Long-term effects of a combination of isoflavones, agnus castus and magnolia extracts on climacteric symptoms and cardiometabolic risk profile in postmenopausal women.

OBJECTIVE: To evaluate the long-term effects of a combination of isoflavones, agnus castus and magnolia extracts (combined isoflavone compound [CIC]) on climacteric symptoms and cardiometabolic risk in symptomatic postmenopausal women. METHODS: This interventional, prospective study evaluated climacteric symptoms, mood and sleep disorders using the 21-item Greene Climacteric Scale (GCS) and 7-item Insomnia Severity Index (ISI) questionnaires; and cardiovascular, metabolic and thrombotic risk markers at baseline (T0) and after 12 months of CIC treatment (T1). RESULTS: In healthy postmenopausal women (N = 71), 12-month CIC treatment significantly reduced patient-reported vasomotor symptoms (100% vs. 17%), mood disorders (67% vs. 25%) and sleep disorders (89% vs. 19%%) (all p < .001) compared with baseline; and significantly improved GCS psychological, somatic, and vasomotor domain scores and ISI sleep disturbance scores (all p < .05). CIC significantly reduced systolic (p = .022) and diastolic blood pressure (p < .001), and heart rate (p < .001); glucose concentrations (p = .018), HOMA index (p = .013), and ALT (p = .035), homocysteine (p = .005) and NT-proBNP (p = .003) levels. CONCLUSIONS: Long-term CIC therapy improved vasomotor symptoms, mood disorders, sleep disorders, hemodynamic measurements and cardiometabolic risk markers in healthy postmenopausal women. CLINICALTRIALS.GOV IDENTIFIER: NCT03699150.

Envelhecimento: combatê-lo ou compreendê-lo?: O climatério como exemplo / Aging: fight it or understand it?: The climacteric as an example

Enquanto aumenta a expectativa de vida, também cresce a preocupação com a qualidade de vida na velhice. Para muitos, o envelhecimento está associado a aspectos negativos como inatividade, doenças, necessidade de cuidados, além de não encontrarem significado nessa fase da vida. Rudolf Steiner considerava que as mesmas forças vitais empenhadas no crescimento e desenvolvimento orgânicos são as que dão sustentação ao pensamento. Assim, a antroposofia considera que há uma metamorfose das forças que promovem o crescimento em forças do pensamento. Da mesma forma, há uma metamorfose no processo do envelhecimento: as forças vitais se desprendem paulatinamente dos órgãos e ficam disponíveis para o desenvolvimento ou o fortalecimento de algumas habilidades. O exemplo do sentido da audição, metamorfoseado em percepção da verdade é citado. De modo marcante, as ondas de calor no climatério (fogachos) caracterizam forças vitais que se desprendem dos ovários e não encontram destino ou utilidade, causando mal-estar à mulher nessa fase da vida. Mas as mulheres descendentes dos maias, no Yucatán (México), não têm a experiência dos fogachos após a menopausa. Para essa sociedade, envelhecer significa evoluir, ganhar posição superior no status social. Além disso, elas tecem e bordam desde jovens e assim continuam a criar, mesmo após o término do período fértil, usando as forças vitais que se desprendem dos ovários. Ao usar a terapia de reposição hormonal, a mulher terá suas forças vitais artificialmente presas aos órgãos, impedindo que a metamorfose citada aconteça. Então, trata-se de uma necessidade de nossa época encontrar uma nova perspectiva para o envelhecimento, pautada pela compreensão da metamorfose das forças vitais no ser humano.(AU)

While the life expectancy increases, there is also a growing concern about the quality of life in old age. For many, aging is associated with negative aspects such as inactivity, illness, need for care and lack of meaning in this stage of life. Rudolf Steiner considered that the same vital forces engaged in organic growth and development, are those that support the thought. Thus, anthroposophy considers that there is a metamorphosis of growth forces into thinking forces. In the same way, there is a metamorphosis in the process of aging: the vital forces gradually detach from the organs and they become available for the development or the strengthening of some abilities. The example of the sense of hearing, metamorphosed into the perception of truth is cited. Significantly, the hot flushes in the climacteric characterize vital forces that are released from the ovaries and do not find a destiny or a utility, causing discomfort to the woman in this phase of life. But the women descendants of the Maya, in the Yucatán (Mexico), do not experience the hot flashes after the menopause. For this society, aging means to progress, to gain a superior position in social status. In addition, they weave and embroider since youth and thus they continue to create, even after the end of the fertile period, using the vital forces that are released from the ovaries. The hormone replacement therapy artificially attaches the vital forces to the organs, and impedes the event of the mentioned metamorphosis. Therefore, finding a new perspective for aging is a necessity of our time, based on the understanding of vital forces metamorphosis in the human being.(AU)

