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.

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.

Calcarea Carbonica Ostrearum para la obesidad en adolescentes mexicanos / Calcarea Carbonica Ostrearum for mexican adolescent obesity

Antecedentes: la obesidad es un problema de salud pública en México que va en aumento en niños y adolescentes, incrementando el riesgo de enfermedades cardiovasculares y metabólicas a temprana edad. Tradicionalmente, en la práctica clínica homeopática, Calcarea carbonica ostrearum se ha utilizado para la obesidad; sin embargo, no existen estudios de calidad metodológica donde se demuestre sueficacia. El objetivo del estudio fue demostrar la eficacia de Calcarea carbonica ostrearum vs placebo para disminuir la obesidad en adolescentes. Material y métodos: se realizó un ensayo clínico controlado, aleatorizado, doble ciego, de 15 semanas de duración en el Hospital General de México (Ciudad de México) de febrero a agosto de 2010, en el que se incluyó a 25 pacientes adolescentesobesos de entre 14 y 18 años de edad. Se les administró Calcarea carbonica ostrearum 30CH, o placebo, junto con cambios en la dieta y ejercicio. Las variables medidas fueron: peso, índice de masa corporal, perímetro abdominal y porcentaje de grasa corporal. Resultados: se encontraron diferencias estadísticamente significativas entre Calcarea carbonica ostrearum 30CH y placebo en el porcentaje de grasa corporal (Calcarea carbonica ostrearum 2.9±1.1 vs placebo 1.3±1.5; diferencia=1.63, p<0.05). En las demás variables (peso, índice de masa corporal y perímetro abdominal) no se encontraron diferencias estadísticamente significativas entre grupos después de 15 semanas de tratamiento. Conclusión: Calcarea carbonica ostrearum 30CH puede ser efectiva para reducir el porcentaje de grasa corporal en adolescentes obesos. Es necesario que se realicen ensayos clínicos controlados con tamaños de muestra más grandes para corroborar estos resultados. (AU)

Background: obesity is a health problem in Mexico. The prevalence of juvenile and child obesity is raising and is strongly related to cardiovascular and metabolic risk factors. Traditionally, in daily homeopathic practice, Calcarea carbonica ostrearum is prescribed for obesity. Nevertheless there is a lack of well-designed studies to prove its efficacy. The objetive of this study was to investigate the efficacy of Calcarea carbonica ostrearum 30CH vs placebo for reducing obesity in adolescents. Methods/design: a randomized, double-blind, placebo-controlled two-arm trial with a 15 weeks follow-up study was conducted in the Hospital General de Mexico in Mexico City. Twenty-five adolescents between 14 and 18 years were included. The outcomes were: weight, body mass index, abdominal circumference and percentage of body fat. Results: percentage of body fat was the only outcome with statistically significant difference between Calcarea carbonica ostrearum 30CH and placebo (Calcarea carbonica ostrearum 2.9±1.1 vs placebo 1.3±1.5, difference=1.63, p<0.05). Neither weight, nor body mass index, nor abdominal circumference were different from placebo after 15 weeks of treatment. Conclusion: Calcarea carbonica ostrearum 30CH could be effective for reducing the percentage of body fat in obese adolescents. Further studies with larger sample sizes are needed to confirm these results. (AU)

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.

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. (AU)

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.