or placebo, and if these alterations have any association with response to depression treatment. METHODS: One hundred and thirty-three Mexican women (40-65 years) with depression, enrolled in the HOMDEP-MENOP study, a randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a 6 week follow-up, underwent a complete medical history and clinical examination. Metabolic parameters were assessed at baseline. Association between baseline metabolic parameters and response to depression treatment was analyzed with bivariate analysis in the three groups. Odds ratios (OR) with their 95% confidence interval (95% CI) were calculated. Metabolic parameters were considered for inclusion in the logistic regression model if they had a statistically significant relationship with response rate on bivariate analysis at p<0.05 or if they were clinically relevant. RESULTS: Overall combined prevalence (obesity and overweight) was 86.5%; 52.3% had hypertriglyceridemia; 44.7% hypercholesterolemia; 46.7% insulin resistance; and 16% subclinical hypothyroidism. There was no statistically significant association between dyslipidemia, overweight, or insulin resistance and non-response in the homeopathy group [OR (95% CI) 1.57 (0.46-5.32), p=0.467; 0.37 (0.003-1.11), p=0.059; 0.67 (0.16-2.7), p=0.579, respectively]. CONCLUSION: Metabolic dysregulation was not significantly associated with response to depression treatment in depressed climacteric women treated with individualized homeopathic treatment (IHT), fluoxetine or placebo. Due to the high prevalence of metabolic disorders and its relationship with depression in the climacteric, further investigation should be focused on whether individualized prescriptions based on classical homeopathy for depressed climacteric women have an effect on metabolic parameters, and/or if treating the metabolic disorders at the same time could lead to higher response rates. ClinicalTrials.gov Identifier: NCT01635218 URL: http://clinicaltrials.gov/ct2/show/NCT01635218?term=depression+homeopathy&rank=1.

Responsabilidad profesional aplicada a la farmacovigilancia: un estudio de caso en México / Professional responsibility applied to drug surveillance: a study case in México / Responsabilidade profissional aplicada à farmacovigilância: um estudo de caso no México

El sistema internacional de farmacovigilancia recopila información sobre eventos adversos por medicamentos a partir de informes emitidos por los médicos en la práctica clínica. Los reportes de reacciones adversas a medicamentos (RAM) son escasos. Diseñamos un cuestionario basado en una escala de Likert de cinco puntos. El cuestionario, de 24 preguntas, se administró a una muestra de médicos. Las respuestas de los cuestionarios indican que es importante contar con sistemas de farmacovigilancia. A pesar de ello, casi tres cuartos de los encuestados no sabían cómo informar de una reacción adversa y dos quintos no deseaban hacerlo. Tres cuartas partes de los encuestados expresaron que la instrucción sobre la elaboración de informes debería comenzar durante la carrera de Medicina. Los resultados sugieren que la elaboración de informes de RAM debe incluirse en la educación médica. Es necesario establecer protocolos que aseguren que los lineamientos para informar RAM sean fáciles de seguir. Es recomendable que los programas de capacitación y educación médica continua generen una conciencia de responsabilidad frente al reporte de RAM.

The international pharmacovigilance system collects adverse drug events reported by physicians in their clinical practice. Adverse drug reactions (ADR) reported are scarce. We designed a questionnaire based on a 5-point Likert scale. The questionnaire (24 questions) was administered to a sample of physicians in Mexico City. Questionnaire responses indicated that having pharmacovigilance systems is important. Despite this, nearly three quarters of respondents did not know how to report an adverse drug reaction, and two-fifths were not willing to do so. Three quarters believed that education regarding reporting and its methods should be initiated during medical school. The results from our questionnaire suggest that medical school training in ADR report writing should be implemented. Good protocols have to be in place to ensure that ADR report forms have easy-to-follow guidelines and are easy to complete. It is recommended that the programs of training and medical education generate conscience of responsability towards the report of ADRs.

O sistema internacional de farmacovigilância recopila informação sobre eventos adversos por medicamentos a partir de informes emitidos pelos médicos na prática clínica. Os informes de reações adversas a medicamentos (RAM) são escassos. Idealizamos um questionário baseado numa escala de Likert de cinco pontos. O questionário, de 24 perguntas, foi administrado a uma mostra de médicos. As respostas dos questionários indicam que é importante contar com sistemas de farmacovigilância. Apesar disso, quase três quartos dos entrevistados não sabiam como informar uma reação adversa e dois quintos não desejavam fazê-lo. Três quartas partes dos entrevistados expressaram que a instrução sobre a elaboração de informes deveria começar durante o curso de Medicina. Os resultados sugerem que a elaboração de informes de RAM deve ser incluido na educação médica. É necessário estabelecer protocolos que assegurem que as orientações para informar RAM sejam fáceis de seguir. É recomendável que os programas de capacitação e educação médica contínua gerem uma consciência de responsabilidade frente ao informe de RAM.