The value of complementary and alternative medicine in the treatment of climacteric symptoms: results of a survey among German gynecologists.

OBJECTIVES: The present study aims to detect the attitude and experience towards complementary and alternative medicine (CAM) in the treatment of climacteric disorders among gynecologists in Germany. STUDY DESIGN: A self-administered questionnaire, containing 15 questions, was sent to all gynecologists in private practice in Germany (n=9589). MAIN OUTCOME MEASURES: Gynecologists were asked about their experience with several forms of CAM. They were asked to rate different procedures as "effective", "sometimes effective" or "unimportant". RESULTS: The response rate was 33.7% (n=3227). We report on 2549 (26.6%) eligible questionnaires. Well-known therapies were black cohosh (Cimicifuga racemosa), chaste tree (Vitex agnus castus) and St. John's wort. More than 98% had had experiences with these therapies. Fewer experiences were stated with hormone-yoga (42.9%), acupuncture (29.1%) and homeopathy (21.6%). The most effective alternative therapy rated was an alteration of lifestyle with 54.4% (n=1325) stating it was effective and 35.7% (n=871) stating it was sometimes effective. Only 3.9% (n=96) prescribed no efficacy to a change of lifestyle. Other treatments rated as effective were St. John's wort (25.0%, n=606) and Black cohosh (21.1%, n=527). Agents regarded most ineffective were hormone-yoga (4.7%, n=109), acupuncture (10.3%, n=243) and homeopathy (10.6%, n=250). Female gynecologists were more likely to vote for a therapy to be effective compared to their male colleagues. CONCLUSIONS: German gynecologists seem to have made positive experiences with CAM when observing their patients, in general. An alteration of lifestyle is seen as the most effective alternative therapy in menopause. Due to their widespread use, possible side effect of natural agents should be excluded.

Aromaterapia e yogaterapia no climatério: Os efeitos de aromaterapia e yogaterapia na qualidade de vida, nos níveis de stress e na intensidade e frequência de fogacho em mulheres na fase do climatério / Aromatherapy and yogatherapy in climacterium: the effects of aromatherapy and yogatherapy on quality of life, stress levels and intensity and frequence of hot flashes in climacteric women

