Effects of Chicory and Fumitory on Hot Flashes Among Breast Cancer Survivors: A Randomized, Double-Blind Placebo-Controlled Trial.

Objectives: Hot flashes are unpleasant long-term complications of breast cancer. This study aimed to evaluate the effects of a traditional Persian medicine containing extracts of Cichorium intybus L. (chicory) and Fumaria parviflora L. (Fumitory) extract syrup (CFS) compared with placebo when used as intended. Design: Randomized, double-blind, placebo-controlled clinical trial. Setting/Location: The Oncology Ward of Shahid Modarres Hospital (Tehran, Iran). Subjects: Breast cancer survivors undergoing hormone deprivation therapy. Interventions: Patients were randomly allocated to receive 5 mL CFS or placebo syrup three times a day, for 4 weeks. Outcome measures: The co-primary outcomes were self-reported daily hot flashes frequency and severity scores assessed using self-reported daily dairies, including 1 week of baseline data. Results: Of the 148 patients screened, 137 were eligible, and 96 were randomly allocated to receive either CFS (n = 48) or placebo (n = 48). All participants who returned their dairies were compliant and analyzed as randomized in the a priori per-protocol analysis. After 4 weeks of treatment, both the mean daily hot flashes frequency and severity score had reduced by 57% in the CFS group and 10% in the placebo group. The overall weekly mean daily hot flashes frequency (effect size ηp2 0.221, p < 0.001, n = 66) and severity scores (effect size ηp2 0.160, p = 0.001, n = 66) were significantly lower in the CFS group compared with the placebo group (one-within one-between repeated-measures analysis of variance adjusted for baseline). CFS was well tolerated, with similar proportions of serious and nonserious adverse events occurring in both groups. Conclusions: This is the first study to report the effects of chicory or fumitory for the treatment of hot flashes. The findings provide preliminary evidence that CFS can improve hot flashes in breast cancer survivors undergoing hormone deprivation therapy. More research is warranted to confirm its effectiveness, safety, and mechanisms of action. Clinical Trial Registration: IRCT20210226050506N1.

Self-Hypnosis for Sleep Disturbances in Menopausal Women.

Poor sleep is one of the most frequent health concerns among menopausal women. All stages of sleep can be impacted by the menopause transition. Negative outcomes of poor sleep are multidimensional and include poor physical, psychological, cognition, and social outcomes. Hypnosis is a nonpharmacological treatment for poor sleep and hot flashes in menopausal women. The goal of hypnosis is to educate and train subjects to perform self-hypnosis to alleviate the underlying symptom. The use of hypnosis as a treatment for poor sleep has shown benefits for both acute and chronic insomnia. Initial findings from the National Center for Complementary and Integrative Health (NCCIH) Hypnosis Intervention for Sleep in Menopause: Examination of Optimal Dose and Method of Delivery randomized control trial of 90 women were presented. Results showed that program and treatment satisfaction were high in all groups, adherence to daily practice met or exceeded adherence benchmarks. There were significant reduction of poor sleep quality in all groups with a significant increase in minutes slept in all groups. The majority of women also showed clinical improvements of duration. There were clinically meaningful improvements in reducing the perception of poor sleep quality in 50%-77% of women across time. Overall, the use of self-hypnosis as a treatment program for sleep problems related to menopause was acceptable for women. Data further support that hypnosis is a promising technique to improve sleep in menopausal women with sleep and hot flashes. Further research is ongoing on self-hypnosis delivery and implementation into wider populations of women using clear definition and control groups.

Acupuncture for the relief of hot flashes in breast cancer patients: A systematic review and meta-analysis of randomized controlled trials and observational studies.

OBJECTIVE: To critically assess the effectiveness and safety of acupuncture for treating hot flashes (HFs) among breast cancer (BC) patients, and to get much more highly compelling evidence then to guide clinical practice. METHODS: Comprehensive systematic literature searches were carried out for identifying randomized controlled trials and observational studies (OSs) published before January 2015. The meta-analysis (MA) was performed by Review Manager 5 software if data could be merged routinely, if not descriptions would be given. RESULTS: A total of 18 studies were eligible ultimately. With respect to HFs frequency, the MA during treatment showed a significant difference (MD = -1.78, 95% confidence intervals [95% CIs]: -3.42--0.14), but no statistical differences were observed when posttreatment or follow-up period. While electroacupuncture versus applied relaxation, they both helped to promote HFs markedly but did not reveal statistically significance between them. Referring to Kupperman's index, all the treatment brought out great assistance when compared with baseline conditions, and there was significant difference between real acupuncture sham acupuncture (posttreatment: MD = -4.40, 95% CI: -6.77--2.03; follow-up: MD = -4.30, 95% CI: -6.52--2.08). In terms of OS, 7 prospective single arm studies focused on exploring the efficacy of traditional acupuncture, and all revealed moderate or great benefit for BC patients suffering from HFs. CONCLUSIONS: Acupuncture still appeared to be an efficacious therapeutic strategy, especially for the less/no side effects. Because of its widespread acceptance and encouraging effectiveness for improving HFs, much more high-quality studies are in need urgently.

