title: Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes: a multicenter, randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Homeopathic medicines have a place among the non-hormonal therapies for the treatment of hot flashes during the menopause.
  
  
  OBJECTIVE
  The objective of this study was to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women.
  
  
  METHODS
  This was a multicenter, randomized, double-blind, placebo-controlled study carried out between June 2010 and July 2011.
  
  
  METHODS
  The study was conducted in 35 active centers in France (gynecologists in private practice).
  
  
  METHODS
  One hundred and eight menopausal women, ≥ 50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥ 5 hot flashes per day with a significant negative effect on the women's professional and/or personal life.
  
  
  METHODS
  Treatment was either BRN-01 tablets, a registered homeopathic medicine containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or identical placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrollment and was continued for 12 weeks.
  
  
  METHODS
  The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded.
  
  
  RESULTS
  One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01.
  
  
  CONCLUSIONS
  BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication. Trial registration number (EudraCT): 2009-016959-21.
authors.affiliation: Department of Gynaecology, Hospital Foch, Suresnes, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Colau
authors.forename: Stéphane
authors.initials: S
authors.lastname: Vincent
authors.forename: Philippe
authors.initials: P
authors.lastname: Marijnen
authors.forename: François-André
authors.initials: FA
authors.lastname: Allaert
mesh_terms: D004311:Double-Blind Method; D005260:Female; D005602:France; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008419:Materia Medica / Q000627:therapeutic use*; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D008419:Materia Medica