Understanding Why Homeopathic Medicines are Used for Menopause: Searching for Insights into Neuroendocrine Features.

BACKGROUND: Menopause is a physiological event that marks the end of a woman's reproductive stage in life. Vasomotor symptoms and changes in mood are among its most important effects. Homeopathy has been used for many years in treating menopausal complaints, though clinical and pre-clinical research in this field is limited. Homeopathy often bases its prescription on neuropsychiatric symptoms, but it is unknown if homeopathic medicines (HMs) exert a neuroendocrine effect that causes an improvement in vasomotor symptoms and mood during menopause. OBJECTIVES: The study's objectives were to address the pathophysiological changes of menopause that could help in the understanding of the possible effect of HMs at a neuroendocrine level, to review the current evidence for two of the most frequently prescribed HMs for menopause (Lachesis mutus and Sepia officinalis), and to discuss the future directions of research in this field. METHODS: An extensive literature search for the pathophysiologic events of menopause and depression, as well as for the current evidence for HMs in menopause and depression, was performed. RESULTS: Neuroendocrine changes are involved in the pathophysiology of vasomotor symptoms and changes in mood during menopause. Gonadal hormones modulate neurotransmitter systems. Both play a role in mood disorders and temperature regulation. It has been demonstrated that Gelsemium sempervirens, Ignatia amara and Chamomilla matricaria exert anxiolytic effects in rodent models. Lachesis mutus and Sepia officinalis are frequently prescribed for important neuropsychiatric and vasomotor symptoms. Dopamine, a neurotransmitter involved in mood, is among the constituents of the ink of the common cuttlefish, Sepia officinalis. CONCLUSION: Based on all the pathophysiologic events of menopause and the improvement in menopausal complaints that certain HMs show in daily practice, these medicines might have a direct or indirect neuroendocrine effect in the body, possibly triggered via an as-yet unidentified biological mechanism. Many unanswered questions in this field require further pre-clinical and clinical research.

Menopause: Questions and Answers for Improving Homeopathic Clinical Practice.

BACKGROUND: Medical attention for menopausal women is frequently delivered by health care providers (general practitioners, gynecologists or homeopathic physicians) who are not specialized in post-reproductive care. Homeopathy has been used for treating menopausal complaints for more than two centuries. Therefore, it is important to improve clinical knowledge in this field among homeopathic physicians. Nowadays, there is a special interest in the study of menopause-related chronic conditions due to the impact on women's quality of life. The aim of this review is to address the important key points of the menopause, clinical assessment, and available tests for evaluating menopausal women, as well as some general topics regarding homeopathic clinical practice for menopause. METHODS AND RESULTS: A literature search regarding menopause and current guidelines and recommendations was performed. To be practical and concise, the information is presented in the form of questions and answers. Currently, there is an international classification of woman's reproductive aging that can be useful for clinical and research purposes in homeopathy. A comprehensive homeopathic approach is mandatory for evaluating women with a healthy menopause, but also for those experiencing co-morbidities. In an integrative health care system, several assessment resources can be incorporated into the homeopathic consultations. Clinical and laboratory examinations for detecting metabolic disorders (dyslipidemia, insulin resistance, diabetes and hypertension, among others), mood disorders, cognitive impairment and osteoporosis are available in many clinical settings. Screening for gynecological cancers is an international recommendation at this stage. All data obtained from homeopathic consultations would help to integrate well-documented case reports. This would give the possibility to generate hypotheses to design high-quality clinical research. CONCLUSION: Improving homeopathic clinical practice for menopause is useful for both clinical and research purposes. The international recommendations for evaluating menopausal women should be incorporated in homeopathic clinical practice, mainly in clinical settings where homeopathy is integrated in outpatient services.

Menopause is more than Hot Flashes: What is Missing in Homeopathic Research? A Narrative Review.

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.

Individualized Homeopathy for Depression in Climacteric Women: Comments on the Retraction by PLoS ONE.

