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Efficacy of a Homeopathic Medicine of Capsicum frutescens L. (Solanaceae) in the Treatment of Hot Flashes in Menopausal Women: A Phase-2 Randomized Controlled Trial.
Andrade, DCDS, Carmona, F, Angelucci, MA, Martinez, EZ, Pereira, AMS
Homeopathy : the journal of the Faculty of Homeopathy. 2019;(2):102-107
Abstract
BACKGROUND Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of Capsicum frutescens L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy Malagueta. METHODS This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine Malagueta (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group. RESULTS The effect of Malagueta on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4, p < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with Malagueta, compared with placebo, also reduced the intensity of the secondary symptoms (p = 0.001) and improved level of activity (p = 0.025) and well-being (p = 0.008). CONCLUSION The homeopathic medicine of Capsicum frutescens (Malagueta) was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.
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Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes.
Kadakia, KC, Loprinzi, CL, Atherton, PJ, Fee-Schroeder, KC, Sood, A, Barton, DL
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2016;(3):1061-9
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Abstract
PURPOSE Hot flashes are a significant source of symptom burden that negatively impacts quality of life (QOL). For women who have contraindications to, or are unwilling to consider, estrogens or antidepressants for bothersome hot flashes, there are limited effective pharmacologic or complementary and alternative medicines. METHODS This single-arm phase II trial studied the efficacy of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes. Eligible women were required to have reported ≥14 hot flashes per week for ≥1 month. The patients were treated with SAMe at a dose of 400 mg twice daily to evaluate whether a reduction in hot flash score appeared to be better than the historical placebo response of approximately 25%. The women kept a daily hot flash diary during a baseline week and then daily during weeks 2-7. The primary endpoint was the change from baseline to week 7 in hot flash score and hot flash frequency. Secondary endpoints included toxicity analyses and the effect of SAMe on QOL. RESULTS From October 28, 2010 to January 30, 2012, 43 women were treated with SAMe. The decrease in mean percent of baseline hot flash score and frequency was 35.4 and 32.6%, respectively. When compared to the historical placebo response of 25%, the effect of SAMe on hot flash score was not statistically significant (p = 0.09). Treatment was well tolerated with expected grade 1/2 gastrointestinal toxicity and no negative effect on QOL. CONCLUSIONS The use of SAMe does not appear to significantly reduce hot flashes more than would be expected with a placebo.
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A Selective Estrogen Receptor Beta Agonist for the Treatment of Hot Flushes: Phase 2 Clinical Trial.
Tagliaferri, MA, Tagliaferri, MC, Creasman, JM, Koltun, WD
Journal of alternative and complementary medicine (New York, N.Y.). 2016;(9):722-8
Abstract
OBJECTIVE The aim of this study was to evaluate the safety, tolerability, and efficacy of a selective estrogen receptor beta (ERβ) agonist, Dr. Tagliaferri's Menopause Formula (MF102), to treat the symptoms of menopause. METHODS An open-label trial of MF102 taken for 12 weeks by 30 postmenopausal women aged 40-65 years, who experienced a minimum of five moderate to severe hot flushes per day. The primary efficacy outcome was a change in the frequency of moderate to severe hot flushes from baseline to week 12. A change in the frequency of hot flushes that woke participants from their sleep from baseline to 12 weeks was a secondary endpoint. Lipid profile and endometrial thickness were also evaluated. RESULTS Thirty postmenopausal women with an average of nine moderate to severe hot flushes per day were treated with MF102 4 g/day; 27 participants completed the study. The median percent reduction in moderate to severe hot flushes was 71% (p < 0.001). The median percent reduction in hot flushes that woke participants from their sleep was 54% (p < 0.001). Low-density lipoprotein (LDL-C) and total cholesterol both declined significantly from baseline. There were no serious adverse events, reports of abnormal uterine bleeding, or significant changes in double-wall endometrial thickness. CONCLUSIONS Treatment with MF102 resulted in a marked decrease in the frequency of moderate to severe hot flushes, was well-tolerated, and demonstrated no safety concerns.
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Effects of conjugated estrogens/bazedoxifene on lipid and coagulation variables: a randomized placebo- and active-controlled trial.
