Isolated vitamin D supplementation improves the adipokine profile of postmenopausal women: a randomized clinical trial.

OBJECTIVE: The aim of the study is to evaluate the effect of vitamin D supplementation alone on the adipokine profile of postmenopausal women. METHODS: In this randomized clinical trial, 160 women were randomized to 2 groups: oral supplementation with 1,000 IU cholecalciferol/d (vitamin D, n = 80) or placebo (PL, n = 80). Women with amenorrhea 12 months or more and aged 50 to 65 years were included. Women with established cardiovascular disease, insulin-dependent diabetes, renal failure, liver diseases, and previous use of menopausal hormone therapy and vitamin D were excluded. The intervention lasted 9 months and serum adiponectin, resistin, and adipsin levels were determined at the start and end of treatment. Intention to treat was adopted as the statistical method using a repeated measures design, followed by Wald's multiple comparison test adjusted for group × time interaction. RESULTS: After 9 months, 25-hydroxyvitamin D concentrations increased from 15.0 ± 7.5 to 27.5 ± 10.4 ng/mL (+45.4%) in the vitamin D group and decreased from 16.9 ± 6. to 13.8 ± 6.0 ng/mL (-18.5%) in the PL group ( P < 0.001). In the vitamin D group, there was an increase in adiponectin (+18.6%) and a decrease in resistin (-32.4%, P < 0.05). At the end point, a difference was observed between the PL and vitamin D groups in mean adiponectin and resistin levels (11.5 ± 5.5 vs 18.5 ± 21.8 ng/mL, P = 0.047, and 16.5 ± 3.5 vs 11.7 ± 3.3 ng/mL, P = 0.027, respectively). There were no significant intervention effects on serum adipsin levels. CONCLUSIONS: Daily supplementation with 1,000 IU of vitamin D alone was associated with an increase in adiponectin and a decrease in resistin, suggesting a beneficial effect on the adipokine profile of postmenopausal women with vitamin D deficiency.

Association Between Metabolic Syndrome and Immunohistochemical Profile at Breast Cancer Diagnosis in Postmenopausal Women.

BACKGROUND: The aim of this study was to evaluate the association between metabolic syndrome (MetS) and the immunohistochemical profile of breast cancer (BC) in postmenopausal women. METHODS: This cross-sectional cohort study included 189 women, aged 45 to 75years and amenorrhea >12 months, with newly diagnosed BC and no previous cancer treatment. Clinical, anthropometric and biochemical data were collected, as well as data on BC hormone status (estrogen receptor, ER; progesterone receptor, PR; human epidermal growth factor receptor-2, HER-2), and epithelial proliferative activity (Ki-67). Tumors were divided into 5 subtypes:luminal A, luminal B HER-2 negative, luminal B HER-2 positive, non-luminal HER-2, and triple negative. Women with three or more of the following criteria were diagnosed with MetS: waist circumference ≥88cm; triglycerides ≥150mg/dL; HDL-cholesterol <50mg/dL; blood pressure ≥130/85mmHg; glucose ≥100mg/dL. RESULTS: Sixty-three (33.3%) of the 189 patients had MetS at the time of diagnosis. Women with MetS had a higher frequency of tumors ≤ 2cm than women without MetS (49.2% vs. 31.8%) (P = .038). There were no differences in histological grade, staging, or axillary lymph node metastasis (P > .05). The proportion of PR-positive (P = .006), HER-2-negative (P = .034), and luminal B HER-2-negative (P = .038) tumors was higher among patients with MetS compared to women without MetS (79.4% vs. 61.8%, 89.9% vs. 78.6% and 44.5% vs. 27.8%, respectively). Multivariate analysis adjusted for age, time since menopause and BMI showed a higher risk for luminal B HER-2-negative tumors among women with MetS (OR 2.00, 95% CI 1.03-3.89), obese patients (OR 2.03, 95% CI 1.06-3.90), and women with abdominal obesity (OR 1.96, 95% CI 1.01-4.03). CONCLUSION: In postmenopausal women with newly diagnosed BC, the presence of MetS was associated with smaller tumor size, PR-positive and HER-2-negative status, and the luminal B tumor subtype.

The impact of letrozole administration on oocyte morphology in breast cancer patients undergoing fertility preservation.

