Comparison of the effect of noninvasive radiofrequency with vaginal estrogen and vaginal moisturizer in the treatment of vulvovaginal atrophy in postmenopausal women: a randomized clinical trial.

OBJECTIVE: To compare the effect of noninvasive radiofrequency (RF) with vaginal estrogen (E), and vaginal moisturizer (M) on improving vulvovaginal atrophy (VVA) in women with genitourinary syndrome of menopause. METHODS: A total of 32 postmenopausal women who met the inclusion criteria were randomized into three intervention arms to receive one of the following treatments: three sessions of noninvasive RF therapy (RF arm); intravaginal estriol cream 1 mg applied daily for 2 weeks, followed by 1 mg applied two times weekly or 1 mg of estradiol vaginal fast-dissolving film applied daily for 2 weeks, followed by 1 mg applied two times weekly (E arm); and intravaginal moisturizer two times a week (M arm). Assessments at baseline and after 4 months were conducted using Vaginal Health Index score, Vaginal Maturation, visual analog scale for VVA symptoms (dyspareunia, dryness, and burning), and Menopause Rating Scale (MRS) for urogenital symptoms. Vaginal wall biopsies were administered to participants who consented, pretreatment and posttreatment (at baseline and after 4 months of follow-up). RESULTS: After 4 months, the Vaginal Health Index showed an increase of 6.6 points in mean total score in the RF arm, also in the E arm (+7.3 points), with no significant improvement in the M arm (+1.5 points) (interaction effect: RF, E ≠ M, P < 0.001). Regarding vaginal maturation, there was a significant increase in superficial cells in the E arm (+31.3), with no significant changes in the RF (+9.3) and M (-0.5) arms (interaction effect: E ≠ M, P < 0.001). Vaginal pH decreased significantly in the E arm (-1.25), with a similar response in the RF arm (-1.7), with no significant improvement in the M arm (-0.25) (interaction effect: RF, E ≠ M, P < 0.001).There was a significant improvement in the MRS score for VVA symptoms in the three intervention arms, with no predominance of any arm, whereas the improvement in the total MRS score for urogenital symptoms showed a predominance of the RF arm (ΔRF: -7.8; ΔE: -3.5; ΔM: -2.3; RF ≠ E, M). According to histopathologic analysis, there was no statistically significant increase in glycogenation ( P = 0.691) or epithelial cone height ( P = 0.935), despite an increase in the median delta (difference between pretreatment and posttreatment) in the three intervention arms (glycogenation: RF arm Δ = +118.4%; E arm Δ = +130.9%; M arm Δ = +24.9%; epithelial cone height: RF arm Δ = +33.5%; E arm Δ = +18.6%; M arm Δ = +22.3%). CONCLUSION: The effect of noninvasive RF on the treatment of vulvovaginal symptoms of genitourinary syndrome of menopause was similar to vaginal estrogen, except for hormonal cytology, and superior to vaginal moisturizer, with improvement in some histomorphometric parameters. These findings are promising, especially for the population that cannot or prefers not to use vaginal estrogen therapy.

Menopause and cognitive impairment: A narrative review of current knowledge.

A severe impairment of cognitive function characterizes dementia. Mild cognitive impairment represents a transition between normal cognition and dementia. The frequency of cognitive changes is higher in women than in men. Based on this fact, hormonal factors likely contribute to cognitive decline. In this sense, cognitive complaints are more common near menopause, a phase marked by a decrease in hormone levels, especially estrogen. Additionally, a tendency toward worsened cognitive performance has been reported in women during menopause. Vasomotor symptoms (hot flashes, sweating, and dizziness), vaginal dryness, irritability and forgetfulness are common and associated with a progressive decrease in ovarian function and a subsequent reduction in the serum estrogen concentration. Hormone therapy (HT), based on estrogen with or without progestogen, is the treatment of choice to relieve menopausal symptoms. The studies conducted to date have reported conflicting results regarding the effects of HT on cognition. This article reviews the main aspects of menopause and cognition, including the neuroprotective role of estrogen and the relationship between menopausal symptoms and cognitive function. We present and discuss the findings of the central observational and interventional studies on HT and cognition.

Medication Use and Sexual Function: A Population-Based Study in Middle Aged Women.