Skouby, SO, Pan, K, Thompson, JR, Komm, BS, Mirkin, S
Menopause (New York, N.Y.). 2015;(6):640-9
Abstract
OBJECTIVE This study aims to evaluate the effects of conjugated estrogens (CE)/bazedoxifene (BZA) on lipid and coagulation variables in a randomized, double-blind, placebo- and active-controlled phase 3 study of nonhysterectomized postmenopausal women. METHODS The Selective estrogens, Menopause, And Response to Therapy (SMART)-5 trial evaluated the efficacy and safety of CE/BZA in postmenopausal women (N = 1,843) with menopausal symptoms. Lipid (N = 1,843) and coagulation (N = 590) variables were assessed in women receiving daily CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, BZA 20 mg, CE 0.45 mg/medroxyprogesterone acetate (MPA) 1.5 mg, or placebo for 12 months. RESULTS At 12 months, CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, BZA 20 mg, and CE 0.45 mg/MPA 1.5 mg decreased total cholesterol and low-density lipoprotein cholesterol compared with placebo (P < 0.01 for all). Both CE/BZA doses and CE/MPA increased high-density lipoprotein cholesterol compared with placebo (P < 0.05 for all). CE 0.45 mg/BZA 20 mg had a neutral effect on triglycerides; CE 0.625 mg/BZA 20 mg and CE/MPA increased triglycerides compared with placebo (P < 0.05). Both CE/BZA doses were associated with small but significant effects on hemostasis variables, including reductions in antithrombin, plasminogen activator inhibitor-1, and fibrinogen activity, and an increase in plasminogen activity relative to placebo at 12 months. Incidences of cardiovascular and venous thromboembolic events were similar among treatment groups. CONCLUSIONS This study provides reassurance that CE/BZA does not adversely affect lipid metabolism or hemostatic balance. In accordance, the incidences of venous thromboembolic events and cardiovascular events in postmenopausal women are similar to those observed with placebo.
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Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause.
Pinkerton, JV, Kagan, R, Portman, D, Sathyanarayana, R, Sweeney, M, ,
Menopause (New York, N.Y.). 2014;(6):567-73
Abstract
OBJECTIVE The goal of this study was to evaluate the efficacy and safety of gastroretentive gabapentin (G-GR) for the treatment of moderate-to-severe menopausal hot flashes. METHODS The primary endpoints of this randomized, placebo-controlled study of G-GR (600 mg am/1,200 mg pm) were the mean daily frequency and severity of hot flashes at weeks 4 and 12. Secondary endpoints included Patients' Global Impression of Change, Clinicians' Global Impression of Change, and daily sleep interference at week 24. RESULTS Six hundred women with 7 or more moderate-to-severe hot flashes/day enrolled; 66.2% completed 24 weeks of treatment. At weeks 4 and 12, G-GR-treated women experienced significantly greater reductions in mean hot flash frequency and severity than placebo-treated women (frequency: week 4, -1.7, P < 0.0001; week 12, -1.14, P = 0.0007; severity: week 4, -0.21, P < 0.0001; week 12, -0.19, P = 0.012). Similar reductions were maintained up to week 24. On the Patient Global Impression of Change, more women receiving G-GR than placebo were "much" or "very much" improved (week 12: 58% vs 44%, P = 0.0008; week 24: 76% vs 55%, P < 0.0001). G-GR significantly reduced sleep interference compared with placebo at week 12 (P = 0.0056) and week 24 (P = 0.0084). Approximately 5% more women taking G-GR withdrew because of adverse events (G-GR/placebo, 16.7%/11.5%). The most common adverse events were dizziness (12.7%/3.4%), headache (9.3%/8.1%), and somnolence (6.0%/2.7%); incidences dropped to sustained low levels after a few weeks. CONCLUSIONS G-GR is a modestly effective nonhormone therapy option for the treatment of moderate-to-severe hot flashes due to menopause and is well tolerated with titration.
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A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes: North Central Cancer Treatment Group N08C7.
