title: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01635218.
  https://clinicaltrials.gov/ct2/show/NCT01635218 [corrected].
authors.affiliation: División de Estudios de Posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Distrito Federal, México; Consulta Externa de Homeopatía, Hospital Juárez de México, Secretaría de Salud, Distrito Federal, México.
authors.forename: Emma Del Carmen
authors.initials: Edel C
authors.lastname: Macías-Cortés
authors.affiliation: Unidad de Salud Mental, Hospital Juárez de México, Secretaría de Salud, Distrito Federal, México.
authors.forename: Lidia
authors.initials: L
authors.lastname: Llanes-González
authors.affiliation: División de Estudios de Posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Distrito Federal, México.
authors.forename: Leopoldo
authors.initials: L
authors.lastname: Aguilar-Faisal
authors.affiliation: División de Estudios de Posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Distrito Federal, México.
authors.forename: Juan
authors.initials: J
authors.lastname: Asbun-Bojalil
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D003863:Depression / Q000188:drug therapy*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006705:Homeopathy / Q000379:methods; D006801:Humans; D008800:Mexico; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects*; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors