Menopausal Symptoms In Postmenopausal Women Research Articles

Effectiveness of red clover in alleviating menopausal symptoms: a 12-week randomized, controlled trial

Objectives Menopausal women are interested in alternative therapy to alleviate climacteric symptoms. This study aimed to investigate the effect of red clover on the severity of menopausal symptoms.Methods This randomized, placebo-controlled, clinical trial included 72 healthy postmenopausal women, who were randomly divided into intervention and placebo groups. Women in the intervention group received two capsules containing 40 mg dried leaves of red clover daily for 12 weeks, while those in the control group received two capsules containing 40 mg starch daily for 12 weeks. Outcome measures of this study were menopausal symptoms determined using the Menopause Rating Scale (MRS) at baseline and at the end of the study. Sociodemographic data of the included women were collected using a questionnaire.Results No significant differences were observed between the two groups with respect to the demographic characteristics and menopausal symptoms before the intervention. At the end of the study, the total score on the MRS decreased from 20.41 to 10.08 in the intervention group and from 20.77 to 17.20 in the control group. This decrease in the total score was attributed to the scores of vegetative somatic and psychological categories of menopausal symptoms. Thus, a remarkable difference was observed in the severity of the menopausal symptoms (95% confidence interval, p = 0.0001).Conclusion These results indicated that, compared to placebo, dried leaves of red clover were more effective in reducing the severity of menopausal symptoms in postmenopausal women.

Evaluation of the presence and severity of menopausal symptoms among postmenopausal women screened for the metabolic syndrome

Background: The prevalence of the metabolic syndrome (METS) increases after the menopause. Reports indicate that the METS and its components, especially obesity, enhance the intensity of menopausal symptoms.Objective: Assess the frequency and severity of menopausal symptoms in postmenopausal women. Factors related to the symptom severity were also analyzed including depressive and metabolic status.Methods: A total of 204 natural postmenopausal women (40–65 years) participating in a METS screening program were asked to fill out the Menopause Rating Scale (MRS), the Hospital Anxiety and Depression Scale (HADS), and a general socio-demographic questionnaire containing personal and partner data. Criteria of the American Heart Association were used to define the METS.Results: Median age of the whole sample was 56 years. A 52.9% presented the METS, with 37.3% presenting hyperglycemia, 51.5% hypertension, 58.3% abdominal obesity, 45.6% high triglyceride and 56.4% low HDL-C levels. Total and subscale MRS scores did not differ in accordance to the presence or not of the METS. The three top prevalent menopausal symptoms were muscle and joint problems (87.2%), physical and mental exhaustion (72%) and depressive mood (64.7%). A 19.6% of women presented total MRS scores above 16 defined as severe. Multivariate linear regression analysis determined that anxiety (higher HADS anxiety subscale scores) was significantly and positively correlated with all components of the MRS (Total and subscale scores). Higher total MRS scores correlated positively with abdominal perimeter and higher parity. Somatic scores correlated inversely with female education and positively with psychotropic drug use; and psychological MRS scores positively correlated depressed mood (higher HADS depressive subscale scores) and abdominal perimeter.Conclusion: In this postmenopausal sample, severity of menopausal symptoms correlated to abdominal obesity, mood and other personal aspects.