EFFECTIVENESS OF IMMUNONUTRITION ON INFLAMMATORY MARKERS IN PATIENTS WITH CANCER; RANDOMIZED CLINICAL TRIAL.

BACKGROUND: malnutrition is a common complication in patients with cancer and is associated with immunosuppression and alterations with inflammatory response. OBJECTIVE: the aim of our study was to evaluate the effect of enteral nutrition supplemented with two enteral formulas on inflammatory markers (CRP, IL-6 and FNTα) in cancer patients undergoing chemotherapy. DESIGN AND METHODS: randomized control trial, conducted at the Hospital Juarez of Mexico in patients with cancer undergoing chemotherapy with IRN < 97.5 and SGA B/C. Patients were randomly allocated to two groups: group I (immunomodulatory), group II (high ω3). The intervention began on the first day of chemotherapy until day 10 after. We evaluated nutritional status and an inflammatory marker on days 0, +5, +10 QT. Statistical analysis was performed with T Student, x2 and analysis of variance for repeated measurements. P < 0.05 was considered statistically significant. RESULTS: a total of 29 patients were analyzed, 27 (62.8%) females and 16 (37.2%) males. Mean age 43.91 + 11.3 years old. Malnutrition prevalence was 48.8% moderate and 51.2% severe. Prealbumin levels significantly increase in group II vs group I (p < 0.05). Both groups maintenance body weight, lean mass and fat mass. No decrease levels of CRP, IL-6 and FNTα. CONCLUSIONS: enteral supplementation during chemotherapy inhibits nutritional deterioration and maintenance body weight and lean mass. No decreased levels of inflammatory markers.

Antecedentes: la desnutrición es una complicación frecuente en los pacientes oncológicos y se relaciona con inmunosupresión y alteraciones en la respuesta inflamatoria. Objetivo: evaluar los efectos de la suplementación de dos fórmulas enterales sobre los marcadores inflamatorios (PCR, IL-6 y el TNF-) en pacientes con cáncer sometidos a quimioterapia. Diseño y métodos: se hizo un ensayo clínico, aleatorizado, realizado en el Hospital Juárez de México en pacientes con cáncer sometidos a quimioterapia con IRN < 97,5 y EGS B o C. Los pacientes se dividieron en dos grupos: grupo I (imunomoduladora), grupo II (ácidos -3). La intervención se inició en el primer día de la quimioterapia hasta el décimo día posterior a esta. Se valoró el estado nutricional y se determinaron los marcadores inflamatorios en los días 0, +5 y +10 de QT. Se hizo análisis paramétrico. Se aplicó t de Student, X2 y análisis de varianza para mediciones repetidas. Se consideró p < 0.05 como estadísticamente significativo. Resultados: se estudiaron 43 pacientes, 27(62,8%) mujeres y 16 (37,2%) hombres. La media de edad fue de 43,91 + 11,3 años. La prevalencia de desnutrición moderada fue de 48,8% y severa de 51,2%. El grupo II presentó un incremento en los niveles de prealbúmina con respecto a la basal vs el grupo I (p < 0,05). En ambos grupos se observó el mantenimiento del peso corporal, el porcentaje de masa magra y de masa grasa. No se observó disminución de los niveles séricos de PCR, IL-6 y TNF(p = NS). Conclusiones: la administración de suplementos enterales durante la quimioterapia inhibe el deterioro nutricional y mantiene el peso y la masa magra. No se observó disminución de los marcadores inflamatorios.

