Aerobic exercise as a treatment for vasomotor menopausal symptoms: randomised controlled trial protocol. Efficacy and tolerability of continuous combined hormone replacement therapy in early postmenopausal women [Clinical effects of hormone replacement therapy with estradiol valerate and cyproterone acetate in perimenopausal women]. Effects of 5 years of hormonal replacement therapy on menopausal symptoms and blood pressure-a randomised controlled study. Identifying meaningful differences in vasomotor symptoms among menopausal women The effects of compounded bioidentical transdermal hormone therapy on hemostatic, inflammatory, immune factors; cardiovascular biomarkers; quality-of-life measures; and health outcomes in perimenopausal and postmenopausal women. Hot flushes, coronary heart disease, and hormone therapy in postmenopausal women Evidence-based review of therapies at the menopause. Vasomotor symptoms and quality of life in previously sedentary postmenopausal women randomised to physical activity or estrogen therapy. Applied relaxation and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Treatment of Vasomotor Symptoms of Menopause with Black Cohosh, Multibotanicals, Soy, Hormone Therapy, or Placebo A randomized, double-blind, controlled trial of a Chinese herbal formula (Er-Xian decoction) for menopausal symptoms in Hong Kong perimenopausal women A randomized, double-blind, controlled trial of a Chinese herbal formula (Er-Xian decoction) for menopausal symptoms in Hong Kong perimenopausal women. Medroxyprogesterone and conjugated oestrogen are equivalent for hot flushes: a 1-year randomized double-blind trial following premenopausal ovariectomy. Hormone replacement therapy use and menopausal symptoms among women participating in a behavioral lifestyle intervention. Androgens and estrogens in relation to hot flushes during the menopausal transition. Menopausal Symptoms in Older Women and the Effects of Treatment With Hormone Therapy
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 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 BACKGROUND In perimenopause many women complain of psychogenic and organic disorders often connected with initial and increasing levels of hypoestrogenism . In this study we evaluated the effects of hormone replacement therapy ( HRT ) in symptomatic women in perimenopause . METHODS We enrolled 100 healthy and symptomatic women who were r and omly distributed to two groups for a 12-month study . Group A : 50 patients received HRT with estradiol valerate and cyproterone acetate ( Pausene(R ) ) ; Group B : 50 patients were used as a control group ( treated with Cacit Vitamin D30(R ) ) . A number of clinical and instrumental tests were performed at 0 , 6 and 12 months to evaluate any changes in vasomotor and urogenital symptoms , bone and serum homeostasis and possible sexual disorders . The statistical analysis was performed using the c2 test . RESULTS The group of women receiving HRT showed a significant reduction in vasomotor clinical symptoms ( p<0.001 ) and sexual disorders ( p<0.002 ) ; this was not reflected in the control group where libido decreased steadily with apparent slight improvements only at the end of the study . The urogenital disorders disappeared almost completely in Group A , whereas they diminished in Group B. HRT patients also showed a slight increase ( p<0.001 ) in the initial value of BMD ( bone mineral density ) , a reduction in the marker for bone turnover and an improved lipid profile ( p<0.05 ) . These changes were unfortunately not noted in Group B. CONCLUSIONS On the basis of these results we conclude that HRT appeared to have a beneficial effect on perimenopausal clinical symptoms over the 12-month period , leading to marked improvements in the psychophysical wellbeing of symptomatic women in perimenopause OBJECTIVES To study the effects of hormonal replacement on hot flushes , other symptoms linked to menopause , and blood pressure . METHODS The study included 1006 early postmenopausal women aged 45 - 58 years , participating in the Danish Osteoporosis Prevention Study ( DOPS ) r and omised to Hormonal replacement therapy ( HRT )  ( n=502 ) or no HRT  ( n=504 ) in an open label trial . Symptom scores were recorded at baseline , after 6 month , 1 , 2 , and 5 years on a modified Greene scale ( range 0 - 4 with 0 equalling no symptoms , and 4 maximal symptoms ) . RESULTS HRT efficiently alleviated hot flushes ( mean+/-S.E.M. score 0.48+/-0.04 in HRT vs. 0.83+/-0.05 in no HRT after 5 years , P<0.01 by repeated