Homeopathic Individualized Q-potencies versus Fluoxetine for Moderate to Severe Depression: Double-blind, Randomized Non-inferiority Trial
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
Faculdade de Medicina de Jundiaı ´, Homeopathy Graduation Programme, Department of Psychobiology,
Universidade Federal de Sa ˜ o Paulo, Sa ˜ o Paulo, Brazi
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 20mg day–1(up to 40mg day–1) in a pro-
spective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy
measure was the analysis of the mean change in the Montgomery & Asberg 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 (P¼0.654) and 8th weeks (P¼0.965) 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.
Keywords: depression – drug therapy – fluoxetine – homeopathy – integrative and
alternative medicine – non-inferiority – Q-potencies – randomized controlled trial – remission –
response
Source : http://ecam.oxfordjournals.org/
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