AEEM-SEGO position statement on menopausal hormone therapy / Posicionamiento AEEM-SEGO sobre la terapia hormonal de la menopausia

According to the latest data from the medical literature, the Spanish Menopause Society (Asociación Española para el Estudio de la Menopausia [AEEM]) has brought together a group of experts to re-evaluate the use of menopausal hormone therapy so that women can make an informed, evidence-based decision to determine the most appropriate dose, formulation, route of administration, and duration of menopausal hormone therapy. There is some disagreement between scientific evidence on the efficacy and safety of menopausal hormone therapy and how this evidence is perceived by menopausal women and the clinicians who care for them, leading to an unnecessary loss of quality of life in those who reject it or in the unjustified fear of those who choose to use it. A critical review of the most recent available literature was conducted. The review mainly covered randomized clinical trials and epidemiological studies published since January 2015. This paper reviews clinical trials published since then, as well as new information on the potential risks and benefits of HT for the treatment of menopausal symptoms. Decisions about menopausal hormone therapy should be based on a woman’s specific health risks, age, and time since onset of the menopause, as well as on the goals of therapy. The Spanish Menopause Society (Asociación Española para el Estudio de la Menopausia) and the Spanish Society of Gynecology and Obstetrics (Sociedad Española de Ginecología y Obstetricia) updated their position statement on menopausal hormone therapy. This statement updates the clinical practice guidelines on the menopause

Conocidos los últimos datos de la literatura médica, la Asociación Española para el Estudio de la Menopausia ha reunido a un grupobde expertos para reevaluar el uso de la terapia hormonal de la menopausia con el fin de adoptar una decisión informada, basada en la evidencia que determina el tipo más apropiado de dosis, formulación, vía de administración y duración del uso de la terapia hormonal de la menopausia. Existe una discordancia entre las evidencias de carácter científico, sobre la eficacia y la seguridad de la terapia hormonal de la menopausia y la percepción que tienen de ello las mujeres que están en la menopausia y los médicos que las atienden, lo que redunda en una pérdida innecesaria de la calidad de vida en las que lo rechazan o en el temor injustificado de las que optan por su utilización. Se ha realizado una revisión crítica de la literatura disponible más reciente, fundamentalmente de ensayos clínicos aleatorizados y estudios epidemiológicos, publicados desde enero de 2015. El presente documento revisa los nuevos ensayos clínicos publicados desde entonces, así como nueva información sobre los posibles riesgos y beneficios de la terapia hormonal de la menopausia para el tratamiento de los síntomas de la menopausia. Las decisiones sobre la terapia hormonal de la menopausia deben basarse en los riesgos de salud específicos de cada mujer, la edad o el tiempo desde la menopausia y los objetivos de la terapia. La Asociación Española para el Estudio de la Menopausia y la Sociedad Española de Ginecología y Obstetricia actualizaron su posicionamiento con respecto a la terapia hormonal de la menopausia. Dicho posicionamiento de la Asociación Española para el Estudio de la Menopausia/Sociedad Española de Ginecología y Obstetricia actualiza las guías de práctica clínica de menopausia ya publicadas

Impétigo herpetiforme durante la gestación con empeoramiento posparto / Impetigo herpetiform during pregnancy with postpartum worsening

El impétigo herpetiforme es una rara enfermedad asociada al embarazo, ocurre habitualmente en el tercer trimestre, con una elevada morbimortalidad maternofetal cuando no se establece el tratamiento adecuado y un control obstétrico estricto. En la mayoría de los casos desaparece en el periodo posnatal y recurre en las siguientes gestaciones de manera más precoz y agresiva. Se presenta el caso de una gestante diagnosticada en la semana 28 de impétigo herpetiforme con evolución en brotes a pesar del tratamiento corticoideo y con empeoramiento del cuadro en el puerperio, precisando la administración de corticoides, ciclosporina y adalimumab (AU)

Impetigo herpetiformis is a rare disease associated with pregnancy, mainly during the third trimester. Without adequate treatment or close maternal-obstetric monitoring, thisdisease carries high mortality. In most cases, the disease resolves in the postnatal period but is associated with an earlier and more aggressive recurrence in subsequent pregnancies. We describe the case of a woman diagnosed with impetigo herpetiformis at week 28 week of pregnancy. Despite corticosteroid therapy, she continued to have recurrences, with worsening in the postpartum period, requiring treatment with corticosteroids, cyclosporine, and adalimumab (AU)

Soy isoflavones, diet and physical exercise modify serum cytokines in healthy obese postmenopausal women.