ABSTRACT: Patients submitted to oncological fertility preservation with letrozole and gonadotropins seem to present a higher rate of immature oocytes and lower fertilization rates in comparison to infertile patients submitted to IVF cycles with gonadotropins. The aim of this study was to evaluate the influence of letrozole on oocyte morphology in patients with breast cancer submitted to fertility preservation. METHODS: Retrospective analysis performed at a public tertiary hospital in São Paulo, Brazil. The oocytes were retrieved from patients with breast cancer undergoing fertility preservation (n=69), and from infertile women undergoing in vitro fertilization (n=92). We evaluated 750 oocytes obtained from breast cancer patients submitted to ovarian stimulation with letrozole and gonadotropins, and 699 oocytes from patients without breast cancer submitted to ovarian stimulation for in vitro fertilization with gonadotropins only due to male factor infertility. The mature oocytes retrieved were analyzed for the presence of refractile bodies, ooplasm color and regularity, central granulation degree, cortical granules, zona pellucida staining and regularity, perivitelline space, presence of vacuoles or abnormal smooth-surfaced endoplasmic reticle and oocyte retraction. RESULTS: There was a higher incidence of alterations in oocyte morphology in the letrozole group when compared to the control group: increased perivitelline space (p=0.007), irregular zona pellucida (p<0.001), refractile bodies (p<0.001), dark ooplasm (p<0.001), granular ooplasm (p<0.001), irregular ooplasm (p<0.001) and dense central granulation (p<0.001). CONCLUSION: Letrozole is a risk factor for worse oocyte morphology. However, the clinical impact of ovarian stimulation protocol with combined use of gonadotropins and letrozole for fertility preservation remains unclear in this setting. These data underline the importance of establishing the predictive potential of morphological dimorphisms of human oocytes in IVF outcomes.

High risk for cardiovascular disease in postmenopausal breast cancer survivors.

OBJECTIVE: Breast cancer patients have a higher mortality risk of cardiovascular disease (CVD) than women from the general population. CVD risk may increase significantly in postmenopausal women with early-stage breast cancer. The aim of this study was to evaluate risk factors for CVD in postmenopausal breast cancer survivors. METHODS: In this cross-sectional study, 96 postmenopausal breast cancer survivors were compared with 192 postmenopausal women. The main group included women with amenorrhea >12 months, aged ≥45 years, with breast cancer, and without established CVD. The control group fulfilled the same criteria, but did not have breast cancer. Groups were matched by age, time since menopause, and body mass index, in a ratio of 1 case to 2 controls (1:2). Women with three or more of the following criteria were diagnosed with metabolic syndrome: waist circumference >88 cm; triglycerides ≥150 mg/dL; high-density lipoprotein cholesterol <50 mg/dL; blood pressure ≥130/85 mm Hg; and glucose ≥100 mg/dL. Immunoassays were used (enzyme-linked immunosorbent assay test) for measurement of plasma heat shock proteins (HSP) 60 and 70 concentrations. Atherosclerotic disease was determined by intima-media thickness (>1 mm) of the carotid arteries and/or the presence of atheromatous plaque assessed by carotid artery ultrasound (scanner duplex). RESULTS: Breast cancer patients had higher HSP60 levels and lower HSP70 levels than controls (P < 0.05). Analysis showed that the odds of developing metabolic syndrome (odds ratio [OR] = 4.21, 95% CI, 2.28-7.76), atheromatous plaque (OR = 2.61, 95% CI, 1.19-5.72), diabetes (OR = 4.42; 95% CI, 1.86-10.49), hypertriglyceridemia (OR = 2.32, 95% CI, 1.33-4.0), and increased waist circumference (OR = 11.22, 95% CI, 4.0-31.65) was significantly higher in women treated for cancer than in women without breast cancer. CONCLUSIONS: Postmenopausal breast cancer survivors had a stronger association with risk factors for cardiovascular disease than postmenopausal women without breast cancer.

Low pretreatment serum concentration of vitamin D at breast cancer diagnosis in postmenopausal women.