INTRODUCAO: Os sintomas de climaterio podem perturbar intensamente a vida, sendo o fogacho o sintoma de maior incidencia. Aromaterapia e yogaterapia podem oferecer tratamentos eficazes para sintomas de climaterio, em especial o fogacho, por apresentarem mecanismos terapeuticos semelhantes ao eixo fisiologico do fogacho. OBJETIVO PRINCIPAL: Verificar e analisar os desfechos clinicos fisiologicos e psicologicos da aromaterapia olfativa e de exercicios respiratorios de yogaterapia, associados e individualmente, na qualidade de vida, nos niveis de stress subjetivo e na intensidade e frequencia do fogacho de mulheres na fase do climaterio. METODO: Foram avaliadas 85 mulheres na fase do climaterio, das quais 64 participaram da Fase 1 (somente avaliacao) do estudo e 34 participaram da Fase 2 (tratamento). A coleta foi realizada no CEPE-USP. O estudo consiste de um ensaio clinico pragmatico com randomizacao restrita, controlado por grupo controle e placebo, duplo-cego, com intervencao baseada no modelo psiconeuroendocrinoimunologico. Foram realizados tratamentos com inalacao de sinergia aromaterapeutica com ou sem exercicios respiratorios de yogaterapia, durante 12 semanas, duas vezes por semana em sessoes de uma hora. O estudo foi aprovado pelo Comite de Etica em Pesquisa da Escola de Educacao Fisica e Esporte da Universidade de Sao Paulo e foi inscrito no clinicaltrials.gov. RESULTADOS E DISCUSSAO: Os resultados da pesquisa mostraram melhora estatisticamente significante dos sintomas de climaterio para os tres grupos de intervencao. Houve diminuicao significativa do sintoma de fogacho, assim como da queixa de fogacho, sendo que o fogacho foi eliminado em cinco sujeitos. A intensidade e a frequencia de fogacho diminuiram em todos os grupos de intervencao e se mantiveram constantes no grupo controle. O tratamento proposto de aromaterapia se mostrou mais eficaz do que o tratamento proposto de yogaterapia na diminuicao do sintoma de fogacho, quando esses tratamentos eram aplicados isoladamente. A associacao das duas terapias se mostrou benefica, aumentando a eficacia e intensificando a melhora do sintoma de fogacho. Os efeitos globais dos tratamentos variaram intensamente quanto aos outros dominios de sintomas do climaterio. A melhora dos sintomas vasomotores do climaterio (fogacho e suor noturno), foi acompanhada de melhora significativa nos niveis de stress subjetivo, na qualidade do sono e da qualidade de vida em todos os grupos de intervencao. Esse trabalho tambem permitiu discussoes secundarias sobre o climaterio e as terapias, permitindo a sua compreensao a partir do modelo psiconeuroendocrinoimunologico. CONCLUSAO: Esse estudo serviu como um delineamento geral dos sintomas de climaterio, da aromaterapia e da yogaterapia a partir do modelo psiconeuroendocrinoimunologico. Os resultados apresentados nao podem ser generalizados para a populacao por causa da amostra pequena, mas podem indicar os resultados mais promissores e, com isso, esse trabalho pode ser o ponto de partida para novos estudos, auxiliando na elaboracao de questoes de pesquisa claras e metodos de pesquisa adequados para estuda-las.(AU)

INTRODUCTION: Climacteric symptoms can disturb life considerably. Hot flashes are the symptom with highest incidence. Aromatherapy and yogatherapy can offer efficient treatments for climacteric symptoms, specially hot flashes, because their therapeutic mechanisms are similar to the physiological mechanism of hot flashes. MAIN OBJECTIVE: To analyze the psychological and physiological clinical outcomes of olfactory aromatherapy and breathing exercises of yogatherapy, associated or individually, on the quality of life, subjective stress levels and intensity and frequency of hot flashes in women in the climacteric period. METHODS: 85 women in the climacteric period were evaluated, 64 of these subjects participated in Phase 1 (assessment) and 34 participated in Phase 2 (treatment) . Data collection was performed at CEPE-USP. The study consists of a doubleblind, pragmatic clinical trial with restricted randomization, controlled by control and placebo groups. The intervention was based on the psychoneuroendocrineimmunological model. Treatments were performed with inhalation of an aromatherapeutic synergy developed for the study with or without yogatherapy breathing exercises for 12 weeks, twice per week in one hour sessions. The study was approved by the ethics comitte Comite de Etica em Pesquisa da Escola de Educacao Fisica e Esporte da Universidade de Sao Paulo and was registered in clinicaltrials.gov. RESULTS AND DISCUSSION: The results showed statistically significant improvement in symptoms of menopause for the three intervention groups. There was significant decrease in symptom of hot flashes, as well as complaints of hot flashes and this symptom was eliminated in five subjects. The intensity and frequency of hot flashes decreased in all intervention groups and remained constant in the control group. Aromatherapy was more effective than yogatherapy to decrease the symptoms of hot flashes, when these treatments were applied separately. The combination of the two therapies proved beneficial, increasing the effectiveness and enhancing the improvement of the symptom of hot flashes. The overall effects of the treatments varied intensely for other climacteric symptoms. The improvement of vasomotor symptoms of menopause (hot flashes and night sweats), was accompanied by a significant improvement in stress levels, quality of sleep and quality of life in all intervention groups. This research also permitted secondary discussions about climacterium and the therapies, permiting their understanding through the psychoneuroendocrineimmunological model. CONCLUSION: This study served as a general outline of climacteric symptoms, aromatherapy and yogatherapy through the psychoneuroendocrineimmunological model. The results cannot be generalized to the population because of the small sample size. However, the most promissing results can be indicated and this research can be the starting point for further studies, assisting in the preparation of clear research questions and suitable research methods to study them .(AU)