OBJECTIVES: Evaluate the effect of diet, physical exercise, and a daily oral intake of a soy isoflavones extract (Fisiogen(®)) contained 200 mg of Glycine max, which corresponded to 80 mg of isoflavone (60.8 mg of genistein, 16 mg of daidzein and 3.2 mg of glicitein) on leptin and other adipokines plasma levels in healthy obese postmenopausal women. METHODS: A multicentric randomized longitudinal prospective cohort study was conducted in a sample of 87 healthy obese postmenopausal women. Patients were randomly assigned to a 1200 kcal diet and exercise group (control group) or a group of 1200 kcal diet, exercise, and daily oral intake of daily oral intake of a soy isoflavones extract (Fisiogen(®)) contained 200 mg of Glycine max, which corresponded to 80 mg of isoflavone (60.8 mg of genistein, 16 mg of daidzein and 3.2 mg of glicitein) (soy isoflavones group) along 6 months. Main outcome measures were: anthropometric measures, body composition, leptin, adiponectin, TNF-alpha, homocysteine, C-reactive protein, glucose, insulin, lipid profile and oestradiol serum levels, Kupperman index and Cervantes Scale. RESULTS: Mean serum leptin and TNF-alpha levels declined after 6 months in both groups of the study, but only women in the soy isoflavones group showed a significant increase of mean serum levels of adiponectin. CONCLUSIONS: Diet, physical exercise and daily oral intake of a soy isoflavones extract (Fisiogen(®)) contained 200 mg of Glycine max, which corresponded to 80 mg of isoflavone (60.8 mg of genistein, 16 mg of daidzein and 3.2 mg of glicitein) have a beneficial effect on serum leptin, adiponectin and TNF-α in healthy obese postmenopausal women after 6 months of treatment.

Soy isoflavones, Mediterranean diet, and physical exercise in postmenopausal women with insulin resistance.

OBJECTIVE: The aim of this study was to evaluate whether a standard dose of 40 mg of soy isoflavones prescribed in routine clinical practice for treatment of menopausal symptoms has some influence on glucose homeostasis in postmenopausal women with insulin resistance (IR). METHODS: A total of 116 postmenopausal women with IR were randomly assigned to a group of Mediterranean diet and physical exercise (control group) or a group of Mediterranean diet, physical exercise, and daily oral ingestion of 40 mg of soy isoflavones (soy isoflavones group). Anthropometric measures, Kupperman Index values, Cervantes Scale score, and blood samples for glucose, insulin, lipid profile, creatinine, uric acid, homocysteine, folic acid, vitamin B12, selenium, and estradiol were determined at baseline and at intervals of 6, 12, 18, and 24 months. RESULTS: Mean homeostasis model assessment of IR (HOMA-IR) values remained unchanged from the baseline in the control group but steadily decreased in the soy isoflavones group at 6 months (P = 0.042). There were no statistically significant differences between both groups in mean HOMA-IR scores at baseline, but statistically significantly lower values were found in the soy isoflavones group at 6 months (P = 0.009), 12 months (P = 0.011), 18 months (P = 0.018), and 24 months (P = 0.012). Changes in HOMA-IR values were also clearly related to body mass index (P < 0.001), abdominal circumference (P < 0.001), and treatment (P = 0.044) when a linear regression analysis was carried out. CONCLUSIONS: Daily intake of 40 mg of soy isoflavones together with a Mediterranean diet and exercise reduced IR in postmenopausal women who had IR in the first place. It was significantly better than lifestyle changes alone. If corroborated, this may be a useful intervention for these women.

Do patients lie? An open interview vs. a blind questionnaire on sexuality.

