Evaluation of Clinical Meaningfulness of Red Clover (Trifolium pratense L.) Extract to Relieve Hot Flushes and Menopausal Symptoms in Peri- and Post-Menopausal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

The meta-analysis presented in this article covered the efficacy of red clover isoflavones in relieving hot flushes and menopausal symptoms in perimenopausal and postmenopausal women. Studies were identified by MEDLINE (PubMed), Embase, and the Cochrane Library searches. The quality of the studies was evaluated according to Cochrane criteria. A meta-analysis of eight trials (ten comparisons) demonstrated a statistically significant reduction in the daily incidence of hot flushes in women receiving red clover compared to those receiving placebo: weighted mean difference (WMD-weighted mean difference) -1.73 hot flushes per day, 95% CI (confidence interval) -3.28 to -0.18; p = 0.0292. Due to 87.34% homogeneity, the performed analysis showed substantive difference in comparisons of postmenopausal women with ≥5 hot flushes per day, when the follow-up period was 12 weeks, with an isoflavone dose of ≥80 mg/day, and when the formulations contained a higher proportion of biochanin A. The meta-analysis of included studies assessing the effect of red clover isoflavone extract on menopausal symptoms showed a statistically moderate relationship with the reduction in the daily frequency of hot flushes. However, further well-designed studies are required to confirm the present findings and to finally determine the effects of red clover on the relief of flushing episodes.

Sustained effects of a brief and standardised acupuncture approach on menopausal symptoms: post hoc analysis of the ACOM randomised controlled trial.

BACKGROUND: Our objective was to investigate whether the effect of a brief and standardised acupuncture approach persists after the end of the acupuncture treatment (post-treatment effect) and whether the anticipation of future acupuncture treatment affects menopausal symptoms (pre-treatment effect). METHOD: This study is a post hoc analysis of data from a randomised controlled trial where women with moderate to severe menopausal symptoms were offered weekly acupuncture treatment over five consecutive weeks and randomised (1:1) to an early intervention group that received treatment immediately and a late intervention group with a 6-week delay. The acupuncture style was Western medical, administered at CV3, CV4 and bilateral LR8, SP6 and SP9. Acupuncturists were general practitioners. The effect was evaluated repeatedly during and after the interventions using scales from the validated MenoScores Questionnaire (MSQ) for hot flushes (HF), day and night sweats (DNS), general sweating (GS) and menopausal-specific sleeping problems (MSSP) with a 26-week follow-up period (corresponding to 21 or 15 weeks post-treatment for the early and late intervention groups, respectively). Multivariable linear mixed models were used to analyse the extent and duration of effects. RESULTS: Seventy participants were included in the study. Four participants dropped out. Furthermore, one participant was excluded from the short- and long-term follow-up analyses after the insertion of a hormonal intrauterine device, and nine participants were excluded from the long-term follow-up analysis due to the initiation of co-interventions. For each of the four outcomes, the effect was sustained up to 21 weeks post-treatment with an effect size that was only slightly diminished. A small, but significant, pre-treatment effect was observed in the HF scale scores. The same trend, although not significant, was observed in the DNS and MSSP scale scores. No serious harms were reported. CONCLUSION: This study demonstrated that the overall effect of a brief and standardised acupuncture treatment on menopause-relevant outcomes was sustained up to 21 weeks post-treatment and that there was a small pre-treatment effect.

Association between hot flashes severity and oxidative stress among Mexican postmenopausal women: A cross-sectional study.

