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Treating hot flushes in menopausal women with homeopathic treatment - Results of an observational study

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Abstract

There is great controversy concerning treatment for menopausal symptoms. We evaluated homeopathic treatments for hot flushes and their effect on quality of life in menopausal women. Open, multi-national prospective, pragmatic and non-comparative observational study of homeopathic treatments prescribed and their effectiveness, observing their impact on quality of life. Ninety-nine physicians in 8 countries took part in this study and included 438 patients with an average age of 55. Homeopathic medicines were prescribed to all patients; 98% of the prescription lines were for homeopathic medicines. Lachesis mutus, Belladonna, Sepia officinalis, Sulphur and Sanguinaria canadensis were the most prescribed. A non-homeopathic treatment and/or food supplement prescribed for 5% of the patients. This observational study revealed a significant reduction (p<0.001) in the frequency of hot flushes by day and night and a significant reduction in the daily discomfort they caused (mean fall of 3.6 and 3.8 points respectively, on a 10cm visual analogue scale; p<0.001). Ninety percent of the women reported disappearance or lessening of their symptoms, these changes mostly taking place within 15 days of starting homeopathic treatment. The results of this observational study suggest that homeopathic treatment for hot flushes in menopausal women is effective. Further studies including randomized controlled trials should be conducted.

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... Klimaktoplan Ò (KP) is a homeopathic drug comprised of four natural products (Cimicifuga racemosais (black cohosh), Sepia officinalis, Strychnos ignatii, and Sanguinaria canadensis) that has been widely used for a long time for relief of menopausal symptoms in several European countries [7][8][9][10][11][12]. Although Cimicifuga racemosa preparations do not contain isoflavones or display estrogenic systemic activity [13][14][15][16], do not change the levels of 17-beta estradiol (E2), follicle-stimulating hormone or luteinizing hormone, and affect vaginal maturation [17], Cimicifuga racemosa is effective on vasomotor symptom of postmenopausal women due to the serotonin partial agonist action [18]. ...
... Although Cimicifuga racemosa preparations do not contain isoflavones or display estrogenic systemic activity [13][14][15][16], do not change the levels of 17-beta estradiol (E2), follicle-stimulating hormone or luteinizing hormone, and affect vaginal maturation [17], Cimicifuga racemosa is effective on vasomotor symptom of postmenopausal women due to the serotonin partial agonist action [18]. Sepia officinalis normalizes the function of the hypothalamic-pituitary-gonadal axis, eliminates hyperhidrosis and headaches, and alleviates depression, irritability, apathy and indifference [9]. Strychnos ignatii relieves depression, irritability, cyclical mood fluctuations, and lack of self-confidence [11]. ...
... Strychnos ignatii relieves depression, irritability, cyclical mood fluctuations, and lack of self-confidence [11]. Sanguinaria canadensis normalizes vascular tone and eliminates migraine headaches, hot flushes, and palpitations [7,9,10]. ...
Article
Objective: With the health concerns of menopausal hormone replacement therapy, alternatives have been sought. Klimaktoplan® is a homeopathic formulation consisting of four main components and has been used for relief of menopausal symptoms for a long time. The study investigated the safety of Klimaktoplan® through its effect on the proliferation of breast cancer (MCF-7) and non-malignant mammary epithelial cells (MCF-10A). Methods: MCF-7 and MCF-10A cells were cultured in 312.5, 625, and 1,250 μg/ml Klimaktoplan®. 17-Beta estradiol (E2) and medroxyprogesterone 17-acetate (MPA) were used for comparison with Klimaktoplan®. E2 only (0.001, 0.01, and 0.1 μM), and the combination of E2 (0.001, 0.01, and 0.1 μM) and MPA (0.01, 0.1, and 1 μM) were tested. Control cells for Klimaktoplan® and E2 groups were treated with dimethylsulfoxide (DMSO), and DMSO + ethanol was used for the combination group. Cellular proliferation was evaluated by the formation of insoluble formazan after incubation of 4 days. Results: Klimaktoplan® had a concentration-dependent anti-proliferative effect on breast cancer cells at 625 and 1,250 μg/ml, while not affecting proliferation of non-malignant mammary cells at any tested concentration. The effect of lactose was evaluated as lactose (the adjuvant of Klimaktoplan®) affect cell growth. E2 and lactose increased the proliferation of both malignant and non-malignant cells. The effect of E2 + MPA on the proliferation of malignant and non-malignant mammary cells was lower than estradiol only, but was higher than control. Conclusions: Klimaktoplan® has an anti-proliferative effect on breast cancer cells, but not for non-malignant mammary epithelial cells, unlike E2 and E2 + P. With further research, KP would be a good alternative or additive in women with menopausal symptoms who wish to avoid conventional E or E + P hormone therapy.
... 14 The observational study on treatment of hot flashes with homeopathy in 438 patients revealed a significant reduction ( p < 0.001) in the frequency of HF and in daily discomfort they cause. 15 An audit report of a National Health Service community menopause clinic through homeopathic intervention suggested that the greatest response was in those who reported headaches, vasomotor symptoms, emotional/psychologic symptoms, and tiredness/fatigue as their primary symptoms. 16 Randomized clinical trials (RCTs) on homeopathy for menopausal symptoms 17 and estrogen withdrawal symptoms 18 in breast cancer survivors did not show the statistically significant results as the primary outcome measure for homeopathy over placebo. ...
... Each symptom in DDCYSS was quantified considering its frequency, duration, and intensity by attributing scores 0-4. Depending upon the baseline symptom score, the intensity of the distress was classified into mild (4-11), moderate (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24), and severe (25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36). Also, every patient was subjected to per vagina and/or per speculum examination as required at the baseline. ...
... Homeopathic treatment was found to be effective in HF, [13][14][15] vasomotor symptoms, emotional/psychologic symptoms, and fatigue. 16 It was observed that the medicines found frequently indicated and useful were Sepia, Lachesis, Sulphur, Pulsatilla, Nat.mur. ...
Article
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The purpose of this study was to ascertain the usefulness of homeopathic therapy in the management of distressing symptoms encountered during climacteric years in women (primary objective) and also the changes brought about in the levels of follicle-stimulating hormone (FSH) and lipid profile in these women after homeopathic treatment (secondary objective). An open, multicenter, prospective, observational study was carried out to ascertain the usefulness of homeopathic treatment in distress during climacteric years (DDCY). Patients were enrolled from the general outpatient department of the six Institutes/Units of Central Council for Research in Homoeopathy (CCRH) and were required to complete a follow-up period of 1 year as per the protocol designed by the CCRH. A uniform questionnaire assessing 15 predefined symptoms of menopause was adopted, with assessment of each symptom at every visit. Levels of serum FSH and lipid profile were monitored at entry and at completion. Effect size of the study was also calculated. CARA Software was used for repertorization of the presenting symptoms of menopause along with the characteristic attributes of each patient to arrive at a simillimum. The selected medicine was prescribed in a single dose as per the homeopathic principles. The assessment of the results was made through statistical analysis using the Wilcoxon signed rank test on Statistical Package for Social Sciences (SPSS) comparing symptom score at entry and completion of 1 year of treatment and t test for analyzing improvement in laboratory findings. Homeopathic therapy was found to be useful in relieving menopausal distressing symptoms such as hot flashes, night sweats, anxiety, palpitation, depression, insomnia, and so on. Influence on serum levels of FSH, high-density lipoprotein, and low-density lipoprotein was not significant but serum levels of cholesterol, triglycerides, and very-low-density lipoprotein decreased significantly. Effect size of the study was found to be large. The medicines found to be most frequently indicated and useful were Sepia, Lachesis, Calcarea carb., Lycopodium, and Sulphur. This study proves the usefulness of homeopathic medicines in relieving DDCY.
... The evidence demonstrates an association between homeopathic treatment and improvement in fatigue, hot flushes, anxiety, depression and quality of life for menopausal women and breast cancer survivors. More homeopathic research is needed specially in the menopausal time period where there is a lack of well-designed RCTs [27,28]. At moment, although homeopathy is frequently prescribed for psychiatric conditions, the need for more high-quality RCTs has been identified [29,30]. ...
... At moment, although homeopathy is frequently prescribed for psychiatric conditions, the need for more high-quality RCTs has been identified [29,30]. Meta-analyses and systematic reviews have drawn mixed conclusions as to whether homeopathy is more effective than placebo in general medicine [26,[23][24][25][26][27][28][29][30][31][32][33][34][35]. Few RCTs of homeopathy and placebo in psychiatry have been performed. ...
Article
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Perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression.A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test).After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.ClinicalTrials.gov NCT01635218.https://clinicaltrials.gov/ct2/show/NCT01635218 [corrected].
... [27,28] The efficacy of these homeopathic medicines in the management of hot flashes has been described in large-scale observational studies. [29,30] In France, the agent BRN-01 (Actheáne Ò ) is commercially available as a homeopathic combination for this indication. As such, it seemed important to evaluate its efficacy and safety in a randomized , double-blind, placebo-controlled therapeutic trial. ...
... ily and nightly hot flashes (p < 0.001) between the enrollment visit and the follow-up visit 2-6 months later. Among those women, 19.4% reported the disappearance of their hot flashes and 70.3% felt an improvement from the first 15 days of treatment onward. They also described a decrease in their daily discomfort and sleep disturbances (p < 0.001). [30] Most of the components found in the composition of BRN-01 were present in the different homeopathic treatments described in those studies, at different homeopathic dilutions: A. racemosa, A. montana, Glonoinum, L. mutus, and S. canadensis. L. mutus is traditionally used for its effects in vascular phenomena such as hot flashes, metrorrh ...
Article
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Background: Homeopathic medicines have a place among the non-hormonal therapies for the treatment of hot flashes during the menopause. Objective: The objective of this study was to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women. Study design: This was a multicenter, randomized, double-blind, placebo-controlled study carried out between June 2010 and July 2011. Setting: The study was conducted in 35 active centers in France (gynecologists in private practice). Patients: One hundred and eight menopausal women, ≥ 50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥ 5 hot flashes per day with a significant negative effect on the women's professional and/or personal life. Intervention: Treatment was either BRN-01 tablets, a registered homeopathic medicine containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or identical placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrollment and was continued for 12 weeks. Main outcome measure: The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded. Results: One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01. Conclusion: BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication. Trial registration number (EudraCT): 2009-016959-21.
