Effect of raloxifene and low-dose percutaneous 17β-estradiol on menopause symptoms and endometrium—A randomized controlled trial

Objective

To investigate the effects on climacteric symptoms and endometrium of percutaneous low-dose 17β-estradiol associated with raloxifene in postmenopausal women.

Design

randomized placebo-controlled study.

Method

Fifty-two postmenopausal women with moderate to severe hot flushes were randomized to receive either 60 mg raloxifene (RLX; n = 20), 0.5 mg percutaneous 17β-estradiol associated to 60 mg raloxifene (RLX + E₂; n = 16) or placebo (PLC; n = 16). Climacteric symptoms (Kupperman index) and vaginal bleeding were evaluated. At baseline and at the end of the study endometrial thickness was measured and endometrial samples were collected for histological study.

Results

At baseline, the mean Kupperman index was 23.7 ± 1.8 in RLX group, 22.9 ± 1.9 in RLX + E₂ group and 22.6 ± 1.9 in the placebo group (NS). After 3 months, there was a significant reduction in Kupperman index mean values in both groups, but no statistical difference was observed between groups. However, RLX + E₂ and placebo were significantly superior to RLX in reducing hot flush severity (p < 0.05). Endometrial thickness did not change in both groups. The association of percutaneous low-dose 17β-estradiol to raloxifene was not associated with proliferation of endometrium neither in hysteroscopies nor in endometrial biopsies at the third month of treatment. No vaginal bleeding was reported during the study.

Conclusions

The association of percutaneous low dose of 17β-estradiol with raloxifene exerted favorable effects on hot flushes severity of postmenopausal women, providing a safe profile in endometrium at least in short-term therapy.     

Serum cathepsin K as a marker of bone metabolism in postmenopausal women treated with alendronate

Context

Cathepsin K is a member of the cysteine protease family that cleaves both helical and telopeptide regions of collagen I, the major type of collagen in bone. Measurement of circulating levels of cathepsin K may be useful to assay the number or function of osteoclasts.

Objective

The aim of the study was to evaluate the role of serum cathepsin K as a biochemical marker of bone metabolism in patients with postmenopausal osteoporosis before and after treatment with alendronate.

Design, setting and participants

The study was a case–control and prospective study with postmenopausal osteoporotic women including a total number of 86 subjects. Serum cathepsin K was determined in 46 women with postmenopausal osteoporosis before and after 3, 6 and 12 months of treatment with alendronate. Basal serum cathepsin K levels were also compared between premenopausal healthy women (n = 20), postmenopausal women without osteoporosis (n = 20) and osteoporotic women. In addition, serum carboxyterminal cross-linked telopeptide of type I collagen (CTX), osteocalcin (OC) and bone-specific alkaline phosphatase (bALP) were measured.

Main outcome measure

Changes in cathepsin K serum levels after alendronate treatment.

Results

Serum cathepsin K levels were higher in postmenopausal women with osteoporosis (9.4 ± 11 pmol/L) compared with healthy postmenopausal women (6.8 ± 8.1 pmol/L; p < 0.01) and premenopausal women (6.3 ± 5.0 pmol/L, p < 0.01). Serum cathepsin K decreases gradually after alendronate treatment (17% at 3 months, 22% at 6 months and 41% at 12 months, p < 0.01). In contrast, the treatment resulted in early and sustained reductions in serum CTX.

Conclusion

We conclude that serum cathepsin K seems to provide additional information on bone metabolism in postmenopausal women treated with alendronate.     

XbaI polymorphism of the estrogen receptor alpha gene influences the effect of raloxifene on the endothelial function

Objectives

Cardiovascular disease is the leading cause of death in postmenopausal women and estrogen deficiency may be an important factor in its development. The selective estrogen receptor modulator, raloxifene, exerts a part of its actions through the estrogen receptor alpha (ESR1) activation. We explored if polymorphisms of the ESR1 modify the effects of 6 months raloxifene treatment on endothelial function.

Methods

A total of 53 postmenopausal women, mean age 59.7 ± 6.2, finished the prospective clinical trial. The PvuII, XbaI, and P325P polymorphisms of the ESR1 gene were analyzed. In all subjects endothelium-dependent flow mediated dilatation (FMD) and cell adhesion molecules (CAM) ICAM-1, VCAM-1 and E-selectin were measured before and after 6 months of raloxifene treatment.

