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A crossover study comparing gabapentin and fluoxetine for the treatment of vasomotor symptoms among postmenopausal women.
Rahmanian, M, Mohseni, A, Ghorbani, R
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2015;(1):87-90
Abstract
OBJECTIVE To compare the effectiveness of fluoxetine and gabapentin for treatment of vasomotor symptoms (VMS) after the menopause. METHODS Between March 2011 and March 2012, a randomized crossover study was performed at a center in Semnan, Iran, among postmenopausal women aged 45-57 years with hot flashes (≥2 per day for previous 4 months) for which they had received no previous treatment. Participants were divided into two groups with consecutive numbers assigned in order of recruitment. In the first treatment round (4 weeks), group A received 20mg/day fluoxetine and group B received 300 mg/day gabapentin. After a 2-week washout period, group A received gabapentin and group B received fluoxetine in a second round (4 weeks). Information about VMS was obtained with the Greene Climacteric Scale questionnaire. Participants and all investigators except one were masked to group assignment. RESULTS Data for 79 participants (39 in group A, 40 in group B) were analyzed. In both treatment rounds, gabapentin caused greater reductions in the severity of hot flashes than did fluoxetine (P<0.001 for both). After the first round of treatment, those who had received gabapentin reported greater reductions in the severity of night sweats (P<0.001). CONCLUSION Gabapentin at a dose of 300 mg/day is more effective for treatment of VMS among postmenopausal women than is 20 mg/day fluoxetine. Iranian Registry of Clinical Trials:IRCT2014092711019N3.
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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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Non-hormonal treatment of hot flushes in breast cancer survivors: gabapentin vs. vitamin E.
Biglia, N, Sgandurra, P, Peano, E, Marenco, D, Moggio, G, Bounous, V, Tomasi Cont, N, Ponzone, R, Sismondi, P
Climacteric : the journal of the International Menopause Society. 2009;(4):310-8
Abstract
OBJECTIVES To assess the efficacy and the tolerability of gabapentin 900 mg/day compared to vitamin E for the control of vasomotor symptoms in 115 women with breast cancer. The secondary objective was to evaluate the effect of the treatments on the quality of sleep and other aspects of the quality of life. METHODS A hot flush diary was completed daily; sleep quality and other menopausal symptoms were assessed with the Pittsburgh Sleep Quality Index (PSQI), the Menopause Rating Scale (MRS) and the SF-36 Health Survey. RESULTS The prescribed treatment with gabapentin was never started by 28.3% of the patients and was interrupted by 28% for side-effects (dizziness and somnolence). Among the women allocated to vitamin E, 16.36% never started therapy and 34.78% dropped out because of inefficacy. Hot flush frequency and score decreased by 57.05% and 66.87%, respectively (p < 0.05) in the gabapentin group. The effect of vitamin E was fairly small: hot flush frequency and score were reduced by 10.02% and 7.28%, respectively (p > 0.05). Gabapentin was also particularly effective in improving the quality of sleep (PSQI score reduction: 21.33%, p < 0.05). CONCLUSION Gabapentin appears to be effective for the treatment of hot flushes with a favorable effect on quality of sleep. Vitamin E has only marginal effect on vasomotor symptoms.
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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.
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Ethnicity and vasomotor symptoms in postmenopausal women.
Appling, S, Paez, K, Allen, J
Journal of women's health (2002). 2007;(8):1130-8
Abstract
OBJECTIVE To determine if there is a difference in the prevalence of vasomotor symptoms between African American and white postmenopausal women. METHODS We conducted a cross-sectional study to evaluate baseline vasomotor symptoms in postmenopausal women enrolled in a randomized, placebo-controlled trial of dietary soy supplements. The Menopause-Specific Quality of Life Questionnaire (MENQOL) vasomotor subscale was used to measure vasomotor symptoms, including hot flashes and night sweats. RESULTS In total, 104 African American and 112 white postmenopausal women (mean age 56.8 +/- 5.6 years) were studied. A multiple linear regression analysis, which controlled for differences in body mass index (BMI) and dietary fat intake, showed that race and age were significantly and independently associated with vasomotor symptoms, explaining 10% of the variance (p < 0.001). Being African American and younger age were associated with increased vasomotor symptoms. CONCLUSIONS The most prevalent postmenopausal symptoms were vasomotor symptoms, which were more bothersome in African American women compared with white women. Factors associated with vasomotor symptoms included race, BMI, and dietary intake of fat calories. Implications for practice include increasing provider awareness to discuss vasomotor symptoms and the need for treatment in postmenopausal African American women. Further research to increase our understanding of racial differences and associated factors that influence the duration and intensity of vasomotor symptoms experienced by postmenopausal women is needed.
