Individualized Homeopathic Treatment and Fluoxetine for Moderate-to-Severe Depression in Peri- and Post-Menopausal Women (HOMDEP-MENOP Study): A Randomized, Double-Dummy, Double-Blind, Placebo-Controlled Trial

Background: Peri-menopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and post-menopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and post-menopausal women with moderate-to-severe depression.

Methods: A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6-week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred and thirty-three peri- and post-menopausal women diagnosed with major depression according to DSM-IV (moderate-to-severe intensity) were included. The outcomes were change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with the Bonferroni post hoc test).

Results: After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate was 15.9%. There was a significant difference among groups in response rate definition but not in remission rate. Fluoxetine–placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.

Keywords: Peri-menopause, post-menopause, climacteric, depression, homeopathy, fluoxetine, Hamilton Rating Scale for Depression, Beck Depression Inventory, Greene Climacteric Scale