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. Black cohosh and fluoxetine in the treatment of postmenopausal symptoms: A prospective, randomized trial Challenges in the conduct of Thai herbal scientific study: efficacy and safety of phytoestrogen, pueraria mirifica (Kwao Keur Kao), phase I, in the alleviation of climacteric symptoms in perimenopausal women. Effects of soy isoflavones on menopausal neurovegetative symptoms. Health related quality of life after combined hormone replacement therapy: randomised controlled trial Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women Equol improves menopausal symptoms in Japanese women. Oral micronized progesterone for vasomotor symptoms—a placebo-controlled randomized trial in healthy postmenopausal women Treatment of Vasomotor Symptoms of Menopause with Black Cohosh, Multibotanicals, Soy, Hormone Therapy, or Placebo A randomized, double-blind, multiple-dose escalation study of a Chinese herbal medicine preparation (Dang Gui Buxue Tang) for moderate to severe menopausal symptoms and quality of life in postmenopausal women Vasomotor symptoms among Japanese-American and European-American women living in Hilo, Hawaii Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial. The Effect of Dietary Soy Supplementation on Hot Flushes Effectiveness of a modified version of the applied relaxation technique in treatment of perimenopausal and postmenopausal symptoms Reducing vasomotor symptoms with acupuncture in breast cancer patients treated with adjuvant tamoxifen: a randomized controlled trial Cognitive-behavior therapy for menopausal symptoms (hot flushes and night sweats): moderators and mediators of treatment effects Fruit, Mediterranean-style, and high-fat and -sugar diets are associated with the risk of night sweats and hot flushes in midlife: results from a prospective cohort study. Benefits of soy germ isoflavones in postmenopausal women with contraindication for conventional hormone replacement therapy. The effects of combined raloxifene and oral estrogen on vasomotor symptoms and endometrial safety Effects of dietary phytoestrogens in postmenopausal women. Efficacy and safety of Pueraria mirifica (Kwao Kruea Khao) for the treatment of vasomotor symptoms in perimenopausal women: Phase II Study. A randomized, double-blind, placebo-controlled trial of Chinese herbal medicine granules for the treatment of menopausal symptoms by stages The effect of soy-derived isoflavones over hot flushes, menopausal symptoms and mood in climacteric women with increased body mass index Soy protein and isoflavone effects on vasomotor symptoms in peri- and postmenopausal women: the Soy Estrogen Alternative Study [Evaluation the efficacy and safety of estradiol and drospirenone tablets in the treatment of menopausal symptoms among postmenopausal Chinese healthy women:a randomized, multi-center, double-blind, placebo-controlled clinical study]. Effect of oral gamolenic acid from evening primrose oil on menopausal flushing A first prospective, randomized, double-blind, placebo-controlled study on the use of a standardized hop extract to alleviate menopausal discomforts. A randomized, double-blind, placebo-controlled study of the effect of a Chinese herbal medicine preparation (Dang Gui Buxue Tang) on menopausal symptoms in Hong Kong Chinese women Identifying meaningful differences in vasomotor symptoms among menopausal women A natural S-equol supplement alleviates hot flushes and other menopausal symptoms in equol nonproducing postmenopausal Japanese women. The effects of Chinese medicinal herbs on postmenopausal vasomotor symptoms of Australian women. A randomised controlled trial. Efficacy and safety of a soy isoflavone extract in postmenopausal women: a randomized, double-blind, and placebo-controlled study.
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 The objective of this study was to evaluate the efficacy of fluoxetine and black cohosh in the treatment of women with postmenopausal symptoms . A total of 120 healthy women with menopausal symptoms were recruited to this prospect i ve study with a follow-up period of 6 mo . They were r and omly assigned to 1 of 2 groups and were treated with fluoxetine or black cohosh . After entry into the study , patients were examined at the first , second , third , and sixth months of the treatment period . The women kept diaries in which they reported the daily number and intensity of hot flushes and night sweats . In addition , at the beginning and end of the third month , they completed question naires consisting of a modified Kupperman Index , Beck ’s Depression Scale , and a R AND -36 Quality -of-Life Question naire . Statistically significant differences were noted in the Kupperman Index and Beck ’s Depression Scale at the end of the third month in both groups compared with baseline values . In the black cohosh group , the Kupperman Index decreased significantly compared with that in the fluoxetine group by the end of the third month . On the other h and , in the fluoxetine group , Beck ’s Depression Scale decreased significantly compared with that in the black cohosh group . Monthly scores for hot flushes and night sweats decreased significantly in both groups ; however , black cohosh reduced monthly scores for hot flushes and night sweats to a greater extent than did fluoxetine . At the end of the sixth month of treatment , black cohosh reduced the hot flush score by 85 % , compared with a 62 % result for fluoxetine . By the sixth month of the study , 40 women had discontinued the study —20 ( 33 % ) in the fluoxetine group and 20 ( 33 % ) in the black cohosh group . Compared with fluoxetine , black cohosh is more effective for treating hot flushes and night sweats . On the other h and , fluoxetine is more effective in improvements shown on Beck ’s Depression Scale OBJECTIVE To evaluate the preliminary efficacy and safety of Pueraria mirifica ( Kwao Keur Kao ) , phytoestrogen , for the alleviation of climacteric symptoms . MATERIAL AND METHOD Perimenopausal women attending with climacteric symptoms , such as hot flushes and night sweats , were invited to join the present study , conducted at the Menopausal Clinic , Hat Yai Regional Hospital . The patients were voluntarily enrolled and r and omly received the raw material of Pueraria mirifica , oral 50 and 100 mg capsule , once daily for six months , as an open-label study . RESULTS Of the 10 enrolled patients , 8 cases were completely evaluated . The modified Greene climacteric scale ( MGCS ) was satisfactorily decreased in both groups . The average scale declined from 44.1 at baseline , to be 26 , 17 , and 11.1 at 1- , 3- , and 6- month follow-up respectively . No other laboratory abnormalities , except one case had transiently increased the creatinine level , and one case of increased blood urea nitrogen . The mean serum estradiol was slightly increased , while the mean serum follicle-stimulating hormone ( FSH ) and luteinizing hormone ( LH ) were nearly stable . CONCLUSION Pueraria mirifica is relatively safe and preliminarily alleviates the climacteric symptoms in perimenopausal . women , but the data is insufficient to draw definite conclusions regarding the estrogenic effect AIM Dietary soy supplementation may reduce the incidence of hot flushes in postmenopausal women due to the presence of phytoestrogens in soy foods . The aim of this study was to assess the effects of a 3-month administration of different doses of either oral or transdermal soy isoflavones on climacteric complaints in postmenopausal women . METHODS Sixty postmenopausal women were assigned r and omly to one of the following groups : groups A and B received 50 mg/day or 75 mg/day of oral isoflavones respectively , while groups C and D received 6 mg/day or 12 mg/day of transdermal isoflavones . A control group ( group E ) was composed of 15 patients that did not receive any treatment . Hot flushes , Kupper-man index and vaginal dryness at baseline and then after 5 , 9 and 13 weeks were evaluated . RESULTS The isoflavone treatment led to a progressive significant ( p<0.01 ) reduction of the number of hot flushes in the groups A , B and D with a dose-related effect in group D. At week 13 , the Kupperman index and hot flush score decreased significantly in all the treated groups , while vaginal dryness score was reduced only in group B. CONCLUSION Our findings suggest that both oral and transdermal soy isoflavones are effective to attenuate slight to moderate menopausal neurovegetative symptoms with a dose-related effect Objective To assess the effect of  combined hormone replacement therapy ( HRT )  on health related