OBJECTIVE: The aim of the study was to evaluate the rate of and risk factors for low pretreatment vitamin D (VitD) levels in postmenopausal breast cancer (BC) women, compared with postmenopausal women without BC. METHODS: A cross-sectional clinical study was conducted to compare 209 women with BC (case group) to 418 women without BC (control group), age range: 45 to 75 years. The case group consisted of women diagnosed with BC, amenorrhea ≥12 months, aged ≥45 years, without use of medication or clinical conditions that might interfere with VitD levels. The control group consisted of women with amenorrhea ≥12 months, aged ≥45 years, without BC. The groups were matched for age and time since menopause, at a case: control ratio of 1:2. Serum 25-hydroxyvitamin-D [25(OH)D] concentration was measured in all women 10 to 20 days after BC diagnosis and before the proposed treatment. Serum levels ≥30 ng/mL were defined as sufficient. The Student's t test or gamma distribution, χ test, and logistic regression (odds ratio, OR) were used for statistical analysis. RESULTS: The BC group had a higher body mass index (BMI) and higher percentage of obesity than the control group (57.4% vs 40.2%, P < 0.0001). In addition, rates of insufficient (20-29 ng/mL) and deficient (<20 ng/mL) 25(OH)D levels were higher in BC patients than in controls (55.6% vs 49.3%, P = 0.039 and 26.2% vs 20.3%, P = 0.018), respectively. In risk analysis (adjusted for age, time since menopause, and BMI), BC patients had a 1.5-fold higher risk of developing low VitD levels (OR = 1.52, 95% CI, 1.04-2.22, P = 0.029) than women without BC. CONCLUSIONS: Postmenopausal women had an increased risk of VitD deficiency at the time of BC diagnosis, associated with a higher rate of obesity, than women of the same age group without cancer.

Isolated vitamin D supplementation improves the immune-inflammatory biomarkers in younger postmenopausal women: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: The aim of this study was to evaluate the effect of vitamin D (VitD) supplementation on immune-inflammatory biomarkers in younger postmenopausal women. METHODS: In this double-blind, placebo-controlled trial, 160 postmenopausal women aged 50 to 65 years with amenorrhea ≥12 months were randomized into two groups: VitD group, oral supplementation with 1000 IU VitD3/day (n = 80) or placebo group (n = 80). The intervention time was 9 months, and the women were assessed at baseline and endpoint. Serum levels of interleukins (ILs)-1ß, IL-5, IL-6, IL-10, IL-12ρ70, IL-17α, tumor necrosis factor-alpha, and interferon-gamma were determined by immunoassay. Plasma concentrations of 25-hydroxyvitamin D [25(OH)D] were measured by high-performance liquid chromatography. Per-protocol analysis was adopted as the statistical method using a gamma distribution and repeated measures design, followed by Wald's multiple comparisons test. RESULTS: The two groups were similar at baseline in terms of clinical and laboratory parameters. After 9 months, there was a significant increase of 25(OH)D levels in the VitD group (+45.4%, P < 0.001) and a decrease (-18.5%, P = 0.049) in the placebo group. A significant decrease in IL-5, IL-12p70, IL-17α, tumor necrosis factor-alpha, and interferon-gamma levels was observed in the VitD group (P < 0.05). IL-5 and IL-6 levels were significantly lower in the VitD group compared to the placebo group (P < 0.05). There were no significant intervention effects on serum IL-1ß or IL-10 levels in either group (P > 0.05). CONCLUSIONS: In younger postmenopausal women, isolated supplementation with 1000 IU of VitD3 for 9 months was associated with a reduction in proinflammatory biomarkers.

Metabolic syndrome as a predictor of endometrial polyps in postmenopausal women.

OBJECTIVE: The aim of the study was to evaluate clinical predictive factors for endometrial polyps in postmenopausal women compared with postmenopausal women without polyps. METHODS: In this cross-sectional study, 132 Brazilian women with a histopathological diagnosis of endometrial polyps were compared with 264 women without endometrial alterations (control). The study group included women aged at least 45 years with amenorrhea for at least 12 months, who underwent hysteroscopic polypectomy. The control group consisted of women aged at least 45 years with amenorrhea for at least 12 months, without postmenopausal bleeding and endometrial thickness less than 5 mm by transvaginal ultrasonography. Clinical, anthropometric (body mass index and waist circumference), laboratory, and ultrasonographic data were collected to evaluate predictive factors for endometrial polyps. The Student's t test, χ test, and logistic regression (odds ratio [OR]) were used for statistical analysis. RESULTS: A higher percentage of women with polyps were obese (72%) when compared with control (39%) (P < 0.0001). Waist circumference was greater among women with polyps (P = 0.0001). The incidence of diabetes, hypertension, and dyslipidemia was higher among women with endometrial polyps (P < 0.0001). According to the diagnostic criteria of the US National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATP III), 48.5% of the women with polyps and 33.3% of the controls were classified as having metabolic syndrome (MetS) (P = 0.004). The risk of endometrial polyps was higher in women with body mass index at least 25 kg/m (OR = 4.66; 95% CI 2.16-10.05); glucose at least 100 mg/dL (OR = 2.83; 95% CI 1.36-5.90); dyslipidemia (OR = 7.02; 95% CI 3.70-13.32); diabetes (OR = 2.58; 95% CI 1.05-6.32); and MetS (OR = 2.76; 95% CI 1.18-6.46) when compared with control, adjusted for age, and time since menopause. CONCLUSIONS: In postmenopausal women, obesity, dyslipidemia, hyperglycemia, and the presence of MetS were predictive factors for endometrial polyps.

