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What Happens After Menopause? (WHAM): A prospective controlled study of cardiovascular and metabolic risk 12 months after premenopausal risk-reducing bilateral salpingo-oophorectomy.
Hickey, M, Moss, KM, Mishra, GD, Krejany, EO, Domchek, SM, Wark, JD, Trainer, A, Wild, RA
Gynecologic oncology. 2021;(1):88-96
Abstract
OBJECTIVE To prospectively measure cardiometabolic risk 12 months after premenopausal risk-reducing bilateral salpingo-oophorectomy (RRBSO) compared to a similar age comparison group, and the effects of Hormone Therapy (HT) on cardiometabolic risk. METHODS Prospective observational study of 95 premenopausal women planning RRBSO and 99 comparisons who retained their ovaries. At baseline and 12 months, blood pressure (BP), Body Mass Index (BMI), waist and hip circumference, fasting total, HDL and LDL cholesterol, triglycerides, high-sensitivity C-reactive protein, glucose and insulin were measured and HOMA-IR was calculated. Chi-square tests, t-tests and adjusted logistic regression models were used to compare groups. RESULTS Baseline cardiometabolic phenotypes were similar between groups but more RRBSO participants were overweight/obese with higher waist/hip ratios. By 12 months, BP and cardiometabolic phenotypes were largely unchanged. Paired t-tests showed statistically significant increases in BMI (p = 0.037) and weight (p = 0.042) and larger increases in waist circumference (p < 0.001) and waist-hip ratio (p = 0.009) after RRBSO vs comparisons. However, these were not significant when adjusted for baseline values. After RRBSO 60% initiated Hormone Therapy (HT). Paired t-tests demonstrated that non-HT users had a significantly greater mean increase in waist circumference of 4.3 cm (95% CI 2.0-6.5) compared to 1.3 cm in HT users (95% CI -0.2-2.7, p < 0.001), which remained significant when adjusted for baseline values (p = 0.02). At 12 months, mean waist circumference was 2.94 cm greater in non-HT users compared to HT users. CONCLUSIONS Cardiometabolic risk markers are largely unchanged 12 months after RRBSO. Hormone Therapy after RRBSO may prevent against an increase in waist circumference.
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Prospective observational study to evaluate the efficacy and safety of the pollen extract Sérélys® in the management of women with menopausal symptoms.
Fait, T, Sailer, M, Regidor, PA
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2019;(4):360-363
Abstract
Safety concerns or contraindications to the use of hormones have resulted in a rise of the use of herbal medicinal products for the management of menopausal symptoms. The pollen extract Sérélys® represents, due to its ingredients and mode of action, a new and innovative alternative for the management of these symptoms. The aim of the present study was to demonstrate the efficacy and safety of Sérélys®. A prospective, open, observational, and multicentre study was performed on 104 menopausal women. The patients received over 3 months the pollen extract Sérélys® containing the extracts PI82 and GC Fem in a dosage of twice 160 mg extract and 5 mg vitamin E. Using a validated menopausal rating score, the improvement of menopausal symptoms was recorded. A significant decrease of different menopausal symptoms was observed between the starting point of the study and after 12 weeks (p < .0001). Hot flashes were reduced by 48.5%, sleep disturbance by 50.1%, depressive mood by 51.2%, irritability by 47.9%, fatigue by 47.8%, vaginal dryness by 39.63% and muscles and joint pain by 27.4%. The pollen extract Sérélys® reduced significant menopausal symptoms showing a very low side effect profile.
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Effect of glycemic treatment and microvascular complications on menopause in women with type 1 diabetes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort.