Pruthi, S, Qin, R, Terstreip, SA, Liu, H, Loprinzi, CL, Shah, TR, Tucker, KF, Dakhil, SR, Bury, MJ, Carolla, RL, et al
Menopause (New York, N.Y.). 2012;(1):48-53
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Abstract
OBJECTIVE Preliminary data suggest that flaxseed, a rich source of dietary lignans, may be a potentially effective treatment of hot flashes. A phase III, randomized, placebo, controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes. METHODS Postmenopausal women with or without breast cancer were randomly assigned to a flaxseed bar (providing 410 mg of lignans) for 6 weeks versus a placebo bar. Participants completed daily, prospective, hot flash diaries during the baseline week, and then ate one study bar per day for 6 weeks while recording their daily hot flashes. The intraparticipant difference in hot flash activity between baseline and the last treatment week was the primary endpoint. Adverse effects were evaluated through a self-report and the Common Terminology Criteria assessment. RESULTS A total of 188 women were enrolled in this trial. The mean hot flash score was reduced 4.9 in the flaxseed group and 3.5 in the placebo group (P = 0.29). In both groups, slightly more than a third of the women received a 50% reduction in their hot flash score. Only one adverse effect was significantly different between groups, grade 1 pruritus, which was more common in the placebo group (8% vs 1%). Both groups reported abdominal distension, flatulence, diarrhea, and nausea. Adherence and ability to detect treatment assignment did not differ between groups. CONCLUSIONS The results of this trial do not support the use of 410 mg of lignans for the reduction of hot flashes. The bars were fairly well tolerated, with both groups reporting gastrointestinal effects, probably due to the fiber content.
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The effect of soy-derived isoflavones over hot flushes, menopausal symptoms and mood in climacteric women with increased body mass index.
Chedraui, P, San Miguel, G, Schwager, G
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2011;(5):307-13
Abstract
BACKGROUND Risk-benefit issues raised after the WHI have significantly increased the use of alternative treatments for the menopause. Despite this, data regarding the effect of soy isoflavones over mood and menopausal symptoms in high risk populations is still lacking. OBJECTIVE To evaluate the effect of soy derived isoflavones over hot flushes, menopausal symptoms and mood in climacteric women with increased body mass index (BMI). METHODS Fifty symptomatic climacteric women aged 40 to 59 with increased BMI (≥ 25) were recruited to receive oral 100 mg/day of soy derived isoflavones (Climasoy) for 3 months. Hot flushes (frequency/intensity), menopausal symptoms (Menopause Rating Scale [MRS]) and mood (Hamilton Depressive Rating Scale [HDRS]) were evaluated at baseline and at 90 days. RESULTS A total of 45 women completed the study. After 3 months of soy isoflavone supplementation hot flushes significantly decreased in percentage, number and severity (100% to 31.1%; 3.9 ± 2.3 to 0.4 ± 0.8 and 2.6 ± 0.9 to 0.4 ± 0.8, respectively, p < 0.001). MRS scores (total and for subscales) reflecting general menopausal symptoms also significantly decreased compared to baseline. Regarding mood, after three months total HDRS scores and the rate of women presenting depressed mood (scores ≥ 8) significantly decreased (16.3 ± 5.4 to 6.9 ± 5.2 and 93.3% to 28.9%, respectively, p < 0.05). There was no effect on blood pressure levels or BMI values after treatment. CONCLUSION In this high risk climacteric population, soy derived isoflavone treatment improved mood as well as vasomotor and general menopausal symptoms. More research is required to determine if the positive effect over mood is a direct or an indirect one through hot flush alleviation.
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First time proof of sage's tolerability and efficacy in menopausal women with hot flushes.
Bommer, S, Klein, P, Suter, A
Advances in therapy. 2011;(6):490-500
Abstract
BACKGROUND This trial aimed to assess the tolerability and efficacy of a fresh sage preparation in treating hot flushes and other menopausal complaints. Sage (Salvia officinalis) has been traditionally used to treat sweating and menopausal hot flushes, as well as to alleviate associated menopausal symptoms and as a general tonic. However, no clinical studies substantiating the use of sage in menopause have been published previously. METHODS In an open, multicenter clinical trial conducted in eight practices in Switzerland, 71 patients (intent-to-treat population [ITT], n=69; with a mean age of 56.4±4.7 years, menopausal for at least 12 months, and with at least five flushes daily) were recruited and treated with a once-daily tablet of fresh sage leaves for 8 weeks after an introductory baseline week. Parameters for the evaluation of efficacy were the change in intensity and frequency of hot flushes, and total score of the mean number of intensity-rated hot flushes (TSIRHF) as determined by diary protocol over the 2-month treatment period. Other variables included assessment of the Menopause Rating Scale (MRS) by the treating physician at baseline and after 2 months of therapy. RESULTS In the ITT population there was a significant decrease in the TSIRHF by 50% within 4 weeks and by 64% within 8 weeks (P<0.0001). The mean total number of hot flushes per day decreased significantly each week from week 1 to 8. The mean number of mild, moderate, severe, and very severe flushes decreased by 46%, 62%, 79%, and 100% over 8 weeks, respectively. The MRS and its somato-vegetative, psychological, and urogenital subscales decreased significantly by 43%, 43%, 47%, and 20% respectively. The treatment was very well tolerated. CONCLUSION A fresh sage preparation demonstrated clinical value in the treatment of hot flushes and associated menopausal symptoms.
