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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.
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Efficacy and safety evaluation of Cimicifuga foetida extract in menopausal women.
Gao, L, Zheng, T, Xue, W, Wang, Y, Deng, Y, Zuo, H, Sun, A
Climacteric : the journal of the International Menopause Society. 2018;(1):69-74
Abstract
OBJECTIVE The aim of this study was to evaluate the efficacy and safety of long-term treatment with Cimicifuga foetida extract in menopausal women. METHODS A prospective, randomized, controlled clinical trial was conducted. A total of 96 early postmenopausal women were randomly assigned to three groups: group A received 1 mg estradiol valerate daily plus 4 mg medroxyprogesterone acetate on days 19-30; group B received 1 mg estradiol valerate daily plus 100 mg micronized progesterone on days 19-30; group C received 100 mg C. foetida extract daily. The efficacy was evaluated. Safety parameters were recorded. RESULTS A total of 81 patients completed the treatment and follow-up visit. The modified Kupperman Menopausal Index scores decreased after 3 months in all groups. No significant changes were observed in the liver, renal function and components of metabolic syndrome in group C (p > 0.05). There were no significant differences in the incidences of metabolic syndrome among the three groups (p > 0.05). After 24 months, the endometrial thickness increased significantly in group B (p = 0.014), but not in the C. foetida extract group (p > 0.05). CONCLUSIONS C. foetida extract is safe and effective for the treatment of menopausal symptoms in postmenopausal women.
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Effects of a standardised extract of Trifolium pratense (Promensil) at a dosage of 80mg in the treatment of menopausal hot flushes: A systematic review and meta-analysis.
Myers, SP, Vigar, V
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2017;:141-147
Abstract
OBJECTIVE To critically assess the evidence for a specific standardised extract of Trifolium pratense isoflavones (Promensil) at a dosage of 80mg/day in the treatment of menopausal hot flushes. DATA SOURCES Systematic literature searches were performed in Medline, Scopus, CINAHL Plus, Cochrane, AMED and InforRMIT and citations obtained from 1996 to March 2016. Reference lists were checked; corresponding authors contacted and the grey literature searched for additional publications. REVIEW METHODS Studies were selected according to predefined inclusion and exclusion criteria. All randomised clinical trials of a specific standardised extract of Trifolium pratense isoflavones (Promensil) used as a mono-component at 80mg/day and measuring vasomotor symptoms were included. The data extraction and quality assessment were performed independently by one reviewer and validated by a second with any disagreements being settled by discussion. Weighted mean differences and 95% confidence intervals were calculated for continuous data using the fixed-effects model. RESULTS Twenty potentially relevant papers were identified, with only five studies meeting the inclusion criteria. The meta-analysis demonstrated a statistical and clinically relevant reduction in hot flush frequency in the active treatment group compared to placebo. Weighted mean difference 3.63 hot flushes per day: [95% CI 2.70-4.56]; p˂0.00001). Due to a lack of homogeneity a priori defined sub-group analyses were performed demonstrating a substantive difference between cross-over and parallel-arm clinical trial designs. CONCLUSION There is evidence for a statistical and clinically significant benefit for using a specific standardised extract of red clover isoflavones (Promensil) at 80mg/day for treating hot flushes in menopausal women across the 3 studies included in the meta-analysis. The preparation was safe over the short-term duration of the studies (3 months).
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Review of Efficacy of Complementary and Alternative Medicine Treatments for Menopausal Symptoms.
Moore, TR, Franks, RB, Fox, C
Journal of midwifery & women's health. 2017;(3):286-297
Abstract
Complementary and alternative medicine (CAM) treatments have been used for thousands of years around the world. There has been increased interest in utilizing CAM for menopausal symptoms since the release of results of the Women's Health Initiative elucidated long-term adverse effects associated with hormone therapy. Women looking for more natural or safer means to treat hot flushes, night sweats, and other menopausal symptoms often turn to CAM such as yoga, phytoestrogens, or black cohosh. Yet there have been few well-conducted studies looking at the efficacy of these treatments. This review examines randomized clinical trials, systematic reviews, and meta-analyses evaluating the effectiveness of commonly used CAM for the treatment of menopausal symptoms.