In April 2020 PLoS ONE retracted an original clinical research article, published in 2015, in which we demonstrated that individualized homeopathic treatment improves depression symptoms in climacteric women. The original assessment of this study was carried out by an expert in psychiatry (depression research) with close to 35 years' experience in the field of mental health. During post-publication discussions, no serious breaches of scientific procedure or misconduct were even insinuated. Our team answered all "points of concern", raised by the current PLoS ONE editors, in extensive detail. All these were potential limitations of our study, which would usually be addressed by one of several appropriate post-publication actions, ranging from discussion of the concern within a systematic review, through to correcting the study itself by adding a correction notice. Therefore, in the interests of transparency and accuracy, a summary of the most relevant points is provided, so that a fair-minded reader can objectively form a clear opinion.

Efficacy of Homeopathy in Addition to a Multidisciplinary Intervention for Overweight or Obesity in Mexican Adolescents: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Current recommendations for treating obesity in adolescence include a comprehensive approach (nutritional, behavioral, and exercise). Calcarea carbonica ostrearum (CCO) is a homeopathic medicine usually prescribed in obese individuals, but its effects on weight and body fat are not completely known. OBJECTIVE: The aim of this study will be to evaluate the efficacy of homeopathic CCO, in addition to a multidisciplinary intervention (diet, motivational support, and exercise program), on body fat and weight in obese adolescents. METHODS/DESIGN: A randomized, placebo-controlled, double-blind, parallel-group, superiority trial with 3-month study duration will be undertaken. The study will be conducted in a public research hospital in Mexico City, Hospital Juárez de México, in the outpatient services of homeopathy and sports medicine. Eighty non-diabetic adolescents, 12 to 19 years old, who are overweight or obese, will be included. The primary outcome: change in body fat percentage at week 12. The secondary outcomes: change in mean total weight, total body mass index, fat mass index, waist-hip ratio, lean muscle mass, fasting glucose, insulin, insulin resistance, lipid profile, score of Center for Epidemiologic Studies Depression Scale Revised (CESD-R) and score of Screen for Child Anxiety-Related Emotional Disorders (SCARED) at week 12. Efficacy data will be analyzed in the intention-to-treat sample. To determine the difference in the outcomes between groups at baseline and week 12, data will be analyzed using Student's t-test. DISCUSSION: This is the first randomized controlled trial aimed to determine the fat-reducing efficacy in obese adolescents of a homeopathic medicine, CCO, given in addition to a multidisciplinary intervention, compared with placebo plus the same intervention. It is an attempt to support scientific evidence in homeopathy for one of the most common chronic diseases, which causes high mortality due to its complications. CLINICALTRIALS. GOV IDENTIFIER: NCT03945396: https://clinicaltrials.gov/ct2/show/NCT03945396?term=homeopathy+for+obesity+in+Mexican+adolescents&rank=1.

Diagnostic accuracy of the Edinburgh Postnatal Depression Scale: consequences of screening in Mexican women.

INTRODUCTION: Postpartum depression is a non-psychotic depressive episode with serious repercussions on the bond between the mother and her child, hence the importance of detecting it in a timely manner. OBJECTIVE: To determine the accuracy of the Edinburgh Postnatal Depression Scale as a diagnostic test and to analyze the consequences of screening and the probability of depression after applying the test. METHOD: Screening of 411 women with the Edinburgh Postnatal Depression Scale during the postpartum period; Beck's Depression Inventory was used as reference. RESULTS: At a cutoff point of 12, a sensitivity of 70.4 %, specificity of 72.2 %, positive predictive value of 36.9 % and negative predictive value of 91.4 % were obtained with Edinburgh Postnatal Depression Scale, as well as an area under the curve of 0.729 and a p-value of 0.0003. Out of 49 women without treatment for postpartum depression, five were identified to require it. CONCLUSIONS: The Edinburgh Postnatal Depression Scale has moderate accuracy; its application is simple, accessible and should be routine. It is necessary for strategies to detect and treat postpartum depression to be implemented in Mexico.

