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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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Acupuncture or phy(F)itoestrogens vs. (E)strogen plus progestin on menopausal symptoms. A randomized study.
Palma, F, Fontanesi, F, Facchinetti, F, Cagnacci, A
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2019;(11):995-998
Abstract
The effect of acupuncture and phytoestrogens on climacteric symptoms was compared to the effect of hormone therapy (HT) with estrogen plus progestin. A total of 75 postmenopausal women with hot flushes were randomized to receive for 3 months conjugated estrogens/medroxyprogesterone acetate (0.30 mg/1.5 mg/d), acupuncture weekly or soy isoflavones (75 mg/2/d). Evaluations were performed prior to, at the end, and 3 months after treatments. Main outcomes were modification of the Greene's climacteric scale and menopause quality of life (MenQoL). The Greene's score significantly declined (p < .05) during HT (-5.6 ± 3.1), acupuncture (-6.9 ± 4.5) and phytostrogens (-3.4 ± 4.3) (p < .05 vs. HT). Mean Greene's vasomotor sub-score declined less during phytoestrogens than HT (-0.8 ± 2.0 vs. -2.0 ± 1.9; p < .05) and a ≥ 80% reduction was observed in 17.4% of women on phytoestrogens (p < .05 vs. HT), 44% of women on HT, and 41.7% of women on acupuncture. MenQoL score improved similarly (p < .05) during HT (-1.4 ± 1.3), acupuncture (-1.7 ± 1.0) and phytoestrogens (-1.0 ± 1.3). Three months after treatment end, benefits on MenQoL were conserved more following acupuncture than HT (p < .006). The present data indicate that acupuncture, and in lesser extent phytoestrogens, can be effective therapies for climacteric symptoms. Trial registration: EudraCT Number 2008-006053-4.
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The Effects and Action Mechanisms of Phytoestrogens on Vasomotor Symptoms During Menopausal Transition: Thermoregulatory Mechanism.
Hairi, HA, Shuid, AN, Ibrahim, N', Jamal, JA, Mohamed, N, Mohamed, IN
Current drug targets. 2019;(2):192-200
Abstract
BACKGROUND Phytoestrogens have recently been claimed to positively influence menopausal discomforts, including hot flashes. However, little is known about the influence of phytoestrogens on core body temperature during oestrogen fluctuation at menopause. OBJECTIVE Previously published findings showed that phytoestrogens could relieve menopausal complaints, thus, the present review was aimed at assessing the effects of phytoestrogens on thermoregulatory mechanism during menopausal transition. RESULTS The molecular mechanisms underlying hot flashes are complex. Oestrogen fluctuations cause hypothalamic thermoregulatory centre dysfunction, which leads to hot flashes during menopause. The phytoestrogens of interest, in relation to human health, include isoflavones, lignans, coumestans, and stilbenes, which are widely distributed in nature. The phytoestrogens are capable of reducing hot flashes via their oestrogen-like hormone actions. The potential effects of phytoestrogens on hot flashes and their molecular mechanisms of action on thermoregulatory centre are discussed in this review. CONCLUSION The effects of phytoestrogens on these mechanisms may help explain their beneficial effects in alleviating hot flashes and other menopausal discomforts.
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Effects of a combination of Nigella sativa and Vitex agnus-castus with citalopram on healthy menopausal women with hot flashes: results from a subpopulation analysis.
Molaie, M, Darvishi, B, Jafari Azar, Z, Shirazi, M, Amin, G, Afshar, S
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2019;(1):58-61
Abstract
The goal of the current study was to evaluate the efficiency of a phytotherapeutic intervention consisting of a combination of Nigella sativa and Vitex agnus-castus with citalopram in the control of hot flashes in healthy menopausal women. An 8 week, double-blind, randomized, placebo-controlled study was performed among 46 women aged between 40 and 60 years experiencing an average of more than four hot flashes per day recruited during July 2016 to June 2017. Data on severity of vasomotor symptoms were collected at the end of the eighth week. Herbal medication or placebo capsules were administered once daily in morning. At the end of the 8-week treatment period, analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including vasomotor (p < .001), physical (p = .036), psychosocial (p = .001) but no significant differences were observed in terms of sexual function (p = .231). Based on the results, the addition of a combination of N. sativa and V. agnus-castus to the citalopram may be a potential clinical application for improving therapeutic outcomes. Larger randomized, controlled trials are also warranted for further investigations of these symptoms.