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Use of a multibotanical (Nutrafem) for the relief of menopausal vasomotor symptoms: a double-blind, placebo-controlled study.
Garcia, JT, Gonzaga, F, Tan, D, Ng, TY, Oei, PL, Chan, CW
Menopause (New York, N.Y.). 2010;(2):303-8
Abstract
OBJECTIVE This study aimed to compare the efficacy and safety of a multibotanical (Nutrafem) with those of placebo for the treatment of menopausal vasomotor symptoms. METHODS In this phase III, double-blind, randomized, placebo-controlled study, 159 postmenopausal women experiencing at least 21 vasomotor symptoms per week were treated with Nutrafem (Bionutra Pte Ltd, Singapore) or a matched placebo for 12 weeks. Treatment outcome was evaluated by the change from baseline in the average weekly number of vasomotor symptoms. RESULTS At the end of the study, Nutrafem reduced the number of vasomotor symptoms by 46% from baseline, and this is significantly superior to placebo (26% from baseline; P = 0.020). Forty-three percent of women taking Nutrafem experienced an at least 50% reduction in the number of symptoms compared with 6% of women taking placebo (P = 0.021; number needed to treat = 2.7). There were no group differences in adverse events, laboratory values, and gynecological data. CONCLUSIONS Nutrafem is an effective botanical treatment for vasomotor symptoms in postmenopausal women.
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Efficacy comparison of Pueraria mirifica (PM) against conjugated equine estrogen (CEE) with/without medroxyprogesterone acetate (MPA) in the treatment of climacteric symptoms in perimenopausal women: phase III study.
Chandeying, V, Sangthawan, M
Journal of the Medical Association of Thailand = Chotmaihet thangphaet. 2007;(9):1720-6
Abstract
OBJECTIVE To evaluate the efficacy comparison of Pueraria mirifica (PM), name in Thai is Kwao Kruea Khao, against conjugated equine estrogen (CEE) with/without medroxyprogesterone acetate (MPA) in the treatment of perimenopuasal women with climacteric symptoms. MATERIAL AND METHOD Perimenopausal women attending the Menopausal clinic of Hat Yai Regional Hospital were voluntarily recruited. The vasomotor symptoms such as hot flushes and night sweats, as well as other unpleasant symptoms, urogenital and psychological symptoms, were also assessed. Patients were voluntarily enrolled and randomly received daily 50 mg raw material of PM, Group A, or daily 0.625 mg of conjugated equine estrogen (CEE) with/without 2.5 mg of medroxyprogesterone acetate (MPA), Group B, depend on non-hysterectomized/hysterectomized condition. RESULTS Seventy-one patients were enrolled. Eleven of those were excluded for failing to complete the initial work-up and follow-up. Sixty cases were evaluated, 30 cases in Group A and 30 cases in Group B. After medication, the mean of modified Greene climacteric scale (MGCS) in Group A/Group B had decreased from 29.0/32.26 to 17.86/18.1, 12.56/9.57 and 9.9/8.16 at 1-, 3-, and 6- month respectively. The clinical satisfaction using MGCS was not statistically significant between PM (Group A) and CEE with/without MPA (Group B) in the alleviation of climacteric symptoms (p-value > 0.05). There were no statistically significant changes of three serum markers: estradiol, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) between both groups. CONCLUSION PM, containing phytoestrogens, has estrogenic effect as similar as CEE, and can alleviate the climacteric symptoms in perimenopausal women. PM demonstrates great promise in the treatment of climacteric symptoms. However, optimal doses should be clinically assessed to meet appropriate individual responses.