Escitalopram versus ethinyl estradiol and norethindrone acetate for symptomatic peri- and postmenopausal women: impact on depression, vasomotor symptoms, sleep, and quality of life

OBJECTIVE: To examine the efficacy and tolerability of escitalopram (ESCIT) compared to estrogen and progestogen therapy (EPT) for the treatment of symptomatic peri- and postmenopausal women. DESIGN: Forty women (aged 40-60 years) with depressive disorders and menopause-related symptoms were randomly assigned to an 8-week open trial with ESCIT (flexible dose, 10-20 mg/day; fixed dose, 10 mg/day for the first 4 weeks) or estrogen plus progestogen therapy (ethinyl estradiol 5 microg/day plus norethindrone acetate 1 mg/day). Primary outcome measures included Montgomery-Asberg Depression Rating Scale and the Greene Climacteric Scale at week 8. Secondary outcome measures included the Clinical Global Impressions as well as sleep and quality of life assessments. RESULTS: Thirty-two women (16 on EPT, 16 on ESCIT) were included in the analyses. Full remission of depression (score of <10 on the Montgomery-Asberg Depression Rating Scale) was observed in 75% (12/16) of subjects treated with ESCIT, compared to 25% (4/16) treated with EPT (P = 0.01, Fisher's exact tests). Remission of menopause-related symptoms (>50% decrease in Greene Climacteric Scale scores) was noted in 56% (9/16) of women treated with ESCIT compared to 31.2% (5/16) on EPT (P = 0.03, Pearson's chi2 tests). Improvement in sleep, hot flashes, and quality of life was observed with both treatments. CONCLUSIONS: ESCIT is more efficacious than EPT for the treatment of depression and has a positive impact on other menopause-related symptoms. ESCIT may constitute a treatment option for symptomatic menopausal women who are unable or unwilling to use hormone therapy.     

Applied relaxation and oral estradiol treatment of vasomotor symptoms in postmenopausal women

OBJECTIVE: The aim was to evaluate and compare the effects of applied relaxation and oral estradiol treatment on hot flushes, mood and psychological wellbeing in postmenopausal women. PATIENTS AND METHODS: In a prospective study, 30 postmenopausal women with vasomotor symptoms were randomized to applied relaxation or oral estradiol treatment during 12 weeks with 6 months follow-up. Number and severity of flushes were registered daily and Kupperman's Index and a general estimate of climacteric symptoms, Mood Scale and Symptom Check List were completed at baseline, 4, 8 and 12 weeks of treatment, and 3 and 6 months after therapy. RESULTS: After 12 weeks of treatment, the number of flushes/24 h decreased significantly over time in both treatment groups. In the group receiving applied relaxation, the mean number of flushes/24 h decreased from 6.0 (95% CI 4.5-7.6) to 3.0 (95% CI 2.1-3.9) after 12 weeks of treatment. The mean number of flushes/24 h was 1.7 (95% CI 0.7-2.5) at 6 months follow-up; i.e. a 72% decrease. In the estrogen group, the mean number of flushes/24h decreased from 8.4 to 0.8; i.e a 90% decrease in the number of flushes after 12 weeks of treatment. The significant change in flushes reached after 12 weeks of treatment and remained to 6 months after end of treatment in both groups. Estrogen therapy reduced flushes significantly faster than applied relaxation. General climacteric symptoms according to the Visual Analogue Scale and the Kupperman's Index decreased significantly over time in both groups. General mood (Mood Scale) increased significantly in the estrogen group, but not in the group receiving applied relaxation. Psychological wellbeing according to Symptom Checklist, increased significantly from baseline to 12 weeks in both groups. CONCLUSIONS: We suggest that applied relaxation may be used as an alternative treatment of vasomotor symptoms for postmenopausal women but should be further evaluated.     