Effectiveness of immunonutrition on inflammatory markers in patients with cancer; randomized clinical trial / Efectividad de la inmunonutrición sobre los marcadores inflamatorios en pacientes con cáncer; ensayo clínico aleatorizado

Background: malnutrition is a common complication in patients with cancer and is associated with immunosuppression and alterations with inflammatory response. Objective: the aim of our study was to evaluate the effect of enteral nutrition supplemented with two enteral formulas on inflammatory markers (CRP, IL-6 and FNTα) in cancer patients undergoing chemotherapy. Design and methods: randomized control trial, conducted at the Hospital Juarez of Mexico in patients with cancer undergoing chemotherapy with IRN < 97.5 and SGA B/C. Patients were randomly allocated to two groups: group I (immunomodulatory), group II (high ω3). The intervention began on the first day of chemotherapy until day 10 after. We evaluated nutritional status and an inflammatory marker on days 0, +5, +10 QT. Statistical analysis was performed with T Student, x2 and analysis of variance for repeated measurements. P < 0.05 was considered statistically significant. Results: a total of 29 patients were analyzed, 27 (62.8%) females and 16 (37.2%) males. Mean age 43.91 + 11.3 years old. Malnutrition prevalence was 48.8% moderate and 51.2% severe. Prealbumin levels significantly increase in group II vs group I (p<0.05). Both groups maintenance body weight, lean mass and fat mass. No decrease levels of CRP, IL-6 and FNTα. Conclusions: enteral supplementation during chemotherapy inhibits nutritional deterioration and maintenance body weight and lean mass. No decreased levels of inflammatory markers (AU)

Antecedentes: la desnutrición es una complicación frecuente en los pacientes oncológicos y se relaciona con inmunosupresión y alteraciones en la respuesta inflamatoria. Objetivo: evaluar los efectos de la suplementación de dos fórmulas enterales sobre los marcadores inflamatorios (PCR, IL-6 y el TNF-α) en pacientes con cáncer sometidos a quimioterapia. Diseño y métodos: se hizo un ensayo clínico, aleatorizado, realizado en el Hospital Juárez de México en pacientes con cáncer sometidos a quimioterapia con IRN < 97,5 y EGS B o C. Los pacientes se dividieron en dos grupos: grupo I (imunomoduladora), grupo II (ácidos ω-3). La intervención se inició en el primer día de la quimioterapia hasta el décimo día posterior a esta. Se valoró el estado nutricional y se determinaron los marcadores inflamatorios en los días 0, +5 y +10 de QT. Se hizo análisis paramétrico. Se aplicó t de Student, X2 y análisis de varianza para mediciones repetidas. Se consideró p < 0.05 como estadísticamente significativo. Resultados: se estudiaron 43 pacientes, 27(62,8%) mujeres y 16 (37,2%) hombres. La media de edad fue de 43,91 + 11,3 años. La prevalencia de desnutrición moderada fue de 48,8% y severa de 51,2%. El grupo II presentó un incremento en los niveles de prealbúmina con respecto a la basal vs el grupo I (p < 0,05). En ambos grupos se observó el mantenimiento del peso corporal, el porcentaje de masa magra y de masa grasa. No se observó disminución de los niveles séricos de PCR, IL-6 y TNFα (p = NS). Conclusiones: la administración de suplementos enterales durante la quimioterapia inhibe el deterioro nutricional y mantiene el peso y la masa magra. No se observó disminución de los marcadores inflamatorios (AU)

Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP study): a randomized, double-dummy, double-blind, placebo-controlled trial.

BACKGROUND: Perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression. METHODS/DESIGN: A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test). RESULTS: After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale. CONCLUSION: Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale. TRIAL REGISTRATION: ClinicalTrials.gov NCT01635218. PROTOCOL PUBLICATION: https://clinicaltrials.gov/ct2/show/NCT01635218 [corrected].

[Efficacy of topical ketorolac for improving visual function after photocoagulation in diabetic patients with focal macular edema]. / Eficacia del ketorolaco tópico para mejorar la función visual después de la fotocoagulación, en diabéticos con edema macular focal.