INTRODUCTION: Postmenopausal women are often hesitant to discuss their sexual attitudes and experiences surrounding sexuality with her doctors. Sociocultural, ethnic, and medical background may affect the attitude towards menopause and the expectations regarding sexuality in these women. AIM: To describe communication about sex between patients and doctors and its relation to extrinsic limiting factors. METHODS: A total of 2,332 women between 45 and 64 years old were involved in this cross-sectional survey. The study used an ad hoc questionnaire covering the demographic and reproductive variables as well as the data related to sexual activity. The Cervantes questionnaire was administered to determine the impact of sexuality on health-related quality of life. MAIN OUTCOMES: Patients' responses to anonymous questionnaires or direct interviews. RESULTS: The percentage of women who recognized having occasional or unconventional partners was twofold higher in the anonymous questionnaire than in the clinical interview. In the medical interview only 15.2% of women recognized that sexuality was not very important compared with more than 40% in the anonymous questionnaire (P < 0.001). The highest concordance between the anonymous questionnaire and the clinical interview was in women who referred to not having any sexual relationship at all (88.07%) whereas in the other conditions concordance was significantly lower (P < 0.001). CONCLUSION: Self-reported data on sexuality diverge from those derived from a direct interview. The proportion of women with low interest in sexuality was higher in the blind questionnaires.

Selenium and health-related quality of life in menopausal women.

OBJECTIVES: The objective of this study was to evaluate whether there is a relation between serum selenium levels and health-related quality of life (HRQoL) in overweight and obese postmenopausal women. STUDY DESIGN: A cross-sectional study was carried out in 104 overweight and obese postmenopausal women attending a gynaecological clinic for their annual gynaecological examination. MAIN OUTCOME MEASURES: Age, anthropometric parameters, educational level, smoking habits, serum glucose, insulin, lipid profile, C-reactive protein, folic acid, vitamin B12, homocysteine and selenium levels were determined, and the Cervantes Scale was used to evaluate HRQoL. RESULTS: Serum selenium mean value levels were similar in the different groups of HRQoL and there were no differences in the four domains of the Cervantes Scale. When women were classified according to serum selenium tertiles, higher levels of serum cholesterol, low-density lipoprotein cholesterol (LDLc) and triglycerides were found in women in the lowest serum selenium tertile. CONCLUSIONS: In overweight and obese postmenopausal women, serum selenium level is not related to HRQoL but higher levels of cholesterol, LDLc and triglyceride values were detected in women in the lowest serum selenium tertile.

Optimización del manejo de la mujer osteoporótica en la consulta de ginecología / Optimal management of osteoporotic women in the gynecological consultation

La osteoporosis es un trastorno metabólico prevalente en la mujer menopáusica, que favorece la aparición de fracturas por impactos de baja energía. La densidad mineral ósea, los marcadores de remodelado óseo y los factores de riesgo para la osteoporosis permiten identificar a las pacientes que se pueden beneficiar del tratamiento. Entre las mujeres menopáusicas de menos de 65 años existe un número significativo de fracturas vertebrales. El tratamiento de la osteoporosis y la osteopenia asociada a una fractura previa se debe sustentar en fármacos potentes y de fácil adherencia, junto con el aporte de suplementos de vitamina D y calcio para evitar el hiperparatiroidismo asociado al déficit de vitamina D (AU)

Osteoporosis is a skeletal metabolic disorder characterized by compromised bone strength predisposing to an increased risk of low-impact fractures. This disorder is highly prevalent in postmenopausal women. Evaluation of bone mineral density, bone markers and osteoporosis risk factors allow to identify patients that may benefit from specific treatment to be identified. Vertebral fractures are common among postmenopausal women aged less than 65 years. The treatment of osteoporosis and osteopenia associated with a previous fracture should be based on adherence to potent drugs along with vitamin D and calcium supplements to prevent the hyperparathyroidism associated with low vitamin D levels (AU)

Factores reguladores del recambio óseo: estrógenos y vitamina D / Regulatory factors involved in bone turnover: estrogens and vitamin D

El tejido óseo es un efector de las hormonasgonadales esteroides y de la vitamina D. Elrecambio óseo es el proceso de renovación deltejido deteriorado y los estrógenos desempeñan unpapel significativo en el tejido, la regulación celulary a nivel molecular. A partir de la menopausiapredomina la resorción ósea y aumenta el riesgo deosteoporosis. El sistema endocrino de la vitamina Dregula el metabolismo celular óseo a través dereceptores específicos y por mecanismos nogenómicos. El déficit de vitamina D es un problemamuy extendido en la población general que guardarelación con la baja exposición solar y baja ingestade precursores de la vitamina. El suplemento devitamina D es una parte importante de las accionesterapéuticas de los tratamientos antirresortivos y paramantener la salud osteomuscular (AU)

