A randomized, placebo-controlled trial of the effects of physical exercises and estrogen therapy on health-related quality of life in postmenopausal women. Physical activity and mental health outcomes during menopause: a randomized controlled trial. Vasomotor symptoms and quality of life in previously sedentary postmenopausal women randomised to physical activity or estrogen therapy. Hormone therapy in menopausal women with cognitive complaints: a randomized, double-blind trial. Randomized trial of exercise therapy in women treated for breast cancer. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Yoga of Awareness program for menopausal symptoms in breast cancer survivors: results from a randomized trial. A pilot study of a supervised group exercise programme as a rehabilitation treatment for women with breast cancer receiving adjuvant treatment. The effects of hormone replacement therapy and resistance training on spine bone mineral density in early postmenopausal women.
The purpose of this study was to evaluate the isolated and associated effects of estrogen therapy (estradiol valerate 1 mg/d orally) and physical exercise (moderate aerobic exercise, 3 h/wk) on health-related quality of life (HRQOL) and menopausal symptoms among women who had undergone hysterectomy.
                A 6-month, randomized, double-blind, placebo-controlled clinical trial with 44 postmenopausal women who had undergone hysterectomy. The interventions were physical exercise and hormone therapy (n = 9), being sedentary and hormone therapy (n = 14), physical exercise and placebo (n = 11), and being sedentary and placebo (n = 10). HRQOL was assessed by a Brazilian standard version of the Medical Outcome Study Short-Form Health Survey and symptoms by Kupperman Index at baseline and after 6 months.
                There was a decrease in symptoms in all groups, but only groups who performed physical exercise showed an increase in quality of life. Analysis of variance showed that changes in physical functioning (P = 0.001) and bodily pain (P = 0.012) scores over the 6-month period differed significantly between women who exercised and women who were sedentary, regardless of hormone therapy. Hormone therapy had no effect, and there was also no significant association between physical exercise and hormone therapy in HRQOL.
                Physical exercises can reduce menopausal symptoms and enhance HRQOL, independent of whether hormone therapy is taken. Many women experience detriments in mental health during the menopausal transition. Physical activity may attenuate these adverse outcomes but few studies investigating such effects exist.
                This study examined the effects of a 4-month randomized controlled exercise trial on mental health outcomes in 164 previously low-active middle-aged women (M age = 49.9; SD = 3.6).
                Participants completed body composition and fitness assessment and a battery of psychological measures at the beginning and end of a 4-month randomized controlled exercise trial with three arms: walking, yoga, control. The results indicated that walking and yoga were effective in enhancing positive affect and menopause-related QOL and reducing negative affect. Women who experienced decreases in menopausal symptoms across the trial also experienced improvements in all positive mental health and QOL outcomes and reductions in negative mental health outcomes. Whether menopausal symptoms increased or decreased across the trial appeared to be determined in part by whether there were increases or decreases in cardiorespiratory fitness.
                Physical activity appears to enhance mood and menopause-related QOL during menopause, however, other aspects of mental health may be affected only as a result of reduction in menopausal symptoms. Increasing cardiorespiratory fitness could be one way to reduce menopausal symptoms. To assess if regular physical exercise or oral oestradiol therapy decreased vasomotor symptoms and increased quality of life in previously sedentary postmenopausal women.
                A prospective, randomised trial at a University Hospital.
                75 postmenopausal, sedentary women with vasomotor symptoms were randomised 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 validated questionnaires.
                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.
                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. To evaluate the effects of hormone therapy (HT) on cognition and subjective quality of life (QoL) in recently postmenopausal women with cognitive complaints.
                Cognitive Complaints in Early Menopause Trial (COGENT) was a randomized, double-blind, placebo-controlled, multicenter, pilot study of 180 healthy postmenopausal women aged 45 to 55 years, randomly assigned to receive either placebo or conjugated equine estrogen 0.625 mg/medroxyprogesterone acetate 2.5 mg for 4 months. Outcome measures included memory, subjective cognition, QoL, sexuality, and sleep, which were assessed at baseline and month 4.