Resilience, depressed mood, and menopausal symptoms in postmenopausal women

This study aims to assess resilience, depressed mood, and menopausal symptoms in postmenopausal women. In this cross-sectional study, 169 postmenopausal women aged 48 to 68 years were asked to fill out the Wagnild and Young Resilience Scale (WYRS), the Center for Epidemiologic Studies Depression Scale (CESD-10), the Menopause Rating Scale (MRS), and a questionnaire containing personal and partner sociodemographic data. The median [interquartile range] age of participating women was 54 [10.0] years. Among the women, 55.6% had increased body mass index, 76.9% had a partner, 17.8% were current smokers, 14.2% had hypertension, 25.4% used psychotropic drugs, and 13.0% used hormone therapy. Forty-five percent of the women had depressed mood (CESD-10 scores ≥10), and 34.9% had severe menopausal symptoms (total MRS scores ≥17). Less resilience (lower WYRS scores) correlated with depressed mood (higher CESD-10 scores) and severe menopausal symptoms (higher total, psychological, and urogenital MRS scores). Multiple linear regression analysis determined that WYRS scores positively correlated with exercising regularly and inversely correlated with CESD-10 scores (depressed mood). CESD-10 scores positively correlated with somatic and psychological MRS subscale scores and inversely correlated with WYRS scores (less resilience). In this postmenopausal sample, depressed mood and participation in regular exercise correlate with lower and higher resilience, respectively. Depressed mood is associated with the severity of menopausal symptoms (somatic and psychological).

Use of intravaginal 17-β estradiol to improve sexual function and menopausal symptoms in postmenopausal women with breast cancer on aromatase inhibitors.

9610 Background: The majority of women with early stage breast cancer (BC) will become long-term survivors, living with the sequelae of treatment. Attention to symptoms and quality of life (QoL) are therefore of increasing importance both during treatment and survivorship. Aromatase inhibitors (AIs) are used to treat postmenopausal women with hormone-receptor positive (HR+) BC and can lead to profound urogenital atrophy. Atrophic vaginitis in BC survivors is prevalent, its management is complex and it negatively impacts QoL. Methods: A prospective longitudinal IRB-approved study was performed at MSKCC in26 postmenopausal women with stage I-III HR+ BC on adjuvant letrozole or anastrozole for at least 3 months and had urogenital atrophy. All women were initiated on 10µg intravaginal 17-β estradiol. Patients completed the Female Sexual Function Index (FSFI) and Menopausal Symptom Checklist (MSCL) at baseline and wks 12 & 24. Increase in FSFI score means better sexual function and a decrease in MSCL score means improved symptoms. We used the Wilcoxon Signed Rank Sum test to compare QoL measures at baseline to wks 12 and 24. The primary endpoint was change in systemic estradiol level from baseline to wk 12. Serial estradiol/FSH levels were measured at baseline and wks 2, 7, 12, 18 & 24; we used a highly sensitive estradiol radioimmunoassay, ESTR-US-CT, from Cisbio US, Inc. Herein we report the results from the QoL secondary endpoints. Results: During treatment with intravaginal 17-β estradiol 10mcg, improvement in sexual function as measured by the FSFI was seen from a median of 12.4 at baseline to 21.2 at wk 12 (p=.0091) and 21.8 at wk 24 (p=.0271). Improvement was seen from baseline to wk 12 in lubrication (p=.0091), desire (p=.0303), satisfaction (p=.0331) and pain (p=.0005) and from baseline to wk 24 in lubrication (p=.0210), desire (p=.0309) and orgasm (p=.0369). A reduction in menopausal symptoms was also seen from 30.0 at baseline to 23.6 at wk 12 (p=.01) and 22.5 at wk 24 (p=.003). Conclusions: Intravaginal 10μg 17-β estradiol provided relief from menopausal symptoms and improvement in sexual dysfunction in the domains of lubrication, desire, satisfaction, orgasm, and pain.

Different Exercise Behaviors Influence Heart Rate Variability, Autonomic Nerve System Function and Menopausal Symptoms in Post-Menopausal Women

Different Exercise Behaviors Influence Heart Rate Variability, Autonomic Nerve System Function and Menopausal Symptoms in Post-Menopausal Women

The effect of red clover isoflavone supplementation over vasomotor and menopausal symptoms in postmenopausal women