Effect of soy lecithin on fatigue and menopausal symptoms in middle-aged women: a randomized, double-blind, placebo-controlled study.

BACKGROUND: Lecithin is a complex mixture of phospholipids which compose lipid bilayer cell membranes. Lipid replacement therapy, or administration of phospholipids for the purpose of repairing the dmaged cell membranes, had been shown to alleviate fatigue. The present study aimed to investigate the effect of soy lecithin on fatigue in middle-aged women, as well as other menopausal symptoms and various health parameters. METHODS: This randomized, double-blind, placebo-controlled study included 96 women aged 40 to 60 years who complained of fatigue. The participants were randomized to receive active tablets containing high-dose (1200 mg/day; n = 32) or low-dose (600 mg/day; n = 32) soy lecithin, or placebo (n = 32), for 8 weeks. The following parameters were evaluated: age, menopausal status, lifestyle factors, physical and psychological symptoms of menopause, subjective symptoms of insomnia and fatigue, body composition, cardiovascular parameters, and physical activities and objective sleep states obtained from actigraphy before and 4 and 8 weeks after treatment. Fatigue was evaluated using the Profile of Mood States (POMS)-brief, Menopausal Health-Related Quality of Life questionnaire, Chalder Fatigue Scale, and Brief Fatigue Inventory. RESULTS: Eighty-nine women completed the study. There were no significant differences in the changes in Chalder Fatigue Scale score (placebo vs low-dose vs high-dose groups: -2.9 ± 1.1, -3.2 ± 1.1, and -3.5 ± 1.0; P = 0.79). On the other hand, the improvements were greater in the high-dose group compared with the placebo group concerning vigor scores in the POMS-brief (1.9 ± 0.7 vs 0.2 ± 0.6; P = 0.02), diastolic blood pressure (-4.1 ± 1.8 vs 1.2 ± 1.9; P = 0.05), and cardio-ankle vascular index (-0.4 ± 0.2 vs 0.07 ± 0.1; P = 0.03) after 8 weeks of treatment. CONCLUSIONS: High-dose (1200 mg/day) soy lecithin not only increases vigor, but also lowers the diastolic blood pressure and cardio-ankle vascular index in middle-aged women who present with fatigue. TRIAL REGISTRATION: UMIN-CTR UMIN000017127 .

Severe menopausal symptoms associated with reduced adherence to antiretroviral therapy among perimenopausal and menopausal women living with HIV in Metro Vancouver.

OBJECTIVES: Although more women living with HIV (WLWH) are entering midlife, the experiences of perimenopausal and menopausal WLWH, including the effects of menopausal symptoms severity, remain understudied. This study longitudinally investigated the correlates of antiretroviral therapy (ART) adherence among perimenopausal and menopausal WLWH from Metro Vancouver. METHODS: Analyses drew on longitudinal data (2014-2017) from Sexual health and HIV/AIDS: Women's Longitudinal Needs Assessment, an ongoing community-based cohort of WLWH, aged 14+, from Metro Vancouver, Canada. At baseline and biannually, participants completed an interviewer-administered questionnaire. Bivariate and multivariable logistic regression with generalized estimating equations were used to identify the correlates of self-reported <95% ART adherence. RESULTS: The sample included 109 perimenopausal and menopausal WLWH (233 observations), with a median age of 49 years (IQR 44-53). Whereas most (68.8%) participants experienced menopausal symptoms, only 17% had received treatment (eg, antidepressants, hormone therapy) at baseline. In multivariable analysis, severe menopausal symptoms (adjusted odds ratio [AOR] 1.03, 95% confidence interval [CI] 1.00-1.06), injection drug use (AOR 2.86, 95% CI 1.44-5.55), and physical/sexual violence (AOR 2.33, 95% CI 1.02-5.26) independently and positively correlated with <95% adherence. CONCLUSIONS: These findings suggest that menopausal symptoms may undermine ART adherence, with overlapping vulnerabilities such as injection drug use and sexual/physical violence further exacerbating poor ART adherence. Women-centred, trauma-informed care approaches to detect menopause and treat menopausal symptoms are urgently needed. Such approaches should holistically address the intersecting barriers to adherence and link WLWH to peripheral health and social services, including trauma counseling and evidence-based harm reduction services.