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The effect of sex and menopause on carotid intima-media thickness and pulse wave velocity in morbid obesity.
van Mil, SR, Biter, LU, van de Geijn, GJM, Birnie, E, Dunkelgrun, M, Ijzermans, JNM, van der Meulen, N, Mannaerts, GHH, Castro Cabezas, M
European journal of clinical investigation. 2019;(7):e13118
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Abstract
BACKGROUND Women are relatively protected from cardiovascular disease compared with men. Since morbid obesity is an independent risk factor for cardiovascular disease, the current study investigated whether the association between sex and cardiovascular risk factors and outcomes can be demonstrated in subjects suffering from morbid obesity. MATERIALS AND METHODS Two hundred subjects enrolled in a study on cardiovascular risk factors in morbid obesity underwent extensive laboratory screening, carotid intima-media thickness (cIMT) and pulse wave velocity (PWV) measurements. Gender differences were analysed using univariate and multivariable linear regression models. In addition, the effect of menopause on cIMT and PWV was analysed. Results of these models were reported as B coefficients with 95% confidence intervals. RESULTS The group consisted of 52 men and 148 women, with a mean age of 41 (±11.8) years and a mean body mass index (BMI) of 42.7 (±5.2) kg/m2 . Both, cIMT and PWV were significantly higher in men than in women, although the difference in cIMT disappeared after adjustment for covariables such as waist circumference, age, high-density lipoprotein cholesterol and mean arterial pressure. PWV was associated with sex after adjustments for covariables in morbidly obese patients. Postmenopausal women had significantly increased cIMT and PWV when compared with premenopausal women. CONCLUSION Sex differences in PWV persist in subjects suffering from morbid obesity. However, no difference was found in cIMT between morbidly obese men and women after adjustment for classic cardiovascular risk factors. Premenopausal morbidly obese women are protected for cardiovascular disease when compared with postmenopausal morbidly obese women.
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The effect of ginseng on sexual dysfunction in menopausal women: A double-blind, randomized, controlled trial.
Ghorbani, Z, Mirghafourvand, M, Charandabi, SM, Javadzadeh, Y
Complementary therapies in medicine. 2019;:57-64
Abstract
OBJECTIVES Sexual problems constitute a largely-overlooked problem for women during menopause. The present study was conducted to determine the effect of Ginseng on sexual function (primary outcome), quality of life and menopausal symptoms (secondary outcomes) in postmenopausal women with sexual dysfunction. DESIGN This randomized controlled trial was conducted on 62 women who were randomly assigned to the intervention/control groups using block randomization. INTERVENTION The intervention group received 500 mg of Panax Ginseng and the control group received placebo twice daily for four weeks. MAIN OUTCOME MEASURES Standard questionnaires including the Female Sexual Function Index (FSFI), the Menopause-Specific Quality of Life (MENQOL) and the Greene Menopausal Symptom Scale were completed before and four weeks after the intervention. RESULTS There were no statistically significant differences between the two groups in terms of demographic characteristics and the baseline scores of sexual function, quality of life and menopausal symptoms (P > 0.05). After the intervention, the mean total score of FSFI (Adjusted Mean Difference = 6.32, 95% CI = 3.48 to 9.16, P < 0.001) was significantly higher in the intervention group compared to the control group. The mean total score of quality of life (AMD=-20.79, 95% CI=-25.83 to -15.75, P < 0.001) and menopausal symptoms (AMD=-8.25, 95% CI=-10.55 to -5.95, P < 0.001) were significantly lower in the treatment group than the control group. CONCLUSION Ginseng has significant effects in improving sexual function and quality of life and mitigating menopausal symptoms. As a multipotent plant, Ginseng can be a suitable alternative for conventional therapies to promote the health of menopausal women.
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The uncertain effect of menopause on blood pressure.
Tikhonoff, V, Casiglia, E, Gasparotti, F, Spinella, P
Journal of human hypertension. 2019;(6):421-428
Abstract
In affluent societies blood pressure increases with age from early life to the eighth decade with sex differences. Before middle age, lower blood pressure values are observed in women than in coeval men, whereas the reverse seems to occur thereafter. Menopause is considered the major determinant of blood pressure rise in women. If this hypothesis is well-founded, menopause can be regarded as one of the main cardiovascular risk factors, involving more than half of the human population, as well as the most ineluctable. In industrialized countries, age at menopause ranges between 50 and 52 years. The popular message is that fertile women are protected from cardiovascular risk by circulating estrogens, a privilege that is lost when postmenopausal women become not different from men from the point of view of risk factors and cardiovascular events. Nevertheless, the hypothesis that menopause or the estrogen decrease are per se associated to blood pressure increase is still under debate. Indeed, the epidemiological challenge is due to the coincidence between advancing menopause and aging, and also to the evidence that both menopause and blood pressure have common determinants such as body mass index, diet, smoking, and socio-economic class. The strongest doubt is whether menopause is a dependent or independent risk factor for high BP, i.e. whether its action on blood pressure-if any-is due directly to estrogen fall or to other indirect factors.
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Habitual dietary lactose and galactose intakes in association with age at menopause in non-galactosemic women.
