Menopausal Quality Research Articles

Efficacy and safety of vaginal estriol and progesterone in postmenopausal women with atrophic vaginitis

The aim of this study was to assess the efficacy and safety of intravaginal estriol and progesterone on atrophic vaginitis in postmenopausal women. Under a physician-sponsored Investigational New Drug application, 19 healthy postmenopausal women with atrophic vaginitis received vaginal suppositories containing estriol (1 mg) and progesterone (30 mg). The participants were instructed to insert one suppository intravaginally once daily for 2 weeks and thrice weekly for a total of 6 months. Vaginal pH, Vaginal Maturation Index, urinalysis, self-reported vaginal dryness, menopausal quality of life, and serum estriol and progesterone levels were measured at enrollment and after 3 and 6 months of suppository use. Endometrial biopsies were obtained at enrollment and at 6 months. After 2 weeks of therapy, six participants had serum estriol and progesterone measured. The Vaginal Maturation Index, vaginal pH, and vaginal dryness rating improved significantly at 3 and 6 months compared with baseline. Menopausal quality of life scores improved significantly in all domains, with the sexual subscale showing the most improvement. There were no cases of endometrial hyperplasia after 6 months of suppository use. Serum preinsertion estriol at week 2 and months 3 and 6 were similar to baseline levels. Serum preinsertion progesterone increased but returned to baseline preinsertion levels at month 6, and preinsertion levels were significantly less at month 6 compared with month 3. Intravaginal administration of a combination estriol and progesterone agent to women with atrophic vaginitis may represent a safe and effective alternative to systemic hormone replacement, although this study was not adequate to provide proof of efficacy given that it was uncontrolled.

Effect of Soy Isoflavone Supplementation on Menopausal Quality of Life

Recent clinical trials have found an increased risk of health problems in women using menopausal hormone therapy. As a result, women are in search of alternative strategies to improve their quality of life. The purpose of this study was to assess the effect of soy isoflavone supplementation on quality of life in postmenopausal women. 403 healthy postmenopausal women (54.0+4.0 yrs) were enrolled in a 2 year multicenter, randomized, controlled trial designed to evaluate the effect of soy isoflavone supplementiation on the prevention of osteoporosis. Quality of life was assessed as a secondary outcome and was measured using the validated Menopause‐Specific Quality of Life Questionnaire (MENQOL) administered at baseline and at annual intervals. Participants were randomly assigned to receive soy isoflavones 80 mg/d, soy isoflavones 120 mg/d, or placebo. Data were analyzed using an analysis of variance (ANOVA). Baseline characteristics were similar among the three groups. There was a non‐significant decrease i.e. improvement, in the vasomotor domain score at one and two years compared to baseline in all three groups. However, there were no differences among groups. In conclusion, soy isoflavones provide no added benefit over placebo in terms of qualifty of life as measured by the MENQOL. Supported by IFAFS 2001‐52102‐11255 USDA CSREES.

Factors influencing women's quality of life in the later half of life

Background Among older women in East Asia, and Taiwan in particular, there is little research on quality of life and the health care they receive to address the symptoms of menopause. This study evaluated factors which influence quality of life among post middle-age women in Taiwan.Methods This cross-sectional study recruited 1250 women between 43 and 77 years of age during the year 2002. The factors investigated were demographics, menstruation status, menopausal symptoms, osteoporosis status, and use of hormone replacement therapy (HRT). SF-36 was used to assess the health-related quality of life of these women. Correlation, multiple regression and path analysis were used to test for direct and indirect relationships among the variables.Results There are statistical significances between menopause symptoms and quality of life across different age groups. Path analysis shows a direct positive effect of HRT and a direct negative effect of climacteric symptoms on both physical and mental components of quality of life. Age, marital status, education and osteoporosis also have direct and indirect effects, some positive and others negative, on the components of quality of life.Conclusions When developing programs to enhance health in post middle-age women, consideration should be given to symptom relief as well as quality of life.