measures ANOVA ) , sleeping difficulties associated with hot flushes ( 0.21+/-0.60 vs. 0.37+/-0.86 , P<0.01 ) , vaginal dryness ( 0.45+/-0.04 vs. 0.73+/-0.05 , P<0.01 ) , dyspareunia ( 0.27+/-0.04 vs. 0.39+/-0.04 , P<0.01 ) , and libido ( 0.48+/-0.05 vs. 0.59+/-0.05 , P=0.08 ) . In the untreated group the occurrence of mood swings ( from 0.77+/-0.05 at baseline to 0.45+/-0.04 after 5 years , 2P<0.01 ) and oedemas ( from 0.59+/-0.04 to 0.43+/-0.04 , 2P=0.02 ) decreased with age while the occurrence of incontinence increased ( from 0.43+/-0.03 to 0.52+/-0.04 , 2P<0.01 ) . These changes were not influenced by HRT . Furthermore , HRT had no influence on presence of headache ( 0.54+/-0.05 vs. 0.58+/-0.05 after 5 years ) , voiding pattern ( 0.49+/-0.04 vs. 0.53+/-0.04 ) , or blood pressure ( mean systolic pressure 123+/-18 vs. 123+/-19 , diastolic pressure 77+/-10 vs. 77+/-11 ) . CONCLUSIONS HRT is efficient in controlling hot flushes and vaginal dryness , and symptoms related to these conditions . However , no effect on blood pressure or other menopause symptoms was recorded 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 Menopause impacts 25 million women world wide each year , and the World Health Organization estimates 1.2 billion women will be postmenopausal by 2030 . Menopause has been associated with symptoms of hot flashes , night sweats , dysphoric mood , sleep disturbance , and conditions of cardiovascular disease , depression , osteoporosis , osteoarthritis , depression , dementia , and frailty . Conventional hormone replacement therapy results in increased thrombotic events , and an increased risk of breast cancer and dementia as evidence d in large prospect i ve clinical trials including Heart and Estrogen/Progestin Replacement Study I and the Women 's Health Initiative . A possible mechanism for these adverse events is the unfavorable net effects of conjugated equine estrogens and medroxyprogesterone acetate on the hemostatic balance and inflammatory and immune factors . Physiologic sex steroid therapy with transdermal delivery for peri/postmenopausal women may offer a different risk/benefit profile , yet long-term studies of this treatment model are lacking . The objective of this study was to examine the long-term effects of compounded bioidentical transdermal sex steroid therapy including estriol , estradiol , progesterone , DHEA , and testosterone on cardiovascular biomarkers , hemostatic , inflammatory , immune signaling factors ; quality -of-life measures ; and health outcomes in peri/postmenopausal women within the context of a hormone restoration model of care . A prospect i ve , cohort , closed-label study received approval from the Human Subjects Committee . Recruitment from outpatient clinics at an academic medical center and the community at large result ed in three hundred women giving signed consent . Seventy-five women who met strict inclusion /exclusion criteria were enrolled .  Baseline hormone evaluation was performed along with baseline experimental measures . Following this , women received compounded transdermal bioidentical hormone therapy of BiEst ( 80%Estriol/20%Estradiol ) , and /or Progesterone for eight weeks to meet established physiologic reference ranges for the luteal phase in premenopausal women . The luteal phase hormone ratios were selected based on animal and epidemiologic studies demonstrating favorable outcomes related to traumatic , ischemic , or neuronal injury . Follow-up testing was performed at eight weeks and adjustment to hormone regimens were made including addition of and rogens of DHEA and Testosterone if indicated . Experimental subjects were monitored for 36 months . Baseline , 2-month , and annual values were obtained for : blood pressure , body mass index , fasting glucose , Homeostasis Metabolic Assessment of Insulin Resistance ( HOMA-IR ) , fasting triglycerides , total Factor VII , Factor VIII , fibrinogen , Antithrombin III , Plasminogen Activator Inhibitor1(PAL-1 ) , C-reactive protein ( CRP ) , Interleukin-6 ( IL-6 ) , Matrix Metalloproteinase-9 ( MMP-9 ) , Tumor Necrosis Factor-alpha ( TNF ) , Insulin-like Growth Factor ( IGF-1 ) , and sex steroid levels . Psychosocial measures included : Greene Climacteric Scale , Visual Analog Pain Scale , Hamilton Anxiety Scale , Hamilton Depression Scale , Holmes Rahe Stress Scale , Job Strain , and Home Strain . Health outcome measures included the number of prescribed medications used , number of co-morbidities , and endometrial thickness in postmenopausal women with