Effects of Yoga and Aerobic Exercise on Actigraphic Sleep Parameters in Menopausal Women with Hot Flashes.

STUDY OBJECTIVES: To determine effects of yoga and aerobic exercise compared with usual activity on objective assessments of sleep in midlife women. METHODS: Secondary analyses of a randomized controlled trial in the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) network conducted among 186 late transition and postmenopausal women aged 40-62 y with hot flashes. Women were randomized to 12 w of yoga, supervised aerobic exercise, or usual activity. The mean and coefficient of variation (CV) of change in actigraph sleep measures from each intervention group were compared to the usual activity group using linear regression models. RESULTS: Baseline values of the primary sleep measures for the entire sample were mean total sleep time (TST) = 407.5 ± 56.7 min; mean wake after sleep onset (WASO) = 54.6 ± 21.8 min; mean CV for WASO = 37.7 ± 18.7 and mean CV for number of long awakenings > 5 min = 81.5 ± 46.9. Changes in the actigraphic sleep outcomes from baseline to weeks 11-12 were small, and none differed between groups. In an exploratory analysis, women with baseline Pittsburgh Sleep Quality Index higher than 8 had significantly reduced TST-CV following yoga compared with usual activity. CONCLUSIONS: This study adds to the currently scant literature on objective sleep outcomes from yoga and aerobic exercise interventions for this population. Although small effects on self-reported sleep quality were previously reported, the interventions had no statistically significant effects on actigraph measures, except for potentially improved sleep stability with yoga in women with poor self-reported sleep quality.

[PHYTOESTROGENS: MECHANISMS OF CORRECTION OF CARDIOVASCULAR COMPLICATIONS OF CLIMACTERIC SYNDROME.]

The pharmacodynamics of phytoestrogens representing nonsteroidal compounds of plant origin with variable affinity to estrogen receptor subtypes has been studied. Clinical and experimental data on the mechanisms of action of phytoestrogens of the isoflavone and lignan classes are presented and their effects ca- pable of reducing the risk of cardiovascular disease development in women with climacteric syndrome and in experimental hypoestrogenemia are considered.

Comparative effectiveness of electro-acupuncture versus gabapentin for sleep disturbances in breast cancer survivors with hot flashes: a randomized trial.

OBJECTIVE: Sleep disturbance is a major consequence of hot flashes among breast cancer survivors. This study evaluated the effects of electro-acupuncture (EA) versus gabapentin (GP) for sleep disturbances among breast cancer survivors experiencing daily hot flashes. METHODS: We analyzed data from a randomized controlled trial involving 58 breast cancer survivors experiencing bothersome hot flashes at least two times per day. Participants were randomly assigned to receive 8 weeks of EA or daily GP (total dose of 900 mg/d). The primary outcome was change in the total Pittsburgh Sleep Quality Index (PSQI) score between groups at week 8. Secondary outcomes include specific PSQI domains. RESULTS: By the end of treatment at week 8, the mean reduction in PSQI total score was significantly greater in the EA group than the GP group (-2.6 vs -0.8, P = 0.044). The EA also had improved sleep latency (-0.5 vs 0.1, P = 0.041) and sleep efficiency (-0.6 vs 0.0, P = 0.05) compared with the GP group. By week 8, the EA group had improved sleep duration, less sleep disturbance, shorter sleep latency, decreased daytime dysfunction, improved sleep efficiency, and better sleep quality (P < 0.05 for all) compared with baseline, whereas the GP group improved in duration and sleep quality only (P < 0.05). CONCLUSIONS: Among women experiencing hot flashes, the effects of EA are comparable with GP for improving sleep quality, specifically in the areas of sleep latency and efficiency. Larger randomized controlled trials with longer follow-ups are needed to confirm this preliminary finding.

Acupuncture for Menopausal Hot Flashes: A Randomized Trial.

