A Pilot Study of the Effects of Phytoestrogen Supplementation on Postmenopausal Endometrium Aerobic exercise as a treatment for vasomotor menopausal symptoms: randomised controlled trial protocol. Androgens and estrogens in relation to hot flushes during the menopausal transition. [The effects of phytoestrogen therapy on the endometrium in postmenopausal women]. Evidence-based review of therapies at the menopause. Dietary factors and vasomotor symptoms in breast cancer survivors: the WHEL Study The effects of micronutrient supplementation on vasomotor symptoms in postmenopausal women Medroxyprogesterone and conjugated oestrogen are equivalent for hot flushes: a 1-year randomized double-blind trial following premenopausal ovariectomy. Dietary flour supplementation decreases post-menopausal hot flushes: effect of soy and wheat. The effect of red clover isoflavone supplementation over vasomotor and menopausal symptoms in postmenopausal women Isoflavone-rich or isoflavone-poor soy protein does not reduce menopausal symptoms during 24 weeks of treatment Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study A cognitive model of menopausal hot flushes and night sweats. Dietary soy supplementation and phytoestrogen levels. Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: Randomized, controlled, double-blind pilot study Effect of soy phytoestrogens on hot flashes in postmenopausal women with breast cancer: a randomized, controlled clinical trial. Efficacy of a Proprietary Trigonella foenum‐graecum L. De‐Husked Seed Extract in Reducing Menopausal Symptoms in Otherwise Healthy Women: A Double‐Blind, Randomized, Placebo‐Controlled Study A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1): Trial protocol Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 2-year randomized, double-blind, placebo-controlled study Comparison of a novel vaginal ring delivering estradiol acetate versus oral estradiol for relief of vasomotor menopausal symptoms A psychological analysis of menopausal hot flushes. Isoflavone treatment for acute menopausal symptoms Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms.
Objective : This study was design ed to assess endometrial histology in postmenopausal women not taking hormone replacement therapy , to evaluate side effects and efficacy of phytoestrogens in treating menopause-associated symptoms , and to determine whether 6 months of phytoestrogen supplementation altered endometrial histology . Methods : We performed a prospect i ve , double-blinded , r and omized , placebo-controlled trial comparing the effects of 6 months of dietary phytoestrogen supplemtation versus placebo in postmenopausal women . Baseline endometrial biopsies were performed and , if adequate , nonhyperplastic , noncancerous , and non-ovulatory , subjects were r and omly assigned to receive daily placebo or soy cereal supplementation for 6 months . Study subjects completed baseline and weekly dietary , symptom , and side effect logs . Repeat endometrial biopsies were obtained at 6 months . Results : Subjects were recruited from January 1998 through June 2000 . Twenty-seven subjects were r and omized , and 19 completed the study . One ( 3.7 % ) baseline endometrial sample was weakly proliferative . All other baseline and final biopsies were consistent with atrophic , inactive endometrium . The maximum risk of endometrial stimulation with phytoestrogens is 35 % . Hot flushes , night sweats , and vaginal dryness were significantly less severe at the final week of the study compared with baseline in the placebo group . Insomnia was more common in the treated group . There were no other statistically significant differences in symptoms or side effects . Conclusion : Phytoestrogens did not cause stimulation of the endometrium . Insomnia was more frequent over the 6-month study in the soy group , whereas hot flushes , night sweats , and vaginal dryness improved from baseline in the placebo group but not in the soy group BACKGROUND Evidence suggests that a high proportion of perimenopausal and postmenopausal women experience vasomotor symptoms ( hot flushes/night sweats ) that can be severe and disruptive and which are the principal reason for seeking medical intervention . Hormone therapy ( HT ) is known to be an effective treatment for troublesome hot flushes/night sweats but research has raised questions about the safety of HT and there have been negative high profile media reports about its use . Consequently many women are seeking alternatives and exercise might be one such option but there is a lack of high quality evidence on its effectiveness . AIMS This RCT initially aims to investigate the feasibility/acceptability of two exercise interventions identified from our previous preference study in 165 women , and if found to be feasible/acceptable , continue to recruit sufficient women ( n=261 ) to examine the effect of these interventions on hot flushes/night sweats and other outcomes relevant to menopausal women . METHOD We aim to recruit inactive perimenopausal and menopausal symptomatic women not using HT and r and omise them to one of two exercise