Daidzein-rich isoflavone aglycones are potentially effective in reducing hot flashes in menopausal women

The aim of this study was to determine the effect of DRIs on hot flash symptoms in menopausal women. This was a randomized, double-blind, placebo-controlled trial of menopausal women, aged 38 to 60 years, who experienced 4 to 14 hot flashes per day. After a 1-week run-in period, a total of 190 menopausal women were randomized to receive a placebo or 40 or 60 mg/day of a DRI for 12 weeks. The primary outcome was the mean changes from baseline to week 12 in the frequency of hot flashes recorded in the participant diary. The secondary outcomes included changes in quality of life and hormonal profiles. A total of 147 women (77%) completed the study. It was found that 40 and 60 mg of DRI improved hot flash frequency and severity equally. At 8 weeks hot flash frequency was reduced by 43% in the 40-mg DRI group and by 41% in the 60-mg DRI group, compared with 32% in the placebo group (P = not significant vs placebo). The corresponding numbers for 12 weeks were 52%, 51%, and 39%, respectively (P = 0.07 and 0.09 vs placebo). When comparing the two treatment groups with the placebo group, there were significant reductions in mean daily hot flash frequency. The supplement (either 40 or 60 mg) reduced hot flash frequency by 43% at 8 weeks (P = 0.1) and 52% at 12 weeks (P = 0.048) but did not cause any significant changes in endogenous sex hormones or thyroid hormones. Menopausal quality of life improved in all three groups, although there were no statistically significant differences between groups. DRI supplementation may be an effective and acceptable alternative to hormone treatment for menopausal hot flashes.

Validation of a menopause quality of life scale: The MENCAV scale

Objective To assess the criterion validity, construct validity and test–retest reliability of the MENCAV menopause quality of life scale. Methods Observational, cross-sectional study covering a random sample of 470 women aged 40–60 years. Two questionnaires were administered, namely, the MENCAV, made up of 37 items in 5 dimensions, and the SF-36. A confirmatory factorial analysis was performed, leaving a final scale with 35 items. To evaluate criterion validity, the relationship between the physical and mental health dimensions of both instruments was estimated. Two experts assessed 40 menopausal women and recorded the correlations with the MENCAV. Construct validity was evaluated by comparing the mean scores of menopausal and non-menopausal women for each of the MENCAV dimensions. To assess test–retest reliability, we estimated the correlation between MENCAV scores when the questionnaire was administered on two separate occasions, 2 weeks apart. Results The final questionnaire comprised 35 items divided into 5 dimensions. All dimensions displayed high levels of reliability, with Cronbach's α values ranging from 0.71 to 0.91, and Cronbach's α for the total scale being 0.89. The intraclass correlation was 0.77 (95% CI: 0.61–0.87). Correlations between the questionnaire and the SF-36 were significant; and those with the experts were significant for the physical, mental and sexual dimensions. Conclusions The MENCAV is a valid and reliable questionnaire for assessing quality of life in menopausal women.

Tamoxifen-related endocrine symptoms in early breast cancer patients are relieved when it is switched to anastrozole

