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1.
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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2.
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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3.
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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4.
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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5.
Equol Decreases Hot Flashes in Postmenopausal Women: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
Daily, JW, Ko, BS, Ryuk, J, Liu, M, Zhang, W, Park, S
Journal of medicinal food. 2019;(2):127-139
Abstract
Soy isoflavones may benefit some, but not all, menopausal women, and the ability of the women to produce equol may be the major determinant of effectiveness. We assessed the efficacy of soy isoflavones and equol for alleviating menopausal symptoms, especially vasomotor symptoms, in postmenopausal women who were equol producers and nonproducers by using systematic review and meta-analysis of randomized clinical trials (RCTs). We searched 12 English, Korean, and Chinese language scientific and medical databases. We selected all available RCTs that assessed the effect of equol, either equol itself or soy isoflavone in equol producers, on menopausal symptoms in peri- or postmenopausal women. The primary outcome was the effect on hot flashes. The severity of hot flashes was determined by the scores, and sensitivity and risk of bias analyses were conducted. Other outcomes of the review, but not meta-analysis, included depression and adverse events. Six studies (779 total subjects) met all criteria for the systematic review, 5 of those could be included in the meta-analysis (728 total subjects). Two studies included in the meta-analysis reported no statistically significant benefits of equol; the other three did report significant benefits of equol. Meta-analysis revealed a significant benefit of equol for lowering hot flash scores and revealed a generally low risk of bias. In conclusion, this study found that supplementing equol to equol nonproducers significantly lowered the incidence and/or severity of hot flashes in menopausal women.
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Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms.
Lobo, RA, Kaunitz, AM, Santoro, N, Bernick, B, Graham, S, Mirkin, S
Climacteric : the journal of the International Menopause Society. 2019;(6):610-616
Abstract
Objective: This study aimed to evaluate the effects of TX-001HR (17β-estradiol [E2] and progesterone [P4] in a single oral capsule) on cardiometabolic markers and outcomes. Methods: Four E2/P4 doses (1 mg/100 mg, 0.5 mg/100 mg, 0.5 mg/50 mg, 0.25 mg/50 mg) were compared with placebo in menopausal women with vasomotor symptoms (VMS) and a uterus in the phase 3 REPLENISH (ClinicalTrials.gov, NCT01942668) trial. Changes in lipid and coagulation parameters and blood glucose from baseline at 6, 9, and 12 months as well as cardiovascular events are summarized. Results: A total of 1835 participants took ≥1 capsule of daily E2/P4; 1684 received E2/P4 and 151 received placebo. No clinically significant changes in lipid parameters, coagulation factors, or glucose were observed between treatment groups. Minimal increases of potential clinical importance were observed in total cholesterol, triglycerides, and glucose at month 12 with E2/P4 (1-4%, 6-11%, and 1%, respectively) and placebo (3%, 7%, and 2%, respectively). One episode of deep venous thrombosis and three cases of cardiovascular disease were observed, similar to expected rates of these events in the general population. Conclusions: In the REPLENISH trial, postmenopausal women with VMS treated with E2/P4 had no clinically meaningful effects on lipids, glucose, or coagulation parameters compared with placebo.
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Efficacy of a Homeopathic Medicine of Capsicum frutescens L. (Solanaceae) in the Treatment of Hot Flashes in Menopausal Women: A Phase-2 Randomized Controlled Trial.
Andrade, DCDS, Carmona, F, Angelucci, MA, Martinez, EZ, Pereira, AMS
Homeopathy : the journal of the Faculty of Homeopathy. 2019;(2):102-107
Abstract
BACKGROUND Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of Capsicum frutescens L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy Malagueta. METHODS This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine Malagueta (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group. RESULTS The effect of Malagueta on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4, p < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with Malagueta, compared with placebo, also reduced the intensity of the secondary symptoms (p = 0.001) and improved level of activity (p = 0.025) and well-being (p = 0.008). CONCLUSION The homeopathic medicine of Capsicum frutescens (Malagueta) was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.
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Efficacy of Crocus sativus (saffron) in treatment of major depressive disorder associated with post-menopausal hot flashes: a double-blind, randomized, placebo-controlled trial.