OBJECTIVE: To assess the association between hot flashes (HFs) severity and oxidative stress (OS) in Mexican postmenopausal women. METHODS: A cross-sectional study was carried out with perimenopausal women aged 40-59 years community-dwelling from Mexico City, Mexico. They participated in Menopause and Oxidative Stress Project. The baseline sample consisted of 476 women recruited to participate; 161 women were excluded due to different reasons. Hence, 315 women were selected to establish two groups, a) 145 premenopausal women (yet with menstrual bleeding), and b) 170 postmenopausal women (without menses). All women were free of cardiovascular, kidney, hepatic or cancer disease, and without antioxidant supplement intake for at least six months prior to the beginning of the study; none had previously received hormone therapy. As OS markers, we measured plasma malondialdehyde using the TBARS assay, erythrocyte superoxide dismutase (SOD) and glutathione peroxidase (GPx), uric acid, and total antioxidant status; also, we calculated SOD/GPx ratio, antioxidant gap and an oxidative stress score ranging from 0 to 7. The HFs were evaluated using the Menopause Rating Scale. The women completed Spanish version of the Athens Insomnia Scale, Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale and a questionnaire of pro-oxidant factors. RESULTS: Stress score increased with HFs severity (mild 2.7±0.17, moderate 2.9±0.20 and severe 3.7±0.20, p = 0.001) in postmenopausal women. We observed a positive correlation between HFs severity and stress score, r = 0.247 (p = 0.001) in postmenopausal women; other test scores were not correlated. Severe HFs were a risk factor for OS (OR = 5.12, 95%CI: 1.99-13.17, p<0.05) in an adjusted multivariate analysis by different postmenopausal symptoms and pro-oxidant factors; we did not see any association in premenopausal women. CONCLUSION: Our findings suggest an association between HFs severity and OS in Mexican postmenopausal women.

To evaluate the efficacy and safety of PLC in perimenopausal or postmenopausal women with Hot Flashes: study protocol for a randomized controlled trial.

BACKGROUND: Hot flashes are the most frequent symptoms of the menopause, with 10-20% of all postmenopausal women reporting nearly intolerable occurrences. Although pharmacopuncture with hominis placenta extract is one of the new acupuncture therapies popular in East Asian medicine with a known efficacy in treating facial flushing, there has been little research on the efficacy and safety of this extract. This study, therefore, aims to evaluate the efficacy and safety of pharmacopuncture with hominis placenta extract (PLC) compared to injections of normal saline, in perimenopausal and postmenopausal women in Korea. METHODS/DESIGN: This study is a randomized placebo-controlled single-blind multi-center parallel-design trial. In total, 128 perimenopausal or postmenopausal women who meet the inclusion criteria will be recruited. The treatment group will receive PLC pharmacopuncture twice a week, for a total of 18 sessions over 9 weeks. The control group will receive injections of normal saline at the same acupoints during the same period. The post-treatment follow-up assessment will occur 4 weeks after the participant has completed the treatment. DISCUSSION: We believe that this trial will provide evidence for the efficacy and safety of PLC pharmacopuncture as a treatment for hot flashes in perimenopausal and postmenopausal women. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, ID: KCT0003533 , Registered on 20 February 2019.

Women in LOVe: Lacto-Ovo-Vegetarian Diet Rich in Omega-3 Improves Vasomotor Symptoms in Postmenopausal Women. An Exploratory Randomized Controlled Trial.

OBJECTIVES: In the postmenopausal period, most women suffer vasomotor symptoms (VMS). It is well-known that VMS can worsen the quality of life. Diet seems to play a relevant role in the development of VMS, but the effect of diet on VMS is mainly limited to observational studies, and analyses of nutritional supplements. The aim of this study was thus to determine the efficacy of a lactoovo- vegetarian (LOVe) diet rich in omega-3 fatty acids vs. a lacto-ovo-vegetarian diet rich in EVO (extra-virgin olive oil) in reducing VMS frequency in postmenopausal women. METHODS: A two-arms (lacto-ovo-vegetarian diet with EVO vs. lacto-ovo-vegetarian diet rich in omega-3) randomized-controlled trial with a follow-up period of 16 weeks. We considered as primary outcome the change in the Kupperman index (follow-up vs. baseline evaluation, reported as delta, D) and in its subscales. Secondary outcomes included changes in common anthropometric and biohumoral measurements. RESULTS: Among 54 women randomly assigned to a study group, 40 (mean age 55.1±5.4 years) completed the study and complied with their assigned diet. Women randomized to the omega-3 group (n=18) showed significant improvements, compared to the EVO group (n=22), in Kupperman index (Δ=-11.4±9.8 vs. -5.9±8.2; p=0.045), hot flashes (Δ=-3.3±3.4 vs. -1.3±2.6; p=0.04), and a marginally significant improvement in nervousness (Δ=-1.7±1.7 vs. -0.8±1.5; p=0.07). No significant differences were observed for the secondary outcomes. No relevant side effects were reported. CONCLUSION: After 16 weeks, a lacto-ovo-vegetarian diet rich in omega-3 reduced VMS frequency in postmenopausal women more than the lacto-ovo-vegetarian diet rich in EVO.

