Climacteric Complaints Research Articles

Complementary and alternative medicine (CAM) in obstetrics and gynaecology: a survey of office-based obstetricians and gynaecologists regarding attitudes towards CAM, its provision and cooperation with other CAM providers in the state of Hesse, Germany.

Whereas we have some information on complementary medicine in the field of oncology, little is known about complementary medicine in the field of obstetrics and gynaecology especially outside of hospitals. All office-based obstetricians and gynaecologists in the state of Hesse, Germany, were contacted and asked to fill in an assessment form regarding cooperation in the field of complementary and alternative medicine (CAM), as well as the perceived efficacy of various CAM methods for a number of pathological conditions in the field of obstetrics and gynaecology. It was found that more than half of Hessian office-based obstetricians and gynaecologists had existing cooperation regarding CAM, especially with colleagues, but also midwives, pharmacists, physiotherapists, and health practitioners. The probability of cooperation was significantly inversely associated with age. It was found that the probability for advising CAM differed between various health problems. The following CAM methods were considered reasonable for the treatment of different conditions: phytotherapy for climacteric complaints and premenstrual syndrome; homoeopathy for puerperal problems; acupuncture and traditional Chinese medicine for complaints during pregnancy; and dietary supplements for the side effects of cancer therapy. The analysis shows that there is much cooperation in the field of CAM. Comparison between physicians' perceived efficacy of CAM methods and objective findings shows that there is a need for the provision of valid information in the field.

Abstract P4-09-03: A diet enriched by soy-derived isoflavones impacts on the development of premalignant stages of breast cancer in an estrogen driven carcinogenesis animal model

Abstract Background: Hundred thousands of mainly postmenopausal women are using dietary supplements enriched with soy-derived isoflavones (sISO), such as the Novasoy® extract, to relief from climacteric complaints. At the same time, hundreds of studies controversially discuss the impact of sISO on the development of breast cancer. Whether sISO positively or negatively affect the tumorigenesis of the mammary gland presumably is dependent on the time point of the sISO exposure. An exposure during gestation, lactation as well as prepubertal is believed to be preventive whereas an exposure later in life might be adverse. Objective: Aim of the study was to assess whether and how sISO influence the development of breast cancer. Therefore, August-Copenhagen-Irish (ACI) rats, a model for estrogen driven carcinogenesis, were exposed towards sISO. Dietary exposure was started preconceptional and maintained in offspring animals continuously throughout the whole individual life. Experimentals: All ACI rats were kept under controlled conditions and had ad libitum access either to a sISO-free control diet or a diet supplemented with 500ppm of the Novasoy®650 extract. Pregnant females were kept under the established dietary regimen throughout gestation and lactation period and the female offspring was investigated in the following experimental procedures. On postnatal day 60 (PND60) the animals of each dietary group randomly were implanted a 17beta-estradiol (E2) releasing (approximately 2mg release in 90 days) or a placebo pellet to induce tumorigenesis of the mammary gland. The rats were weekly palpated for mammary tumors and weighed weekly for the duration of the experiment (until PND240). Finally, we assessed physiological (e.g. organ weights, sISO exposition, mammary gland areas), (patho-)histological (HE staining), immunohistological (PCNA expression) as well as molecular end points (gene expression) of the resulting mammary gland phenotypes. Results: Control diet animals had a daily sISO exposure of ∼0.5mg/kg body weight, whereas animals of the Novasoy®650 group had a daily exposure of ∼30mg/kg body weight. Independent of the dietary background, none of the animals with an implanted placebo pellet showed tumor precursors. Ductual carcinomas in situ (DCIS) were detected in 83.3% of the animals of the control diet and in 100% of the animals of the Novasoy®650 diet, both following implantation of an E2-release pellet. Moreover, control diet animals exposed to E2 had significantly reduced mammary gland areas compared to the respective placebo group. This difference was not detectable in the Novasoy®650 dietary group. Additionally, no differences in the uterus as well as liver wet weights were noticed. On a molecular level, the expression of several genes responsible for proliferation (Ki67), estrogenicity (Tff1) and cell cycle control (Cdk4) were modified in animals lifelong exposed towards sISO. Conclusions: In ACI rats, a prenatally started and lifelong maintained sISO exposure clearly affects the estradiol induced malignant transformation of the mammary gland. This is evidenced by a higher number of DCIS as well as increased proliferation levels which were found in animals chronically exposed to sISO. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-09-03.