10597 Background: To determine how menopausal symptoms and quality of life changed when adjuvant tamoxifen has been suspended for any reason in favor of anastrozole in early breast cancer (BC) patients (pts). Methods: Major inclusion criteria: severe side effects or serious potential diseases caused by tamoxifen (20 mg die) that switched to anastrozole (1 mg die); confirmed early BC radically resected and with positive hormonal receptors; postmenopausal status; adjuvant chemo and/or radiotherapy suspended at least 4 wks before the hormonal switch. Exclusion criteria: discontinuation of tamoxifen for endocrine symptoms. Menopausal symptoms and health-related quality of life were assessed by the series of Functional Assessment of Cancer Therapy-Breast (FACT-B) plus endocrine subscale (ES) questionnaires at the switch and 3, 6, 9, and 12 months later. Sample size was decided by the effect size method (SD fixed as 0.5, effect of medium value). Score modifications were evaluated by one-way ANOVAS. Results: From Feb 2002 to Jun 2003, a total of 44 women were enrolled into the study. Discontinuation of tamoxifen was for: asymptomatic uterine problems (endometrium thickening or fibromatosis) in 56% of pts; cardiovascular disorders (mainly leg thrombosis and phlebitis) in 18%; patient’s refusal in 9%; GI persistent side effects in 5%; other reasons in 12% of pts. Endocrine symptoms ameliorated between baseline and 3 months, and stabilized thereafter. Mean ES scores improvement from baseline test was +3 (95% CI, 1 to 5), +4 (95% CI, 3 to 6), +5 (95% CI, 3 to 7), and +4 (95% CI, 3 to 6) at 3, 6, 9 and 12 months, respectively. FACT-ES global score had a mean improvement during 1-yr period of 9 points (95% CI 6 to 13, p < .0005), with 22 patients (50%) ever reaching an increase ≥ 5% of the baseline score. There also was a significant improvement in TOI score (+4 points, 95% CI 2 to 6, p < .0005), and physical and breast cancer subscales (+2, 95% CI 1 to 2, p < .001, and +1, 95% CI, 1 to 2, p < .001, respectively). Pts receiving anastrozole reported higher rate of mild arthritic and bone pain (27% vs 7%, p = .021). Conclusion: When a patient develops an endocrine symptom while on tamoxifen, a change in favor of anastrozole should be considered to minimize those symptoms and to improve quality of patient’s life. No significant financial relationships to disclose.

Pilot Study of Hormone Replacement Therapy and Menopausal Symptoms, Depression, and Quality of Life in Korean Climacteric Women

This cross-sectional survey compared scores on the Menopausal Symptoms Index, Depression, and the Quality of Life for 65 Korean climacteric women receiving regular hormone replacement therapy (M age=52.8 yr., SD=6.3) and 70 Korean climacteric patients not receiving such therapy (M age =51.6 yr., SD=7.1). Depression scores were positively correlated with the Menopausal Symptoms Index in both groups (r = .58 in the Therapy group and r = .50 in the Control group) and negatively correlated with scores for Quality of Life (r = -.48 in the Therapy group and r = -.68 in the Control group). Scores on the Menopausal Symptoms Index were negatively correlated with ratings of Quality of Life in both groups (r = -.53 in the Therapy group and r = -.45 in the Control group). These results suggest that hormone replacement therapy is associated with reduced Depression scores and higher Quality of Life scores in this sample of Korean climacteric women.

Quality of life assessment in a chemoprevention trial: Fenretinide and oral or transdermal HRT

Background Oral conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA) relief menopause symptoms, but may increase breast cancer risk, while the effects of transdermal estradiol (E2) and MPA are less known. In previous studies, fenretinide decreased second breast malignancies in premenopausal but not in postmenopausal women, suggesting a hormone-sensitizing effect. We have evaluated the quality of life through a self-administered questionnaire during a randomized study of oral CEE or transdermal E2 and fenretinide or placebo. Methods A total of 226 postmenopausal women were randomly assigned to either CEE 0.625 mg/day and placebo ( n = 55), or CEE and fenretinide 100 mg/bid ( n = 56), or E2, 50 μg/day and placebo ( n = 59), or E2 and fenretinide ( n = 56) for 12 months. Sequential MPA 10 mg/day was added in all groups. Treatment effects were investigated using a validated questionnaire, the Menopause Quality of Life questionnaire (MENQOL). Results Oral CEE and transdermal E2 have a comparable activity in reducing menopausal symptoms ( p = ns). Both routes ameliorate significantly the symptoms after 1 year of treatment ( p < 0.0001). Fenretinide does not modify the effects of hormonal replacement therapy. Conclusions Oral CEE and transdermal E2 have similar effect on menopausal symptoms relief. The choice of the best estrogen replacement therapy (ERT) route should be decided based on a careful analysis of all the clinical aspects of every subject, considering that transdermal therapy may have a safer effect on the cardiovascular system.