Anxiety, depressive symptoms, and cardiac autonomic function in perimenopausal and postmenopausal women with hot flashes: a brief report.

OBJECTIVE: The aim of the study was to examine whether anxiety and depressive symptoms are associated with an adverse cardiac autonomic profile among midlife women with hot flashes. METHODS: Anxiety and depressive symptoms were evaluated by validated self-administered questionnaires among peri- and postmenopausal women in a randomized trial of slow-paced respiration for hot flashes. Pre-ejection period (PEP), a marker of sympathetic activation, and respiratory sinus arrhythmia (RSA), a marker of parasympathetic activation, were measured at baseline and 12 weeks using impedance cardiography and electocardiography. Multivariable repeated measures linear regression models examined associations between anxiety and depression symptoms and autonomic markers, corrected for multiple comparisons with Benjamini-Hochberg procedure, and adjusted for age and body mass index. RESULTS: Among the 121 participants, greater state anxiety was associated with shorter PEP, reflecting higher sympathetic activity (ß = -0.24, P = 0.02). Greater trait anxiety and cognitive anxiety were associated with lower RSA, reflecting decreased parasympathetic activity (ß = -0.03, P < 0.01 for Spielberger Trait Anxiety; ß = -0.06, P = 0.02 for Hospital Anxiety and Depression Scale [HADS] Anxiety Subscale). Greater depressive symptoms were associated with lower RSA (ß = -0.06, P = 0.03 for HADS Depression Subscale; ß = -0.03, P = 0.04 for Beck Depression Inventory). CONCLUSIONS: Among peri- and postmenopausal women with hot flashes, greater self-reported anxiety and depressive symptoms were associated with lower levels of resting cardiac parasympathetic activity, and greater state anxiety was associated with higher levels of cardiac sympathetic activity. Findings suggest that midlife women with increased anxiety and depressive symptoms may have an unfavorable cardiac autonomic profile with potential implications for their overall cardiovascular risk.

N-3 Polyunsatured Fatty Acids in Menopausal Transition: A Systematic Review of Depressive and Cognitive Disorders with Accompanying Vasomotor Symptoms.

Depression is one of the most important health problems worldwide. Women are 2.5 times more likely to experience major depression than men. Evidence suggests that some women might experience an increased risk for developing depression during "windows of vulnerability", i.e., when exposed to intense hormone fluctuations, such as the menopause transition. Indeed, this period is associated with different symptoms, including vasomotor, depressive, and cognitive symptoms, which have all been shown to worsen as women approach menopause. Even though hormonal therapy represents the most effective treatment, side effects have been reported by several studies. Therefore, an increased number of women might prefer the use of alternative medicine for treating menopausal symptoms. N-3 long-chain polyunsaturated fatty acids (n-3 LCPUFAs) are included among these alternative treatments. We here provide a review of studies investigating the effects of n-3 LCPUFAs on hot flashes and depressive and cognitive disorders in menopausal women. The reported results are scattered and heterogeneous. In conclusion, a beneficial role of n-3 LCPUFAs in hot flashes, and depressive and cognitive symptoms related to menopausal transition is still far from conclusive.

