Trial reportDrugs in R&D2012
Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes: a multicenter, randomized, double-blind, placebo-controlled trial.
Trial report in Drugs in R&D, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.
- Assessing the magnitude of reporting bias in trials of homeopathy: a cross-sectional study and meta-analysis.BMJ evidence-based medicine · 2022Pooled it
- Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review.BJOG : an international journal of obstetrics and gynaecology · 2020Pooled it
- Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis.Systematic reviews · 2017Pooled it
- Does a homeopathic medicine reduce hot flushes induced by adjuvant endocrine therapy in localized breast cancer patients? A multicenter randomized placebo-controlled phase III trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019Trial
- Evidence-Based Human Homeopathy and Veterinary Homeopathy. Comment on Bergh et al. A Systematic Review of Complementary and Alternative Veterinary Medicine: "Miscellaneous Therapies".Animals : an open access journal from MDPI · 2022Article
- Perceptions of homeopathy in supportive cancer care among oncologists and general practitioners in France.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Article
- Add-On Complementary Medicine in Cancer Care: Evidence in Literature and Experiences of Integration.Medicines (Basel, Switzerland) · 2017Review
- Integrative Oncology: An International Perspective from Six Countries.Integrative cancer therapiesArticle
- Prescribing practices of Hormone Therapy for Menopausal females by OBGYN of Pakistan.Pakistan journal of medical sciencesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHomeopathic medicines have a place among the non-hormonal therapies for the treatment of hot flashes during the menopause.
objectiveThe objective of this study was to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women. STUDY
designThis was a multicenter, randomized, double-blind, placebo-controlled study carried out between June 2010 and July 2011.
settingThe 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.
interventionTreatment 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 measureThe 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.
resultsOne 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.
conclusionBRN-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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.