... El presente trabajo tiene como objetivo evaluar la efectividad de la terapéutica homeopática en el climaterio en mujeres mexicanas con el uso de la Menopause Rating Scale o Escala de Calificación Menopáusica (MRS, por sus siglas en inglés). La MRS es un instrumento de medición de la calidad de vida específicamente desarrollado para su aplicación en el climaterio, y ha sido utilizado para evaluar el climaterio en otras poblaciones [18][19][20][21][22][23] . El uso de la MRS en esta investigación busca evidenciar de forma objetiva la efectividad de la terapéutica homeopática en dichos síntomas. ...
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Evaluación del Tratamiento Homeopático de Mujeres en Climaterio entre los 45 y 60 años con la Menopause Rating Scale (MRS) Resumen La terapia hormonal es el tratamiento convencional para contrarrestar síntomas propios del climaterio; sin embargo, algunas mujeres tienen contraindicada esta terapia debido a los efectos adversos que provoca. El objetivo de este estudio fue evaluar la utilidad del tratamiento homeopático durante el climaterio con el uso de la Menopause Rating Scale (MRS) o Escala de Calificación Menopáusica. El estudio incluyó a 31 mujeres, sin problemas cardiacos, sin terapia de reemplazo hormonal y sin antecedentes de cáncer, a quienes se les aplicó el cues-tionario de la MRS para obtener un puntuaje antes del tratamiento. Para determinar el tratamiento se utilizó el repertorio electrónico Radar 10.0 para Windows, con el objetivo de repertorizar los síntomas característicos de cada paciente y determinar el medicamento similar. El medicamento fue prescrito en dinamizaciones 30CH, indicando 5 gotas sublinguales cada 8 horas. La evaluación de los pacientes se llevó a cabo cada mes durante tres meses. Se realizó una evaluación final a los tres meses por comparación de puntajes de la escala inicial y final, a través de un análisis estadístico y utilizando la prueba de Wilcoxon. Lachesis trigonocephalus y Pulsatilla nigricans fueron los medicamentos indicados con mayor frecuencia, de acuerdo con los síntomas de cada paciente. La comparación del puntaje, antes y después del tratamiento, evidenció una reducción de síntomas con diferencia estadística, lo cual reflejó una mejoría global del 35%. Esta evi-dencia sugiere que el tratamiento homeopático beneficia a las mujeres en el climaterio.
... The majority of change took place in the first 15 days of treatment. 29 Greene in an insightful review of observational studies challenges the notion that observational studies and randomized clinical trials are in competition with each other. 30 In fact they reflect a complete process with an initial step of observation followed by experimentation, and that first step is used to uncover patterns and formulate hypotheses regarding cause-and-effect relationships. ...
Article
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Homeopathy is a system of therapeutics placed outside the boundaries of orthodox medicine and regarded as a complementary and alternative medicine. Homeopathy has been used to alleviate menopausal symptoms both in the climacteric and in breast cancer survivors. Individualized treatment by a homeopath, regarded as the gold standard of homeopathic care, is a complex intervention where the homeopathic medicine is matched to the individual using holistic principles. This review article describes and interprets the existing evidence from observational studies and clinical trials and makes recommendations for trial design in the future.
... On retrouve également des méta analyses (Commission Européenne, 1996;Cucherat et al., 2000;Jonas, 2003;Kleijnen et al., 1991;Linde et al., 1994;Linde et al., 1997;Mathie, 2003;Reilly et al., 1994;Smith, 2003), des études sur le développement de la recherche (ECCH, 2007;Eisenberg et Kaptchuk, 2003;Fisher, 1995 La preuve de l'efficacité d'une thérapeutique passe également par les recherches fondamentales. En homéopathie, on retrouve entre autres des études sur le mécanisme 31 On peut donner comme exemples les recherches sur des conditions comme les diarrhées chez les enfants (Jacobs, 1994;Jacobs et al., 2000), les otites (Frei et al., 2001;Friese et al., 1997;Hanison et al., 1999;Jacobs et al., 2001), problèmes musculo squelettiques (Fisher, 1986;Gibson et al., 1980;Shealy et al., 1998), la fibromyalgie (Bell et al., 2004;Fisher et al., 1989), les allergies (Kim et al., 2005;Reilly et al., 1985;Reilly et al., 1994;Taylor et al., 2000), les blessures (Schneider et al., 2008), les céphalées (Muscari Tomaioli et al., 2001), le désordre de déficit d'attention (Coulter, 2008;Frei et al., 2005;Kenyon, 1993;Lamont, 1998), les troubles reliés à la ménopause (Bordet et al., 2008;Clover et Ratsey, 2002;Relton et Weatherley-Jones, 2005;Thomas et al., 2001;Thompson et Reilly, 2003), la dépression (Bell, 2005;Makich et al., 2007;Pilkington et al, 2005), les troubles reliés à la période prémenstruelle (Yakir et al., 2001;Jones, 2003), les problèmes de fertilité (Bergmann et al., 2000), la fatigue chronique (Weatherly- Jones et al., 2004), les affections du système respiratoire (Adler, 1999;Riley et al., 2001;Trichard et al., 1994;Trichard et al., 2005), les troubles cutanés (Itamura, 2007;Keil et al., 2008), la sclérose en plaques (Saine, 1987;Whitmarsh, 2003), la paralysie cérébrale (Sajedi et al., 2008), les soins palliatifs, le cancer (Bhattacharjee et al., 2007;Ramakrishnan et Coulter, 2001). d'action du remède, en immunologie ou en physique (Bastide, 1997(Bastide, , 2001Belon et al., 2004;Coulter, 1980;Gray, 2000;Halm, 2005;Lorenz et al., 2003) et des travaux théoriques sur des nouveaux modèles d'analyse (Bastide, 1999;Conte et al., 2000;ECCH, 2005;ECH, 2005;Lagache, 1997b;Walach et al., 2005). ...
Article
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La médecine homéopathique fait partie de ce que certains auteurs nomment maintenant « les systèmes complexes » propres aux médecines non conventionnelles (MNC). Ces médecines ne s'inscrivent pas de la même manière que les médecines alternatives et complémentaires (MAC) dans la réalité médicale ou sociale. Certaines recherches sociologiques ont été faites à propos des MNC ou des MAC, toutes thérapies confondues, mais très peu exclusivement sur la médecine homéopathique. L'homéopathie est à la fois, la plus controversée des MNC et la plus utilisée dans le monde. Comme dans la plupart des sociétés occidentales, le recours à la consultation en médecine homéopathique est en croissance constante, mais n'a pas chez nous de légitimité juridique. Dans ce contexte social, comment les gens arrivent-ils à consulter un homéopathe et pour quelles raisons ? Pourquoi adoptent-ils par la suite, cette pratique de santé? Quel en est l'impact médical et social sur leur santé à long terme et dans leur vie? Pour répondre à ces questions il est nécessaire de considérer d'abord le paradigme holiste selon lequel la médecine homéopathique aborde la santé, la maladie et les soins de santé. Ensuite, il convient de tenir compte de la façon dont l'homéopathe s'adresse à la personne qui consulte en l'envisageant comme un sujet actif, savant et compétant. Cette recherche, prenant la perspective du constructivisme social féministe et se servant de l'analyse thématique descriptive, présente le résultat de l'étude d'entrevues menées auprès de mères québécoises qui ont consulté un ou une homéopathe pour elles-mêmes et leurs enfants. En redonnant la place à leur discours et à leur expertise, ces femmes nous révèlent la complexe démarche qui les a conduites à la consultation en médecine homéopathique, les transformations qui s'y sont opérées à travers un empowerment et leur perception sur l'efficacité sans équivoque de cette médecine face à leurs divers problèmes de santé. Cette étude dévoile ainsi la singularité de la consultation homéopathique comme espace social unique, laquelle autorise un partage des savoirs, un apprentissage incomparable sur le couple santé-maladie et pourrait représenter une solution à long terme pour les besoins de santé d'une population. ______________________________________________________________________________ MOTS-CLÉS DE L’AUTEUR : Santé, Médecine homéopathique, Efficacité, Sociologie, Pratique de santé, Mères, Constructivisme social féministe, Consultation médicale.
... Homeopathy: Many homeopathic medicines have been used in the treatment of VMS, including Lachesis mutus, Belladonna, Sepia offi cinalis, Sulphur, Sanguinaria canadensis, and Amylium nitrosum. 50 To date, two randomized placebo-controlled studies have evaluated the use of homeopathic medicine either alone or in combination. 51 At present, the use of a single homeopathic medicine is not the gold standard in homeopathic care, as the numbers in these trials were too small to provide meaningful results. ...
Article
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Background: New breast cancers occur in 25% to 30% of women < 50 years of age. These young women undergo ablative surgery, chemotherapy, or hormonal/targeted treatment. These treatments have resulted in increased survival but at the expense of early menopause, marked by distressing vasomotor symptoms, sexual dysfunction, decreased metabolism, and musculoskeletal and cardiovascular effects. Methods: A comprehensive literature search was performed using PubMed. This article reviews the evidence-based approaches to the treatment of these distressing symptoms in young breast cancer survivors. Results: Menopausal symptoms in young patients are typically more severe due to the abrupt and rapid decrease in estrogen, and chemotherapy and hormones worsen these symptoms. Evidence supporting the efficacy of most complementary therapies is scarce. Behavioral modification and yoga may be helpful in mild cases of vasomotor symptoms, whereas newer antidepressants are promising in moderate to severe cases, and stellate ganglion block may be used in refractory cases. Local vaginal moisturizers, and in refractory cases low-dose estrogen creams, may ameliorate most urogenital symptoms. Bisphosphonates, vitamin D, and calcium can treat osteoporosis, and weight-bearing exercises decrease bone mineral density loss and help to control weight. Smoking cessation, exercise, and dietary modifications should be recommended to all young patients to decrease cardiac morbidity. At present, there is insufficient evidence to support any natural agent as a viable alternative to hormone replacement therapy to treat these symptoms. Conclusions: No single agent can ameliorate vasomotor, cardiac, skeletal, and sexual concerns of young breast cancer survivors coping with menopausal symptoms. Quality-of-life research involving premenopausal breast cancer survivors is lacking. Further study is needed to identify safe and effective treatments for menopausal symptoms and to confirm their long-term safety in young breast cancer survivors.
... 127 A third observational study of 438 women without cancer showed a reduction in the frequency of hot flashes and in daily discomfort. 210 In contrast, 2 randomized controlled trials of homeopathy for menopausal symptoms in breast cancer survivors failed to find any benefits over placebo. 128,129 Vitamins Vitamin E has received attention as possible treatment for the alleviation of hot flashes since the 1940s 211 and has been studied in 3 clinical trials. ...