Percutaneous 17beta-estradiol gel for the treatment of vasomotor symptoms in postmenopausal women

OBJECTIVE: To determine the efficacy and tolerability of two strengths of percutaneous 17beta-estradiol in a hydroalcoholic gel and placebo in controlling vasomotor symptoms of menopause. DESIGN: A total of 221 postmenopausal women were assigned randomly to treatment with percutaneous 17beta-estradiol gel 1.25 g (containing 0.75 mg of estradiol) or 2.5 g (containing 1.5 mg of estradiol) or placebo gel applied once daily for 12 weeks. The primary efficacy variable was the mean change from baseline in the frequency of moderate/severe hot flushes. In addition, the mean changes from baseline in the frequency and severity of all hot flushes were assessed. Safety and tolerability were evaluated from endometrial biopsy, adverse events, and laboratory tests. RESULTS: A significant reduction (P < 0.05) in the mean frequency of moderate-to-severe hot flushes and mean frequency and severity of all hot flushes was observed with both 17beta-estradiol gel groups compared with placebo. The mean number of moderate-to-severe hot flushes at the end of the study with 17beta-estradiol gel 2.5 g, 17beta-estradiol gel 1.25 g, and placebo gel was 2.0, 2.8 and 5.2, respectively. The overall incidence of adverse events was not significantly different among groups, though a higher incidence of estrogen-related adverse events was reported with the 17beta-estradiol gel 2.5-g dose. CONCLUSIONS: 17beta-estradiol gel was effective and well tolerated for alleviating moderate-to-severe hot flushes in postmenopausal women. Therapy may be initiated with the 1.25-g dose with an increase to the 2.5-g dose if needed.     

Associations of blood selenium and serum lipid levels in Japanese premenopausal and postmenopausal women

OBJECTIVE: The purpose of this study was to investigate whether the level of selenium in serum or the level of selenium in erythrocytes (E-Se) was associated with serum lipid parameters (total cholesterol [TC], triglycerides, and high-density and low-density lipoprotein cholesterol [LDL-C]) in pre- and postmenopausal women. DESIGN: Healthy female workers aged 35 to 60 years were recruited, and TC, triglycerides, high-density lipoprotein cholesterol, LDL-C, E-Se, and serum-Se levels were measured in 68 premenopausal and 59 postmenopausal women after excluding those who were treated for hyperlipidemia, receiving hormone therapy, had previous gynecological surgeries, or had irregular menstrual cycles. Information on these women, such as smoking status, current status of menstruation, and current or previous medical treatments, was obtained from a self-administered questionnaire. Correlation analyses and stepwise multiple regression analysis were applied to reveal the interrelationship between serum lipids and Se levels after adjusting for age, body mass index, smoking, and menopause status. RESULTS: Postmenopausal women had significantly higher levels of TC, triglycerides, and LDL-C and lower levels of E-Se than premenopausal women. TC and LDL-C levels after menopause correlated negatively with E-Se. These associations were also statistically significant after controlling for age, smoking status, and body mass index. E-Se was selected as a significant related variable to explain TC and LDL-C levels as well as body mass index by multiple regression analysis. CONCLUSION: E-Se may be one of the possible associated factors that decrease the levels of TC and LDL-C after menopause. Further studies are needed to clarify the cause-and-effect relationship of nutritional Se status and lipid profile.     

The effect of exercise on physical fitness and quality of life in postmenopausal women

OBJECTIVES: This study was designed to determine the effect of exercise on the physical fitness level and quality of life in postmenopausal women. 81 volunteer postmenopausal women who entered the menopause naturally and have been taking hormone replacement treatment (HRT) were divided randomly into two groups: exercise (n=41) and control (n=40). METHODS: Physical fitness tests and the Nottingham Health Profile (NHP) were used to assess physical fitness and quality of life in both groups, both before and after 6 weeks. The study group participated in an exercise programme, which was composed of sub-maximal aerobic exercises for a 6-week period 3 times a week. The statistical analyses were done by paired samples t-test and independent samples t-test. RESULTS: At the end of 6 weeks exercise period, when the two groups were compared after the exercise period, we found statistically significant differences in strength, endurance, flexibility and balance parameters in the exercise group (P<0.05). There was also a statistically significant change in the exercise group for the NHP indicating an improvement in the quality of life (P<0.05). CONCLUSIONS: In this study, it was concluded that the fitness level and quality of life on postmenopausal women could be improved by a regular and controlled exercise programme of 6 weeks.     

