Research - Menopause
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Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP Study): A Randomized, Double-Dummy, Double-Blind, Placebo-Controlled Trial
Abstract
Background
Perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression.
Methods/Design
A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test).
Results
After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.
Conclusion
Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.
Source : PLOSOne
Link to Full Article
Homeopathy for menopausal symptoms in breast cancer survivors: a preliminary randomized controlled trial.
Jacobs J, Herman P, Heron K, Olsen S, Vaughters L.
Department of Epidemiology, University of Washington School of Public Health and Community Medicine, Seattle, WA, USA.
Abstract
OBJECTIVES: To carry out a preliminary trial evaluating the effectiveness of two types of homeopathy for the treatment of menopausal symptoms in breast cancer survivors.
DESIGN: Randomized, double-blinded, placebo-controlled.
SETTINGS/LOCATION: Private medical clinic, Seattle, WA.
SUBJECTS: Women with a history of breast cancer who had completed all surgery, chemotherapy, and radiation treatment and who had an average of at least three hot flashes per day for the previous month.
INTERVENTIONS: Subjects were randomized to receive either an individualized homeopathic single remedy, a homeopathic combination medicine, or placebo. Patients were seen by homeopathic providers every 2 months for 1 year.
OUTCOME MEASURES: Hot flash frequency and severity, Kupperman Menopausal Index (KMI), Short Form 36 (SF-36).
RESULTS: There was no significant difference found in the primary outcome measure, the hot flash severity score, although there was a positive trend in the single remedy group during the first 3 months of the study (p = 0.1). A statistically significant improvement in general health score in both homeopathy groups (p < 0.05) on the SF-36 after 1 year was found. Evidence of a homeopathic "drug proving" in the subjects receiving the homeopathic combination medicine who were not taking tamoxifen also was found.
CONCLUSIONS: Small sample size precludes definitive answers, but results from this preliminary trial suggest that homeopathy may be of value in the treatment of menopausal symptoms and improving quality of life, especially in those women not on tamoxifen. Larger studies should be carried out that also include healthy women who want to avoid hormone replacement therapy.
Source : J Altern Complement Med. 2005 Feb;11(1):21-7.
Link to abstract
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.
Department of Gynaecology, Hospital Foch, Suresnes, France.
AbstractBackground: 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.
Source : Drugs R D. 2012 Aug 1. doi: 10.2165/11640240-000000000-00000
Link to Abstract
Treating hot flushes in menopausal women with homeopathic treatment--results of an observational study.
Bordet MF, Colas A, Marijnen P, Masson J, Trichard M.
SourceBoiron, Sainte-Foy-lès-Lyon, France.
AbstractOBJECTIVE: There is great controversy concerning treatment for menopausal symptoms. We evaluated homeopathic treatments for hot flushes and their effect on quality of life in menopausal women.
METHODS: Open, multi-national prospective, pragmatic and non-comparative observational study of homeopathic treatments prescribed and their effectiveness, observing their impact on quality of life.
RESULTS: Ninety-nine physicians in 8 countries took part in this study and included 438 patients with an average age of 55. Homeopathic medicines were prescribed to all patients; 98% of the prescription lines were for homeopathic medicines. Lachesis mutus, Belladonna, Sepia officinalis, Sulphur and Sanguinaria canadensis were the most prescribed. A non-homeopathic treatment and/or food supplement prescribed for 5% of the patients. This observational study revealed a significant reduction (p<0.001) in the frequency of hot flushes by day and night and a significant reduction in the daily discomfort they caused (mean fall of 3.6 and 3.8 points respectively, on a 10cm visual analogue scale; p<0.001). Ninety percent of the women reported disappearance or lessening of their symptoms, these changes mostly taking place within 15 days of starting homeopathic treatment.
CONCLUSIONS: The results of this observational study suggest that homeopathic treatment for hot flushes in menopausal women is effective. Further studies including randomized controlled trials should be conducted.
Source : Homeopathy. 2008 Jan;97(1):10-5
Link to Abstract
Management of distress during climacteric years by homeopathic therapy.
Nayak C, Singh V, Singh K, Singh H, Gupta J, Lamba CD, Sharma A, Sharma B, Indira B, Bhuvaneshwari S, Bindra SK, Luxmi KS.