Article
Answer questions and earn CME/CNE Hot flashes are prevalent and severe symptoms that can interfere with mood, sleep, and quality of life for women and men with cancer. The purpose of this article is to review existing literature on the risk factors, pathophysiology, and treatment of hot flashes in individuals with cancer. Electronic searches were conducted to identify relevant English-language literature published through June 15, 2012. Results indicated that risk factors for hot flashes in cancer include patient-related factors (eg, age, race/ethnicity, educational level, smoking history, cardiovascular risk including body mass index, and genetics) and disease-related factors (eg, cancer diagnosis and dose/type of treatment). In addition, although the pathophysiology of hot flashes has remained elusive, these symptoms are likely attributable to disruptions in thermoregulation and neurochemicals. Therapies that have been offered or tested fall into 4 broad categories: pharmacological, nutraceutical, surgical, and complementary/behavioral strategies. The evidence base for this broad range of therapies varies, with some treatments not yet having been fully tested or showing equivocal results. The evidence base surrounding all therapies is evaluated to enhance hot flash treatment decision-making by clinicians and patients. CA Cancer J Clin 2013;. © 2013 American Cancer Society.
... Une équipe française a publié une étude d'observation conduite sur les bouffées de chaleur de la ménopause 1 . Dans cette étude effectuée auprès de 157 médecins généralistes ou gynécologues volontaires dans 8 pays, et portant sur 438 patients suivis, l'efficacité en pratique réelle de l'homéopathie s'est avérée positive pour les patientes : disparition des symptômes chez 83 d'entre elles et réduction significative chez 301 femmes recrutées. ...
... Bordet et al. conducted a multi-national prospective non-comparative observational study of homeopathic treatments for hot flushes and suggest that further investigation is justified [29]. Jacobs et al. conducted a randomized, double-blind study versus placebo performed over one year with 83 women suffering from breast cancer; patients received either individualized homeopathic treatment or a homeopathic complex or a placebo. ...
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Background: The perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depressive symptoms. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression. In classical homeopathy, an individually selected homeopathic remedy is prescribed after a complete case history of the patient. The aim of this study is to assess the efficacy and safety of the homeopathic individualized treatment versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. Methods/design: A randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a six-week follow-up study was designed. The study will be conducted in a public research hospital in Mexico City (Juárez de México Hospital) in the outpatient service of homeopathy. One hundred eighty nine peri- and postmenopausal women diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (moderate to severe intensity) will be included. The primary outcome is change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression after the fourth and sixth week of treatment. Secondary outcomes are: Beck Depression Inventory change in mean score, Greene's Scale change in mean score, response and remission rates and safety. Efficacy data will be analyzed in the intention-to-treat population. To determine differences in the primary and secondary outcomes among groups at baseline and weeks four and six, data will be analyzed by analysis of variance for independent measures with the Bonferroni post-hoc test. Discussion: This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic individualized treatment using C-potencies versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. It is an attempt to deal with the obstacles of homeopathic research due to the need for individual prescriptions in one of the most common psychiatric diseases. Trial registration: ClinicalTrials.gov Identifier: NCT01635218.
... 38 Hot flushes was relieved by about 40% to 50% in a observational study on homoeopathy. Moreover, Bordet et al. 39 reported that significant improvement was seen during both day and night hot flushes in their study performed in 2008. However, the results of randomized controlled study on homeopathy was insufficient to prove its positive effects on improvement of vasomotor symptoms. ...
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Vasomotor symptoms start about 2 years prior to menopause in women who are approaching menopause, and early menopause symptoms appear including emotional disturbance and anxiety, followed by physical changes such as vaginal dryness, urinary incontinence and skin wrinkles. As time progresses, osteoporosis, cardiovascular diseases, and dementia occur consecutively. Hormone therapy is primarily considered for the relief of menopause symptoms in postmenopausal women. However, as hormone replacement has emerged as a therapy that increases the potential risk of thrombosis, cerebral infarction and breast cancer, complementary and alternative medicine has drawn much attention. This study aimed to examine the types and effects of evidence-based complementary and alternative therapies that are currently used.
... Homeopathy has been used since 1990. 23 More recently Bulgarian authors have started analysing the wide-spread utilisation of dietary food supplements against minor ailments. [24][25][26] No published data about CAM use by children are available. ...
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Introduction: Few data document the use of complementary and alternative medicine (CAM) in Europe, with even fewer investigating use by children. Methods: A narrative, non-systematic review of CAM use in Europe was performed by combining data from published surveys with expert perspectives. Limitations created by a lack of representative studies, varying definitions of CAM use, and what qualifies as CAM in different countries was partially overcome by integrating local experts to summarise information available only in the national language and provide their perspectives about CAM availability, quality, use and popularity in their countries using a semi-structured questionnaire. Local and international published surveys were summarised, and the prevalence of CAM use was extrapolated. Results: Data from 20 European countries were available, representing 69% of the European population. Some data about CAM use by the general population were available for 90% of the examined countries, whereas peer-reviewed published surveys were available for only 60%. We extrapolated that 56% (range: 10-90%, adjusted for population size) of the European population in general had used CAM at least once in the past year. Surveys in CAM use by children were available for 55% of the investigated countries. The extrapolated prevalence of CAM use by children in Europe was 52% (range: 5-90%, adjusted for population size). Paediatric CAM experts reported an increasing awareness for and use of CAM in healthcare institutions. Conclusion: This precursor for further surveys indicates that CAM appears to be popular not only among adults in Europe, but also for children. Development of a pan-European definition of CAM use and CAM therapies are required to achieve surveys comparable between European countries. Additionally, more research investigating the efficacy and potential adverse effects of CAM therapies is needed because of increasing CAM use by children in Europe.
... An observational study of various homeopathic treatments in 438 patients with menopausal symptoms found S. canadensis remedies ranked fifth most likely out of 16 remedies to result in symptom disappearance or improvement. However, the study type and design prevented an assessment of efficacy [257]. ...
Article
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Sanguinaria canadensis, also known as bloodroot, is a traditional medicine used by Native Americans to treat a diverse range of clinical conditions. The plants rhizome contains several alkaloids that individually target multiple molecular processes. These bioactive compounds, mechanistically correlate with the plant’s history of ethnobotanical use. Despite their identification over 50 years ago, the alkaloids of S. canadensis have not been developed into successful therapeutic agents. Instead, they have been associated with clinical toxicities ranging from mouthwash induced leukoplakia to cancer salve necrosis and treatment failure. This review explores the historical use of S. canadensis, the molecular actions of the benzophenanthridine and protopin alkaloids it contains, and explores natural alkaloid variation as a possible rationale for the inconsistent efficacy and toxicities encountered by S. canadensis therapies. Current veterinary and medicinal uses of the plant are studied with an assessment of obstacles to the pharmaceutical development of S. canadensis alkaloid based therapeutics.
... Clinical studies have shown homeopathy to potentially reduce many of the toxic effects of oncology treatments, while improving global health and well-being. 10 These include cancer-related fatigue, 11 hot flashes due to hormonal treatment in patients with breast cancer, [12][13][14][15][16] and radiation-induced dermatitis. 17,18 A 2009 Cochrane review on the benefits of homeopathy identified 8 clinical trials that were of adequate quality (n = 664), and though the review did not find any clear evidence for the effectiveness of homeopathy for treatment-related outcomes (ie, survival), it did suggest a beneficial impact in reducing radiation-induced dermatitis and chemotherapy-induced stomatitis. ...
Research
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Background: Homeopathy has the potential to reduce symptoms related to cancer treatment. The present study examined the feasibility of a homeopathic consultation and treatment program, provided as part of an integrative oncology service. Methods: The electronic medical files of patients undergoing a homeopathic consultation in an integrative oncology service clinic were examined retrospectively. Adherence to the homeopathic treatment regimen and perceived response to the treatment were evaluated. Results: The files of 124 patient (34 males, 90 females) were examined, of which two-thirds reported acquiring and self-administering the homeopathic remedy as prescribed, and nearly three-quarters reporting a beneficial effect. Adherence to the homeopathic treatment regimen was greatest among patients attending a second visit, as opposed to having only telephone/e-mail follow-up (P < .005). An association was found between a perceived beneficial effect of treatment with attending a follow-up visit (P = .04), female gender (P = .02), younger age (P = .048), diagnosis of breast cancer (P = .014), and current radiation treatment (vs chemotherapy; P = .003). Patients reporting chemotherapy-induced peripheral neuropathy were also more likely to report a beneficial effect (P = .004), as were female patients reporting hot flashes (P = .005) and those referred by an oncologist (P = .046). No adverse effects were attributed to the homeopathic treatment. Conclusions: Homeopathy can be successfully incorporated within a supportive care integrative oncology service. In addition to demographic and cancer-related characteristics, as well as symptoms, patients attending a second visit (vs only telephone/e-mail follow-up) were more likely to adhere to and perceive a beneficial effect from the homeopathic regimen.
... In Homoeopathy, the fresh root is used to prepare mother tincture, it is reported to affect circulation producing congestion locally and depression of cardiac action; in mucous membrane it initially causes dryness followed by catarrh; in Uterus and ovaries it has produces polyp and excessive bleeding; in nervous system it leads to excitement [17] . It is mainly used in management of right sided Migraine [18] of periodical nature better by sleep, arthritis and climacteric problems [19][20][21] . A study conducted by Andrew croaker et al, shows that Homoeopathy formulations Hylands menopause treatment for climacteric complaints and Zee formulation for osteoarthritis with Sanguinaria canadensis as one of its content, improved the patients complaints [14] . ...
Article
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Viral infections affect respiratory tract commonly, Most of the infections are mild and in some it would be severe with direct or indirect complications. Homoeopathic medicines are extensively used to treat influenza since long time. Several of those medicines have been possess anti-viral properties in ultra-diluted doses. Similarity in the pharmacodynamic properties and patient signs are the basis of Homoeopathic treatment. The curing property of these drugs is based on its disease causing property. Sanguinaria canadensis is one such important medicine used in Homoeopathy to treat influenza and its complications, both individually as well as in combination preparations. The signs and symptoms of most of the severe viral respiratory infections are similar to that of the drug proving observations on Sangunaria canadensis. The Sangunaraia respiratory symptoms are observed along with gastric and cardiac symptoms. The symptoms observed and recorded in Homoeopathic repertories are very similar to that of influenza like illness ranging from mild to severe respiratory illnesses. Secondary Metabolites action of Sangunaria canadensis displays antiviral activity impeding HIV protease. Protopine in addition to allocryptopine are more vigorous against Parainfluenza Virus-3. Sanguinarine is seen as the inhibitor of aminopeptidase A, dipeptidyl peptidase IV and aminopeptidase N. APN inhibitors could meddle in certain processes of the pathogenetic course of aggravation, tumor infiltration through the basal membrane and viral infection. Numerous plants produce Antiviral phyto-constituents which can target viral proteins, lipid envelope, and viral nucleic acids. DNA-intercalating drugs curb DNA and RNA polymerases and protein biosynthesis, and diminish viral replication. Fundamental oils and polyphenols are dynamic against the free infection, the intercalators can likewise repress the viral replication inside the host cell. Among the intercalating PSMs, alkaloids of the isoquinoline, quinoline and β-carboline type give a few incredible antiviral mixes to model. sanguinarine, in Sanguinaria canadensis is a solid DNA intercalator with articulated cytotoxic, antibacterial and antiviral properties. Homoeopathic dynamizations of Sanguinaria Canadensis are safe and has been successfully used for viral respiratory pneumonia for long time. This medicine in homoeopathy potencies could have a potential for inhibiting viral replication and disease progression. Based on the clinical experience gained from the use of Sanguinaria on viral respiratory illness and the adjuvant facts noted above, the potentized homoeopathic medicine Sanguinaria canadensis can be further studied for its application in severe viral respiratory illness like SARS Covid-2 as a stand-alone treatment or as an adjuvant treatment.