INTRODUCTION: Medications used to treat chronic diseases have contributed to increasing longevity and improving quality of life. These medications are considered an indispensable resource in the management of most treatable diseases. However, they can affect sexual function through their effects on the central or the peripheral nervous system or due to hormonal effects. AIM: To evaluate the association between the use of medication for chronic diseases and sexual dysfunction in Brazilian women 45-60 years of age. METHODS: A secondary analysis of household survey data from a previous cross-sectional, population-based study conducted with a sample of 749 women of a population of 257,434 female urban residents in the age bracket of interest. Sexual function was evaluated using the Short Personal Experiences Questionnaire (SPEQ). Associations between the use of medication and sexual function were evaluated, as were correlations with other variables. MAIN OUTCOME MEASURE: We found associations of the individual SPEQ domains with the use of some medications. RESULTS: Mean age of participants was 52.5 ± 4.4 years. Mean age at menopause was 46.5 ± 5.8 years. The overall prevalence of medication use was 68.8%, with the drugs predominantly consisting of those used for cardiovascular diseases. In the Poisson regression analysis, sexual dysfunction, as based on the overall SPEQ score, was associated with sexual inactivity (prevalence ratio [PR] = 4.05; 95% CI 3.16-5.20; P < .001), a sedentary lifestyle (PR = 1.49; 95% CI 1.06-2.09; P = .021), and untreated anxiety (PR = 1.44; 95% CI 1.08-1.92; P = .014). Analysis of the individual SPEQ domains revealed that women who scored low in the desire domain were more likely to use antihypertensive agents (P = .019), whereas a lower score for the arousal domain was associated with the use of antidepressants, with treatment for osteoarticular diseases and with polypharmacy (P = .003). Women with lower scores in the satisfaction domain were more likely to use antidepressants, drugs for osteoarticular diseases, diabetes medication, and polypharmacy (P = .019). A lower score in the orgasm domain was associated with the use of antidepressants, the treatment of osteoarticular diseases, and diabetes (P < .001). Hormone therapy proved protective against loss of libido (P = .036). CLINICAL IMPLICATIONS: Some medications can interfere with sexual function negatively and, clinicians have to be aware of it to choose the treatment with fewer collateral effects. STRENGTH & LIMITATIONS: The strength of our study is the large, population-based sample of middle-aged women evaluated for sexual dysfunction with the SPEQ. However, it was a self-reported cross sectional study. CONCLUSION: This study found no association between the use of medication for chronic diseases and the overall SPEQ score, whereas untreated anxiety was 1 of the main factors associated with female sexual dysfunction. On the other hand, medical treatments were found to contribute to lower scores in the different sexual function domains. Common drug culprits included antihypertensives, antidepressants, treatment for osteoarticular disease, diabetes medications, and polypharmacy. Hormone therapy protected against loss of libido. Gueldini de Moraes AV, Ribeiro Valadares AL, Lui Filho JF, et al. Medication Use and Sexual Function: A Population-Based Study in Middle Aged Women. J Sex Med 2019;16:1371-1380.

Opinions and main sources of information about menopause among middle-aged Brazilian women.

OBJECTIVES: The aim of this study was to evaluate women's opinions about menopause and the sources of information they use to deepen their understanding of the topic. METHODS: Population-based study with 749 Brazilian women aged 45 to 60 years. The answers to the question "What is menopause?" were typed and coded, and categories that emerged from the interviewees' own speech were created. The answers to the question: "Where or from whom did you get information about menopause?" were also analyzed. RESULTS: The mean age of women was 52.5 (± 4.4) years. Of them, 68% were postmenopausal. According to 67.5% of the interviewees, the concept of menopause encompassed changes in the menstrual cycle and hormones. For 48%, menopause meant physical changes such as "hot flushes and vaginal dryness." For 22.7%, menopause represented psychological changes. The concept of menopause was associated with some change in sexuality for 7.6% of the interviewees. Approximately 18% could not explain what menopause meant. Regarding the sources of information, 44.5% of the women attributed this knowledge to friends and relatives. Doctors or health services were mentioned by 44.3% of women. Television or radio was cited by 22.0%; magazines, newspapers, or books were cited by 14.0%; and the Internet was cited by 6.8% of women. Fifty-two women (6.9%) reported having no source of information about menopause. CONCLUSIONS: Most of the interviewees relate the term "menopause" to physiological events. There seems to be a suppressed demand for information on the various aspects of the menopausal transition among middle-aged Brazilian women.

Medication use and climacteric syndrome: a cross-sectional population-based study.

OBJECTIVE: The aim of this study was to evaluate medication use during the climacteric period and assess its association with sociodemographic factors, morbidities, and climacteric symptoms. METHODS: Secondary analysis of data from a previous exploratory cross-sectional population-based study, conducted with 749 women (45-60 y), with the help of home interviews. Associations between medication use and climacteric symptoms were analyzed, and their correlations with other variables were made. Univariate analysis was made using the χ test, followed by Bonferroni correction (multiple comparison method). Values were adjusted for age using the polytomic logistic multivariate regression analysis. Using Poisson regression analysis, simple and multiple, we identified the main factors for medication use, with forward stepwise variable selection criteria (95% CI). RESULTS: The mean age was 52.5 years and menopause occurred at 46.5 years (mean). The overall prevalence of medication use was 68.8%. The use of exclusive medications for relieving climacteric symptoms was associated with the absence of diseases (prevalence ratio [PR] = 8.2; 95% CI = 3.5-18.9; P<0.001) and menopause onset between 40 and 44 years (PR = 4.9; 95% CI = 2.0-11.9; P<0.001). Polypharmacy was associated with the highest number of diseases (PR = 10.6; 95% CI = 4.6-24.2; P<0.001) and somatic Menopause Rating Scale (MRS) score >3 (PR = 1.4; 95% CI = 1.01-1.96; P = 0.044). CONCLUSIONS: The prevalence of medication use among middle-aged women was high and was associated with the age of menopause onset, chronic diseases, and obesity/overweight status.