Central Council for Research in Homoeopathy (CCRH), New Delhi, India. [email protected]
Abstract
OBJECTIVES: The purpose of this study was to ascertain the usefulness of homeopathic therapy in the management of distressing symptoms encountered during climacteric years in women (primary objective) and also the changes brought about in the levels of follicle-stimulating hormone (FSH) and lipid profile in these women after homeopathic treatment (secondary objective).
MATERIALS AND METHODS:
An open, multicenter, prospective, observational study was carried out to ascertain the usefulness of homeopathic treatment in distress during climacteric years (DDCY). Patients were enrolled from the general outpatient department of the six Institutes/Units of Central Council for Research in Homoeopathy (CCRH) and were required to complete a follow-up period of 1 year as per the protocol designed by the CCRH. A uniform questionnaire assessing 15 predefined symptoms of menopause was adopted, with assessment of each symptom at every visit. Levels of serum FSH and lipid profile were monitored at entry and at completion. Effect size of the study was also calculated. CARA Software was used for repertorization of the presenting symptoms of menopause along with the characteristic attributes of each patient to arrive at a simillimum. The selected medicine was prescribed in a single dose as per the homeopathic principles. The assessment of the results was made through statistical analysis using the Wilcoxon signed rank test on Statistical Package for Social Sciences (SPSS) comparing symptom score at entry and completion of 1 year of treatment and t test for analyzing improvement in laboratory findings.
RESULTS:
Homeopathic therapy was found to be useful in relieving menopausal distressing symptoms such as hot flashes, night sweats, anxiety, palpitation, depression, insomnia, and so on. Influence on serum levels of FSH, high-density lipoprotein, and low-density lipoprotein was not significant but serum levels of cholesterol, triglycerides, and very-low-density lipoprotein decreased significantly. Effect size of the study was found to be large. The medicines found to be most frequently indicated and useful were Sepia, Lachesis, Calcarea carb., Lycopodium, and Sulphur.
CONCLUSIONS: This study proves the usefulness of homeopathic medicines in relieving DDCY.
Source : J Altern Complement Med. 2011 Nov;17(11):1037-42.
Link to Abstract
Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP Study): A Randomized, Double-Dummy, Double-Blind, Placebo-Controlled Trial
Abstract
Background
Perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression.
Methods/Design
A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test).
Results
After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.
Conclusion
Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.
Source : PLOSOne
Link to Full Article
Homeopathy for menopausal symptoms in breast cancer survivors: a preliminary randomized controlled trial.
Jacobs J, Herman P, Heron K, Olsen S, Vaughters L.
Department of Epidemiology, University of Washington School of Public Health and Community Medicine, Seattle, WA, USA.
Abstract
OBJECTIVES: To carry out a preliminary trial evaluating the effectiveness of two types of homeopathy for the treatment of menopausal symptoms in breast cancer survivors.
DESIGN: Randomized, double-blinded, placebo-controlled.
SETTINGS/LOCATION: Private medical clinic, Seattle, WA.
SUBJECTS: Women with a history of breast cancer who had completed all surgery, chemotherapy, and radiation treatment and who had an average of at least three hot flashes per day for the previous month.
INTERVENTIONS: Subjects were randomized to receive either an individualized homeopathic single remedy, a homeopathic combination medicine, or placebo. Patients were seen by homeopathic providers every 2 months for 1 year.
OUTCOME MEASURES: Hot flash frequency and severity, Kupperman Menopausal Index (KMI), Short Form 36 (SF-36).
RESULTS: There was no significant difference found in the primary outcome measure, the hot flash severity score, although there was a positive trend in the single remedy group during the first 3 months of the study (p = 0.1). A statistically significant improvement in general health score in both homeopathy groups (p < 0.05) on the SF-36 after 1 year was found. Evidence of a homeopathic "drug proving" in the subjects receiving the homeopathic combination medicine who were not taking tamoxifen also was found.
CONCLUSIONS: Small sample size precludes definitive answers, but results from this preliminary trial suggest that homeopathy may be of value in the treatment of menopausal symptoms and improving quality of life, especially in those women not on tamoxifen. Larger studies should be carried out that also include healthy women who want to avoid hormone replacement therapy.
Source : J Altern Complement Med. 2005 Feb;11(1):21-7.
