Terapias alternativas no climatério / Alternative therapies in climacteric

O climatério representa um fenômeno de transição entre a fase reprodutiva e a não reprodutiva, caracterizando um estado fisiológico de hipoestrogenismo progressivo. Existe, atualmente, muito interesse e procura por terapias alternativas à terapia hormonal (TH), uma vez que alguns estudos sugerem que a TH pode aumentar o risco de desenvolvimento de doenças cardiovasculares e câncer de mama. Objetiva-se identificar na literatura evidências recentes acerca dos benefícios das terapias alternativas à TH na redução dos sintomas climatéricos. Dessa forma, foi realizada uma revisão na literatura por meio de consulta nas principais bases de dados e no site Up to date utilizando como estratégia de busca combinação entre as palavras climatério, atividade física, ioga, técnicas de relaxamento, acupuntura, fitoestrogênios, e antidepressivos priorizando artigos mais recentes e com maior nível de evidência. Os resultados demonstraram que, paulatinamente, a terapia não hormonal tem ganhado espaço no tratamento dos sintomas climatéricos, por diversas razões. Entretanto, são necessários mais estudos controlados/randomizados para mostrar eficácia das diversas modalidades de terapia alternativa e também para delinear o perfil das pacientes que teriam maior benefício com esse tipo de tratamento, pois existe um grupo de mulheres que ainda se beneficiam da TH devido a não adaptação às terapias alternativas.(AU)

The climacteric is a phase of transition between the reproductive and the non-reproductive stage, featuring a progressive physiological state of hypoestrogenism. There is a current and increasing demand for alternative therapies to hormone therapy (HT), since same studies suggest that HT may significantly increase the risk of developing cardiovascular disease and breast cancer. This study aims to identify recent evidence in the literature about the benefits of alternative therapies to HT in reducing climacteric symptoms. Thereby, we conducted a literature review in the main database and the website Up To Date, researching the combination between the words climacteric, physical activity, yoga, relaxation techniques, acupuncture, phytoestrogens and antidepressants. The most recent articles with highest level of evidence were prioritized. The results showed that, gradually, alternative therapies to hormones have gained reliability in the treatment of climacteric symptoms for several reasons. However, additional controlled studies / trials are needed to show efficacy of various forms of alternative therapy and also to outline the profile of patients who would most benefit from this type of treatment. Besides, there is a group of women who would still benefit from HT since they are maladapted to alternative therapies.(AU)

Evaluation of the measurement model and clinically important differences for menopause-specific quality of life associated with bazedoxifene/conjugated estrogens.

OBJECTIVE: This study aims to confirm the factor structure of the Menopause-Specific Quality of Life (MENQOL) questionnaire by using confirmatory factor analysis (CFA) and to determine whether improvements in menopause-specific health-related quality of life (HRQOL) observed with bazedoxifene (BZA)/conjugated estrogens (CE) relative to placebo are clinically meaningful. METHODS: Postmenopausal women with seven or more moderate to severe hot flushes per day (or ≥50 per wk) received BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo for 12 weeks. HRQOL and treatment satisfaction were evaluated using the MENQOL questionnaire and the Menopause Symptoms Treatment Satisfaction Questionnaire, respectively. The structure of the MENQOL questionnaire was evaluated using CFA. To estimate clinically important differences (CIDs) in HRQOL, we used a repeated-measures model to estimate changes in MENQOL domain and total scores using Menopause Symptoms Treatment Satisfaction Questionnaire items as anchors. RESULTS: The CFA model fits the MENQOL data (Bentler's comparative fit index >0.9). CID estimates ranged from 0.5 to 1.2 for the MENQOL domains and total score. Change from baseline in MENQOL vasomotor domain score for BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg compared with placebo was greater than the estimated CID, as were changes in MENQOL physical domain and total scores for BZA 20 mg/CE 0.625 mg compared with placebo. CONCLUSIONS: CFA confirms the factor structure of the MENQOL questionnaire. Treatment with BZA/CE provides clinically meaningful improvements in HRQOL in a population of postmenopausal women with bothersome vasomotor symptoms.

Changes in bone mineral density are correlated with bone markers and reductions in hot flush severity in postmenopausal women treated with bazedoxifene/conjugated estrogens.