                The study was terminated before the expected final sample size of 275 due to a decrease in enrollment coinciding with the publication of findings from the Women's Health Initiative. There were no differences between groups on any cognitive or QoL measures, except for an increase in sexual interest and thoughts with HT. Modest negative effects on short- and long-term verbal memory approached significance (p < 0.10). Women with baseline vasomotor symptoms (VMS) showed a decrease in VMS and an improvement in general QoL, but no cognitive benefit vs placebo.
                With the power to detect an effect size of >or=0.45, this study suggests potential modest negative effects on verbal memory that are consistent with previous hormone therapy trials in older women. To examine the effects of aerobic exercise therapy on quality of life (QoL) and associated outcomes in women treated for breast cancer. Evidence suggests that exercise may be beneficial, but no trial has included an exercise-placebo and a usual-care group to control for the attention effects that might be associated with aerobic exercise interventions in cancer patients.
                A total of 108 women who had been treated for breast cancer 12 to 36 months previously were randomly assigned to supervised aerobic exercise therapy (n = 34), exercise-placebo (body conditioning; n = 36), or usual care (n = 38). Exercise therapy and exercise-placebo sessions took place three times per week for 8 weeks. Outcomes included QoL, depression, exercise behavior, aerobic fitness; outcomes were assessed at baseline and at the 8- and 24-week follow-up.
                Analyses of covariance revealed a significant mean difference of 9.8 units in Functional Assessment of Cancer Therapy-General (primary outcome) favoring aerobic exercise therapy at 8 weeks, relative to usual care. Significant differences that favored aerobic exercise therapy relative to usual care were recorded for Functional Assessment of Cancer Therapy-Breast, social/family well-being, functional well-being, and breast cancer subscale scores at 8-week follow-up. Psychological health outcomes improved modestly for both intervention groups; these improvements were sustained for several end points.
                Exercise therapy had large, clinically meaningful, short-term beneficial effects on QoL in women treated for breast cancer; this finding cannot be attributable to attention, given that the exercise-placebo group did not report similar effects relative to usual care. Herbal supplements are widely used for vasomotor symptoms.
                To test the efficacy of 3 herbal regimens and hormone therapy for relief of vasomotor symptoms compared with placebo.
                1-year randomized, double-blind, placebo-controlled trial conducted from May 2001 to September 2004.
                Group Health, Washington State.
                351 women age 45 to 55 years with 2 or more vasomotor symptoms per day; 52% of the women were in menopausal transition and 48% were postmenopausal.
                Rate and intensity of vasomotor symptoms (1 = mild to 3 = severe), and Wiklund Vasomotor Symptom Subscale.
                1) Black cohosh, 160 mg daily; 2) multibotanical with black cohosh, 200 mg daily, and 9 other ingredients; 3) multibotanical plus dietary soy counseling; 4) conjugated equine estrogen, 0.625 mg daily, with or without medroxyprogesterone acetate, 2.5 mg daily; or 5) placebo.
                Vasomotor symptoms per day, symptom intensity, Wiklund Vasomotor Symptom Subscale score did not differ between the herbal interventions and placebo at 3, 6, or 12 months or for the average over all the follow-up time points (P > 0.05 for all comparisons) with 1 exception: At 12 months, symptom intensity was significantly worse with the multibotanical plus soy intervention than with placebo (P = 0.016). The difference in vasomotor symptoms per day between placebo and any of the herbal treatments at any time point was less than 1 symptom per day; for the average over all the follow-up time points, the difference was less than 0.55 symptom per day. The difference for hormone therapy versus placebo was -4.06 vasomotor symptoms per day for the average over all the follow-up time points (95% CI, -5.93 to -2.19 symptoms per day; P < 0.001).
                The trial did not simulate the whole-person approach used by naturopathic physicians. Differences between treatment groups smaller than 1.5 Vasomotor symptoms per day cannot be ruled out.
                Black cohosh used in isolation, or as part of a multibotanical regimen, shows little potential as an important therapy for relief of vasomotor symptoms. Clinical Trials Registration number: NCT00169299. Breast cancer survivors have limited options for the treatment of hot flashes and related symptoms. Further, therapies widely used to prevent recurrence in survivors, such as tamoxifen, tend to induce or exacerbate menopausal symptoms. The aim of this preliminary, randomized controlled trial was to evaluate the effects of a yoga intervention on menopausal symptoms in a sample of survivors of early-stage breast cancer (stages IA-IIB).