Link to abstract
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.
Department of Gynaecology, Hospital Foch, Suresnes, France.
AbstractBackground: 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.
Source : Drugs R D. 2012 Aug 1. doi: 10.2165/11640240-000000000-00000
Link to Abstract
Treating hot flushes in menopausal women with homeopathic treatment--results of an observational study.
Bordet MF, Colas A, Marijnen P, Masson J, Trichard M.
SourceBoiron, Sainte-Foy-lès-Lyon, France.
AbstractOBJECTIVE: There is great controversy concerning treatment for menopausal symptoms. We evaluated homeopathic treatments for hot flushes and their effect on quality of life in menopausal women.
METHODS: Open, multi-national prospective, pragmatic and non-comparative observational study of homeopathic treatments prescribed and their effectiveness, observing their impact on quality of life.
RESULTS: Ninety-nine physicians in 8 countries took part in this study and included 438 patients with an average age of 55. Homeopathic medicines were prescribed to all patients; 98% of the prescription lines were for homeopathic medicines. Lachesis mutus, Belladonna, Sepia officinalis, Sulphur and Sanguinaria canadensis were the most prescribed. A non-homeopathic treatment and/or food supplement prescribed for 5% of the patients. This observational study revealed a significant reduction (p<0.001) in the frequency of hot flushes by day and night and a significant reduction in the daily discomfort they caused (mean fall of 3.6 and 3.8 points respectively, on a 10cm visual analogue scale; p<0.001). Ninety percent of the women reported disappearance or lessening of their symptoms, these changes mostly taking place within 15 days of starting homeopathic treatment.
CONCLUSIONS: The results of this observational study suggest that homeopathic treatment for hot flushes in menopausal women is effective. Further studies including randomized controlled trials should be conducted.
Source : Homeopathy. 2008 Jan;97(1):10-5
Link to Abstract
Management of distress during climacteric years by homeopathic therapy.
Nayak C, Singh V, Singh K, Singh H, Gupta J, Lamba CD, Sharma A, Sharma B, Indira B, Bhuvaneshwari S, Bindra SK, Luxmi KS.
Central Council for Research in Homoeopathy (CCRH), New Delhi, India. [email protected]
Abstract
OBJECTIVES: The purpose of this study was to ascertain the usefulness of homeopathic therapy in the management of distressing symptoms encountered during climacteric years in women (primary objective) and also the changes brought about in the levels of follicle-stimulating hormone (FSH) and lipid profile in these women after homeopathic treatment (secondary objective).
MATERIALS AND METHODS:
An open, multicenter, prospective, observational study was carried out to ascertain the usefulness of homeopathic treatment in distress during climacteric years (DDCY). Patients were enrolled from the general outpatient department of the six Institutes/Units of Central Council for Research in Homoeopathy (CCRH) and were required to complete a follow-up period of 1 year as per the protocol designed by the CCRH. A uniform questionnaire assessing 15 predefined symptoms of menopause was adopted, with assessment of each symptom at every visit. Levels of serum FSH and lipid profile were monitored at entry and at completion. Effect size of the study was also calculated. CARA Software was used for repertorization of the presenting symptoms of menopause along with the characteristic attributes of each patient to arrive at a simillimum. The selected medicine was prescribed in a single dose as per the homeopathic principles. The assessment of the results was made through statistical analysis using the Wilcoxon signed rank test on Statistical Package for Social Sciences (SPSS) comparing symptom score at entry and completion of 1 year of treatment and t test for analyzing improvement in laboratory findings.
RESULTS:
Homeopathic therapy was found to be useful in relieving menopausal distressing symptoms such as hot flashes, night sweats, anxiety, palpitation, depression, insomnia, and so on. Influence on serum levels of FSH, high-density lipoprotein, and low-density lipoprotein was not significant but serum levels of cholesterol, triglycerides, and very-low-density lipoprotein decreased significantly. Effect size of the study was found to be large. The medicines found to be most frequently indicated and useful were Sepia, Lachesis, Calcarea carb., Lycopodium, and Sulphur.
CONCLUSIONS: This study proves the usefulness of homeopathic medicines in relieving DDCY.
Source : J Altern Complement Med. 2011 Nov;17(11):1037-42.
Link to Abstract