Objective. To evaluate the effect of red clover isoflavone supplementation over vasomotor and overall menopausal symptoms in postmenopausal women. Methods. One hundred and nine postmenopausal women aged 40 or more were assigned to randomly receive either two daily capsules of the active compound (80 mg red clover isoflavones, Group A) or placebo of equal appearance (Group B) for a 90-day period. After a washout period of 7 days, medication was crossed over and taken for 90 days more. Daily hot flush and night sweat frequency and overall menopausal symptom intensity (Kupperman Index) were measured at baseline, 90, 97 and 187 days. Results. Daily hot flush/night sweat frequency and Kupperman Index values were similar in both studied groups at baseline. All indices significantly decreased after red clover phase in Group A, corresponding, respectively to a 73.5%, 72.2% and 75.4% average decrement. These decrements were significantly higher than those observed for Group B after placebo phase (8.2%, 0.9% and 6.7% respectively). In Group A, after washout and placebo phases all values significantly increased. In Group B, all indices remained similar after placebo and washout phases, however significantly dropping after red clover treatment. These values were also significantly lower than those observed in Group A after placebo phase. No side effects were encountered after treatment with the active compound or placebo. Conclusion. Red clover isoflavone supplementation was more effective than placebo in reducing daily vasomotor frequency and overall menopausal intensity in postmenopausal women.

The effect of rexflavone (Sophorae Fructus Extract) on menopausal symptoms in postmenopausal women: A randomized double-blind placebo controlled clinical trial

To observe the protective effect of orally administrated Rexflavone (Sophorae fructus extract) for the postmenopausal symptoms, a randomized double-blind placebo controlled clinical trial was designed. Rexflavone significantly improved 11 menopausal symptoms including hot flash, which was evaluated by the modified Kupperman Index (KI), while hormone level and lipid profile were little changed by consumption. Rexflavone group significantly decreased KI score (-14.91 +/- 8.79) compared to placebo group (-11.45 +/- 6.62) as a representative index for improvement of menopausal symptoms (p < 0.05). We found that Rexflavone has no adverse effect to be safe for long term consumption. It was shown that the consumption of Rexflavone possessed beneficial effects on the postmenopausal symptoms in postmenopausal women.

The Effect of Isoflavone and Gamma-linolenic Acid Supplementation on Serum Lipids and Menopausal Symptoms in Postmenopausal Women

This study was performed to examine the combined effects of gamma linolenic acid and isoflavone supplementation on menopausal symptoms and serum lipids in 73 postmenopausal women. A total subjects were randomly assigned to isoflavone (30 ㎎) + gamma-linolenic acid (110 ㎎) group or placebo group. We measured menopausal symptoms by modified Kupperman Index (KI) and oxidized LDL, lipid peroxides, blood components and anthropometric parameters before and after the 12 week intervention period. After the 12 weeks of supplementation, supplement group and placebo group showed a significant reduction of modified kupperman index (p < 0.001). Isoflavone (30 ㎎) + gamma-linolenic acid (110 ㎎) supplement group showed a significant reduction of oxidized LDL cholesterol concentration (p = 0.006) whereas placebo group did not show significant change. Isoflavone and gamma-linolenic acid consumption did not significantly affect plasma concentrations of total, LDL, HDL cholesterol, triglyceride, apo A1, B and blood components. The result of present study demonstrated the supplementation of 30 ㎎ isoflavone and 110 ㎎ gamma-linolenic acid per day for 12 weeks may protect LDL cholesterol from oxidative stress.

A Randomized Trial of Oral DHEA Treatment for Sexual Function, Well-Being, and Menopausal Symptoms in Postmenopausal Women with Low Libido