Síndrome climatérico en mujeres de edad mediana desde un enfoque médico social / Climacteric syndrome in middle-aged women from a social medical approach

Se realizó un estudio descriptivo y transversal, a fin de describir las principales manifestaciones clínicas del síndrome climatérico en 341 mujeres de edad mediana que asistieron a la consulta especializada para la atención al climaterio y la menopausia del Hospital Dr Juan Bruno Zayas Alfonso de Santiago de Cuba, desde enero de 2009 hasta mayo de 2012. La edad promedio de las pacientes en la etapa perimenopáusica fue de 47,2 años, mientras que en las posmenopáusicas resultó ser de 49,4 años. Se aplicó la escala climatérica cubana, desde un enfoque médico social. En la posmenopausia artificial, los síntomas fueron muy molestos para 69,1 por ciento de las afectadas; asimismo, los sofocos predominaron en 88,2 por ciento, seguidos de las sudoraciones nocturnas en 82,7 por ciento de ellas. La depresión y el insomnio figuraron entre los síntomas psicológicos más relevantes, con 84,7 y 78,0 por ciento, respectivamente. La medicina natural y la terapia hormonal de reemplazo constituyeron las principales modalidades de tratamiento(AU)

A descriptive and cross-sectional study was conducted in order to describe the main clinical manifestations of the climacteric syndrome in 341 middle-aged women, who attended the specialized care for climacteric and menopause of Dr Juan Bruno Zayas Alfonso Hospital in Santiago de Cuba, from January 2009 to May 2012. The average age of patients in the perimenopausal stage was 47.2 years, while in postmenopausal women was found to be 49.4 years. The Cuban climacteric scale was applied from a social medical approach. In the artificial postmenopause, the symptoms were very bothersome for 69.1 percent of those affected; also, hot flashes prevailed in 88.2 percent, followed by the night sweats in 82.7 percent of them. Depression and insomnia were among the most significant psychological symptoms, with 84.7 and 78.0 percent, respectively. Natural medicine and hormone replacement therapy were the main treatment modalities(AU)

Eficacia de la terapia floral en trastornos de climaterio y menopausia / Effectiveness of flower essence therapy in climateriun and menopausia disorders

Se realizó un estudio de intervención terapéutica, aleatorizado, para evaluar la eficacia de la terapia floral en pacientes con trastornos de climaterio y menopausia. La muestra quedó establecida por 72 pacientes del sexo femenino con dichos trastornos, que acudieron a la consulta de Medicina Natural y Tradicional perteneciente al Policlínico Universitario Ramón López Peña de Santiago de Cuba, desde mayo del 2010 a enero del 2011. Un grupo estudio que se trató con terapia floral y el grupo control con tratamiento convencional medicamentoso. Se utilizó como medida de resumen, las frecuencias absolutas y el porcentaje. Como principales resultados obtuvimos que todas las pacientes tratadas con terapia floral mejoraron la mayor parte de los síntomas en los 21 días y sin reacciones adversas. Se concluyó que la terapia floral, constituye una opción de tratamiento en los trastornos asociados al climaterio y menopausia más efectivo que el tratamiento convencional como tratamiento único(AU)

It was performed a therapeutic, ramdomized, intervention research in order to evaluate the effectiveness of flower essence therapy in patients with climaterium and menopausia disorders. The sample was stablished by 72 female patients with these disorders, who assisted to the Natural and Traditional Medicine consult belonging to the University Polyclinic Ramon Lopez Peña of Santiago de Cuba, since May 2010 to January 2011. The group of study was treated with flower therapy and the control group with conventional medicine treatment. The measures for the summary were the absolute frequency and percentage. The results evidenced that all patients treated with flower therapy improved most of the symptoms within 21 days and without adverse reactions. It was concluded that flower essence therapy constitutes a treatment option for the disorders associated to climaterium and menopausia and it is more effective than the conventional treatment as the unique treatment(EU)

Effectiveness of phytoestrogens in climacteric medicine.