High dose black cohosh extract for climacteric complaints

High dose black cohosh extract for climacteric complaints

Plant derived alternatives for hormone replacement therapy (HRT).

Abstract Hormone replacement therapy (HRT) has undisputable positive effects on climacteric complaints, in the bone and on body weight but also several undesired side effects. Therefore, plant-derived alternatives are currently promoted. Phytoestrogens - primarily the isoflavones genistein, daidzein and coumestrol, stemming from soy (Glycine max) or red clover (Trifolium pratense) - were suggested to have the desired but not the undesired effects of estrogens. Most recently published placebo-controlled studies question the beneficial effects. When taken at the time of puberty however, phytoestrogens appear to protect against mammary cancer later in life. Extracts from the rhizome of Cimicifuga racemosa (black cohosh) have no estrogenic effects. In a narrow dose range they have beneficial effects on climacteric complaints, which are due to several compounds with dopaminergic, noradrenergic, serotoninergic and GABAergic actions that act together in the hypothalamus. Ecdysone is produced by several plants, including spinach (Spinacia oleracea) and was very early on shown to increase muscle mass. Later it became apparent that spinach extracts containing ecdysone decreased body fat load, thereby reducing secretion of proinflammatory cytokines by visceral adipocytes and oxidative stress. This had beneficial effects on body weight and serum lipids not only in obese postmenopausal but also in premenopausal women and in men. For the above-described plant extracts, solid placebo-controlled clinical trials are available. For other plant extracts claiming beneficial effects on climacteric complaints or postmenopausal diseases, no solid data are available.

Efficacy and safety of Cimicifuga foetida extract on menopausal syndrome in Chinese women

Background It is now recognized that Cimicifuga foetida extract is effective in alleviating menopausal symptoms. But the durations reported were usually short. This paper compares the clinical effects of different regimens of three-month course on climacteric symptoms in Chinese women, so as to evaluate the efficacy and safety of Cimicifuga foetida extract. Methods This was a prospective, randomized trial. Ninety-six early menopausal women were recruited and randomly assigned into 3 groups to take different kinds of medicine for 3 months; participants were given Cimicifuga foetida extract daily in group A (n=32), given estradiol valerate and progesterone capsule cycle sequentially in group B (n=32), and given estradiol valerate and medroxyprogesterone acetate cycle sequentially in group C (n=32). The questionnaires of Kupperman menopause index, Menopause-Specific Quality of Life, and Hospital Anxiety and Depression Scale were finished before and after the treatment. The status of vaginal bleeding and breast tenderness was recorded every day. Results Eighty-nine participants (89/96, 92.7%) completed the treatment. Kupperman menopause index decreased after taking the medicine for 3 months in each group (with all P<0.001), but the score after the treatment was higher in group A than in the other 2 groups. Except for the score of sexual domain in group A (P=0.103), the scores of all domains of the Menopause-Specific Quality of Life decreased significantly after the treatment in all groups (with all P≤0.01). Score of anxity decreased significantly in group A (P=0.015) and B (P=0.003). Incidence of breast tenderness was 12.9% (4/31) in group A, 36.7% (11/30) in group B, and 14.3% (4/28) in group C. Incidence of vaginal bleeding was 6.5% (2/31) in group A, 26.7% (8/30) in group B, and 82.1% (23/28) in group C. Conclusions Cimicifuga foetida extract is effective and safe in the treatment of menopausal syndrome. It is worth extending its use in the treatment of climacteric complaints, especially among those having contradiction for hormone replacement therapy.