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Pomegranate (Punica granatum) Seed Oil for Treating Menopausal Symptoms: An Individually Controlled Cohort Study.
Huber, R, Gminski, R, Tang, T, Weinert, T, Schulz, S, Linke-Cordes, M, Martin, I, Fischer, H
Alternative therapies in health and medicine. 2017;(2):28-34
Abstract
Context • In the folk medicine of Mediterranean countries and in ancient Ayurveda, Punica granatum seeds (ie, pomegranate seeds) have been used for treatment of various disorders, including those that nowadays are classified as menopausal symptoms (MSs). Pomegranate seed oil (PSO) from those seeds mainly contains unsaturated fatty acids such as γ-linoleic acid and linolenic acid, but it also includes phytoestrogens. It is, therefore, regarded as a promising option for treating MSs today. Objectives • The study intended to investigate the safety and effectiveness of PSO as a defined P granatum seed oil for patients with MSs. Design • The research team designed an individually controlled, investigator-initiated cohort study. Setting • The treatments were performed at 2 institutions: (1) the Center for Complementary Medicine at the University Medical Center Freiburg (Freiburg, Germany); and (2) in the medical practice of H. Fischer (Freiburg, Germany). Participants • Seventy-eight patients, who had a mean duration of MSs of 46 mo, participated in the study. Intervention • After 4 wk without treatment, which functioned as a period providing an individual control, each participant took 1000 mg of PSO daily in 2 capsules for 8 wk. Outcome Measures • The symptom severity was scored on the German version of the menopausal rating scale (MRS) at baseline, after 4 wk without treatment, after 4 wk of treatment, and postintervention, with 0 = absence of symptoms and 4 = very strong symptoms. The efficacy and tolerability were estimated on scales from 0-4. Each participant's 17ß estradiol was determined at baseline and after postintervention using the patient's sera. The content of the β-sitosterol was determined in the PSO preparations by gas chromatography. Results • The content of β-sitosterol in the PSO used in the study was 6.3 mg/1000 mg. In the intention to treat analysis, most MRS symptoms were significantly and relevantly reduced (eg, hot flushes changed from 2.32 ± 1.04 to 1.41 ± 1.07, P < .001). Remarkably, urogenital tract symptoms (ie, a dry vagina) also significantly improved, moving from 1.32 ± 1.43 to 0.85 ± 1.19, P < .001. Few patients reported gastrointestinal symptoms. The tolerability was excellent at 3.69 ± 0.71 after 4 wk of treatment and 3.71 ± 0.65 after 8 wk of treatment. The 17ß estradiol was unchanged. Conclusions • Participants showed significant improvements in all domains of the MRS, remarkably including the difficult-to-treat urogenital symptoms. No changes occurred in the 17ß-estradiol in patients' sera after the PSO treatment. The results are promising and encourage the investigation of PSO rich in β-sitosterol for treatment of MSs in placebo-controlled studies.
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Long-term exercise training and soy isoflavones to improve quality of life and climacteric symptoms.
Fontvieille, A, Dionne, IJ, Riesco, E
Climacteric : the journal of the International Menopause Society. 2017;(3):233-239
Abstract
OBJECTIVE To verify the efficacy of phytoestrogen supplementation combined with aerobic and resistance training on the improvement of climacteric symptoms and health-related quality of life (HRQoL) in postmenopausal women. METHODS From a pool of women who had participated in a 1-year intervention study and were randomly assigned to either exercise + phytoestrogen (EX + PHY) or exercise + placebo (EX + PL), a total of 31 healthy but overweight women (mean age 59.2 ± 4.8 years, body mass index 29.1 ± 3.5 kg/m2) finished the study (EX + PHY, n = 15; EX + PL, n = 16). All the following variables were measured before, after 6 months and after 12 months of intervention: body composition (fat and lean body mass, DXA), HRQoL (SF-36 questionnaire: physical and mental component summaries and subscales; and the 10-item Perceived Stress Scale questionnaire), climacteric symptoms (Kupperman Index questionnaire). RESULTS After 1 year of intervention, physical functioning (p = 0.003), role-emotional (p = 0.031), vitality (p = 0.007), and global health (p < 0.001) were significantly and similarly increased in both groups. Regarding climacteric symptoms, an improvement in the Kupperman index total score (p = 0.015) was observed. CONCLUSION Our results demonstrate that adding phytoestrogens to exercise training does not provide the additive effect for HRQoL in postmenopausal and overweight women. Moreover, exercise and phytoestrogen may interfere in the improvement of climacteric symptoms in the long term.