Nonalcoholic fatty liver disease and metabolic syndrome in postmenopausal women.

Nonalcoholic fatty liver disease (NAFLD) is considered the most common cause of chronic liver disease in the Western countries. NAFLD includes a spectrum ranging from a simple steatosis to a nonalcoholic steatohepatitis (NASH) which is defined by the presence of inflammatory infiltrate, cellular necrosis, hepatocyte ballooning, and fibrosis and cirrhosis that can eventually develop into hepatocellular carcinoma. Studies emphasize the role of insulin resistance, oxidative stress, pro-inflammatory cytokines, adipokines in the development and progression of NAFLD. It seems to be independently associated with type II diabetes mellitus, increased triglycerides, decreased HDL-cholesterol, abdominal obesity and insulin resistance. These findings are in accordance with the criteria used in the diagnosis of metabolic syndrome (MetS). Here, we will discuss the current knowledge on the epidemiology, pathophysiology and diagnosis of NAFLD and the association of metabolic syndrome in postmenopausal women.

The 60- and 70-kDa heat-shock proteins and their correlation with cardiovascular risk factors in postmenopausal women with metabolic syndrome.

We investigated the association between circulating levels of 60 and 70 kDa heat-shock proteins (HSP60 and 70) and cardiovascular risk factors in postmenopausal women with or without metabolic syndrome (MetS). This cross-sectional study included 311 Brazilian women (age ≥45 years with amenorrhea ≥12 months). Women showing three or more of the following diagnostic criteria were diagnosed with MetS: waist circumference (WC) ≥88 cm, blood pressure ≥130/85 mmHg, triglycerides ≥150 mg/dl, high-density lipoprotein (HDL) <50 mg/dl, and glucose ≥100 mg/dl. Clinical, anthropometric, and biochemical parameters were collected. HSP60, HSP70, antibodies to HSP60 and HSP70, and C-reactive protein (CRP) levels were measured in serum. Student's t test, Kruskal-Wallis test, chi-square test, and Pearson correlation were used for statistical analysis. Of the 311 women, 30.9 % (96/311) were diagnosed with MetS. These women were, on average, obese with abdominal fat deposition and had lower HDL values as well as higher triglycerides and glucose levels. Homeostasis model assessment-insulin resistant (HOMA-IR) test values in these women were compatible with insulin resistance (P < 0.05). CRP and HSP60 concentrations were higher in women with MetS than in women without MetS (P < 0.05). HSP60, anti-HSP70, and CRP concentrations increased with the number of features indicative of MetS (P < 0.05). There was a significant positive correlation between anti-HSP70 and WC, blood pressure and HOMA-IR, and between CRP and WC, blood pressure, glucose, HOMA-IR, and triglycerides (P < 0.05). In postmenopausal women, serum HSP60 and anti-HSP70 concentrations increased with accumulating features of the metabolic syndrome. These results suggest a greater immune activation that is associated with cardiovascular risk in postmenopausal women with metabolic syndrome.

Different tools for estimating cardiovascular risk in Brazilian postmenopausal women.