INTRODUCCIÓN: La depresión posparto es un episodio depresivo no psicótico con repercusiones graves en el vínculo de la madre con su hijo, de ahí la importancia de detectarla oportunamente. OBJETIVO: Determinar la exactitud de la Escala de Depresión Posnatal de Edimburgo como prueba diagnóstica y analizar las consecuencias del tamizaje y la probabilidad de depresión después de aplicar la prueba. MÉTODO: Tamizaje con la Escala de Depresión Posnatal de Edimburgo a 411 mujeres durante el posparto; se utilizó el Inventario de Depresión de Beck como referencia. RESULTADOS: En un punto de corte de 12, con la Escala de Depresión Posnatal de Edimburgo se obtuvo sensibilidad de 70.4 %, especificidad de 72.2 %, valor predictivo positivo de 36.9 % y valor predictivo negativo de 91.4 %, así como un valor del área bajo la curva de 0.729 y p = 0.0003. De 49 mujeres sin atención para depresión posparto, en cinco se identificó que la necesitaban. CONCLUSIONES: La Escala de Depresión Posnatal de Edimburgo tiene una exactitud moderada; su aplicación es sencilla, accesible y debería ser rutinaria. Es necesario que en México se implementen estrategias para detectar y tratar la depresión posparto.

Response to Individualized Homeopathic Treatment for Depression in Climacteric Women with History of Domestic Violence, Marital Dissatisfaction or Sexual Abuse: Results from the HOMDEP-MENOP Study.

BACKGROUND: Although individualized homeopathic treatment is effective for depression in climacteric women, there is a lack of well-designed studies of its efficacy for depression in battered women or in post-traumatic stress disorder. The aim of this study was to assess the association between individualized homeopathic treatment or fluoxetine and response to depression treatment in climacteric women with high levels of domestic violence, sexual abuse or marital dissatisfaction. MATERIALS AND METHODS: One hundred and thirty-three Mexican climacteric women with moderate-to-severe depression enrolled in the HOMDEP-MENOP Study (a randomized, placebo-controlled, double-blind, double-dummy, three-arm trial, with a 6-week follow-up study) were evaluated. Domestic violence, marital dissatisfaction and sexual abuse were assessed at baseline. Response to depression treatment was defined by a decrease of 50% or more from baseline score of Hamilton scale. Association between domestic violence, sexual abuse, and marital dissatisfaction and response to depression treatment was analyzed with bivariate analysis in the three groups. Odds ratio (OR) and 95% confidence interval (CI) were calculated. RESULTS: Homeopathy versus placebo had a statistically significant association with response to depression treatment after adjusting for sexual abuse (OR [95% CI]: 11.07 [3.22 to 37.96]), domestic violence (OR [95% CI]: 10.30 [3.24 to 32.76]) and marital dissatisfaction (OR [95% CI]: 8.61 [2.85 to 25.99]). CONCLUSIONS: Individualized homeopathic treatment is associated with response to depression treatment in climacteric women with high levels of domestic violence, sexual abuse or marital dissatisfaction. Further studies should be conducted to evaluate its efficacy specifically for post-traumatic stress disorder in battered women. CLINICALTRIALS. GOV IDENTIFIER: NCT01635218,: URL: http://clinicaltrials.gov/ct2/show/NCT01635218?term=depression+homeopathy&rank=1.

Is metabolic dysregulation associated with antidepressant response in depressed women in climacteric treated with individualized homeopathic medicines or fluoxetine? The HOMDEP-MENOP Study.

