Efficacy and safety of homeopathy for moderate major depression - a randomized placebo-controlled trial

Efficacy and safety of homeopathy for moderate major depression - a randomized placebo-controlled trial


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 2x2 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.


Publication:

Adler UC, Krüger S, Teut M, Lüdtke R, Schützler L, Martins F, Willich SN, Linde K, Witt CM. Homeopathy for Depression: A Randomized, Partially Double-Blind, Placebo-Controlled, Four-Armed Study (DEP-HOM). PLoS ONE 2013 8(9): e74537.

Adler UC, Krüger S, Teut M, Lüdtke R, Bartsch I, Schützler L, Melcher F, Willich SN, Linde K, Witt CM. Homeopathy for depression--DEP-HOM: study protocol  for a randomized, partially double-blind, placebo controlled, four armed study. Trials. 2011 Feb 14;12(1):43.

 

Principle investigator:
Witt, MD, MBA

Research associate:
Adler, MD
Schützler
Hohmann
Melcher
Teut, MD

Statistics:
Lüdtke

Coorperation:
Krüger, MD

Data management:
Icke
Binting

Study nurse:
Bartsch
Eden

Project duration:
2010-2013

Project status:
completed

Funding:
Investigator Initiated Trial 
Carstens Foundation