Can the use of probiotics in association with isoflavone improve the symptoms of genitourinary syndrome of menopause? Results from a randomized controlled trial.

OBJECTIVE: To evaluate the effect of isoflavone administration, either in conjunction with probiotic use or not, on the symptoms of genitourinary syndrome of menopause, and compare the effects with those of hormone therapy. METHODS: A randomized clinical trial was conducted on 60 postmenopausal women aged 40 to 60 years, randomly assigned to receive oral isoflavone (150 mg dry extract of glycine max) alone or isoflavone plus probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactococcus lactis, Bifidobacterium bifidum, and Bifidobacterium lactis) or hormone therapy (1 mg estradiol and 0.5 mg norethisterone acetate). The urogenital symptom subscale of the Menopause Rating Scale and International Consultation on Incontinence Questionnaire-Short Form were used to assess genitourinary symptoms. Vaginal maturation value, pH, vaginal health score, and vaginal flora were used to evaluate vaginal atrophy. Equol, equol intermediate, O-dimethylangolensin, and aglycones were measured using gas chromatography coupled to mass spectrometry. RESULTS: After 16 weeks of treatment, the urogenital symptoms, mainly vaginal dryness and sexual problem complaints, improved significantly in the hormone therapy group. There was a significant increase in the daidzein, glycitein, equol intermediate, and O-dimethylangolensin contents after 16 weeks in the isoflavone plus probiotic group. The maturation value, vaginal pH, and vaginal flora improved in the hormone therapy group. The vaginal health score increased in the isoflavone and hormone therapy groups. CONCLUSIONS: Probiotics improved the metabolism of isoflavones after 16 weeks of treatment. However, the increase in the contents of isoflavones and their metabolites failed to yield an estrogenic effect on the urogenital tract and relieve the vulvovaginal symptoms.

Efficacy of misoprostol before diagnostic hysteroscopy in postmenopausal women: a randomized clinical trial.

OBJECTIVE: To evaluate pain and determine the efficacy of misoprostol, compared with placebo, for postmenopausal women before diagnostic hysteroscopy. METHODS: This randomized, double-blind, placebo-controlled clinical trial included 158 postmenopausal women who received either 200 µg of misoprostol or placebo through the vaginal route before diagnostic hysteroscopy (79 women/group). The primary outcome was pain assessment (presence and intensity) during the four steps of hysteroscopy: cervical grasping with a Pozzi tenaculum forceps immediately before hysteroscopy, during hysteroscopy, during performance of the endometrial biopsy, and postprocedure. The secondary outcomes were duration of the procedure, need for additional cervical dilatation, complications, and adverse effects. RESULTS: Mean ages of the women were 62 ±â€Š8.2 years and 60 ±â€Š7.3 years in the misoprostol and placebo groups, respectively. Abnormal bleeding (misoprostol group, 45.6%; placebo, 43%) and endometrial thickening (54.4% in the misoprostol group and 57% in the placebo group) were the most common indications for the examination in both groups (P = 0.49). There was no significant difference between groups in the pain intensity of the four steps of the procedure. The duration of hysteroscopy was similar in both groups (misoprostol group, 2.5 ±â€Š2.7 minutes; placebo, 2.1 ±â€Š1.6 minutes; P = 0.43). Additional cervical dilatation was needed in 11 women in the misoprostol group versus 9 in the placebo group (P = 0.63). In both groups, there was no significant difference in terms of complications. Adverse effects were reported by 25.3% of women using misoprostol (vaginal bleeding, 11.3%; cramping, 12.6%; diarrhea, 2.5%; 1 woman reported both vaginal bleeding and cramping). In the placebo group, only 2.5% of women developed adverse effects (P < 0.0001). CONCLUSION: Misoprostol does not reduce pain intensity, the duration of the procedure, or need for additional cervical dilatation, and causes more adverse effects when used in postmenopausal women before diagnostic hysteroscopy.

Risk factors associated with intensity of climacteric symptoms in Brazilian middle-aged women: a population-based household survey.