Relationship between blood pressure levels and bone mineral density in postmenopausal Turkish women

Introduction

We investigated the association between bone mineral density (BMD) detected by dual-energy X-ray absorptiometric (DXA) method and blood pressure (BP) in a large sample of postmenopausal women.

Material and methods

The current study was based on a retrospective analysis of 586 postmenopausal women with a mean age of 60.8 ±8.8 years, who were screened for osteopenia or osteoporosis by DXA. Patients with hypertension (HT, n= 306) were compared with normotensive (NT, n = 290) individuals. Bone mineral density results for the femur neck and spine were classified into 3 groups according to World Health Organization criteria: normal (T score > –1.0 SD), osteopenia (T score –1.0 to –2.5 SD) and osteoporosis (T score < –2.5 SD). Patients with osteopenia or osteoporosis (T score < –1.0 SD) were grouped as having low bone mass (LBM).

Results

There were no significant differences in femur T score, femur BMD, femur Z score, spinal T score, spinal BMD and spinal Z score between hypertensive and normotensive groups. The group of patients with low bone mass calculated from femur T scores had higher age, systolic BP, duration of hypertension and duration of menopause, but lower BMI. Similarly, patients with low spine BMD had higher age and duration of menopause, but lower BMI. Linear regression analysis showed a significant correlation between systolic BP and femur BMD and T score values. Furthermore, logistic regression analysis revealed that hypertension is an independent predictor of spinal osteopenia and osteoporosis.

Conclusions

The presence of hypertension is an independent predictor of spinal low bone density in Turkish women after menopause.     

Relationship between health-related quality of life domains and bone status in postmenopausal Japanese women

OBJECTIVE: To assess the relationship between health-related quality of life domains and bone status, including bone metabolism, in postmenopausal Japanese community women. DESIGN: The study subjects were 88 women who were participants in a screening program for osteoporosis in 2003 without a history of mental disorders, metabolic disorders, smoking, bone fractures, and/or estrogen treatment. The participation rate was 75.9%. The age range was 50 to 68 years (mean, 57), and body mass index (BMI) ranged from 15.7 to 36.6 (mean, 22.4). Health-related quality of life domains were evaluated using the Medical Outcomes Study Short-Form 36 Health Survey, and bone mineral content was measured by quantitative ultrasound of the calcaneus. Serum total osteocalcin and serum N-telopeptide were measured by enzyme-linked immunosorbent assay. Multiple linear regression models were used to study the association of age, BMI, and eight health-related quality of life domains as independent variables in age-corrected bone status and markers of bone turnover as dependent ones. RESULTS: The participants' calcaneal Z scores by quantitative ultrasound ranged from -2.14 to 2.71. The mean Z score was -0.17 (-0.27, -0.07). Multiple regression analysis revealed that BMI (P < 0.05), physical function (P < 0.01), and role-emotional (role limitations caused by emotional problems) (P < 0.01) were factors in increasing bone mineral content. Also, a positive relationship was found between vitality (P < 0.01), social function (P < 0.05), and total osteocalcin. CONCLUSIONS: Although causality is not clear, in addition to low BMI, role limitations due to poor emotional status and low physical function are related to low bone mineral content in postmenopausal Japanese community women. These results imply that when we are concerned about osteoporosis in postmenopausal women, we should pay attention not only to their physical function but also to their psychological state.     