Results

There was no difference in FMD between the ESR1 genotypes, at baseline. After raloxifene treatment, the FMD was significantly greater in subjects with XX genotype of XbaI polymorphism compared to xx (p = 0.03) and borderline greater when compared to Xx genotype (p = 0.053). The FMD increased significantly with raloxifene treatment in women with Xx genotype of XbaI and Pp genotype of PvuII polymorphisms (p = 0.027 and p = 0.034, respectively). The P325P polymorphism did not influence the FMD after raloxifene. None of the ESR1 gene polymorphisms had any impact on the levels of CAM before or after the treatment. When analysing the whole group, a significant decrease in E-selectin (p < 0.001) and a small increase in ICAM-1 levels (p = 0.029) was observed with raloxifene treatment, but no influence on VCAM-1 levels or FMD overall was seen.

Conclusion

Our data suggest that XbaI and possibly PvuII polymorphisms of the ESR1 gene influence the impact of raloxifene treatment on endothelial function. This effect could be of pharmacogenomic and clinical importance.     

Effects of continuous combined hormone replacement therapy and clodronate on bone mineral density in osteoporotic postmenopausal women: A 5-year follow-up

Objective

To determine the effects of HRT with or without clodronate on bone mineral density (BMD) change and bone turnover markers.

Design

Prospective, partly randomized trial.

Setting

Kuopio University Hospital, Finland.

Population

167 osteoporotic women (61 ± 2.7 years; T-score ≤ −2.5 SD).

Methods

Estradiol 2 mg + NETA 1 mg, randomization to additional 800 mg clodronate (n = 55, HT + C-group) or placebo (n = 55, HT-group); if contraindications to HRT, clodronate (n = 57, C-group).

Main outcome measures

BMD by DXA after 1, 3 and 5 years, serum osteocalcin (OC) and bone-specific alkaline phosphatase (BAP) at the baseline and after 3 years.

Results

After 5 years, adjusted lumbar BMD increased by 4.2% in the HT-group and 3.7% in the HT + C-group. The C-group showed a decrease of −1.1%, the total difference being 5.3% and 4.8% between HT, HT + C vs. C-group, respectively (p < 0.001). In the femoral neck, the adjusted 5-year BMD benefit was 1.3% and 2.4% in the HT- and HT + C-groups, respectively, the net loss of BMD in the C-group was −3.3% (p < 0.05 between HT + C vs. C). By 3 years, OC decreased by 55.0%, 70.3% and 53.8% in the HT-, HT + C- and C-groups, respectively (p < 0.001 vs. baseline). The significant decreases of BAP were 39.4% in the HT-group, 42.1% in the HT + C-group and 30.2% in the C-group with no significant differences between the groups after adjustments.

Conclusions

In postmenopausal women with osteoporosis, HRT increased spinal and femoral BMD, but the combination of HRT and clodronate did not offer an extra gain of bone mass.     

Association of the (TAAAA)n repeat polymorphism of SHBG gene with the age at menopause in Greek postmenopausal women

Objective

To assess the potential association of the pentanucleotide (TAAAA)n repeat polymorphism in the promoter of SHBG gene with the age at menopause in a Greek female population.

Study design

Cross-sectional study. Two hundred and ten postmenopausal women aged 46–63 years were enrolled. The age at the last menstrual period and anthropometric parameters were recorded in all participants. Blood sampling for genotyping of the (TAAAA)n polymorphism of SHBG gene was performed.

Main outcome measure(s)

Frequency and association of the (TAAAA)_n alleles with age at menopause.

Results

The alleles with seven and eight TAAAA repeats were associated with the age at menopause. The age at menopause was higher in carriers than in non-carriers of the (TAAAA)₇ allele (50.2 ± 3.1 years vs. 48.0 ± 4.8 years, p = 0.026). Furthermore, the age at menopause was lower in women carrying the (TAAAA)₈ allele (47.5 ± 4.8 years) than in women not carrying this allele (48.8 ± 4.4 years, p = 0.048).

Conclusions

The (TAAAA)₇ and (TAAAA)₈ alleles of the SHBG (TAAAA)_n polymorphism may contribute to variation in the timing of natural menopause in postmenopausal women of Northwestern Greece.     

Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life

Objective

To use the Menopause-Specific Quality of Life Questionnaire (MENQOL) to assess the impact of menopausal symptoms on health-related quality of life in a large US population-based study.