OBJECTIVE: To determine the factors associated with the intensity of climacteric somatovegetative, psychological, and urogenital symptoms among middle-aged women in the Metropolitan Region of Campinas, Brazil. METHODS: A cross-sectional population-based household survey was conducted with 749 women aged 45 to 60 years. The dependent variable was the intensity of menopausal symptoms assessed using the Menopause Rating Scale. The independent variables were sociodemographic data, health-related habits and problems, self-perception of health, and gynecological background. RESULTS: The mean age of the women was 52.5 ±â€Š4.4 years, and the mean age at onset of menopause was 46.5 ±â€Š5.8 years. The intensity of menopausal symptoms was defined using the subscale scores of the median Menopause Rating Scale. Poisson multiple regression for somatovegetative, psychological, and urogenital symptoms showed several associated factors of each subscale, though some factors were common. Factors associated with moderate to severe climacteric symptoms in all the subscales of the Menopause Rating Scale were self-perception of health as "fair"/"poor"/"very poor" (P < 0.01), depression/anxiety (P < 0.01), and osteoarticular diseases (P < 0.01). CONCLUSIONS: The severity of climacteric symptoms in the different Menopause Rating Scale domains was related to a broad set of factors. Each Menopause Rating Scale subscale had its own set of factors, but some were common. Presence of chronic diseases, depression or anxiety, and worst self-perception of health were highlighted. A better understanding of these factors may help to not only reduce the effect of climacteric symptoms on the quality of life of middle-aged women, but also identify groups of women who need multidisciplinary health care.

Does obesity increase the risk of hot flashes among midlife women?: a population-based study.

OBJECTIVE: To evaluate the association between vasomotor symptoms and obesity in climacteric women. METHODS: We conducted a cross-sectional population-based study of 749 women aged 45 to 60 years. The dependent variable was intensity of menopausal symptoms evaluated by the menopause rating scale questionnaire. Independent variables were sociodemographic and clinical characteristics, and obesity evaluated by body mass index. RESULTS: There was no significant difference in the majority of clinical and sociodemographic characteristics between the body mass index groups. Obese women had less physical activity (P = 0.019) and a higher prevalence of hypertension (P < 0.001), diabetes (P = 0.002), urinary incontinence (P < 0.001), and urge incontinence (P = 0.0006). The total mean menopause rating scale score was 9.7. Scores for hot flashes increased progressively and were higher for participants with body mass index greater than 30 kg/m (P = 0.027). Joint and muscle pain scores also increased with increased body mass index (P < 0.001). Regarding urogenital symptoms, there was a significant difference in urinary problems only, which were more intense in obese women (body mass index >30 kg/m) (P < 0.0001). There was no significant difference in any psychological symptoms on the menopause rating scale. Factors associated with hot flash scores were higher body mass index, presence of urinary urgency, and vaginal dryness. CONCLUSIONS: We found that menopausal symptoms, including vasomotor, joint, and urinary symptoms, were related to obesity. Hot flashes were associated with higher body mass index, urinary urgency, and vaginal dryness. Understanding this relationship may contribute to the development of healthcare strategies aimed at minimizing the impact of obesity on several health issues of climacteric women.

Efficacy of vaginally applied estrogen, testosterone, or polyacrylic acid on vaginal atrophy: a randomized controlled trial.

OBJECTIVE: Vaginal atrophy is a common chronic condition among postmenopausal women that can affect their quality of life. Recent studies have evaluated new treatment alternatives for vaginal atrophy; however, few therapeutic options have been thoroughly evaluated. This study aimed to compare the effectiveness and adverse effects of estrogen, testosterone, polyacrylic acid, and placebo lubricant for the treatment of postmenopausal women with vaginal atrophy. METHODS: We conducted a randomized clinical trial with 80 postmenopausal women aged between 40 and 70 years who were being followed up at the Menopause Clinic of CAISM UNICAMP between November 2011 and January 2013. Women were randomly assigned to topical vaginal treatment with estrogen, testosterone, polyacrylic acid, and placebo lubricant, three times a week for 12 weeks. We used the vaginal maturation index, pH, vaginal health score, vaginal flora, laboratory tests, and ultrasound to evaluate changes of vaginal atrophy at baseline and after 6 and 12 weeks of treatment. RESULTS: After a 12-week treatment with topical estrogen and testosterone compared with the lubricant, an increased percentage of participants had vaginal pH less than 5, increased vaginal score, and an increase in the number of lactobacilli. Treatment with topical estrogen improved the vaginal maturation index and showed increased levels of estradiol in three women. No changes were observed in the endometrial evaluation of all treatment groups. CONCLUSIONS: After a 12-week treatment with testosterone and estrogen compared with placebo lubrication, there was a significant improvement in vaginal trophism in postmenopausal women with vaginal atrophy.

Subjective urinary urgency in middle age women: A population-based study.