绝经后妇女骨质疏松患者血清IGF-1、IGFBP-3与骨密度及骨代谢指标的关系

目的： 探讨胰岛素样生长因子-1（IGF-1）和胰岛素样生长因子结合蛋白-3（IGFBP-3）与绝经后妇女骨密度及骨代谢指标之间的关系。方法： 通过检测90例绝经后妇女骨质疏松患者及70例绝经后骨量正常的健康对照组血清IGF-1、IGFBP-3、骨钙素（BGP）、I型胶原异构C端肽（β-CTX）、雌激素（E₂）、降钙素（CT）、甲状旁腺激素（PTH）、钙（Ca）、磷（P）等指标，然后同用双能X线骨密度仪检测的两组研究对象的腰椎（L2-L4）侧位、左股骨颈骨密度进行比较。结果： 绝经后骨质疏松组妇女腰椎、股骨颈骨密度显著低于对照组（均P<0.01）；血清IGF-1、IGFBP-3、E₂、CT、BGP水平均低于对照组（均P<0.01）；血清β-CTX、PTH均高于对照组（均P<0.01），血清Ca、P两组之间无差异（均P>0.05）。骨质疏松组和对照组腰椎侧位、左股骨颈BMD均与IGF-1、IGFBP-3、E₂、BGP、CT水平呈正相关，与β-CTX、PTH水平呈负相关，而与血钙、血磷无明显关系。结论： IGF-1、IGFBP-3、E₂、BGP、CT、β-CTX、PTH血清水平与腰椎、左股骨质具有明显的相关性，通过检测上述指标可考虑作为筛查绝经后妇女是否容易患有骨质疏松症的一项有价值的生化参考指标。     

Long-term effect of transdermal hormonal therapy on aspects of quality of life in postmenopausal women

The long-term effect on aspects of quality of life (QoL) of treatment with transdermal oestrogen for 2 weeks followed by transdermal oestrogen/progestogen norethisterone acetate/oestradiol TTS 0.25/0.05 mg/day for the next 2 weeks was investigated in postmenopausal women within the framework of a 1-year seven-centre trial. Of the 136 women who were included (mean age 53 ± 4.8 years), 110 completed the study. Aspects of QoL that are of relevance in the perimenopause and postmenopause were evaluated using the Psychological General Well-Being (PGWB) index, the Women's Health Questionnaire (WHQ) and the Sleep Dysfunction Scale before and after 3 and 9 months of therapy in the oestrogen phase. Climacteric complaints were also assessed by means of the Kupperman Index. Improved well-being, i.e. less anxiety and depression, increased vitality and better self-control (P < 0.0001) were observed, as well as reduced sleep disturbance (P < 0.0001). The WHQ showed decreased vasomotor and somatic symptoms, and improved sex life, emotions and cognitive function (P < 0.0001). Improvement was the same at 3 and 9 months. According to the Kupperman Index, climacteric symptoms were alleviated (P < 0.0001). Relief of vasomotor symptoms was correlated with improvement in the WHQ (r = 0.82), the PGWB index (r = 0.58, P < 0.0001) and sleep (r = 0.51, P < 0.0001). Because of the absence of a placebo control group, the results must be regarded with caution until confirmed in a placebo-controlled trial.     

Effects and safety of Pueraria mirifica on lipid profiles and biochemical markers of bone turnover rates in healthy postmenopausal women

OBJECTIVE: To evaluate the effect of Pueraria mirifica on lipid profiles and biochemical markers of bone turnover rates in healthy postmenopausal women and to evaluate the safety of Pueraria mirifica on endometrium; breast tissue; and hematologic, hepatic, and renal systems. DESIGN: This was a randomized, double-blind, placebo-controlled study in a university hospital of healthy postmenopausal women aged 45 to 60 years old. Women were enrolled voluntarily and randomly received 20, 30, or 50 mg Pueraria mirifica in capsules or identical placebo once daily for 24 weeks. Outcome measures were lipid profiles, bone-specific alkaline phosphatase level, endometrial thickness, endometrial histology, breast ultrasonography, complete blood count, liver function test, and renal function test. RESULTS: After 24 weeks of treatment, 71 women were evaluated. Of the 71 women, 51 randomly received varying doses of Pueraria mirifica and 20 received placebo. Pueraria mirifica and placebo significantly increased triglyceride levels by 15% from baseline levels (P<0.05). The Pueraria mirifica group showed a significant decrease in bone-specific alkaline phosphatase levels after 24 weeks of treatment compared with the placebo group; from 0.22+/-0.18 U/L to 0.13+/-0.01 U/L in the Pueraria mirifica group and from 0.20+/-0.10 U/L to 0.20+/-0.14 U/L in the placebo group. Endometrial thickness did not change after treatment in both groups (P>0.05). No endometrial proliferation or hyperplasia was reported after 24 weeks of treatment in both groups. There were no significant differences in adverse effects on breast tissue, complete blood count, and liver and renal function tests between the Pueraria mirifica and placebo groups in this study. CONCLUSION: Pueraria mirifica at a dose of 20, 30, and 50 mg/d for a 24-week period demonstrated an estrogen-like effect on bone turnover rate. Pueraria mirifica did not demonstrate an estrogen-like effect on endometrial thickness and endometrial histology. Mild adverse effects occurred after Pueraria mirifica and placebo treatment.     