IntroductionDehydroepiandrosterone (DHEA) and its sulfate DHEAS, which are the most abundant steroids in women, decline with age. We have shown association between low sexual function and low circulating DHEAS levels in women. AimThe aim of this study was to evaluate whether restoration of circulating DHEA levels in postmenopausal women to the levels seen in young individuals improves sexual function. MethodsNinety-three postmenopausal women not using concurrent estrogen therapy were enrolled in a 52-week randomized, double-blind, placebo controlled trial and received either DHEA 50 mg or placebo (PL) daily. Main Outcome MeasuresEfficacy was assessed through 26 weeks. The main outcome measures were the change in total satisfying sexual events (SSE) and the change in the Sabbatsberg Sexual Self-Rating Scale (SSS) total score. Secondary measures were the Psychological General Well-Being Questionnaire (PGWB), and the Menopause—Specific Quality of Life Questionnaire (MENQOL). Hormonal levels, adverse events (AEs), serious adverse events (SAEs) and clinical labs were evaluated over 52 weeks. ResultsEighty-five participants (91%) were included in the 26-week efficacy analysis. There were no significant differences between the DHEA and PL groups in the change in total SSE per month or the SSS, PGWB, and MENQOL change scores. Overall AE reports and number of withdrawals as a result of AEs were similar in both groups; however more women in the DHEA group experienced androgenic effects of acne and increased hair growth. ConclusionsIn this study treatment of postmenopausal women with low sexual desire with 50 mg/day DHEA resulted in no significant improvements in sexual function over PL therapy over 26 weeks. Panjari M, Bell RJ, Jane F, Wolfe R, Adams J, Morrow C, and Davis SR. A randomized trial of oral DHEA treatment for sexual function, well-being and menopausal symptoms in postmenopausal women with low libido. J Sex Med 2009;6:2579–2590.

THE EFFECT OF SOYMILK ON ALKALINE PHOSPHATASE, TOTAL ANTIOXIDANT LEVELS, AND VASOMOTOR SYMPTOMS IN MENOPAUSE WOMEN

Objective The aim of this study was to determine the effect of revival soymilk consumption and moderate exercise on vasomotor symptoms, total antioxidant capacity (TAC) and alkaline phosphates activity in postmenopausal women. Materials and Methods In this study, daily for 3 months, 37 postmenopausal women (mean age = 52.2± 4.6 years) were randomly assigned to soymilk (n=15), exercise +soymilk (n=12) and control (n= 10). The daily soymilk consisted of Revival brand Maxsoy, which contained 12.5 g of soy protein with Genistein (13 mg) and Daidzein (4.13 mg). Menopausal symptoms were measured using the Kupperman index, a standard measure of climacteric symptoms that has been validated in menopausal women at baseline and 3 months of daily consumption of soymilk. Total antioxidant status (TAS) of serum was measured using the ferric reducing ability of plasma (FRAP) assay. Total alkaline phosphatase (TALP) was assayed calorimetrically with Hitachi 902 autoanalyzer assay. Results Soymilk supplementation, soymilk and moderate exercise significantly (p<0.05) improved TAC level and TALP activity. Vasomotor symptoms were improved (p < 0.05) in the soymilk consumption plus moderate exercise and soymilk groups as compared with the control group. The data showed a decrease in menopausal symptoms p <0 .05, paired t test, two-tailed, between the baseline and soymilk groups, and p < 0.05, ANOVA test, between the control and two groups. Vaginal problem, sexual symptoms and vasomotor significantly changed (p<0.05) after soymilk consumption. Conclusion These data may suggest that consumption of soymilk for 3 months enhances antioxidant and TALP status and reduces menopausal symptoms in postmenopausal women.

Efficacy and tolerability of estradiol 1 mg and drospirenone 2 mg in postmenopausal korean women: A double-blind, randomized, placebo-controlled, multicenter study

