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Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms - an update on the evidence.
Castelo-Branco, C, Gambacciani, M, Cano, A, Minkin, MJ, Rachoń, D, Ruan, X, Beer, AM, Schnitker, J, Henneicke-von Zepelin, HH, Pickartz, S
Climacteric : the journal of the International Menopause Society. 2021;(2):109-119
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Abstract
A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR (p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John's wort (Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.
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Effects of an equol-containing supplement on advanced glycation end products, visceral fat and climacteric symptoms in postmenopausal women: A randomized controlled trial.
Yoshikata, R, Myint, KZY, Ohta, H, Ishigaki, Y
PloS one. 2021;(9):e0257332
Abstract
INTRODUCTION Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered a potentially effective agent for relieving climacteric symptoms, for the prevention of lifestyle-related diseases, and for aging care in postmenopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging and climacteric symptoms with respect to internally produced equol in postmenopausal women. METHODS A single-center, randomized controlled trial (registration number: UMIN000030975) on 57 postmenopausal Japanese women (mean age: 56±5.37 years) was conducted. Twenty-seven women received the equol supplement, while the remaining received control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese postmenopausal women. RESULTS Three months post-intervention, the treatment group showed significant improvement in climacteric symptoms compared to the control group (81% vs. 53%, respectively, p = 0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations, significant improvement in skin autofluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. CONCLUSION Women receiving equol supplementation showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously produced equol to improve skin aging and visceral fat in certain populations.
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The effect of oral capsule of curcumin and vitamin E on the hot flashes and anxiety in postmenopausal women: A triple blind randomised controlled trial.
Ataei-Almanghadim, K, Farshbaf-Khalili, A, Ostadrahimi, AR, Shaseb, E, Mirghafourvand, M
Complementary therapies in medicine. 2020;:102267
Abstract
OBJECTIVE The decline and eventual cessation of estrogen production cause a variety of symptoms during menopause, affecting each woman differently. Most women reported severe hot flashes and night sweats during menopause. The present study aimed to determine and compare the efficacy of curcumin and vitamin E on hot flashes and anxiety (primary objectives), sexual function, menopausal symptoms and adverse effects (secondary objectives). MATERIALS AND METHODS This was a triple-blind randomized controlled clinical trial. The participants consisted of 93 postmenopausal women in Ahar city-Iran. They were assigned into three groups (two intervention groups and one control group). The first intervention group received oral capsule of curcumin (500 mg), the second intervention group was given oral tablets of vitamin E (200 IU/day), and the third group (control) received placebo twice a day for eight weeks. The participants completed the hot flash checklist one week before the intervention, and 4 weeks and 8 weeks after the intervention. They also filled out the Anxiety Scale, the Female Sexual Function Index (FSFI), the Greene Climacteric Scale before the intervention, and 4 weeks and 8 weeks after the intervention. One-way ANOVA, repeated measures ANOVA and ANCOVA tests were used for data analysis. RESULTS There was no statistically significant difference between groups in terms of demographic characteristics, mean number of hot flashes, mean score of anxiety, sexual function index and menopausal symptoms before the intervention (p > 0.05). The mean age of participants was 51.7 years. Mean number of hot flashes in the curcumin group (adjusted mean difference = -10.7, 95%confidence interval = -3.6 to -17.9, P = 0.001) and in the vitamin E group (-8.7, -0.6 to -15.0, P = 0.029) was significantly lower than the placebo group after the intervention. The first significant effect of curcumin on hot flashes was observed after four weeks (P = 0.027). However, there was no significant difference between vitamin E group and placebo four weeks after intervention (P = 0.052) and the first significant effect of vitamin E on hot flashes was observed after eight weeks (P = 0.025). There was no statistically significant difference between the groups in terms of sexual function index, anxiety and menopausal symptoms (P > 0.05). CONCLUSION The results of this study showed that oral intake of curcumin and vitamin E significantly reduced hot flashes in postmenopausal women but had no significant effect on anxiety, sexual function and menopausal symptoms.
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Efficacy and Safety of Kudzu Flower-Mandarin Peel on Hot Flashes and Bone Markers in Women during the Menopausal Transition: A Randomized Controlled Trial.
