[Omeo33] Art 1039 - eCAM, 2009, doi: 10.1093/ecam/nep114

Gino Santini g.santini a ismo.it
Lun 24 Ago 2009 19:22:56 CEST


Homeopathic Individualized Q-potencies versus Fluoxetine for Moderate  
to Severe Depression: Double-blind, Randomized Non-inferiority Trial
U. C. Adler, N. M. P. Paiva, A. T. Cesar, M. S. Adler, A. Molina, A.  
E. Padula and H. M. Calil

Homeopathy is a complementary and integrative medicine used in  
depression, The aim of this study is to investigate the non- 
inferiority and tolerability of individualized homeopathic medicines  
[Quinquagintamillesmial (Q-potencies)] in acute depression, using  
fluoxetine as active control. Ninety-one outpatients with moderate to  
severe depression were assigned to receive an individualized  
homeopathic medicine or fluoxetine 20 mg day–1 (up to 40 mg day–1) in  
a prospective, randomized, double-blind double-dummy 8-week, single- 
center trial. Primary efficacy measure was the analysis of the mean  
change in the Montgomery & Åsberg Depression Rating Scale (MADRS)  
depression scores, using a non-inferiority test with margin of 1.45.  
Secondary efficacy outcomes were response and remission rates.  
Tolerability was assessed with the side effect rating scale of the  
Scandinavian Society of Psychopharmacology. Mean MADRS scores  
differences were not significant at the 4th (P = 0.654) and 8th weeks  
(P = 0.965) of treatment. Non-inferiority of homeopathy was indicated  
because the upper limit of the confidence interval (CI) for mean  
difference in MADRS change was less than the non-inferiority margin:  
mean differences (homeopathy–fluoxetine) were –3.04 (95% CI –6.95,  
0.86) and –2.4 (95% CI –6.05, 0.77) at 4th and 8th week, respectively.  
There were no significant differences between the percentages of  
response or remission rates in both groups. Tolerability: there were  
no significant differences between the side effects rates, although a  
higher percentage of patients treated with fluoxetine reported  
troublesome side effects and there was a trend toward greater  
treatment interruption for adverse effects in the fluoxetine group.  
This study illustrates the feasibility of randomized controlled double- 
blind trials of homeopathy in depression and indicates the non- 
inferiority of individualized homeopathic Q-potencies as compared to  
fluoxetine in acute treatment of outpatients with moderate to severe  
depression.

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