AIMS: There are few population-based studies evaluating the epidemiology of overactive bladder syndrome (OAB) in women, especially in the climacteric stage where there is a decrease in estrogen production. This study aimed to assess the prevalence of OAB and associated factors in climacteric Brazilian women. METHODS: A descriptive, exploratory, cross-sectional study was conducted between September 2012 and June 2013 with 749 women (a population-based household survey). The dependent variable was OAB, defined as the presence of urinary urgency, with or without urinary incontinence, and when there was no concomitant stress urinary incontinence. The independent variables were sociodemographic data, health related habits and problems, self-perception of health, and gynecological background. Statistical analysis was carried out by Chi-square test and Poisson regression using the backward selection criteria. RESULTS: Mean age was 52.5 (± 4.4) years. With regard to menopausal status, 16% were premenopausal, 16% perimenopausal and 68% postmenopausal. The prevalence of OAB was 7.8%. The vast majority of women had only urinary urgency. Only two women who responded to the interview reported urge incontinence. In the final statistical model, vaginal dryness (PR 1.75; 95% CI 1.13-2.69; p=0.012) and bilateral oophorectomy (PR 2.21; 95% CI 1.11-4.40; p=0.025) were associated with a greater prevalence of OAB. CONCLUSIONS: Health professionals should adopt a proactive behavior in surgically menopausal women and those with a history of genital atrophy to identify and treat OAB, thus contributing to an improved quality of life and healthier aging.

Prevalence of urinary incontinence and its association with multimorbidity in women aged 50 years or older: A population-based study.

AIMS: To evaluate the prevalence and associated risk factors for urinary incontinence, as well as its association with multimorbidity among Brazilian women aged 50 or over. METHODS: This was a secondary analysis of a cross-sectional population-based study including 622 women 50 years or older, conducted in the city of Campinas-SP-Brazil. The dependent variable was Urinary Incontinence (UI), defined as any complaint of urine loss. The independent variables were sociodemographic data, health-related habits, self-perception of health and functional capacity evaluation. Statistical analysis was carried out using the Chi-square test and Poisson regression. RESULTS: The mean age of the women was 64. UI was prevalent in 52.3% of these women: Mixed UI (26.6%), Urge UI (13.2%) and Stress UI (12.4%). Factors associated with a higher prevalence of UI were hypertension (OR 1.21, CI 1:01-1:47, P = 0.004), osteoarthritis (OR 1.24, CI 1:03-1:50, P = 0.022), physical activity ≥3 days/week (OR 1.21, CI 1:01-1:44, P = 0.039), BMI ≥ 25 at the time of the interview (OR 1.25, CI 1:04-1:49, P = 0.018), negative self-perception of health (OR 1.23, CI 1:06-1:44 P = 0.007) and limitations in daily living activities (PR 1:56 CI 1:16-2:10, P = 0.004). CONCLUSIONS: The prevalence of UI was high. Mixed incontinence was the most frequent type of UI. Many associated factors can be prevented or improved. Thus, health policies targeted at these combined factors could reduce their prevalence rate and possibly decrease the prevalence of UI.

Effects of a soy-based dietary supplement compared with low-dose hormone therapy on the urogenital system: a randomized, double-blind, controlled clinical trial.

OBJECTIVE: This study aims to compare the effects of a soy-based dietary supplement, low-dose hormone therapy (HT), and placebo on the urogenital system in postmenopausal women. METHODS: In this double-blind, randomized, placebo-controlled trial, 60 healthy postmenopausal women aged 40 to 60 years (mean time since menopause, 4.1 y) were randomized into three groups: a soy dietary supplement group (90 mg of isoflavone), a low-dose HT group (1 mg of estradiol plus 0.5 mg of norethisterone), and a placebo group. Urinary, vaginal, and sexual complaints were evaluated using the urogenital subscale of the Menopause Rating Scale. Vaginal maturation value was calculated. Transvaginal sonography was performed to evaluate endometrial thickness. Genital bleeding pattern was assessed. Statistical analysis was performed using χ(2) test, Fisher's exact test, paired Student's t test, Kruskal-Wallis test, Kruskal-Wallis nonparametric test, and analysis of variance. For intergroup comparisons, Kruskal-Wallis nonparametric test (followed by Mann-Whitney U test) was used. RESULTS: Vaginal dryness improved significantly in the soy and HT groups (P = 0.04). Urinary and sexual symptoms did not change with treatment in the three groups. After 16 weeks of treatment, there was a significant increase in maturation value only in the HT group (P < 0.01). Vaginal pH decreased only in this group (P < 0.01). There were no statistically significant differences in endometrial thickness between the three groups, and the adverse effects evaluated were similar. CONCLUSIONS: This study shows that a soy-based dietary supplement used for 16 weeks fails to exert estrogenic action on the urogenital tract but improves vaginal dryness.

The effect of soy dietary supplement and low dose of hormone therapy on main cardiovascular health biomarkers: a randomized controlled trial.

