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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

4 Evolution of hot flash scores over 12 weeks in the BRN-01 and placebo treatment groups.
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Fig4: 4 Evolution of hot flash scores over 12 weeks in the BRN-01 and placebo treatment groups.

Mentions: To accommodate the fact that the baseline HFS was higher in the placebo group, the AUCs for each group were adjusted using Cole’s least mean square method, to provide normalized baseline values for the HFS at week 1 (before treatment) for each treatment group, with the corresponding baseline level as the covariance, and compared again. This analysis also showed that the HFS was significantly lower in the BRN-01 group than in the placebo group over the 12 weeks of treatment (88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). This translates into a relative decrease in the HFS of 21.5% in favor of women treated with BRN-01. Furthermore, a clinically relevant decrease of 3 points in the HFS was obtained after 3.2 ± 1.5 weeks in the BRN-01 group versus 3.6 ± 2.5 weeks in the placebo group, although with no inter-group difference (p = 0.3632). The evolution of the HFS over the course of the study is shown in figures 4 and 5.


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)

4 Evolution of hot flash scores over 12 weeks in the BRN-01 and placebo treatment groups.
© Copyright Policy
Related In: Results  -  Collection

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

Fig4: 4 Evolution of hot flash scores over 12 weeks in the BRN-01 and placebo treatment groups.
Mentions: To accommodate the fact that the baseline HFS was higher in the placebo group, the AUCs for each group were adjusted using Cole’s least mean square method, to provide normalized baseline values for the HFS at week 1 (before treatment) for each treatment group, with the corresponding baseline level as the covariance, and compared again. This analysis also showed that the HFS was significantly lower in the BRN-01 group than in the placebo group over the 12 weeks of treatment (88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). This translates into a relative decrease in the HFS of 21.5% in favor of women treated with BRN-01. Furthermore, a clinically relevant decrease of 3 points in the HFS was obtained after 3.2 ± 1.5 weeks in the BRN-01 group versus 3.6 ± 2.5 weeks in the placebo group, although with no inter-group difference (p = 0.3632). The evolution of the HFS over the course of the study is shown in figures 4 and 5.

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