... (Table -5). In a study by Bordet et al [7] it was observed that Sepia was the medicines found frequently indicated and useful along with other medicines. This corroborates with our present analysis. ...
Article
Background-Climacteric is the phase in the ageing of women marking the transition from the reproductive phase to the non reproductive state. According to a survey, 44% of post menopausal women used hormonal replacement therapy (HRT). Aim: The present analysis is of the cases prescribed with Sepia officinalis to evaluate its efficacy in DDCY. Method-An open prospective observational study was undertaken by a research institute at six centers for a period of 4 years (including a follow up period of 1 year) as per the protocol. The cases where Sepia (n=53) was found indicated and prescribed were taken up for analysis. The data was analyzed statistically by using the "Wilcoxon sign rank test" on SPSS for the symptoms score and gynecological findings and "t test" for laboratory findings. Results-The mean symptom score at the base line was 13.68
... [6] Observational studies revealed the positive role of Homoeopathy in alleviating the menopausal complaints and improving quality of life. [7][8][9] An audit report of National Health Service community menopause clinic through homoeopathic intervention suggested greatest response in those patients who reported headaches, vasomotor symptoms, emotional or psychological symptoms and tiredness or fatigue, respectively, as their primary symptoms. [10] Randomised-controlled trials (RCTs) on Homoeopathy for menopausal symptoms and oestrogen withdrawal symptoms in breast cancer survivors did not show statistically significant results. ...
Article
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Background: Based on the results of Central Council for Research in Homoeopathy's previous study, wherein Sepia was indicated and prescribed in maximum number of cases, this study was planned to further validate efficacyof Sepia in the management of menopausal symptoms. Objectives: The study was conducted with the objectives of evaluating the efficacy of homoeopathic medicine – Sepia in the management of menopausal symptoms using 'The Greene Climacteric Scale' (GCS) and the quality of life using Utian Quality of Life (UQOL) scale. Materials and Methods: A randomised double-blind placebo-controlled clinical study was conducted from April 2012 to September 2014 at four research centres of Central Council for Research in Homoeopathy. Perimenopausal cases were screened (n = 471), and those fulfilling the eligibility criteria (n = 88) were enrolled and randomised to receive either homoeopathic intervention, i.e., Sepia (n = 44) or identical placebo (n = 44) and followed up for 6 months to assess them on predefined clinical parameters. The primary outcome was the change in the menopausal complaints assessed using GCS and the secondary outcome measure was change in UQOL scale. Results: Eighty-eight patients were considered for primary outcome analysis. The primary outcome measure, i.e., total score of GCS, when compared after 6 months, was reduced from 30.23 ± 8.1 to 7.86 ± 4.6 in Sepia group (improvement of 73.9%) and from 30.05 ± 8.9 to 12.73 ± 8.3 in placebo group (improvement of 57.63%) (P = 0.001). There was a statistically significant difference between both the groups, when compared after 6 months (P = 0.001). With respect to secondary outcome, the total UQOL score was 59.09 ± 7.74 for Sepia group and 57.39 ± 7.80 for placebo group at baseline, and 62.43±7.71 for Sepia group and 63.48±7.53 for placebo group after treatment indicating slight difference in quality of life after 6 months. Conclusion: Sepia is able to allay the menopausal symptoms when prescribed on symptomatic indications as per homoeopathic principles.
... Mechanism of action hypothesized, in particular, the involvement of the hypotensive activity of Actaea racemosa, the cardiovascular activity of Arnica Montana, Glonoinum, Lachesis mutus and Sanguinaria Canadensis, and neuroendocrine activity of Lachesis mutus. The constitutive components are homeopathic drugs indicated for the management of menopausal HF [11,12]. A placebo-controlled trial reported the efficacy of BRN-01 on the frequency and intensity of menopausal HF experienced over a 12-week period. ...
Article
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Purpose Endocrine therapy (ET) used to reduce the risk of recurrence in hormone receptor-expressing disease (75% of breast cancers) is associated with worsening of climacteric symptoms with a negative impact on quality of life (QoL). Homeopathy might allow a better management of hot flushes (HF). Methods In this multicenter randomized double-blind placebo-controlled phase III study (ClinicalTrials.gov NCT01246427), we enrolled ≥ 18 years old women with histologically proven non metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤ 1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients should not be scheduled for chemotherapy or radiotherapy, and had no associated pathology known to induce HF. After a 2- to 4-week placebo administration, we randomly assigned (1:1) patients with HFS ≥ 10 using an interactive web-based centralized platform to BRN-01 homeopathic medicine complex (Actheane®) in arm A or Placebo (Arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. Primary endpoint was assessed at 4-week post-randomization, as the variation between pre- and 4w-HFS. Secondary endpoints included HFS variation between pre- and 8w-HFS, compliance and tolerance assessed 8 weeks after randomization, and QoL and satisfaction assessed at 4- and 8-week post-randomization. Results Two hundred ninety-nine patients were included, and 138 (46.2%) randomized (A, 65; P, 73). Median 4w-HFS absolute variation (A, − 2.9; P, − 2.5 points, p = 0.756) and relative decrease (A, − 17%; P, − 15%, p = 0.629) were not statistically different. However, 4w-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4w-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p = 0.470). Conclusions The efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a good tolerance profile.
... An observational study of various homeopathic treatments in 438 patients with menopausal symptoms found S. canadensis remedies ranked fifth most likely out of 16 remedies to result in symptom disappearance or improvement. However, the study type and design prevented an assessment of efficacy [257]. ...
... Clinical studies have shown homeopathy to potentially reduce many of the toxic effects of oncology treatments, while improving global health and well-being. 10 These include cancer-related fatigue, 11 hot flashes due to hormonal treatment in patients with breast cancer, [12][13][14][15][16] and radiation-induced dermatitis. 17,18 A 2009 Cochrane review on the benefits of homeopathy identified 8 clinical trials that were of adequate quality (n = 664), and though the review did not find any clear evidence for the effectiveness of homeopathy for treatment-related outcomes (ie, survival), it did suggest a beneficial impact in reducing radiation-induced dermatitis and chemotherapy-induced stomatitis. ...
Article
Full-text available
Background: Homeopathy has the potential to reduce symptoms related to cancer treatment. The present study examined the feasibility of a homeopathic consultation and treatment program, provided as part of an integrative oncology service. Methods: The electronic medical files of patients undergoing a homeopathic consultation in an integrative oncology service clinic were examined retrospectively. Adherence to the homeopathic treatment regimen and perceived response to the treatment were evaluated. Results: The files of 124 patient (34 males, 90 females) were examined, of which two-thirds reported acquiring and self-administering the homeopathic remedy as prescribed, and nearly three-quarters reporting a beneficial effect. Adherence to the homeopathic treatment regimen was greatest among patients attending a second visit, as opposed to having only telephone/e-mail follow-up ( P < .005). An association was found between a perceived beneficial effect of treatment with attending a follow-up visit ( P = .04), female gender ( P = .02), younger age ( P = .048), diagnosis of breast cancer ( P = .014), and current radiation treatment (vs chemotherapy; P = .003). Patients reporting chemotherapy-induced peripheral neuropathy were also more likely to report a beneficial effect ( P = .004), as were female patients reporting hot flashes ( P = .005) and those referred by an oncologist ( P = .046). No adverse effects were attributed to the homeopathic treatment. Conclusions: Homeopathy can be successfully incorporated within a supportive care integrative oncology service. In addition to demographic and cancer-related characteristics, as well as symptoms, patients attending a second visit (vs only telephone/e-mail follow-up) were more likely to adhere to and perceive a beneficial effect from the homeopathic regimen.
Article
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95 Recently, many developing countries have had changes in the composition of population and have become aging societies. Therefore, anti-aging medicine which is believed to have beneficial effect on the risk factors of geriatric associated diseases has been paid much attention. Complementary and alternative medicine (CAM) has been widely accepted by the general population, and is consequently known to account for a large share of health care costs in many countries. Hormone therapy (HT) is the gold standard to alleviate menopausal symptoms, but only 2.3% of Korean menopausal women are on HT. Many other women seek alternative means, including Korean traditional medicine, phytoestrogen-containing products such as black cohosh, soy (isoflavone), Dong quai, Ginseng, and evening primrose oil. Bioidential hormone therapy (BHT) is HT with individually compounded recipes of steroids in various doses. Its efficacy is yet to be confirmed and the risks of developing endometrial hyperplasia and breast cancer have been reported. Other CAM methods involving lifestyle and behavioral interventions include exercise, caloric restriction, weight reduction, and 'mind-body medicine (homeopathy).' Dermatologic, plastic, and ophthalmologic interventions have been introduced through the exhibition, as well. Physicians have ignored this novel trend of patients preference to 'natural hormonal therapy,' however, they should be aware of the pros and cons of CAM and be able to guide their patients to make right choices. Clinical trials, and the evaluation of every CAM practice should be undertaken. Abstract
Article
Zusammenfassung Die Homöopathie ist in Deutschland eine der 3 im Sozialgesetzbuch V verankerten besonderen Therapierichtungen. Festlegung von Ziel und Inhalt sowie die Anerkennung der absolvierten Zusatzweiterbildung Homöopathie erfolgt durch die zuständigen Landesärztekammern. Die klassische Homöopathie mit dem erforderlichen ausführlichen Erstgespräch und anschließender Repertorisation wird von der Bevölkerung und den anwendenden Ärzten sehr geschätzt. Homöopathische Komplexmittel werden auch von vielen Ärzten ohne Zusatzweiterbildung zur Behandlung von Patientinnen eingesetzt. Nach einer allgemeinen Beschreibung der Homöopathie werden Studien zur klassischen Homöopathie und zu Komplexmitteln bei den Indikationen Kinderwunsch und klimakterische Beschwerden erläutert, praktische Empfehlungen gegeben und spezielle Schwierigkeiten bei der Durchführung von Studien zur Untersuchung der Wirksamkeit der Homöopathie diskutiert. Der pragmatische Einsatz dieser weitverbreiteten Therapiemethode gerade in schwierigen Therapiesituationen und bei empfindlichen Patienten ist möglich, und weitere gut geplante wissenschaftliche Untersuchungen der Homöopathie sind sinnvoll und erforderlich.