The 5HTT and MAO-A polymorphisms associate with depressive mood and climacteric symptoms in postmenopausal women

The aim of this study was to assess the influence of the 44-bp polymorphism in the 5HTTLPR (SLC 6A4) (serotonin-transporter-linked polymorphic region, solute carrier family 6 member 4) promoter region and the 30-bpVNTR (variable number of tandem repeats) polymorphism in the MAO-A (monoamine oxidase A) promoter region on the prevalence of depressive mood and the severity of climacteric symptoms in postmenopausal women. The study involved 630 women from northern Poland who had their last menstrual period at least one year before the study. The women did not abuse alcohol or cigarettes, had not been diagnosed as having endocrinological, cancerous or mental diseases, and had not received psychiatric treatment by the time. This survey-based study was performed using the following research instruments: the Beck Depression Inventory (BDI), to evaluate depressive symptoms, and the Blatt-Kupperman Menopausal Index, to measure the severity of climacteric symptoms. The average age of the women was 57.5 ± 6.4 years. Depressive symptoms of different severity according to the BDI were diagnosed in 29.2% of the women (minor-18.6%, moderate-7.1%, severe-3.5%) and according to the Blatt-Kupperman Menopausal Index were diagnosed in 42% of the women (minor-24.1%, moderate-9.2%, severe-8.7%). Allele 'l' was significantly more common in the women without climacteric symptoms than those with minor, moderate or severe climacteric complaints (p ≤ 0.05). There was a significant correlation between the severity of climacteric and depressive symptoms (p ≤ 0.05). The women who had severe climacteric symptoms also had more severe depressive symptoms. 1. The 5HTTLPR gene polymorphism contributes to climacteric symptoms in postmenopausal women. 2. The Blatt-Kupperman Menopausal Index is an instrument which can not only be used for the measurement of the severity of climacteric symptoms but also the early detection of perimenopausal women at the risk of developing depressive symptoms.

Influências das famílias no cuidado às mulheres climatéricas

ABSTRACT This descriptive, qualitative study was performed with the objective to understand the influences that families have on the care for climacteric women. This study was performed in September of 2011, at an outpatient clinic of a public university in the state of Ceara, Brazil. Participants were nine workingwomen of ages between 44 and 57 years. Data were collected in focal groups and by observation, and submitted to content analysis technique as proposed by Bardin(2010). The following categories were developed: influences of families on the care for climacteric women, with positive aspects observed in the demonstration of affection, encouragement, the family’s experience and affection to relieve stress and promote care; and the family’s negative influences, mainly the non-cooperation in housework and relatives’ lack of understanding regarding climacteric complaints. Results suggest an effective implementation of public policies and programs to encourage family participation in issues regarding women’s health and strengthening of families. Descriptors: Nursing; Comprehensive Health Care; Women's Health; Climacteric; Family.

The effect of a Cimicifuga racemosa extracts Ze 450 in the treatment of climacteric complaints – an observational study

BackgroundRoot extracts of Cimicifuga racemosa (L.) Nutt. have been successfully used in the treatment of climacteric complaints. MethodIn this observational study, Cimicifuga racemosa (CR) extract Ze 450 was studied in 442 unselected ambulatory female outpatients with menopausal complaints under daily practice conditions.Physicians were suggested to treat patients for the first 3 months with 13mg/d CR (high dose, HD) and to continue over additional 6 months either with this treatment or to switch to 6.5mg/d CR (low dose, LD). The choice of treatment and its dose, however, was fully at the discretion of the physician. ResultsAfter 3-months treatment with HD, symptom severity (Kupperman Menopause Index, KMI) decreased significantly (p<0.001) from baseline values. Continuation of treatment with HD or LD decreased total KMI and its sub-item scores further (HD, LD: p<0.001). However, more patients (84.9%) responded to HD than to LD (78.4%) and showed an improvement of symptoms (p=0.011). ConclusionThis observational study demonstrated that treatment with CR in unselected patients with climacteric complaints under the conditions of daily practice resulted in a significant improvement of menopausal symptoms assessed by the total KMI score and its sub-item scores with an effect size similar to that in a previous randomized, controlled clinical trial.

