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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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The effect of programmed exercise over anxiety symptoms in midlife and older women: a meta-analysis of randomized controlled trials.
Martínez-Domínguez, SJ, Lajusticia, H, Chedraui, P, Pérez-López, FR, ,
Climacteric : the journal of the International Menopause Society. 2018;(2):123-131
Abstract
We aimed to perform a systematic review and meta-analysis in order to clarify the effect of programmed exercise over mild-to-moderate anxiety symptoms (ASs) in midlife and older women. A structured search of PubMed, Medline, Web of Science, Scopus, Embase, Cochrane Library, Scielo, and the US, UK and Australian Clinical Trials databases (from inception through July 27, 2017) was performed, with no language restriction using the following terms: 'anxiety', 'anxiety symptoms', 'exercise', 'physical activity', 'menopause', and 'randomized controlled trial' (RCTs) in mid-aged and older women. We assessed RCTs that compared the effect of exercise for at least 6 weeks versus no intervention over ASs as outcome (as defined by trial authors). Exercise was classified according to duration as 'mid-term exercise intervention' (MTEI; for 12 weeks to 4 months), and 'long-term exercise intervention' (LTEI; for 6-14 months). Mean ± standard deviations of changes for ASs, as assessed with different questionnaires, were extracted to calculate Hedges' g and then used as effect size for meta-analyses. Standardized mean differences (SMDs) of ASs after intervention were pooled using a random-effects model. Ten publications were included for analysis related to 1463 midlife and older women (minimum age 54.2 ± 3.5 and maximum age 77.6 ± 5.4 years). Eight MTEIs were associated with a significant reduction of ASs (SMD = -0.42; 95% CI -0.81 to -0.02) as compared to controls. There was no reduction of ASs in seven LTEIs (SMD = -0.03; 95% CI -0.18 to 0.13). It can be concluded that MTEIs of low-to-moderate intensity seem to improve mild-moderate ASs in midlife and older 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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Association of Vasomotor and Other Menopausal Symptoms with Risk of Cardiovascular Disease: A Systematic Review and Meta-Analysis.
Muka, T, Oliver-Williams, C, Colpani, V, Kunutsor, S, Chowdhury, S, Chowdhury, R, Kavousi, M, Franco, OH
PloS one. 2016;(6):e0157417
Abstract
IMPORTANCE Vasomotor symptoms (hot flushes and night sweats) and other symptoms, including depression, anxiety and panic attacks, are commonly experienced by menopausal women and have been associated with an unfavourable cardiovascular risk profile. OBJECTIVE To investigate whether presence of menopausal symptoms is associated with the development of cardiovascular disease (CVD). METHODS Five electronic databases (Medline, EMBASE and Web of Science) were search until February 17th, 2015 to identify relevant studies. Observational cohort studies or randomised intervention studies were eligible for inclusion if they followed participants prospectively (at least 1 year of follow-up), and reported relevant estimates on the association of any vasomotor symptoms, or other menopausal symptoms, with risk of CVD, coronary heart disease (CHD), or stroke in perimenopausal, menopausal, or postmenopausal women. Data were extracted by two independent reviewers using a pre-designed data collection form. Separate pooled relative risks (RRs) for age and non-established cardiovascular risk factors (e.g., education, ethnicity) adjusted data and for established cardiovascular risk factors and potential mediators-adjusted data (e.g., smoking, body mass index, and hypertension) were calculated. RESULTS Out of 9,987 initially identified references, ten studies were selected, including 213,976 women with a total of 10,037 cardiovascular disease outcomes. The age and non-established cardiovascular risk factors adjusted RRs) [95% confidence intervals] for development of CHD, Stroke and CVD comparing women with and without any menopausal symptoms were 1.34 [1.13-1.58], 1.30 [0.99-1.70], 1.48 [1.21-1.80] respectively, and the corresponding RRs adjusted for cardiovascular risk factors and potential mediators were 1.18 [1.03-1.35], 1.08 [0.89-1.32], 1.29 [0.98-1.71]. However, these analyses were limited by potential unmeasured confounding and the small number of studies on this topic. CONCLUSION Presence of vasomotor symptoms and other menopausal symptoms are generally associated with an increased risk of cardiovascular disease, which is mainly explained by cardiovascular risk factors.
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Ginseng for managing menopausal woman's health: A systematic review of double-blind, randomized, placebo-controlled trials.
Lee, HW, Choi, J, Lee, Y, Kil, KJ, Lee, MS
Medicine. 2016;(38):e4914
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Abstract
BACKGROUND The aim of this systematic review was to update, complete, and critically evaluate the evidence from placebo-controlled randomized clinical trials (RCTs) of ginseng for managing menopausal women's health. METHODS We searched the literature using 13 databases (MEDLINE, AMED, EMBASE, the Cochrane Library, 6 Korean Medical, and 3 Chinese Databases) from their inception to July 2016 and included all double-blind RCTs that compared any type of ginseng with a placebo control in postmenopausal women. The methodological quality of all studies was assessed using a Cochrane risk of bias tool. RESULTS Ten RCTs met our inclusion criteria. Most RCTs had unclear risk of bias. One RCT did not show a significant difference in hot flash frequency between Korean red ginseng (KRG) and placebo. The second RCT reported positive effects of KRG on menopausal symptoms. The third RCT found beneficial effects of ginseng (Ginsena) on depression, well-being, and general health. Four RCTs failed to show significant differences in various hormones between KRG and placebo controls except dehydroepiandrosterone. Two other RCTs failed to show effects of KRG on endometrial thickness in menopausal women. The other RCT also failed to show the effects of American ginseng on oxidative stress markers and other antioxidant enzymes. CONCLUSION Our systematic review provided positive evidence of ginseng for sexual function and KRG for sexual arousal and total hot flashes score in menopausal women. However, the results of KRG or ginseng failed to show specific effects on hot flash frequency, hormones, biomarkers, or endometrial thickness. The level of evidence for these findings was low because of unclear risk of bias.
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Vasomotor symptoms in women and cardiovascular risk markers: Systematic review and meta-analysis.
Franco, OH, Muka, T, Colpani, V, Kunutsor, S, Chowdhury, S, Chowdhury, R, Kavousi, M
Maturitas. 2015;(3):353-61
Abstract
UNLABELLED We performed a systematic review and meta-analysis of the observational or interventional studies assessing the association of vasomotor symptoms (hot flushes and night sweats) with various cardiovascular risk markers (systolic (SBP) and diastolic blood pressure (DBP), hypertension, total cholesterol, body mass index (BMI), and measures of subclinical atherosclerosis), in peri-menopausal, menopausal, or postmenopausal women. Eleven unique studies were identified with data available on 19,667 non-overlapping participants. Pooled analysis showed that women with hot flushes, compared to those without, tended to have significant higher levels of SBP (mean difference (MD): 1.95 mmHg (95%CI, 0.27 to 33.63)), and DBP (MD 1.17 mmHg (95%CI, -0.21 to 2.54)) and higher odds of having hypertension (OR: 1.18, 95%CI: 0.93 to 1.51), albeit non-significant. Similarly, women who reported night sweats compared to those who did not, had significant higher levels of SBP, (MD: 1.33 mmHg (95%CI, 0.63 to 2.03)), DBP (MD: 0.55 mmHg (95%CI, 0.19 to 0.91)), total cholesterol (MD: 0.17 mmHg (95%CI, 0.03 to 0.31)) and BMI (MD: 0.64 mmHg (95%CI, 0.47 to 0.80)). Vasomotor symptoms in women were not associated with measures of subclinical atherosclerosis. Women with vasomotor symptoms may have an unfavorable cardiovascular risk profile compared to women without vasomotor complaints.
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Efficacy of phytoestrogens for menopausal symptoms: a meta-analysis and systematic review.
Chen, MN, Lin, CC, Liu, CF
Climacteric : the journal of the International Menopause Society. 2015;(2):260-9
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Abstract
OBJECTIVE To perform a meta-analysis examining the efficacy of phytoestrogens for the relief of menopausal symptoms. METHODS Medline, Cochrane, EMBASE, and Google Scholar databases were searched until September 30, 2013 using the following key words: vasomotor symptoms, menopausal symptoms, phytoestrogens, isoflavones, coumestrol, soy, red clover. Inclusion criteria were (1) randomized controlled trial (RCT), (2) perimenopausal or postmenopausal women experiencing menopausal symptoms, (3) intervention with an oral phytoestrogen. Outcome measures included Kupperman index (KI) changes, daily hot flush frequency, and the likelihood of side-effects. RESULTS Of 543 potentially relevant studies identified, 15 RCTs meeting the inclusion criteria were included. The mean age of the subjects ranged from 49 to 58.3 and 48 to 60.1 years, respectively, in the placebo and phytoestrogen groups. The number of participants ranged from 30 to 252, and the intervention periods ranged from 3 to 12 months. Meta-analysis of the seven studies that reported KI data indicated no significant treatment effect of phytoestrogen as compared to placebo (pooled mean difference = 6.44, p = 0.110). Meta-analysis of the ten studies that reported hot flush data indicated that phytoestrogens result in a significantly greater reduction in hot flush frequency compared to placebo (pooled mean difference = 0.89, p < 0.005). Meta-analysis of the five studies that reported side-effect data showed no significant difference between the two groups (p = 0.175). CONCLUSION Phytoestrogens appear to reduce the frequency of hot flushes in menopausal women, without serious side-effects.
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Menstrual and reproductive history and use of exogenous sex hormones and risk of thyroid cancer among women: a meta-analysis of prospective studies.