Kim, JE, Jeong, H, Hur, S, Lee, J, Kwon, O
Nutrients. 2020;(11)
Abstract
This randomized controlled study aimed to assess the efficacy and safety of an extract mixture of kudzu flower and mandarin peel (KM) on hot flashes (HFs) and markers of bone turnover in women during the menopausal transition. Healthy women aged 45-60 years with the menopausal HFs were randomly assigned in a 1:1 ratio to either KM (1150 mg/day) or placebo arms for 12 weeks (n = 84). The intent-to-treat analysis found that compared with the placebo, the KM significantly attenuated HF scores (p = 0.041) and HF severities (p < 0.001), with a mean difference from baseline to week 12. The KM also improved bone turnover markers, showing a significant reduction in bone resorption CTx (p = 0.027) and a tendency of increasing bone formation OC relative to the placebo. No serious adverse events and hormonal changes were observed in both groups. These findings suggest that KM consumption may improve the quality of life in ways that are important to symptomatic menopausal women.
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Evaluation of the effect of Silybum marianum extract on menopausal symptoms: A randomized, double-blind placebo-controlled trial.
Saberi, Z, Gorji, N, Memariani, Z, Moeini, R, Shirafkan, H, Amiri, M
Phytotherapy research : PTR. 2020;(12):3359-3366
Abstract
The tendency to use herbs to manage menopausal symptoms has increased in recent years. The purpose of this study was to evaluate the effect of Silybum marianum (L.) compared with placebo in women with hot flashes. Eighty women were randomly allocated into two equal groups (S. marianum extract [400 mg/d] or placebo capsules). Hot flashes frequency and severity were evaluated in 12 weeks with the Greene Climacteric Scale (GCS) and the Hot Flash Related Daily Interference Scale (HFRDIS). The data were analyzed in SPSS software using t-test, Mann-Whitney, chi-square test and repeated measure analysis. Hot flashes frequency and severity decreased from 4.32 ± 0.20/day to 1.31 ± 0.15/day and from 5.25 ± 0.22 to 1.62 ± 0.08, respectively, during the study in test group (p < .001) which were significantly better than effects of placebo in all steps of study (p < .001). Significant decreases in GCS and HFRDIS scores were also detected in S. marianum group compared with placebo after 4, 8 and 12 weeks (p < .001). The results showed that S. marianum can decrease frequency and severity of hot flashes significantly. Considering the safety and high consumption of this herbal medicine worldwide, its use in women with menopausal symptoms can be helpful.
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Women dealing with hot flushes: the role of β-alanine.
Andreeva, E, Tkeshelashvili, B
European review for medical and pharmacological sciences. 2020;(9):5148-5154
Abstract
Hot flushes (HFs) are a very frequent condition in menopausal women, associated with a marked decrease in quality of life, impaired ability to carry on daily activities and sleep disturbances. However, this condition is often only given poor attention in daily practice and in clinical research. Indeed, several treatments for HFs exist. The most effective is considered to be hormone replacement therapy, but this strategy has been associated with a poor risk-benefit ratio given its link with the development of cancer. Other treatments have been tested and are currently used, but they are usually only poorly effective or cannot be recommended in all patients due to potential side effects or interference with other molecules. Therefore, there is a major need for new treatment options for HFs. β-alanine supplementation is widely used for the enhancement of energetic metabolism and is known to be devoid of any relevant adverse effect. BA has also been widely used for the treatment of HFs. This narrative review will discuss the current pharmacological management of HFs and will present the role of β-alanine in this setting.
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Scientific Evidence Supporting the Beneficial Effects of Isoflavones on Human Health.
Gómez-Zorita, S, González-Arceo, M, Fernández-Quintela, A, Eseberri, I, Trepiana, J, Portillo, MP
Nutrients. 2020;(12)
Abstract
Isoflavones are phenolic compounds with a chemical structure similar to that of estradiol. They are present in several vegetables, mainly in legumes such as soy, white and red clover, alfalfa and beans. The most significant food source of isoflavones in humans is soy-derived products. Isoflavones could be used as an alternative therapy for pathologies dependent on hormonal disorders such as breast and prostate cancer, cardiovascular diseases, as well as to minimize menopausal symptoms. According to the results gathered in the present review, it can be stated that there is scientific evidence showing the beneficial effect of isoflavones on bone health and thus in the prevention and treatment of osteoporosis on postmenopausal women, although the results do not seem entirely conclusive as there are discrepancies among the studies, probably related to their experimental designs. For this reason, the results should be interpreted with caution, and more randomized clinical trials are required. By contrast, it seems that soy isoflavones do not lead to a meaningful protective effect on cardiovascular risk. Regarding cancer, scientific evidence suggests that isoflavones could be useful in reducing the risk of suffering some types of cancer, such as breast and endometrial cancer, but further studies are needed to confirm these results. Finally, isoflavones could be useful in reducing hot flushes associated with menopause. However, a limitation in this field is that there is still a great heterogeneity among studies. Lastly, with regard to isoflavone consumption safety, it seems that they are safe and that the most common adverse effect is mild and occurs at the gastrointestinal level.