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The effect of dietary intake on hot flashes in menopausal women.
Dormire, S, Howharn, C
Journal of obstetric, gynecologic, and neonatal nursing : JOGNN. 2007;(3):255-62
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Abstract
OBJECTIVES To describe the relation between dietary intake and menopausal hot flashes. DESIGN Two studies are reported: a controlled, repeated-measures study and a descriptive study. SETTING The controlled study was conducted in a general clinical research center of a large Midwestern university. The descriptive study was conducted in a metropolitan community in the Southwest. PARTICIPANTS Ten healthy symptomatic postmenopausal women participated in the controlled study and 21 symptomatic women completed the observational study. INTERVENTIONS The controlled study included a 30-hour intensive blood sampling protocol of two sequential experimental phases with an observational phase between them. In the observational phase, each participant served protocol-specific meals and snacks at predetermined times. MAIN OUTCOME MEASURE Skin conductance monitoring provided continual assessment while blood glucose levels were analyzed every 30 minutes in the controlled study. RESULTS Eating provided a hot flash-free period that averaged 90 minutes in both studies. Also, hot flash frequency increased as time between meals increased. CONCLUSIONS Our evidence indicates that hot flash frequency is suppressed after eating, while hot flashes are experienced when blood glucose falls between meals. Nursing interventions aimed at maintaining stability in blood glucose level may be effective in reducing menopausal hot flashes.
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Clinical study comparing the effects of sequential hormone replacement therapy with oestradiol/dydrogesterone and conjugated equine oestrogen/norgestrel on lipids and symptoms.
Cieraad, D, Conradt, C, Jesinger, D, Bakowski, M
Archives of gynecology and obstetrics. 2006;(2):74-80
Abstract
UNLABELLED A clinical study comparing the effects of sequential hormone replacement therapy with oestradiol/dydrogesterone and conjugated equine oestrogen/norgestrel on lipids and symptoms. OBJECTIVE The objective of the study was to compare the effects of sequential 17beta-oestradiol/dydrogesterone and conjugated equine oestrogens (CEE)/norgestrel on lipid parameters, climacteric symptoms, bleeding patterns and tolerability. STUDY DESIGN This double-blind study was conducted in 193 peri- and post-menopausal women randomised to receive six, 28-day cycles of oral sequential oestradiol 1 mg/dydrogesterone 10 mg or CEE 0.625 mg/norgestrel 0.15 mg. The change from baseline in serum lipids and hot flushes was analysed using a two-way analysis of variance. RESULTS After 24 weeks there was a statistically significant increase in high-density lipoprotein (HDL) cholesterol in the oestradiol/dydrogesterone group and a significant reduction in the CEE/norgestrel group. The difference between the groups was significant (P=0.001). The number of hot flushes was reduced by 86% in both groups; this improvement was supported by the Greene Climacteric Symptom Scale score, the patients' opinion and quality of life assessments. The percentage of women experiencing cyclic bleeding was greater with CEE/norgestrel, as was the mean duration and severity of bleeding. Both treatments were well tolerated. CONCLUSION Oestradiol/dydrogesterone and CEE/norgestrel were equally effective in treating climacteric symptoms, but oestradiol/dydrogesterone showed some advantages in terms of lipid profile and incidence of bleeding.
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Efficacy of Cimicifuga racemosa on climacteric complaints: a randomized study versus low-dose transdermal estradiol.