Caini, S, Gibelli, B, Palli, D, Saieva, C, Ruscica, M, Gandini, S
Cancer causes & control : CCC. 2015;(4):511-8
Abstract
PURPOSE Thyroid cancer has a higher incidence in women than in men, and it has been hypothesized that hormonal factors may explain such disparity. We performed a meta-analysis of observational prospective studies to investigate the association between menstrual and reproductive variables and exogenous hormone use and the risk of thyroid cancer among women. METHODS We calculated summary relative risks and 95% confidence intervals (95% CI) using random effect models. RESULTS Overall, 5,434 thyroid cancer cases from twenty-four papers were included. Increasing age at first pregnancy/birth (SRR 1.56, 95% CI 1.01-2.42) and hysterectomy (SRR 1.43, 95% CI 1.15-1.78) were associated with thyroid cancer risk. Women that were in menopause at enrolment had a reduced thyroid cancer risk (SRR 0.79, 95% CI 0.62-1.01). No other menstrual, reproductive, and hormonal variable was associated with thyroid cancer risk. CONCLUSIONS Menstrual and reproductive factors may play a role in the etiology of thyroid cancer, possibly through the mediation of estrogen receptors.
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[Treating menopause syndrome by kuntal capsule and hormone replacement therapy: a meta-analysis of efficacy and safety comparison].
Li, CC, Wang, JJ, Chen, C, Li, YF, Zheng, QS, Yang, J, Liu, HX
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2013;(9):1183-90
Abstract
OBJECTIVE To evaluate the efficacy and safety of Kuntai Capsule (KC) and hormone replacement therapy (HRT) in treating menopause syndrome by Meta-analysis. METHODS Randomized controlled trials were electronically retrieved from PubMed, EMbase, The Cochrane Library, CBM, CNKI, Chinese Doctoral Dissertation Full Text Database, Chinese Outstanding Masters' Dissertation Full Text Database, and VIP database, Wanfang Database, and some other related papers were manually checked. All papers were assessed according to the Cochrane Handbook for Systematic Reviews of interventions and then effective data were analyzed by RevMan 5.0.2 Software. RESULTS Eight randomized control trials involving 675 patients were included. Results of Meta-analysis showed that there was no statistical difference in the Kupperman Menopausal Scores [MD = 1.91, 95% CI (-0.31, 4.12)] and the effective rate of Kupperman Menopausal Scores [OR = 1.37, 95% CI (0.66, 2.85)] between the KC group and the estrogen replacement therapy group (P > 0.05). Compared with the KC group, the E2 level [MD = -12.8, 95% CI (-22.85, -2.76)] and the FSH level [MD = 17.96, 95% CI (3.03, 32.88)] could be significantly improved in the estrogen replacement therapy group. Compared with the estrogen replacement group, KC could significantly reduce the total incidence of adverse reactions [OR = 0.41, 95% CI (0.24, 0.73)], the incidence of breast distending pain [OR = 0.65, 95% CI (0.42, 1.00)], and the incidence of vaginal bleeding [OR = 0.26, 95% CI (0.17, 0.40) ] (P < 0.05). CONCLUSIONS The current limited evidence showed that, when compared with the estrogen replacement therapy group, KC could also improve climacteric symptoms. It was inferior to the estrogen replacement therapy group in improving in vivo hormone levels. But it was superior in reducing the incidence of adverse reactions, breast distending pain, and vaginal bleeding.
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Suspected black cohosh hepatotoxicity: no evidence by meta-analysis of randomized controlled clinical trials for isopropanolic black cohosh extract.
Naser, B, Schnitker, J, Minkin, MJ, de Arriba, SG, Nolte, KU, Osmers, R
Menopause (New York, N.Y.). 2011;(4):366-75
Abstract
OBJECTIVE Black cohosh, a popular herbal treatment for menopausal symptoms, has been implicated in a number of hepatotoxicity case reports. The purpose of this investigation was to analyze data gained from clinical trials on the effect of black cohosh on liver function. METHODS A meta-analysis of randomized, double-blind, and controlled clinical trials was conducted. These studies primarily evaluated the efficacy and safety of the isopropanolic black cohosh extract (iCR) in perimenopausal and postmenopausal women. Raw data on liver function values of aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltranspeptidase were considered in this analysis, if these data at baseline and after 3 to 6 months of treatment were available. Standard methods of descriptive statistics were used in this analysis. RESULTS Five studies involving a total of 1,117 women were included in the meta-analyses. A total of 1,020 women (test population=517 and reference population=503) completed the studies. Perimenopausal and postmenopausal women (40-60 y) were treated daily with iCR (corresponding to 40-128 mg drug) for 3 to 6 months. The meta-analyses of the standardized mean differences in the "test" versus "reference" showed no significant effects and no differences between double-blind, placebo-controlled and other trials. The overall fixed effect ± SEM was 0.055 ± 0.062 (P=0.37) for aspartate aminotransferase and 0.063 ± 0.062 (P=0.31) for alanine aminotransferase. The nonsignificant effects concerned the overall analyses of all included studies as well as the proportion of placebo-controlled studies. CONCLUSIONS The results of this meta-analysis of five randomized, double-blind, and controlled clinical trials showed no evidence that iCR has any adverse effect on liver function.