Article
Da starke klimakterische Beschwerden nur bei etwa einem Drittel der Frauen in der Peri- und Postmenopause auftreten, ist eine Behandlung nicht für jede Frau erforderlich, die Prävention altersassoziierter Erkrankungen dagegen ist für alle sinnvoll. Klassische Naturheilverfahren und Komplementärmedizin bieten viele Möglichkeiten zur Selbsthilfe und sind sowohl zur Prävention als auch zur Besserung verschiedener Symptome geeignet. Da bei (Selbst-)Anwendung nichtpharmakologischer Verfahren kein Risiko für Arzneimittelinteraktionen besteht und das sonstige Risikopotenzial gering ist, lassen sie sich auch bei nicht umfassender Evidenz vorrangig empfehlen. Bei jeder Anwendung wirkstoffbasierter Behandlungen ist die ärztliche Überwachung ratsam, da grundsätzlich ein Risiko- und Interaktionspotenzial besteht, die vorhandene Evidenz i.d.R. nur auf kurzen Therapiezeiten basiert und bei Nahrungsergänzungsmitteln statusbedingt mit Qualitätsproblemen zu rechnen ist. Das Vorgehen sollte sich im Rahmen eines Stufenkonzepts an Art und Ausprägung der Beschwerden sowie an den individuellen Risiken, Möglichkeiten und Vorerfahrungen orientieren.
Article
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Paper aims at considering all important aspects of the scientific framework of homeopathic practice, looking at the levels of scientific evidence of each aspect in an objective way, through an extensive review of literature. Levels of evidence considered are: I) existence of meta-analyses and/or systematic positive reviews of literature; IIa) multiple positive randomized controlled trials (RCTs); IIb) some positive RCTs; IIIa) positive multiple cohorts studies; IIIb) positive studies with some cohorts; IV) opinion of experts (clinical and daily practice cases). Conclusions are clear: homeopathy must stay within the framework of medical practice, and it is even a necessity for public health.
Article
Los síntomas resultantes de la carencia estrogénica durante la menopausia son deletéreos para la calidad de vida de las mujeres, en particular las oleadas de calor vasomotoras, los trastornos cognitivos y el riesgo de fractura osteoporótica. La eficacia global del tratamiento hormonal de la menopausia sobre estos síntomas está demostrada. En cambio, desde la publicación de los grandes estudios aleatorizados estadounidenses en 2002, sobre todo el de la Women Health Initiative (WHI), este tratamiento fue considerado deletéreo respecto al riesgo de cáncer de mama y a los riesgos cardiovasculares y tromboembólicos venosos. Desde hace 10 años, varias reevaluaciones de estos estudios y la publicación de estudios más recientes inducirían a atemperar estas conclusiones, sin duda alguna demasiado apresuradas. La prescripción de un tratamiento con estrógenos naturales por vía percutánea y progesterona natural no aumentaría los riesgo mamarios y de tromboembolismo venoso. Además, si el tratamiento se inicia en mujeres jóvenes al principio de la menopausia, tendería a ejercer un efecto protector sobre el riesgo cardiovascular y de demencia. La clave del tratamiento hormonal de la menopausia sería respetar las indicaciones correctas y una elección pensada y personalizada sobre su uso en función de las características y de la edad de las pacientes.
Article
To evaluate the efficacy and safety of a complex remedy compared with placebo to treat menopausal symptoms. A total of 102 peri- and postmenopausal women requiring treatment for menopausal symptoms were randomized to receive a complex anthroposophic remedy prepared in the homeopathic manner (Apis regina tota GL D4, Argentum metallicum D5, Ovaria bovis GL D4), 3 × 10 globuli daily (2 × 12 weeks) and placebo (12 weeks) in different orders of remedy (R) and placebo (P) (1: R/R/P, 2: P/R/R, 3: R/P/R). The primary endpoint was change in climacteric symptoms assessed by the Menopause Rating Scale II (MRS II) after 12 weeks. Secondary endpoints were changes of symptoms and safety throughout the study. Reduction of symptoms after 12 weeks did not differ between remedy and placebo (total score MRS II: -1.4, 95% confidence interval (CI) -2.8 to 0 vs. -2.3, 95% CI -4.4 to -0.3, p = 0.441) and had no clinical relevance (defined as reduction in MRS II ≥ -3.5). Comparison of secondary outcomes at 12 weeks between remedy and placebo or between groups after the 2nd or 3rd period compared to previous periods did not differ. Treatment with remedy for 24 consecutive weeks did not reach clinical relevance either. However, total reduction of symptoms after three periods in Group 1 (R/R/P) (-5.0, 95% CI -7.5 to -2.5) and Group 2 (P/R/R) (-5.9, 95% CI -8.7 to -3.1) reached clinical relevance whereas almost no decrease of symptoms after three periods was seen in Group 3 (R/P/R) (-0.5, 95% CI -2.9 to 1.9). Treatment with the complex remedy for 12 or 24 weeks did not result in clinically significant improvement of menopausal symptoms.
Article
The menopause is seen as a highly variable adjustment phase where for some women difficult symptoms can significantly impact on quality of life and in breast cancer that adjustment phase can be intensified and prolonged by anti-oestrogen medication. Homeopathy, defined as one of the many complementary and alternative medicines which women use to manage this transition, has been delivered within the National Health Service since its inception and has been used to alleviate menopausal symptoms both in the climacteric and more recently in breast cancer survivors. Individualized treatment by a homeopath, regarded as the gold standard of homeopathic care, is a complex intervention where the homeopathic medicine is matched to a woman presenting with a range of symptoms such as hot flushes, sleep and mood disturbance, joint pains and fatigue. These symptoms are thought to represent a whole system disturbance and the homeopathic medicine chosen reflects this disturbance. This article describes the delivery of homeopathic care within the UK, as part of an integrated approach to difficult symptoms, basic science that might offer a potential model of action, and reviews available data from observational studies and randomised trials in this clinical setting.
Article
Background: Menopausal complaints are frequently treated with homeopathy in daily practice worldwide. Recently, vasomotor symptoms have been understood to have implications as predictors of other important and long-term outcomes, causing increased risk of mortality and/or disability. Methods: A comprehensive search of the literature was conducted to investigate whether homeopathic treatments for menopausal women with vasomotor symptoms have a positive effect on other important health outcomes associated with menopause, such as cardiovascular disease, neurocognitive impairment, metabolic and mood disorders, or osteoporosis. Results: Though observational studies have shown encouraging results in reducing the severity and frequency of hot flashes in women treated with homeopathy, few randomized controlled trials have shown positive results. In most of the studies using homeopathy, the primary outcome is reduction in the frequency and severity of hot flashes, and other menopausal complaints are assessed secondarily as a part of the symptoms evaluated in the menopausal scales. Quality of life improves with homeopathic treatments for hot flashes, but there is scarce evidence of the effect of homeopathy on other health outcomes associated with menopause. Limited evidence exists in the case of menopausal women treated with individualized homeopathy for depression and metabolic disorders. Conclusion: A more comprehensive approach for treating menopause in routine homeopathic practice constitutes a valuable opportunity to increase knowledge and high-quality research in this field. Future homeopathic research for menopause should be focused on well-designed, double-blind, placebo-controlled, randomized trials as well as on pragmatic trials to show whether homeopathic treatments for vasomotor symptoms can also improve outcomes that are well-known to increase the risk of mortality and/or disability.
Article
Ovarian function can start to decline a few years before the eventual cessation of the menstrual cycle. The average age of Menopause in the UK is 51, and it is a restrospective diagnosis after 12 months of amenorrhoea. Women can experience many symptoms such as vasomotor and vulvovaginal symptoms that can impact them physically, psychologically, sexually and impact their overall wellbeing. Women may have medical contraindications to hormonal therapy or may prefer non-hormonal or alternative treatments. This review looks at the evidence, efficacy and safety of a range of complementary or alternative treatments and non-hormonal pharmacological treatments for the treatment of vasomotor symptoms and vulvovaginal atrophy of menoopause.
Article
Concerns about the safety of oestrogen-based hormone replacement therapy after publication of the Women's Health Initiative study and Million Women Study has led to women turning to alternative therapies, erroneously believing that they are safer and 'more natural'. Evidence from randomized trials that alternative and complementary therapies improve menopausal symptoms or have the same benefits as conventional pharmacopoeia is poor. There are no recognized international criteria for the design of clinical trials of alternative therapies as there are for standard medicines and medical devices for endpoints of treatment and safety evaluations. Studies may have limitations such as design, sample size and duration. There is a wide range of different preparations, making comparison difficult. The evidence regarding botanicals, homeopathy, steroids, vitamin supplements, dietary changes and functional foods, and physical interventions are discussed in this chapter. Standard pharmacopoeia such as clonidine, selective serotonin re-uptake inhibitors and progestogens are also examined.
Article
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The Women's Health Initiative (WHI) and other clinical trials indicate that significant health risks are associated with combination hormone use. Less is known about the effect of hormone therapy on health-related quality of life. The WHI randomly assigned 16,608 postmenopausal women 50 to 79 years of age (mean, 63) with an intact uterus at base line to estrogen plus progestin (0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate, in 8506 women) or placebo (in 8102 women). Quality-of-life measures were collected at base line and at one year in all women and at three years in a subgroup of 1511 women. Randomization to estrogen plus progestin resulted in no significant effects on general health, vitality, mental health, depressive symptoms, or sexual satisfaction. The use of estrogen plus progestin was associated with a statistically significant but small and not clinically meaningful benefit in terms of sleep disturbance, physical functioning, and bodily pain after one year (the mean benefit in terms of sleep disturbance was 0.4 point on a 20-point scale, in terms of physical functioning 0.8 point on a 100-point scale, and in terms of pain 1.9 points on a 100-point scale). At three years, there were no significant benefits in terms of any quality-of-life outcomes. Among women 50 to 54 years of age with moderate-to-severe vasomotor symptoms at base line, estrogen and progestin improved vasomotor symptoms and resulted in a small benefit in terms of sleep disturbance but no benefit in terms of the other quality-of-life outcomes. In this trial in postmenopausal women, estrogen plus progestin did not have a clinically meaningful effect on health-related quality of life.