Methods

Participants were recruited from the US population through random-digit-dialing and probability sampling. Analyses included 2703 postmenopausal women 40–65 years old in our Menopause Epidemiology Study. Respondents answered a 30-min questionnaire, including the MENQOL.

Results

Scores for each domain were: vasomotor: 3.2 ± 2.2; psycho-social: 3.3 ± 1.8; physical: 3.5 ± 1.5; sexual: 2.9 ± 2.1. There were significant differences in the MENQOL scores by age, smoking, exercise, education, employment status and BMI. Women aged 60–65 years (p < 0.0001), with a bachelor’s degree or higher level of education (p < 0.0001), who exercised at least 3 days a week (p < 0.0001), who had never smoked (p < 0.0001), with a body mass index ≤25 kg/m² (p < 0.0001), and who had significantly lower scores indicating better quality of life. Hot flashes affected work (46.0%), social activities (44.4%), leisure activities (47.6%), sleep (82.0%), mood (68.6%), concentration (69.0%), sexual activity (40.9%), total energy level (63.3%) and overall quality of life (69.3%).

Conclusion

Symptoms experienced during menopause and socio-demographic characteristics affect the quality of life in postmenopausal women. Hot flashes impact the daily activities of most postmenopausal women, especially those with more frequent/severe symptoms. Treatments that safely and effectively treat these symptoms could improve quality of life among postmenopausal women.     

Arm span increases predictive value of models for prevalent vertebral deformities: The Japanese Population-based Osteoporosis (JPOS) Study

Objective

We examined anthropometric indicators to improve predictive ability of asymptomatic vertebral fracture screening models.

Study design and setting

Data were obtained from the 1996 Japanese Population-based Osteoporosis (JPOS) Study. McCloskey–Kanis criteria diagnosed vertebral deformities on X-ray absorptiometric images in 693 women aged ≥50.The multiple logistic regression model included age, height, weight, postmenopausal status, total hip BMD, and arm span (AS) or sitting height as explanatory variables. Akaike's information criterion (AIC) evaluated model goodness-of-fit.

Results

Age-adjusted AS and sitting height in subjects with and without vertebral deformities were 147.2 ± 0.6 cm and 148.5 ± 0.2 cm (P = 0.055), 78.5 ± 0.5 cm and 79.9 ± 0.2 cm (P = 0.007), respectively. Every 5-cm increase in AS indicated 1.5-fold increased risk of prevalent vertebral deformity in the model including age, height, weight, postmenopausal status, and BMD. Including the explanatory variable AS in models yielded better predictive accuracy than excluding AS (AIC, 441.7 vs 446.6, respectively). Sitting height did not significantly influence model predictive ability.

Conclusion

Predictive accuracy of model for vertebral fracture including age, height, weight, postmenopausal status, and BMD improved when AS was added as an explanatory variable. Models to screen for asymptomatic vertebral fractures should include AS.     

Factors related to increased daytime sleepiness during the menopausal transition as evaluated by the Epworth Sleepiness Scale

Background

Sleep disorders and sleep-apnea/hypopnea syndromes are very frequent in women, being misdiagnosed in many cases. The menopause, regardless of age, is associated to poor sleep quality and daytime sleepiness that can lead to impaired quality of life, and reduced productivity and functioning.

Objective

To assess daytime sleepiness and related risk factors among middle aged Ecuadorian women using the Epworth Sleepiness Scale (ESS).

Methods

In this cross-sectional study 149 women aged 40–59 years were assessed for hot flush presence and intensity using the Menopause Rating Scale (MRS) and requested to fill out the ESS and a questionnaire containing personal and partner data.

Results

Mean age of surveyed women was 47.6 ± 5.5 years, with 67.8% having less than 12 years of schooling, 33.6% being postmenopausal, and 2.7% on hormone therapy. A 10.1% were current smokers and 20.8% were sedentary. According to the MRS (item 1) 51.7% presented hot flushes, which were graded as severe–very severe in 42.8% of cases. Regarding the partner (n = 132), erectile dysfunction was present in 10.6%, premature ejaculation 6.1% and 17.4% abused alcohol. Mean total ESS score was 8 ± 4.4 (median 8), with 33.6% considered having some degree of daytime sleepiness (ESS score ≥10). Logistic regression analysis determined that postmenopausal status (OR 6.58, CI 95% [2.51–17.23], p = 0.001), sedentarism (OR 3.43, CI 95% [1.14–10.26], p = 0.02) and hot flush presence (OR 2.61, CI 95% [1.02–6.65], p = 0.04) among women were risk factors for increased daytime sleepiness (ESS total score ≥10) whereas partner faithfulness decreased this risk (OR 0.47, CI 95% [0.24–0.90], p = 0.02).