PURPOSE: To assess the effects of a soy dietary supplement on the main biomarkers of cardiovascular health in postmenopausal women compared with the effects of low-dose hormone therapy (HT) and placebo. METHODS: Double-blind, randomized and controlled intention-to-treat trial. Sixty healthy postmenopausal women, aged 40-60 years, 4.1 years mean time since menopause were recruited and randomly assigned to 3 groups: a soy dietary supplement group (isoflavone 90mg), a low-dose HT group (estradiol 1 mg plus noretisterone 0.5 mg) and a placebo group. Lipid profile, glucose level, body mass index, blood pressure and abdominal/hip ratio were evaluated in all the participants at baseline and after 16 weeks. Statistical analyses were performed using the χ2 test, Fisher's exact test, Kruskal-Wallis non-parametric test, analysis of variance (ANOVA), paired Student's t-test and Wilcoxon test. RESULTS: After a 16-week intervention period, total cholesterol decreased 11.3% and LDL-cholesterol decreased 18.6% in the HT group, but both did not change in the soy dietary supplement and placebo groups. Values for triglycerides, HDL-cholesterol, glucose level, body mass index, blood pressure and abdominal/hip ratio did not change over time in any of the three groups. CONCLUSION: The use of dietary soy supplement did not show any significant favorable effect on cardiovascular health biomarkers compared with HT. CLINICAL TRIAL REGISTRY: The trial is registered at the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), number RBR-76mm75.

The effect of soy dietary supplement and low dose of hormone therapy on main cardiovascular health biomarkers: a randomized controlled trial / O efeito de um suplemento alimentar à base de soja e terapia hormonal em baixa dose sobre os principais marcadores de risco cardiovascular: ensaio clínico randomizado controlado

PURPOSE: To assess the effects of a soy dietary supplement on the main biomarkers of cardiovascular health in postmenopausal women compared with the effects of low-dose hormone therapy (HT) and placebo. METHODS: Double-blind, randomized and controlled intention-to-treat trial. Sixty healthy postmenopausal women, aged 40-60 years, 4.1 years mean time since menopause were recruited and randomly assigned to 3 groups: a soy dietary supplement group (isoflavone 90mg), a low-dose HT group (estradiol 1 mg plus noretisterone 0.5 mg) and a placebo group. Lipid profile, glucose level, body mass index, blood pressure and abdominal/hip ratio were evaluated in all the participants at baseline and after 16 weeks. Statistical analyses were performed using the χ2 test, Fisher's exact test, Kruskal-Wallis non-parametric test, analysis of variance (ANOVA), paired Student's t-test and Wilcoxon test. RESULTS: After a 16-week intervention period, total cholesterol decreased 11.3% and LDL-cholesterol decreased 18.6% in the HT group, but both did not change in the soy dietary supplement and placebo groups. Values for triglycerides, HDL-cholesterol, glucose level, body mass index, blood pressure and abdominal/hip ratio did not change over time in any of the three groups. CONCLUSION: The use of dietary soy supplement did not show any significant favorable effect on cardiovascular health biomarkers compared with HT. Clinical Trial Registry: The trial is registered at the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), number RBR-76mm75. .

OBJETIVO: Avaliar os efeitos do uso de um suplemento alimentar à base de soja sobre os principais marcadores de risco cardiovascular e compará-los com o uso da terapia hormonal (TH) de baixa dose e grupo placebo em mulheres na pós-menopausa. MÉTODOS: Foram selecionadas 60 participantes do ambulatório de menopausa com idade entre 40 e 60 anos, com idade média de 4,1 anos na menopausa para participar de um ensaio clínico randomizado, duplo-cego e controlado com duração de 16 semanas. As pacientes foram randomizadas em 3 grupos: um grupo que recebeu suplemento dietético à base de soja (isoflavona 90 mg), um grupo que recebeu TH em baixa dose (estradiol 1 mg e noretisterona 0,5 mg) e um grupo placebo. Os seguintes parâmetros foram avaliados no início e ao término das 16 semanas de intervenção: perfil lipídico, glicemia de jejum, índice de massa corpórea, pressão sanguínea arterial e circunferência abdominal. A análise estatística foi realizada usando-se o teste do χ2, teste exato de Fisher, teste não paramétrico de Kruskal-Wallis, análise de variância (ANOVA), teste t de Student pareado e teste de Wilcoxon. RESULTADOS: Ao final do período de intervenção de 16 semanas, houve uma diminuição do colesterol total em 11,3% e do LDL-colesterol em 18,6% no grupo da TH, porém ambos não tiveram mudanças tanto no grupo do suplemento alimentar à base de soja quanto no grupo placebo. Os valores de triglicérides, HDL-colesterol, glicemia de jejum, índice de massa corpórea, pressão sanguínea arterial e circunferência abdominal não mudaram ao longo da intervenção em nenhum dos grupos estudados. CONCLUSÃO: Do ponto de vista cardiovascular, o suplemento alimentar à base de soja não mostrou efeito ...