interventions or usual care for six months . RESULTS We will assess outcomes at baseline and 6 and 12 months from r and omisation . CONCLUSION We hope this RCT will contribute towards increasing the evidence regarding the question of whether exercise is an effective treatment for vasomotor symptoms in women not taking HT In this paper , the association of hormones to vasomotor complaints during the menopausal transition is discussed . Fifty-seven regularly menstruating women without history of hormone replacement therapy ( HRT )  were selected for a longitudinal , prospect i ve study around the menopausal transition . The mean age at the start of the study was 51.3 ( + /-2.0 ) years . At intervals of 12 months all women went through a semi-structured interview and filled in question naires .  Venous blood sample s were collected every 12-month for analyses of estradiol ( E2 ) , testosterone , and rostendione , dehydroepi and rosterone-sulphate ( DHEA-S ) , follicle stimulating hormone ( FSH ) , thyrotropin ( TSH ) , and luteinizing hormone ( LH ) . Vasomotor complaints were tested using questions about hot flushes and bouts of sweating in terms of occurrence , frequency and degree of distress . Forty-six percent of the subjects reported hot flushes and bouts of sweating before menopause , increasing to 67 % during the first year after menopause and 49 % in the second year postmenopause . Low levels of estradiol and high levels of FSH were associated with vasomotor complaints before menopause . During menopause high levels of TSH were related to vasomotor complaints . The first year after menopause , women , who at this point achieved hot flushes , were characterised by high levels of E2 , but declining and low levels of FSH , but increasing . Postmenopausal , high levels of testosterone and DHEA-S seemed to protect against vasomotor symptoms . Our most important finding was , that among women who achieved hot flushes at the first assessment postmenopause , the high and rogen levels was a significant predictor of recovery from hot flushes at the last assessment , 1 year later AIM The purpose of the present study was to carry out a comparative histological analysis of the endometrium in postmenopausal women who made use of phytoestrogens in order to assess the efficacy and possible side effects of this therapy . METHODS This study was carried out by forming 2 groups in order to compare the results . One group was given a dietary supplement of phytoestrogens for 24 months , whereas the other was given a placebo for the same period of time . At the beginning of this study endometrial bioptical sample s were taken from those patients who had been previously selected at our University Centre . This study was started only with those postmenopausal patients whose bioptical sample was histologically suitable , and it was neither hyperplastic , nor cancerous and nor secretive . During these 24 months there have been frequent contacts aim ed at verifying the st and ard therapeutic behaviour , symptoms and appearance of side effects . At the end of the study new and final bioptical sample s of endometrium were taken from both groups . RESULTS One-hundred and forty-one patients completed the study . Five patients ( 3.4 % ) who were su bmi tted to phytoestrogens therapy showed a weak proliferative endometrium bioptical sample . All the other biopsies at the beginning and at the end of the study showed an atrophic and inactive sample . Hot flushes , night sweats , vaginal dryness and dyspareunia improved at the end of the study for the group treated with phytoestrogens as compared to the one treated with a placebo . Although there have not been very significant differences ias to symptoms and side effects , it was noted that insomnia was the most common symptom in the group treated with non-hormonal therapy based on phytoestrogens . CONCLUSIONS Phytoestrogens did not cause any sensitive and worrisome stimulation of the endometrial mucosa . Insomnia was more frequent in the group treated pharmacologically in the 24 months of the study , whereas hot flushes , night sweats , vaginal dryness and dyspareunia persisted or increased as compared to the beginning of the study in the group treated with a placebo , but this did not occur for the group treated with phytoestrogens Background and Objective The highest level of scientific evidence available for each therapy for menopausal symptoms was sought , for example , systematic review s of r and omised controlled trials ( RCTs ) . Results There is reasonable evidence that some symptoms are modified by lifestyle , for example , cessation of smoking , exercise , reduction of alcohol , diet and alleviation of psychosocial stress . No complementary medicine , for example , phytoestrogens , black cohosh , herbal or homeopathic medicines or complementary therapies , for example , acupuncture , yoga , chiropractic manipulation , reflexology or magnetic devices have a greater effect than the usual placebo effect seen in quality blinded RCTs . Some have potential side-effects . So-called ' bioidentical hormones ' have no evidence -base