Kashani, L, Esalatmanesh, S, Eftekhari, F, Salimi, S, Foroughifar, T, Etesam, F, Safiaghdam, H, Moazen-Zadeh, E, Akhondzadeh, S
Archives of gynecology and obstetrics. 2018;(3):717-724
Abstract
PURPOSE Due to concerns regarding the side effects of hormone therapy, many studies have focused on the development of non-hormonal agents for treatment of hot flashes. The aim of this study was to evaluate the efficacy and safety of saffron (stigma of Crocus sativus) in treatment of major depressive disorder associated with post-menopausal hot flashes. METHODS Sixty women with post-menopausal hot flashes participated in this study. The patients randomly received either saffron (30 mg/day, 15 mg twice per day) or placebo for 6 weeks. The patients were assessed using the Hot Flash-Related Daily Interference Scale (HFRDIS), Hamilton Depression Rating Scale (HDRS) and the adverse event checklist at baseline and also at the second, fourth, and sixth weeks of the study. RESULTS Fifty-six patients completed the trial. Baseline characteristics of the participants did not differ significantly between the two groups. General linear model repeated measures demonstrated significant effect for time × treatment interaction on the HFRDIS score [F (3, 162) = 10.41, p = 0.0001] and HDRS score [F (3, 162) = 5.48, p = 0.001]. Frequency of adverse events was not significantly different between the two groups. CONCLUSIONS Results from this study revealed that saffron is a safe and effective treatment in improving hot flashes and depressive symptoms in post-menopausal healthy women. On the other hand, saffron, with fewer side effects, may provide a non-hormonal and alternative herbal medicine option in treatment of women with hot flashes.
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Effect of omega-3 supplements on vasomotor symptoms in menopausal women: A systematic review and meta-analysis.
Mohammady, M, Janani, L, Jahanfar, S, Mousavi, MS
European journal of obstetrics, gynecology, and reproductive biology. 2018;:295-302
Abstract
OBJECTIVE We aimed to investigate the effect of omega-3 supplements on relief of vasomotor symptoms among menopausal women. STUDY DESIGN The Cochrane Library, MEDLINE, SCOPUS, EMBASE, ProQuest, Google Scholar, Web of Science, CINAHL, IranMedex and SID databases were searched until September 2017. Inclusion criteria were (1) women were experiencing vasomotor symptoms in the menopause period, (2) intervention was omega-3 supplements (3) randomized controlled trial (RCT) or quasi-RCT, and (4) outcome measures included changes in the frequency and severity of hot flush or night sweats, sleep problems and side effects. RESULTS Three randomized controlled trials involving 483 women in the age range of 51 to 54.7 years were included in the review. Overall, the risk of bias in the included studies was moderate. All the participants were found to be blinded. Meta-analysis of the data showed no difference in the frequency and severity of hot flushes, insomnia severity, sleep quality, quality of life and adverse effects between the two groups. Compared to placebo group, women who received omega-3 supplements experienced lower frequency (mean difference: -1.82, 95% CI: -2.81, -0.83) and severity (mean difference: -.89, 95% CI: -1.25, -0.53) of night sweats. CONCLUSIONS RCTs which investigate the impact of omega-3 supplements on vasomotor symptoms in menopausal women are scarce. A comprehensive search in a wide range of databases found only three relevant papers. Our analysis suggests that omega-3 supplements may alleviate night sweats but have no benefit in reducing hot flushes, or improving sleep quality and quality of life during the menopausal period. We recommend high quality RCTs along with a longer follow-up period to investigate this important subject, as there was insufficient evidence to conclude that omega-3 supplements are of benefit in alleviating vasomotor symptoms in menopausal women.
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Soy germ extract alleviates menopausal hot flushes: placebo-controlled double-blind trial.
Imhof, M, Gocan, A, Imhof, M, Schmidt, M
European journal of clinical nutrition. 2018;(7):961-970
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Abstract
BACKGROUND/OBJECTIVES A double-blind, placebo-controlled study was performed to assess the potency of a soy germ preparation for the alleviation of menopausal hot flushes. SUBJECTS/METHODS Caucasian women with at least seven hot flushes daily were treated with soy germ extract (100 mg isoflavone glycosides) daily or with placebo for 12 weeks, followed by 12 weeks of open treatment with soy. Outcome parameters were the number of hot flushes and the evaluation of the Greene Climacteric Scale. RESULTS A total of 192 women were included. As the hot flush diaries from one study centre were lost, the assessment of hot flushes was based on 136 participants (soy: 54 women; placebo: 82 women). After 12 weeks, 180 women were available for the analysis of Greene Scale and safety (soy and placebo: each 90 women). Hot flushes were reduced by 43.3% (-3.5 hot flushes) with soy and by 30.8% with placebo (-2.6; p < 0.001). After the open treatment phase with soy, both original groups showed a reduction of 68% of hot flushes. A subgroup analysis showed better effects for soy when symptoms were classified as "severe" at baseline. After 12 weeks of double-blind treatment, there was an improvement from baseline values of 71 and 78% with soy with the items "hot flushes" and "sweating", compared with 24% for both items with placebo. Hormonal safety parameters remained uninfluenced. CONCLUSIONS Soy germ extract with 100 mg of isoflavone glycosides was shown to modestly, but significantly reduce menopausal hot flushes.