Homeopathy for depression: a randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM).

BACKGROUND: The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. AIMS: To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks. METHODS: A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed. RESULTS: A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI -1.2;5.2) for Q-potencies vs. placebo and -3.1 (-5.9;-0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups. CONCLUSIONS: Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43.

Homeopathy for depression--DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study.

BACKGROUND: Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history. METHODS/DESIGN: A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 x 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history. DISCUSSION: For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the challenges of homeopathic research and the results might be useful information in the current discussion about the evidence on homeopathy TRIAL REGISTRATION: ClinicalTrials.gov: NCT01178255.

Da padronização farmacêutica à pesquisa clínica: 20 anos de experiência com diluições cinquenta-milesimais / From pharmaceutical standardizing to clinical research: 20 years of experience with fifty-millesimal dilutions

Há 20 anos iniciamos uma padronização dos procedimentos para o preparo e uso das diluições cinquenta-milesimais (LM ou Q) de acordo com a 6ª edição do Organon. O presente artigo visa relatar as principais etapas dessa padronização e nossa experiência com o ensino e a pesquisa usando os princípios essenciais da obra de Hahnemann. Observamos uma menor incidência de agravações homeopáticas com o uso de medicamentos padronizados, em relação à nossa experiência anterior com diluições LM não padronizadas. O protocolo clínico-farmacêutico, que aqui denominamos Organon.modus, mostrou-se adequado ao ensino da homeopatia na Faculdade de Medicina de Jundiaí, primeira escola de medicina no Brasil a oferecer uma especialização em homeopatia para médicos. Diluições LM individualizadas não foram inferiores ao antidepressivo fluoxetina no tratamento de pacientes com depressão moderada a grave em um estudo randomizado e duplo-cego. Conclui-se assim que o protocolo Organon.modus mostrou-se adequado ao ensino acadêmico da homeopatia e eficaz em um estudo clínico controlado, resultados que favorecem seu uso como denominador comum entre a arte de curar e a ciência médica.

Twenty years ago we began to standardize the procedures of preparation and use of fifty-millesimal dilutions (LM or Q) according to indications in the 6th edition of Hahnemann’s Organon. This article describes the main stages in standardization as well as our teaching and research experience on Organon 6th edition. With the use of standardized LM dilutions we observed a lower incidence of homeopathic aggravation than with our earlier experience with non standardized preparations. Organon.modus, a clinical-pharmaceutical protocol derived from the standardization was adequate for the teaching of homeopathy at Faculty of Medicine of Jundiai (São Paulo), the first Brazilian medical school with a graduate course on homeopathy. A randomized double-blind trial comparing individualized homeopathic medicines prescribed in LM dilutions and fluoxetine showed the former not be inferior to the latter in the treatment of moderate-to-severe depression. Protocol Organon.modus showed to be adequate to graduate-level teaching of homeopathy and efficient in a controlled clinical trial, favoring its use as common denominator between the art of healing and medical science.

Da padronização farmacêutica à pesquisa clínica: 20 anos de experiência com diluições cinquenta-milesimais / From pharmaceutical standardizing to clinical research: 20 years of experience with fifty-millesimal dilutions

Há 20 anos iniciamos uma padronização dos procedimentos para o preparo e uso das diluições cinquenta-milesimais (LM ou Q) de acordo com a 6ª edição do Organon. O presente artigo visa relatar as principais etapas dessa padronização e nossa experiência com o ensino e a pesquisa usando os princípios essenciais da obra de Hahnemann. Observamos uma menor incidência de agravações homeopáticas com o uso de medicamentos padronizados, em relação à nossa experiência anterior com diluições LM não padronizadas. O protocolo clínico-farmacêutico, que aqui denominamos Organon.modus, mostrou-se adequado ao ensino da homeopatia na Faculdade de Medicina de Jundiaí, primeira escola de medicina no Brasil a oferecer uma especialização em homeopatia para médicos. Diluições LM individualizadas não foram inferiores ao antidepressivo fluoxetina no tratamento de pacientes com depressão moderada a grave em um estudo randomizado e duplo-cego. Conclui-se assim que o protocolo Organon.modus mostrou-se adequado ao ensino acadêmico da homeopatia e eficaz em um estudo clínico controlado, resultados que favorecem seu uso como denominador comum entre a arte de curar e a ciência médica.(AU)

Twenty years ago we began to standardize the procedures of preparation and use of fifty-millesimal dilutions (LM or Q) according to indications in the 6th edition of Hahnemann’s Organon. This article describes the main stages in standardization as well as our teaching and research experience on Organon 6th edition. With the use of standardized LM dilutions we observed a lower incidence of homeopathic aggravation than with our earlier experience with non standardized preparations. Organon.modus, a clinical-pharmaceutical protocol derived from the standardization was adequate for the teaching of homeopathy at Faculty of Medicine of Jundiai (São Paulo), the first Brazilian medical school with a graduate course on homeopathy. A randomized double-blind trial comparing individualized homeopathic medicines prescribed in LM dilutions and fluoxetine showed the former not be inferior to the latter in the treatment of moderate-to-severe depression. Protocol Organon.modus showed to be adequate to graduate-level teaching of homeopathy and efficient in a controlled clinical trial, favoring its use as common denominator between the art of healing and medical science.(AU)

Inflammatory aspects of depression.

A bidirectional relation between depression and natural immunity has been identified: depressive episodes are associated to a relative immunodeficiency, conversely inflammatory activity has been implicated in the development of depressive symptoms and in the pathophysiology of depression. Depression has been associated with a decrease in the number and activity of NK lymphocytes and hence patients with depression may show immunodeficiency towards intracellular microorganisms and tumors. Paradoxically, depression is sometimes accompanied by an inflammatory state, developed from the peripheral stimuli (atopy) or central stimuli (chronic stress) and mediated by proinflammatory cytokines (IL-6, TNF and IL-1). These cytokines can play a role in the pathophysiology of depression and of various diseases, supporting the hypothesis that many chronic diseases are individual manifestations of a common proinflammatory denominator.