Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP study): a randomized, double-dummy, double-blind, placebo-controlled trial

Abstract

Background: Perimenopausal 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 postmenopausal 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 postmenopausal women with moderate to severe depression.

Methods/design: 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 thirty-three peri- and postmenopausal 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 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, 15.9%. There was a significant difference among groups in response rate definition only, 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.

Conclusion: Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.

Trial registration: ClinicalTrials.gov NCT01635218.

Protocol publication: https://clinicaltrials.gov/ct2/show/NCT01635218 [corrected].

Fig 1. CONSORT flow diagram of study participants through the trial.

Fig 2. Mean change in 17-item Hamilton Rating Scale for Depression score after six weeks of treatment according to the study group.

HRSD scores range from 0 (no depression) up to 52 (maximum depression severity). IHT and flouxetine groups improved significantly faster than placebo group. І bars denote 95% CI.

Fig 3. Mean change in Beck Depression Inventory score after six weeks of treatment according to the study group.

BDI scores range from 0 (no depression) up to 63 (maximum depression severity). IHT and flouxetine groups did not improve significantly faster than placebo group. І bars denote 95% CI.

Fig 4. Mean change in Greene Climacteric Scale score after six weeks of treatment according to the study group.

GS scores range from 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). IHT improved significantly faster than placebo group. І bars denote 95% CI.