BACKGROUND: Climacteric is associated with both depression and metabolic dysregulation. Scarce evidence suggests that metabolic dysregulation may predict poor response to conventional antidepressants. Response to depression treatment has not been studied in homeopathic medicine. The aim of this study was to investigate the prevalence of metabolic disorders in depressed climacteric women treated with homeopathic medicines, fluoxetine or placebo, and if these alterations have any association with response to depression treatment. METHODS: One hundred and thirty-three Mexican women (40-65 years) with depression, enrolled in the HOMDEP-MENOP study, a randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a 6 week follow-up, underwent a complete medical history and clinical examination. Metabolic parameters were assessed at baseline. Association between baseline metabolic parameters and response to depression treatment was analyzed with bivariate analysis in the three groups. Odds ratios (OR) with their 95% confidence interval (95% CI) were calculated. Metabolic parameters were considered for inclusion in the logistic regression model if they had a statistically significant relationship with response rate on bivariate analysis at p<0.05 or if they were clinically relevant. RESULTS: Overall combined prevalence (obesity and overweight) was 86.5%; 52.3% had hypertriglyceridemia; 44.7% hypercholesterolemia; 46.7% insulin resistance; and 16% subclinical hypothyroidism. There was no statistically significant association between dyslipidemia, overweight, or insulin resistance and non-response in the homeopathy group [OR (95% CI) 1.57 (0.46-5.32), p=0.467; 0.37 (0.003-1.11), p=0.059; 0.67 (0.16-2.7), p=0.579, respectively]. CONCLUSION: Metabolic dysregulation was not significantly associated with response to depression treatment in depressed climacteric women treated with individualized homeopathic treatment (IHT), fluoxetine or placebo. Due to the high prevalence of metabolic disorders and its relationship with depression in the climacteric, further investigation should be focused on whether individualized prescriptions based on classical homeopathy for depressed climacteric women have an effect on metabolic parameters, and/or if treating the metabolic disorders at the same time could lead to higher response rates. ClinicalTrials.gov Identifier: NCT01635218 URL: http://clinicaltrials.gov/ct2/show/NCT01635218?term=depression+homeopathy&rank=1.

Exactitud diagnóstica de la Escala de Depresión Posnatal de Edimburgo: consecuencias del tamizaje en mujeres mexicanas / Diagnostic accuracy of the Edinburgh Postnatal Depression Scale: consequences of screening in Mexican women

Resumen Introducción: La depresión posparto es un episodio depresivo no psicótico con repercusiones graves en el vínculo de la madre con su hijo, de ahí la importancia de detectarla oportunamente. Objetivo: Determinar la exactitud de la Escala de Depresión Posnatal de Edimburgo como prueba diagnóstica y analizar las consecuencias del tamizaje y la probabilidad de depresión después de aplicar la prueba. Método: Tamizaje con la Escala de Depresión Posnatal de Edimburgo a 411 mujeres durante el posparto; se utilizó el Inventario de Depresión de Beck como referencia. Resultados: En un punto de corte de 12, con la Escala de Depresión Posnatal de Edimburgo se obtuvo sensibilidad de 70.4 %, especificidad de 72.2 %, valor predictivo positivo de 36.9 % y valor predictivo negativo de 91.4 %, así como un valor del área bajo la curva de 0.729 y p = 0.0003. De 49 mujeres sin atención para depresión posparto, en cinco se identificó que la necesitaban. Conclusiones: La Escala de Depresión Posnatal de Edimburgo tiene una exactitud moderada; su aplicación es sencilla, accesible y debería ser rutinaria. Es necesario que en México se implementen estrategias para detectar y tratar la depresión posparto.