The increased interest in phytoestrogens in the management of menopausal symptoms followed the publication of the Women's Health Initiative study. A wide-spread perception that these plant-derived compounds are equivalent to estrogen was established. These compounds evolved to fulfill the needs of plant physiological processes and are natural for the plant cells but not natural to the human cell. Epidemiological data suggest a possible protective effect of phytoestrogen if consumed during adolescence, but later on in life this effect is not clear. The utility of phytoestrogen as a "natural and safe" alternative to estrogen in alleviating vasomotor symptoms has failed the test in randomized clinical trials. Because many breast cancer sufferers seek in phytoestrogen a relief of estrogen deficiency symptoms, the possible interaction of such remedies with risk of recurrence of breast cancer or interference with tamoxifen action should not be overlooked.

Posicionamiento de la Asociación Española para el Estudio de la Menopausia sobre el uso clínico de la Cimicífuga racemosa en el climaterio / Position statement of the Spanish Menopause Society on the Clinical Use of Cimicifuga racemosa during menopause

Objetivo: Dado el creciente interés en los países occidentales acerca de la utilización de ciertas plantas para el tratamiento de los síntomas relacionados con la menopausia, la AsociaciónEspañola para el Estudio de la Menopausia (AEEM)ha evaluado el papel de la Cimicífuga racemosa en el tratamiento de los síntomas climatéricos sobre la base de las mejores evidencias disponibles. Material y métodos. Se reunió un panel de expertos, clínicos e investigadores, en el campo dela fitoterapia. Los estudios seleccionados se obtuvieron mediante una búsqueda electrónica que incluyó buscadores de Internet, MEDLINE (1985-mayo 2008) y el Registro de Ensayos Clínicos Controlados Cochrane. Resultados: La mayoría de los estudios publicados en los últimos años están realizados con el extractoisopropanólico de Cimicífuga racemosa. La dosis más estudiada ha sido 40 mg/día y ha demostrado obtener una reducción moderada de las sofocaciones, sobre todo en las mujeres con sofocos más intensos, y una mejoría del estado de ánimo. Utilizada a las dosis recomendadas, no hay riesgo relevante desde el punto de vista hepático. Los datos disponibles sobre su efecto en la enfermedad cardiovascular, el hueso, la función cognitiva y la piel son muy escasos o inexistentes. Conclusiones: La Cimic ífuga racemosa es un tratamiento eficaz en el alivio de los síntomas vasomotores, al menos en una población adecuada de mujeres peri y posmenopáusicas, si bien se precisan mejores ensayos clínicos con suficiente número de pacientes incluidas y mayor duración del estudio (AU)

Objective: Due to an increasing interest in the symptoms related to menopause in western countries, the Spanish Menopause Society (SMS)has assessed the role of cimicifuga racemosa in relieving those symptoms based on the mostreliable evidence available. Material and methods: A meeting was held with a panel of experts, health scientists and researchers specialised in the field of phytotherapy. The studies selected were obtained through electronic search which included INTERNET, MEDLINE (1985-May 2008), and the Cochrane Controlled Clinical Trials Register. Results: Most studies published in recent years have been carried out using an isopropanol extract of cimicifuga racemosa. The dose most commonly studied was 40mg/day and was shown to result ina moderate decrease in hot flushes, particularly in those women with the most intense hot flushes, and an improvement in their mood. When recommended doses are used there is no significant risk to the hepatic system. Available data on the effect of cimicifuga racemosa on cardiovascular disease, bones, cognitive function or skin are scarce or non-existent. Conclusions: Cimicifuga racemosa is an effective treatment for relief of vasomotor symptoms, at least within a suitable population of peri- and postmenopausal women. Nevertheless, more accurate clinical trials which include sufficient numbers of patients and a longer follow-up are required (AU)

Terapêutica não hormonal no tratamento de distúrbios do climatério / Nonhormonal therapeutics in the treatment of climacteric disorders