quality of life . Design R and omised placebo controlled double blind trial . Setting General practice s in United Kingdom ( 384 ) , Australia ( 94 ) , and New Zeal and ( 24 ) . Participants Postmenopausal women aged 50 - 69 at r and omisation ; 3721 women with a uterus were r and omised to combined oestrogen and progestogen  ( n=1862 ) or placebo  ( n=1859 ) . Data on health related quality of life at one year were available from 1043 and 1087 women , respectively . Interventions Conjugated equine oestrogen 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg or matched placebo orally daily for one year . Main outcome measures Health related quality of life and psychological wellbeing as measured by the women ’s health question naire . Changes in emotional and physical menopausal symptoms as measured by a symptoms question naire and depression by the Centre for Epidemiological Studies depression scale ( CES-D ) . Overall health related quality of life and overall quality of life as measured by the European quality of life instrument ( EuroQol ) and visual analogue scale , respectively . Results After one year small but significant improvements were observed in three of nine components of the women ’s health question naire for those taking combined HRT compared with those taking placebo :  vasomotor symptoms ( P<0.001 ) , sexual functioning ( P<0.001 ) , and sleep problems ( P<0.001 ) . Significantly fewer women in the combined HRT group reported hot flushes ( P<0.001 ) , night sweats ( P<0.001 ) , aching joints and muscles ( P=0.001 ) , insomnia ( P<0.001 ) , and vaginal dryness ( P<0.001 ) than in the placebo group , but greater proportions reported breast tenderness ( P<0.001 ) or vaginal discharge ( P<0.001 ) . Hot flushes were experienced in the combined HRT and placebo groups by 30 % and 29 % at trial entry and 9 % and 25 % at one year , respectively . No significant differences in other menopausal symptoms , depression , or overall quality of life were observed at one year . Conclusions Combined HRT started many years after the menopause can improve health related quality of life . Trial registration IS RCT N 63718836 Objectives Drospirenone is a novel progestogen that , combined with 17β-estradiol , reduces the frequency and severity of menopausal vasomotor symptoms ( VMS ) in different population s. This double-blind , multicenter study compared the efficacy , safety and tolerability of 2 mg drospirenone/1 mg estradiol ( DRSP/E2 ) vs. placebo in Chinese postmenopausal women with moderate to severe VMS . Methods Women , aged 45–65 years , were r and omized to  DRSP/E2  ( n = 183 ) or placebo ( n = 61 ) once daily for four 28-day cycles . Changes in the frequency and severity of hot flushes were analyzed as primary variables , together with other climacteric and urogenital symptoms , clinical global improvement , adverse events and physical/gynecological parameters . Results Relative changes in numbers of hot flushes/week were −80.4 % for DRSP/E2 vs. −51.9 % for placebo ( treatment difference −28.5 % , p < 0.0001 ) . There were trends toward a greater reduction in severity of hot flushes with DRSP/E2 treatment . Patients treated with DRSP/E2 were more often free from sweating episodes ( p < 0.0001 ) and vaginal dryness ( p = 0.0008 ) . Other climacteric symptoms , including nervousness and pollakisuria , followed a trend of greater response with DRSP/E2 . Similar to other combination HRT regimens , DRSP/E2  increased occurrences of bleeding , but these decreased over time . Adverse events in patients treated with DRSP/E2 were mostly mild to moderate and withdrawal rates were low . Conclusions Daily treatment of postmenopausal Chinese women  with DRSP/E2 for 16 weeks significantly reduced the incidence of hot flushes and demonstrated advantages vs. placebo for other climacteric symptoms . These results indicate that DRSP/E2 is effective , safe and well tolerated in postmenopausal Chinese women It has been well documented that the frequency of vasomotor menopausal symptoms , such as hot flashes and night sweats , of Japanese menopausal women is less than that of Western women . High intake of soy isoflavones in the traditional Japanese diet has been postulated as the possible explanation of the difference . Epidemiological studies have reported that the content of equol , which is a biologically active metabolite of the isoflavone , daidzein , is lower in the women who complain of severe vasomotor symptoms . To investigate the involvement of equol in the manifestation of menopausal symptoms , especially vasomotor symptoms , and the possible therapeutic role of a supplement containing equol ( natural S-equol developed by Otsuka Pharmaceutical ) on the menopausal symptoms of Japanese women , 3 r and omized clinical trials were conducted . The studies indicated that a daily dose of 10 mg of natural S-equol improved menopausal symptoms . In the confirmation study , menopausal women who were equol nonproducers who consumed 10 mg/d of natural S-equol for 12 wk had significantly reduced severity and frequency of hot flashes as well as a significant reduction in the severity of neck or shoulder stiffness . The equol-ingesting group also showed trends of improvement in sweating and irritability and a significant improvement in the somatic category symptoms . Thus , it is concluded that the supplement containing natural S-equol , a novel soybean-derived functional component , has a promising role as an alternative remedy in the management of menopausal symptoms Objective The aim of this study was to compare oral micronized progesterone ( progesterone ) with placebo as therapy for postmenopausal hot flushes and night sweats ( vasomotor symptoms [ VMS ] ) .  Methods Healthy volunteer community women 1 to 10 years since final menstruation were recruited for a r and omized double-blind  placebo-controlled trial of progesterone ( 300 mg daily at bedtime ) between 2003 and 2009 and were screened for clinical , physical , or laboratory evidence of cardiovascular risks ( nonsmoking , moderate body mass index [ < 35 kg/m2 ] , normal lipids , electrocardiogram , nondiabetic ) . Women recorded daily frequency and severity ( 1 - 4 ) of VMS in the Daily Menopause Diary during run-in ( 4 wk ) and intervention ( 12 wk ) . Average daily VMS score ( day frequency × day severity + night frequency × night severity ) during final 28 therapy days was the primary outcome , analyzed by therapy , with run-in score as covariate . Results R and omized participants were 133 healthy community women with VMS , ages 44 to 62 years , with a mean ( SD ) VMS score of 17.0 ( 10.4 ) at run-in ( VMS frequency 6.8 [ 3.2 ] episodes/d ) . Women were r and omized to progesterone ( n = 75 ) or  placebo  ( n = 58 ) ; analysis included all with VMS data at run-in and on therapy ( n = 68 and 46 , respectively ) . The VMS scores of women taking progesterone were better than placebo ( mean adjusted difference , −4.3 ( 95 % CI , −6.6 to −1.9 ) , with mean reductions of 10.0 ( 95 % CI , −12.0 to −8.1 ) and 4.4 ( 95 % CI , −6.6 to −2.2 ) in the progesterone and placebo arms , respectively . Discontinuation with adverse events was 9 % ( progesterone , 8 ; placebo , 4 ) , with no serious cases . Conclusions Oral micronized progesterone is effective for treatment of hot flushes and night sweats in healthy women early in postmenopause Context Caution about taking estrogen for treating  postmenopausal vasomotor symptoms has led to increasing substitution of herbal regimens despite few tests of their effectiveness . Contribution The authors r and omly assigned 351 perimenopausal or postmenopausal women to herbal treatments ( black cohosh , multibotanicals , or multibotanicals plus counseling about dietary soy ) , estrogen with or without progesterone , or placebo . At 3 , 6 , and 12 months , patients receiving the herbal interventions had the same change in vasomotor symptoms as those receiving placebo ( except for more severe symptoms at 12 months for patients taking multibotanicals plus dietary soy ) . Estrogen substantially decreased vasomotor symptoms . Caution s Most participants were white and were well-educated . Implication s Herbal regimens did not reduce postmenopausal vasomotor symptoms in this sample of women . The Editors Hormone therapy remains the recommended treatment for vasomotor symptoms , but trials have shown serious risks with even short-term use ( 1 , 2 ) . The use of herbs , particularly black cohosh , multibotanical supplements , and dietary soy for menopausal symptoms has grown dramatically ( 36 ) . Few of these approaches have been scientifically evaluated . Women and providers are seeking safe , effective alternatives to hormone therapy . We design ed the Herbal Alternatives for Menopause Trial ( HALT ) to provide rigorous evidence on the efficacy and short-term safety of commonly used naturopathic approaches for management of vasomotor symptoms . Methods Design Overview and Setting HALT was a 1-year double-blind , r and omized , controlled trial design ed to investigate the effects of 3 naturopathic approaches for  vasomotor symptom relief and hormone therapy compared with placebo . Study methods have been described elsewhere ( 7 ) . The Group Health Institutional Review Board approved this study , and a data and safety monitoring committee monitored it . The study was conducted at Group Health , an integrated health plan in Washington State . Participants Eligibility criteria were as follows : age 45 to 55 years ; late menopausal transition ( 1 skipped menses within the preceding 12 months ) or postmenopausal ( no bleeding within 12 months , or follicle-stimulating hormone level > 20 IU/mL if patient had undergone hysterectomy without bilateral oophorectomy ) ; and 2 or more vasomotor symptoms per day over 2 weeks ( 6 moderate to severe symptoms ) . Women in menopausal transition were included because many are highly symptomatic and trial data are lacking for this group . Exclusion criteria were the following : contraindications to hormone therapy ; use of hormone therapy or oral contraceptives within 3 months before the trial ; use of herbal medicines for menopausal symptoms within 1 month before the trial ; soy allergy ; bilateral oophorectomy ; history of breast cancer ; and nonadherence during the run-in period ( < 80 % of capsules taken ) . From May 2001 through August 2003 , women were recruited by using direct mail . Screening calls determined initial eligibility . Women attended an orientation visit at which eligibility was confirmed , physical measurements were collected , and placebo medication and question naires for the 2-week run-in period were provided . R and omization and Interventions Participants were r and omly assigned by using SAS software ( SAS Institute , Inc. , Cary , North Carolina ) , stratified by previous hormone therapy and hysterectomy ; block sizes within strata ranged from 5 to 25 . Treatment assignments were sent to the University of Washington Research Pharmacy , where medications were bottled and labeled with a sequential identification number without treatment group indication . At the r and omization visit , vasomotor symptom diaries and medication counts were examined to confirm eligibility and adherence . The study nurse determined the appropriate stratum , assigned the participant the next study number in that stratum without knowledge of group assignment , and distributed study medications . The publication of results from the Women 's Health Initiative ( WHI ) estrogenprogestin trial ( 2 ) raised new concerns about the safety of estrogen therapy . New study participants were given the choice of 5-arm ( including hormone therapy ) versus 4-arm ( no hormone therapy ) r and omization . Current participants gave consent again , incorporating risk estimates from the WHI , and were given the option of finding out whether they had been assigned to hormone therapy ; 16 were unblinded , 1 discontinued use of the study drug , and all remained enrolled . Following publication of the WHI Memory Study ( 8 , 9 ) , we informed participants of those findings and restricted r and omization to herbs and placebo . No further women were unblinded or discontinued use of the study drug . Naturopathic medicine provided the model for study interventions . The herbal products , doses , and soy diet were based on approaches used by naturopaths when the study was design ed ( 7 ) . The study groups were as follows : 1 ) black cohosh  ( Actaea racemosa or Cimicifuga racemosa , 160 mg daily ; 2.5 % triterpene glycosides ; 70 % ethanol extract ) ; 2 )  multibotanical ;  3 )  multibotanical plus soy diet counseling ; 4 ) conjugated equine estrogen , 0.625 mg daily , with ( for women with a uterus ) or without ( for women without a uterus ) medroxyprogesterone acetate , 2.5 mg ; and 5 ) placebo . The multibotanical delivered daily doses of the following : black cohosh , 200 mg ; alfalfa ( Medicago sativa ) , 400 mg ; boron , 4 mg ; chaste tree ( Vitex agnus-castus ) , 200 mg ; dong quai ( Angelica sinensis ) , 400 mg ; false unicorn ( Chamaelirium luteum ) , 200 mg ; licorice ( Glycyrrhiza glabra ) , 200 mg ; oats ( Avena sativa ) , 400 mg ; pomegranate ( Punica granatum ) , 400 mg ; Siberian ginseng ( Eleutherococcus senticosus , st and ardized constituents 0.8 % eleutherosides E and B ) , 400 mg . Black cohosh was provided by Pure World , Inc. , ( Hackensack , New Jersey ) . The multibotanical , ProGyne , was purchased from Progena Professional Formulations ( Albuquerque , New Mexico ) and encapsulated to study specifications . Both companies follow current good manufacturing practice s , and single batches were used . ConsumerLab.com ( White Plains , New York ) tested the products after the study commenced . Dong quai , false unicorn , and pomegranate were not detected , suggesting that they were of poor quality or did not contain the tested marker compounds . Other marker compounds were detected in the approximate doses as labeled ( 7 ) . The Appendix Table describes the herbal products in detail . Appendix Table . Consoli date d St and ards of Reporting Trials ( CONSORT ) Requirements for Controlled Trials of Herbal Interventions To facilitate blinding , medications and lactose placebo were encapsulated to provide 2 white and 2 blue capsules to each woman , and medication boxes were labeled with a unique identification number that did not indicate study group . The soy food intervention was modeled after a successful 5-a-day intervention ( 10 ) . We chose soy foods because of uncertainty about the efficacy of isoflavone supplements and because naturopaths commonly recommend whole soy foods . Participants received 5 telephone calls from a clinical dietitian and a 34-page booklet recommending 2 soy food servings per day ( 12 to 20 g of soy protein ) ( 7 ) . Other participants received 1 telephone call and a similar booklet reinforcing fruit and vegetable intake . Participants were instructed not to discuss dietitian calls with study nurses and were unaware that soy counseling was linked to the multibotanical . Outcomes and Measurements The primary outcomes were change from baseline ( measured over 2-week run-in period ) to 3 , 6 , and 12 months ( each measured for 4 weeks ) and change from baseline to the average for all follow-ups with regard to the mean frequency and intensity of vasomotor symptoms ( daytime hot flashes plus night sweats ) and the mean Wiklund Vasomotor Symptom Subscale score ( 11 , 12 ) . We also evaluated change from baseline to follow-up ( months 3 , 6 , and 12 and average change ) for daytime hot flash rate , night sweat rate , and the total Wiklund Menopause Symptom Scale score . Symptom diaries and global ratings of menopause symptoms are almost universally used in studies of vasomotor symptoms . Participants used a  vasomotor symptom diary  to record daytime hot flashes and night sweats , rating intensity as mild , moderate , or severe ( scale , 1 to 3 ) , as recommended by the U.S. Food and Drug Administration ( 13 ) . Women completed the Wiklund Menopause Symptom Scale , rating the severity of 13 menopausal symptoms ( sweats , hot flashes , sleep disturbance , fatigue , vaginal dryness , depression , headache , irritability , muscle/joint pain , breast tenderness , nervousness , palpitations , and dizziness/fainting on a scale of 0 ( none ) to 10 ( severe ) ( 11 ) . Soy food intake was monitored by using a self-reported , vali date d soy food question naire ( 14 ) . Follow-up Procedures Participants returned to the research clinic at 3 , 6 , and 12 months . Question naires were collected , and study medication was dispensed . Medication adherence counts were conducted by staff without participant contact and without knowledge of treatment assignment . Study nurses encouraged adherence and monitored adverse events during monthly telephone calls and at visits . Adverse events were identified through participants ' responses to the question , Have you had any medical problems or been hospitalized ? Responses were recorded and adverse events were followed until they were resolved . The study nurse determined intensity ( mild , moderate , or severe ) and whether the event was serious ( yes or no ) . Events were review ed by the study