Managing Hot Flushes in Menopausal Women: A Review.

Hot flushes during menopause are distressing for women and result in poor quality of life. Purpose of the current review was to evaluate the available treatment modalities that should be utilised for the management of hot flushes. Menopause refers to last menses of women life and can be declared after amenorrhea of 12 months. Vasomotor symptoms including hot flushes and night sweats are common after menopause, affecting almost 50 - 85% women older than 45 years. The mean increment in core body and skin temperature is 0.5°C and 0.25 - 3°C during a hot flush attack. Low level of estrogen during menopause and its association in triggering episodes of hot flushes, is still under debate. The most accepted hypothesis is a narrowing of the thermoneutral zone (TNZ) triggered by estrogen fluctuations. Although, hormone replacement therapy (HRT) remains the standard treatment for the alleviation of such symptoms, incidence of life threatening side effects restrained medical professionals from its use. Complications associated with the use of HRT can be avoided by appropriate evaluation of patients before initiating therapy. Several guidelines have also recommended HRT (estrogen and progesterone) to be safe for up to a period of seven years. Both hormonal and non-hormonal treatments are used for the management of hot flushes. Since hot flushes are the least appreciated and neglected complication of menopause, current review provides detailed information on its background, pathophysiology and management, and emphasises the need of its treatment.

Acupuncture for the Treatment of Paraneoplastic Night Sweats.

This case report describes acupuncture treatment to manage paraneoplastic night sweating secondary to pancreatic cancer. A 56-year-old gentleman with a 2-month history of night sweating responded well over a 10-week course of acupuncture treatment. Acupuncture was selected for symptom management after no success was achieved with pharmacological and conventional managements. The severity of night sweating had reduced from 9/10 to 1/10 on visual analog scale at the end of treatment. This case report suggests that acupuncture has a favorable effect on paraneoplastic night sweating in patients with advanced pancreatic cancer and recommends further research.

Management of Menopausal Symptoms for Women Who Are at High Risk of Thrombosis.

For women at elevated risk of thrombosis, clinicians are challenged to relieve menopausal symptoms without increasing the risk of thrombosis. Oral menopausal hormone therapy increases the risk of venous thromboembolism by 2-fold to 3-fold. Observational studies suggest less thrombotic risk with transdermal therapies and with progesterone over synthetic progestogens (progestins), but the data are limited. Beneficial nonpharmacologic therapies include cognitive behavioral therapy and clinical hypnosis, whereas beneficial nonhormonal pharmacologic therapies include selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors. For treatment of the genitourinary syndrome of menopause, vaginal lubricants and moisturizers, low-dose vaginal estrogen, and intravaginal dehydroepiandrosterone are options.

Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials.

Study Objectives: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects relative to control in women with comparably severe insomnia symptoms and VMS. Methods: We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ≥ 12, and ≥14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10-20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8-12 weeks of treatment. Results: CBT-I produced the greatest reduction in ISI from baseline relative to control at -5.2 points (95% CI -7.0 to -3.4). Effects on ISI were similar for exercise at -2.1 and venlafaxine at -2.3 points. Comparably small decreases in ISI were observed with escitalopram, yoga, and estradiol. The largest reduction in PSQI from baseline was with CBT-I at -2.7 points (-3.9 to -1.5), although PSQI decreases of 1.2 to 1.6 points were significantly better than control with escitalopram, exercise, yoga, estradiol, and venlafaxine. Omega-3 supplements did not improve insomnia symptoms. Conclusions: This study's findings support current recommendations for CBT-I as a first line treatment in healthy midlife women with insomnia symptoms and moderately bothersome VMS.

The prevalence of unmet needs in 625 women living beyond a diagnosis of early breast cancer.