Conclusion

Increased daytime sleepiness in this middle aged series was related to female (hormonal status and sedentarism) and partner factors; several which are susceptible of intervention.     

Results from a randomized trial of a web-based,tailored decision aid for women at high risk for breast cancer

Objective

To assess the impact of Guide to Decide (GtD), a web-based, personally-tailored decision aid designed to inform women's decisions about prophylactic tamoxifen and raloxifene use.

Methods

Postmenopausal women, age 46–74, with BCRAT 5-year risk ≥1.66% and no prior history of breast cancer were randomized to one of three study arms:intervention (n = 690), Time 1 control (n = 160), or 3-month control (n = 162). Intervention participants viewed GtD prior to completing a post-test and 3 month follow-up assessment. Controls did not. We assessed the impact of GtD on women's decisional conflict levels and treatment decision behavior at post-test and at 3 months, respectively.

Results

Intervention participants had significantly lower decisional conflict levels at post-test (p < 0.001) and significantly higher odds of making a decision about whether or not to take prophylactic tamoxifen or raloxifene at 3-month follow-up (p < 0.001) compared to control participants.

Conclusion

GtD lowered decisional conflict and helped women at high risk of breast cancer decide whether to take prophylactic tamoxifen or raloxifene to reduce their cancer risk.

Practice implications

Web-based, tailored decision aids should be used more routinely to facilitate informed medical decisions, reduce patients’ decisional conflict, and empower patients to choose the treatment strategy that best reflects their own values.     

Assessment of self-esteem in mid-aged women

Objective

To assess self-esteem and affecting factors in a middle-aged Ecuadorian female population using the Rosenberg Self-Esteem Scale (RSES).

Study design

This was a cross-sectional study in which 149 women (40–59 years) were requested to fill out the RSES and a general socio-demographic form containing personal and partner data.

Results

Mean age of sample was 47.6 ± 5.5 years, a 67.8% had less than 12 years of schooling and 33.6% were postmenopausal. At the moment of the survey 2.7% were on hormone therapy, and 2% were taking psychotropic drugs. Mean total RSES score was 26.6 ± 3.1 (median 26, range 17–35). A 35.6% and 18.1% of women respectively presented total RSES scores below 26 (median) and 25 (25th percentile) suggesting lower self-esteem. Total scores did not differ when comparing older age, menopausal phases or time since the menopause. Logistic regression analysis determined that women with lower parity and an unhealthy partner were related to lower total RSES scores (below the 25th percentile) suggesting lower self-esteem.

Conclusions

In this mid-aged series lower self-esteem was not related to the aging process per se yet to socio-demographic female/male aspects. More research is needed in this regard that incorporates other sociological aspects.     

The effect of short-term aerobic training on coagulation and fibrinolytic factors in sedentary healthy postmenopausal women

Objective

The purpose of this study was to assess the effect of short-term aerobic training on the fibrinolytic and coagulative factors in postmenopausal women.

Study design

Twenty volunteer sedentary healthy postmenopausal women (48–53 years), who entered the menopause naturally, were divided randomly into two groups: training (n = 10) and control (n = 10).

Methods and main outcome measures

Training consisted of 10 sessions of submaximal aerobic cycling, 35 min for each session (5 min warm-up, 25 min aerobic training with 70% HRmax, 5 min active and 15 min passive recovery), 3 times a week. Coagulation and fibrinolytic factors were assessed both before and after aerobic program in both groups.

Results

Fibrinogen, von Willbrand factor (vWF-Ag) antigen, plasminogen activator inhibitor-1 activity (PAI-1:Ac) and antigen (PAI-1:Ag) showed significant reduction after 10 sessions in the training group (P < 0.05). Also after training, prothrombin time (PT), partial thromboplastin time (PTT), tissue plasminogen activator activity (tPA:Ac) and antigen (tPA:Ag) increased (P < 0.05).

Conclusion

It was concluded that fibrinolytic activity on postmenopausal women could be improved by a 3-week regular submaximal training program. These changes on the hemostatic factors suggest that short-term aerobic training may prevent the decline in fibrinolytic function observed in sedentary postmenopausal women.     