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The impact of combined nutraceutical supplementation on quality of life and metabolic changes during the menopausal transition: a pilot randomized trial.
Villa, P, Amar, ID, Bottoni, C, Cipolla, C, Dinoi, G, Moruzzi, MC, Scambia, G, Lanzone, A
Archives of gynecology and obstetrics. 2017;(4):791-801
Abstract
PURPOSE The aim of this study was to assess the efficacy of a combined nutraceutical supplement on symptoms and early metabolic alterations during the menopausal transition. This pilot randomized study was conducted at the service for menopause disorders of the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. METHODS Ninety women in menopausal transition who attended our service with menopausal symptoms were enrolled in the study. Sixty patients, randomly assigned to the treatment group, were prescribed one daily tablet of a combined nutraceutical compound with phytoestrogen substances, vitamins, micronutrients and passion flower herbal medicine for 6 months. Thirty patients did not receive any treatment and comprised the control group. The intensity of perimenopausal symptoms was assessed by the modified Kuppermann Index (KI) at enrollment and at 3 and 6 months of treatment. At baseline and at the end of the study, patients underwent a clinical evaluation, a pelvic ultrasound and analysis of blood samples. RESULTS In the nutraceutical supplemented group, a significant reduction in menopausal symptoms was demonstrated according to the KI after 3 and 6 months of supplementation (p < 0.01). The within-group analysis of different KI parameters in the treated group showed a significant improvement in hot flushes (p < 0.001), insomnia (p < 0.01), fatigue (p < 0.01) and irritability (p < 0.01). Metabolic parameters did not change significantly in the nutraceutical supplemented group. In the control group, total cholesterol level showed a significant increase (p < 0.05). CONCLUSIONS Combined nutraceutical supplementation provides an effective and safe solution for early symptoms occurring during menopausal transition.
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Vasomotor symptoms resulting from natural menopause: a systematic review and network meta-analysis of treatment effects from the National Institute for Health and Care Excellence guideline on menopause.
Sarri, G, Pedder, H, Dias, S, Guo, Y, Lumsden, MA
BJOG : an international journal of obstetrics and gynaecology. 2017;(10):1514-1523
Abstract
BACKGROUND Vasomotor symptoms (VMSs) are the hallmarks of menopause, occurring in approximately 75% of postmenopausal women in the UK, and are severe in 25%. OBJECTIVES To identify which treatments are most clinically effective for the relief of VMSs for women in natural menopause without hysterectomy. SEARCH STRATEGY English publications in MEDLINE, Embase, and The Cochrane Library up to 13 January 2015 were searched. SELECTION CRITERIA Randomised controlled trials (RCTs) of treatments for women with a uterus for the outcomes of frequency of VMSs (up to 26 weeks), vaginal bleeding, and discontinuation. DATA COLLECTION AND ANALYSIS Bayesian network meta-analysis (NMA) using mean ratios (MRs) and odd ratios (ORs). MAIN RESULTS Across the three networks, 47 RCTs of 16 treatment classes (n = 8326 women) were included. When compared with placebo, transdermal estradiol and progestogen (O+P) had the highest probability of being the most effective treatment for VMS relief (69.8%; MR 0.23; 95% credible interval, 95% CrI 0.09-0.57), whereas oral O+P was ranked lower than transdermal O+P, although oral and transdermal O+P were no different for this outcome (MR 2.23; 95% CrI 0.7-7.1). Isoflavones and black cohosh were more effective than placebo, although not significantly better than O+P. Not only were selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) found to be ineffective in relieving VMSs, but they also had significantly higher odds of discontinuation than placebo. Limited data were available for bleeding, therefore no conclusions could be made. CONCLUSION For women who have not undergone hysterectomy, transdermal O+P was the most effective treatment for VMS relief. TWEETABLE ABSTRACT Which treatment best relieves menopause flushes? Results from the #NICE guideline network meta-analysis.