Objectives The aim of this study was to demonstrate that the therapeutic efficacy of an estradiol 1 mg/drospirenone 2 mg (E2/DRSP) preparation is superior to a placebo in postmenopausal Korean women with hot flushes and other climacteric symptoms, and to demonstrate that this treatment is both safe and tolerable. Methods This was a double-blind, randomized, placebo-controlled, multicenter study over four 28-day treatment cycles. A total of 158 subjects were screened and 90 women were randomized into two treatment groups (E2/DRSP group, n = 45; placebo group, n = 45). The primary efficacy parameter was the individual relative change of hot flushes. The secondary efficacy parameters such as other climacteric, urogenital symptoms and vaginal bleeding patterns were also evaluated, and the occurrence of any adverse events was noted. In addition, physical, gynecological examinations and laboratory analyses were performed at the beginning and end of the study. Results The mean number of hot flushes per week during treatment weeks 3–16 decreased by 48.1% during treatment with placebo, and by 84.4% during treatment with E2/DRSP ( p < 0.001). The E2/DRSP combination also reduced the incidence and intensity of menopausal symptoms in postmenopausal women. Most of adverse events was mild or moderate degree of intensity. None of the parameters measured in the study, including laboratory analyses, physical and gynecological examinations, vital signs, and weight, led to any concerns of safety. Conclusions The E2 1 mg/DRSP 2 mg combination tested in the study was efficacious and safe in the treatment of hot flushes and other climacteric symptoms in postmenopausal Korean women.

Topical Progesterone Cream Does Not Increase Thrombotic and Inflammatory Factors in Postmenopausal Women.

Postmenopausal women have an increased risk of cardiovascular disease, and heart disease is the leading cause of death in postmenopausal American women. Conventional hormone replacement therapy has been shown to result in an increase in thrombotic events in large prospective clinical trials including HERS I, and the recently halted Women's Health Initiative. One possible mechanism for this observed increase is the unfavorable net effects of conjugated equine estrogens and medroxyprogesterone acetate on the hemostatic balance and inflammatory factors. An estimated 50 million American women are peri or postmenopausal and clinical therapies for menopausal symptoms remain a significant challenge in light of the known thrombotic risks. In this prospective blinded study, we examined the short-term effect of topical progesterone cream on menopausal symptom relief in 30 healthy postmenopausal women. Potential adverse effects of topical progesterone on hemostatic and inflammatory factors and cortisol levels were also examined. Subjects were randomized to first receive either 20 mg of topical progesterone cream or placebo cream for 4 weeks. Following a subsequent 4-week washout period, subjects were crossed over to either placebo cream or active drug for an additional 4-week period. In each case, progesterone and cortisol levels were monitored by salivary sampling. Baseline values, 4-week follow-up values and end-of-study values were also obtained for the Greene Climacteric Scale, total factor VII:C, factor VIIa, factor V, fibrinogen, antithrombin, PAI-1, CRP, TNFα, and IL-6. For subjects receiving 20 mg of topical progesterone cream for 4 weeks, Greene Climacteric Scale scores were consistently and significantly improved (decreased) over baseline, demonstrating significant relief from menopausal symptoms. In addition, in a subpopulation of hypercortisolemic women, topical progesterone was associated with a favorable decrease in nocturnal cortisol. Surprisingly, and in sharp contrast to earlier studies with conventional hormone replacement therapy, topical progesterone had no effect on any of the hemostatic components examined: total factor VII:C, factor VIIa, factor V, fibrinogen, antithrombin, and PAI-1 levels were all unchanged. Levels of CRP, TNFα and IL-6 also remained unchanged. From this study we conclude that administration of topical progesterone cream at a daily dose of 20 mg significantly relieves menopausal symptoms in postmenopausal women without adversely altering prothrombotic potential. Since the thrombotic complications that are typically observed with conventional hormone replacement therapy do not seem to occur with topical progesterone, this treatment should be seriously considered as an effective and safe alternative clinical therapy for women suffering from menopausal symptoms.