Relationships between serum uric acid,adiponectin and arterial stiffness in postmenopausal women

Objectives

Cardiovascular disease (CVD) is a leading cause of death in postmenopausal women. Elevated serum uric acid levels, hypoadiponectinemia and arterial stiffness are strongly associated with cardiovascular diseases. We investigated the relationships among uric acid, adiponectin and arterial stiffness in postmenopausal women.

Study design

9555 subjects who had the routine health check-ups, 841 postmenopausal women aged 50 years or older who had not had a menstrual period for more than 12 consecutive months were included in this study.

Main outcome measures

BMI, WC, and serum concentrations of uric acid, adiponectin, glucose, lipids (total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol) were measured. Insulin resistance was estimated by the insulin resistance index of homeostasis model assessment (HOMA-IR). Pulse wave velocity (PWV) was evaluated to assess arterial stiffness.

Results

The subjects were stratified into three groups according to uric acid values. PWV values gradually increased and adiponectin level decreased with uric acid tertiles. Serum uric acid levels in postmenopausal women correlated significantly with age, BMI, WC, TG, HDL-C, insulin, HOMA-IR, adiponectin and PWV. Multiple regression analysis showed that WC (β = 0.141, P < 0.01), HOMA (β = 0.137, P < 0.01), adiponectin (β = −0.104, P < 0.01), and PWV (β = 0.129, P < 0.01) were independently correlated with uric acid levels. In multiple logistic regression analysis after adjusting for risk factors, uric acid was a significant contributor to increased PWV.

Conclusions

These findings indicate that serum uric acid is independently associated with adiponectin and arterial stiffness in postmenopausal women.     

Carotid intima-media thickness and calcification in relation to bone mineral density in postmenopausal women—The OSTPRE-BBA study

Objectives

Atherosclerosis (AS) and osteoporosis are common diseases in elderly people and may be metabolically related. The aim of this cross-sectional population-based study was to explore the association between common carotid artery intima-media thickness (cIMT), carotid artery calcification (CAC), and BMD in postmenopausal women. In addition, the association of postmenopausal hormone therapy (HT) and selected diseases with cIMT and carotid calcification was studied.

Study design

The 290 women (mean age 73.6 years) included in this Bone Brain Atherosclerosis study (OSTPRE-BBA) were randomly selected from the population-based Kuopio Osteoporosis Risk Factor and Prevention (OSTPRE) study cohort, Finland.

Main outcome measures

For this cross-sectional study, cIMT was measured with B-mode ultrasound; femoral neck and total body BMD were measured with dual-energy X-ray absorptiometry.

Results

There were no statistically significant associations between mean cIMT and femoral neck T-score (p > 0.05). However, an increased maximum cIMT was significantly associated with low femoral neck T-score. In the osteoporotic group (T-score <−2.5, n = 20), the maximum cIMT was 2.51 ± 0.88 mm (mean ± SD); in the normal BMD group (T-score >−1, n = 122), it was 1.93 ± 0.64 mm (p = 0.001). The odds of having CAC were approximately four-fold higher in the osteoporotic group compared with the group with a normal femoral neck T-score (odds ratio [OR] = 4.2, p = 0.038). The maximum cIMT was smaller in HT users (1.98 ± 0.56 mm, n = 190) than in non-users (2.16 ± 0.74 mm, n = 156, p = 0.036).

Conclusions

The results of our population-based study suggest that BMD is related to AS, at least in carotid arteries. They indirectly support the hypothesis of partially shared pathophysiological mechanisms between these two disorders.     

Autonomic dysfunction and arterial stiffness in female overactive bladder patients and antimuscarinics related effects

Objectives

To investigate the characteristics of autonomic function and arterial stiffness of OAB women, their relations with urodynamic parameters, and the impact of antimuscarinics on the above parameters.

Study design

A total of 85 OAB women and another 65 women without OAB were selected. Forty-two OAB women who enrolled before March 2009 were treated with tolterodine for 12 weeks, and another 43 OAB women who enrolled thereafter were treated with solifenacin.

Main outcome measures

The differences of the heart rate variability, cardio-ankle vascular index (CAVI) and ankle-brachial pressure index (ABI) between OAB and asymptomatic women, and their changes after 12 weeks’ antimuscarinics for OAB women.