Abstract Introduction Postpartum depression is a non-psychotic depressive episode with serious repercussions on the bond between the mother and her child, hence the importance of detecting it in a timely manner. Objective: To determine the accuracy of the Edinburgh Postnatal Depression Scale as a diagnostic test and to analyze the consequences of screening and the probability of depression after applying the test. Method: Screening of 411 women with the Edinburgh Postnatal Depression Scale during the postpartum period; Beck's Depression Inventory was used as reference. Results: At a cutoff point of 12, a sensitivity of 70.4 %, specificity of 72.2 %, positive predictive value of 36.9 % and negative predictive value of 91.4 % were obtained with Edinburgh Postnatal Depression Scale, as well as an area under the curve of 0.729 and a p-value of 0.0003. Out of 49 women without treatment for postpartum depression, five were identified to require it. Conclusions: The Edinburgh Postnatal Depression Scale has moderate accuracy; its application is simple, accessible and should be routine. It is necessary for strategies to detect and treat postpartum depression to be implemented in Mexico.

Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP study): a randomized, double-dummy, double-blind, placebo-controlled trial.

BACKGROUND: 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. METHODS/DESIGN: 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). RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01635218. PROTOCOL PUBLICATION: https://clinicaltrials.gov/ct2/show/NCT01635218 [corrected].

Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial.

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.

Depresión y homeopatía: una alternativa de tratamiento / Depression y homeopatía: una alternative tratamiento

La depresión es el trastorno mental que más afecta a la población y una de lãs rincipales causas de discapacidad en el orbe, lo que se demuestra claramente con la información oficial de la Organización Mundial de la Salud, la cual señala que la enfermedad es parte de la vida de más de 350 millones de personas en todo el mundo (datos actualizados al año 2014). La falta de profesionales de la salud, sobre todo quienes son responsables de ofrecer la atención primaria, y el estigma social asociado a los trastornos mentales son algunas de la barreras para que la población reciba un tratamiento eficiente. De allí la importancia de la hipótesis de este trabajo, publicado originalmente en La Homeopatía de México entre enero de 2006 y enero de 2007, que señala: “la Homeopatia sí es una alternativa de tratamiento integral para este tipo de pacientes, ya que toma en cuenta tanto la sintomatología mental como física para su prescripción, luego entonces constituye una opción de tratamiento para pacientes com síntomas de depresión, lo que redundaría en un gran beneficio para la población”.

Depression is a mental disorder that affects the population and one of the ain causes of disability in the world, which is clearly demonstrated by the official information from the World Health Organization, which states that illness is part of the lives of over 350 million people worldwide (updated to 2014 data).The lack of health professionals, particularly those who are responsible for providing primary health care, and social stigma associated with mental disorders are some of the barriers for people to receive an effective treatment. Hence the importance of the hypothesis of this work, originally published in Homeopathy of Mexico between January 2006 and January 2007, which states: "Homeopathy itself is a comprehensive alternative treatment for these patients, since it takes into account both mental and physical symptoms for prescribing, then so is a treatment option for patients with a depression symptoms, which would result in great benefit to the population. "

Enfoque médico homeopático de la depresión posparto / Homeopathic medical approach of postpartum depression

La depresión posparto es un trastorno depresivo no psicótico que inicia después del alumbramiento. Frecuentemente es subdiagnosticado y no tratado, por lo que las repercusiones en la relación materno-filial son importantes. Su detección es sencilla cuando el personal médico y la población en general tienen conocimiento de él. Su tratamiento habitual se basa en psicoterapia cognitivo-conductual y antidepresivos, si bien la administración de estos últimos es controversial porque se excretan por la leche materna. La Homeopatia puede utilizarse para tratar la depresión en este período. A pesar de que no existe suficiente evidencia de ensayos clínicos de calidad metodológica, una adecuada toma de caso ayuda a encontrar el medicamento para cada experiencia en particular.

Depresión y homeopatía una alternativa de tratamiento (parte 1) / Depression and Homeopathy an alternative treatment (part 1)

La sociedad está empezando a reconocer a la depresión como un problema importante de salud pública. En EUA se están realizando programas que buscan atender este problema (Regier y Col., 1988), al igual que en la Gran Bretaña (Paykel y Priest, 1992). A menudo se subestima el impacto de la depresión tanto en términos de sufrimiento personal como el de la carga económica sobre el sistema de salud y la comunidad.