physician , who determined whether the event was study related , without knowledge of group assignment . Adverse events were coded by using the Coding Symbols for Thesaurus of Adverse Reaction Terms ( 15 ) . The Data and Safety Monitoring Committee review ed study progress and unblinded outcome and safety data 5 times . Statistical Analysis The study was powered to detect an effect of Objective This study is a phase II clinical trial that aims to investigate the dose-response relationship of a Chinese herbal medicine preparation , Dang Gui Buxue Tang ( DBT ) , with short-term menopausal symptoms and quality of life in local postmenopausal women . Methods A r and omized , double-blind , multiple-dose escalation trial was performed in 60 postmenopausal women experiencing severe hot flashes and night sweats . The participants were r and omized to receive DBT preparations at 1.5 , 3.0 , or 6.0 g/day for 12 weeks . The primary outcomes were vasomotor symptoms , Greene Climacteric Scale ( GCS ) score , and Menopause-Specific Quality of Life ( MENQOL ) score . Secondary outcomes included serum hormones and lipids . Results There were between-group differences in psychological/psychosocial ( P = 0.015 , GCS ; P = 0.013 , MENQOL ) and somatic/physical ( P = 0.019 , GCS ; P = 0.037 , MENQOL ) domains , and improvement was significantly greatest ( P < 0.05 ) in the 6.0 g/day dose group . The frequency and severity of hot flashes and night sweats were significantly reduced in the 3.0 g/day ( 14.5%-21.2 % , P < 0.05 , hot flashes ; 28.6%-39.6 % , P < 0.05 , night sweats ) and 6.0 g/day ( 34.9%-37.4.0 % , P < 0.01 , hot flashes ; 10.1%-12.8 % , P < 0.01 , night sweats ) dose groups . The female hormones follicle-stimulating hormone , luteinizing hormone , and 17&bgr;-estradiol , as well as the lipids total cholesterol , triglycerides , low-density lipoprotein cholesterol , and high-density lipoprotein cholesterol , were not significantly different within groups and between groups . Conclusions DBT preparations at 6.0 g/day significantly improve physical and psychological scores and significantly reduce vasomotor symptoms from baseline . The treatment was well tolerated , with no serious adverse events noted during the 12-week intervention period . The changes do not affect hormones and lipid profiles Objective : The Hilo Women 's Health Survey  was design ed and administered to gather baseline data on women 's health in Hilo , HI . This r and omized , cross-sectional study allowed for a focus on ethnic differences in symptom reporting . The results presented here focus on hot flash and night sweat experience among Japanese-American and European-American women . Design : Survey packets were mailed to street addresses associated with parcel numbers pulled r and omly from Hilo tax maps . Of the 6,401 survey packets delivered to households , 1,824 question naires were completed and returned . The results reported here are based on 869 women aged 40 to 60 , of whom 249 described themselves to be 100 % Japanese and 203 described themselves to be 100 % European-American . Logistic regression analyses were used to examine whether the relationship between ethnicity and vasomotor symptoms persisted after controlling for other variables . Results : European-American participants were more likely to have ever experienced a hot flash as compared with Japanese-American participants ( 72 % vs 53 % , P < 0.01 ) . During the 2 weeks before the survey , European-American participants were more likely to have experienced hot flashes ( P < 0.05 ) and night sweats ( P < 0.01 ) . In logistic regression analyses , after controlling for age , body mass index , menopause status , level of education , financial comfort , smoking habits , alcohol intake , exercise , use of hormone therapy , and soy intake , European-American women were still significantly more likely to have experienced hot flashes ( odds ratio = 1.858 ) and night sweats ( odds ratio = 2.672 ) . Conclusions : The results , based on self-reporting of menopausal symptoms , indicate that Japanese-American women report fewer hot flashes and night sweats than European-American women . Japanese-American women reported a higher intake of soy , but soy intake was not associated with fewer vasomotor symptoms CONTEXT Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women r and omized to hormone replacement therapy  have increased interest in other therapies for menopausal symptoms . Dietary supplements containing isoflavones are widely used as alternatives to hormonal therapies for hot flashes , but there is a paucity of data supporting their efficacy . OBJECTIVE To compare the efficacy and safety of 2 dietary supplements derived from red clover with placebo in symptomatic menopausal women . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial of menopausal women , aged 45 to 60 years , who were experiencing at least 35 hot flashes per week . The study was conducted between November 1999 and March 2001 at 3 US medical centers and included women who were recently postmenopausal ( mean [ SD ] , 3.3 [ 4.5 ] years since menopause ) experiencing 8.1 hot flashes per day . Women were excluded if they were vegetarians , consumed soy products more than once per week , or took medications affecting isoflavone absorption . INTERVENTION After a 2-week placebo run-in , 252 participants were r and omly assigned to Promensil ( 82 mg of total isoflavones per day ) , Rimostil ( 57 mg of total isoflavones per day ) , or an identical placebo , and followed-up for 12 weeks . MAIN OUTCOME MEASURE The primary outcome measure was the change in frequency of hot flashes measured by participant daily diaries . Secondary outcome measures included changes in quality of life and adverse events . RESULTS Of 252 participants , 246 ( 98 % ) completed the 12-week protocol . The reductions in mean daily hot flash count at 12 weeks were similar for the Promensil ( 5.1 ) , Rimostil ( 5.4 ) , and placebo ( 5.0 ) groups . In comparison with the placebo group , participants in the Promensil group ( 41 % ; 95 % confidence interval [ CI ] , 29%-51 % ; P = .03 ) , but not in the Rimostil group ( 34 % ; 95 % CI , 22%-46 % ; P = .74 ) reduced hot flashes more rapidly . Quality -of-life improvements and adverse events were comparable in the 3 groups . CONCLUSION Although the study provides some evidence for a biological effect of Promensil , neither supplement had a clinical ly important effect on hot flashes or other symptoms of menopause Objective To assess the effect of daily dietary supplementation of soy protein isolate powder on hot flushes in post-menopausal women . Methods We carried out a double-blind , parallel , multi-center , r and omized  placebo-controlled trial of 104 post-menopausal women . Fifty-one patients ( age range 48–61 years ) took 60 g of isolated soy protein daily and 53 patients ( age range 45–62 years ) took 60 g of placebo ( casein ) daily . The study lasted 12 weeks . Using analysis of covariance , we analyzed changes from baseline in mean number of moderate to severe hot flushes ( including night sweats ) during treatment . Results Soy was significantly superior to placebo ( P < .01 in reducing the mean number of hot flushes per 24 hours after 4 , 8 , and 12 weeks of treatment . In particular , women taking soy had a 26 % reduction in the mean number of hot flushes by week 3 and a 33 % reduction by week 4 ( P < .001 by the Wilcoxon exact test ) . By the end of the 12th week , patients taking soy had a 45 % reduction in their daily hot flushes versus a 30 % reduction obtained with the placebo ( P < .01 ) . The overall rates of adverse effects were similar for soy and casein-placebo .  Twenty-five patients dropped out of the study : 11 in the soy group and 14 in the  placebo group . Gastrointestinal side effects were the most common cause of premature withdrawal from the study ( seven patients in each group ) . Conclusion Soy protein isolate added daily to the diet substantially reduced the frequency of hot flushes in climacteric women Background Awareness of the risks associated with hormone therapy for menopausal symptoms has sparked a global decline in this treatment . Alternative treatments to relieve menopausal symptoms are therefore required . The applied relaxation ( AR ) technique has proven to be successful for symptom amelioration , but requires participation in 12 weekly classes . The purpose of this study was to determine the effectiveness of a modified relaxation version ( MR ) of AR for treatment of hot flashes , night sweats , and sleep disturbances . Methods We conducted a12-week , r and omized , parallel , open-label , controlled trial in perimenopausal and postmenopausal women visiting the menopausal clinic . Participants were r and omly assigned to an MR or AR group . The MR group ( n=36 ) received a single session of ( MR ) training and the AR group ( n=35 ) received conventional 12-week training . Participants were instructed to practice the techniques daily at home for 12 weeks . The main outcome was the measure on the severity scale and frequency of hot flashes , night sweats , and sleep disturbances . Results All participants completed the study .  