Kim, C, Cleary, PA, Cowie, CC, Braffett, BH, Dunn, RL, Larkin, ME, Gatcomb, PM, Wessells, HB, Nathan, DM, Sarma, AV, et al
Diabetes care. 2014;(3):701-8
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Abstract
OBJECTIVE We examined the impact of intensive versus conventional diabetes treatment upon menopause among women with type 1 diabetes in the Diabetes Control and Complications Trial (DCCT), a randomized controlled trial of intensive diabetes treatment, and its observational follow-up, the Epidemiology of Diabetes Interventions and Complications (EDIC) study. RESEARCH DESIGN AND METHODS In a secondary analysis of women in the DCCT/EDIC (n = 657), outcomes were the cumulative incidences of natural menopause and surgical menopause. Cox regression analyses were used to examine associations with treatment group, time-varying estimates of hemoglobin A1c (HbA1c), insulin dosage, BMI, and microvascular complications (retinopathy, nephropathy, and neuropathy). RESULTS By EDIC year 18, after an average of 28 years of follow-up, 240 (38%) women had experienced natural menopause and 115 (18%) women had experienced surgical menopause. Age at natural menopause was similar in the intensive versus conventional groups (49.9 vs. 49.0 years; P = 0.28), and age at surgical menopause was similar in the intensive versus conventional groups (40.8 vs. 42.0 years; P = 0.31). In multivariable models, treatment group, HbA1c, and microvascular complications were not associated with risk of natural or surgical menopause. Each 10 unit/day increase in insulin dosage decreased risk of natural menopause (hazard ratio [HR] 0.91, 95% CI 0.75-0.98) and each kg/m(2) increase in BMI increased risk of surgical menopause (HR 1.08, 95% CI 1.00-1.16). CONCLUSIONS In the DCCT/EDIC, intensive versus conventional treatment group and HbA1c level were not associated with menopause risk. Greater insulin dose was associated with lower menopause risk.
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Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause.
Archer, DF, Pinkerton, JV, Guico-Pabia, CJ, Hwang, E, Cheng, RF, ,
Menopause (New York, N.Y.). 2013;(1):47-56
Abstract
OBJECTIVE A previous trial of the serotonin-norepinephrine reuptake inhibitor desvenlafaxine (administered as desvenlafaxine succinate) raised concerns on potential serious cardiovascular and hepatic events. The current study was designed to estimate these events in desvenlafaxine versus placebo in a larger population followed for 1 year. METHODS Healthy postmenopausal women seeking treatment of vasomotor symptoms were randomized to placebo or desvenlafaxine 100 mg/day in a 1-year, multicenter, double-blind study. Safety was monitored throughout. Potential ischemic cardiovascular events (coronary heart disease-related death, new-onset myocardial infarction or unstable angina requiring hospitalization, and unscheduled revascularization procedures) and cerebrovascular events (definite stroke or probable stroke) identified by investigator reports and periodic adverse event review based on Standardized medical dictionary for regulatory activities Query were reviewed by blinded adjudication boards. Hepatic events (aspartate aminotransferase or alanine aminotransferase >5 times the upper limit of normal) were evaluated. RESULTS A total of 2,118 participants (1,066 desvenlafaxine, 1,052 placebo) took one or more doses of study medication (mean, 280 d). There was one cardiovascular event; a placebo-treated participant was adjudicated to have had a myocardial infarction. One desvenlafaxine-treated participant was adjudicated to have had a probable stroke. Two participants in each treatment group had hepatic events. The excess risk (90% CI) of desvenlafaxine over placebo per 1,000 woman-years was -1.07 (-2.86 to 0.72) for cardiovascular events, 1.11 (-0.68 to 2.9) for cerebrovascular events, and 0.08 (-3.51 to 3.67) for hepatic events. CONCLUSIONS There is no evidence for an increased risk of cardiovascular, cerebrovascular, or hepatic events associated with desvenlafaxine 100 mg/day compared with placebo for the treatment of menopausal vasomotor symptoms.
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The effect of a Cimicifuga racemosa extracts Ze 450 in the treatment of climacteric complaints--an observational study.
Drewe, J, Zimmermann, C, Zahner, C
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2013;(8-9):659-66
Abstract
BACKGROUND Root extracts of Cimicifuga racemosa (L.) Nutt. have been successfully used in the treatment of climacteric complaints. METHOD In this observational study, Cimicifuga racemosa (CR) extract Ze 450 was studied in 442 unselected ambulatory female outpatients with menopausal complaints under daily practice conditions. Physicians were suggested to treat patients for the first 3 months with 13 mg/d CR (high dose, HD) and to continue over additional 6 months either with this treatment or to switch to 6.5mg/d CR (low dose, LD). The choice of treatment and its dose, however, was fully at the discretion of the physician. RESULTS After 3-months treatment with HD, symptom severity (Kupperman Menopause Index, KMI) decreased significantly (p<0.001) from baseline values. Continuation of treatment with HD or LD decreased total KMI and its sub-item scores further (HD, LD: p<0.001). However, more patients (84.9%) responded to HD than to LD (78.4%) and showed an improvement of symptoms (p=0.011). CONCLUSION This observational study demonstrated that treatment with CR in unselected patients with climacteric complaints under the conditions of daily practice resulted in a significant improvement of menopausal symptoms assessed by the total KMI score and its sub-item scores with an effect size similar to that in a previous randomized, controlled clinical trial.