BACKGROUND: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting. OBJECTIVE: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs. DESIGN: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954). SETTING: Community in Australia. PARTICIPANTS: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. INTERVENTIONS: 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture. MEASUREMENTS: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models. RESULTS: 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, -1.87 to 2.52]; P = 0.77). No serious adverse events were reported. LIMITATION: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause. CONCLUSION: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs. PRIMARY FUNDING SOURCE: National Health and Medical Research Council.

Effects of isoflavones and amino acid therapies for hot flashes and co-occurring symptoms during the menopausal transition and early postmenopause: a systematic review.

AIMS: Review controlled clinical trials of isoflavones and amino acid preparation effects on hot flashes and at least one other symptom including mood, sleep, pain, and cognitive function that women report during the menopausal transition and early postmenopause. METHODS: An experienced reference librarian searched PubMed/Medline, CINAHL Plus, PsycInfo, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Web of Science, EMBASE, AMED, and Alt-Health Watch for English-language randomized controlled trials between 2004 and July 2011. Seventeen trials of isoflavones and amino acid effects on hot flashes and one additional symptom were identified. RESULTS: In five trials of soy isoflavone preparations, two (6g soy germ extract and 25 g soy protein in soy nuts) significantly decreased hot flashes, but no other symptoms. In the seven trials of other isoflavones, six significantly reduced hot flashes; in addition, red clover (80 mg) significantly reduced mood symptoms; Rexflavone (350 mg) for women with Kupperman Index>20 significantly reduced sleep symptoms; two trials had significant reductions for pain: isoflavone powder (90 mg) and red clover (80 mg). The only trial in this systematic review that significantly reduced cognitive symptoms was red clover (80 mg). In one trial, red clover isoflavone (80 mg/day) significantly relieved hot flashes, mood, pain, and cognitive symptoms. Amino acids yielded no significant results. Equol supplements of 30 mg/day for non-Equol producing women significantly reduced mood symptoms in one trial. The magnolia bark extract combination significantly reduced hot flashes, mood, and sleep symptoms. CONCLUSIONS: Isoflavone trials yielded significant reductions on hot flashes and co-occurring symptoms during the menopausal transition and postmenopause, but studies require replication with larger sample sizes and attention to measurement of outcomes.

Chiropractic intervention in the treatment of postmenopausal climacteric symptoms and insomnia: A review.

INTRODUCTION: Insomnia is a frequent postmenopausal symptom and may be due to hormonal changes, depressive states related to this period of life, hot flashes or nocturia. Chiropractic care has been demonstrated to be effective in the treatment of these symptoms. OBJECTIVES: The aim of this study was to review chiropractic interventions in postmenopausal women as a possible management approach to menopausal symptoms and insomnia. METHODS: A PubMed search was conducted by cross-referencing the key words insomnia, sleep, and menopause with chiropractic. The search used an end date of January 2014 and retrieved 17 articles. RESULTS: Three articles were eligible for the study. All epidemiological data from large surveys demonstrated a lack of evidence for chiropractic intervention as a complementary and alternative therapeutic method in the management of menopausal symptoms and insomnia. CONCLUSIONS: There is no evidence for the effectiveness of chiropractic intervention as a complementary and alternative therapy for menopausal symptoms and insomnia. Further studies with proper methodological designs are warranted.

Black cohosh and breast cancer: a systematic review.

BACKGROUND: Many women use black cohosh as a natural treatment for menopausal symptoms. However, controversy exists around safety in breast cancer, because of its purported estrogenic activity. We conducted a systematic review of black cohosh use in women with or at risk of breast cancer. METHODS: We searched MEDLINE, Embase, the Cochrane Library, and AMED from inception to July 2012 and October 2012 for human interventional or observational data pertaining to the safety and efficacy of black cohosh in patients with or at risk of breast cancer, including an assessment of the effect of black cohosh on estrogen responsive tissues. RESULTS: Of 450 records, we included 26 articles: 14 randomized controlled trials, 7 uncontrolled trials, and 5 observational studies.The evidence on efficacy for ho t flashes is divided, with some benefits seen when compared with baseline, but not when compared with placebo. Two observational studies found no association between black cohosh and risk of breast cancer, whereas 2 studies reported significant reductions in risk of primary breast cancer among postmenopausal women (adjusted odds ratio = 0.47, 95% confidence interval = 0.27-0.82), and risk of recurrence (adjusted hazard ratio = 0.75, 95% confidence interval = 0.63-0.89). Seventeen trials showed no significant impact on circulating hormone levels or proliferation in estrogen responsive tissues. CONCLUSIONS: Current evidence does not support an association between black cohosh and increased risk of breast cancer. There is a lack of evidence supporting the efficacy of black cohosh for reduction of hot flashes in breast cancer patients. Given conflicting but promising results, and apparent safety, further research is warranted.