intact uteri . Subjects receiving  compounded transdermal bioidentical hormone therapy showed significant favorable changes in : Greene Climacteric Scale scores , Hamilton Anxiety Scale , Hamilton Depression Scale , Visual Analog Pain Scale , fasting glucose , fasting triglycerides , MMP-9 , C-reactive Protein , fibrinogen , Factor VII , Factor VIII , Insulin-Like Growth Factor 1 , and health outcomes of co-morbidities and a number of prescribed medications . Antithrombin III levels were significantly decreased at 36 months . All other measures did not exhibit significant effects . Administration of compounded transdermal bioidentical hormone therapy in doses targeted to physiologic reference ranges administered in a daily dose significantly relieved menopausal symptoms in peri/postmenopausal women . Cardiovascular biomarkers , inflammatory factors , immune signaling factors , and health outcomes were favorably impacted , despite very high life stress , and home and work strain in study subjects . The therapy did not adversely alter the net prothrombotic potential , and there were no associated adverse events . This model of care warrants consideration as an effective and safe clinical therapy for peri/postmenopausal women especially in population s with high perceived stress and a history of stressful life events prior to , or during the menopausal transition Objective : The aim of this study was to examine interactions between hot flushes , estrogen plus progestogen therapy ( EPT ) , and coronary heart disease ( CHD ) events in postmenopausal women with CHD . Methods : We analyzed data from the Heart and Estrogen/Progestin Replacement Study , a r and omized , placebo-controlled trial of 0.625 mg conjugated equine estrogens plus 2.5 mg medroxyprogesterone acetate in 2,763 postmenopausal women with CHD .  Hot flushes were assessed at baseline using self-administered question naires ; women reporting bothersome hot flushes " some " to " all " of the time were considered to have clinical ly significant flushing . Cox regression models were used to examine the effect of EPT on risk of CHD events among women with and without significant flushing at baseline . Results : The mean age of participants was 66.7 ± 6.8 years , and 89 % ( n = 2,448 ) were white . Sixteen percent ( n = 434 ) of participants reported clinical ly significant hot flushes at baseline . Among women with baseline flushing , EPT increased risk of CHD events nine-fold in the first year compared with placebo ( hazard ratio = 9.01 ; 95 % CI , 1.15 - 70.35 ) ; among women without baseline flushing , treatment did not significantly affect CHD event risk in the first year ( hazard ratio = 1.32 ; 95 % CI , 0.86 - 2.03 ; P = 0.07 for interaction of hot flushes with treatment ) . The trend toward differential  effects of EPT on risk for CHD among women with and without baseline flushing did not persist after the first year of treatment . Conclusions : Among older postmenopausal women with CHD  , EPT may increase risk of CHD events substantially in the first year of treatment among women with clinical ly significant hot flushes but not among those without hot flushes 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 To assess if regular physical exercise or oral oestradiol therapy decreased vasomotor symptoms and increased quality of life in previously sedentary postmenopausal women . SETTING A prospect i ve , r and omised trial at a University Hospital . METHODS 75 postmenopausal , sedentary women with vasomotor symptoms were r and omised to : exercise three-times weekly over 12 weeks ( 15 women ) , oral oestradiol therapy for 12 weeks ( 15 women ) and 45 women to three other treatment arms . Results from the exercise and oestradiol groups are presented here . The effects on vasomotor symptoms and wellbeing were assessed with logbooks and vali date d question naires . RESULTS Ten women fulfilled 12 weeks of exercise . The number of flushes was rather unchanged in five women and decreased to 28 % ( range 18 - 42 % ) of baseline in the other five women . Five of the ten women continued to exercise another 24 weeks , thus in all 36 weeks . The mean number of flushes decreased by about 50 % in these five women ( from 6.2/24 to 3.2 flushes/24 h at 36 weeks ) . In the same group a score made as the product of reduction in number and severity of flushes decreased by 92 % at 12 weeks , 75 % at 24 weeks and 72 % at 36 weeks compared with baseline . In the estrogen group flushes decreased from 8.4 to 0.8 ( P<0.001 ) after 12 weeks