OBJECTIVE: A post hoc exploratory analysis was conducted to examine correlations between changes in bone density, bone markers, and hot flushes after the treatment of postmenopausal women with bazedoxifene (BZA)/conjugated estrogens (CE). METHODS: In a 2-year phase 3 study, 3,397 postmenopausal women were randomized to BZA 10 mg/CE 0.45 mg, BZA 20 mg/CE 0.45 mg, BZA 40 mg/CE 0.45 mg, BZA 10 mg/CE 0.625 mg, BZA 20 mg/CE 0.625 mg, BZA 40 mg/CE 0.625 mg, raloxifene 60 mg, or placebo. In this analysis, bone density changes at 2 years were compared with baseline levels of the bone markers serum C-telopeptide and osteocalcin. Correlations between changes in bone density and changes in 12-week hot flush composite scores in symptomatic women were also analyzed. RESULTS: Treatment with BZA 20 mg/CE 0.45 mg or BZA 20 mg/CE 0.625 mg increased lumbar spine bone density more in women with higher bone resorption and formation, categorized by baseline levels of C-telopeptide and osteocalcin (P < 0.001, both BZA/CE doses). With placebo, larger decreases in lumbar spine bone density were seen in the highest tertile of serum C-telopeptide. There was no correlation between changes in total hip bone density and baseline bone markers. There were significant correlations between percent change in hot flush score at week 12 and percent changes in lumbar spine (r = -0.31, P = 0.006) and total hip (r = -0.23, P = 0.044) bone densities at month 24. CONCLUSIONS: With 2-year BZA/CE treatment, women with larger increases in lumbar spine and total hip densities also have higher baseline bone markers. Early reductions in hot flush score (12 wk) are predictive of long-term increases in bone density (24 mo).

Bupropion for control of hot flashes in breast cancer survivors: a prospective, double-blind, randomized, crossover, pilot phase II trial.

CONTEXT: Hot flashes (HFs) and sexual dysfunction often affect breast cancer (BC) survivors and compromise their quality of life. Bupropion is an antidepressive medication used for smoking cessation and also has been previously studied for the treatment of sexual dysfunction. OBJECTIVES: We aimed to evaluate bupropion's efficacy in controlling HFs in BC survivors. METHODS: This was a randomized, double-blind, crossover, placebo-controlled pilot study that enrolled 55 BC survivors who reported more than seven HFs per week. Subjects were randomized to receive either bupropion 150mg twice daily for four weeks followed by one week of washout and four more weeks of placebo twice daily or vice versa. The primary end point was average daily HF activity (number of HFs and a score combining number and severity) reported while on bupropion or on placebo. Secondary end points were sexual dysfunction, depression, and quality of life evaluated with the Arizona Sexual Experience Scale, Beck Depression Inventory, and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, respectively. RESULTS: Bupropion reduced HFs by 1.26 per day and the HF score by 6.31%, whereas placebo reduced HFs by 2.11 per day (P>0.05) and the HF score by 30.47% (P>0.05). There were no statistically significant differences between bupropion and placebo in the Arizona Sexual Experience Scale, Beck Depression Inventory, and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. At the end of the study, 47% of the patients preferred bupropion, whereas 53% preferred placebo. There were no statistically significant differences in side effects between the study groups. CONCLUSION: Compared with placebo, bupropion did not control HFs in this group of BC survivors.

Evaluation of the efficacy of flaxseed meal and flaxseed extract in reducing menopausal symptoms.

The objective of this study was to evaluate the efficacy of flaxseed meal and flaxseed extract in reducing climacteric symptoms of menopausal women. Ninety menopausal women were randomly distributed into three study groups: group I received 1 g per day of flaxseed extract containing at least 100 mg of secoisolariciresinol diglucoside (SDG), group II received 90 g per day of flaxseed meal containing at least 270 mg of SDG, and group III received 1 g per day of collagen (placebo group). Subjects were assessed for menopausal symptoms by the Kupperman index at the beginning and at the end of the 6 months of treatment. Subjects were also assessed for endometrial thickness and vaginal cytology. The Kupperman index values at the beginning and end of the treatments were analyzed using the paired t-test. Both the flaxseed extract (P=.007) and the flaxseed meal (P=.005) were effective in reducing the menopausal symptoms when compared with the placebo control (P=.082). Alternatively, the changes in Kupperman index were also computed and submitted to analysis of variance. In this case, no significant differences were found (P=.084) although the data indicate a decreasing tendency for the Kupperman index by both the flaxseed extract and the flaxseed meal groups. Neither the flaxseed extract nor the flaxseed meal exerted clinically important estrogenic effects on the vaginal epithelium or endometrium as revealed by the absence of changes in the blood levels of follicle stimulating hormone and estradiol, as well as in the endometrial thickness, and vaginal epithelial maturation value. No serious adverse events related to the treatments were reported. Although the results of the present study do not allow an unequivocal conclusion about the action of flaxseed on the menopausal symptoms, they suggest that it could be premature to conclude that no such action exists. Clearly the matter still deserves further experimental attention.

