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Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes: a multicenter, randomized, double-blind, placebo-controlled trial.

Colau JC, Vincent S, Marijnen P, Allaert FA - Drugs R D (2012)

Bottom Line: All adverse events (AEs) were recorded.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.BRN-01 seemed to have a significant effect on the HFS, compared with placebo.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynaecology, Hospital Foch, Suresnes, France.

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.

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.

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Related in: MedlinePlus

Table I. Sociodemographic characteristics and lifestyle habits of the patients in the two treatment groups
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Tab1: Table I. Sociodemographic characteristics and lifestyle habits of the patients in the two treatment groups

Mentions: The mean (± SD) age of the patients was 54.5 ± 4.4 years. There was no statistically significant difference between treatment groups in any of the sociodemographic characteristics or lifestyle habits of the patients (table I). The first signs of the menopause appeared at 50.8 ± 2.9 years and the first hot flashes appeared 2.5 ± 2.9 years before enrollment in the study. Previous treatments for the menopause were homogeneous between the groups: 42.0% of patients in the BRN-01 group and 31.4% in the placebo group had already been treated for the menopause (p = 0.2677): 23.8% versus 18.8%, respectively, had received phytoestrogens (p = 1.0000); 52.4% versus 56.3%, respectively, had received non-hormonal allopathic treatment (Abufene®; p = 0.8150); 14.3% versus 37.6%, respectively, had received homeopathic treatment (p = 0.1357); and 19.0% versus 25.0%, respectively, had received other food supplements for the menopause (p = 0.7048).


Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes: a multicenter, randomized, double-blind, placebo-controlled trial.

Colau JC, Vincent S, Marijnen P, Allaert FA - Drugs R D (2012)

Table I. Sociodemographic characteristics and lifestyle habits of the patients in the two treatment groups
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3585763&req=5

Tab1: Table I. Sociodemographic characteristics and lifestyle habits of the patients in the two treatment groups
Mentions: The mean (± SD) age of the patients was 54.5 ± 4.4 years. There was no statistically significant difference between treatment groups in any of the sociodemographic characteristics or lifestyle habits of the patients (table I). The first signs of the menopause appeared at 50.8 ± 2.9 years and the first hot flashes appeared 2.5 ± 2.9 years before enrollment in the study. Previous treatments for the menopause were homogeneous between the groups: 42.0% of patients in the BRN-01 group and 31.4% in the placebo group had already been treated for the menopause (p = 0.2677): 23.8% versus 18.8%, respectively, had received phytoestrogens (p = 1.0000); 52.4% versus 56.3%, respectively, had received non-hormonal allopathic treatment (Abufene®; p = 0.8150); 14.3% versus 37.6%, respectively, had received homeopathic treatment (p = 0.1357); and 19.0% versus 25.0%, respectively, had received other food supplements for the menopause (p = 0.7048).

Bottom Line: All adverse events (AEs) were recorded.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.BRN-01 seemed to have a significant effect on the HFS, compared with placebo.

View Article: PubMed Central - PubMed

Affiliation: Department of Gynaecology, Hospital Foch, Suresnes, France.

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.

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.

Show MeSH
Related in: MedlinePlus