BACKGROUND: There are over half a million women with a previous breast cancer diagnosis living in the UK. It is important to establish their level of unmet physical and psychosocial needs, as many are not routinely seen for follow-up under current models of care. METHODS: We conducted a retrospective analysis of early breast cancer survivors entering an Open Access Follow-Up (OAFU) programme in 2015. Unmet needs were assessed using the Holistic Needs Assessment (HNA) or extracted directly from the electronic patient record (EPR), when the HNA had not been completed. RESULTS: Six hundred and twenty-five patients were eligible. Sixty-one per cent of the survivors had at least one unmet need and 18% had ⩾5 needs. Consistently higher levels of unmet needs were identified using the formal HNA checklist as opposed to extraction from EPR (P<0.001). Physical and emotional needs were the most frequently reported (55 and 24% respectively). Patients receiving endocrine therapy and those who had received chemotherapy were more likely to report unmet needs (both P<0.001). CONCLUSIONS: Unmet physical and emotional needs are common in breast cancer survivors. It is vital that the services are available for these patients as they transition from hospital-based follow-up to patient-led self-management models of care.

Trajectories of response to acupuncture for menopausal vasomotor symptoms: the Acupuncture in Menopause study.

OBJECTIVE: To examine the trajectories of responses to acupuncture treatment for menopausal vasomotor symptoms (VMS) and the characteristics of women in each trajectory. METHODS: Two hundred nine perimenopausal and postmenopausal women aged 45 to 60 years experiencing at least four VMS per day were recruited and randomized to receive up to 20 acupuncture treatments within 6 months or to a waitlist control group. The primary outcome was percent change from baseline in the mean daily VMS frequency. Finite mixture modeling was used to identify patterns of percent change in weekly VMS frequencies over the first 8 weeks. The Freeman-Holton test and analysis of variance were used to compare characteristics of women in different trajectories. RESULTS: Analyses revealed four distinct trajectories of change in VMS frequency by week 8 in the acupuncture group. A small group of women (11.6%, n = 19) had an 85% reduction in VMS. The largest group (47%, n = 79) reported a 47% reduction in VMS frequency, 37.3% (n = 65) of the sample showed only a 9.6% reduction in VMS frequency, and a very small group (4.1%, n = 7) had a 100% increase in VMS. Among women in the waitlist control group, 79.5% reported a 10% decrease in VMS frequency at week 8. Baseline number of VMS, number of acupuncture treatments in the first 8 weeks, and traditional Chinese medicine diagnosis were significantly related to trajectory group membership in the acupuncture group. CONCLUSIONS: Approximately half of the treated sample reported a decline in VMS frequency, but identifying clear predictors of clinical response to acupuncture treatment of menopausal VMS remains challenging.

[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.

Daily salivary cortisol patterns in midlife women with hot flashes.

OBJECTIVE: Diurnal salivary cortisol patterns in healthy adults are well established but have not been studied in midlife women with hot flashes. We hypothesized that frequent hot flashes are associated with aberrant cortisol patterns similar to sleep-deficient individuals. DESIGN: Cross-sectional. PARTICIPANTS: A total of 306 women, ages 40-62, randomized to a behavioural intervention for hot flashes. MEASUREMENTS: Baseline comparisons of cortisol geometric means (nmol/l) from four daily time points averaged over two consecutive days plus other calculated cortisol measures were made between groups defined by baseline: (i) mean daily hot flash frequency tertile (≤5·5, N = 103; >5·5-8·8, N = 103; >8·8, N = 100) and (ii) selected characteristics. Repeated-measures linear regression models of log-transformed cortisol evaluated group differences, adjusting for covariates. RESULTS: Women were 67% White and 24% African American, with 7·6 (SD 3·9) hot flashes per day. Salivary cortisol geometric means (nmol/l) among all women were as follows: 75·0 (SD 44·8) total, 8·6 (SD 5·6) wake, 10·0 (SD 7·5) wake +30 min, 3·7 (SD 3·3) early afternoon and 1·6 (SD 1·8) bedtime. Wake + 30-minute values showed an 18% median rise from wake values (interquartile range -24 to 96%), and means varied by hot flash frequency tertile, from lowest to highest: 11·4(SD 7·3), 10·3 (SD 6·5) and 8·6 (SD 7·8), respectively, P = 0·003. Beside the early afternoon value (P = 0·02), cortisol values did not vary by hot flash frequency. CONCLUSION: Taken together, these findings suggest that high frequency of moderate-to-severe hot flashes may be associated with subtle abnormalities in cortisol concentrations - a pattern consistent with chronic sleep disturbance.

Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms.

OBJECTIVE: To describe the effects of six interventions for menopausal vasomotor symptoms relative to control in a pooled analysis, facilitating translation of the results for clinicians and symptomatic women. The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network tested these interventions in three randomized clinical trials. METHODS: An analysis of pooled individual-level data from three randomized clinical trials is presented. Participants were 899 perimenopausal and postmenopausal women with at least 14 bothersome vasomotor symptoms per week. Interventions included 10-20 mg escitalopram per day, nonaerobic yoga, aerobic exercise, 1.8 g per day omega-3 fatty acid supplementation, 0.5 mg low-dose oral 17-beta-estradiol (E2) per day, and 75 mg low-dose venlafaxine XR per day. The main outcome measures were changes from baseline in mean daily vasomotor symptom frequency and bother during 8-12 weeks of treatment. Linear regression models estimated differences in outcomes between each intervention and corresponding control group adjusted for baseline characteristics. Models included trial-specific intercepts, effects of the baseline outcome measure, and time. RESULTS: The 8-week reduction in vasomotor symptom frequency from baseline relative to placebo was similar for escitalopram at -1.4 per day (95% confidence interval [CI] -2.7 to -0.2), low-dose E2 at -2.4 (95% CI -3.4 to -1.3), and venlafaxine at -1.8 (95% CI -2.8 to -0.8); vasomotor symptom bother reduction was minimal and did not vary across these three pharmacologic interventions (mean -0.2 to -0.3 relative to placebo). No effects on vasomotor symptom frequency or bother were seen with aerobic exercise, yoga, or omega-3 supplements. CONCLUSION: These analyses suggest that escitalopram, low-dose E2, and venlafaxine provide comparable, modest reductions in vasomotor symptom frequency and bother among women with moderate hot flushes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00894543 (MsFLASH 01), NCT01178892 (MsFLASH 02), and NCT01418209 (MsFLASH 03).

Device-guided slow-paced respiration for menopausal hot flushes: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of device-guided slow-paced respiration for reducing the frequency and severity of menopausal hot flushes. METHODS: Perimenopausal or postmenopausal women reporting four or more hot flushes per day were recruited into a parallel-group, randomized trial of slow-paced respiration using a portable guided-breathing device. Women were randomly assigned to use a standard device to practice slowing their resting breathing rate to less than 10 breaths per minute for at least 15 minutes everyday or use an identical-appearing control device programmed to play relaxing nonrhythmic music while monitoring spontaneous breathing. The primary outcome, change in hot flush frequency over 12 weeks, was assessed using data from validated 7-day diaries abstracted by blinded analysts. RESULTS: Among the 123 participants, mean age was 53.4 (±3.4) years. Women reported an average of 8.5 (±3.5) hot flushes per day at baseline. After 12 weeks, women randomized to paced respiration (n=61) reported an average reduction of 1.8 (95% confidence interval [CI] 0.9-2.6) hot flushes per day (-21%) compared with 3.0 (95% CI 2.1-3.8) hot flushes per day (-35%) in the music-listening group (n=62) (P=.048). Paced respiration was associated with a 19% decrease in frequency of moderate-to-severe hot flushes compared with a 44% decrease with music listening (P=.02). CONCLUSION: In this randomized trial, women assigned to device-guided slow-paced respiration reported modest improvements in the frequency and severity of their hot flushes, but the paced respiration intervention was significantly less effective than a music-listening intervention in decreasing the frequency and severity of these symptoms. LEVEL OF EVIDENCE: I.