Menopausal age, related factors and climacteric symptoms in Libyan women.

OBJECTIVE: Studies of the menopause have received much attention recently as fluctuating hormone levels are known to influence a woman's mood and well-being. The present study aimed to evaluate the onset of natural menopause in Libyan women together with the prevalence of postmenopause-related symptoms experienced. METHOD: A cross-sectional survey was conducted in Tripoli city, from October 2008 to June 2009; 91 women were recruited from urban and rural areas. Data were collected using a structured questionnaire and included a number of lifestyle variables. RESULTS: The mean age of participants was 53 years, and the median age at menopause for postmenopausal women was 47 years. Out of 20 possible symptoms, the mean number of symptoms was 8.36. The most frequent symptoms were hot flushes and aching in muscles and joints (74.4%). Increasing level of education was positively associated with more symptoms, and increased tea or coffee consumption resulted in fewer symptoms. Of the total subjects, 8.1% reported no symptoms. In the four domains, 87.2% reported physical symptoms, 83.7% reported psychosocial symptoms, 76.6% reported vasomotor symptoms and 48.8% reported sexual symptoms. Our data showed that the most common disease associated with the frequency of menopausal symptoms was osteoarthritis, followed by hypertension, heart diseases and diabetes mellitus. CONCLUSION: The age of menopause in Libyan women, as in other developing countries, is less than the median age reported for Western women. The menopausal women experienced various symptoms and morbidities as part of a normal life stage, and their quality of life was negatively affected by these symptoms.

Acupuncture relieves menopausal discomfort in breast cancer patients: a prospective, double blinded, randomized study.

BACKGROUND: This study evaluates the effect of acupuncture on hot flashes and disturbed night sleep in patients treated for breast cancer. The effect of acupuncture was tested against a sham-acupuncture group and a no-treatment control group. Plasma estradiol was measured to rule out this as cause of effect. Side effects of the treatment were registered. METHODS: We randomized 94 women into the study: 31 had acupuncture, 29 had sham acupuncture and 34 had no treatment. FINDINGS: In the acupuncture group, 16 patients (52%) experienced a significant effect on hot flashes compared with seven patients (24%) in the sham group (p < 0.05). The effect came after the second acupuncture session and lasted for at least 12 weeks after last treatment. A statistically significant positive effect was seen on sleep in the acupuncture group compared with the sham-acupuncture and no-treatment groups. The effect was not correlated with increased levels of plasma estradiol. No side effects of acupuncture were registered. INTERPRETATION: We find that acupuncture significantly relieves hot flashes and sleep disturbances and is a good and safe treatment in women treated for breast cancer.

Effect of therapeutic massage on insomnia and climacteric symptoms in postmenopausal women.

INTRODUCTION: Physiological and psychological alterations in the climacteric period frequently influence women's quality of life. Hot flushes, nocturia, mood alterations, respiratory disturbances, insomnia and restless leg syndrome all affect sleep, and the altered hormonal state in this period impacts the aging process. As hormonal therapy is not indicated in some cases, the search for complementary therapies, such as massage therapy, to improve insomnia in the climacteric period is increasing. OBJECTIVE: To evaluate the effect of therapeutic massage on insomnia and climacteric symptoms in postmenopausal women. METHODS: Forty-four volunteers were randomly distributed into three groups: therapeutic massage (TM), passive movement (PM) and control (CTL). The women received 32 therapeutic massage sessions and passive movement twice a week. Questionnaires were given in the pre-trial and the 16th and 32nd sessions. The Insomnia Severity Index (ISI), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Menopause Quality of Life questionnaire (MENQOL), Kupperman Menopausal Index and Lipp Symptoms of Stress Inventory were assessed. In addition, the women underwent polysomnography at baseline and post-treatment. Statistical analyses were calculated using Friedman and Wilcoxon non-parametric tests. The level of significance was fixed at p ≤ 0.05. RESULTS: There was an improvement in ISI in the TM group (p = 0.000) and in the PM group (p = 0.001). A decrease in the BDI occurred in the TM group (p = 0.004), and the MENQOL improved in the TM group (p = 0.015). Furthermore, there were no significant differences in polysomnography parameters in the TM group, with only an increase in minimal saturation (p = 0.053). CONCLUSION: The TM group exhibited improved subjective data considering the changes in symptoms according to the ISI and the MENQOL and a decrease in symptoms according to the BDI.

