[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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