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Effects of Chlorogenic Acids on Menopausal Symptoms in Healthy Women: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Trial.
Enokuchi, Y, Suzuki, A, Yamaguchi, T, Ochiai, R, Terauchi, M, Kataoka, K
Nutrients. 2020;(12)
Abstract
A reduction in estrogen levels in the perimenopausal and postmenopausal periods causes various symptoms in women, such as hot flushes, sweats, depression, anxiety, and insomnia. Chlorogenic acids (CGAs), which are phenolic compounds widely present in plants such as coffee beans, have various physiological functions. However, the effects of CGAs on menopausal symptoms are unknown. To examine the effects of CGAs on menopausal symptoms, especially hot flushes, a randomized, placebo-controlled, double-blind, parallel-group trial was conducted in healthy women. Eighty-two subjects were randomized and assigned to receive CGAs (270 mg) tablets or the placebo for 4 weeks. After 4 weeks of intake, the number of hot flushes, the severity of hot flushes during sleep, and the severity of daytime sweats decreased significantly in the CGA group compared to the placebo group. The modified Kupperman index for menopausal symptoms decreased significantly after 2 weeks in the CGA group compared to the placebo group. Adverse effects caused by CGAs were not observed. The results show that continuous intake of CGAs resulted in improvements in menopausal symptoms, especially hot flushes, in healthy women.
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Effectiveness of the short-term use of Cimicifuga racemosa in the endothelial function of postmenopausal women: a double-blind, randomized, controlled trial.
Fernandes, ES, Celani, MFS, Fistarol, M, Geber, S
Climacteric : the journal of the International Menopause Society. 2020;(3):245-251
Abstract
Objective: This study aimed to assess the effects of daily use of Cimicifuga racemosa on endothelial function through flow-mediated dilation of the brachial artery, when used for 28 days by healthy postmenopausal women.Methods: The double-blind, randomized, placebo-controlled study included two groups of postmenopausal women (n = 31 each). The subjects were clinically assessed and flow-mediated dilation of the brachial artery was measured before and after 28 days of treatment. Patients received dry extract corresponding to 160 mg C. racemosa (extract with 4 mg of triterpene glycosides) or placebo.Results: Mean age, time since menopause, and body mass index in the two groups were similar. The measurements of flow-mediated dilation of the brachial artery, pre and post treatment, respectively, showed a significant increase in patients who used C. racemosa (p = 0.006), unlike patients who used placebo, who did not present changes in the outcome of flow-mediated dilation of the brachial artery after 28 days of use (p ≥ 0.05). When comparing the number of women in both groups who showed an increase in flow-mediated dilation, a significant difference was found in the measurements of the treated group after the use of the medication (p = 0.018).Conclusions: Daily use of 160 mg C. racemosa extract by postmenopausal women for 28 days beneficially influences endothelial function by promoting elasticity of the brachial artery.
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Effect of Fenugreek on vasomotor symptoms in menopausal women: A protocol for systematic review and meta-analysis.
Wu, T, Yue, R, He, M, Xu, C
Medicine. 2020;(23):e20526
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Abstract
BACKGROUND Vasomotor symptoms (hot flashes or night sweats) are closely related to the impaired quality of life in menopausal women. Fenugreek is the ripe seed of Trigonella foenum graecum Linn. In China, this plant is used to relieve menopausal symptoms in women. Although recent studies have shown that fenugreek may have a good effect on the menopausal symptoms, there is no meta-analysis to systematically evaluate its efficacy in improving menopausal vasomotor symptoms. METHODS Randomized controlled trials that met the inclusion criteria will be retrieved in 5 English online databases and 4 Chinese online databases. The primary outcomes are changes in frequency and intensity of vasomotor symptoms that measured by validated scales. The secondary outcomes will include quality of life, blood hormone parameters, blood biochemical parameters, and adverse events. Heterogeneity of data will be assessed by I and Cochrane Q statistics. Sensitivity analysis and subgroup analysis will be performed to explore the sources of heterogeneity. Egger test and Begg test will be used to assess the publication bias. Finally, we will evaluate the quality of evidence by the GRADE approach. All the data statistics will be performed using the STATA 15.0 software. RESULTS All the results of will be published in a peer-reviewed journal. CONCLUSIONS This meta-analysis will systematically evaluate the efficacy and safety of fenugreek in the treatment of menopausal vasomotor symptoms. OSF REGISTRATION NUMBER 10.17605/OSF.IO/3BCY8.