Attitude of German women towards hormone therapy: results of a lay survey

Objective: Hormone therapy (HT) use has experienced a substantial change since publication of Women’s Health Initiative (WHI) controlled trial. We aimed to investigate the attitude towards HT in German women aged 45–60 years.Study design: A questionnaire was sent to 9785 randomly selected women in Germany aged between 45 and 60 years.Results: Response rate was 19.3% (n = 1,893). Of those, 81% experienced climacteric symptoms. Vasomotor symptoms were most frequently reported (71.2%; n = 1332). Of the respondents, 19.7% (n = 369) used HT. The most frequently mentioned benefits of HT were the improvement of climacteric complaints (71.2%; n = 1346), followed by the relief of osteoporosis (37.2%; n = 697) and the “anti-aging” effect (16.3%; n = 305). Breast cancer was stated as the main risk (64.9%; n = 1215), closely followed by weight gain (53.4%; n = 1000) and thromboembolism (48%; n = 898). About 44% of the women who has been advised by gynaecologists choose a HT, whereas this rate dropped down to 14.3% and 11.3% for women who have been advised by friends or media.Conclusion: German women were generally aware of the main risks and benefits of HT. “More informed” women appear to be more likely to use HT compared to “less informed” women. The media produces negative impression of HT.

The relationship between urogenital symptoms and climacteric complaints

Objective To evaluate the relationship between urogenital symptoms and climacteric complaints, including anxiety, depression, somatic, vasomotor and sexual subscores according to the Greene Climacteric Scale (GCS).Methods We retrospectively reviewed the records of 1278 patients and the 908 patients who fulfilled the inclusion criteria were included in the study. The relationships were evaluated between GCS and vaginal symptoms, including vaginal pain, dyspareunia, itching, discharge, burning, dryness, and postcoital bleeding, and urinary symptoms, including dysuria, frequency, nocturia and incontinence, by using univariate and multivariate analyses.Results Among vaginal symptoms, somatic and sexual scores and, among urinary symptoms, anxiety and somatic scores were found to be the most associated factors. Of the vaginal symptoms, the highest odds ratios for somatic score and sexual score were found to be 2.21 (95% confidence interval (CI) 1.69–2.88, p < 0.001) and 2.08 (95% CI 1.70–2.56, p = 0.029), respectively. Multivariate logistic regression analyses for urinary symptoms revealed that the highest odds ratios for anxiety, somatic, depression and sexual scores were 1.53 (95% CI 1.20–1.95, p = 0.001), 1.92 (95% CI 1.38–2.66, p = 0.01), 1.47 (95% CI 1.11–1.94, p = 0.007), and 1.28 (95% CI 1.06–1.55, p < 0.001), respectively.Conclusions There is a strong relationship between urogenital symptoms and GCS subscores. Therefore, clinicians should be aware of urogenital problems in the presence of severe climacteric symptoms and this may provide earlier treatment for urogenital complaints.

Differentiated Evaluation of Extract-Specific Evidence on Cimicifuga racemosa's Efficacy and Safety for Climacteric Complaints.

Past reviews on Cimicifuga racemosa (CR) without differentiation between extracts, quality, and indication altogether led to inconsistent data. Therefore, for the first time, we meet the requirements of the system's logic of evidence-based phytotherapy by taking into consideration extracts, pharmaceutical quality (reflected in a regulatory status as medicinal product), and indication. A literature search for clinical studies examining CR's efficacy and safety for menopausal complaints was conducted. The results were sorted by type of extract, regulatory status, and indication. Accordingly, Oxford Levels of Evidence (LOE) and Grades of Recommendation (GR) were determined. CR extracts demonstrated a good to very good safety in general, on estrogen-sensitive organs and the liver. However, only registered CR medicinal products were able to prove their efficacy. Best evidence was provided by the isopropanolic CR extract (iCR): the multitude of studies including more than 11,000 patients demonstrated consistent confirmatory evidence of LOE 1b (LOE 1a for safety) leading to GR A. The studies on the ethanolic extract BNO 1055 including more than 500 patients showed exploratory evidence of LOE 2b resulting in GR B. A positive benefit-risk profile is stated and limited to Cimicifuga racemosa products holding a marketing authorisation for treating climacteric complaints.

