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, H M Calil, U C Adler, N M P Paiva, A T Cesar, M S Adler, A Molina, A E Padula, H M Calil

Abstract

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 = .654) and 8th weeks (P = .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.

Figures

Figure 1
Figure 1
Diagram flow of subjects throughout the study.
Figure 2
Figure 2
MADRS mean scores at baseline and on 4th and 8th weeks of randomized treatment with fluoxetine or individualized homeopathic Q-potencies (ITT population).
Figure 3
Figure 3
Non-inferiority representation of the difference (homeopathy versus fluoxetine) in the mean change of the MADRS scores on the 4th and 8th weeks of randomized, double-bind treatment. Error bars indicate two-sided 95% CIs. Tinted area indicates zone of non-inferiority. Delta indicates the margin of non-inferiority. Mean differences (homeopathy-fluoxetine) were −3.04 (−6.95 to 0.86) and −2.64 (−6.05 to 0.77) at weeks 4th and 8th, respectively.

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