and potential for harm . None of the above therapies have evidence of efficacy and long-term safety . Selective serotonin and noradrenaline re-uptake inhibitors ameliorate vasomotor symptoms and sometimes menopausal depression better than placebo . The most effective therapy for menopausal ( oestrogen ) deficiency symptoms is oestrogen which is the main component of hormone replacement therapies ( HRT ) . Compared with placebo HRT is highly effective in relieving hot flushes , night sweats , dry vagina and dyspareunia . It also improved joint pains , sexuality and sleeplessness and reduced subsequent fractures in RCTs . The increased risk of oral HRT for thromboembolism is small around menopause , for those without thrombotic risk factors , and is not elevated with non-oral routes . Cardiovascular disease may be reduced when HRT is initiated near menopause . Breast cancer risk increases after several years with the use of oral HRT containing progestogens at an annual rate of 8/10 000 ( < 0.1 % ) . No increase in breast cancer risk was seen with oestrogen-only HRT Objective : Vasomotor symptoms (VMS)(hot flashes , night sweats ) are associated with natural or surgically or chemotherapy-induced menopause , the latter occurring frequently in women treated for breast cancer . To manage VMS , some women seek alternatives to menopausal hormone therapy , such as supplements or modified food choices . The objective of the present analyses was to assess associations of VMS occurrence and change in severity of VMS over 12 months with dietary intakes of fiber , fat , and selected soy-containing foods , and use of phytoestrogen or vitamin E supplements in women with recent early stage breast cancer , adjusting for covariates . Design : Using multivariate logistic regression , data were analyzed from 2,198 women with early-stage breast cancer who enrolled 2 to 48 months after diagnosis in the Women 's Healthy Eating and Living r and omized , controlled trial of a high-vegetable , high-fiber , reduced-fat diet .  Results : Being peri- or postmenopausal , using tamoxifen , having low social support or depressive symptoms , and using vitamin E or phytoestrogen supplements were significantly associated cross-sectionally with reporting moderate/severe VMS at enrollment . Increased symptom severity after 12 months was significantly associated with higher body mass index , tamoxifen use , and smoking . Decreased symptom severity at 12 months was significantly associated with high dietary fiber intake ; no decrease was observed in women who were peri- or postmenopausal , using tamoxifen , or had low fat intake or low social support . Conclusions High dietary fiber intakes , premenopausal , and high social support were related to decreased severity of VMS 1 year after study enrollment in women recently treated for breast cancer ABSTRACT Objective Estrogen is the most effective treatment for vasomotor symptoms . Given its potential risks , herbal preparations and nutritional supplements have been developed as alternative remedies . The main aim of this double-blind , r and omized , placebo-controlled trial was to assess any impact of a nutritional supplement containing 12 vitamins and nine minerals on the frequency and severity of hot flushes in postmenopausal women over a 3-month period . Subjects and methods Ninety-one postmenopausal women were r and omized to either the placebo ( n = 45 ) or the treatment arm ( n = 46 ) . Seventy out of the 91 women completed the study ( 36 from the treatment group and 34 from the placebo group ) . At baseline and the 14-week post-intervention assessment s , study participants completed question naires on the frequency and severity of hot flushes and night sweats , the Profile of Mood State question naire , the World Health Organization Quality of Life Question naire , the National Adult Reading Test and the Rey Auditory-Verbal Learning Test . Between assessment s , the women also completed hot flush diaries . Results There was a significant decrease ( p < 0.01 ) in the number ( ±st and ard error of the mean ) of hot flushes experienced per week for treatment ( pre 31.3 ± 4.7 ; post 23.1 ± 4.8 ) and placebo groups ( pre 28.1 ± 4.7 ; post 17.3 ± 4.0 ) . A significant decrease ( p < 0.001 ) in the number of night sweats experienced per week was also observed in the treatment ( pre 6.1 ± 1.0 ; post 4.2 ± 0.7 ) and placebo groups ( pre 5.9 ± 0.7 ; post 3.7 ± 0.7 ) . Conclusions This study demonstrates a significant placebo effect on hot flushes and night sweats , as consistent with other studies . The micronutrient supplement containing 21 vitamins and minerals was not superior over placebo in effects on hot flushes and night sweat experiences Oestrogen therapy is the gold st and ard treatment for hot flushes/night sweats , but it and oestrogen/progestin are not suitable for all women . MPA ( medroxyprogesterone acetate ) reduces hot flushes , but its effectiveness compared with oestrogen is unknown . In the present study , oral oestrogen [ CEE ( conjugated equine oestrogen ) ] and MPA were compared for their effects on hot flushes in a planned