Bone tissue responds to gonadal steroid hormones and vitamin D. Bone turnover is the process of replacing deteriorated tissue, and estrogens play a significant role at the tissular, cellular and molecular levels. After menopause, bone resorption predominates and increases the risk of osteoporosis. The vitamin D endocrine system also regulates bone metabolism through specific receptors and non-genomic mechanisms. Vitamin D deficiency is widespread among the general population and has been related to low sun exposure and low dietary intake. Vitamin D supplementation is an important antiresorptive measure and helps to maintain musculoskeletal health (AU)

Insulin resistence and health-related quality of life in postmenopausal women.

Health-related quality of life (HR-QOL) was similar between the menopausal women with and without Insulin Resistance (IR). However, when IR women with Metabolic Syndrome were considered, a higher level of problems on the HR-QOL global score was found and the difference was mainly due to Health and Sexuality domains.

Impact of anthropometric parameters on quality of life during menopause.

OBJECTIVE: To investigate whether body mass index (BMI), abdominal obesity, and fat distribution in postmenopausal women influence quality of life. DESIGN: Cross-sectional survey. SETTING: Outpatient clinics in the hospital setting and private practices. PATIENT(S): 274 postmenopausal Spanish women, distributed by body phenotype, fat distribution (android or gynoid), and BMI. INTERVENTION(S): The Cervantes scale, a specific health-related quality of life (HRQOL) questionnaire. MAIN OUTCOME MEASURE(S): The quality of life of the obese and overweight patients was compared by age, sex, education, marriage, and municipality with matched healthy normal-weight controls. RESULT(S): Women of the pyknoid phenotype have worse general HRQOL, menopausal symptoms, and psychological and sexuality scores than athletic or lean women. Android fat distribution is also related to low global Cervantes scale scores. All scores on the Cervantes scale worsened with increasing BMI (>or=25). CONCLUSION(S): Pyknoid phenotype, android fat distribution, and a higher BMI are related to poor HRQOL.

Understanding how personality factors may influence quality of life: development and validation of the Cervantes Personality Scale.

OBJECTIVE: To develop and validate a simple personality scale to be used as a complementary tool for menopause-specific quality-of-life instruments. DESIGN: A population-based random sample of 2,274 Spanish women stratified by age groups and education level was used in the validation phase. The initial 94-item questionnaire was reduced to 20 items by examining the frequency and variability with which women were responding to each of the items. The measurement properties were tested by conducting reliability (internal consistency and test-retest) and validation analyses (correlations, and factor analysis). RESULTS: The final 20-item scale consisted of three domains: introversion (seven items), emotional instability (seven items), and insincerity (control subscale, six items). Cronbach's alpha coefficients for the subscales of emotional instability, introversion, and insincerity were 0.7966, 0.7135, and 0.7042, respectively. The test-retest correlation was r = 0.763 for introversion, r = 0.720 for emotional instability, and r = 0.680 for insincerity (P < 0.001). The Cervantes Personality Scale is short and easy to administer. Scores range from 0 (the most extraverted personality) to 35 (the most introverted personality) for the introversion domain, from 0 (the most emotionally stable personality) to 35 (the most emotionally unstable personality) for the emotional instability domain, and from 0 (the most sincere response) to 30 (the most insincere response) for the insincerity domain. CONCLUSIONS: A novel self-report 20-item scale for assessing three stable personality traits (introversion, emotional instability, and insincerity) in peri- and postmenopausal women is presented. We provide preliminary evidence that the Cervantes Personality Scale is a useful psychometric tool for studying personality in women going through the menopausal transition.

Differences in health related quality of life in a sample of Spanish menopausal women with and without obesity.