of therapy and remained at this level after 36 weeks . Well-being according to different measurements improved significantly in both groups , albeit more markedly in the estrogen group . CONCLUSIONS Apart from many other health benefits regular physical exercise may decrease vasomotor symptoms and increase quality of life in postmenopausal women , but this has to be further evaluated scientifically . Exercise should be introduced gradually to ensure compliance OBJECTIVE The aim was to evaluate and compare the effects of applied relaxation and oral estradiol treatment on hot flushes , mood and psychological wellbeing in postmenopausal women . PATIENTS AND METHODS In a prospect i ve study , 30 postmenopausal women with vasomotor symptoms were r and omized to applied relaxation or oral estradiol treatment during 12 weeks with 6 months follow-up . Number and severity of flushes were registered daily and Kupperman 's Index and a general estimate of climacteric symptoms , Mood Scale and Symptom Check List were completed at baseline , 4 , 8 and 12 weeks of treatment , and 3 and 6 months after therapy . RESULTS After 12 weeks of treatment , the number of flushes/24 h decreased significantly over time in both treatment groups . In the group receiving applied relaxation , the mean number of flushes/24 h decreased from 6.0 ( 95 % CI 4.5 - 7.6 ) to 3.0 ( 95 % CI 2.1 - 3.9 ) after 12 weeks of treatment . The mean number of flushes/24 h was 1.7 ( 95 % CI 0.7 - 2.5 ) at 6 months follow-up ; i.e. a 72 % decrease . In the estrogen group , the mean number of flushes/24h decreased from 8.4 to 0.8 ; i.e a 90 % decrease in the number of flushes after 12 weeks of treatment . The significant change in flushes reached after 12 weeks of treatment and remained to 6 months after end of treatment in both groups . Estrogen therapy reduced flushes significantly faster than applied relaxation .  General climacteric symptoms according to the Visual Analogue Scale and the Kupperman 's Index decreased significantly over time in both groups . General mood ( Mood Scale ) increased significantly in the estrogen group , but not in the group receiving applied relaxation .  Psychological wellbeing according to Symptom Checklist , increased significantly from baseline to 12 weeks in both groups . CONCLUSIONS We suggest that applied relaxation may be used as an alternative treatment of vasomotor symptoms for postmenopausal women but should be further evaluated 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 The aim of this study is to investigate the effectiveness and safety of a Chinese herbal formula , Er-Xian decoction ( EXD ) , in the treatment of menopausal symptoms among Hong Kong perimenopausal women . Methods A r and omized , double-blind , controlled trial was conducted for 12 weeks among 108 Hong Kong perimenopausal women who reported Menopause Rating Scale ( MRS ) total scores of 28 or higher . Posttreatment follow-up was performed 3 months after the intervention . The primary outcome measure was the frequency and severity of hot flushes . The secondary outcome measures included the MRS , the Menopause-Specific Quality of Life question naire , and serum hormone levels . Results Among 108 participants , 101 participants finished the study . EXD significantly reduced the mean ( SD ) frequency of hot flushes from 5.8 ( 5.0 ) to 2.2 ( 3.0 ) in the treatment group and from 5.0 ( 3.8 ) to 2.4 ( 2.5 ) in the placebo group ( P = 0.04 ) . The mean ( SD ) hot flush score was also reduced from 19.6 ( 6.6 ) to 4.9 ( 7.8 ) in the treatment group and from 16.6 ( 5.4 ) to 7.0 ( 6.4 ) in the placebo group ( P = 0.02 ) . The superiority of EXD to placebo was also observed with greater improvement in the total scores for the MRS ( P = 0.03 ) and the Menopause-Specific Quality of Life question naire ( P < 0.01 ) . There were no differences in serum hormone levels between the EXD group and the placebo group . There were no serious adverse events , and the safety indices of whole blood counts , renal function , and liver function were within the normal range before and after treatment . Conclusions The Chinese herbal formula EXD is superior to placebo in reducing the frequency and severity of hot flushes and in improving menopausal symptoms in Hong Kong perimenopausal women . It is well tolerated , with no serious adverse events noted during the study period OBJECTIVE The aim of this study is to investigate the effectiveness and safety of a Chinese herbal formula , Er-Xian decoction ( EXD ) , in the treatment of menopausal