Article
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The Women's Health Initiative (WHI) trial of estrogen plus progestin was stopped early because of adverse effects, including an increased risk of stroke in the estrogen plus progestin group. To assess the effect of estrogen plus progestin on ischemic and hemorrhagic stroke and in subgroups, and to determine whether the effect of estrogen plus progestin was modified by baseline levels of blood biomarkers. Multicenter double-blind, placebo-controlled, randomized clinical trial involving 16 608 women aged 50 through 79 years with an average follow-up of 5.6 years. Baseline levels of blood-based markers of inflammation, thrombosis, and lipid levels were measured in the first 140 centrally confirmed stroke cases and 513 controls. Participants received 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate (n = 8506) or placebo (n = 8102). Overall strokes and stroke subtype and severity were centrally adjudicated by stroke neurologists. One hundred fifty-one patients (1.8%) in the estrogen plus progestin and 107 (1.3%) in the placebo groups had strokes. Overall 79.8% of strokes were ischemic. For combined ischemic and hemorrhagic strokes, the intention-to-treat hazard ratio (HR) for estrogen plus progestin vs placebo was 1.31 (95% confidence interval [CI], 1.02-1.68); with adjustment for adherence, the HR was 1.50 (95% CI, 1.08-2.08). The HR for ischemic stroke was 1.44 (95% CI, 1.09-1.90) and for hemorrhagic stroke, 0.82 (95% CI, 0.43-1.56). Point estimates of the HRs indicate that excess risk of all stroke was apparent in all age groups, in all categories of baseline stroke risk, and in women with and without hypertension, prior history of cardiovascular disease, use of hormones, statins, or aspirin. Other risk factors for stroke, including smoking, blood pressure, diabetes, lower use of vitamin C supplements, blood-based biomarkers of inflammation, higher white blood cell count, and higher hematocrit levels did not modify the effect of estrogen plus progestin on stroke risk. Estrogen plus progestin increases the risk of ischemic stroke in generally healthy postmenopausal women. Excess risk for all strokes attributed to estrogen plus progestin appeared to be present in all subgroups of women examined.
Article
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Postmenopausal women have a greater risk than men of developing Alzheimer disease, but studies of the effects of estrogen therapy on Alzheimer disease have been inconsistent. On July 8, 2002, the study drugs, estrogen plus progestin, in the Women's Health Initiative (WHI) trial were discontinued because of certain increased health risks in women receiving combined hormone therapy. To evaluate the effect of estrogen plus progestin on the incidence of dementia and mild cognitive impairment compared with placebo. The Women's Health Initiative Memory Study (WHIMS), a randomized, double-blind, placebo-controlled clinical trial, began enrolling participants from the Women's Health Initiative (WHI) estrogen plus progestin trial in May 1996. Of the 4894 eligible participants of the WHI study, 4532 (92.6%) postmenopausal women free of probable dementia, aged 65 years or older, and recruited from 39 of 40 WHI clinical centers were enrolled in the WHIMS. Participants received either 1 daily tablet of 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate (n = 2229), or a matching placebo (n = 2303). Incidence of probable dementia (primary outcome) and mild cognitive impairment (secondary outcome) were identified through a structured clinical assessment. The mean (SD) time between the date of randomization into WHI and the last Modified Mini-Mental State Examination (3MSE) for all WHIMS participants was 4.05 (1.19) years. Overall, 61 women were diagnosed with probable dementia, 40 (66%) in the estrogen plus progestin group compared with 21 (34%) in the placebo group. The hazard ratio (HR) for probable dementia was 2.05 (95% confidence interval [CI], 1.21-3.48; 45 vs 22 per 10 000 person-years; P =.01). This increased risk would result in an additional 23 cases of dementia per 10 000 women per year. Alzheimer disease was the most common classification of dementia in both study groups. Treatment effects on mild cognitive impairment did not differ between groups (HR, 1.07; 95% CI, 0.74-1.55; 63 vs 59 cases per 10 000 person-years; P =.72). Estrogen plus progestin therapy increased the risk for probable dementia in postmenopausal women aged 65 years or older. In addition, estrogen plus progestin therapy did not prevent mild cognitive impairment in these women. These findings, coupled with previously reported WHI data, support the conclusion that the risks of estrogen plus progestin outweigh the benefits.
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The Women's Health Initiative trial of combined estrogen plus progestin was stopped early when overall health risks, including invasive breast cancer, exceeded benefits. Outstanding issues not previously addressed include characteristics of breast cancers observed among women using hormones and whether diagnosis may be influenced by hormone effects on mammography. To determine the relationship among estrogen plus progestin use, breast cancer characteristics, and mammography recommendations. Following a comprehensive breast cancer risk assessment, 16 608 postmenopausal women aged 50 to 79 years with an intact uterus were randomly assigned to receive combined conjugated equine estrogens (0.625 mg/d) plus medroxyprogesterone acetate (2.5 mg/d) or placebo from 1993 to 1998 at 40 clinical centers. Screening mammography and clinical breast examinations were performed at baseline and yearly thereafter. Breast cancer number and characteristics, and frequency of abnormal mammograms by estrogen plus progestin exposure. In intent-to-treat analyses, estrogen plus progestin increased total (245 vs 185 cases; hazard ratio [HR], 1.24; weighted P<.001) and invasive (199 vs 150 cases; HR, 1.24; weighted P =.003) breast cancers compared with placebo. The invasive breast cancers diagnosed in the estrogen plus progestin group were similar in histology and grade but were larger (mean [SD], 1.7 cm [1.1] vs 1.5 cm [0.9], respectively; P =.04) and were at more advanced stage (regional/metastatic 25.4% vs 16.0%, respectively; P =.04) compared with those diagnosed in the placebo group. After 1 year, the percentage of women with abnormal mammograms was substantially greater in the estrogen plus progestin group (716 [9.4%] of 7656) compared with placebo group (398 [5.4%] of 7310; P<.001), a pattern which continued for the study duration. Relatively short-term combined estrogen plus progestin use increases incident breast cancers, which are diagnosed at a more advanced stage compared with placebo use, and also substantially increases the percentage of women with abnormal mammograms. These results suggest estrogen plus progestin may stimulate breast cancer growth and hinder breast cancer diagnosis.
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Recent randomized clinical trials have suggested that estrogen plus progestin does not confer cardiac protection and may increase the risk of coronary heart disease (CHD). In this report, we provide the final results with regard to estrogen plus progestin and CHD from the Women's Health Initiative (WHI). The WHI included a randomized primary-prevention trial of estrogen plus progestin in 16,608 postmenopausal women who were 50 to 79 years of age at base line. Participants were randomly assigned to receive conjugated equine estrogens (0.625 mg per day) plus medroxyprogesterone acetate (2.5 mg per day) or placebo. The primary efficacy outcome of the trial was CHD (nonfatal myocardial infarction or death due to CHD). After a mean follow-up of 5.2 years (planned duration, 8.5 years), the data and safety monitoring board recommended terminating the estrogen-plus-progestin trial because the overall risks exceeded the benefits. Combined hormone therapy was associated with a hazard ratio for CHD of 1.24 (nominal 95 percent confidence interval, 1.00 to 1.54; 95 percent confidence interval after adjustment for sequential monitoring, 0.97 to 1.60). The elevation in risk was most apparent at one year (hazard ratio, 1.81 [95 percent confidence interval, 1.09 to 3.01]). Although higher base-line levels of low-density lipoprotein cholesterol were associated with an excess risk of CHD among women who received hormone therapy, higher base-line levels of C-reactive protein, other biomarkers, and other clinical characteristics did not significantly modify the treatment-related risk of CHD. Estrogen plus progestin does not confer cardiac protection and may increase the risk of CHD among generally healthy postmenopausal women, especially during the first year after the initiation of hormone use. This treatment should not be prescribed for the prevention of cardiovascular disease.
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The effects of continuous combined hormone therapy on gynecologic cancers have not been investigated previously in a randomized trial setting. To determine the possible associations of estrogen plus progestin on gynecologic cancers and related diagnostic procedures. Randomized, double-blind, placebo-controlled trial of 16 608 postmenopausal women, who had not had a hysterectomy at baseline and who had been recruited from 40 US clinical centers between September 1993 and October 1998 (average follow-up, 5.6 years). One tablet per day containing 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate (n = 8506) or placebo (n = 8102). Incident invasive cancer of the ovary and endometrium. In 5.6 years of follow-up, there were 32 cases of invasive ovarian cancer, 58 cases of endometrial cancer, 1 case of nonendometrial uterine cancer, 13 cases of cervical cancer, and 7 cases of other gynecologic cancers. The hazard ratio (HR) for invasive ovarian cancer in women assigned to estrogen plus progestin compared with placebo was 1.58 (95% confidence interval [CI], 0.77-3.24). The HR for endometrial cancer was 0.81 (95% CI, 0.48-1.36). No appreciable differences were found in the distributions of tumor histology, stage, or grade for either cancer site. The incidence of other gynecologic cancers was low and did not differ by randomization assignment. More women taking estrogen plus progestin required endometrial biopsies (33% vs 6%; P<.001). This randomized trial suggests that continuous combined estrogen plus progestin therapy may increase the risk of ovarian cancer while producing endometrial cancer rates similar to placebo. The increased burden of endometrial biopsies required to assess vaginal bleeding further limits the acceptability of this regimen. These data provide additional support for caution in the use of continuous combined hormones.
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In the Women's Health Initiative trial of estrogen-plus-progestin therapy, women assigned to active treatment had fewer fractures. To test the hypothesis that the relative risk reduction of estrogen plus progestin on fractures differs according to risk factors for fractures. Randomized controlled trial (September 1993-July 2002) in which 16 608 postmenopausal women aged 50 to 79 years with an intact uterus at baseline were recruited at 40 US clinical centers and followed up for an average of 5.6 years. Women were randomly assigned to receive conjugated equine estrogen, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet (n = 8506) or placebo (n = 8102). All confirmed osteoporotic fracture events that occurred from enrollment to discontinuation of the trial (July 7, 2002); bone mineral density (BMD), measured in a subset of women (n = 1024) at baseline and years 1 and 3; and a global index, developed to summarize the balance of risks and benefits to test whether the risk-benefit profile differed across tertiles of fracture risk. Seven hundred thirty-three women (8.6%) in the estrogen-plus-progestin group and 896 women (11.1%) in the placebo group experienced a fracture (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.69-0.83). The effect did not differ in women stratified by age, body mass index, smoking status, history of falls, personal and family history of fracture, total calcium intake, past use of hormone therapy, BMD, or summary fracture risk score. Total hip BMD increased 3.7% after 3 years of treatment with estrogen plus progestin compared with 0.14% in the placebo group (P<.001). The HR for the global index was similar across tertiles of the fracture risk scale (lowest fracture risk tertile, HR, 1.20; 95% CI, 0.93-1.58; middle tertile, HR, 1.23; 95% CI, 1.04-1.46; highest tertile, HR, 1.03; 95% CI, 0.88-1.24) (P for interaction =.54). This study demonstrates that estrogen plus progestin increases BMD and reduces the risk of fracture in healthy postmenopausal women. The decreased risk of fracture attributed to estrogen plus progestin appeared to be present in all subgroups of women examined. When considering the effects of hormone therapy on other important disease outcomes in a global model, there was no net benefit, even in women considered to be at high risk of fracture.