Results

OAB women had higher low frequency/high frequency ratios (LF/HF) (OAB: 1.5 ± 1.1 vs. the control: 1.1 ± 0.7, P = 0.04). Nonetheless, CAVI and ABI did not differ between OAB and the control group. The square root of the mean squared differences of successive NN intervals (RMSSD) is associated with nocturia (Spearman's ρ = 0.23, P = 0.049), LF is associated with urgency episodes (Spearman's ρ = 0.28, P = 0.01), and maximum urethral closure pressure is negatively associated with CAVI (Spearman's ρ = −0.26, P = 0.02). After 12 weeks’ treatment, a decrease of RMSSD, HF, CAVI and an increase of LF/HF were found in the tolterodine group but not in the solifenacin group.

Conclusions

OAB women have higher severity of autonomic dysfunction with sympathetic predominance. Tolterodine may improve arterial stiffness but may deteriorate autonomic dysfunction to more sympathetic predominance. Thus, tolteridine should be used for OAB with caution in women with preexisting symptoms of autonomic dysfunction.     

Ospemifene,a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: A randomised,placebo-controlled,phase III trial

Objective

To evaluate the efficacy and safety of ospemifene, a novel selective oestrogen receptor modulator, in the treatment of vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA).

Study design

A 12 week, multicentre, randomised, double-blind, parallel-group phase III study of women (40–80 years) with VVA and self-reported vaginal dryness as their most bothersome symptom.

Main outcome measures

The co-primary efficacy endpoints were the change from baseline to Week 12 in (1) percentage of parabasal cells in the maturation index (MI), (2) percentage of superficial cells in the MI, (3) vaginal pH, and (4) severity of vaginal dryness. Safety assessments included physical examination, cervical Papanicolaou test and clinical laboratory analyses. Endometrial thickness and histology was also assessed.

Results

A total of 314 women were randomised to once-daily ospemifene 60 mg/day (n = 160) or placebo (n = 154). Significant improvements in the percentages of parabasal and superficial cells in the MI and vaginal pH were observed with ospemifene compared with placebo (p < 0.001 for all parameters). The mean change from baseline in severity score of vaginal dryness reported by women receiving ospemifene compared with those receiving placebo approached statistical significance (p = 0.080). Improvements in each of the four co-primary endpoints with ospemifene were statistically significant compared to placebo in the per protocol population. The majority of treatment-emergent adverse events were considered mild to moderate in severity.

Conclusions

Once-daily oral ospemifene 60 mg was effective for the treatment of VVA in postmenopausal women with vaginal dryness.     

Menopause is an independent predictor of metabolic syndrome in Iranian women

Background

Gender differences in prevalence and consequences of the metabolic syndrome as a strong predictor of cardiovascular disease (CVD), are challenging problems. Postmenopausal status may explain in part the cause of acceleration of CVD with aging. The purpose of this study was to investigate the relation of menopause and metabolic syndrome independent of aging among Iranian women.

Methods

On the basis of consecutive recruitment, 940 women between 20 and 76 years old participated in the study. Anthropometric indices, fasting blood glucose, lipid profile were measured, Framingham risk score and homeostasis model assessment (HOMA-IR) were calculated for all participants. The metabolic syndrome (MetS) was defined according to the National Cholesterol Education Program Adult Treatment Panel III. We used IDF definition for metabolic syndrome modified by our recent local data as an alternative measurements.

Results

The overall prevalence of metabolic syndrome was 26.4%. Its prevalence was 53.5% in postmenopausal versus 18.3% in premenopausal women. On binary logistic regression analysis, HOMA index, body mass index, waist to hip ratio, family history of diabetes and hypertension had an independent and significant effect on metabolic syndrome. Age-adjusted odds ratio (OR) of postmenopausal status for metabolic syndrome was 2.85 (95%CI: 1.31–6.20) (P < 0.008). Framingham risk score was 8.3 ± 7.7 in MetS+ve cases versus 1.9 ± 2.1 in MetS−ve cases (P < 0.001). There were significant differences between Framingham risk score in postmenopause 9.1 ± 6.4 versus premenopause 1.6 ± 1.6 (P < 0.001). A significant correlation was found between Framingham risk score and body mass index, waist to hip ratio, HOMA-IR and components of metabolic syndrome (P < 0.001). Forty percent of participants with premature menopause had metabolic syndrome versus 24% in age-matched group and Framingham risk score was significantly higher than normal cases 5.4 ± 4.9 versus 2.0 ± 2.3 (P < 0.001).