Síntomas vasomotores en la mujer climatérica / Vasomotor symptoms in climateric woman

Introducción: los síntomas más precoces y característicos del período climatérico son los síntomas vasomotores, los cuales se producen por la pérdida intermitente del control vasomotor por la falta de retroalimentación negativa del estradiol sobre el hipotálamo. Objetivo: aportar un conocimiento actualizado sobre la fisiopatología de la sintomatología vasomotora presentada en la mujer climatérica. Métodos: se realizó una revisión bibliográfica actualizada sobre la sintomatología vasomotora relacionada con el síndrome climatérico. Se revisaron textos, revistas y monografías. Resultados: se confeccionaron cuadros resúmenes y esquemas de la fisiopatología de los síntomas, así como una propuesta de algoritmo para el manejo de los síntomas vasomotores en la Atención Primaria de Salud. Conclusiones: las modificaciones perimenopáusicas suelen comenzar durante la quinta década de la vida. En este período, los síntomas más precoces son los sofocos y sudoraciones que afectan al 75 - 85 por ciento de las mujeres(AU)

Introduction: the more precocious and characteristic symptoms of climateric period are the vasomotor symptoms, which are produced due to the intermittent loss of vasomotor control by lack of a negative feedback of estradiol on the hypothalamus. Objective: to provide an updated knowledge on the physiopathologic features of vasomotor symptomatology in climateric woman. Methods: authors carried out an updated bibliographic review on above mentioned symptomatology related to climateric syndrome, as well as texts, journals and monographs. Results: summarized pictures and schemes of the physiopathologic features of symptoms, as well as a proposal of algorithm for management of vasomotor symptoms in the Health Primary Care. Conclusions: the perimenopause modifications may to begin during the fifth decade of life. In this period the earlier symptoms include: suffocations and sweatings involving the 75-85 percent of women(AU)

Síntomas vasomotores en la mujer climatérica / Vasomotor symptoms in climateric woman

Introducción: los síntomas más precoces y característicos del período climatérico son los síntomas vasomotores, los cuales se producen por la pérdida intermitente del control vasomotor por la falta de retroalimentación negativa del estradiol sobre el hipotálamo. Objetivo: aportar un conocimiento actualizado sobre la fisiopatología de la sintomatología vasomotora presentada en la mujer climatérica. Métodos: se realizó una revisión bibliográfica actualizada sobre la sintomatología vasomotora relacionada con el síndrome climatérico. Se revisaron textos, revistas y monografías. Resultados: se confeccionaron cuadros resúmenes y esquemas de la fisiopatología de los síntomas, así como una propuesta de algoritmo para el manejo de los síntomas vasomotores en la Atención Primaria de Salud. Conclusiones: las modificaciones perimenopáusicas suelen comenzar durante la quinta década de la vida. En este período, los síntomas más precoces son los sofocos y sudoraciones que afectan al 75 - 85 por ciento de las mujeres

Introduction: the more precocious and characteristic symptoms of climateric period are the vasomotor symptoms, which are produced due to the intermittent loss of vasomotor control by lack of a negative feedback of estradiol on the hypothalamus. Objective: to provide an updated knowledge on the physiopathologic features of vasomotor symptomatology in climateric woman. Methods: authors carried out an updated bibliographic review on above mentioned symptomatology related to climateric syndrome, as well as texts, journals and monographs. Results: summarized pictures and schemes of the physiopathologic features of symptoms, as well as a proposal of algorithm for management of vasomotor symptoms in the Health Primary Care. Conclusions: the perimenopause modifications may to begin during the fifth decade of life. In this period the earlier symptoms include: suffocations and sweatings involving the 75-85 percent of women

The effect of dietary soy supplementation compared to estrogen and placebo on menopausal symptoms: a randomized controlled trial.

OBJECTIVES: To compare the effects of daily ingestion of dietary soy supplementation, low-dose hormone therapy (HT) and placebo on psychological, somatic and urogenital symptoms in postmenopausal women. STUDY DESIGN: A double-blind, randomized, controlled trial. Sixty healthy, symptomatic, postmenopausal women of 40-60 years of age were allocated to use dietary soy supplementation (containing 90 mg of isoflavone) or HT (1mg estradiol and 0.5mg norethisterone acetate) or placebo. MAIN OUTCOME MEASURES: the Menopause Rating Scale (MRS) was used to assess menopausal symptoms at baseline and after 16 weeks of treatment. Intention-to-treat analyses were performed using the chi-square test, Fisher's exact test, the Kruskal-Wallis non-parametric test and analysis of variance (ANOVA). RESULTS: No statistically significant differences were found between the groups with respect to baseline clinical and sociodemographic characteristics. The psychological, somatic and urogenital symptoms analyzed in the MRS improved during treatment in all the groups, except for urogenital symptoms in the placebo group in which no significant changes were detected. Comparison between groups revealed a statistically significant improvement in somatic symptoms (hot flashes and muscle pain) in the users of HT (-45.6%) and dietary soy supplementation (-49.8%). Urogenital symptoms (vaginal dryness) improved significantly in HT users (-38.6%) and in users of the dietary soy supplementation (-31.2%). There was no statistically significant difference between the groups with respect to overall MRS score or to scores obtained in the psychological symptoms subscale. CONCLUSION: Dietary soy supplementation may constitute an effective alternative therapy for somatic and urogenital symptoms of the menopause.