Analysis of uterine and ovarian arterial blood flow and ovarian hormone levels prior to and after hysteroscopic endometrial resection

The objective of this study was to evaluate the effect of hysteroscopic endometrial ablation on the ovarian and uterine artery blood flow and on follicle stimulating hormone (FSH) and oestradiol (E2) levels. A total of 26 consecutive women with abnormal uterine bleeding refractory to medical treatment had undergone hysteroscopic electrosurgical transcervical resection of the endometrium (TCRE). Ultrasonographic measurement of ovarian volumes and colour Doppler flow assessment of the uterine and ovarian arteries were performed on all patients before surgery (group 1) and 1 week (group 2) and 6 months (group 3) after surgery. Blood samples were also collected for determination of FSH and E2 levels, 4 weeks before and 1 month after surgery. No statistically significant change was observed between preoperative and postoperative (1st week and 3rd month) volumes of the ovaries. The mean pulsatility index (PI) of the uterine and ovarian artery did not show statistically significant differences between postoperative 1st week and 3rd month measurements of uterine and ovarian artery PI. The increase in serum levels of FSH and E2 after endometrial resection did not reach statistical significance. Although women may present with climacteric complaints of hot flushes and nocturnal sweating after endometrial resection, this is probably a psychological response to hypomenorrhoea and amenorrhoea, as no statistically significant changes in FSH and E2 levels and uterine/ovarian blood flow were demonstrated in the early postoperative period.

Efficacy of Cimicifuga racemosa, Hypericum perforatum and Agnus castus in the treatment of climacteric complaints: a systematic review

Objective: The systematic review examines whether Cimicifuga racemosa (CR), Hypericum perforatum (HP), Agnus castus, vitamins and minerals, either as monotherapy or in combination, have an evidence-based impact on vasomotor, genital and psychological climacteric complaints. Data sources and methods of study selection: We searched in the databases EMBASE, OVID and PubMed using the keywords “vasomotor symptoms, hot flashes, vaginal atrophy, psychological problems, endometrium, sleep, concentration, cognition in combination with vitamins, multivitamins, minerals, multiminerals, black cohosh, Cimicifuga, Agnus castus, chasteberry, chaste tree, monk’s pepper and menopause” for randomized controlled trials (RCT). Relevant studies were reviewed by four independent reviewers qualitatively. Results: Most of the studies with a comparison of CR vs. placebo do not show an evidence-based significant effect of CR on climacteric symptoms. The combination of CR and HP shows an improvement of climacteric complaints in comparison to placebo. In some RCTs, there was no significant difference between CR and hormone-replacement therapy. The combination of HP and Agnus castus showed no significant difference in the treatment of climacteric complaints. Conclusion: CR monotherapy as well as HP and Agnus castus showed no better effect than placebo. The combination of CR with HP demonstrated a positive effect on climacteric complaints.

Dose-Dependent Effects of theCimicifuga racemosaExtract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study

Extracts from Cimicifuga racemosa (CR, synonym Actaea racemosa) have shown efficacy in trials in women with menopausal symptoms. Yet, dose dependency remains unclear. Therefore, 180 female outpatients with climacteric complaints were treated for 12 weeks in a randomized, double-blind, placebo-controlled, 3-armed trial (CR extract Ze 450 in 6.5 mg or 13.0 mg, or placebo). Primary outcome was the difference in menopausal symptoms (vasomotor, psychological, and somatic), assessed by the Kupperman Menopausal Index between baseline and week 12. Secondary efficacy variables were patients' self-assessments of general quality of life (QoL), responder rates, and safety. Compared to placebo, patients receiving Ze 450 showed a significant reduction in the severity of menopausal symptoms in a dose-dependent manner from baseline to endpoint (mean absolute differences 17.0 (95% CI 14.65–19.35) score points, P < 0.0001 for 13.0 mg; mean absolute differences 8.47 (95% CI 5.55–11.39) score points, P = 0.0003 for 6.5 mg). QoL and responder rates corresponded with the main endpoint. Changes in menopausal symptoms and QoL were inversely correlated. Reported adverse events and clinical laboratory testing did not raise safety concerns. The CR extract Ze 450 is an effective and well-tolerated nonhormonal alternative to hormone treatment for symptom relief in menopausal women.

Hormone therapy after endometrial cancer.