Conclusion

Menopausal status can be a predictor of metabolic syndrome independent of age in Iranian women. Menopause is a process closely related to insulin resistance and cardiovascular risk factors.     

Effects of a nutritional intervention in obese postmenopausal women on atypical antipsychotics

Objectives

To investigate the effects of a nutritional intervention on the body weight, body composition, blood glucose and lipid levels of obese postmenopausal women taking atypical antipsychotics in Greece.

Study design

In a case–control design, 25 obese postmenopausal women treated with antipsychotic medications and 28 obese healthy comparisons were followed for 3 months. A nutritional program was individually designed for each participant.

Main outcome measures

At baseline and at 3 months of the study, anthropometric, body composition, blood glucose and lipid measurements were performed.

Results

Significant reductions in body weight, body mass index (BMI), fat and waist circumference were found both in the patients and their healthy comparisons from baseline to 3 months (P < 0.05). Patients reduced significantly less their BMI (P = 0.044) and body fat percentage compared to the healthy women (P = 0.023). Waist circumference was significantly reduced in both subject groups, with no significant difference found between them (P = 0.07). Glucose and lipid levels were not altered during the intervention in the patients’ group, while significant changes were observed in the healthy women in total cholesterol (P = 0.016), low density lipoprotein cholesterol (P = 0.022) and triglycerides (P = 0.042).

Conclusions

Obese postmenopausal women on atypical antipsychotic medication appear to respond favorably to a nutritional program. The improvements seen in BMI and body fat are attenuated in the patients compared to their healthy counterparts; moreover no change in lipid levels was found in the patients’ group. These findings suggest that atypical antipsychotics may play an adverse role in fat loss and lipid metabolism in this population.     

The effect of physical activity on weight loss is mediated by eating self-regulation

Objective

This study tested whether different forms of physical activity (PA) were associated with eating self-regulation during weight control, and if changes in eating behavior mediated the relationship between PA and weight loss, in overweight/obese women.

Methods

239 women (37.6 ± 7.0 years; 31.3 ± 4.1 kg/m²) participated. The intervention group received a 12-month group behavioral treatment designed to increase autonomy and self-regulation for weight control. Controls received a health education program. Assessments included body weight, structured and lifestyle exercise/PA, and eating self-regulation.

Results

Moderate + vigorous and lifestyle PA were associated with 12-month change in most eating variables (p < 0.05) and with body weight change (p < 0.01). Mediation analysis showed that flexible cognitive restraint and emotional eating fully mediated the relation between lifestyle PA and weight change (effect ratio: 0.63). About 34% of the effect of moderate + vigorous PA on weight change was explained by these same mediators (partial mediation).

Conclusion

Exercise and PA may positively influence weight control through eating self-regulation. Flexible dietary control and reduced emotional overeating are mechanisms by which an active lifestyle can contribute to long-term weight management.

Practice implications

Regular exercise and PA can contribute to improved eating behaviors during weight management. This could represent an important incentive for people seeking weight control.     

Treatment of menopausal hot flashes with 5-hydroxytryptophan

Objective

Much recent research has focused on nonhormonal treatments for menopausal hot flashes. The purpose of the present study was to determine the effects of 5-hydroxytroptophan (5-HTP), the immediate precursor of serotonin, upon menopausal hot flashes. Selective, serotonergic, reuptake inhibitors (SSRIs), which increase the amount of serotonin in the synaptic gap, have shown some promise in the amelioration of hot flashes.

Methods

We administered 5-HTP or placebo, in double-blind fashion, to 24 postmenopausal women reporting frequent hot flashes. Treatment outcome was measured using a miniature, electronic, hot flash recorder.

Results

No significant effects of 150 mg/day 5-HTP upon hot flash frequency were found. The 5-HTP group had 23.8 ± 5.7 (SD) hot flashes/24 h prior to treatment and 18.5 ± 9.6 at the end of treatment. The placebo group had 18.5 ± 9.6 before treatment and 22.6 ± 12.4 at treatment completion.

Conclusions

At the dose given, 5-HTP does not significantly ameliorate frequency of menopausal hot flashes, as measured objectively with an electronic recorder. Given the small size, this study must be considered preliminary in nature.     

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.