Total severity scores in both groups decreased after 12 weeks , but there was no difference between the groups ( P=0.93 ) . The severity score for hot flashes in the MR group decreased more than in the AR group ( P=0.02 ) . The severity scores for night sweats and sleep disturbances decreased in both groups . The frequency of hot flashes , night sweats , and sleep disturbances were also decreased in both groups . Conclusion A shorter , modified version of the AR was equally effective or slightly better than the conventional AR for the relief of hot flashes , night sweats , and sleep disturbances in perimenopausal and postmenopausal women . Recommendations for future research include confirmatory studies and trials with larger sample To evaluate true acupuncture to control acupuncture ( CTRL ) ( non-insertive stimulation at non-acupuncture points ) in breast cancer patients treated with adjuvant tamoxifen suffering from hot flushes and sweatings . Eighty-four patients were r and omized to receive either true acupuncture or CTRL twice a week for 5 weeks . Seventy-four patients were treated according to the protocol . In the true acupuncture group 42 % ( 16/38 ) reported improvements in hot flushes after 6 weeks compared to 47 % ( 17/36 ) in the CTRL group ( 95 % CI , −28 to 18 % ) . Both groups reported improvement regarding severity and frequencies in hot flushes and sweatings but no statistical difference was found between the groups . In a sub analysis regarding the severity of sweatings at night a statistically significant difference P = 0.03 was found in the true acupuncture group . Former experience of true acupuncture did not influence the perception of true acupuncture or CTRL . No significant differences in hormonal levels were found before and after treatment . In conclusion , convincing data that true acupuncture is more effective than CTRL  in reducing vasomotor symptoms is still lacking . Our study shows that both true and CTRL  reduce vasomotor symptoms in breast cancer patients treated with adjuvant tamoxifen Objective Cognitive-behavior therapy ( CBT ) has been found in recent r and omized controlled trials ( MENOS1 and MENOS2 ) to reduce the impact of hot flushes and night sweats ( HFNS ) . In the MENOS2 trial , group CBT was found to be as effective as self-help CBT in reducing the impact of HFNS . This study investigates for whom and how CBT works for women in the MENOS2 trial . Methods This study performed a secondary analysis of 140 women with problematic HFNS who were recruited to the MENOS2 trial : 48 were r and omly assigned to group CBT , 47 were r and omly assigned to  self-help CBT , and 45 were r and omly assigned to usual care . Self-report question naires were completed at baseline , 6 weeks postr and omization , and 26 weeks postr and omization . Potential moderators and mediators of treatment effects on the primary outcome —hot flush problem rating — were examined using linear mixed-effects models and path analysis , respectively . Results CBT was effective at reducing HFNS problem rating regardless of age , body mass index , menopause status , or psychological factors at baseline . Fully reading the manual in the self-help CBT arm and completing most homework assignments in the group CBT arm were related to greater improvement in problem rating at 6 weeks . The effect of CBT on HFNS problem rating was mediated by changes in cognitions ( beliefs about coping/control of hot flushes , beliefs about night sweats and sleep ) but not by changes in mood . Conclusions These findings suggest that CBT is widely applicable for women having problematic HFNS , regardless of sociodemographic or health-related factors , and that CBT works mainly by changing the cognitive appraisal of HFNS BACKGROUND Diet has been suggested to be a potential risk factor for  vasomotor menopausal symptoms ( VMSs )  , ie , hot flushes and night sweats . OBJECTIVE We investigated the associations between dietary patterns and risk of VMSs by using data from middle-aged women born between 1946 and 1951 in the Australian Longitudinal Study on Women 's Health . DESIGN A prospect i ve cohort study of 6040 women with a natural menopause were followed up at 3-y intervals over 9 y. Dietary intake was assessed at baseline in 2001 , and the presence of VMSs was assessed at baseline and follow-up . Factor analysis and generalized estimating equation models for binary repeated measures were performed . RESULTS Six dietary patterns were identified from factor analysis : cooked vegetables , fruit , Mediterranean style , meat and processed meat , dairy , and high fat and sugar . A higher consumption of the fruit or Mediterranean-style diet was inversely associated with VMSs in a comparison of the top with the bottom quintile , with adjusted ORs of 0.81 ( 95 % CI : 0.71 , 0.93 ; P-trend = 0.0009 ) and 0.80 ( 95 % CI : 0.69 , 0.92 ; P-trend = 0.0004 ) , respectively . The high-fat and -sugar pattern increased the risk of VMSs in a comparison of the top with the bottom quintile , with an adjusted OR of 1.23 ( 95 % CI : 1.05 , 1.44 ; P-trend = 0.02 ) . CONCLUSIONS Consumption of a fruit or Mediterranean-style diet decreased the risk of reporting VMSs , whereas consumption of a high-fat and -sugar diet increased the risk of VMSs . These results may eventually lead to a basis for the development of dietary preventive measures for VMSs OBJECTIVE To evaluate the effects of isoflavones on vasomotor symptoms and blood lipids in postmenopausal women with contraindication for conventional hormone replacement therapy ( HRT ) . METHODS This prospect i ve , double-blind and placebo-controlled study included 50 postmenopausal women r and omly divided into two groups : 25 women on soy germ isoflavones ( 60 mg per day , capsules ) and 25 women on placebo .  Inclusion criteria included : non-vegetarian , non-asian women whose last menstruation date d at least 12 months prior to the beginning of the study , with FSH > 40 mIU/ml , hot flushes and contraindication for HRT , not using tamoxifen or antibiotic and no disease of the gastrointestinal tract . For 6 months , the Kupperman menopausal index ( KMI ) , the vaginal cytological maturation value ( MV ) and both hormonal and lipid profiles were assessed . The t-test and analysis of variance ( ANOVA ) were employed to compare the two groups . RESULTS In both groups , a decreased KI rate was observed . However , isoflavone was significantly superior to placebo in reducing hot flushes ( 44 % versus 10 % , respectively ) ( P < 0.05 ) . After 6 months , the isoflavone group showed increased estradiol levels with unchanged FSH , LH , and vaginal cytology , and a reduction of 11.8 % in LDL and an increase of 27.3 % in HDL ( P < 0.05 ) . In the placebo group , just a reduction in MV was observed after 6 months ( P < 0.05 ) . CONCLUSIONS Soy germ isoflavone exerted favorable effects on vasomotor symptoms and lipid profile , showing itself to be an interesting alternative therapy for the postmenopausal women with contraindication for conventional HRT Objective : To compare effects of 52 weeks ' treatment with either raloxifene 60 mg/day alone ( RLX ) or in combination with 17&bgr;-estradiol 1 mg/day ( RLX + E ) on vasomotor symptoms ( n = 83 ) and endometrial safety ( n = 123 ) in postmenopausal women who transitioned from estrogen-progestin therapy .  