Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

Faculdade de Medicina de Jundiaí, Homeopathy Graduation Programme, Department of Psychobiology, Universidade Federal de São Paulo, R. Napoleão de Barros, 925 São Paulo, SP 04024-002, Brazil.
Evidence-based Complementary and Alternative Medicine (Impact Factor: 1.88). 08/2009; 2011(1741-427X):520182. DOI: 10.1093/ecam/nep114
Source: PubMed


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.

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    • "dynamization, which consists of dilutions by sequential stirrings in small volumes and has applications to both human and animal diets (Adler et al., 2011). Animal homeopathy is a science applied in several areas (Fisher, 2012), being ideal due to its low cost, efficiency and absence of toxicity. "
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    ABSTRACT: Current assay evaluates the physical, chemical and microbiological quality of fillets and mechanically separated meat (MSM) plus the sensory aspects of fillets of the Nile Tilapia (Oreochromis niloticus) treated with Homeopatila 100 ®. The moisture, fixed mineral residue, lipid, crude protein, pH, color, water activity (Aw), Staphylococcus coagulase, coliforms were reported at 45°C. Escherichia coli, Salmonella sp., counting viable aerobic mesophilic and psychrotrophic amounts of the fillets and MSM were determined. Acceptance, intention test and shear force of fillets also were performed. The fillets examined by softer tissue (6.08 N ± 0.04), lower Aw (0.990 ± 0.001), less total amounts of psychrotropic aerobic bacteria (2.12 ± 0.01 Log 10 UFC/g) and by low component value of colour. L* (luminosity) (65.78 ± 0.37) and a* (red/green) (1.50 ± 0.01) for MSM and of high value of b* (yellow/blue) for MSM (13.54 ± 0.11) and fillets (4.93 ± 0.03) sensory acceptability was 80.11%. The colours of fillet and MSM were related to the results of fish stressed prior to slaughter. The results indicated that the use of Homeopatila 100 ® in the diet of the Nile Tilapia did not change the muscle quality and the sensory acceptability.
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    • "The products of homeopathy, a complementary and alternative medicine, are produced by dinamization, a process that involves sequentially stirred dilutions in small volumes applied to human and animal diets (Adler et al., 2011). The use of population homeopathy reduces stress to animals, especially in intensive systems that are very different from the natural environment, and increases the production potential and survival. "
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    ABSTRACT: The homeopathic product Homeopatila 100 ® in the diet of Nile tilapia reduces stress during production and improves the well-being of fish. The objective of this study was to develop nuggets of tilapia fed with Homeopatila 100 ® and to assess their quality. Physical, chemical, microbiological and sensory analyses were performed on three formulations with 25, 50 and 75% mechanically separated meat (MSM) for each of the treatments. The nuggets with 75% MSM revealed a higher pH (5.89 ± 0.02), the tissue was softer (1.29 N ± 0.04), and they had a higher lipid value (15.96% ± 0.05). With 50 and 75%, the color (L *) was darker (60.76% ± 0.91 and 60.03% ± 0.78), and there were lower protein amounts (15.54% ± 0.31 and 13.55% ± 0.35). Nuggets had an acceptable value of lipid oxidation (0.672 ± 0.007 mg MDA/kg). The microbiological analyses demonstrated that the product met the requirements of legislation. Nuggets with 25 and 50% MSM were deemed acceptable. There was no difference (p > 0.05) between the control treatment group and the Homeopatila 100 ® group for the analysis undertaken. The results indicated that the use of Homeopatila 100 ® in the diet of the Nile tilapia did not change the physical, chemical, microbiological and sensorial quality characteristics of the nuggets, ensuring consumer acceptability.
    African journal of pharmacy and pharmacology 03/2015; 9(6):182-189. DOI:10.5897/AJPP2014.4173 · 0.84 Impact Factor
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    • "The authors of this study concluded that individualized homeopathic Q-potencies are inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. This trial had no placebo control and interestingly, responder rates (defined as a decrease of at least 50% from baseline on the Montgomery & Åsberg depression rating scale) of both the homeopathic medicine and fluoxetine groups were higher (homeopathy 84.6%; fluoxetine 82.8%) than those usually found for antidepressants in trials (43–75%) [13], presuming a strong placebo effect. One might speculate that this could be due to the more extensive homeopathic case history in the study that compared homeopathic medicines with fluoxetine. "
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    ABSTRACT: The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. 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. A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed. 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. 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. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43.
    PLoS ONE 09/2013; 8(9):e74537. DOI:10.1371/journal.pone.0074537 · 3.23 Impact Factor
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