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Women commonly use soy products, herbs, and other complementary and alternative medicine (CAM) therapies for menopausal symptoms. Randomized, controlled trials have evaluated the efficacy and short-term safety of these therapies. To review randomized, controlled trials of CAM therapies for menopausal symptoms in order to better inform practice and guide future research. Searches of MEDLINE for articles published from January 1966 through March 2002, of the Alternative and Complementary Database (AMED) of the British Library for articles published from January 1985 through December 2000, and of the authors' own extensive files. Search terms were hot flash/flush, menopause, and climacteric, combined with phytoestrogens, alternative medicine, herbal medicine, traditional medicine, Traditional Chinese Medicine (TCM ), Ayurveda, naturopathy, chiropractic, osteopathy, massage, yoga, relaxation therapy, homeopathy, aromatherapy, and therapeutic touch. 29 randomized, controlled clinical trials of CAM therapies for hot flashes and other menopausal symptoms were identified; of these, 12 dealt with soy or soy extracts, 10 with herbs, and 7 with other CAM therapies. Each author extracted information from half of the studies on the number of patients, study design, outcome measures, and results; the other author then checked these results. Soy seems to have modest benefit for hot flashes, but studies are not conclusive. Isoflavone preparations seem to be less effective than soy foods. Black cohosh may be effective for menopausal symptoms, especially hot flashes, but the lack of adequate long-term safety data (mainly on estrogenic stimulation of the breast or endometrium) precludes recommending long-term use. Single clinical trials have found that dong quai, evening primrose oil, a Chinese herb mixture, vitamin E, and acupuncture do not affect hot flashes; two trials have shown that red clover has no benefit for treating hot flashes. Black cohosh and foods that contain phytoestrogens show promise for the treatment of menopausal symptoms. Clinical trials do not support the use of other herbs or CAM therapies. Long-term safety data on individual isoflavones or isoflavone concentrates are not available.
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Sheffield's National Health Service community menopause clinic has run a homeopathy service since 1998. The service provides an alternative treatment option for those women who cannot take hormone replacement therapy, do not want it, have found it ineffective, or have been advised to stop it. Patients receive homeopathic treatment (monthly consultations plus individualized homeopathic medicines) for up to six sessions. An audit was undertaken of all patients referred to this service between 2001 and 2003, in which patients completed the Measure Yourself Medical Outcome Profile. Patients reported significant benefit from the service. The greatest response was seen in those reporting headaches, vasomotor symptoms, emotional/psychological symptoms and tiredness/fatigue as their primary symptoms.
Article
CONTEXT: Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain. OBJECTIVE: To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States. DESIGN: Estrogen plus progestin component of the Women's Health Initiative, a randomized controlled primary prevention trial (planned duration, 8.5 years) in which 16608 postmenopausal women aged 50-79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993-1998. INTERVENTIONS: Participants received conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet (n = 8506) or placebo (n = 8102). MAIN OUTCOMES MEASURES: The primary outcome was coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome. A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, and death due to other causes. RESULTS: On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits. This report includes data on the major clinical outcomes through April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% confidence intervals [CIs]) were as follows: CHD, 1.29 (1.02-1.63) with 286 cases; breast cancer, 1.26 (1.00-1.59) with 290 cases; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10 000 person-years. CONCLUSIONS: Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women. All-cause mortality was not affected during the trial. The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD.
Article
Background Recent randomized clinical trials have suggested that estrogen plus progestin does not confer cardiac protection and may increase the risk of coronary heart disease (CHD). In this report, we provide the final results with regard to estrogen plus progestin and CHD from the Women's Health Initiative (WHI). Methods The WHI included a randomized primary-prevention trial of estrogen plus progestin in 16,608 postmenopausal women who were 50 to 79 years of age at base line. Participants were randomly assigned to receive conjugated equine estrogens (0.625 mg per day) plus medroxyprogesterone acetate (2.5 mg per day) or placebo. The primary efficacy outcome of the trial was CHD (nonfatal myocardial infarction or death due to CHD). Results After a mean follow-up of 5.2 years (planned duration, 8.5 years), the data and safety monitoring board recommended terminating the estrogen-plus-progestin trial because the overall risks exceeded the benefits. Combined hormone therapy was associated with a hazard rati...
Article
Background: Ovarian cancer is the fourth most common cancer in women in the UK, with about 6700 developing the malignancy and 4600 dying from it every year. However, there is limited information about the risk of ovarian cancer associated with the use of hormone replacement therapy (HRT). Methods: 948,576 postmenopausal women from the UK Million Women Study who did not have previous cancer or bilateral oophorectomy were followed-up for an average of 5.3 years for incident ovarian cancer and 6.9 years for death. Information on HRT use was obtained at recruitment and updated where possible. Relative risks for ovarian cancer were calculated, stratified by age and hysterectomy status, and adjusted by area of residence, socioeconomic group, time since menopause, parity, body-mass index, alcohol consumption, and use of oral contraceptives. Findings: When they last reported HRT use, 287,143 women (30%) were current users and 186 751 (20%) were past users. During follow-up, 2273 incident ovarian cancers and 1591 deaths from the malignancy were recorded. Current users were significantly more likely to develop and die from ovarian cancer than never users (relative risk 1.20 [95% CI 1.09-1.32; p=0.0002] for incident disease and 1.23 [1.09-1.38; p=0.0006] for death). For current users of HRT, incidence of ovarian cancer increased with increasing duration of use, but did not differ significantly by type of preparation used, its constituents, or mode of administration. Risks associated with HRT varied significantly according to tumour histology (p<0.0001), and in women with epithelial tumours the relative risk for current versus never use of HRT was greater for serous than for mucinous, endometroid, or clear cell tumours (1.53 [1.31-1.79], 0.72 [0.52-1.00], 1.05 [0.77-1.43], or 0.77 [0.48-1.23], respectively). Past users of HRT were not at an increased risk of ovarian cancer (0.98 [0.88-1.11] and 0.97 [0.84-1.11], respectively, for incident and fatal disease). Over 5 years, the standardised incidence rates for ovarian cancer in current and never users of HRT were 2.6 (2.4-2.9) and 2.2 (2.1-2.3) per 1000, respectively-ie, one extra ovarian cancer in roughly 2500 users; death rates were 1.6 (1.4-1.8) and 1.3 (1.2-1.4) per 1000, respectively-ie, one extra ovarian cancer death in roughly 3300 users. Interpretation: Women who use HRT are at an increased risk of both incident and fatal ovarian cancer. Since 1991, use of HRT has resulted in some 1300 additional ovarian cancers and 1000 additional deaths from the malignancy in the UK.
Article
Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain. To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States. Estrogen plus progestin component of the Women's Health Initiative, a randomized controlled primary prevention trial (planned duration, 8.5 years) in which 16608 postmenopausal women aged 50-79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993-1998. Participants received conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet (n = 8506) or placebo (n = 8102). The primary outcome was coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome. A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, and death due to other causes. On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits. This report includes data on the major clinical outcomes through April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% confidence intervals [CIs]) were as follows: CHD, 1.29 (1.02-1.63) with 286 cases; breast cancer, 1.26 (1.00-1.59) with 290 cases; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10 000 person-years. Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women. All-cause mortality was not affected during the trial. The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD.
Article
Hot flushes are a common problem, especially for menopausal women for whom hormone replacement therapy (HRT) is contra-indicated or who prefer not to take it and patients receiving Tamoxifen. Some seek homeopathic treatment. We report an uncontrolled, pilot outcome study, conducted at the Tunbridge Wells Homeopathic Hospital (TWHH) in 1998-1999. The study was conducted in out-patient consultations booked in the usual way. Thirty-one patients referred to the Department for menopausal flushes and seen for an initial consultation and at least one follow-up review, were assessed in three groups: Hot flushes: No history of carcinoma of the breast. Hot flushes: Treatment for breast carcinoma, not receiving Tamoxifen. Hot flushes: Treatment for breast cancer including Tamoxifen. For all patients, the initial and follow-up assessments included review of hot flush frequency and severity. Patients also completed their own self-assessment rating after follow-up consultations. The results indicate useful symptomatic benefit for all three groups of patients.
Article
Significant numbers of patients in developed countries use complementary, alternative, or unconventional medicine. Homeopathy is one of the most widespread and controversial of these therapies and has been used for over 150 years. There are two main theoretical tenets: the principle of "similars" and the use of dilutions called "potencies". The principle of "similars" states that patients with particular signs and symptoms can be cured if given a drug that produces the same signs and symptoms in a healthy individual. The second principle is that remedies retain biological activity if they are repeatedly diluted and agitated or shaken between each dilution. Data from case histories, observational studies and uncontrolled trials suggest that the homeopathic approach can offer a clinically relevant choice for women with menopausal symptoms and those with breast cancer whether they are taking tamoxifen or not. Randomised controlled trials are being conducted to investigate this potential benefit.
