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

BackgroundPerimenopausal 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/DesignA 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).ResultsAfter 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.ConclusionHomeopathy 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 RegistrationClinicalTrials.gov NCT01635218 Protocol Publication http://www.trialsjournal.com/content/14/1/105.

Characteristics of Homeopathy Users among Internal Medicine Patients in Germany

“…Although 1.3% of the general population may use homeopathy for psychiatric symptoms [26], this use is more frequently associated with anxiety disorders than with depression. The evidence for the efficacy of homeopathy in the treatment of depression is limited to moderate to severe depression [27]. The prevalence of subthreshold depression has been receiving increasing attention, however, and has been linked to greater healthcare utilization [28].…”

Individualized Homeopathy for Depression in Climacteric Women: Comments on the Retraction by PLoS ONE

“…1 The results of this study showed, for the first time, that individualized homeopathic treatment (IHT) using 30c and 200c potencies, as well as fluoxetine, was effective in improving depression in climacteric women after a 6-week period of treatment. 2 even though all of the issues of the concern raised during postpublication discussions with the journal were answered by us in full, as well as the overarching point that none of them was sufficiently serious to justify retraction.…”

“…The individualized homeopathic consultation (IHC) was carried out according to the "classical" homeopathy methods described in Hahnemann's Organon of Medicine (paragraphs 83-104), stated in the Methods section of the article. 2 During post-publication discussions, we provided a detailed guidance and step-by-step explanation as to how the consultation was carried out. As this technique is the "gold-standard" for the homeopathic prescription in daily practice worldwide, it has also been replicated multiple times in clinical research.…”

Depressive disorders in women of climacteric age (review of foreign literature for 2012–2016)

“…Четырехнедельная терапия армодафинилом (150 мг/д) [43] повышала показатели по Menopause Specific Quality Life (р = 0,0001): вазомоторных симптомов и когнитивной функции, подавленности, печали, плаксивости, анергии, колебаний настроения, усталости. Вызывает сомнение превосходство гомеопатии над флуоксетином и плацебо в рандомизированном исследовании антидепрессивной терапии у мексиканских женщин [44]. По PubMed, Medline выполнен обзор об аугментационной роли гормонотерапии в сочетании с антидепрессантами [45]; не отличаются новизной положения, что 50% женщин климактерического возраста нуждаются в фармакотерапии по снижению симптомов КД, в 30% случаев диагностируется ДР, взаимовлияние депрессивных и личностных расстройств и преморбидная депрессивная предрасположенность ведут к хронизации депрессии.…”