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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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Abstract Objective: This study was done to determine characteristics and management of patients in France visiting allopathic general practitioners (AGPs) and homeopathic general practitioners (HGPs) for influenza-like illness (ILI). Materials and Methods: Design: This was a prospective observational study. Settings/location: It was conducted in metropolitan France during the 2009-2010 influenza season. Subjects: Sixty-five HGPs and 124 AGPs recruited a total of 461 patients with ILI. Interventions: Patients were treated for ILI by their GPs. GPs and patients completed questionnaires recording demographic characteristics and patient symptoms when patients were included in the study. Patients reported satisfaction with treatment on day 4. Prescriptions were recorded by the GPs. Outcome measures: Outcome measures were patient characteristics, demographics, and symptoms at baseline; medications prescribed by type of physician; and satisfaction with treatment by type of physician and medication. Results: Most AGPs (86%), and most patients visiting them (58%) were men; whereas most HGPs (57%; p<0.0001), and most patients visiting them (56%; p=0.006) were women. Patients visiting AGPs were seen sooner after the appearance of symptoms, and they self-treated more frequently with cough suppressants or expectorants (p=0.0018). Patients visiting HGPs were seen later after the appearance of symptoms and they self-treated with homeopathic medications more frequently (p<0.0001). At enrollment, headaches (p=0.025), cough (p=0.01), muscle/joint pain (p=0.049), chills/shivering (p<0.001), and nasal discharge/congestion (p=0.002) were more common in patients visiting AGPs. Of these patients, 37.1% visiting AGPs were prescribed at least one homeopathic medication, and 59.6% of patients visiting HGPs were prescribed at least one allopathic medication. Patient satisfaction with treatment did not differ between AGPs and HGPs but was highest for patients treated with homeopathic medications only. Conclusions: In France, homeopathy is widely accepted for the treatment of ILI and does not preclude the use of allopathic medications. However, patients treated with homeopathic medications only are more satisfied with their treatment than other patients.
Journal of alternative and complementary medicine (New York, N.Y.) 07/2012; DOI:10.1089/acm.2011.0706 · 1.52 Impact Factor