OBJECTIVE: To compare estimation of cardiovascular risk using the Framinghan Risk Score (FRS) and the presence of the metabolic syndrome (MetS) in postmenopausal women to prevent primary cardiovascular disease (CVD). METHODS: This cross-sectional study included 497 Brazilian women (aged ≥45 years and amenorrhea >12 months). Cardiovascular risk was calculated using the FRS that includes age, total cholesterol, HDL, systolic blood pressure and smoking status. Women showing three or more of the following criteria were diagnosed with MetS: waist circumference (WC) >88 cm, blood pressure ≥130/85 mmHg, triglycerides ≥150 mg/dl, HDL < 50 mg/dl and glucose ≥100 mg/dl. For statistical analysis, the Chi-square, Fisher's exact, and logistic regression (odds ratio-OR) were used. RESULTS: The mean age was 55.3 ± 7.0 years and time since menopause 7.2 ± 5.9 years. Based on FRS, 72.4% of women were classified as low-risk, 16.5% moderate risk and 11.1% a high-risk. MetS was identified in 40% of the women, and 46.2% were considered of moderate risk for CVD, while 84.9% of those without MetS were classified as low-risk (p < 0.001). The risk for CVD increased significantly with age at menopause (OR1.10; 95% CI, 1.04-1.17), time since menopause (OR1.13; 95% CI, 1.08-1.18), elevated triglycerides (OR1.03; 95% CI, 1.0-1.10) and presence of MetS (OR1.72; 95% CI 1.48-1.84). CONCLUSIONS: By using only FRS to estimate cardiovascular risk, a substantial number of postmenopausal women showing evidence of MetS were not identified, even though women with MetS are at higher risk of CVD.

Muscle mass gain after resistance training is inversely correlated with trunk adiposity gain in postmenopausal women.

The aim of this study was to evaluate alterations in trunk adiposity (TA) over 9 months of resistance training (RT) and associate these changes with the hypertrophy of muscle mass (MM) in postmenopausal women (PW). The investigation used a sample that consisted of 22 PW (44-69 years old). The group was subjected to RT (60-80% of 1 repetition maximum) for the total body 3 d · wk(-1). Body composition (dual-energy x-ray absorptiometry) and plasma levels of insulin-like growth factor-1 (IGF-1), follicle-stimulating hormone, E2 (Immulite system), and interleukin-6 (IL-6; enzyme-linked immunosorbent assay) were assessed at the beginning and end of the experiment. After RT, only women who acquired up to 5% TA gained MM, whereas women who acquired >5% TA exhibited increased IL-6 and no MM gain (p < 0.05). The ΔMM was negatively associated with time of menopause (r = -0.45, p < 0.05) and positively associated with baseline IGF-1 (r = 0.47, p < 0.05). Only ΔLE (leg extension) was negatively associated with baseline IL-6 (p < 0.05). Trunk adiposity growth (ΔTF, kilograms) was positively correlated with changes in IL-6 (r = 0.68, p < 0.05). The MM gain was negatively correlated with ΔTF (r = -0.63, p < 0.05) and changes in IL-6 (r = -0.73, p < 0.05). After adjusting all of the confounding variables, only baseline IGF-1 (positively) and changes in IL-6 (negatively) influenced MM, and only the increase in TA influenced IL-6. Our study suggests that increased levels of TA during RT increase IL-6 concentrations, which is a significant negative predictor of MM gain in PW.

Low appendicular muscle mass is correlated with femoral neck bone mineral density loss in postmenopausal women.

BACKGROUND: After menopause, rapid bone mass loss occurs in response to hypoestrogenism. Several studies suggest that muscle mass and bone mineral density (BMD) are positively associated in postmenopausal women. Therefore, it may be assumed that postmenopausal low appendicular muscle mass (aMM) can increase BMD loss in a short period of time. OBJECTIVE: The purpose of this study was to assess relationship of aMM with femoral neck BMD in postmenopausal women. METHODS: Prospective, controlled clinical Trial including 64 women aged 45-70 years, who had not had their last menstruation for at least one year. Subjects were divided into two groups: low aMM (n = 32), and normal aMM (n-32). Femoral neck BMD and muscle mass were measured by DXA at baseline and after twelve months. Pairwise and independent t tests were used for data analysis. RESULTS: Baseline weight, BMI and muscle mass (total and appendicular) significantly differ between groups (p < 0.05). After twelve months, femoral neck BMD was significantly lower in the group with low aMM, whereas no significant difference was observed in the group with normal aMM (p < 0.05). CONCLUSION: In postmenopausal women, low appendicular muscle mass is associated negatively with femoral neck BMD in a short period of time.

Associations between healthy eating patterns and indicators of metabolic risk in postmenopausal women.