Factors relating to insomnia during the menopausal transition as evaluated by the Insomnia Severity Index.

BACKGROUND: Although the menopause associates to poor sleep quality, insomnia severity data in the menopausal transition is scarce or lacking. OBJECTIVE: To assess insomnia prevalence, severity and related factors in mid-aged women. METHODS: In this cross-sectional study 340 women (40 to 59 years) completed the Insomnia Severity Index (ISI) and a general questionnaire containing personal/partner data. Hot flush presence and intensity was also assessed with the Menopause Rating Scale (MRS). RESULTS: Median age of the sample was 48.0 years, with 63.5% having lower education and 52.9% being postmenopausal. At the moment of the survey 7.1% were on hormone therapy, 8.2% on phytoestrogens and 2.1% on psychotropic drugs. A 63.8% were abdominally obese (waist circumference > 88 cm) and 65.5% sedentary. According to item 1 of the MRS, 60.9% presented hot flushes, graded in 17.4% as severe-very severe. Regarding the partner (n=255), erectile dysfunction was present in 23.9%, premature ejaculation 37.6%, 35.3% abused alcohol and 42.4% were faithful. The ISI tool displayed a high internal consistency (alpha Cronbach coefficient=0.87), identifying 41.5% of women with some degree of insomnia (Total ISI score ≥8) further categorized as sub-threshold or mild (32.0%), moderate (7.4%) and severe (2.1%). Multiple linear regression analysis obtained two best fit models predicting total ISI scores, one not including and one including partner data. In the first model, hot flush severity, psychotropic use and sedentarism displayed significant positive correlations with total ISI scores. In the second, hot flush intensity, psychotropic drug use and male erectile dysfunction positively correlated whereas partner faithfulness inversely with ISI scores. CONCLUSION: In this mid-aged series insomnia severity was related to female and partner factors; several of which are susceptible of intervention.

Non-hormonal treatment strategies for vasomotor symptoms: a critical review.

Hot flashes (or flushes) are the most commonly reported symptoms during the menopause transition and early postmenopausal years, particularly in Western societies; they affect 60-90% of women and can lead to significant physical discomfort and functional impairment. The emergence of hot flashes and night sweats (also known as vasomotor symptoms [VMS]) coincide with a period in life that is also marked by dynamic changes in hormone and reproductive function that interconnect with the aging process, changes in metabolism, lifestyle behaviours and overall health. Estrogen-based therapies have long been the treatment of choice for women suffering from VMS. More recent concerns over long-term safety of menopausal hormone treatments, however, have led physicians and patients to pursue non-hormonal strategies to alleviate their symptoms. In this article, we review most of the efficacy and safety data on non-hormonal treatments for VMS published over the past 20 years. We discuss the evidence for treating symptomatic women in different clinical scenarios, e.g. VMS with and without concomitant depression or VMS following the use of anti-estrogen therapies. Overall, efficacy data support the use of some psychotropic medications, including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors and gabapentin. Complementary and alternative methods for VMS also showed limited but promising results, although more definitive studies are warranted. Clinicians should therefore be able to tailor treatment strategies for those who are unable or unwilling to use hormones to alleviate VMS and improve overall functioning and quality of life.

Acupuncture for hot flashes in postmenopausal hemodialysis-dependent women: two case reports.

OBJECTIVE: This study aimed to observe the effects of acupuncture for hot flashes in postmenopausal hemodialysis-dependent women. METHODS: Two postmenopausal hemodialysis-dependent women were treated with individualized manual acupuncture for 1 and 3 months to reduce the occurrence of hot flashes and were observed through 7 and 11 months, respectively, from baseline. RESULTS: Hot flashes were significantly improved after acupuncture treatment in both of the patients, and the effects persisted through the final observation period (hot flash scores decreased from 57 to 33 and 22 at 1 and 11 months from baseline in patient 1, and from 14 to 6 and zero at 1 and 7 months from baseline in patient 2). The beneficial effects of acupuncture on quality of life were partially observed in these 2 patients. No acupuncture-related serious adverse events occurred during the study. CONCLUSIONS: Further controlled studies need to be conducted among larger samples to determine whether acupuncture is an effective and safe treatment for hot flashes in postmenopausal hemodialysis-dependent women.