Nappi, RE, Malavasi, B, Brundu, B, Facchinetti, F
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2005;(1):30-5
Abstract
OBJECTIVE To investigate, in a randomized clinical study, the efficacy of an isopropanolic aqueous extract of Cimicifuga racemosa (CR) on climacteric complaints in comparison with low-dose transdermal estradiol (TTSE2). Hormonal parameters, lipid profile and endometrial thickness were also evaluated. METHODS Sixty-four postmenopausal women were enrolled and over the course of 3 months filled in a diary recording the number of hot flushes per day. Other climacteric symptoms (vasomotor and urogenital symptoms) as well as anxiety and depression, were evaluated at baseline and after 3 months. Gonadotropins (follicle-stimulating hormone (FSH), luetinizing hormone (LH)), prolactin (PRL), 17 beta-estradiol (17beta-E2) and cortisol, lipid profile (total cholesterol high-density lipoprotein (HDL)/low-density lipoprotein (LDL)-cholesterol, triglycerides, liver function (glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase) and endometrial thickness were measured. Patients were randomly allocated to receive, for 3 months, either 40 mg isopropanolic aqueous CR extract daily or 25 microg TTSE2 every 7 days plus dihydrogesterone 10 mg/day for the last 12 days of the 3-month estradiol treatment. RESULTS Both CR and low-dose TTSE2 significantly reduced the number of hot flushes per day (p < 0.001) and vasomotor symptoms (p < 0.001), starting at the first month of treatment. Such a positive effect was maintained throughout the 3 months of observation, without any significant difference between the two treatments. An identical effect was evident also for both anxiety (p < 0.001) and depression (p < 0.001) which were significantly reduced following 3 months of both CR and low-dose TTSE2. Total cholesterol was unchanged by CR treatment but significantly (p < 0.033) reduced by 3 months of low-dose TTSE2. A slight but significant increase of HDL-cholesterol (p < 0.04) was found only in women treated with CR, while LDL-cholesterol levels were significantly lowered by 3 months of both CR (p < 0.003) and low dose TTSE2 (p < 0.002). Triglycerides were not affected by both treatments, nor was liver function. FSH, LH and cortisol were not significantly affected after the 3-month treatment, while PRL (p < 0.005) and 17 beta-E2 (p < 0.001) were increased slightly only by low-dose TTSE2. Endometrial thickness was not affected by either CR or low-dose TTSE2. CONCLUSIONS CR (40 mg/day) may be a valid alternative to low-dose TTSE2 in the management of climacteric complaints in those women who cannot be treated with or just refuse conventional strategies.
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Application of Gabapentin in Thai women with menopausal syndrome.
Bunyaratavej, N, Songpatanasilp, T
Journal of the Medical Association of Thailand = Chotmaihet thangphaet. 2005;:S21-3
Abstract
Application of 100 mg. three times a day of Gabapentin group, 70 women to relieve menopausal syndrome with the following symptoms:Paresthesia,sweating, hot flushes in a comparative study with the amitriptyline group, 52 women 10 mg once daily. Analysis of data was done by Chi square which assumed that the Gabapentin is superior to amitripyline as accept alternative hypothesis (Ha) and other reject null hypothesis(H0) assumed both have the same action. The result of Chi square showed that the value of calculated Chi square (39.32) is higher than Table Chi square (6.63) at p < 0.01 so the authors have to accept that Ha means that Gabapentin therapy is more significantly effective than amitripyline(p < 0.01). In addition, the present study showed that the number need to treat (NNT) of Gabapentin =2.
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Effect of isoflavones on lipids and bone turnover markers in menopausal women.
Schult, TM, Ensrud, KE, Blackwell, T, Ettinger, B, Wallace, R, Tice, JA
Maturitas. 2004;(3):209-18
Abstract
OBJECTIVES The purpose of this analysis was to compare the effects of two dietary supplements derived from red clover to placebo on lipids and bone turnover markers in symptomatic menopausal women. METHODS The study was a 12-week randomized, double-blind, placebo-controlled trial. Two hundred and fifty-two menopausal women ages 45-60 years experiencing > or =35 hot flashes per week were randomly assigned to Promensil (82 mg total isoflavones), Rimostil (57.2 mg total isoflavones), or placebo. Primary outcome measures were mean absolute changes for HDL-cholesterol, serum osteocalcin, and urinary N-telopeptide. Secondary outcome measures were mean changes of total cholesterol, LDL-cholesterol, the ratio of HDL- to LDL-cholesterol, and triglycerides. RESULTS Ninety-eight percent of participants completed the 12-week protocol. Women taking Rimostil or Promensil compared to those taking placebo had greater mean increases in HDL-cholesterol; however, this change was small in magnitude (<2 mg/dl) and did not reach significance. There was a significant decrease in triglyceride levels among women taking Rimostil (14.4 mg/dl, P = 0.02) or Promensil (10.9 mg/dl, P = 0.05) compared to those taking placebo. The decrease was primarily among women with elevated baseline triglyceride levels (P for interaction = 0.009). There were no differences in mean changes of total cholesterol, LDL-cholesterol, or the ratio of HDL- to LDL-cholesterol among treatment groups. There were no statistically significant differences among treatment groups for bone turnover markers. CONCLUSIONS Compared with placebo, both of the supplements containing isoflavones decrease levels of triglycerides in symptomatic menopausal women; however, this effect is small in magnitude.