BACKGROUND: Since human diets contain many components that may work synergistically to prevent or promote disease, assessing diet quality may be informative. The purpose of this study was to investigate the association between quality diet, by using Healthy Eating Index (HEI), and metabolic risk indicators in postmenopausal women. METHODS: This cross-sectional study included a total of 173 Brazilian women, aged 45-75 years, seeking healthcare at a public outpatient center. Food consumption assessed by 24 h-recall food inquiry was used to calculate HEI scores: >80 implied diet good, 80-51 diet "needed improvement", and <51 diet poor. Anthropometric data included: body mass index (BMI = weight/height(2)), waist-circumference (WC), body fat (%BF) and lean mass (%LM). Data on total cholesterol (TC), high density lipoprotein cholesterol (HDLC), low density lipoprotein cholesterol (LDLC), and triglycerides (TG) were also collected. Fisher's Exact test, and logistic regression method (to determine odds ratio, OR) were used in the statistical analysis. RESULTS: Overweight and obesity were observed in 75.7% of the participants. Excessive %BF (> 35%) was observed in 56.1%, while %LM was reduced (< 70%) in 78.1%. WC was elevated (≥88 cm) in 72.3%. Based on HEI values, diet quality was good in 3% (5/173), needed improvement in 48.5% (84/173), and was poor in 48.5% (84/173) of the cases. In this group, 75% of women had high intakes of lipids (> 35%), predominantly saturated and monounsaturated fat. On average, plasma TC, LDLC, and TG levels were higher than recommended in 57.2%, 79.2% and 45.1% of the women, respectively, while HDLC was low in 50.8%. There was association between HEI scores and the %BF that it was higher among women with HEI score < 80 (p = 0.021). There were not observed significant risk associations between HEI and lipid profile. CONCLUSION: Among the Brazilian postmenopausal women attending a public outpatient clinic, diet was considered to need improvement or to be of poor quality, attributed to high saturated fat ingestion, which probably caused a negative impact on metabolic risk indicators, namely body composition.

Plasma hormones, muscle mass and strength in resistance-trained postmenopausal women.

OBJECTIVE: To associate changes of body composition, muscle strength (MS) and plasma hormones (PH) in resistance-training protocol in sedentary postmenopausal women (PMW). DESIGN: This randomized controlled trial, Brazilian 43 PMW (45-70-year-old) able for physical exercises were selected after they have accomplished medical and ethical criteria. They were assigned in two groups: RT, resistance training (n=22); and CT, not trained control (n=21); with supervision sessions of two to three exercise for large and one exercise for smaller groups in three series of 8-12 rep. (60-80%1RM) for each exercise. The training period lasted 16 weeks and was preceded by low-load exercise (40-50%1RM) adaptation period of 4 weeks (3/(times week)). Body weight, height, body mass index (BMI), and composition (BIA) along with fast-PH (FSH, LH, estradiol, cortisol, IGF-1 and testosterone) were assessed before (M0) and after (M16) the 4 weeks period with the MS (1RM) determined also at 8 weeks (M8). The values were correlated by Person's test and the means compared by Student's t-test and ANOVA. RESULTS: At baseline both groups were similar in age, time of PMW, body composition, MS and fast-PH. However after 16 weeks, RT presented higher BMI (2.1%), IGF-1 (37.8%) and MM gain (1.8+/-0.8 kg) than CT. MM correlated positively with IGF-1 (r=0.45, p<0.05) and MS progressively increased in all exercise greater in pectoral than legs and upper arms. CONCLUSION: Former sedentary postmenopausal women submitted to resistance training gained MM and MS irrespectively of fat mass changes but significantly associated with IGF-1 increase.

Effect of raloxifene on the vaginal epithelium of postmenopausal women.