Assessment of the clinical effect of Chinese medicine therapy combined with psychological intervention for treatment of patients of peri-menopausal syndrome complicated with hyperlipidemia.

OBJECTIVE: To observe the effect of Chinese medicine therapy combined with psychological intervention (combined therapy) on the clinical symptoms and levels of blood lipids and sex hormones of patients of peri-menopausal syndrome complicated with hyperlipidemia. METHODS: With the use of a randomizing digital table method, 185 patients that fit the registration standard were randomly assigned to three groups. The 59 cases in Group A were treated with two Chinese patents, Kunbao Pill and Modified Xiaoyao Pill; the 63 in Group B received psychological intervention alone; and the 63 in Group C were treated with both (the combined therapy), with the treatment course for all six months. The items of observation included: (1) scoring by SCL-90 on eight factors and seven symptoms; (2) scoring on Chinese medicine symptoms by Kupermann scale, including anxiety and bad temper, scorching sense action with sweating, dizziness, tinnitus, soreness and weakness of the loin and knees, palpitation, insomnia, lassitude, weakness, and hyposexuality; (3) blood contents of total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), apoprotein AI (ApoAI) and B (ApoB); (4) levels of sex hormones, including estradiol (E(2)), progesterone (P), pituitary prolactin (PRL), follicular stimulating hormone (FSH), and), luteinzing hormone (LH) in some randomly selected patients; (5) adverse reaction; and (6) one-year follow-up study on long-term effect. RESULTS: A total of 21 patients (6, 8, and 7 cases in Groups A, B, and C, respectively) dropped out; the drop-out rate was insignificant among groups. (1) The markedly effective rates in Group A, B, and C were 26.42% (14/53), 18.18% (10/55), and 53.57% (30/56), respectively, and the total effective rates in them were 64.15% (34/53), 50.91% (28/55), and 87.50% (49/56), respectively, suggesting the therapeutic efficacy in Group C was significantly better than that in Groups A and B (P<0.01). (2) SCL-90 scoring showed that the total scores decreased significantly after treatment in Group C (P<0.01), but remained unchanged in Groups A and B (P>0.05). (3) Scoring on Chinese medicine symptoms showed the same results as shown by SCL-90 scoring in terms of total scores and individual symptoms, except that menstrual disorder and amenorrhea were unchanged in all three groups (P>0.05). (4) Levels of HDL-C, ApoAI, and E(2) increased and those of TG, TC, LDL-C, ApoB, FSH, and LH decreased after treatment in Group C, reaching near normal levels; similar trends of blood lipids were shown in Group A, but the level of sex hormones was unchanged. In Group B all the above-mentioned indices were unchanged (P>0.05). (5) A one-year follow-up study showed the markedly effective rate and the total effective rate in Group C were higher than those in the other two groups respectively (P<0.01). (6) No adverse reaction was found. CONCLUSION: Chinese medicine therapy combined with psychological intervention could not only improve the nervous symptoms, but also regulate the blood levels of lipids and sex hormones in patients of peri-menopausal syndrome complicated with hyperlipidemia.

Safety of herbal medicinal products in women with breast cancer.

OBJECTIVE: To review and summarise current evidence on the efficacy and safety of herbal medicinal products for the relief of hot flushes in women with previous breast cancer. METHODS: A literature search was conducted in the databases of Medline, EMBASE, The Cochrane Central Register of Controlled Trials (CENTRAL), PSYCHINFO, AMED (Allied and Complementary Medicine), NCCAM (The National Centre for Complementary and Alternative Medicine). RESULTS: Black cohosh and phytoestrogens have received the most research attention but there is currently insufficient evidence to recommend either for relief of flushes. Black cohosh use appears safe in women with previous breast cancer. Opposing advice has been given regarding the safety of dietary phytoestrogen use for women with previous breast cancer, but there is emerging data that soyfood phytoestrogen intake may have a beneficial effect on tumour recurrence. CONCLUSIONS: The majority of studies, regarding the efficacy of herbal treatments for hot flushes, have not been conducted in women with breast cancer and many are of short duration. Increased pharmacovigilance practices for herbal medicines are required with initiatives to stimulate reporting of suspected adverse reactions.