analysis of a secondary outcome for a 1-year r and omized double-blind parallel group controlled trial in an urban academic medical centre . Participants were healthy menstruating women prior to hysterectomy/ovariectomy for benign disease . A total of 41 women { age , 45 ( 5 ) years [ value is mean ( S.D. ) ] } were enrolled ; 38 women were included in this analysis of daily identical capsules containing CEE ( 0.6 mg/day ) or MPA ( 10 mg/day ) . Demographic variables did not differ at baseline . Daily data provided the number of night and day flushes compared by group . The vasomotor symptom day-to-day intensity change was assessed by therapy assignment . Hot flushes/night sweats were well controlled in both groups , one occurred on average every third day and every fourth night . Mean/day daytime occurrences were 0.363 and 0.187 with CEE and MPA respectively , but were not significantly different ( P=0.156 ) . Night sweats also did not differ significantly ( P=0.766 ) . Therapies were statistically equivalent ( within one event/24 h ) in the control of vasomotor symptoms . Day-to-day hot flush intensity decreased with MPA and tended to remain stable with CEE ( P<0.001 ) . In conclusion , this analysis demonstrates that MPA and CEE are equivalent and effective in the control of the number of hot flushes/night sweats immediately following premenopausal ovariectomy Plants contain compounds with oestrogen -- like action called phytoestrogens . Soy contains daidzin , a potent phytoestrogen , and wheat flour contains less potent enterolactones . We aim ed to show in 58 postmenopausal women ( age 54 , range 30 - 70 years ) with at least 14 hot flushes per week , that their daily diet supplemented with soy flour ( n = 28 ) could reduce flushes compared with wheat flour ( n = 30 ) over 12 weeks when r and omised and double blind . Hot flushes significantly decreased in the soy and wheat flour groups ( 40 % and 25 % reduction , respectively < 0.001 for both ) with a significant rapid response in the soy flour group in 6 weeks ( P < 0.001 ) that continued . Menopausal symptom score decreased significantly in both groups ( P < 0.05 ) . Urinary daidzein excretion confirmed compliance . Vaginal cell maturation , plasma lipids and urinary calcium remained unchanged . Serum FSH decreased and urinary hydroxyproline increased in the wheat flour group Objective . To evaluate the effect of red clover isoflavone supplementation over vasomotor and overall menopausal symptoms in postmenopausal women . Methods . One hundred and nine postmenopausal women aged 40 or more were assigned to r and omly receive either two daily capsules of the active compound ( 80 mg red clover isoflavones , Group A ) or placebo of equal appearance ( Group B ) for a 90-day period . After a washout period of 7 days , medication was crossed over and taken for 90 days more . Daily hot flush and night sweat frequency and overall menopausal symptom intensity ( Kupperman Index ) were measured at baseline , 90 , 97 and 187 days . Results . Daily hot flush/night sweat frequency and Kupperman Index values were similar in both studied groups at baseline . All indices significantly decreased after red clover phase in Group A , corresponding , respectively to a 73.5 % , 72.2 % and 75.4 % average decrement . These decrements were significantly higher than those observed for Group B after placebo phase ( 8.2 % , 0.9 % and 6.7 % respectively ) . In Group A , after washout and placebo phases all values significantly increased . In Group B , all indices remained similar after placebo and washout phases , however significantly dropping after red clover treatment . These values were also significantly lower than those observed in Group A after placebo phase . No side effects were encountered after treatment with the active compound or placebo . Conclusion . Red clover isoflavone supplementation was more effective than placebo in reducing daily vasomotor frequency and overall menopausal intensity in postmenopausal women Objective We examined the change in menopausal symptoms in response to 24 weeks of isoflavone-rich ( 80.4 mg/day ) and isoflavone-poor ( 4.4 mg/day ) soy protein isolate treatment in perimenopausal women . Design In this double-blind 24-week study , 69 women were r and omized to treatment : isoflavone-rich soy protein ( n = 24 ) , isoflavone-poor soy protein ( n = 24 ) , or whey protein control ( n = 21 ) . A Menopausal Index was used to assess change in hot flushes and night sweats , as well as other symptoms , at baseline , week 12 , and week 24 . Results Repeated measures analysis of variance indicated no treatment effect on change in hot flush ( p = 0.18 ) and night sweat ( p = 0.92 ) frequency , whereas there was a significant decline in hot flush ( p = 0.0003 ) and night sweat ( p = 0.0007 ) frequency with time in all treatment groups . & khgr;2 analyses indicated no treatment effect on severity of hot flushes or night sweats at any time point , as well as no treatment effect on frequency or severity of other vasomotor symptoms . At the completion of the study , we found no treatment effect on