BACKGROUND: Photocoagulation reduces the incidence of visual loss in diabetic patients with focal macular edema, but it can induce it for Efficacy of topical ketorolac for improving visual function after photocoagulation in diabetic patients with focal macular edema 6 weeks after treatment and produces visual improvement in some cases. Topical ketorolac may reduce the inflammation caused by photocoagulation and improve visual outcome. PURPOSE: To determine the efficacy of topical ketorolac for improving visual function after photocoagulation in diabetic patients with focal macular edema. METHODS: An experimental, comparative, prospective, longitudinal study in diabetic patients with focal macular edema was conducted. Eyes were randomized into two groups of topical treatment for 3 weeks after photocoagulation (A: ketorolac, B: placebo). Best corrected visual acuity before and after treatment was compared in each group (paired t test), and the proportion of eyes with visual improvement was compared between groups (χ(2)). The evaluation was repeated after stratifying for initial visual acuity (≥ 0.5, < 0.5). RESULTS: There were 105 eyes included. In group A (n= 46) mean visual acuity changed from 0.50 to 0.58 (p= 0.003), and from 0.55 to 0.55 in group B (n= 59, p= 0.83); mean percent change was 22.3% in group A and 3.5% in group B (p= 0.03). Visual improvement was identified in 25 eyes from group A (54.3%) and 19 from group B (32.2%, p= 0.019, RR 1.65); the difference only persisted when initial visual acuity was ≥ 0.5 (10 [40%], group A, 5 [14.7%], group B, p= 0.02, RR 2.72). CONCLUSION: Topical ketorolac was more effective than placebo to improve best corrected visual acuity in diabetic patients with focal macular edema.

Antecedentes: la fotocoagulación reduce la incidencia de pérdida visual en diabéticos con edema macular focal, aunque puede inducirla durante 6 semanas; la mejoría visual después del tratamiento es excepcional. El ketorolaco tópico puede limitar la inflamación causada por la fotocoagulación, y mejorar el desenlace visual. Objetivo: determinar la eficacia del ketorolaco tópico en la mejoría de la función visual después de la fotocoagulación, en diabéticos con edema macular focal. Material y métodos: estudio experimental, comparativo, prospectivo, longitudinal efectuado en diabéticos con edema macular focal, asignados al azar a dos grupos de tratamiento tópico durante 3 semanas después de la fotocoagulación (A: ketorolaco, B: placebo). En cada grupo se comparó la agudeza visual antes y después del tratamiento (t pareada) y entre grupos la proporción de ojos con mejoría visual (χ2). La evaluación se repitió con estratificación por agudeza visual inicial (≥ 0.5, < 0.5). Resultados: se analizaron 105 ojos; en el grupo A (n= 46) el promedio de agudeza visual cambió de 0.50 a 0.58 (p= 0.003), en el B (n= 59) de 0.55 a 0.55 (p= 0.83); el promedio del cambio porcentual fue 22.3% en el grupo A y 3.5% en el B (p= 0.03). Hubo mejoría visual en 25 ojos del grupo A (54.3%) y 19 del B (32.2%, p= 0.019, RR 1.65); la diferencia persistió cuando la agudeza visual inicial era ≥ 0.5 (10 [40%], grupo A, 5 [14.7%], grupo B, p= 0.02, RR 2.72). Conclusiones: el ketorolaco fue más eficaz que el placebo para mejorar la agudeza visual en pacientes diabéticos con edema macular focal.

Effect of antiretroviral therapy on inflammatory markers of endothelial dysfunction in HIV treatment-naïve infected patients.

The aim of this study was to evaluate the effect of antiretroviral therapy on inflammatory markers of endothelial dysfunction in HIV treatment-naïve infected patients. This was a prospective cohort study in HIV treatment-naïve infected patients. The patients were assigned to a untreated group or a treatment group according to the therapeutic strategy received. Patients in the treatment group received efavirenz or lopinavir/ritonavir, each given with zidovudine and lamivudine. HIV RNA, CD4(+) cell count, and the levels of hsCRP, sCD40L, sICAM-1, sVCAM-1, and sE-selectin were measured before and 12 weeks after treatment. Fifty patients were enrolled: 13 in the untreated group and 37 in the treatment group; 48 (96%) completed the follow-up. The mean (± SD) age was 33 ± 9 years, and 38 (79%) were men. The median pretreatment CD4(+) cell counts were 263 cells/ml (IQR 118-341) in the treatment group and 658 cells/ml (IQR 475-887) in the untreated group. In the treatment group, the median serum sVCAM-1 and sICAM-1 levels decreased by a small but significant amount (1,400 and 228 ng/ml, respectively, P<0.05) from before to after the 12 weeks. These levels did not change in the untreated group. Antiretroviral therapy is associated with a decrease in sVCAM-1 and sICAM-1 levels after 12 weeks of treatment.

Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial.