Article
Women using combined estrogen and progestin hormone replacement therapy (CHRT) have an increased risk of breast cancer; however, data on use for long durations and on risk associated with patterns of use are lacking. To evaluate relationships between durations and patterns of CHRT use and risk of breast cancer by histological type and hormone receptor status. Population-based case-control study. Three counties in western Washington State. Nine hundred seventy-five women 65-79 years of age diagnosed with invasive breast cancer from April 1, 1997, through May 31, 1999 (histology: 196 lobular cases, 656 ductal cases, 114 cases with other histological type, and 9 cases with an unspecified histological type; estrogen receptor (ER)/progesterone receptor (PR) status: 646 ER+/PR+ cases, 147 ER+/PR- cases, and 101 ER-/PR- cases [6 ER-/PR+ cases and 75 cases with unknown ER/PR status were not included in the analyses herein]) and 1007 population controls. Risks of invasive lobular, ductal, ER+/PR+, ER+/PR-, and ER-/PR- breast carcinomas. Women using unopposed estrogen replacement therapy (ERT) (exclusive ERT use), even for 25 years or longer, had no appreciable increase in risk of breast cancer, although the associated odds ratios were not inconsistent with a possible small effect. Ever users of CHRT (includes CHRT users who also had used ERT) had a 1.7-fold (95% confidence interval [CI], 1.3-2.2) increased risk of breast cancer, including a 2.7-fold (95% CI, 1.7-4.3) increased risk of invasive lobular carcinoma, a 1.5-fold (95% CI, 1.1-2.0) increased risk of invasive ductal carcinoma, and a 2.0-fold (95% CI, 1.5-2.7) increased risk of ER+/PR+ breast cancers. The increase in risk was greatest in those using CHRT for longer durations (users for 5-14.9 years and >or=15 years had 1.5-fold [95% CI, 1.0-2.3] and 1.6-fold [95% CI, 1.0-2.6] increases in risk of invasive ductal carcinoma, respectively, and 3.7-fold [95% CI, 2.0-6.6] and 2.6-fold [95% CI, 1.3-5.3] increases in risk of invasive lobular carcinoma, respectively. Associations of similar magnitudes were seen among users of both sequential and continuous CHRT. Risks of ER+/PR- and ER-/PR- tumors were not increased by use of any form of hormone replacement therapy; however, small numbers of these tumors limited power to detect possible associations. These data suggest that use of CHRT is associated with an increased risk of breast cancer, particularly invasive lobular tumors, whether the progestin component was taken in a sequential or in a continuous manner.
Article
This paper reports on an investigation of the homeopathic approach to the management of symptoms of oestrogen withdrawal in women with breast cancer. Forty-five patients entered the study. The most common presenting symptoms were hot flushes (HF) (n=38), mood disturbance (n=23), joint pain (n=12), and fatigue (n=16). Other symptoms included sleeplessness, reduced libido, weight gain, cystitis, vaginal dryness and skin eruptions. The active intervention was an individualised homeopathic medicine. Forty women (89%) completed the study. Significant improvements in mean symptom scores were seen over the study period and for the primary end-point 'the effect on daily living' scores. Symptoms other than HF such as fatigue and mood disturbance appear to be helped. Significant improvements in anxiety, depression and quality of life were demonstrated over the study period. The homeopathic approach appears to be clinically useful in the management of oestrogen withdrawal symptoms in women with breast cancer whether on or off Tamoxifen and improves mood disturbance. A placebo-controlled trial would be the next stage in this line of inquiry.
Article
Current use of hormone-replacement therapy (HRT) increases the incidence of breast cancer. The Million Women Study was set up to investigate the effects of specific types of HRT on incident and fatal breast cancer. 1084110 UK women aged 50-64 years were recruited into the Million Women Study between 1996 and 2001, provided information about their use of HRT and other personal details, and were followed up for cancer incidence and death. Half the women had used HRT; 9364 incident invasive breast cancers and 637 breast cancer deaths were registered after an average of 2.6 and 4.1 years of follow-up, respectively. Current users of HRT at recruitment were more likely than never users to develop breast cancer (adjusted relative risk 1.66 [95% CI 1.58-1.75], p<0.0001) and die from it (1.22 [1.00-1.48], p=0.05). Past users of HRT were, however, not at an increased risk of incident or fatal disease (1.01 [0.94-1.09] and 1.05 [0.82-1.34], respectively). Incidence was significantly increased for current users of preparations containing oestrogen only (1.30 [1.21-1.40], p<0.0001), oestrogen-progestagen (2.00 [1.88-2.12], p<0.0001), and tibolone (1.45 [1.25-1.68], p<0.0001), but the magnitude of the associated risk was substantially greater for oestrogen-progestagen than for other types of HRT (p<0.0001). Results varied little between specific oestrogens and progestagens or their doses; or between continuous and sequential regimens. The relative risks were significantly increased separately for oral, transdermal, and implanted oestrogen-only formulations (1.32 [1.21-1.45]; 1.24 [1.11-1.39]; and 1.65 [1.26-2.16], respectively; all p<0.0001). In current users of each type of HRT the risk of breast cancer increased with increasing total duration of use. 10 years' use of HRT is estimated to result in five (95% CI 3-7) additional breast cancers per 1000 users of oestrogen-only preparations and 19 (15-23) additional cancers per 1000 users of oestrogen-progestagen combinations. Use of HRT by women aged 50-64 years in the UK over the past decade has resulted in an estimated 20000 extra breast cancers, 15000 associated with oestrogen-progestagen; the extra deaths cannot yet be reliably estimated. Current use of HRT is associated with an increased risk of incident and fatal breast cancer; the effect is substantially greater for oestrogen-progestagen combinations than for other types of HRT.
Article
Hot flashes are a common experience for menopausal women, with an 85-percent incidence in the West. With the increased knowledge of side effects attributable to conventional treatment options, more women are exploring natural alternatives. Although more definitive research is necessary, several natural therapies show promise in treating hot flashes without the risks associated with conventional therapies. Soy and other phytoestrogens, black cohosh, evening primrose oil, vitamin E, the bioflavonoid hesperidin with vitamin C, ferulic acid, acupuncture treatment, and regular aerobic exercise have been shown effective in treating hot flashes in menopausal women.
Article
To carry out a preliminary trial evaluating the effectiveness of two types of homeopathy for the treatment of menopausal symptoms in breast cancer survivors. Randomized, double-blinded, placebo-controlled. Private medical clinic, Seattle, WA. Women with a history of breast cancer who had completed all surgery, chemotherapy, and radiation treatment and who had an average of at least three hot flashes per day for the previous month. Subjects were randomized to receive either an individualized homeopathic single remedy, a homeopathic combination medicine, or placebo. Patients were seen by homeopathic providers every 2 months for 1 year. Hot flash frequency and severity, Kupperman Menopausal Index (KMI), Short Form 36 (SF-36). There was no significant difference found in the primary outcome measure, the hot flash severity score, although there was a positive trend in the single remedy group during the first 3 months of the study (p = 0.1). A statistically significant improvement in general health score in both homeopathy groups (p < 0.05) on the SF-36 after 1 year was found. Evidence of a homeopathic "drug proving" in the subjects receiving the homeopathic combination medicine who were not taking tamoxifen also was found. Small sample size precludes definitive answers, but results from this preliminary trial suggest that homeopathy may be of value in the treatment of menopausal symptoms and improving quality of life, especially in those women not on tamoxifen. Larger studies should be carried out that also include healthy women who want to avoid hormone replacement therapy.
Article
To pilot an investigation of individualized homeopathy for symptoms of estrogen withdrawal in breast cancer survivors. Randomized, double-blinded, placebo-controlled trial. Outpatient department of a National Health Service (NHS) homeopathic hospital. Fifty-seven (57) women met inclusion criteria and 53 were randomized to the study. After 2 weeks of baseline assessment, all participants received a consultation plus either oral homeopathic medicine or placebo, assessed every 4 weeks for 16 weeks. The primary outcome measures were the activity score and profile score of the Measure Yourself Medical Outcome Profile (MYMOP). Eighty-five percent (85%) (45/53) of women completed the study. There was no evidence of a difference seen between groups for either activity (adjusted difference =-0.4, 95% confidence interval CI -1.0 to 0.2, p = 0.17) or profile scores (adjusted difference = -0.4, 95% CI -0.9 to 0.1, p = 0.13) using this trial design, although post hoc power calculations suggests that 65-175 would be needed per group to detect differences of this magnitude with sufficient precision. Clinically relevant improvements in symptoms and mood disturbance were seen for both groups over the study period. Improvements were seen for symptom scores over the study period. However, presuming these improvements were caused by the individualized homeopathic approach, the study failed to show clearly that the specific effect of the remedy added further to the nonspecific effects of the consultation. Future trial design must ensure adequate power to account for the nonspecific impact of such complex individualized interventions while pragmatic designs may more readily answer questions of clinical and cost effectiveness.
Article
Numerous reports in the medical literature and popular media have discussed the effectiveness of various nonhormonal agents in reducing menopausal hot flash symptoms. Data for these therapies are limited, and most of the studies have been conducted in women with a history of breast cancer. Selective serotonin reuptake inhibitors and venlafaxine have been shown to reduce hot flashes by 19 to 60 percent and were well tolerated by study participants. Soy isoflavones reduced hot flashes by 9 to 40 percent in some trials, but most trials showed no difference compared with placebo. Black cohosh and red clover also have had inconsistent results, with some trials showing benefit and some no difference compared with placebo. Soy isoflavones, black cohosh, and red clover were well tolerated in clinical trials. Other agents that have been used to alleviate hot flashes include belladonna/ergotamine tartrate/phenobarbital combination, dong quai, evening primrose oil, gabapentin, ginseng, mirtazapine, trazodone, vitamin E, and wild yam, but few data regarding their effectiveness have been published. Further randomized controlled trials are needed.
Article
Young women with breast cancer often experience early menopause as a result of the therapy for their malignant disease. The sudden occurrence of menopause resulting from chemotherapy, oophorectomy, radiation, or gonadal dysgenesis frequently results in hot flashes that begin at a younger age and may occur at a greater frequency and intensity than hot flashes associated with natural menopause. Hormone therapy relieves symptoms effectively in 80%-90% of women who initiate treatment. This therapy, however, is generally contraindicated in estrogen-dependent cancers, such as breast cancer, because of the potentially increased risk for recurrence. Many agents have been investigated as potential means for alleviating hot flashes in survivors of breast cancer, such as progestagens, clonidine, gabapentin, and anti-depressants. Several complementary and alternative medicines frequently used by patients have also been studied. These include black cohosh, phytoestrogens, homeopathy, vitamin E, acupuncture, and behavior strategies. To support the use of one of more of these nonpharmacological or pharmacological options in the treatment of hot flashes in breast cancer patients, more evidence from well-controlled clinical trials is needed. In particular, soundly based scientific research with complementary and alternative medicine therapies is lacking. Pharmacological treatments appear to be more beneficial than nonpharmacological treatments. This article reviews the current literature to assess the epidemiology and diagnosis of hot flashes and the nonpharmacological and pharmacological options for the treatment of hot flashes, in breast cancer patients in particular. When specific treatment options have not been evaluated in breast cancer patients specifically, published data on the management of hot flashes with this modality in healthy postmenopausal women are described.
Women's Health Initiative Investigators. Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures: the Women's Health Initiative randomized study
  • Anderson Gl Judd Hl
  • Kaunitz
  • Am
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