Ondas de calor ou fogachos representam uma das queixas mais comuns entre as mulheres no período do climatério. A sua fisiopatologia é parcialmente conhecida. A terapia com estrogênios permanece como a mais efetiva para os sintomas vasomotores. No entanto, em decorrência de contraindicações ou pelos conceitos próprios do que seja seguro, muitas mulheres relutam em utilizá-la. Alguns tratamentos farmacológicos não hormonais têm sido avaliados em estudos randomizados, clínicos e prospectivos para alívio destes sintomas. Foi realizada revisão da literatura com o objetivo de descrever as opções não hormonais na abordagem dos sintomas vasomotores baseada nas evidências científicas disponíveis. Atualmente, os inibidores de recaptação seletiva da serotonina (SSRIs) e os inibidores de recaptação da serotonina e norepinefrina (SNRIs) são os agentes mais estudados para mulheres sintomáticas com ou sem história prévia de câncer de mama. Os dados sugerem que a paroxetina e a venlafaxina são os agentes mais efetivos, embora comparações diretas entre os diferentes agentes não tenham sido conduzidas. A gabapentina e a clonidina também se revelaram opções bem toleradas e eficazes. As isoflavonas apresentaram resultados conflitantes, provavelmente justificados pela falta de padronização das doses utilizadas

Hot flashes represent one of the most common complaints in climacteric, and its pathophysiology is partly known. The estrogen therapy remains as the most effective one for vasomotor symptoms. However, because of the contraindications or their own concepts about security, many women are reluctant to use it. Some pharmacological nonhormonal options have been evaluated in randomized clinical trials and prospective trials for the relief of the symptoms. The authors performed a review of the literature aiming at describing the nonhormonal options in the approach of the vasomotor symptoms based on the scientific evidence available. Currently, the selective serotonin reuptake inhibitors (SSRIs) and the selective serotonin and norepinephrine reuptake inhibitors (SNRIs) are the most analyzed drugs for symptomatic women with or without a history of breast cancer. Data suggest that paroxetine and venlafaxine are the most effective agents, though comparisons between different agents have not been done. Gabapentin and clonidine proved to be tolerable and effective options, too. Isoflavones presented conflicting results, probably due to the lack of standardization of the used doses

[Distribution characteristics of common syndrome types and syndrome elements extracted by experts' experience in perimenopausal and postmenopausal women].

OBJECTIVE: To compare the distribution characteristics of common syndrome types and syndrome elements of menopause syndrome in perimenopausal and postmenopausal women on the basis of standardized syndrome differentiation extracted by experts' experiences. METHODS: A total of 1 582 outpatients with menopause syndrome who met with the diagnosis and inclusion criteria in seven grade 3 hospitals from October 2006 to June 2007 were included. A clinical epidemiological survey in the patients was carried out. The syndrome elements of disease location and characteristics were extracted and analyzed statistically by standardizing the syndrome differentiation of experts' experience in traditional Chinese medicine. RESULTS: There were 105 syndrome types after initial standardization, and the common syndrome types were kidney yin deficiency, deficiency of liver and kidney yin, stagnation of liver qi, and deficiency of both kidney yin and yang. Six syndrome elements of the disease location were extracted, among which the common elements were kidney, liver, spleen and heart. Seventeen syndrome elements of the disease characteristics were extracted, among which the common elements were yin deficiency, qi stagnation, qi deficiency, yang deficiency and deficiency. Syndrome types of stagnation of liver qi, deficiency of spleen and kidney, and qi stagnation were more frequently diagnosed during perimenopausal period, while the syndrome type of kidney yin deficiency was more frequently diagnosed during postmenopausal period, and the kidney was the main disease location. The distribution characteristics of the other syndrome types and elements were similar during the two periods. CONCLUSION: The syndrome type distribution in women with menopause syndrome is complex, while the syndrome element distribution is simple. Generally, the syndrome type and syndrome element distributions during perimenopausal and postmenopausal periods are similar, but there are significant differences in some syndrome types and syndrome elements between the two periods. All of these can give support for revealing the distribution rule of the common syndrome types and syndrome elements and give a theoretical basis for clinical treatment of menopause syndrome.

Vasomotor symptoms and depression in women, part 2. Treatments that cause remission and prevent relapses of major depressive episodes overlap with treatments for vasomotor symptoms.