Differential effects of estrogen-androgen and estrogen-only therapy on vasomotor symptoms, gonadotropin secretion, and endogenous androgen bioavailability in postmenopausal women.

OBJECTIVE: To investigate somatic symptom relief, gonadotropin secretion, and endogenous androgen bioavailability (protein-bound and free) during 3 months of estrogen-androgen therapy or matched estrogen-only replacement therapy. DESIGN: Ninety-three naturally menopausal outpatients with 6 or more months of amenorrhea, who were experiencing mild-to-moderate vasomotor symptoms, were randomized to receive one of five treatments: oral esterified estrogens (0.625 mg or 1.25 mg), oral esterified estrogens combined with methyltestosterone (0.625 mg combined with 1.25 mg methyltestosterone or esterified estrogens 1.25 mg combined with 2.5 mg methyltestosterone), or placebo for 12 weeks. All treatments were preceded by a 4-week placebo lead-in period. RESULTS: Patients receiving the lower dose of estrogen-androgen therapy had fewer somatic menopausal symptoms than patients receiving the lower dose estrogen (0.625 mg), and they experienced somatic symptom relief similar to those patients receiving the higher dose of estrogen (1.25 mg). Significantly greater luteinizing hormone suppression (p < or = 0.03) occurred in estrogen-androgen groups compared to estrogen groups, suggesting that added androgen might mediate a more pronounced negative feedback on the hypothalamic-pituitary axis. Sex hormone-binding globulin increased significantly in both estrogen-treated groups (p < or = 0.01), whereas decreases occurred in both estrogen-androgen groups (p < or = 0.006). The higher dose estrogen-only preparation significantly reduced androstenedione (p < or = 0.01) and dehydroepiandrosterone sulfate (p < or = 0.005). CONCLUSION: The extent of relief with lower dose estrogen-androgen therapy was similar to higher dose estrogen-only treatment. The greater efficacy of combination therapy on somatic symptoms could be mediated by the same mechanism responsible for the suppressive effects of estrogen-androgen therapy on luteinizing hormone secretion. The marked differences in circulating levels of sex hormone building globulin, which were increased by estrogen and decreased by estrogen-androgen, and the resulting impact on bioavailable androgens and estrogens could also explain the differential somatic relief with both treatments. Endogenous adrenal androgens were lower in women treated with esterified estrogens 1.25 mg/day, suggesting that estrogen therapy can produce a significant hypoandrogenic state by inhibiting production or accelerating clearance of adrenal androgens.     

A prospective,randomized, placebo-controlled study of the dose effect of oral oestradiol on menopausal symptoms,psychological well being,and quality of life in postmenopausal Chinese women

OBJECTIVES: Hypoestrogenism occurring in association with the menopause may result in the development of vasomotor symptoms and it may also have a detrimental effect on psychological well being and quality of life (QOL). The aims of this study were to measure menopausal symptoms, mood and QOL in postmenopausal Chinese women and to assess the effect of different doses of oestrogen on these outcome indicators. METHODS: A prospective, randomized, placebo-controlled study of the effect of 1 and 2 mg oestradiol on menopausal symptoms, anxiety and depressive symptoms, and QOL in 152 postmenopausal women over a 12 month study period. Menopausal symptoms were measured using a modified Kupperman's scale. Anxiety and depressive symptoms and QOL were measured using the Hospital Anxiety and Depression Scales and a modification of the World Health Organization Quality of Life questionnaire, respectively. RESULTS: Baseline scoring of vasomotor symptoms in our population was low whilst QOL scoring was relatively high. Over 12 months, after adjustment for differences in baseline scoring, there was a significant reduction in menopausal symptom scores in the 2 mg oestradiol group compared with placebo but not in the 1 mg group. There were no statistically significant changes in levels of anxiety and depression or QOL in either the 1 or the 2 mg group compared with placebo. CONCLUSIONS: These results suggest that relatively few Chinese women will be expected to benefit from hormone replacement in terms of either QOL or mood. In addition, the overall benefit of treatment for vasomotor symptoms will be less for a given number of Chinese women than for Caucasians. Therefore, when considering the reasons for prescribing hormone replacement therapy in this population, protection against osteoporosis will for most women be the prime consideration.     