symptoms among Hong Kong perimenopausal women . METHODS A r and omized , double-blind , controlled trial was conducted for 12 weeks among 108 Hong Kong perimenopausal women who reported Menopause Rating Scale ( MRS ) total scores of 28 or higher . Posttreatment follow-up was performed 3 months after the intervention . The primary outcome measure was the frequency and severity of hot flushes . The secondary outcome measures included the MRS , the Menopause-Specific Quality of Life question naire , and serum hormone levels . RESULTS Among 108 participants , 101 participants finished the study . EXD significantly reduced the mean ( SD ) frequency of hot flushes from 5.8 ( 5.0 ) to 2.2 ( 3.0 ) in the treatment group and from 5.0 ( 3.8 ) to 2.4 ( 2.5 ) in the placebo group ( P = 0.04 ) . The mean ( SD ) hot flush score was also reduced from 19.6 ( 6.6 ) to 4.9 ( 7.8 ) in the treatment group and from 16.6 ( 5.4 ) to 7.0 ( 6.4 ) in the placebo group ( P = 0.02 ) . The superiority of EXD to placebo was also observed with greater improvement in the total scores for the MRS ( P = 0.03 ) and the Menopause-Specific Quality of Life question naire ( P < 0.01 ) . There were no differences in serum hormone levels between the EXD group and the placebo group . There were no serious adverse events , and the safety indices of whole blood counts , renal function , and liver function were within the normal range before and after treatment . CONCLUSIONS The Chinese herbal formula EXD is superior to placebo in reducing the frequency and severity of hot flushes and in improving menopausal symptoms in Hong Kong perimenopausal women . It is well tolerated , with no serious adverse events noted during the study period 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 BACKGROUND The decision to take hormone replacement therapy ( HRT ) is a choice many women encounter when entering menopause . The purpose of this study was to examine the choice to take HRT while participating in a lifestyle intervention to reduce cardiovascular risk through the menopause . METHODS The Women 's Healthy Lifestyle Project is a r and omized clinical trial design ed to examine whether a behavioral lifestyle intervention can decrease the expected rise in cardiovascular risk through the menopause . Participants ( N = 535 ) completed question naires and were interviewed regarding menopausal symptoms , menopausal status , hot flashes , and  HRT  use at baseline and 54 months . RESULTS The intervention was successful in preventing risk elevation through the 54-month visit . At the final visit , there was no difference between the intervention and control groups in the percentage who had become postmenopausal ( 32.9 % vs 35.0 % , respectively ) , there was no difference between control and intervention with  HRT  use , with 31.2 % reporting use of HRT , and there was no difference between groups with menopausal symptoms . The women started HRT an average of 6 months after they missed a period . Baseline risk factors did not predict HRT use at the 54-month visit . CONCLUSIONS A sizable number of women reported HRT use . The decision to use HRT was not influenced by the lifestyle intervention or their baseline cardiovascular risk , and these women started HRT very early in the peri- to postmenopause . Further , weight loss in the perimenopause did not affect menopausal symptoms 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 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
Evidence was insufficient to show whether exercise is an effective treatment for vasomotor menopausal symptoms .
One small study suggested that HT is more effective than exercise .
Evidence was insufficient to show the relative effectiveness of exercise when compared with HT or yoga
BACKGROUND Evidence suggests that many perimenopausal and early postmenopausal women will experience menopausal symptoms ; hot flushes are the most common .
Symptoms caused by fluctuating levels of oestrogen may be alleviated by hormone therapy ( HT ) , but a marked global decline in its use has result ed from concerns about the risks and benefits of HT .
Consequently , many women are seeking alternatives .
As large numbers of women are choosing not to take HT , it is increasingly important to identify evidence -based lifestyle modifications that have the potential to reduce vasomotor menopausal symptoms .
OBJECTIVES To examine the effectiveness of any type of exercise intervention in the management of vasomotor symptoms in symptomatic perimenopausal and postmenopausal women .