OBJECTIVE: The objective was to analyze the effect of raloxifene on the vaginal epithelium of postmenopausal women. STUDY DESIGN: In this non-randomized clinical trial, 80 women (mean age = 60.6 years) were prospectively studied. Forty patients received 60 mg/day of raloxifene (RG), and 40 women constituted a non-treated control group (CG), paired by age and time since menopause. The treated group consisted of patients with osteoporosis of the lumbar spine. Those with a diagnosis of infection in the lower genital tract and using hormone therapy (HT) up to 6 months prior to the study were excluded. Vaginal smears were collected at baseline and after 6 months of intervention. The vaginal maturation value (VMV) was determined, and counts of superficial, intermediate and parabasal cells were performed. Smears were analyzed by only one cytopathologist who was blinded to patient data. The t-test, Wilcoxon test, and Chi-Squared test were used in the statistical analysis. RESULTS: The study groups were homogeneous regarding age, time since menopause, parity, HT use, smoking, and body mass index. No statistically significant differences were observed in VMV median values (RG, 39.7 and 35.7; CG, 50.0 and 50.0, respectively) or in the percentage of superficial, intermediate and parabasal cells between the groups at baseline and after 6 months (p>0.05). There was no significant correlation between VMV and age, time since menopause, previous HT use, or body mass index, in either of the groups. CONCLUSION: Treatment with raloxifene for 6 months has no effect on the maturation of the vaginal epithelium in postmenopausal women with osteoporosis.

Efficacy and safety of a soy isoflavone extract in postmenopausal women: a randomized, double-blind, and placebo-controlled study.

OBJECTIVE: To investigate the efficacy of soy isoflavone on climacteric symptoms in postmenopausal women. DESIGN: In this double-blind, randomized, placebo-controlled study, a total of 80 women (mean age = 55.1 years), who reported 5 or more hot flush episodes per day, were randomized to receive either 250 mg of standardized soy extract (Glycine max AT) a total of 100mg/day of isoflavone (n = 40) or placebo (n = 40). Exclusion criteria included: contra-indication for hormone therapy (HT), chronic gastrointestinal diseases, and users of HT within the preceding 6-months. For 10-months, climacteric symptoms were evaluated using a score card and the menopausal Kupperman index. Compliance and safety were also assessed. At baseline and the end of the study, lipid and hormonal profiles, as well as vaginal, mammographic and ultrasonographic parameters were measured. The t-test, Wilcoxon test and ANOVA were used in the statistical analysis. RESULTS: At baseline, the mean number of hot flushes was 9.6 +/- 3.9 per day in the isoflavone group and 10.1+/-4.9 in the placebo group (p>0.05). After 10 months, there was a significant reduction in frequency of hot flushes among isoflavone users when compared to those on placebo (3.1 +/- 2.3 and 5.9 +/- 4.3, respectively) (p<0.001). Kupperman index mean values showed a significant reduction in both groups. However, soy isoflavone was significantly superior to placebo, in reducing hot flush severity (69.9% and 33.7%, respectively) (p<0.001). Endometrial thickness, mammography, vaginal cytology, lipids and hormonal profile did not change in both groups. No serious adverse event related to isoflavone treatment was reported. CONCLUSIONS: The soy isoflavone extract exerted favorable effects on vasomotor symptoms and good compliance, providing a safe and effective alternative therapeutic for postmenopausal women.

Effects of soy protein and resistance exercise on body composition and blood lipids in postmenopausal women.

OBJECTIVE: To assess the effect of soy protein and progressive resistance training on body composition and lipids in postmenopausal women. DESIGN: In a controlled trial, 46 postmenopausal women were randomized to one of four groups: 25 g of soy protein (SP, n=10), 25 g of soy protein plus resistance exercise (SPE, n=14), 25 g of maltodextrine (placebo) (PL, n=11), or placebo plus resistance exercise (PLE, n=11). Progressive resistance training was held three times a week for 16 weeks and included 8 exercises (3 series of 8-12 repetitions). At baseline and after 16 weeks, body mass index, waist circumference (WC), body fat, muscle mass and serum lipid levels were measured. To confirm isoflavone absorption, urinary concentrations were determined. The t-test of Student and ANOVA were used in the statistical analysis. RESULTS: Subjects were classified as overweight and showed android fat distribution. Urinary isoflavone excretion indicated compliance to soy protein treatment. After 16 weeks of intervention, both SPE and PLE groups showed a significant increase of 1.3 kg in muscle mass and reduction in WC of -1.4 and -2.1cm, respectively (p<0.05). Significant decreases in the mean values of total cholesterol and LDL (-29.0 and -24.0 mg/dL, p<0.001 and p<0.006, respectively) were observed in the users of soy protein alone (SP). CONCLUSIONS: Soy protein supplementation did not influence the indicators of body composition. However, it exerted possible favorable effects on lipid profile in postmenopausal women. The increase in muscle mass and reduction in abdominal fat were correlated with resistance training.