Abstract
BackgroundHomeopathy 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/DesignA randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 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.DiscussionFor 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 homeopathyTrial registrationClinicalTrials.gov: NCT01178255
Highlights
DiscussionFor the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression
Homeopathy is often sought by patients with depression
Antidepressants are the standard pharmacotherapy for major depression, with a significant difference to placebo, the National Institute of Clinical Excellence (NICE) in the UK stresses that the severity of depression at which antidepressants show consistent benefits over placebo is poorly defined, emphasizing that, in general, the more severe the symptoms, the greater the benefit [7]
Summary
For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. The protocol is in accordance with the EMEA (European Medicines Agency) Guidelines, which recommends placebo-controlled studies and the duration of six weeks for trials investigating medicines for depression [26], considering that during antidepressant pharmacotherapy, one must reckon with a delay of several weeks until sufficient antidepressant effects can be seen [27]. It is the first trial on classical homeopathy after the 15th amendment to the German Medicines Act (Arzneimittelgesetz, AMG) [28].
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