Effects of a phyto complex on well-being of climacteric women.

AIM: The aim of this study was to assess the effects of a phyto complex on menopausal symptoms. MATERIAL AND METHODS: A total of 151 women aged 42-67 years were enrolled. They were in spontaneous or surgical menopause by at least 12 months, reporting symptoms referable to the climacteric syndrome. Two validated and standardized tests were given to the whole sample at the entrance of the study (T0) and after 6 months of treatment (T6): the Greene Climacteric Scale (GCS) and the Beck Depression Inventory (BDI). Interim evaluations were carried out at 1-3 months (T1 and T3) on five symptoms selected from the GCS. The phyto complex was given to each enrolled woman, from the T0 to T6 time-points, for a total of 180 days. RESULTS: At the T0 time-point, the average scores were: GCS, 28.98 (standard deviation [SD] ± 10.71); BDI, 14.48 (SD ± 6.5). At the T1 time-point, five parameters of the GCS were assessed with a reduction of 36.25% in symptoms (5.69, SD ± 3.53). At the T6 time-point the assessment was completed: average GCS results were 11.54 (SD ± 8.01) with a 60.17% improvement; and average BDI results were 6.11 (SD ± 4.6) with a 58.91% improvement in the depressive symptoms. CONCLUSIONS: The phyto complex under consideration is an effective tool to counter, in a quick and long-lasting manner, the most common and nagging symptoms of the climacteric syndrome, such as hot flushes, insomnia and depression.

Soy isoflavones, inulin, calcium, and vitamin D3 in post-menopausal hot flushes: an observational study.

PURPOSE OF INVESTIGATION: To evaluate the effect of soy isoflavones and inulin (SII) on hot flushes (HF) and quality of life in a clinical setting, the authors conducted an observational study. MATERIALS AND METHODS: The authors performed an observational, prospective, multicentric study on women in peri-/post-menopause treated or untreated with a product present on the Italian market, consisting in a mixture of calcium (500 mg), vitamin D3 (300 IU), inulin (3 g) and soy isoflavones (40 mg). RESULTS: A total of 135 patients, 75 (55.6%) in the SII group and 60 (44.4%) in the untreated group entered the study. After three months, the mean number of HF declined of 2.8 (SD 3.7) in the SII group and 0.0 in the untreated one. The corresponding values after six months were -3.7 (SD 2.7) in the SII group and -0.9 (SD 5.3) in the control group (p = 0.02). CONCLUSION: This observational trial suggests a possible beneficial effect of a dietary soy supplement containing 40 mg of isoflavone/day plus inulin in the management of menopausal symptoms such as hot flashes.

Acupuncture and traditional Chinese medicine for hot flushes in menopause: a randomized trial.

OBJECTIVE: To evaluate the effect of acupuncture on hot flushes and other menopause-related symptoms used in an integrated system, including such therapeutic techniques as diet therapy and Tuina self-massage. DESIGN: Randomized trial. SETTING: Outpatient center. PARTICIPANTS: One hundred women in spontaneous menopause with at least three episodes of hot flushes daily were randomly allocated to two treatment groups (50 per group): Women in group A were given diet, self-massage training, and treatment with acupuncture, and women in group B (the control group) were given the same diet and self-massage training, but treatment with acupuncture started 6 weeks after they were enrolled into the study. INTERVENTION: Acupuncture treatments were scheduled twice weekly for 6 consecutive weeks. OUTCOME MEASURES: Mean change in frequency and/or intensity in menopause-related symptoms were estimated by questionnaire after treatment at week 4. RESULTS: Treatment with acupuncture significantly reduced the occurrence of hot flushes and sudden sweating (p<.001). Other symptoms (sleep disorders, tightness in the chest, irritability, bone pain, feeling depressed) significantly improved. CONCLUSIONS: Acupuncture in an integrated system that includes therapeutic techniques such as diet therapy and Tuina self-massage can be used to treat hot flushes and selected symptoms in postmenopausal women.