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Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial.
Pinkerton, JV, Constantine, G, Hwang, E, Cheng, RF, ,
Menopause (New York, N.Y.). 2013;(1):28-37
Abstract
OBJECTIVE The aim of this study was to assess the 12-week efficacy of desvenlafaxine in treating moderate to severe vasomotor symptoms and the clinical relevance of improvements in postmenopausal women experiencing 50 or more moderate to severe hot flashes per week. METHODS Participants were randomized to placebo or desvenlafaxine 100 mg/day in the 12-week efficacy substudy of a year-long, multicenter, parallel-group, double-blind study. Coprimary outcomes were changes from baseline in the daily number and severity of hot flashes on weeks 4 and 12. The percentage of women achieving the minimal clinically important difference (MCID) in the number of hot flashes on week 12 was determined. RESULTS The efficacy substudy modified intent-to-treat population included 365 women (desvenlafaxine, n = 184; placebo, n = 181). Desvenlafaxine 100 mg/day significantly reduced the number and severity of hot flashes versus placebo on week 4 (P < 0.001) and week 12 (P < 0.001). On week 12, desvenlafaxine reduced the number of moderate and severe hot flashes by 7.3 (62%) per day (placebo, -4.5 [38%] per day) and the severity score by 0.59 (25%) per day (placebo, -0.28 [12%] per day). MCID-a reduction of 5.35 moderate and severe hot flashes per day-was achieved by 64% of desvenlafaxine-treated women (placebo, 41%; P < 0.001). In all, 17.2% (67/390) of participants discontinued, 10.0% (20/200) of participants taking desvenlafaxine and 3.7% (7/190) of participants taking placebo discontinued because of adverse events (P = 0.016), and 2.5% (5/200) of participants taking desvenlafaxine and 8.4% (16/190) of participants taking placebo discontinued because of lack of efficacy (P = 0.012). CONCLUSIONS Postmenopausal women with moderate to severe hot flashes who are treated with desvenlafaxine achieve rapid symptom reduction that is clinically relevant based on MCID.
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A natural S-equol supplement alleviates hot flushes and other menopausal symptoms in equol nonproducing postmenopausal Japanese women.
Aso, T, Uchiyama, S, Matsumura, Y, Taguchi, M, Nozaki, M, Takamatsu, K, Ishizuka, B, Kubota, T, Mizunuma, H, Ohta, H
Journal of women's health (2002). 2012;(1):92-100
Abstract
OBJECTIVE The objective of this clinical trial was to examine the efficacy of a supplement containing natural S-(-)equol, a daidzein metabolite, in reducing menopausal symptoms. METHODS In this multicenter, double-blind placebo-controlled trial, 160 equol nonproducing, postmenopausal Japanese women who experienced at least 1 hot flush/day were randomly assigned to consume 10 mg/day S-(-)equol (n=77 women) or placebo (n=83 women) for 12 weeks. Participants completed a standardized menopausal symptom checklist and rated five common menopause symptoms by a visual analog scale at baseline, week 12, and week 18 (6-week postintervention). Physical, blood, and urine examinations were conducted. One hundred twenty-six women completed the study. RESULTS At baseline, daily hot flush frequency was 2.9±2.1 for the S-(-)equol group and 3.2±2.4 for the placebo group. After the 12-week intervention, the S-(-)equol group had a greater decrease from baseline in hot flush frequency compared with the placebo group (-1.9±1.8/day, -58.7%, vs. -1.0±2.0/day, -34.5%, p=0.009). The severity of hot flushes and neck or shoulder muscle stiffness significantly decreased in the S-(-)equol group compared with the placebo group. No changes in clinical parameters or serious adverse effects were reported. CONCLUSIONS This is the first trial to show beneficial effects of a 10-mg natural S-(-)equol supplement consumed daily for 12 weeks on major menopausal symptoms, specifically, hot flushes and neck or shoulder muscle stiffness, in postmenopausal Japanese women. This supplement offers a promising alternative for management of menopausal symptoms.
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Alterations in platelet function and cell-derived microvesicles in recently menopausal women: relationship to metabolic syndrome and atherogenic risk.