Knowledge about osteoporosis in postmenopausal women undergoing antiresorptive treatment.

UNLABELLED: A good understanding and knowledge of osteoporosis is a prerequisite for the success of preventive measures as well as treatment adherence. OBJECTIVE: To assess knowledge about osteoporosis in postmenopausal women with osteoporosis or osteopenia undergoing antiresorptive treatment. SUBJECTS AND METHODS: A cross-sectional study was based on a sample of 232 postmenopausal women with osteopenia or osteoporosis diagnosed by bone density studies and seen at the Menopause Outpatient Clinic at Caism/Unicamp. Women's knowledge of osteoporosis was assessed by means of the OPQ (Osteoporosis questionnaire), a 20-item questionnaire about osteoporosis in areas of general information, risk factors, consequences and treatment. RESULTS: The average age of the women was 61.6 years (±8.2 years) and the average time since menopause was 16.8 years. The average knowledge score obtained by the OPQ was 3.78. The average score for correct answers was 9.8 points, while the average score for incorrect answers was 6 points and 'don't know' answers was 4.1 points. Bivariate analysis showed the variables most closely associated with greater knowledge: education (p<0.01), reading (p<0.02), socioeconomic status (p<0.03), means of acquiring osteoporosis medication (p<0.02), and absence of comorbidities (p<0.04). On multiple regression analysis, the factors which remained associated with better knowledge were higher education, higher socioeconomic status scores and absence of comorbidities. CONCLUSION: Knowledge of osteoporosis in postmenopausal women diagnosed with the disease was limited. Level of education was a strong predictor of knowledge.

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.

Atividade física e qualidade de vida em mulheres com 60 anos ou mais: fatores associados / Physical activity and quality of life in women aged 60 or older: associated factors

OBJETIVO: avaliar o nível de atividade física, a qualidade de vida e os fatores associados em mulheres com 60 anos ou mais. MÉTODOS: estudo de corte transversal que incluiu 271 mulheres frequentadoras de um centro de lazer e de mulheres atendidas no Ambulatório de Menopausa em Campinas (SP). As mulheres foram convidadas a participar da pesquisa, que foi realizada com o uso de entrevistas. Os instrumentos utilizados foram o International Physical Activity Questionnaire (IPAQ), versão 8, modificado para a população idosa para avaliar o nível de atividade física, e o Questionário de Qualidade de Vida da Organização Mundial da Saúde, específico para este grupo (WHOQOL-OLD), para avaliar o escore de qualidade de vida. Os resultados do IPAQ foram avaliados por meio de tercis, e a associação entre resultados do WHOQOL-OLD e IPAQ e características das mulheres pelos testes t de Student/Mann-Whitney e de análises múltiplas. RESULTADOS: a média etária das mulheres foi de 67,4±5,3 anos. Destas, 33 por cento foram classificadas como pouco ativas. A análise de cada domínio da atividade física mostrou que 60,8 por cento do tempo foi gasto em atividade sentada (1.701,6±986,1 minutos/semana). Ser frequentadora de um centro de lazer, ter maior idade, sem companheiro, maior escolaridade e boa autopercepção do estado de saúde, sem antecedentes de doenças e maior renda foram características que se associaram significativamente à prática de exercícios físicos de intensidade moderada/vigorosa. A análise múltipla evidenciou que frequentar um centro de lazer em Campinas (SP) e ter 70 anos ou mais aumentaram a chance de praticar exercícios físicos de intensidade moderada ou vigorosa, respectivamente, em 11,4 vezes e 2,8 vezes. O escore médio de qualidade de vida foi de 66,9±11,7. O maior valor foi observado no domínio referente às habilidades sensoriais (72,0±18,8), e o menor no que se refere à autonomia (60,3±16,2). A regressão linear mostrou que a boa autopercepção da saúde aumentou o escore de qualidade de vida em 7,3 pontos; o uso de maior número de medicamentos diminuiu em 4,4 pontos; e a prática de exercícios físicos moderados ou vigorosos aumentou em 4,8 pontos o referido escore. CONCLUSÕES: as mulheres despendem muito tempo na posição sentada. Evidenciou-se a importância da prática de exercícios físicos de intensidade moderada/vigorosa contribuindo para a obtenção de uma boa qualidade de vida.