Bone turnover markers and bone mineral density in hypertensive postmenopausal women on treatment

Objective

To evaluate bone mineral density (BMD) and bone metabolism in hypertensive postmenopausal women, and to differentiate the effect of thiazides from that of other antihypertensive agents.

Subjects and methods

A community-based population of 636 postmenopausal women, 293 with hypertension (160 receiving thiazides, and 133 receiving other antihypertensive treatments), and 343 control women, were evaluated. Serum levels of aminoterminal propeptide of type I collagen (P1NP), C-terminal telopeptide of type I collagen (β-CTX), 25-hydroxivitamin D, and intact parathyroid hormone were measured by electrochemiluminiscence. BMD was determined by DXA, and heel quantitative ultrasound measurements (QUS) with a gel-coupled device.

Results

BMD expressed as Z-score was higher in both groups of hypertensive women at all locations. Expressed as g/cm², it was also higher in patients on thiazides at femoral neck and lumbar spine. Only in the latter site, differences remained significant after adjusting for potential confounding variables, including BMI. Bone turnover markers were lower in both groups of hypertensive women, although the difference was greater in those on thiazides. After adjusting for potential confounders, differences remained significant only in the thiazide group.

Conclusions

Our results add evidence to the idea that thiazides are beneficial to prevent bone loss.     

Vasomotor symptoms and quality of life in previously sedentary postmenopausal women randomised to physical activity or estrogen therapy

OBJECTIVE: To assess if regular physical exercise or oral oestradiol therapy decreased vasomotor symptoms and increased quality of life in previously sedentary postmenopausal women. SETTING: A prospective, randomised trial at a University Hospital. METHODS: 75 postmenopausal, sedentary women with vasomotor symptoms were randomised to: exercise three-times weekly over 12 weeks (15 women), oral oestradiol therapy for 12 weeks (15 women) and 45 women to three other treatment arms. Results from the exercise and oestradiol groups are presented here. The effects on vasomotor symptoms and wellbeing were assessed with logbooks and validated questionnaires. RESULTS: Ten women fulfilled 12 weeks of exercise. The number of flushes was rather unchanged in five women and decreased to 28% (range 18-42%) of baseline in the other five women. Five of the ten women continued to exercise another 24 weeks, thus in all 36 weeks. The mean number of flushes decreased by about 50% in these five women (from 6.2/24 to 3.2 flushes/24 h at 36 weeks). In the same group a score made as the product of reduction in number and severity of flushes decreased by 92% at 12 weeks, 75% at 24 weeks and 72% at 36 weeks compared with baseline. In the estrogen group flushes decreased from 8.4 to 0.8 (P<0.001) after 12 weeks of therapy and remained at this level after 36 weeks. Well-being according to different measurements improved significantly in both groups, albeit more markedly in the estrogen group. CONCLUSIONS: Apart from many other health benefits regular physical exercise may decrease vasomotor symptoms and increase quality of life in postmenopausal women, but this has to be further evaluated scientifically. Exercise should be introduced gradually to ensure compliance.     