retrospective perception of frequency , duration , or severity of hot flushes or night sweats . Since time had a significant effect on symptoms with all groups reporting a decline in overall symptoms , this indicated either a placebo effect or simply an improvement in symptoms during the study . Conclusion In this study , we found no evidence that isoflavone-rich or isoflavone-poor soy protein provided relief of vasomotor or of other menopausal symptoms Objective : To evaluate in a 12-month , prospect i ve , r and omized , double-blind , placebo-controlled study whether pure administration of the phytoestrogen genistein ( 54 mg/d ) might reduce the number and severity of hot flushes in postmenopausal women with no adverse effect on the endometrium . Design : A total of 389 participants met the main study criteria and were r and omly assigned to receive the phytoestrogen genistein ( n = 198 ) or placebo ( n = 191 ) . About 40 % of participants in both groups did not suffer from hot flushes , and the evaluation was performed in a subgroup of 247 participants ( genistein , n = 125 ; placebo , n = 122 ) . Reductions from baseline in the frequency and severity of hot flushes were the principal criteria of efficacy . Endometrial thickness was evaluated by ultrasonography . The maturation value was also used to determine hormonal action on the vaginal cells . Results : There were no significant differences in age , time since menopause , body mass index , and vasomotor symptoms between groups at baseline ( 4.4 ± 0.33 hot flushes per day in the genistein group and 4.2 ± 0.35 hot flushes per day in the control group ) . The effect was already evident in the first month and reached its peak after 12 months of genistein therapy ( −56.4 % reduction in the mean number of hot flushes ) . Furthermore , there was a significant difference between the two groups at each evaluation time ( 1 , 3 , 6 , and 12 months ) . No significant difference was found in mean endometrial thickness and maturation value score between the two groups , either at baseline or after 12 months . Conclusions : The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on endometrium Hot flushes and night sweats ( HF/NS ) are commonly experienced by mid-aged women during the menopause transition . They affect approximately 70 % of women but are regarded as problematic for 15 - 20 % largely due to physical discomfort , distress , social embarrassment , and sleep disturbance . There is a need for effective and acceptable nonmedical treatments for menopausal symptoms due to the declining use of hormone therapy ( HT ) following publication of the Women 's Health Initiative and other prospect i ve studies which associated HT use with increased risk of stroke and breast cancer . HF/NS are an example of a physiological process embedded within , and moderated by , psychological processes , as evidence d by discrepancies between subjective experiences and physiologically measured symptoms . We describe a cognitive model of menopausal hot flushes that can explain symptom perception , cognitive appraisal , and behavioral reactions to symptoms . Theoretically , the model draws on symptom perception theory , self-regulation theory , and cognitive behavioral theories . The model can be used to identify the variables to target in psychological interventions for HF/NS and to aid underst and ing of possible mediating factors . As part of Phase II intervention development , we describe a cognitive behavioral treatment which links the bio-psycho-social processes specified in the model to components of the intervention OBJECTIVE To investigate the relationship between levels of  phytoestrogens  in blood and urine and symptom control in postmenopausal women whose diets were supplemented with soy containing high levels of phytoestrogen . METHODS Phytoestrogen levels in blood and urine were correlated with the number of hot flushes and vaginal maturation indices in 104 postmenopausal women whose diets were supplemented with 60 g of soy powder daily for 3 months in a double-masked , parallel , placebo-controlled trial . The effect of soy supplementation on menopausal symptoms in this study population was reported previously . RESULTS Serum levels of genistin , daidzin , and equol were significantly higher in women after soy diet supplementation ( + 756 % , + 593 % , + 1008 % , and 57 % respectively ) . The concentration of enterolactone in the soy group was increased by 57 % compared with baseline , but the difference with placebo was not statistically significant . The increase in phytoestrogen levels in the soy group in blood or urine did not correlate with fewer hot flushes . Vaginal maturation indices did not change in the soy group . CONCLUSION Phytoestrogen levels increased in women who consumed soy supplement , but that does not fully explain climacteric symptom reduction . It is possible that other types of yet unknown phytoestrogens or components in soy other than phytoestrogen influence hot flushes Objective . To determine the efficacy and safety of the herbal formula Phyto-Female Complex ( SupHerb , Netanya , Israel ; ingredients : st and ardized extracts of black cohosh , dong quai , milk thistle , red clover , American ginseng , chaste-tree berry ) for the relief of menopausal symptoms . Methods . A r and omized , double-blind , placebo-controlled trial in 50 healthy pre and postmenopausal women , aged 44–65 years , to whom oral Phyto-Female Complex or matched placebo was prescribed twice daily for 3 months . A structured question naire on the frequency and intensity of menopausal symptoms was administered weekly from one week before throughout the 3-month treatment period , followed by biochemical tests , breast check , and transvaginal ultrasonography . Results . The women receiving Phyto-Female Complex reported a significantly superior mean reduction in menopausal symptoms than the placebo group . The effect of treatment improvements in menopausal symptoms increased over time ; by 3 months there was a 73 % decrease in hot flushes and a 69 % reduction of night sweats , accompanied by a decrease in their intensity and a significant benefit in terms of sleep quality . Hot flushes ceased completely in 47 % of women in the study group compared with only 19 % in the placebo group . There were no changes in findings on vaginal ultrasonography or levels of relevant hormones ( estradiol , follicle-stimulating hormone ) , liver enzymes or thyroid-stimulating hormone in either group . Conclusion . Phyto-Female Complex is safe and effective for the relief of hot flushes and sleep disturbances in pre- and postmenopausal women , at least for 3 months ' use PURPOSE Vasomotor symptoms , such as hot flashes and night sweats , in breast cancer survivors are often worsened by chemotherapy and tamoxifen , and /or the discontinuation of hormone replacement therapy at diagnosis . This study evaluated the acceptability and effectiveness of a soy beverage containing phytoestrogens as a treatment for hot flashes in postmenopausal women with breast cancer . METHODS A r and omized , placebo-controlled , double-blind clinical trial was conducted in postmenopausal women with moderate hot flashes who were previously treated for early-stage breast cancer . Women were stratified for tamoxifen use and r and omized to a soy beverage ( n = 59 ) containing 90 mg of isoflavones or to a placebo rice beverage ( n = 64 ) . Women recorded the number and severity of hot flashes daily with a daily menopause diary for 4 weeks at baseline and for 12 weeks while consuming 500 mL of a soy or placebo beverage . RESULTS There were no significant differences between the soy and placebo groups in the number of hot flashes or hot flash scores . However , presumably because of a strong placebo effect , both groups had significant reductions in hot flashes . Mild gastrointestinal side effects were experienced by both groups but occurred with greater frequency and severity with soy . The mean serum genistein concentration at 6 weeks was significantly higher in women who consumed soy ( 0.61 + /- 0.43 micromol/L ) compared with placebo ( 0.43 + /- 0.37 micromol/L ) ( P = .02 ) . Overall acceptability and compliance were high and similar in both groups . CONCLUSION The soy beverage did not alleviate hot flashes in women with breast cancer any more than did a placebo . Future research into other compounds is recommended to identify safe and effective therapies for hot flashes in breast cancer survivors & NA ; Trigonella foenum‐graecum seed extract has demonstrated hormone modulatory activity , providing biological plausibility for relieving menopausal symptoms . The study aim ed to assess efficacy of a st and ardized T. foenum‐graecum de‐husked seed extract in reducing menopausal symptoms in healthy aging women . The study was a double‐blind , r and omized , placebo‐controlled trial that recruited 115 women aged 40 to 65 years of which 59 were allocated to active ( n = 54 completed ) and 56 to  placebo  ( n = 50 completed ) . Active treatment was T. foenum‐graecum de‐husked seed extract , 600 mg per day for 12 weeks . Outcome measures included Menopause‐Specific Quality of Life ( MENQOL ) question naire , frequency of hot flushes and night sweats and serum estradiol levels . There was a significant reduction in menopausal symptoms in the active group compared with placebo as assessed by total MENQOL score ( p < 0.001 ) ; reflected by significant improvements in the vasomotor ( p < 0.001 ) , psychosocial ( p < 0.001 ) , physical ( p < 0.001 ) and sexual symptoms ( p < 0.001 ) domains . Vasomotor outcomes correlated with hot flushes , the active group reporting significantly less daytime hot flushes and night sweats at 12 weeks ( p < 0.001 ) . The average estradiol levels were similar in both the active group and placebo group after treatment . This study demonstrated that this proprietary T. foenum‐graecum de‐husked seed extract may reduce menopausal symptoms in healthy women Background This trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms ( hot flushes and night sweats ) in women who have had breast cancer treatment .  Hot flushes and night sweats are highly prevalent but challenging to treat in this population . Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients . Two hypotheses are tested : Compared to usual care , group cognitive behavioural therapy will:1 . Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-r and omisation.2 . Improve mood and quality of life after six weeks of treatment and at six months post-r and omisation . Methods / Design Ninety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London . They are r and omised to either six weekly group cognitive behavioural therapy ( Group CBT ) sessions or to usual care . Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer , monitoring and modifying precipitants , relaxation and paced respiration , stress management , cognitive therapy for unhelpful thoughts and beliefs , managing sleep and night sweats and maintaining changes . Prior to r and omisation women attend a clinical interview , undergo 24-hour sternal skin conductance monitoring , and complete question naire measures of hot flushes and night sweats , mood , quality of life , hot flush beliefs and behaviours , optimism and somatic amplification . Post-treatment measures ( sternal skin conductance and question naires ) are collected six to eight weeks later and follow-up measures ( question naires and a use of medical services measure ) at six months post-r and omisation . Discussion MENOS 1 is the first r and omised controlled trial of cognitive behavioural therapy for hot flushes and night sweats that measures both self-reported and physiologically indexed symptoms . The results will inform future clinical practice by developing an evidence -based , non-medical treatment , which can be delivered by trained health professionals . Trial Registration Current Controlled Trials IS RCT Objective : To evaluate in a 24-month , prospect i ve , r and omized , double-blind , placebo-controlled study whether pure administration of the phytoestrogen genistein ( 54 mg/d ) might reduce the number and severity of hot flushes in postmenopausal women , with no adverse effect on the endometrium and vagina . Methods : A total of 389 participants met the parent study criteria and were r and omly assigned to receive the phytoestrogen genistein ( n = 198 ) or placebo ( n = 191 ) . About 40 % of participants in both groups did not experience hot flushes , and the evaluation was performed in a subgroup of 236 participants ( genistein , n = 119 ; placebo , n = 117 ) . Reductions from the baseline in the frequency and severity of hot flushes were the principal criteria of efficacy . Endometrial thickness was evaluated by ultrasonography . The maturation value was also used to determine hormonal action on the vaginal cells . Results : There were no significant differences in vasomotor symptoms between groups at the baseline ( 4.4 ± 0.33 hot flushes per day in the genistein group and 4.2 ± 0.35 hot flushes per day in the control group ) . After 12 months of genistein therapy , there was a significant reduction ( −56.4 % ) in the mean number of hot flushes , with a significant difference compared with the control group . After 24 months , there was no further decrease in the number of hot flushes in both groups . No significant difference was found in mean endometrial thickness and the maturation value score between the two groups , either at the baseline or after 24 months . Conclusions : The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on the endometrium and vagina , but after the first year , there was no further improvement in the decrease in hot flushes Objective : To compare a novel vaginal ring releasing estradiol acetate ( Menoring ® ; Galen Holdings ) with oral estradiol for relief of moderate to severe vasomotor symptoms in healthy postmenopausal women . Design : This was a prospect i ve , double-blind , multicenter , r and omized , parallel-group study . Method : Women ( n = 159 ) aged < 65 years experiencing ≥ 20 hot flushes/night sweats per week received either a vaginal ring releasing estradiol acetate at a rate equivalent to 50 μg/day estradiol plus placebo tablets or oral estradiol 1 mg/day plus a placebo vaginal ring for 24 weeks . For patients with inadequate control of symptoms , the dosage was doubled at 12 weeks . A 24-week , open-label extension of the vaginal ring treatment followed double-blind treatment . Results : The frequency of hot flushes/night sweats was significantly reduced ( p < 0.001 ) in both groups at 12 and 24 weeks from baseline , by 84 % and 94 % for the vaginal ring group and by 73 % and 83 % for the oral group , respectively . The mean intensity of urogenital symptoms decreased from screening to the end of treatment in both groups . The incidence of adverse events was similar for both groups . No clinical ly relevant local effects of the vaginal ring were observed . Conclusions : The vaginal ring relieved both systemic and urogenital symptoms and was well tolerated and accepted . Overall , the efficacy , safety and acceptability of the vaginal ring were comparable with those of oral estradiol therapy Hot flushes and night sweats are one of the main symptoms accompanying the menopause , and are a main