PURPOSE: to evaluate the level of physical activity, quality of life and associated factors in women aged 60 or older. METHODS: a cross-sectional study was conducted on 271 women who go to a Leisure Center and women attended at a menopause ambulatory in Campinas (SP). The women were invited to take part in the research, carried out through interviews. The instruments used were the version 8 of the International Physical Activity Questionnaire (IPAQ) modified for the elderly population in order to evaluate their physical activity, and the World Health Organization Questionnaire of Quality of Life specific for this group (WHOQOL-OLD) to evaluate their quality of life. IPAQ results were assessed using tertiles. The association between the WHOQOL-OLD and the IPAQ results and subject characteristics was assessed by the Student's t test, Mann-Whitney test and multiple analyses. RESULTS: the average age of women was 67.4±5.3 years. Among these women, 33 percent were classified as being less active. Analysis of each physical activity domain showed that 60.8 percent of the time was spent in sitting activities (1,701.6±986.1 minutes/week). Multiple analyses indicated that attending a leisure center in Campinas (SP) and being 70 years old or older increased the chances of engaging in moderate-intensity or vigorous-intensity physical activity by 11.4 and 2.8 times, respectively. The average quality of life score was 66.9±11.7. The highest value was observed in the domain related to sensory abilities (72.0±18.8) and the lowest value was related to autonomy (60.3±16.2). Linear regression showed that a good self-perception of health increased the quality of life score by 7.3 points, the use of a bigger amount of medication decreased it by 4.4 points and the performance of moderate or vigorous physical exercise increased the score by 4.8 points. CONCLUSION: women spend prolonged periods of time in sitting activities. The importance of engaging in moderate/vigorous-intensity physical activity is evident for obtaining a good quality of life.

[Physical activity and quality of life in women aged 60 or older: associated factors]. / Atividade física e qualidade de vida em mulheres com 60 anos ou mais: fatores associados.

PURPOSE: to evaluate the level of physical activity, quality of life and associated factors in women aged 60 or older. METHODS: a cross-sectional study was conducted on 271 women who go to a Leisure Center and women attended at a menopause ambulatory in Campinas (SP). The women were invited to take part in the research, carried out through interviews. The instruments used were the version 8 of the International Physical Activity Questionnaire (IPAQ) modified for the elderly population in order to evaluate their physical activity, and the World Health Organization Questionnaire of Quality of Life specific for this group (WHOQOL-OLD) to evaluate their quality of life. IPAQ results were assessed using tertiles. The association between the WHOQOL-OLD and the IPAQ results and subject characteristics was assessed by the Student's t test, Mann-Whitney test and multiple analyses. RESULTS: the average age of women was 67.4 ± 5.3 years. Among these women, 33% were classified as being less active. Analysis of each physical activity domain showed that 60.8% of the time was spent in sitting activities (1,701.6 ± 986.1 minutes/week). Multiple analyses indicated that attending a leisure center in Campinas (SP) and being 70 years old or older increased the chances of engaging in moderate-intensity or vigorous-intensity physical activity by 11.4 and 2.8 times, respectively. The average quality of life score was 66.9 ± 11.7. The highest value was observed in the domain related to sensory abilities (72.0 ± 18.8) and the lowest value was related to autonomy (60.3 ± 16.2). Linear regression showed that a good self-perception of health increased the quality of life score by 7.3 points, the use of a bigger amount of medication decreased it by 4.4 points and the performance of moderate or vigorous physical exercise increased the score by 4.8 points. CONCLUSION: women spend prolonged periods of time in sitting activities. The importance of engaging in moderate/vigorous-intensity physical activity is evident for obtaining a good quality of life.

Quality of life in women with postmenopausal osteoporosis: correlation between QUALEFFO 41 and SF-36.

OBJECTIVE: To evaluate quality of life (QoL) in women with postmenopausal osteoporosis, correlating the QUALEFFO 41 with the short-form health survey 36 (SF-36) and evaluated some factors that can influenced the QoL of women with osteoporosis. METHODS: A cross-sectional study was conducted in 220 postmenopausal women (ages ranging from 55 to 80 years). Of the total number, 110 women had osteoporosis and 110 women did not have osteoporosis and these women were age-matched (+/-3 years). Two questionnaires were administered to all subjects for evaluation of QoL: the quality of life questionnaire of the European foundation for Osteoporosis 41 (QUALEFFO 41) and the short-form health survey 36 (SF-36). For data analysis, a significance level of 5% was set (p<0.05). RESULTS: Clinical characteristics between the groups were similar, with statistically significant differences only in body mass index (BMI), race, school education, age at menopause and use of hormone therapy (HT) (p<0.001). Women with osteoporosis had a worse QoL both in the QUALEFFO 41 and in the SF-36, in all domains studied. Data was adjusted for BMI, race, school education and use of HT (p<0.001). There was a significant correlation between all domains in the QUALEFFO 41 questionnaire and their corresponding domains in the SF-36 (p<0.001). The only factors related to worse QoL were BMI>25 and sedentary lifestyle. In contrast, paid work was associated with a better QoL (CI=95%). CONCLUSION: Women with osteoporosis had an impaired QoL, especially relating to the physical, psychological and social aspects. The factors associated with QoL were obesity, sedentary lifestyle and paid work.