Cognitive behavior therapy for menopausal hot flashes: Two case reports

Two case reports of women treated with an individual cognitive behavioral treatment (CBT) for menopausal hot flashes are presented. Both women reported substantial improvements in the number of hot flashes experienced as well as in their quality of life as measured by the Menopause Quality of Life Scale (MENQOL), the Hamilton Rating Scale for Depression (HAM-D), and the Hamilton Rating Scale for Anxiety (HAM-A). Improvements in hot flashes and quality of life were maintained 6 months after treatment ended. It is hypothesized that CBT reduces hot flashes by reducing central sympathetic activation, perceptions of stress, and self-critical thoughts. The long-term efficacy of CBT for hot flashes should be examined in large controlled clinical trials.

Menopausal symptoms in a hospital-based sample of women in southern Thailand

Objective To evaluate menopausal symptoms and quality of life in middle-aged women.Study design Hospital-based, cross-sectional study.Methods A survey was conducted among 270 women aged 45–65 years who attended the gynecological and menopause clinic, Songklanagarind Hospital. We used the MENQOL questionnaire as the instrument.Results The average age at menopause of the postmenopausal women was 48.7 years (range 40–57 years). The prevalences of the classical menopausal symptoms – hot flushes, night sweats, and vaginal dryness – in the women aged 45–65 years were 36.8%, 20.8 and 55.3%, respectively. The three most prevalent symptoms in perimenopause were aching in muscles and joints, experiencing poor memory, and change in sexual desire. Within the four domains (vasomotor, psychological, physical, and sexual symptoms), more suffering was reported in the perimenopausal and postmenopausal subjects than in the premenopausal subjects (p < 0.001).Conclusions Peri- and postmenopausal women had a significant decrease in quality of life compared to premenopausal women.

Does the menopausal transition affect health-related quality of life?

Does the menopausal transition affect health-related quality of life?

A Multicenter, Open-Label Study to Evaluate Satisfaction and Menopausal Quality of Life in Women Using Transdermal Estradiol/Norethindrone Acetate Therapy for the Management of Menopausal Signs and Symptoms

Aim: This multicenter, open-label, single-arm study evaluated subject satisfaction and improvements in menopausal quality of life among menopausal women using the CombiPatch^® transdermal system consisting of 17β-estradiol 0.05 mg plus norethindrone acetate 0.14 mg in a matrix patch formulation. Methods: The 193 postmenopausal women between the ages of 45 and 65 years who comprised the modified intent-to-treat population (at least one patch and one efficacy assessment) were required to have reported at least five daily moderate-to-severe hot flashes and episodes of nocturnal sweating upon study entry for at least 1 month and applied one patch twice a week for 12 weeks. At weeks 0, 6, and 12, the women completed the Menopause-Specific Quality of Life (MENQOL) Questionnaire and, as a secondary study outcome, reported the scale of their application site discomfort. During weeks 1–12, they also kept diary records of number and severity of hot flashes and four other menopausal symptoms. Skin tolerance and adherence of the transdermal system were evaluated at weeks 6 and 12 by qualified evaluators. At week 6 and the end of the study, both subjects and physicians rated their satisfaction with the system. Results: Among women in the modified intent-to-treat population, transdermal 17β-estradiol plus norethindrone acetate significantly reduced the mean daily number of moderate-to-severe hot flashes experienced by women from 4.1 at week 1 to 0.6 at week 12 (p < 0.0001). The mean ratings of headache severity, insomnia, and vaginal irritation/dryness also improved significantly by week 6 and were maintained at week 12. At week 12, 92.4% of the subjects and 97.3% of the physicians reported that they were ‘satisfied’ or ‘very satisfied’ with the transdermal hormone delivery system. Conclusions: The results of this study compare favorably with previous placebo-controlled studies of transdermal hormone therapy in managing menopausal signs and symptoms. Furthermore, quality of life was significantly improved by the transdermal hormone therapy system, and both subjects and physicians reported high levels of satisfaction.