Design : In this r and omized , double-blind clinical trial , the frequency of vasomotor symptoms , hot flashes , and night sweats was assessed for up to 52 weeks . Endometrial thickness was assessed by transvaginal ultrasonography at baseline and at 12 and 52 weeks . An exit endometrial biopsy was performed at study completion or early termination . Results : The frequency of vasomotor symptoms , hot flashes , and night sweats was unchanged from baseline with RLX but was significantly reduced in women treated with RLX + E , from baseline ( all P < 0.001 ) and the RLX group at 6 , 12 , 24 , 36 , and 52 weeks ( all P < 0.01 ) . Women in the RLX + E group had significantly increased endometrial thickness ( 0.74 ± 0.28 mm , mean ± SEM ) at 52 weeks , from baseline and RLX ( P < 0.05 ) , with no statistically significant changes in women treated with RLX . Two women , both in the RLX + E group , had endometrial hyperplasia ( one with atypia ) on the exit biopsy . Conclusions : In women transitioning from estrogen-progestin therapy , occurrence of vasomotor symptoms was unchanged from baseline with RLX treatment , but these symptoms were significantly reduced with combined RLX + E therapy . Signs of endometrial stimulation were observed in the RLX + E group . Further studies using different estrogen doses and preparations are needed before concomitant use of raloxifene with systemic estrogens can be recommended The aim of this study was to test the hypothesis that increased dietary intake of phytoestrogens reduces the health impact of the menopause .  To test this hypothesis , a double-blind , r and omized , entry-exit , cross-over study was conducted to assess the effects of three dietary manipulations -- soy and linseed diets ( high in phytoestrogens ) and a wheat diet ( low in phytoestrogens ) .  Postmenopausal women were recruited and r and omly assigned to one of the three dietary regimens . Urinary phytoestrogen concentrations , hot flush rate , vaginal smears , bone mineral density and bone mineral content were assessed for two 12-week periods . Comparative analysis showed no significant differences , but , when analyzed separately , groups consuming high phytoestrogen diets had between 10 and 30 times higher urinary excretion of phytoestrogens compared to those consuming the low phytoestrogen diet ( p < 0.01 ) . Study participants consuming soy , linseed and wheat diets had a 22 % ( not significant , n.s . ) , 41 % ( p < 0.009 ) and 51 % ( p < 0.001 ) reduction in hot flush rate ; a 103 % ( p < 0.04 ) , 5.5 % ( n.s . ) and 11 % ( n.s . ) increase in vaginal cytology maturation index ; and a 5.2 % ( p < 0.04 ) , 5.2 % ( n.s . ) and 3.8 % ( n.s . ) increase in bone mineral content , respectively . No changes were detected in bone mineral density . The differential effects of high phytoestrogen dietary manipulations on outcomes may represent tissue-specific responses to isoflavones and lignans contained in soy and linseed , respectively . Whilst health outcome measures were not significantly different between groups , the data obtained from separate analysis suggest that phytoestrogens in soy and linseed may be of use in ameliorating some of the symptoms of menopause . Furthermore , the significant decrease in hot flush rate in the wheat group can not be attributable to phytoestrogens measured in this study . Due to subject variability , larger studies are still needed to evaluate population benefit OBJECTIVES To evaluate the preliminary efficacy and safety of Pueraria mirifica in the treatment of vasomotor symptoms . DESIGN Open-label study . SETTING Hat Yai Regional Hospital , Thail and . SUBJECTS Pre and postmenopausal women with vasomotor symptoms , such as hot flushes and night sweats . Other unpleasant symptoms , urogenital and psychological symptoms , were also evaluated . MATERIAL AND METHOD Patients were enrolled voluntarily and r and omly received 50 mg or 100 mg of Pueraria mirifica in capsules , once daily for six months . RESULTS Of the 48 enrolled patients , 11 cases were excluded for failing to complete the initial work-up . Thirty-seven cases were evaluated . 20 of 37 ( 54.1 % ) r and omly received a dose of 50 mg/day of Pueraria mirifica ( Group A ) , and 17 of 37 ( 45.9 % ) received 100 mg/day of Pueraria mirifica ( Group B ) . The mean of the modified Greene climacteric scale decreased from 35.6 to 26.6 , 17.2 and 15.1 in group A , while group B , declined from 32.6 to 21.0 , 14.8 and 13.6 at 1- , 3- and 6-month respectively . The mean serum estradiol , fluctuated from the baseline of 76.6 to 55.4 , 56.7 , 72.5 , 69.2 , 114.2 and 74.5 pg/ml at 1- , 2- , 3- , 4- , 5- and 6-month respectively . Whereas the mean serum follicle-stimulating hormone (FSH)/luteinizing hormone ( LH ) was stable in the range of ; 27.1/12.6 , 28.3/12.9 and 22.5/11.4 mIU/ml at baseline , 3- and 6-month respectively . CONCLUSIONS Pueraria mirifica , containing phytoestrogens , relatively alleviated the climacteric symptoms in perimenopausal women . The transient negative profiles occurred in a small number of subjects that included anemia , and liver profiles . While there was a slight decrease in lipoproteins and an increase in hormonal profiles , Pueraria mirifica demonstrates great promise in the treatment of climacteric symptoms among perimenopausal women . However , optimal doses should be clinical ly assessed , to meet appropriate individual responses Objective : The study aims to evaluate the effectiveness and safety of Chinese herbal medicine granules Danzhi Qing’e formula ( DZQE ) , Erzhi formula ( EZ ) , and their combination ( Combined formula ) in the treatment of menopausal symptoms at different stages of menopause . Methods : Women between the ages of 40 to 60 years , who met menopausal symptoms diagnostic criteria and experienced hot flushes at least 14 times/week in the last 4 weeks , were recruited to participate in a stratified r and omized , double-blind , placebo-controlled  clinical trial ( n = 389 ) . They received a treatment period of 8 weeks and were followed up for 4 weeks . Participants were categorized into two subgroups : 197 in the perimenopausal subgroup ( menstrual disorder to 1 y after amenorrhea ) and 192 in the early postmenopausal subgroup ( 1 - 5 y after amenorrhea ) . Participants were r and omly assigned to placebo or one of the three herbal formula treatments . The primary outcome instrument was the Menopause-Specific Quality of Life ( MENQOL ) question naire . Results : When analyzing the two subgroups together , DZQE markedly decreased the MENQOL total score at the end of 12th week with statistical significance ( P = 0.02 ) and improved vasomotor symptoms after 8 weeks treatment and 4 weeks follow-up ( P < 0.05 ) . What is more , the combined formula also greatly improved the participants ’ vasomotor symptoms compared with placebo after the 4 weeks follow-up . No statistically meaningful difference was observed in any other outcomes among the groups . The results of subgroup analysis showed that DZQE and Combined formula were more effective than placebo in improving MENQOL total score for perimenopausal women at the end of week 12 . For typical menopausal symptoms such as hot flushes and night sweats , DZQE displayed more favorable effects on early postmenopausal participants . Compared to placebo , the DZQE both showed statistically significant differences after 8 weeks treatment and 4 weeks follow-up . Although at the end of 12th week , DZQE also had better effects than placebo in the perimenopausal subgroup on vasomotor symptoms . Participants in the EZ group did not show a significant difference of any domains in MENQOL compared with participants in the placebo group . Conclusions : The DZQE formula improves the quality of life for menopausal women , especially for those with vasomotor symptoms during the whole menopausal period . The DZQE and EZ combination formula is effective only on perimenopausal symptoms Background . Risk-benefit issues raised after the WHI have significantly increased the use of alternative treatments for the menopause . Despite this , data regarding the effect of soy isoflavones over mood and menopausal symptoms in high risk population s is still lacking . Objective . To evaluate the effect of soy derived isoflavones over hot flushes , menopausal symptoms and mood in climacteric women with increased body mass index ( BMI ) . Methods . Fifty symptomatic climacteric women aged 40 to 59 with increased BMI ( ≥25 ) were recruited to receive oral 100 mg/day of soy derived isoflavones ( Climasoy ® ) for 3 months  . Hot flushes ( frequency/intensity ) , menopausal symptoms ( Menopause Rating Scale [ MRS ] ) and mood ( Hamilton Depressive Rating Scale [ HDRS ] ) were evaluated at baseline and at 90 days . Results . A total of 45 women completed the study . After 3 months of soy isoflavone supplementation hot flushes significantly decreased in percentage , number and severity ( 100 % to 31.1 % ; 3.9 ± 2.3 to 0.4 ± 0.8 and 2.6 ± 0.9 to 0.4 ± 0.8 , respectively , p < 0.001 ) . MRS scores ( total and for subscales ) reflecting general menopausal symptoms also significantly decreased compared to baseline . Regarding mood , after three months total HDRS scores and the rate of women presenting depressed mood ( scores ≥ 8) significantly decreased ( 16.3 ± 5.4 to 6.9 ± 5.2 and 93.3 % to 28.9 % , respectively , p < 0.05 ) . There was no effect on blood pressure levels or BMI values after treatment . Conclusion . In this high risk climacteric population  , soy derived isoflavone treatment improved mood as well as vasomotor and general menopausal symptoms . More research is required to determine if the positive effect over mood is a direct or an indirect one through hot flush alleviation Objective To investigate the efficacy of dietary soy proteins containing differing amounts of isoflavones on the number and severity of  vasomotor symptoms ( hot flashes and night sweats ) in peri- and postmenopausal women . Design A double-masked , r and omized , controlled , clinical trial was conducted . A total of 241 community-dwelling women reporting vasomotor symptoms at baseline were r and omized into one of three groups . In all groups , participants consumed a daily supplement containing 25 g of soy protein and were r and omly assigned to one of three groups : ( a ) isoflavone extracted soy protein ( control ) , ( b ) soy protein with a medium dose of isoflavones ( 42 mg/day ) , or ( c ) soy protein with a higher dose of isoflavones ( 58 mg/day ) . The primary outcome measure in this trial was change in reported vasomotor symptoms . Results A reduction in the number and severity of vasomotor symptoms was observed in all three treatment groups . No significant differences in the number and severity of vasomotor symptoms were observed among the high isoflavone , middle isoflavone , or control groups . The lack of a between-treatment group effect was observed even after stratified by number of baseline symptoms and use of traditional hormone replacement therapy . Conclusions These data suggest that soy protein containing 42 or 58 mg of isoflavones is no more effective than isoflavone-extracted soy protein for improving the number and severity of vasomotor symptoms in peri- and postmenopausal women OBJECTIVE To study the efficacy and safety of estradiol and drospirenone tablets ( Angeliq ) in treatment of menopausal symptoms among postmenopausal Chinese healthy women . METHODS Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were r and omly assigned into estradiol and drospirenone ( observation group , n = 183 ) or placebo group ( n = 61 ) by the ratio of 3:1 for 16 weeks in this r and omized multi-center double-blind placebo-controlled study . During the trial , the follow-up visits were conducted at week 4 , 8 , 12 , 16 of treatment and 2 weeks after treatment respectively . Height , weight , vital signs , hot flushes , other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit , while the clinical global impression scale was assessed at 16 weeks as well . RESULTS It showed that hot flushes were reduced significantly more in observation group than that in placebo group ( P < 0.01 ) , although both treatments were effective . The absolute values of mean severity index of total hot flushes decreased by -0.6 ± 0.5 in observation group and -0.4 ± 0.4 in placebo group from baseline respectively , which reached significant difference ( P < 0.05 ) . However , the absolute values of mean severity index of moderate to severe hot flushes decreased by -0.6 ± 0.8 in observation group and -0.3 ± 0.6 in placebo group from baseline respectively , which had no significant difference ( P > 0.05 ) . After 16 weeks treatment , it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating , vaginal dryness and clinical global impression scale ( P < 0.01 ) . During the trial , blood pressure in observation group was stable . The rate of vaginal bleeding in observation group was higher than that in the placebo group , especially during the week 4 to week 8 when 48.9 % ( 87/178 ) in observation group and 10.7 % ( 6/56 ) in placebo group of patients bled . Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle ( 28 days ) , it increased gradually along with duration of the treatment . The commonest adverse event in observation group was breast tenderness which accounted for 12.0 % ( 22/183 ) . The level of serum potassium was in the normal range in observation group mostly . Meanwhile , the other adverse events rate was low . Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related . CONCLUSION Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmenopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy Abstract Objective : To evaluate the efficacy of gamolenic acid provided by evening primrose oil in treating hot flushes and sweating associated with the menopause . Design : R and omised , double blind , placebo controlled study . Setting : District general hospital and teaching hospital . Subjects : 56 menopausal women suffering hot flushes at least three times a day . Intervention : Four capsules twice a day of 500 mg evening primrose oil with 10 mg natural vitamin E or 500 mg liquid paraffin for six months . Main outcome measures - Change in the number of hot flushes or sweating episodes a month . Results : 56 diaries were analysed , 28 from women taking gamolenic acid and 28 from those taking placebo .  Only 18 women given gamolenic acid and 17 given placebo  completed the trial . The mean ( SE ) improvement in the number of flushes in the last available treatment cycle compared with the control cycle was 1.9 ( 0.4 ) ( P<0.001 ) for daytime flushes and 0.7 ( 0.3 ) ( P<0.05 ) for night time flushes in womentaking placebo ; the corresponding values for women taking gamolenic acid were 0.5 ( 0.4 ) and 0.5 ( 0.3 ) . In women taking gamolenic acid the only significant improvement was a deduction in the maximum number of night time flushes ( 1.4 ( 0.6 ) ; P<0.05 ) . Conclusion : Gamolenic acid offers no benefit over placebo in treating menopausal flushing OBJECTIVES To examine the efficacy of a hop extract enriched in 8-prenylnaringenin ( 8-PN , the phytoestrogen in hops , Humulus lupulus L. ) on relief of  menopausal discomforts .  METHODS A prospect i ve , r and omized , double-blind , placebo-controlled study over 12 weeks with 67 menopausal women , who were administered a hop extract st and ardized on 8-PN ( 100 or 250 microg ) . The responses were determined by means of a modified Kupperman index ( KI ) and a patients ' question naire . RESULTS All groups , including placebo , showed a significant reduction of the KI both after 6 weeks and after 12 weeks . The hop extract at 100 microg 8-PN was significantly superior to placebo after 6 weeks ( P=0.023 ) but not after 12 weeks ( P=0.086 ) . No dose-response relationship could be established , as the higher dose ( 250 microg ) was less active than the lower dose both after 6 weeks and after 12 weeks . Still , a trend for a more rapid decrease of KI was noticed for both active groups as compared to placebo . In particular , the decrease in hot flush score ( isolated from the KI ) was found significant for both treatment groups after 6 weeks ( P<0.01 ) with respect to placebo . Results of the patients ' question naire were consistent with those of the KI , with the most pronounced effects being observed for the 100-microg treatment . CONCLUSIONS Daily intake of a hop extract , st and ardized on 8-PN as a potent phytoestrogen , exerted favorable effects on vasomotor symptoms and other menopausal discomforts . Hop-derived prenylated flavonoids may provide an attractive addition to the alternative treatments available for relief of hot flushes and other menopausal discomforts Objective Many complementary or alternative medicines are being used for the treatment of menopausal symptoms but most have not been properly tested for efficacy or for safety . This study examined the effect of a Chinese herbal preparation ( Dang Gui Buxue Tang ) on menopausal symptoms in Hong Kong Chinese women . Methods A 6-month r and omized , double-blind , placebo-controlled study of the effect of Dang Gui Buxue Tang ( a 1 : 5 combination of Dang Gui ( Angelicae sinensis ) and Huang Qi ( Astragalus membranaceus ) ) on acute menopausal symptoms . A total of 103 symptomatic women were enrolled . Three failed to meet inclusion criteria , leaving 50 subjects for inclusion in each group . Results Overall , mild hot flushes were reported more frequently than either moderate or severe flushes . In analysis by severity of flushes , there was a significant reduction in the number of mild hot flushes per month in the treatment group but not in the placebo group ( from 18.9 ± 23.5 at baseline to 8.6 ± 17.1 at 6 months in the treatment group ( p < 0.01 ) and from 26.0 ± 43.5 to 12.4 ± 17.6 in the placebo group ( p = 0.062 ) ) . For moderate flushes , there was a significant reduction in the placebo group compared with the treatment group ( from 18.9 ± 28.7 at baseline to 11.1 ± 29.9 at 6 months in the placebo group ( p < 0.05 ) and from 10.5 ± 22.3 to 6.0 ± 16.0 in the treatment group ( p = 0.107 ) ) . There was no significant change in either treatment or placebo groups in the reporting of severe hot flushes . Episodes of night sweats decreased significantly in the placebo but not in the treatment group ( from 6.8 ± 10.0 at baseline to 1.9 ± 5.7 at 6 months in the placebo group ( p < 0.05 ) and from 5.4 ± 8.9 to 3.2 ± 8.5 in the treatment group ( p = 0.471 ) ) . In the vasomotor domain of the Menopause Specific Quality of Life , there was a significant reduction in scoring in the placebo group ( from 2.8 ± 1.6 to 1.7 ± 1.3 , p < 0.01 ) but not in the treatment group ( from 2.8 ± 2.1 to 2.3 ± 1.6 , p = 0.247 ) . Conclusions This study found overall no significant difference between Dang Gui Buxue Tang and placebo in the treatment of vasomotor symptoms  in Hong Kong Chinese women .  