                Thirty-seven disease-free women experiencing hot flashes were randomized to the 8-week Yoga of Awareness program (gentle yoga poses, meditation, and breathing exercises) or to wait-list control. The primary outcome was daily reports of hot flashes collected at baseline, posttreatment, and 3 months after treatment via an interactive telephone system. Data were analyzed by intention to treat.
                At posttreatment, women who received the yoga program showed significantly greater improvements relative to the control condition in hot-flash frequency, severity, and total scores and in levels of joint pain, fatigue, sleep disturbance, symptom-related bother, and vigor. At 3 months follow-up, patients maintained their treatment gains in hot flashes, joint pain, fatigue, symptom-related bother, and vigor and showed additional significant gains in negative mood, relaxation, and acceptance.
                This pilot study provides promising support for the beneficial effects of a comprehensive yoga program for hot flashes and other menopausal symptoms in early-stage breast cancer survivors. This pilot study examined whether exercise as an adjunctive rehabilitation therapy could benefit women who have early stage breast cancer and are currently receiving chemotherapy/radiotherapy. The study was designed as a randomised controlled trial (RCT). Physical functioning, fatigue and Quality of Life (QoL) outcomes were evaluated pre and post a 12-week intervention. The results showed that after 12 weeks the women who participated in the exercise programme (n = 12) displayed significantly higher levels of physical functioning and reported higher QoL scores than the controls (n = 10). Changes in fatigue and satisfaction with life favoured the intervention group but did not reach significance. These results are encouraging and suggest that a structured group exercise programme during adjuvant treatment is a safe, well tolerated and effective way of providing physical and psychological health benefits to women during treatment for early stage breast cancer. Since this was a pilot study the numbers did not allow appropriately powered analyses of some variables of interest and favoured relatively young and socio-economically advantaged women. Future studies need to address these issues and determine if these short-term benefits can be sustained. This study evaluated the additive effects of hormone replacement therapy (HRT) and a 1-year site-specific resistance-training (RT) program involving two free weight exercises (i.e., squat and deadlift) 2 days/week as a strategy to reverse or attenuate bone loss at the lumbar spine in early postmenopausal women. Participants from a group of self-selected HRT or non-HRT (N=141) users were randomly assigned to RT (exercise) or no training, creating four groups: 1) non-HRT plus RT [NHRT plus exercise (n=35)]; 2) HRT plus RT [HRT plus exercise (n=37)]; 3) HRT no resistance training [HRT no exercise (n=35)]; or 4) control [non-HRT no resistance training group (n=34)]. Mean age and months past menopause did not differ between groups (52.1+/-3.0 years and 52.8+/-9.9 months, respectively). Post-menopausal status was confirmed by follicle-stimulating hormone levels > or =40 mIU/mL. Bone mineral density (BMD) of the spine was assessed by Dual Energy X-ray Absorptiometry (Hologic), at baseline and month 12. Data were analyzed using a 4 (experimental condition) x 2 (time) repeated measures multivariate analysis of variance to determine the effects of RT on HRT and non-HRT in early postmenopausal women. The main effects for group (P<0.007), time (P<0.001), and the group by time interaction (P<0.001) were each significant. Control participants experienced an average of -3.6% reduction of BMD at the spine. HRT treatment with no exercise showed bone loss of -0.66%. One year of RT produced increases in spine BMD of +0.43% and +0.70%, respectively for the NHRT plus exercise, and HRT plus exercise groups with no differences between the NHRT and HRT exercise groups. In conclusion, RT alone was as effective as HRT in preventing bone loss at the spine and was more effective than HRT alone in attenuating bone loss at the spine. Moreover, there was no additional benefit in combining HRT with RT for preventing bone loss at the spine in this group of early postmenopausal women.
The existing studies provided insufficient evidence to determine the effectiveness of exercise as a treatment for vasomotor menopausal symptoms, or whether exercise is more effective than HRT or yoga.