Endometrial carcinoma is one of the absolute contraindications of hormone therapy (HT). After all the existing opinions so far, HT after Stage I or II is still thought of as a possibility and up to now, the continuously combined estrogen (CAS 53-16-7) / progestogen (CAS 57-83-0) replacement therapy (CCEPT) has been recommended. However, only observational studies have been conducted as yet. Although no study established an increased rate of recurrence or mortality, alternatives such as phyto-preparations, tibolone, or particular psychotherapeutic drugs such as venlafaxine should be considered for the relief of climacteric complaints. In particular considered is progestogen-only therapy. However, the currently discussed possible progestogen effects regarding the risk of breast cancer have to be taken into account. Generally after hysterectomy, at least for patients with cardiovascular risk factors, the preference today is to use low-dose estrogen therapy (patches, gels) instead of CCEPT, and this also is now recommended for patients after endometrial cancer. This is important because of the risk factors for endometrial carcinoma, such as hypertension, obesity, polycystic ovary syndrome, diabetes mellitus etc. However, each form of HT should only be exceptionally recommended, and the patients must be informed about the risks that exist and the use of alternatives.

20-OH-Ecdysone Prevents Hot Flushes in Ovariectomized Rats

Hot flushes are due to the lack of estrogens and are the most characteristic climacteric complaints. Hormone replacement therapy was the standard treatment but now its use is limited because of side effects. Need therefore arises to search for non-estrogenic alternatives. The molting hormone 20-beta-hydroxyecdysone (Ecd) is produced by several plants including spinach and has no estrogenic or androgenic properties but enhances GABAergic effects in neurons. Since GABAergic compounds can ameliorate hot flushes, we investigated the effects of Ecd on subcutaneous body temperature of intact and ovariectomized (ovx) rats. The subcutaneous body temperature was recorded at 5-min intervals over a period of 3 hours. Rats were then ovx, and skin temperatures were recorded after an acute intravenous (5 mg) and during subchronic and chronic oral application of Ecd (73 mg/animal/day). For additional control purposes, a group of ovx rats received food containing estradiol-17 β (E2). Skin temperature in individual ovx animals fluctuated largely with peaks (hot flushes) occurring every 20-40 minutes. Following the i.v. treatment with Ecd, skin temperature dropped by more than 1 °C, an effect much larger than in the controls. One and two weeks later, hot flushes were only seen in ovx controls but not in intact, E2-, or Ecd-treated animals. As a consequence, E2 and Ecd intake significantly (p < 0.05) reduced the mean temperature in ovx rats during the various time points of the study. These results suggest that Ecd is efficient to prevent hot flushes in ovx rats.

Black cohosh (Cimicifuga racemosa) relaxes the isolated rat thoracic aorta through endothelium-dependent and -independent mechanisms

Aim of the studyThe rhizome of the Cimicifuga racemosa (commonly known as black cohosh) has been used in treatment of climacteric complaints for decades in North America and Europe. A number of studies investigated the estrogenic potential of black cohosh, but its effectiveness is still controversial. Recently, it was reported that the extract of black cohosh acted as an agonist at the serotonin (5-HT) receptor and 5-HT derivative was isolated out of the black cohosh extract. Because it is well known that the 5-HT elicited the various cardiovascular effects including vasorelaxation, we investigated the vasorelaxant effects of the extract of black cohosh and its possible mechanisms of action. Materials and methodsThe extract of black cohosh (BcEx) was examined for its vasorelaxant effects in isolated rat aorta. The aortic rings were equilibrated under resting tension and induced reproducible contraction in organ bath. The control contraction was produced by 300nM NE, and then BcEx were added. In experiments where specific inhibitors were used, they were added 20min before NE contraction. ResultsBcEx elicited two phases of relaxation in rat aorta pre-contracted with norepinephrine. The first, a rapid relaxation, which occurred within seconds of BcEx administration, was eliminated by pretreatment with NG-nitro-l-arginine (l-NNA) or methylene blue. The endogenous NO synthase substrate l-Arg markedly reversed the action of l-NNA, indicating that BcEx elicited the vasorelaxant effect via the NO/cGMP pathway. The second, slowly developing relaxation was not affected by the endothelium denudation. BcEx-induced endothelium-independent vasorelaxation appears to involve the inhibition of calcium influx mediated by the opening of inward rectifier potassium channels. ConclusionsBcEx elicits the vasorelaxant effect via endothelium-dependent and -independent mechanisms and may contribute to a better understanding of a potential link between the use of black cohosh and its beneficial effects on vascular health.