Soy protein and isoflavone effects on vasomotor symptoms in peri- and postmenopausal women: the Soy Estrogen Alternative Study

OBJECTIVE: To investigate the efficacy of dietary soy proteins containing differing amounts of isoflavones on the number and severity of vasomotor symptoms (hot flashes and night sweats) in peri- and postmenopausal women. DESIGN: A double-masked, randomized, controlled, clinical trial was conducted. A total of 241 community-dwelling women reporting vasomotor symptoms at baseline were randomized into one of three groups. In all groups, participants consumed a daily supplement containing 25 g of soy protein and were randomly assigned to one of three groups: (a) isoflavone extracted soy protein (control), (b) soy protein with a medium dose of isoflavones (42 mg/day), or (c) soy protein with a higher dose of isoflavones (58 mg/day). The primary outcome measure in this trial was change in reported vasomotor symptoms. RESULTS: A reduction in the number and severity of vasomotor symptoms was observed in all three treatment groups. No significant differences in the number and severity of vasomotor symptoms were observed among the high isoflavone, middle isoflavone, or control groups. The lack of a between-treatment group effect was observed even after stratified by number of baseline symptoms and use of traditional hormone replacement therapy. CONCLUSIONS: These data suggest that soy protein containing 42 or 58 mg of isoflavones is no more effective than isoflavone-extracted soy protein for improving the number and severity of vasomotor symptoms in peri- and postmenopausal women.     

Bazedoxifene/conjugated estrogens and quality of life in postmenopausal women

Objective

To assess the effects of bazedoxifene/conjugated estrogens (BZA/CE) on sleep parameters and health-related quality of life (HR-QOL).

Methods

This was a 12-week, multicenter, double-blind, placebo-controlled phase 3 study. Postmenopausal women with an intact uterus and experiencing ≥7 moderate-to-severe hot flushes daily were randomized to BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo. In these secondary efficacy analyses, the Medical Outcomes Study (MOS) sleep scale and Menopause-Specific Quality of Life (MENQOL) questionnaires and the Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) evaluated measures of sleep, menopausal symptoms, and satisfaction with treatment, respectively.

Results

A total of 318 subjects (mean age, 53.4 years) received ≥1 dose of study drug. At Week 12, BZA 20 mg/CE 0.45 and 0.625 mg showed significant improvements over placebo in the MOS sleep scale for time to fall asleep, sleep adequacy, sleep disturbance, and sleep problems indexes I and II (P < 0.001). A reduction in hot flush frequency was significantly associated with improvement in sleep parameters (P < 0.05) based on linear regression and responder analyses. Both BZA/CE doses showed significantly greater improvements over placebo in vasomotor function and total MENQOL score (P < 0.001). Results of the MS-TSQ showed that subjects treated with BZA/CE versus placebo reported significantly greater overall satisfaction with treatment (P < 0.05), as well as greater satisfaction with sleep quality, ability to control hot flushes during the day and night, effect on mood/emotions, and tolerability.

Conclusion

Symptomatic postmenopausal women treated with BZA/CE experienced significant improvements in sleep parameters and overall HR-QOL.     

The influence of tibolone on quality of life in postmenopausal women.

OBJECTIVES: To examine the effect of tibolone, a synthetic steroid with tissue-specific activity, on quality of life in a randomised, double-blind, placebo-controlled study in healthy postmenopausal women. MATERIAL AND METHODS: A total of 85 women (54.2+/-4.7 years), were randomised to 2.5 mg tibolone (Livial) or to identically appearing placebo pills daily for 12 months. Quality of life was assessed with the Nottingham Health Profile (NHP). Also, information on the occurrence of climacteric complaints and incidences of vaginal bleeding/spotting was gathered. RESULTS: Compared to baseline values, the tibolone group significantly improved on three out of six NHP domains: overall 46.8-25.3, emotional reactions 6.8-2.9 and sleep 19.0-7.2. In the placebo group a significant difference from baseline was observed on the 'physical mobility' parameter: 6.9-3.0. Significant between-group difference was only reached on the domains 'sleep': tibolone 7.2 versus placebo 15.2 and 'physical mobility': tibolone 3.8 versus placebo 3.0. The occurrence of hot flushes and nightly sweats was significantly lower in the tibolone group compared to placebo after 12 months of treatment. Throughout the study period a total of four women in the placebo, compared to 16 women in the tibolone group, reported vaginal bleeding/spotting. CONCLUSIONS: A trend favouring tibolone was observed. However, improvements from baseline were only reflected in a significant between-group difference on the domains of sleep and physical mobility. The limited sample size might have caused this ambiguity. Further research in a larger population is recommended to clear this inconsistency.