Trial reportPloS one2015
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.
Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to trial NCT01635218 (Efficacy of Individualized Homeopathic Treatment for Moderate to Severe Depression in Peri- and Postmenopausal Women), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of Individualized Homeopathic Treatment for Moderate to Severe Depression in Peri- and Postmenopausal Women: a Randomized Placebo-controlled, Double-blind, Double-dummy, Study Protocol
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- Antidepressants during and after Menopausal Transition: A Systematic Review and Meta-Analysis.Scientific reports · 2020Pooled it
- Trial
- Article
- Placebo Effect in the Treatment of Depression and Anxiety.Frontiers in psychiatry · 2019Review
- [Homeopathy for psychiatric patients-for and against].Der Nervenarzt · 2018Review
- Homeopathy Use in the United States and Implications for Public Health: A Review.Homeopathy : the journal of the Faculty of Homeopathy · 2018Review
- Add-On Complementary Medicine in Cancer Care: Evidence in Literature and Experiences of Integration.Medicines (Basel, Switzerland) · 2017Review
- Near-Infrared Spectroscopy Reveals Abnormal Hemodynamics in the Left Dorsolateral Prefrontal Cortex of Menopausal Depression Patients.Disease markers · 2017Article
- Homeopathy Use by US Adults: Results of a National Survey.American journal of public health · 2016Article
- Article
Corrections and comments
- Correction · 2015-05-04Error in Text ·
- Retraction · 2020-04-23Concerns/Issues about Data · Concerns/Issues about Results and/or Conclusions · Investigation by Journal/Publisher ·
- Commented on by
- Commented on by
- Erratum issued
- Retracted
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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: https://clinicaltrials.gov/ct2/show/NCT01635218 [corrected].
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