Acupuncture improves health-related quality-of-life (HRQoL) and sleep in women with breast cancer and hot flushes

Evaluate effects of electro-acupuncture (EA) and hormone therapy (HT) on health-related quality-of-life (HRQoL) and sleep in breast cancer survivors with vasomotor symptoms. Forty-five women, randomized to EA (n = 27) for 12weeks or HT (n = 18) for 24months, were followed for up to 2years. Distress caused by, and numbers of, hot flushes, hours slept and times woken up/night, Psychological and General Well-being Index (PGWB) and Women's Health Questionnaire (WHQ) were registered before and during treatment and at 6, 9, 12, 18 and 24months after start of treatment. After 12weeks of EA (n = 19), WHQ improved from 0.32 (IQR 0.23-0.53) at baseline to 0.24 (IQR 0.12-0.39; p < 0.001) and PGWB from 78 (IQR 53-89) to 79 (IQR 68-93; p = 0.002). All sleep parameters improved and Hot Flush Score (HFS) decreased by 80%. At 12months, WHQ, PGWB and all sleep parameters remained significantly improved (n = 14) and HFS decreased by 65%. After 12weeks of HT (n = 18), WHQ improved from 0.29 (IQR 0.15-0.44) at baseline to 0.15 (IQR 0.05-0.22; p = 0.001), PGWB from 75 (IQR 59-88) to 90 (62-97; p = 0.102) and three of five sleep parameters improved. Both EA and HT increased HRQoL and sleep, probably through decreasing numbers of and distress by hot flushes. Although flushes decreased less in the EA group than in the HT group, HRQoL improved at least to the same extent maybe due to other effects of EA, not induced by HT, e.g. on anxiety, vitality and sleep, supported by subscale analyses. EA should be further evaluated as treatment for women with breast cancer and climacteric complaints, since HT no longer can be recommended for these women.

Black cohosh (Cimicifuga racemosa) in tamoxifen-treated breast cancer patients with climacteric complaints – a prospective observational study

Objective. The antihormonal therapy of breast cancer patients with the antiestrogen tamoxifen often induces or aggravates menopausal complaints. As estrogen substitution is contraindicated, herbal alternatives, e.g. extracts of black cohosh are often used.Design. A prospective observational study was carried out in 50 breast cancer patients with tamoxifen treatment. All patients had had surgery, most of them had undergone radiation therapy (87%) and approximately 50% had received chemotherapy. Every patient was treated with an isopropanolic extract of black cohosh (1–4 tablets, 2.5 mg) for 6 months. Patients recorded their complaints before therapy and after 1, 3, and 6 months of therapy using the menopause rating scale (MRS II).Results. The reduction of the total MRS II score under black cohosh treatment from 17.6 to 13.6 was statistically significant. Hot flashes, sweating, sleep problems, and anxiety improved, whereas urogenital and musculoskeletal complaints did not change. In all, 22 patients reported adverse events, none of which were linked with the study medication; 90% reported the tolerability of the black cohosh extract as very good or good.Conclusions. Black cohosh extract seems to be a reasonable treatment approach in tamoxifen treated breast cancer patients with predominantly psychovegetative symptoms.

Morningness-eveningness in women around the transition through menopause and its relationship with climacteric complaints

One of the most striking facts is the transition to eveningness in adolescence around the age of 12–14 years which seems to be associated with pubertal development and with increasing sexual hormones. As women in their transition during menopause (at approx. 50 years) experience the contrary pattern, namely the reduction of sexual hormones, one should expect a turn towards morningness during these developmental stages. Women between 40 and 55 years, who were unaffected by hormone replacement therapy, gynaecological operations or hormonal contraceptives, participated in our study (pre-, peri- and post-menopausal stages). We found that women became more morning-orientated during the transition through menopause, which is considered an effect of hormonal changes rather than of age. Sleep problems increased from pre- to post-menopause while psychological complaints were highest during the peri-menopause. Further, we found a correlation between eveningness and psychological complaints, and a correlation between sleep problems and morningness. The presence of a partner was associated with higher morningness scores and earlier bed and rise times on weekends.