Literature review of instruments to assess health-related quality of life during and after menopause

Menopause is a physiological event occurring in women at about the age of 50. It signals the end of the reproductive years and is associated with signs of estrogen deficiency having a considerable impact on women's health-related quality of life (HRQoL). The most common form of treatment is hormone replacement therapy (HRT). Studies have shown negative events can arise from long-term use of HRT. The aim of this review is to determine if there are any HRQoL instruments that address the impact of menopausal symptoms including positive and negative effects of HRT. The following eight instruments were identified: Greene Climacteric Scale, Women's Health Questionnaire (WHQ), Qualifemme, Menopause-Specific QOL Questionnaire (MENQOL), Menopausal Symptoms List (MSL), Menopause Rating Scale (MRS), Menopausal Quality of Life Scale (MQOL), and the Utian Quality of Life Scale (UQOL). All instruments reviewed proved to be reasonably structured and have their place in applied research. None were found that addressed all aspects of the impact of HRT on HRQoL. In order to capture the possible short-term side effects of HRT on HRQoL, it is necessary to modify one or more of the existing instruments or develop a new instrument applicable in many different countries and languages.

Desempeño laboral y climaterio en trabajadoras de instituciones públicas

During climacteric, the presence of disabling symptoms and the higher incidence of chronic diseases, may impair the job performance of women. To relate job performance levels with the climacteric period and associated factors in working women aged from 42 to 55 years old. In a cross-sectional and correlative design, 64 secretaries at two public organizations at the Eighth Region of Chile, were assessed using the following instruments: Menopause-Specific Quality of Life Questionnaire (University of Toronto), adapted for Chile by PROSAM, Climacteric Self-care Questionnaire, Perceived Social Support Scale and Biodemographics Variables Questionnaire. A Perception of the Job Performance Scale was applied to the persons that superintended these woman. The Department Heads or persons supervising these women, determined that most workers did their work well. The best evaluations were given by older bosses. Most women under study showed a moderate alteration of the Menopause Quality of Life. A deficit of self-care during the climacteric period was detected in 92.2%. The perceived social support from friends correlated with job performance. Menopause quality of life in its different domains had no correlation with job performance variable. No association between changes during the climacteric period and job performance was observed among women participating in this study.

Breast cancer: relationship between menopausal symptoms, physiologic health effects of cancer treatment and physical constraints on quality of life in long‐term survivors

The purpose of this study is to describe the relationship between menopausal symptoms, physiologic health effects of cancer treatment and the physical contributors to quality of life in long-term survivors of breast cancer. The treatment of menopausal symptoms is hotly debated, especially for women with breast cancer. Common treatments for menopausal symptoms are considered to be contraindicated in women with breast cancer. This is a descriptive, cross-sectional study of long-term breast cancer survivors; a subset of a study that responded to a mailed survey targeting long-term cancer survivors treated at The University of Texas M.D. Anderson Cancer Center. In 291 breast cancer patients information was available that included items that commonly relate to menopausal symptoms including hot flushes, painful sexual intercourse, inability to concentrate, fatigue and sleep disturbances. Ninety per cent were Caucasian American and the mean time since diagnosis was 16 +/- 8 years. All patients had been treated with surgery, (60%) with radiotherapy, (68%) with chemotherapy and (37%) with hormonal therapy. Forty-six per cent of the breast cancer survivors indicated that having breast cancer affected their overall health. Self-reported health effects were more common in those survivors who had received a combination of chemotherapy and radiotherapy. A menopausal quality of life score was determined using the items about hot flushes, ability to concentrate, painful sexual intercourse, fatigue, unhappiness and sleep disturbances. This study reminds us that breast cancer and menopause are independent issues. Quality of life parameters need to be rigidly defined and time sensitive. There are complex interactions between quality of life indicators and specific physiologic consequences of treatment. However, menopausal signs and symptoms may not be different for the breast cancer survivor and they should not be confused with the quality of life/psychosocial issues of the cancer survivor. Menopause is not a disease process but a normal developmental stage for women. It is important for nurses not only to understand the client needs of the menopausal woman, but also to be able to differentiate between quality of life issues related to menopause and to cancer treatment in order to provide holistic nursing care.