OBJECTIVE: To investigate whether body mass index, abdominal obesity or fat distribution in postmenopausal women influence their quality of Life. METHODS: A cross-sectional study was carried out on 250 postmenopausal women (age: 50-64 years), with intact uterus and ovaries, sexually active, and non-hormone therapy users. Various anthropometric measurements were considered and a specific health-related quality of life (HR-QoL) instrument, the Cervantes scale, was performed. RESULTS: Thirty-three women were not included as they refused to participate in the study, had chronic disease such as hypertension, diabetes type 2, depression or did not answer all the scale items, so 217 patients were evaluated. According with BMI values, 34% of women were obese, 46.1% were in overweight, 19.8% were in normal weight and there were not underweight women. Any consistent relation was found between BMI and global values of HR-QoL, but obese women were diagnosed with "high level of problems" in the "psychical domain" and in the "sexuality domain". This difference in "sexuality domain" was also appreciated in women with abdominal obesity. Fat or lean mass was not correlated with HR-QoL. CONCLUSION: In our study, obesity did not affect the global HR-QoL in Spanish postmenopausal women, but could have an influence on the psychical and sexual domains. Others anthropometric measurements are not associated with changes in HR-QoL. Additional research with HR-QoL specific and validated instruments and with a longitudinal design seems necessary to confirm our results.

[Health-related quality of life in the Spanish women through and beyond menopause. Development and validation of the Cervantes Scale]. / Calidad de vida relacionada con la salud en la mujer española durante la perimenopausia y posmenopausia. Desarrollo y validación de la Escala Cervantes.

BACKGROUND AND OBJECTIVE: There are numerous health-related quality of life questionnaires but only a few are specific for the menopause. The objective of this study was to develop and validate a specific scale, the Cervantes Scale, for menopause in Spanish women. SUBJECTS AND METHOD: This cross-sectional study included a pilot phase, construction of the questionnaire, validation, and test-retest reliability. A population-based sample of 2,274 women ponderated by age groups and education levels was used in the validation phase. Internal consistency was assessed with the Cronbach's alpha analysis. RESULTS: The final questionnaire included 31 items ("menopause and health" with 15 items made up of vasomotor symptoms, health and aging, "sexuality" with 4 items, "couple relationship" with 3 items and "psychical domain" with 9 items). The Cronbach's (coefficient of the scale was 0.9092. The correlation coefficient of the test-retest was r=0.847 (p<.001). The Cervantes Scale is short, easy to administer (about 7 minutes), has a minimal score of 0 and a maximal score of 155 (from better to worse quality of life) and scores can be compared to reference values in younger women and women of the same age. CONCLUSIONS: The Cervantes Scale is included in the new generation of instruments of health-related quality of life specific for the menopause and is intended to be used in Spanish women aged between 45 and 64 years.

Calidad de vida relacionada con la salud en la mujer española durante la perimenopausia y posmenopausia. Desarrollo y validación de la Escala Cervantes / Health-related quality of life in the Spanish women through and beyond menopause. Development and validation of the Cervantes Scale

FUNDAMENTO Y OBJETIVO: Existen numerosos cuestionarios para medir la calidad de vida relacionada con la salud, pero muy pocos son específicos para la menopausia. El objetivo de este estudio fue diseñar y validar una escala específica para la menopausia en la mujer española, la Escala Cervantes, original en castellano y adaptada a nuestro medio. SUJETOS Y MÉTODO: El estudio transversal constaba de una fase piloto, construcción del cuestionario, validación y fiabilidad test-retest. Para la validación se utilizó una muestra de 2.274 mujeres de la población española ponderada por grupos de edad y nivel de estudios. La consistencia interna se valoró mediante el coeficiente de Cronbach. RESULTADOS: La escala definitiva constaba de 31 ítems (distribuidos en las dimensiones menopausia y salud, con 15 ítems que incluían sintomatología vasomotora, salud y envejecimiento; sexualidad, con 4 ítems; relación de pareja, con 3 ítems, y dominio psíquico, con 9 ítems). El coeficiente de Cronbach de la escala global fue de 0,9092 y el de las diferentes subescalas osciló entre 0,7989 y 0,8501. El coeficiente de correlación en la prueba test-retest fue de r = 0,847 (p < 0,001). La Escala Cervantes es corta, fácil de aplicar (unos 7 min), tiene una puntuación mínima de 0 y máxima de 155 (de mejor a peor calidad de vida) y dispone de baremos para comparar el resultado con mujeres más jóvenes o de la misma edad. CONCLUSIONES: La Escala Cervantes forma parte de una nueva generación de instrumentos de calidad de vida relacionada con la salud específicos para la menopausia. Su ámbito de aplicación es la población femenina española de entre 45 y 64 años de edad (AU)