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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>A 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.</p> <p>Discussion</p> <p>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</p> <p>Trial registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01178255">NCT01178255</a></p

Homeopathy for Depression: A Randomized, Partially Double-Blind, Placebo-Controlled, Four-Armed Study (DEP-HOM)

<div><p>Background</p><p>The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated.</p><p>Aims</p><p>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.</p><p>Methods</p><p>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.</p><p>Results</p><p>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.</p><p>Conclusions</p><p>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.</p><p>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.</p><p>Trial registration</p><p>clinicaltrials.gov identifier <a href="http://clinicaltrials.gov/ct2/show/NCT01178255" target="_blank">NCT01178255</a>.</p><p><b><i>Protocol publication:</i></b><a href="http://www.trialsjournal.com/content/12/1/43" target="_blank">http://www.trialsjournal.com/content/12/1/43</a></p></div

Baseline demographics and clinical characteristics.

<p>Baseline demographics and clinical characteristics.</p

Trend line (cumulative) of included patients/month until February 2012 (end of the recruitment phase).

<p>Trend line (cumulative) of included patients/month until February 2012 (end of the recruitment phase).</p

HAM-D development (x axis) over time (y axis) baseline and weeks 2, 4, 6 in the four groups for the single cases.

<p>HAM-D development (x axis) over time (y axis) baseline and weeks 2, 4, 6 in the four groups for the single cases.</p

Outcomes after 2, 4 and 6 weeks: mean differences and confidence intervals of pooled groups (HAM-D = Hamilton Depression Scale values <0 favor homeopathy or case history I, BDI = Beck Depression Inventory values <0 favor homeopathy or case history I, SF-12 = short form 12 health related quality of life questionnaire values >0 favor homeopathy or case history I).

<p>Outcomes after 2, 4 and 6 weeks: mean differences and confidence intervals of pooled groups (HAM-D = Hamilton Depression Scale values <0 favor homeopathy or case history I, BDI = Beck Depression Inventory values <0 favor homeopathy or case history I, SF-12 = short form 12 health related quality of life questionnaire values >0 favor homeopathy or case history I).</p