reason for seeking medical help at this time . This study of 61 women ( reporting hot flushes once a week or more ) investigates dimensions of subjective reporting using open questions and rating scales . Two separate factors were delineated using a principal component factor analysis - frequency ( of hot flushes and night sweats ) and problem ratings ( of distress , interference and perception of flushes as problematic ) - which had high test-retest reliability . The frequency ratings correlated highly with prospect i ve daily monitoring . Depressed mood , anxiety and low self-esteem , but not frequency , discriminated between those who regarded flushes as problematic and those who did not . It is suggested that these two subjective measures should be used in assessment and in evaluation of hormonal and psychological interventions Objective : The onset of climacteric symptoms ( hot flashes and night sweats ) is the primary reason for perimenopausal women to start hormone therapy . The association of a lower incidence of postmenopausal symptoms with high intake of soybeans in Asian women suggests that phytoestrogens are an alternative to estrogen therapy . The main effective compounds in soybean are isoflavones , which have a higher binding affinity to estrogen receptor & bgr ; than to estrogen receptor & agr;. The aim of present study was to evaluate the effects of isoflavone treatment in postmenopausal women . Design : This was a double-blind prospect i ve study . Sixty healthy postmenopausal women were r and omly assigned by computer into two groups to receive 60 mg isoflavones or placebo daily for 3 months . Before and after treatment , climacteric symptoms were recorded ; serum was collected to measure the levels of lipoprotein lipids , estradiol , and follicle-stimulating hormone ; and biopsy specimens from endometrium and breast were analyzed to investigate the expression level of steroid receptors and proliferation . Endometrial thickness was measured by ultrasound . Results : Fifty-one women finished the 12-week study . In women receiving 60 mg isoflavones daily , hot flashes and night sweats were reduced by 57 % and 43 % , respectively . The treatment did not change the levels of circulating estradiol or follicle-stimulating hormone . Immunohistochemical staining of endometrial and breast biopsy specimens revealed that isoflavones did not affect expression levels of steroid receptors ; estrogen receptors & agr ; , & bgr ; , and & bgr;cx ; progesterone receptors A and B ; or the proliferation marker Ki67 . No side effects on body weight or lipoprotein lipids were observed . Conclusions : This short-term prospect i ve study implies that isoflavones could be used to relieve acute menopausal symptoms AIM The aim of the present study was to assess the efficacy and safety of a st and ardized compound based on an extract of soy phytoestrogens , with high doses of isoflavones in the management of  menopausal hot flushes . METHODS A total of 180 women aged 40 - 65 years with a minimum of five moderate-to-severe hot flushes in the last 7 days at baseline and absence of menstruation for at least 6 months participated in a 12-week prospect i ve , r and omized , double-blind , placebo-controlled multicenter trial . After a 2-week run-in period , women received one tablet a day of 80 mg isoflavones ( corresponding to 60 mg of genistein ) or a matching placebo . RESULTS The mean daily number of moderate-to-severe hot flushes decreased in both study groups , but the reduction was greater in the isoflavones arm at 6 ( 36.2 % ) and 12 weeks ( 41.2 % ) than in the placebo arm ( 24.0 % at 6 weeks , 29.3 % at 12 weeks ) , with a difference of 1.1 ( 95 % CI [ -2.0 to -0.06 ] ) ( P = 0.038 ) at 6 weeks and 1.1 ( 95 % CI [ -2.05 to -0.15 ] ) ( P = 0.023 ) at 12 weeks . Similar findings were obtained for hot flushes of any intensity . The Kupperman index decreased in both study groups . Relief of hot flushes was greater when time to menopause was > or=12 months and in cases of BMI > or=27 kg/m(2 ) . CONCLUSION In daily practice conditions , high doses of isoflavones , particularly genistein , can be used for the management of hot flushes in postmenopausal women not treated with hormone replacement therapy due to their superior efficacy to placebo and very good safety profile
There is no evidence of effectiveness in the alleviation of  menopausal symptoms with the use of phytoestrogen treatments
BACKGROUND Vasomotor symptoms , such as hot flushes and night sweats , are very common during the menopausal transition .
Hormone replacement therapy has traditionally been used as a very effective treatment but concerns over increased risks of some chronic diseases have markedly increased the interest of women in alternatives .
Some of the most popular of these are treatments based on foods or supplements enriched with phytoestrogens , plant-derived chemicals that have oestrogenic action .
OBJECTIVES To assess the efficacy , safety and acceptability of foods and supplements based on high levels of phytoestrogens for reducing hot flushes and night sweats in postmenopausal women .