Intranasal versus transdermal matrix oestrogen replacement in Australasian women

Objectives: To compare the efficacy and patient acceptability of intranasal and transdermal 17β-oestradiol delivery systems for postmenopausal symptoms in Australasian women. Methods: Symptomatic postmenopausal women were randomly assigned to treatment with either intranasal 17β-oestradiol, 300 μg daily ( n = 66) or transdermal matrix patch 17β-oestradiol, 50 μg/day ( n = 66) for 12 weeks, followed by a 4-week period with the alternate treatment. Efficacy was compared between groups using the modified Greene climacteric scale, the menopause quality of life (MENQOL) questionnaire and vasomotor symptoms at week 12. Patient acceptability was compared by a satisfaction questionnaire at week 16 and patient preference at week 16. Results: Intranasal and transdermal therapy produced significant reductions in both the Modified Greene and MENQOL scores, and in the occurrence of hot flushes and night sweats at week 12. The overall rate of reported vasomotor symptoms was lower on patients treated with the nasal spray. Both therapies were well tolerated with similar adverse event rates. Satisfaction and preference were similar for both modes of drug delivery. Conclusions: Intranasal oestradiol therapy route has comparable efficacy and safety to that of transdermal oestradiol matrix patch therapy with no difference in patient preference or satisfaction.

The effects of post-surgical administration of goserelin plus anastrozole compared to goserelin alone in patients with severe endometriosis: a prospective randomized trial

Among patients using GnRH analogues for endometriosis it has been postulated that peripheral and inflammation-induced in-situ aromatization of adrenal androgens are probably the main reasons for the high rates of failure during follow-up. We hypothesized that in cases with premenopausal severe endometriosis, use of a combination of anastrozole and goserelin to achieve almost maximal endocrine blockade of estrogen synthesis after conservative surgery may increase the pain-free interval and reduce the recurrence rates as compared to goserelin alone. In a prospective randomized trial, we evaluated the efficacy of using either a combination of anastrozole and goserelin for 6 months or goserelin alone for 6 months after conservative surgery for severe endometriosis. The primary outcome measures were the symptom recurrence rates and the impact of treatment on endometriosis-related multidimensional score. The secondary outcome measures were the impact of allocated treatment regimens on menopausal quality of life and on lumbar spine bone mineral density (BMD). When we analyzed the Kaplan-Meier survival curves, we detected a statistically significant advantage of goserelin plus anastrozole as compared to goserelin only, in terms of the median time to detect symptom recurrence (>2.4 versus 1.7 months; log-rank test; P=0.0089). This statistically significant advantage occurred with a relative risk of 4.3 [95% confidence interval (CI) 1.3-9.8]. Three cases out of 40 recurred in the goserelin plus anastrozole arm (7.5%), whereas we detected recurrences in 14 cases out of 40 cases in the goserelin-only arm (35%) during the follow-up period of 24 months. Based on these data, the interpretation of Kaplan-Meier curves indicates that at the end of follow-up, 54.7 versus 10.4%, respectively, of the patients were free of recurrence. The mean of the differences in terms of Deltabaseline-24 months post-medical therapy multidimensional score were statistically significant in favour of goserelin and anastrozole (9.2 +/- 2.1 versus 6.7 +/- 2.8; paired t-test; P<0.0001; 95% CI 1.5-4.0). We observed a statistically significant difference in suppression of estradiol concentrations and a significantly greater BMD loss at the end of treatment in the goserelin and anastrozole arm as compared to goserelin-only arm. However, this did not elicit deterioration in menopausal quality of life and the observed bone loss was not significant in terms of DeltaBMD between the groups at 2 years of treatment withdrawal. Six months of treatment with anastrozole and goserelin as compared to goserelin alone increased the pain-free interval and decreased symptom recurrence rates in patients following surgery for severe endometriosis. Furthermore, menopausal quality of life and BMD at 2 years after medical therapy remained unaffected.

