PMID- 22852580
OWN - NLM
STAT- MEDLINE
DCOM- 20130219
LR  - 20211021
IS  - 1179-6901 (Electronic)
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 12
IP  - 3
DP  - 2012 Sep 1
TI  - Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes: a 
      multicenter, randomized, double-blind, placebo-controlled trial.
PG  - 107-19
LID - 10.2165/11640240-000000000-00000 [doi]
AB  - 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. STUDY DESIGN: This was a 
      multicenter, randomized, double-blind, placebo-controlled study carried out 
      between June 2010 and July 2011. SETTING: The study was conducted in 35 active 
      centers in France (gynecologists in private practice). PATIENTS: 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. INTERVENTION: 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. 
      MAIN OUTCOME MEASURE: 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. CONCLUSION: 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.
FAU - Colau, Jean-Claude
AU  - Colau JC
AD  - Department of Gynaecology, Hospital Foch, Suresnes, France.
FAU - Vincent, Stephane
AU  - Vincent S
FAU - Marijnen, Philippe
AU  - Marijnen P
FAU - Allaert, Francois-Andre
AU  - Allaert FA
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - 0 (Materia Medica)
SB  - IM
MH  - Double-Blind Method
MH  - Female
MH  - France
MH  - Hot Flashes/*drug therapy
MH  - Humans
MH  - Materia Medica/*therapeutic use
MH  - Menopause/*drug effects
MH  - Middle Aged
MH  - Quality of Life
MH  - Treatment Outcome
PMC - PMC3585763
EDAT- 2012/08/03 06:00
MHDA- 2013/02/21 06:00
PMCR- 2012/12/18
CRDT- 2012/08/03 06:00
PHST- 2012/08/03 06:00 [entrez]
PHST- 2012/08/03 06:00 [pubmed]
PHST- 2013/02/21 06:00 [medline]
PHST- 2012/12/18 00:00 [pmc-release]
AID - 12030107 [pii]
AID - 10.2165/11640240-000000000-00000 [doi]
PST - ppublish
SO  - Drugs R D. 2012 Sep 1;12(3):107-19. doi: 10.2165/11640240-000000000-00000.