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

Ubiratan C Adler,Stefan N Willich,Michael Teut,Claudia M Witt,Friederike Martins,Stephanie Krüger,Klaus Linde,Rainer Lüdtke,Lena Schützler,James Coyne

doi:10.1371/journal.pone.0074537

Abstract

BackgroundThe specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated.AimsTo 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.MethodsA 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.ResultsA 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.ConclusionsAlthough 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 registrationclinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43

Highlights

Depression is the most disabling mental disorder in the European Union (EU), affecting almost 7% of the EU population each year [1]
The treatment consists of two main elements: taking case histories and prescribing individually selected homeopathic medicines [10]
The homeopathic case history aims to ascertain the totality of signs and symptoms of each patient, enabling the selection of an individualized homeopathic medicine

Summary

Introduction

Depression is the most disabling mental disorder in the European Union (EU), affecting almost 7% of the EU population each year [1]. Homeopathy is sought by patients as complementary or alternative treatment for depressive disorders [2,3,4,5,6,7,8,9]. The treatment consists of two main elements: taking case histories and prescribing individually selected homeopathic medicines [10]. The homeopathic case history aims to ascertain the totality of signs and symptoms of each patient, enabling the selection of an individualized homeopathic medicine. It attempts to understand the patients background, environment and daily routine. The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated

Results

Discussion

Conclusion