A Pilot Study of a Kampo Formula, EH0202, with Intriguing Results for Menopausal Symptoms

To investigate the effects of EH0202, a Japanese herbal supplement, on the immune and endocrine systems in women with menopausal symptoms. Thirty-two (32) postmenopausal women (53.0 +/- 5.1 years old) presenting with menopausal complaints were enrolled in a clinical study. Patients were given an herbal supplement, EH0202 (6 g per day for 6 months) and were assessed for reduction of their overall symptoms using Greene's Climacteric Scale and Visual Analog Scale. Plasma interleukin-6 (IL-6), soluble IL-6 receptor, tumor necrosis factor-alpha, granulocyte macrophage-colony stimulating factor (GM-CSF), granulocyte-colony stimulating factor, follicle-stimulating hormone (FSH), and luteinizing hormone concentrations were measured before and 6 months after EH0202 administration. There was a significant decrease in the climacteric scale score (p = 0.0007) and visual analogue scale (p < 0.0001) after 6 months of EH0202 treatment. There was significant increase (p = 0.0097) in plasma GM-CSF levels and a significant decrease (p = 0.018) in plasma FSH levels after 6 months of EH0202 administration. EH0202 (MACH) decreased the plasma FSH level and stimulated myelopoiesis through the cytokine system, thereby clinically reduced menopausal symptoms in postmenopausal women. Therefore, in postmenopausal women, this product probably acts as an immunomodulator and endocrine modulator.

Clinical Efficacy of EH0202, a Kampo Formula, on the Health of Middle-Aged Women

To investigate the clinical effects of EH0202, a Japanese herbal supplement, on the menopausal symptoms and physical status of peri- and post-menopausal women. Thirty-two post-menopausal women (53.0+/-5.1 years) presented with menopausal complaints were enrolled in the clinical study. Patients were administered an herbal supplement, EH0202 (6 g/day for 6 months), and were assessed for improvement of their overall symptoms using the Greene Climacteric Scale and the Visual Analog Scale (VAS). Blood pressure, skin surface blood flow and plasma lipid profiles were measured before and 1,3 and 6 months after EH0202 administration. There was a significant decrease in the climacteric scale score (P < 0.001) and VAS (P < 0.0001) after 6 months of EH0202 treatment. There was a significant decrease in systolic (P < 0.001) and diastolic (P < 0.05) blood pressure, and a significant decrease in facial skin surface blood flow (P < 0.05) after 3 months of EH0202 administration. We observed a significant decrease in plasma TG and LDL-cholesterol concentrations after 3 months of EH0202 administration (P < 0.05). EH0202 (MACH) reduced blood pressure, excess facial skin blood flow (flushing) and abnormal lipid levels, as well as clinically improved menopausal symptoms in post-menopausal women. In post-menopausal women, this product appears to help maintain normal biological function and improves quality of life.

The effects of soy protein containing phytoestrogens on menopausal symptoms in postmenopausal women

Objective To analyze the impact of soy protein dietary supplements containing phytoestrogens on menopausal symptoms in healthy postmenopausal women.Methods A double-blind, placebo-controlled trial was conducted in 94 healthy postmenopausal women aged 50–75 years, with 44 randomized to soy supplements containing 118 mg of isoflavones (daidzein, genistein, glycitein and their respective glycosides), and 50 to an identically presented casein placebo. A validated questionnaire on menopausal symptoms was administered at baseline and at 3 months of treatment. Compliance was assessed by high-performance liquid chromatography assay of urinary phytoestrogens. Statistical analysis was completed using non-parametric statistical methods and multivariate analysis.Results At baseline 80% of women recruited were experiencing menopausal symptoms, although symptom severity was mild. Those consuming phytoestrogen supplements had 13- and 17-fold increases in urinary excretion of genistein and daidzein, respectively, with no change in the placebo group. Active soy supplements did not significantly alter either individual symptoms or specific symptom category scores when compared to placebo. Within-group comparisons revealed that the active group reported a significant improvement in vaginal dryness (p = 0.01), libido (p =0.009), facial hair (p = 0.04) and dry skin (p =0.027). However, similarly, those on placebo reported an improvement in libido (p =0.015), facial hair (p = 0.014) and dry skin (p = 0.011) but not vaginal dryness.Conclusions In this group of 94 older postmenopausal women with a high frequency of mild menopausal symptoms, 3 months of soy supplements containing phytoestrogens did not provide symptomatic relief compared with placebo.