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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

2 Comparison of symptoms of the menopause (other than hot flashes) experienced by the women in the BRN-01 and placebo treatment groups.
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Fig2: 2 Comparison of symptoms of the menopause (other than hot flashes) experienced by the women in the BRN-01 and placebo treatment groups.

Mentions: The characteristics of the vasomotor symptoms were also comparable in the two groups at enrollment (table II). Similarly, the distribution of other symptoms of the menopause was comparable in the two groups (figure 2). In association with hot flashes, the women experienced insomnia (79.2% on average in the two groups); nervousness, irritability, and palpitations (68.3%); asthenia (60.4%); skin or mucocutaneous dryness (46.5%); problems with libido (35.6%); problems with memory (20.8%); migraines (15.8%); and mastodynia and mastopathy (12.9%). The mean HFS at enrollment was 12.7 ± 9.5 in the BRN-01 group compared with 15.3 ± 14.7 in the placebo group (p = 0.2902). QoL evaluated using the HFRDIS score (ranging from 0 = not affected to 10 = extremely affected) was also comparable between the groups (4.6 ± 1.9 in the BRN-01 group versus 4.8 ± 2.2 in the placebo group; p = 0.7327), as were all of the ten individual dimensions of QoL (figure 3). When evaluated using a VAS (ranging from 0 mm = no effect to 100 mm = a significant effect), the repercussions of hot flashes and night sweats on professional life were 58.6 ± 23.2 mm in the BRN-01 group versus 61.7 ± 24.7 mm in the placebo group (p = 0.5390) and the repercussions on personal life were 63.6 ± 16.0 mm versus 65.8 ± 18.4 mm, respectively (p = 0.5349).


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)

2 Comparison of symptoms of the menopause (other than hot flashes) experienced by the women in the BRN-01 and placebo treatment groups.
© Copyright Policy
Related In: Results  -  Collection

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

Fig2: 2 Comparison of symptoms of the menopause (other than hot flashes) experienced by the women in the BRN-01 and placebo treatment groups.
Mentions: The characteristics of the vasomotor symptoms were also comparable in the two groups at enrollment (table II). Similarly, the distribution of other symptoms of the menopause was comparable in the two groups (figure 2). In association with hot flashes, the women experienced insomnia (79.2% on average in the two groups); nervousness, irritability, and palpitations (68.3%); asthenia (60.4%); skin or mucocutaneous dryness (46.5%); problems with libido (35.6%); problems with memory (20.8%); migraines (15.8%); and mastodynia and mastopathy (12.9%). The mean HFS at enrollment was 12.7 ± 9.5 in the BRN-01 group compared with 15.3 ± 14.7 in the placebo group (p = 0.2902). QoL evaluated using the HFRDIS score (ranging from 0 = not affected to 10 = extremely affected) was also comparable between the groups (4.6 ± 1.9 in the BRN-01 group versus 4.8 ± 2.2 in the placebo group; p = 0.7327), as were all of the ten individual dimensions of QoL (figure 3). When evaluated using a VAS (ranging from 0 mm = no effect to 100 mm = a significant effect), the repercussions of hot flashes and night sweats on professional life were 58.6 ± 23.2 mm in the BRN-01 group versus 61.7 ± 24.7 mm in the placebo group (p = 0.5390) and the repercussions on personal life were 63.6 ± 16.0 mm versus 65.8 ± 18.4 mm, respectively (p = 0.5349).

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