Eficácia e tolerabilidade da homeopatia e da fluoxetina no tratamento da depressão

• Ano de defesa: 2009
• Autor(a) principal: Adler, Ubiratan Cardinalli [UNIFESP]
• Tipo de documento: Tese
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade Federal de São Paulo (UNIFESP)
• Palavras-chave em Português: Transtornos depressivos; Homeopatia; Potências Q; Remissão; Resposta; Ensaio clínico controlado aleatório; Fluoxetina; Homeopathy; Fluoxetine; Depression; Q potencies; Randomized controlled trial; Remission; Response
• Link de acesso: http://repositorio.unifesp.br/handle/11600/9449

Background: Homeopathy is a Complementary and Integrative Medicine used in depression. Aims: this study investigated the non-inferiority and tolerability of individualized homeopathic medicines (Q-potencies) in acute depression, using fluoxetine as active control. Methods: Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg/day (up to 40 mg/day) 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 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. Results: 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 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 weeks 4th and 8th, 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 adverse side effects and a there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. Conclusions: 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.