BACKGROUND: The perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depressive symptoms. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression. In classical homeopathy, an individually selected homeopathic remedy is prescribed after a complete case history of the patient. The aim of this study is to assess the efficacy and safety of the homeopathic individualized treatment versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. METHODS/DESIGN: A randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a six-week follow-up study was designed. The study will be conducted in a public research hospital in Mexico City (Juárez de México Hospital) in the outpatient service of homeopathy. One hundred eighty nine peri- and postmenopausal women diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (moderate to severe intensity) will be included. The primary outcome is change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression after the fourth and sixth week of treatment. Secondary outcomes are: Beck Depression Inventory change in mean score, Greene's Scale change in mean score, response and remission rates and safety. Efficacy data will be analyzed in the intention-to-treat population. To determine differences in the primary and secondary outcomes among groups at baseline and weeks four and six, data will be analyzed by analysis of variance for independent measures with the Bonferroni post-hoc test. DISCUSSION: This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic individualized treatment using C-potencies versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. It is an attempt to deal with the obstacles of homeopathic research due to the need for individual prescriptions in one of the most common psychiatric diseases. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01635218.

[Pregnancy and breast cancer]. / Embarazo y cáncer de mama.

INTRODUCTION: association of breast cancer and pregnancy is not common. The objective of this investigation was to evaluate the pregnancy, young age, stage, treatment, prognosis and mortality of women with breast cancer during pregnancy. METHODS: retrospective analysis from March 1992 to February 2009, 16 patients were included with breast cancer and pregnancy. They were analized: histological characteristic of tumor, therapeutic response of the oncological treatment, evolution of the pregnancy. From of baby born: Apgar and weight. The woman's mortality with breast cancer during pregnancy was evaluated for age group and for interval of time between late pregnancy and diagnosis posterior of breast cancer and pregnancy. RESULTS: characteristic predominant clinicohistological: stage III (81.2%), T3-T4 (75%), N+ 93.7%, invasive ductal carcinoma (87.5%), histological grade 2-3 (93.7%), receptor estrogeno positive (43.7%); RPpositive (25%); HER-2/neu positive (31.2%). 27 chemotherapy cycles were applied with 5-fluorouracil, epirubicin and cyclophosphamide during the second or third trimester of the pregnancy, there were not severe adverse effects for the mothers and the baby born exposed to chemotherapy. The mean time to disease recurrence was 18.8 months (range, 6-62 months). The rate of mortality for specific age (< 35 years) was of 31.3% (p = 0.358). From the 16 patients, 7 have died and 9 were live without evidence of disease. CONCLUSIONS: the advanced stage and the number of affected axillary lymph node more than the age was predictors of worse pronostic influencing the relapse and mortality of the young patients with breast cancer and pregnancy.

Vigilancia del consumo de antimicrobianos en hospitales de México: situación actual y guía práctica para su implementación / Surveillance of antimicrobial drug use in Mexican hospitals: current situation and practical guidelines for its implementation

En México se han constatado un elevado consumo de antibióticos, su uso irracional en la atención primaria y altas tasas de resistencia en bacterias causantes de infecciones nosocomiales. Se hace necesario revisar la metodología recomendada para informar el consumo de antimicrobianos, de manera que la cuantificación se realice mediante estudios de utilización de medicamentos. Estos estudios, que permiten conocer los medicamentos utilizados en el hospital, requieren de una fuente de datos de consumo de antimicrobianos accesible y con el menor riesgo de sesgos, un sistema de identificación único para los fármacos y la adopción de unidades de medida extrapolables. Se propone usar la metodología elaborada por el Centro Colaborador de la Organización Mundial de la Salud para la Metodología Estadística de Medicamentos, basada en la clasificación anatómica, terapéutica y química (ATC) y la dosis diaria definida (DDD). A pesar de sus limitaciones, el empleo de esta metodología para el monitoreo local del consumo de antimicrobianos permite detectar diferencias en los patrones de uso respecto a otras instituciones y, sobre todo, las tendencias dentro de una misma institución. Esto ayudaría a alertar oportunamente sobre posibles problemas en la utilización de antimicrobianos y la necesidad de implementar intervenciones específicas.

Antibiotic use in Mexico is characterized by high levels of consumption, irrational use in primary care services, and high rates of bacterial resistance that cause hospital infections. Changes are needed in the recommended method for reporting antimicrobial drug use, so that quantification can be carried out through drug utilization studies. Such studies, which make it possible to know which drugs are used in hospitals, require an accessible source of data on antimicrobial drug use with the least risk of biases, a single drug identification system, and the adoption of units of measure that can be extrapolated. The methodology developed by the WHO Collaborating Centre for Drug Statistics Methodology, based on the anatomical, therapeutic, and chemical classification (ATC) system and the daily defined dosage (DDD), is proposed. Despite its limitations, employing this methodology to monitor local antimicrobial drug use will make it possible to detect differences in usage patterns among institutions, and, especially, trends within a given institution. This would facilitate timely alerts about potential problems related to the use of antimicrobial drugs and the need for specific interventions.

