Vol. 2, Issue 6, Part K (2016)

Methods/design: A randomized, placebo-controlled, double-blind and three-arm trial with a six-week follow-up study was designed. The statistical study was conducted in a public research hospital in Mexico City (Juárez de México Hospital) in the outpatient service of homeopathy. One hundred eighty nine peri- and postmenopausal women diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders. The primary outcome is change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression after the fourth and sixth week of treatment. Secondary outcomes are: Back Depression Inventory change in mean score, Greene’s Scale change in mean score, response and remission rates and safety. Efficacy data was analyzed in the intention-to-treat population. To determine differences in the primary and secondary outcomes among groups at baseline and weeks four and six, data was analyzed by analysis of variance for independent measures with the Bonferroni post-hoc test.

Discussion: This study is the first trial of classical homeopathy that would evaluate the efficacy of homeopathic individualized treatment using C-potencies versus administration of placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. It is an attempt to deal with the obstacles of homeopathic research due to the need for individual prescriptions in one of the most common psychiatric diseases.