Vasomotor symptoms may be linked to changing levels of estrogen, which can affect levels of neurotransmitters and neural proteins that modulate the risk of depression in some women, thus serving as harbingers of oncoming depression or signs of incomplete recovery from a major depressive episode (MDE).¹â»4The question arises whether clinicians who normally diagnose and treat depression should also diagnose and treat vasomotor symptoms, and if so, how.

Confirmation of the efficacy of ERr 731 in perimenopausal women with menopausal symptoms.

OBJECTIVE: In a previous study, the special extract ERr 731 of Rheum rhaponticum significantly reduced vasomotor and other menopausal symptoms associated with perimenopause. This trial was conducted to confirm the efficacy of ERr 731. DESIGN: A multicenter, randomized, placebo-controlled, clinical trial with 112 perimenopausal women with menopausal symptoms receiving either 1 enteric-coated tablet of ERr 731 (n = 56) or placebo (n = 56) daily for 12 weeks. Primary outcome criterion for efficacy of ERr 731 compared to placebo was the change of the Menopause Rating Scale (MRS) total score from day 0 to day 84. Other efficacy assessments analyzed included the number and severity of hot flushes, individual symptoms of the MRS, treatment outcome, and various safety parameters. RESULTS: By 12 weeks, ERr 731 caused a highly significant reduction of the MRS total score from 27.0 +/- 4.7 points to 12.4 +/- 5.3 points when compared to the placebo-induced decrease from 27.0 +/- 5.3 points to 24.0 +/- 6.2 points (P < .0001). A significant reduction in each individual MRS item score, in hot flushes and the hot flush weekly weighted score, together with a marked improvement in treatment outcome were also observed (P < .0001). These results confirm the efficacy of ERr 731 in alleviating menopausal symptoms in perimenopausal women. Fourteen adverse events were reported in total: 11 by 5 women receiving ERr 731 and 3 by 3 women receiving placebo. ERr 731 was well tolerated by the majority of the women. CONCLUSION: ERr 731 was confirmed to be effective for the treatment of menopausal symptoms in perimenopause.

[Adrenopause]. / Adrenopauza.

The hypothalamic-pituitary-adrenal axis activity in the aging people is characterised by an unexplained reduction of dehydroepiandrosterone (DHEA) and its sulfate (DHEAS) secretion while ACTH and cortisol production remains relatively unchanged. This decline in the biological activity of the zona reticularis, referred to as 'adrenopause', may contribute to the physiology of human aging. The reduced endogenous concentrations of DHEA and DHEAS found in advancing age have been correlated with a constellation of health problems. Because these steroids seem to play a role in the maintenance of immunity, musculoskeletal integrity, and cardiovascular health, age-associated declines in adrenal androgen production may lead to decreased immune function, osteoporosis, and atherosclerosis. Despite clear benefits of DHEA administration in patients with adrenal insufficiency, the results of DHEA supplementation in healthy euadrenal subjects are not so clear-cut. Studies assessing its action on sexual function, metabolism and cardiovascular functions have provided conflicting results. This paper summarises the present state of knowledge on the age-related changes in adrenal androgen production and discusses pros and cons of DHEA use in older people.

Effects of aromatherapy massage on blood pressure and lipid profile in korean climacteric women.

This study investigated the effects of aromatherapy massage on the lipid profile and blood pressure in Korean climacteric women. A wait-listed control group, pretest-posttest design was used. The subjects comprised 58 climacteric women: 30 in the experimental group and 28 in the control group. Aromatherapy massage using lavender, rose geranium, rose, and jasmine was given to the experimental group only. Each massage session lasted 30 minutes, and was performed once weekly for two 8-week periods with self abdominal daily massage at home. The intervention produced significant differences in the systolic blood pressure compare to pretreatment and significant differences in systolic and diastolic blood pressures at posttreatment between the two groups. These results suggest that aromatherapy massage may exert positive effects on blood pressure. However, more objective, clinical measures should be applied in a future study with a randomized placebo-controlled design.

[Hormone replacement therapy: curse or blessing?]. / Hormonersatztherapie: Fluch oder Segen?