Rostami Dovom, M, Moslehi, N, Mirmiran, P, Azizi, F, Ramezani Tehrani, F
PloS one. 2019;(3):e0214067
Abstract
INTRODUCTION Rodent models and studies on women with galactosemia suggest the ovo-toxicity effect of galactose. However, the association between galactose intake from dietary sources and the ovarian function in women without galactosemia has not yet been described. Therefore, this study aimed to investigate the associations between both dietary galactose and lactose intake, and ovarian dysfunction as the odds of early menopause in women without galactosemia. MATERIALS AND METHODS This cross-sectional study was conducted on 821 women without galactosemia, participants of the Tehran Lipid and Glucose Study (TLGS), who experienced natural menopause. Habitual dietary intakes of lactose and galactose during the past 12 month were assessed, using a food-frequency questionnaire (FFQ). In this study, early menopause was defined as natural menopause before the age of 45 years. RESULTS Mean- and menopausal age of women were reported as 59.3±7.94 and 48.6±4.81 years, respectively. No statistically significant linear association was observed between the daily intakes of lactose and galactose and the odds of early menopause. After adjusting for age, energy intake, and age at menarche, women in the middle tertiles of lactose (62%, 95%CI: 1.07, 2.46) and galactose (58%, 95% CI: 1.05, 2.39) intake had significantly higher odds of early menopause, than those in the first tertile. When the daily intake of lactose and galactose were expressed as the percentage of energy intake, the higher odds of early menopause among women in the middle tertile compared to those with the first tertile were reduced and became non-significant. CONCLUSION No statistically significant linear associations were reported between the intake of lactose and galactose and age of menopause. However, the odds of early menopause in those women with the middle tertile of lactose and galactose intake were significantly higher than those women in the first tertile.
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Isoflavone Supplements for Menopausal Women: A Systematic Review.
Chen, LR, Ko, NY, Chen, KH
Nutrients. 2019;(11)
Abstract
Isoflavones have gained popularity as an alternative treatment for menopausal symptoms for people who cannot or are unwilling to take hormone replacement therapy. However, there is still no consensus on the effects of isoflavones despite over two decades of vigorous research. This systematic review aims to summarize the current literature on isoflavone supplements, focusing on the active ingredients daidzein, genistein, and S-equol, and provide a framework to guide future research. We performed a literature search in Ovid Medline using the search terms "isoflavone" and "menopause", which yielded 95 abstracts and 68 full-text articles. We found that isoflavones reduce hot flashes even accounting for placebo effect, attenuate lumbar spine bone mineral density (BMD) loss, show beneficial effects on systolic blood pressure during early menopause, and improve glycemic control in vitro. There are currently no conclusive benefits of isoflavones on urogenital symptoms and cognition. Due to the lack of standardized research protocols including isoflavone component and dosage, outcomes, and trial duration, it is difficult to reach a conclusion at this point in time. Despite these limitations, the evidence thus far favors the use of isoflavones due to their safety profile and benefit to overall health.
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Urtica dioica in comparison with placebo and acupuncture: A new possibility for menopausal hot flashes: A randomized clinical trial.
Kargozar, R, Salari, R, Jarahi, L, Yousefi, M, Pourhoseini, SA, Sahebkar-Khorasani, M, Azizi, H
Complementary therapies in medicine. 2019;:166-173
Abstract
OBJECTIVES The purpose of this research was to investigate the effect of Urtica dioica in comparison with placebo, acupuncture and combined therapy on hot flashes and quality of life in postmenopausal women. METHODS In a double-blinded randomized controlled trial, patients were treated for 7 weeks then followed up 4 weeks. Seventy-two postmenopausal women who reported at least 20 hot flashes attacks per week were randomly allocated into one of the 4 groups of Urtica dioica 450 mg/day and acupuncture 11 sessions (A), acupuncture and placebo (B), sham acupuncture and Urtica dioica (C), and sham acupuncture and placebo (D). The primary outcomes were the change in hot flashes score from baseline to the end of treatment and follow up; and the change in the quality of life (MENQOL) from baseline to the end of treatment. Secondary outcomes included changes in FSH, LH, and ESTRADIOL levels from baseline to the end of treatment. The trial was conducted from October 2017 to July 2018 in Acupuncture clinic of a teaching hospital in Iran. RESULTS A total of 72 women 45-60 years old were enrolled, and 68 were included in the analyses. The median (IQR) hot flashes score decreased in the A group by 20.2 (31.7) and 21.1 (25.1), B group by 19 (18) and 17.3 (27), C group by 14.6 (25.4) and 20.8 (13), and D group by 1.6 (11.6) and 1 (13.3) at the end of treatment and follow up (P < 0.0001, P < 0.0001); no significant difference between A, B and C groups. The mean (SD) of MENQOL score decreased in the A group by 42.6 (21.1), B group by 40.7 (29.8), C group by 37.8 (26.8) and D group by 9.8 (14.3) at the end of treatment (P = 0.001); no significant difference between A, B and C groups. CONCLUSIONS Urtica dioica can decrease menopausal hot flashes and increase the quality of life of postmenopausal women better than placebo-sham control but same as acupuncture. The combination of Urtica dioica and acupuncture did not add to the effects of those therapies.