An evaluation of the benefits of taking hormone replacement therapy with other prescription drugs

Objectives: Clinical trials of hormone replacement therapy (HRT) exclude women who have other health problems. The aim of our community survey was to investigate the impact of HRT on women with a variety of other health problems. Method: Questionnaire sample of 935 women aged 45–58 years. The questionnaire assessed menopausal quality of life (QOL); self reported health status, prescription drug use and history of hormone supplement use. Results: Thirty five percent of the total sample had taken a variety of prescription drugs in the last 2 months. Prescription drug use was significantly higher in current and former users of HRT/ERT than in non-HRT/ERT users. Current and former HRT users who also took prescription drugs had a significantly lower mean length of HRT/ERT use when compared to women who took HRT/ERT with no prescription drugs. Peri and postmenopausal women currently taking HRT/ERT reported significantly higher MQOL than both former and non-HRT users, which suggest that the benefits of taking hormone supplements during the menopausal transition for some women. There was a significant interaction between hormone use, level of prescription drug use and QOL. Among women who have high levels of prescription drug use, those who take hormone supplements report significantly fewer deficits in QOL when compared to non or former users of HRT/ERT. Additionally, women taking selective serotonin re-uptake inhibitors (SSRI) plus HRT report significantly higher levels of QOL compared to women taking SSRI alone. Conclusions: The advantages of taking HRT among who take prescription drugs could be attributed to the mood enhancing effects of estrogens. HRT should be considered for some peri and postmenopausal women who are taking SSRIs or who are taking at least three different types of prescription drugs.

Transdermal progesterone and its effect on vasomotor symptoms, blood lipid levels, bone metabolic markers, moods, and quality of life for postmenopausal women

To determine whether transdermal progesterone cream has any effect on vasomotor symptoms, mood, sexual response, cardiovascular lipid levels, or bone mineral metabolic markers. A parallel, double-blind, randomized, placebo-controlled trial comparing the effect of a transdermal cream containing a progesterone (32 mg daily) with a placebo cream. Eighty postmenopausal women in the Menopause Centre at the Royal Hospital for Women, Sydney, were randomly allocated to receive either the progesterone cream or the placebo. They were evaluated using the Greene Climacteric Scale and the Menopause Quality of Life Questionnaire, as well as blood analysis for lipids and bone markers over a period of 12 weeks. Women were prescribed a cream containing either progesterone at 32 mg daily or a placebo cream for a period of 12 weeks. There was no detectable change in vasomotor symptoms, mood characteristics, or sexual feelings, nor was there any change in blood lipid levels or in bone metabolic markers, despite a slight elevation of blood progesterone levels. The use of the transdermal route to administer progesterone at 32 mg daily does not seem to allow sufficient hormone to enter the body to achieve a biological effect on lipid levels, bone mineral metabolic markers, vasomotor symptoms, or moods.

Effects of low-dose, continuous combined estradiol and noretisterone acetate on menopausal quality of life in early postmenopausal women

Objectives: To describe the effects of low dose hormonal replacement therapy (LD-HRT) on quality of life in early postmenopausal women, since the postmenopausal estrogen deprivation in mid age women often brings along a series of changes and symptoms, which may greatly affect quality of life. Methods: Fifty normal postmenopausal women were recruited and randomly treated with LD-HRT, 17β-estradiol (1 mg/day) and norethisterone acetate (0.5 mg/day) (LD-HRT) or calcium supplement (controls). No significant differences in age, age at menopause, the presence of chronic diseases and socio-economic status were present in the two groups. The Women's Health Questionnaire (WHQ), a validated quality-of-life instrument for perimenopausal and postmenopausal women, was administered at baseline and after 6 and 12 weeks of treatment in both groups. Results: At baseline no significant differences in WHQ scores were present in the two groups. In the control group the scores in all different areas showed no significant modification either after 6 and 12 weeks of observation. Conversely, the LD-HRT group showed a significant decrease in the scores of vasomotor symptoms, somatic symptoms, anxiety/fear, depressed mood and sleep problem items. No effects on memory/concentration and menstrual symptoms areas were evident. Conclusion: Although quality of life is also and may be mainly influenced by socio-economic and cultural factors, LD-HRT definitively can improve not only vasomotor symptoms, but also more general aspects of physical and psychological well-being of symptomatic postmenopausal women.