Jayachandran, M, Litwiller, RD, Lahr, BD, Bailey, KR, Owen, WG, Mulvagh, SL, Heit, JA, Hodis, HN, Harman, SM, Miller, VM
Journal of cardiovascular translational research. 2011;(6):811-22
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A woman's risk for metabolic syndrome (MS) increases at menopause, with an associated increase in risk for cardiovascular disease. We hypothesized that early menopause-related changes in platelet activity and concentrations of microvesicles derived from activated blood and vascular cells provide a mechanistic link to the early atherothrombotic process. Thus, platelet functions and cellular origin of blood-borne microvesicles in recently menopausal women (n = 118) enrolled in the Kronos Early Estrogen Prevention Study were correlated with components of MS and noninvasive measures of cardiovascular disease [carotid artery intima medial thickness (CIMT), coronary artery calcium (CAC) score, and endothelial reactive hyperemic index (RHI)]. Specific to individual components of the MS pentad, platelet number increased with increasing waist circumference, and platelet secretion of ATP and expression of P-selectin decreased with increasing blood glucose (p = 0.005) and blood pressure (p < 0.05), respectively. Waist circumference and systolic blood pressure were independently associated with monocyte- and endothelium-derived microvesicles (p < 0.05). Platelet-derived and total procoagulant phosphatidylserine-positive microvesicles, and systolic blood pressure correlated with CIMT (p < 0.05), but not with CAC or RHI. In summary, among recently menopausal women, specific platelet functions and concentrations of circulating activated cell membrane-derived procoagulant microvesicles change with individual components of MS. These cellular changes may explain in part how menopause contributes to MS and, eventually, to cardiovascular disease.
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Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms.
Ferrari, A
The journal of obstetrics and gynaecology research. 2009;(6):1083-90
Abstract
AIM: The aim of the present study was to assess the efficacy and safety of a standardized compound based on an extract of soy phytoestrogens, with high doses of isoflavones in the management of menopausal hot flushes. METHODS A total of 180 women aged 40-65 years with a minimum of five moderate-to-severe hot flushes in the last 7 days at baseline and absence of menstruation for at least 6 months participated in a 12-week prospective, randomized, double-blind, placebo-controlled multicenter trial. After a 2-week run-in period, women received one tablet a day of 80 mg isoflavones (corresponding to 60 mg of genistein) or a matching placebo. RESULTS The mean daily number of moderate-to-severe hot flushes decreased in both study groups, but the reduction was greater in the isoflavones arm at 6 (36.2%) and 12 weeks (41.2%) than in the placebo arm (24.0% at 6 weeks, 29.3% at 12 weeks), with a difference of 1.1 (95% CI [-2.0 to -0.06]) (P = 0.038) at 6 weeks and 1.1 (95% CI [-2.05 to -0.15]) (P = 0.023) at 12 weeks. Similar findings were obtained for hot flushes of any intensity. The Kupperman index decreased in both study groups. Relief of hot flushes was greater when time to menopause was >or=12 months and in cases of BMI >or=27 kg/m(2). CONCLUSION In daily practice conditions, high doses of isoflavones, particularly genistein, can be used for the management of hot flushes in postmenopausal women not treated with hormone replacement therapy due to their superior efficacy to placebo and very good safety profile.
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Treating hot flushes in menopausal women with homeopathic treatment--results of an observational study.
Bordet, MF, Colas, A, Marijnen, P, Masson, J, Trichard, M
Homeopathy : the journal of the Faculty of Homeopathy. 2008;(1):10-5
Abstract
OBJECTIVE There is great controversy concerning treatment for menopausal symptoms. We evaluated homeopathic treatments for hot flushes and their effect on quality of life in menopausal women. METHODS Open, multi-national prospective, pragmatic and non-comparative observational study of homeopathic treatments prescribed and their effectiveness, observing their impact on quality of life. RESULTS Ninety-nine physicians in 8 countries took part in this study and included 438 patients with an average age of 55. Homeopathic medicines were prescribed to all patients; 98% of the prescription lines were for homeopathic medicines. Lachesis mutus, Belladonna, Sepia officinalis, Sulphur and Sanguinaria canadensis were the most prescribed. A non-homeopathic treatment and/or food supplement prescribed for 5% of the patients. This observational study revealed a significant reduction (p<0.001) in the frequency of hot flushes by day and night and a significant reduction in the daily discomfort they caused (mean fall of 3.6 and 3.8 points respectively, on a 10cm visual analogue scale; p<0.001). Ninety percent of the women reported disappearance or lessening of their symptoms, these changes mostly taking place within 15 days of starting homeopathic treatment. CONCLUSIONS The results of this observational study suggest that homeopathic treatment for hot flushes in menopausal women is effective. Further studies including randomized controlled trials should be conducted.