The effects of micronutrient supplementation on vasomotor symptoms in postmenopausal women Aerobic exercise as a treatment for vasomotor menopausal symptoms: randomised controlled trial protocol. Medroxyprogesterone and conjugated oestrogen are equivalent for hot flushes: a 1-year randomized double-blind trial following premenopausal ovariectomy. A Pilot Study of the Effects of Phytoestrogen Supplementation on Postmenopausal Endometrium Androgens and estrogens in relation to hot flushes during the menopausal transition. 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 A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1): Trial protocol Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: Randomized, controlled, double-blind pilot study Identifying meaningful differences in vasomotor symptoms among menopausal women Evidence-based review of therapies at the menopause. Treatment of Vasomotor Symptoms of Menopause with Black Cohosh, Multibotanicals, Soy, Hormone Therapy, or Placebo Isoflavone-rich or isoflavone-poor soy protein does not reduce menopausal symptoms during 24 weeks of treatment Relief of Hot Flushes With New Plant-Derived 10-Component Synthetic Conjugated Estrogens Synthetic Conjugated Estrogens-B and Postmenopausal Nocturnal Vasomotor Symptoms: A Randomized Controlled Trial A cognitive model of menopausal hot flushes and night sweats. Efficacy and tolerability of continuous combined hormone replacement therapy in early postmenopausal women Menopausal Symptoms in Older Women and the Effects of Treatment With Hormone Therapy
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 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 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 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 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 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 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 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 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 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 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 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 : A study was conducted to evaluate the safety and efficacy of 3 different doses of synthetic conjugated estrogens B , a new plant-derived 10-component conjugated estrogens product , for the treatment of menopausal vasomotor symptoms . METHODS : This was a r and omized , double-blind , placebo-controlled trial . Highly symptomatic menopausal women ( N = 281 ) received 12 weeks of a once-daily oral treatment with 0.3 mg , 0.625 mg , or 1.25 mg of 10-component synthetic conjugated estrogen or placebo . Patients recorded the daily frequency and severity of hot flushes . Statistical analyses compared results at weeks 4 , 8 , and 12 with baseline values . RESULTS : Statistically significant reductions ( P < .05 ) in the frequency and severity of vasomotor symptoms were observed for all 3 dosage strengths of 10-component synthetic conjugated estrogen compared with placebo . The most commonly reported adverse events in all treatment groups were headaches . No difference in the incidence of treatment-related adverse events was seen between placebo and 10-component synthetic conjugated estrogen groups . CONCLUSION : The 0.3-mg , 0.625-mg and 1.25-mg dose strengths of 10-component synthetic conjugated estrogen significantly reduced the frequency and severity of vasomotor symptoms compared with placebo , and were well tolerated during this 12-week study . LEVEL OF EVIDENCE : OBJECTIVE : To evaluate two doses of oral synthetic conjugated estrogens-B tablets compared with placebo on the frequency of awakenings result ing from nocturnal vasomotor symptoms in postmenopausal women over a 12-week treatment period . METHODS : A double-blind , r and omized , placebo-controlled multicenter study enrolled a total of 157 women who were experiencing daytime vasomotor symptoms and a minimum of at least three nocturnal awakenings per night as a result of hot flushes . Participants were evenly r and omized to one of three treatment groups ( 0.3 mg , 0.625 mg , or matching placebo ) and treated for up to 12 weeks . Subjective sleep quality also was assessed . RESULTS : Significantly greater reductions from baseline in the weekly mean frequency of awakenings result ing from hot flushes occurred for participants r and omized to either synthetic conjugated estrogens-B dose relative to placebo ( mean reductions , 3.55 , P=.004 , and 4.65 , P<.001 for 0.3 mg and 0.625 mg , respectively ) . In addition , a significantly greater proportion of participants at either estrogen dose had complete elimination of nocturnal awakenings ( 36.5 % for 0.3 mg , 34 % for 0.625 mg compared with 9.8 % for placebo ; P⩽.002 ) with a general finding of improved sleep based on actigraphy data . No differences were observed in measures of sleep quality or daytime sleepiness . CONCLUSION : In this symptomatic postmenopausal population of women experiencing sleep disruption result ing from nocturnal vasomotor symptoms , a daily dose of synthetic conjugated estrogens-B as low as 0.3 mg appears to be effective in treating nocturnal hot flushes that lead to unwanted awakenings . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00592839 . LEVEL OF EVIDENCE : 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 . Continuous combined hormone replacement therapy ( ccHRT ) based on estradiol valerate ( E2V ) and medroxyprogesterone acetate ( MPA ) is effective for relief of menopausal symptoms three years or more after the menopause . This study was undertaken to examine the efficacy and tolerability of ccHRT in early postmenopausal women ( last menstrual period 1.3 years before study entry ) . Study design . This was a 52-week , r and omized , double-blind , multinational study of ccHRT comprising three different dose combinations of E2V/MPA in 459 early postmenopausal non-hysterectomized women experiencing 30 or more moderate to severe hot flushes a week and /or vasomotor symptoms requiring treatment . Main outcomes measures . The primary endpoint was change in frequency and severity of moderate to severe hot flushes at 12 weeks . Secondary outcome measures included number of bleeding days and evaluation of tolerability . Results . The frequency of hot flushes was reduced by ≥70 % after one month ( P<0.001 for all doses at week 2 onwards ) , with little evidence of statistically different dose effects . Severity of flushing was also attenuated by  ccHRT . Mean number of bleeding days fell to < 1 per 28-day cycle at 52 weeks . Rates of amenorrhoea approached 80–90 % at the end of the study , but were significantly lower at several time points with the highest-dose regimen ( 2 mg E2V + 5 mg MPA ) than with the lower-dose options ( 1 mg E2V + 2.5 mg MPA and 1 mg E2V + 5 mg MPA ; P<0.05 ) . Adverse events declined in frequency over time with all regimens but throughout the study were more numerous with the highest-dose regimen than with lower doses ( P= 0.0002 ) . Conclusions . Continuous combined HRT was effective for the relief of climacteric symptoms in early postmenopausal women and was well tolerated OBJECTIVE In some women , hot flashes and other symptoms attributed to menopause persist for many years after the cessation of menses . The frequency and severity of such symptoms and response to hormone therapy in older women have not been well documented . METHODS We used data from the Heart and Estrogen/Progestin Replacement Study , a blinded , clinical trial among 2763 women with documented coronary disease and a uterus who were r and omized to receive either conjugated estrogens 0.625 mg plus medroxyprogesterone acetate 2.5 mg in one tablet or placebo .  Participants were queried at baseline and annually regarding menopausal symptoms . Breast symptoms were self‐reported , and uterine bleeding was recorded on a daily diary . RESULTS Symptoms associated with menopause were relatively common among Heart and Estrogen/Progestin Replacement Study participants , whose average age was 67 years and who averaged 18 years since menopause . At baseline , 16 % of women reported frequent hot flashes , 26 % vaginal dryness , 10 % genital irritation , 55 % trouble sleeping , and 53 % early awakening . Women assigned to hormone therapy reported less frequent hot flashes , vaginal dryness , and trouble sleeping compared with women assigned to placebo , but more frequent vaginal discharge , genital irritation , uterine bleeding , and breast symptoms . The reporting of breast symptoms among women in the hormone group decreased from 40 % at 1 year to 13 % by the 4th year . Uterine bleeding was reported by 31 % and spotting by an additional 33 % of women in the hormone group during the 1st year of treatment ; by the 4th year , these proportions had fallen to 11 % and 20 % , respectively . CONCLUSION Symptoms typically attributed to menopause are common in elderly women .  Postmenopausal hormone therapy  reduces hot flashes , trouble sleeping , and vaginal dryness , but at st and ard doses in elderly women is associated with vaginal discharge , genital irritation , uterine bleeding , and breast symptoms
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 .