There is a controversial discussion on the risks and benefits of hormonal replacement therapy (HRT), and many women and doctors have revised their opinions of HRT over the last few years. Complementary and alternative therapies can be considered an option to treat menopausal symptoms. The following issue summarizes the actual knowledge of treatment options of menopausal symptoms.

[Complementary and alternative therapies for climacteric symptoms]. / Alternative Therapiemoglichkeiten im Klimakterium.

OBJECTIVE: Review on complementary and alternative therapies for climacteric symptoms. METHODS: Search for publications about complementary or alternative treatments for climacteric symptoms based on Cochrane Library and Medline (1966-2006) including the references from the identified clinical trials and reviews. RESULTS: Cimicifuga may influence climacteric symptoms, especially hot flushes. Results for phytoestrogens, hop and Salvia seem promising but are less convincing. St. John's wort is an option for the treatment of moderate depressive symptoms. Phytoestrogens seem to have some potential for the prevention of osteoporosis and cardiovascular diseases. Results for the influence of lifestyle on hot flushes are conflicting, but interventions have demonstrated their use for the prevention of osteoporosis and cardiovascular diseases. CONCLUSIONS: Lifestyle modifications, Cimicifuga and phytoestrogens may relieve climacteric symptoms. Phytoestrogens and Cimicifuga should not be given to breast cancer survivors.

Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To investigate the efficacy and safety of the special extract ERr 731 from the roots of Rheum rhaponticum compared to placebo in perimenopausal women with climacteric complaints. DESIGN: A multicenter, prospective, randomized, double-blind, placebo-controlled, clinical trial in which 109 women with climacteric complaints received either one enteric-coated tablet of ERr 731 (n = 54) or placebo (n = 55) daily for 12 weeks. Primary outcome criterion for efficacy was the change in Menopause Rating Scale II (MRS II) total score after 12 weeks. Other efficacy assessments analyzed number and severity of hot flushes, menopause-specific quality of life, number of bleeding/spotting days, and treatment outcome. RESULTS: By 12 weeks, the MRS II total score and each MRS II symptom significantly decreased in the ERr 731 group compared to the placebo group (P < 0.0001). After 4 weeks, ERr 731 also significantly decreased the number and severity of hot flushes (P < 0.0001). After 12 weeks, the overall menopause-specific quality of life was significantly better in women treated with ERr 731 compared with placebo (P < 0.05). Treatment outcome assessed by investigators and participants was better in the ERr 731 group, and ERr 731 was better tolerated than placebo. There were no differences in gynecological findings including endometrial biopsies, bleeding, weight, blood pressure, pulse, and laboratory safety parameters between the treatment groups. No adverse events were classified as being related to the investigational medication. CONCLUSIONS: Compared to placebo, ERr 731 significantly reduces the occurrence and severity of climacteric complaints in perimenopause. It is also safe and well tolerated.

Ovarian cortical transplantation may be an alternative to hormone therapy in patients with early climacterium.

OBJECTIVE: To discuss the 18-month follow-up results of fresh ovarian cortical tissue transplant. DESIGN: Case study. SETTING: Academic medical center. PATIENT(S): A 46-year-old patient who was operated on for uterine fibroids, and who then received an ovarian tissue transplant in July 2003. INTERVENTION(S): Serum hormone levels were measured at 3-month intervals. MAIN OUTCOME MEASURE(S): Follicular development evident by ultrasound examination; serum hormone levels (FSH, LH, E2). RESULT(S): Preoperative and 3rd-, 6th-, 9th-, 12th-, 15th-, and 18th-month hormone levels were, respectively, as follows: FSH: 9.06, 79.5, 13.7, 16.66, 51.91, 44.37, and 24.17 mIU/mL; LH: 5.91, 33.92, 8.78, 21.83, 38.31, 40.85, and 22.4 mIU/mL; E2: 166, 46, 48, 117, 31, 14.4, and 137.7 pg/mL. Folliculogenesis was confirmed by ultrasonography at the 6th, 9th, and 18th months during the follow-up period. CONCLUSION(S): Fresh ovarian autotransplantation may be a logical alternative for hormonal support for a specific patient group.