The frequency of mild , moderate and severe hot flushes decreased in both treatment and placebo groups , but Dang Gui Buxue Tang was statistically superior to placebo only in the treatment of mild hot flushes . There were no serious adverse events attributable to treatment during the study period Objective : First , to identify treatment satisfaction thresholds for interpreting treatment-related changes in vasomotor symptoms , and , second , to determine the doses of desvenlafaxine ( DVS ) ( administered as desvenlafaxine succinate ) that effectively provide relief of vasomotor symptoms considered important by menopausal women . Design : Efficacy and treatment satisfaction were assessed in 620 postmenopausal women with moderate to severe vasomotor symptoms participating in a double-blind , placebo-controlled trial and r and omly assigned to placebo or 50 , 100 , 150 , or 200 mg DVS .  Number and severity of hot flushes and number of nighttime awakenings were recorded in daily diaries for 12 weeks of treatment . At week 12 , responses to the Menopause Symptoms Treatment Satisfaction Question naire were compared with efficacy results . Results : Greater percentages of participants in the DVS groups reported being " satisfied " or " extremely satisfied " with daytime and nighttime control of hot flushes compared with placebo . The treatment satisfaction threshold , defined as the difference between the average reduction in vasomotor symptoms for women who were " neutral " versus " satisfied , " was 1.64 for moderate to severe hot flushes and 0.42 for nighttime awakenings . Statistically significant reductions with 100 , 150 , and 200 mg DVS exceeded treatment satisfaction threshold results for at least one of these thresholds , and results with 100 mg DVS compared with placebo exceeded both treatment satisfaction thresholds . Conclusions : Among menopausal women with moderate to severe vasomotor symptoms , the treatment satisfaction thresholds that were meaningful to participants were 1.64 fewer moderate to severe hot flushes per day and 0.42 fewer nighttime awakenings per night . A dose of 100 mg DVS met both of these important vasomotor symptom change thresholds OBJECTIVE The objective of this clinical trial was to examine the efficacy of a supplement containing natural S-(-)equol , a daidzein metabolite , in reducing  menopausal symptoms . METHODS In this multicenter , double-blind placebo-controlled trial , 160 equol nonproducing , postmenopausal Japanese women who experienced at least 1 hot flush/day were r and omly assigned to consume 10 mg/day S-(-)equol ( n=77 women )  or placebo ( n=83 women ) for 12 weeks . Participants completed a st and ardized menopausal symptom checklist and rated five common menopause symptoms by a visual analog scale at baseline , week 12 , and week 18 ( 6-week postintervention ) . Physical , blood , and urine examinations were conducted . One hundred twenty-six women completed the study . RESULTS At baseline , daily hot flush frequency was 2.9±2.1 for the S-(-)equol group and 3.2±2.4 for the placebo group . After the 12-week intervention , the S-(-)equol group had a greater decrease from baseline in hot flush frequency compared with the placebo group ( -1.9±1.8/day , -58.7 % , vs. -1.0±2.0/day , -34.5 % , p=0.009 ) . The severity of hot flushes and neck or shoulder muscle stiffness significantly decreased in the S-(-)equol group compared with the placebo group . No changes in clinical parameters or serious adverse effects were reported . CONCLUSIONS This is the first trial to show beneficial effects of a 10-mg natural S-(-)equol supplement consumed daily for 12 weeks on major menopausal symptoms , specifically , hot flushes and neck or shoulder muscle stiffness , in postmenopausal Japanese women . This supplement offers a promising alternative for management of menopausal symptoms OBJECTIVE To evaluate the effects of a defined formula of Chinese medicinal herbs ( CMH ) on menopausal symptoms . DESIGN A double-blind r and omised placebo-controlled trial . METHODS Between August 1998 and April 1999 , 55 postmenopausal Australian women recruited from an urban population completed 12 weeks of intervention with either a defined formula of CMH ( n = 28 ) or placebo ( n = 27 ) taken twice daily as a beverage . MAIN OUTCOME MEASURES The primary end-point was change in frequency of vasomotor events ( hot flushes and night sweats ) . The secondary end-points were changes in score for the domains measured in the Menopause Specific Quality of Life ( MENQOL ) Question naire . RESULTS There was a reduction in average weekly frequency of vasomotor events with CMH ( -15 % ; 95 % CI , -31 % to + 1 % ) and with placebo ( -31 % ; 95 % CI , -42 % to -21 % ) . The difference between groups favoured the use of placebo ; however , this was not significant ( P=0.09 ) . Although significant reductions in scores for the various domains of the MENQOL Question naire were observed for both CMH and placebo , there were no significant differences between the two treatment groups for any domain . There was evidence for effect modification by previous use of natural therapies for the vasomotor , physical and sexual domains of the MENQOL Question naire : women with no prior use of natural therapies for their menopausal symptoms responded to therapy , whereas prior users did not . CONCLUSIONS The defined formula of CMH was no more effective than placebo in reducing vasomotor episodes in Australian postmenopausal women , or in improving any of the four symptom domains in the MENQOL Question naire . Three of the MENQOL Question naire domains were modified by prior use of natural therapies . This finding has implication s for future studies OBJECTIVE To investigate the efficacy of soy isoflavone on climacteric symptoms in postmenopausal women . DESIGN In this double-blind , r and omized , placebo-controlled study , a total of 80 women ( mean age = 55.1 years ) , who reported 5 or more hot flush episodes per day , were r and omized to receive either 250 mg of st and ardized soy extract ( Glycine max AT ) a total of 100mg/day of isoflavone ( n = 40 ) or placebo ( n = 40 ) . Exclusion criteria included : contra-indication for hormone therapy ( HT ) , chronic gastrointestinal diseases , and users of HT within the preceding 6-months . For 10-months , climacteric symptoms were evaluated using a score card and the menopausal Kupperman index . Compliance and safety were also assessed . At baseline and the end of the study , lipid and hormonal profiles , as well as vaginal , mammographic and ultrasonographic parameters were measured . The t-test , Wilcoxon test and ANOVA were used in the statistical analysis . RESULTS At baseline , the mean number of hot flushes was 9.6 + /- 3.9 per day in the isoflavone group and 10.1+/-4.9 in the placebo group ( p>0.05 ) . After 10 months , there was a significant reduction in frequency of hot flushes among isoflavone users when compared to those on placebo ( 3.1 + /- 2.3 and 5.9 + /- 4.3 , respectively ) ( p<0.001 ) . Kupperman index mean values showed a significant reduction in both groups . However , soy isoflavone was significantly superior to placebo , in reducing hot flush severity ( 69.9 % and 33.7 % , respectively ) ( p<0.001 ) . Endometrial thickness , mammography , vaginal cytology , lipids and hormonal profile did not change in both groups . No serious adverse event related to isoflavone treatment was reported . CONCLUSIONS The soy isoflavone extract exerted favorable effects on vasomotor symptoms and good compliance , providing a safe and effective alternative therapeutic for postmenopausal women
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 .