[Surveillance of antimicrobial drug use in Mexican hospitals: current situation and practical guidelines for its implementation]. / Vigilancia del consumo de antimicrobianos en hospitales de México: situación actual y guía práctica para su implementación.

Antibiotic use in Mexico is characterized by high levels of consumption, irrational use in primary care services, and high rates of bacterial resistance that cause hospital infections. Changes are needed in the recommended method for reporting antimicrobial drug use, so that quantification can be carried out through drug utilization studies. Such studies, which make it possible to know which drugs are used in hospitals, require an accessible source of data on antimicrobial drug use with the least risk of biases, a single drug identification system, and the adoption of units of measure that can be extrapolated. The methodology developed by the WHO Collaborating Centre for Drug Statistics Methodology, based on the anatomical, therapeutic, and chemical classification (ATC) system and the daily defined dosage (DDD), is proposed. Despite its limitations, employing this methodology to monitor local antimicrobial drug use will make it possible to detect differences in usage patterns among institutions, and, especially, trends within a given institution. This would facilitate timely alerts about potential problems related to the use of antimicrobial drugs and the need for specific interventions.

Prediction of remission of depression with clinical variables, neuropsychological performance, and serotonergic/dopaminergic gene polymorphisms.

OBJECTIVE: The aim of our work is to study the possible role of clinical variables, neuropsychological performance, and the 5HTTLPR, rs25531, and val108/58Met COMT polymorphisms on the prediction of depression remission after 12 weeks' treatment with fluoxetine. These variables have been studied as potential predictors of depression remission, but they present poor prognostic sensitivity and specificity by themselves. METHODS: Seventy-two depressed patients were genotyped according to the aforementioned polymorphisms and were clinically and neuropsychologically assessed before a 12-week fluxetine treatment. RESULTS: Only the La allele of rs25531 polymorphism and the GG and AA forms of the val 108/158 Met polymorphism predict major depressive disorder remission after 12 weeks' treatment with fluoxetine. None of the clinical and neuropsychological variables studied predicted remission. CONCLUSIONS: Our results suggest that clinical and neuropsychological variables can initially predict early response to fluoxetine and mask the predictive role of genetic variables; but in remission, where clinical and neuropsychological symptoms associated with depression tend to disappear thanks to the treatment administered, the polymorphisms studied are the only variables in our model capable of predicting remission. However, placebo effects that are difficult to control require cautious interpretation of the results.

Human ß-defensin-2 induction in nasal mucosa after administration of bacterial lysates.

BACKGROUND AND AIMS: The airway epithelium produces antimicrobial peptides (AMPs) that prevent colonization of host tissues by a wide range of pathogens. Human ß-defensin 2 (hBD-2) is one of the most well-documented AMPs in humans. Several bacterial products can induce production of this peptide. Bacterial immunostimulants containing bacterial lysates have long been used in the treatment of respiratory infections, but their effects on hBD-2 release have not been investigated. We undertook this study to induce production of hBD-2 after stimulation of the nasal mucosa with bacterial lysates. METHODS: A nasal lavage (NL) was performed in 12 healthy volunteers under basal conditions and after a nasal challenge with separate and subsequent stimuli with either bacterial lysates (20 million), cholecalciferol (400 IU), or sham-challenge with glycerol plus isotonic saline solution. Immunohistochemistry was performed in nasal biopsies 48 h after stimulation with bacterial lysates to identify the presence of hBD-2. RESULTS: Increased levels of hBD-2 (4668.99 ± 2829.33 pg/mL) were measured with ELISA in NL fluids following bacterial challenge. However, hBD-2 concentrations were below the limit of detection in NL fluids at baseline and after the administration of cholecalciferol or the sham-challenge. Through immunohistochemistry, hBD-2 was predominantly localized to the epithelium. CONCLUSIONS: hBD-2 can be induced in the nasal mucosa after administration of bacterial lysates. Stimulation of the innate immune system to produce hBD-2 could be used to prevent or even treat infections caused by respiratory pathogens.