Flushes In Postmenopausal Women Research Articles

Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women

To evaluate in a 24-month, prospective, randomized, double-blind, placebo-controlled study whether pure administration of the phytoestrogen genistein (54 mg/d) might reduce the number and severity of hot flushes in postmenopausal women, with no adverse effect on the endometrium and vagina. A total of 389 participants met the parent study criteria and were randomly assigned to receive the phytoestrogen genistein (n = 198) or placebo (n = 191). About 40% of participants in both groups did not experience hot flushes, and the evaluation was performed in a subgroup of 236 participants (genistein, n = 119; placebo, n = 117). Reductions from the baseline in the frequency and severity of hot flushes were the principal criteria of efficacy. Endometrial thickness was evaluated by ultrasonography. The maturation value was also used to determine hormonal action on the vaginal cells. There were no significant differences in vasomotor symptoms between groups at the baseline (4.4 +/- 0.33 hot flushes per day in the genistein group and 4.2 +/- 0.35 hot flushes per day in the control group). After 12 months of genistein therapy, there was a significant reduction (-56.4%) in the mean number of hot flushes, with a significant difference compared with the control group. After 24 months, there was no further decrease in the number of hot flushes in both groups. No significant difference was found in mean endometrial thickness and the maturation value score between the two groups, either at the baseline or after 24 months. The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on the endometrium and vagina, but after the first year, there was no further improvement in the decrease in hot flushes.

Effects of L-Isoleucine and L-Valine on Hot Flushes and Serum Homocysteine

To investigate whether L-isoleucine was effective in the treatment of hot flushes and whether L-isoleucine, L-valine, or the combination of both amino acids reduced fasting serum homocysteine. After a 1-week baseline period, 100 postmenopausal women experiencing at least five moderate-severe hot flushes per day were randomized with equal probability to one of four groups (phase 1/phase 2): placebo/L-valine, placebo/L-valine and L-isoleucine, L-isoleucine/L-valine, and L-isoleucine/L-valine and L-isoleucine. Phase 1 was 12 weeks long, and phase 2 was 10 weeks long. Patients took five capsules by mouth, twice a day throughout the study, with each capsule containing 500 mg of compound. Data were obtained from daily hot flush diaries, fasting blood work, and several questionnaires. The primary outcome variable was the percent change in hot flush composite score from baseline to week 12. In phase 1 of the study, there were no significant differences between the L-isoleucine and placebo groups for any of the outcome measures. At week 12, there was a mean 13.9% decrease in hot flush composite score compared with baseline in the L-isoleucine group and a mean 25% decrease in the placebo group (P=.28). In phase 2 of the study, there was no significant change in fasting serum homocysteine levels associated with any of the amino acid therapies. L-isoleucine therapy appears to be ineffective in the treatment of hot flushes in postmenopausal women. L-isoleucine and L-valine, either alone or in combination, appear to have no effect on fasting serum homocysteine levels. CLINCIAL TRIAL REGISTRATION: ClinicalTrials.gov, (www.clinicaltrials.gov), NCT00081952. I.

CYP17 polymorphism and hot flushes in postmenopausal women

Objective To investigate the association between the CYP17α gene polymorphism and hot flushes in postmenopausal women.Methods Ninety-three non-hysterectomized, postmenopausal women were enrolled in this study. Vasomotor symptoms were assessed at the baseline visit and based on information provided by each participant. The genotypic polymorphism of CYP17α gene was analyzed by PCR-RFLP assay using genomic DNA isolated from peripheral blood lymphocytes.Results Thirty-six women reported hot flushes of mild intensity, 25 reported hot flushes of moderate intensity and 32 of severe intensity. There was no significant difference between the severity of hot flushes and the CYP17 genotype or allele frequencies, 0.58 and 0.67 respectively. No association was found between hot flush severity and the CYP17 allele (odds ratio = 1.17, p = 0.61).Conclusion The results of this study suggest that the CYP17 MspAI polymorphism was not significantly associated with an increased risk of reporting hot flushes.At the World Congress on Menopause in Madrid, May 2008, Dr Massad-Costa was awarded the Robert Greenblatt Prize for Basic Science for the study reported in this paper.

Lowest Effective Transdermal 17β-Estradiol Dose for Relief of Hot Flushes in Postmenopausal Women

To investigate the efficacy of micro-dose transdermal estrogen in relieving menopausal vasomotor symptoms. A randomized, double-blind, placebo-controlled, multi-center trial. Healthy postmenopausal women with at least seven moderate or severe hot flushes per day for at least 1 week, or at least 50 per week, applied transdermal patches with a nominal delivery of 0.023 mg/d 17beta-estradiol and 0.0075 mg/d levonorgestrel (low-dose E2/levonorgestrel; n=145), 0.014 mg/d E2 (micro-dose; n=147), or placebo (n=133) for 12 weeks. The coprimary efficacy variables were the mean changes from baseline in frequency and severity of moderate and severe hot flushes at the week 4 and 12 endpoints. At the week 12 endpoint, mean weekly frequencies of moderate and severe hot flushes were significantly reduced compared with placebo with low-dose E2/levonorgestrel (-51.80; P<.001) and micro-dose E2 (-38.46; P<.001). Severity scores were also significantly reduced with both treatments compared with placebo. At week 12 endpoint, 41.3% of women receiving micro-dose E2 were treatment responders (75% or more reduction from baseline in hot flush frequency; P=.003 compared with 24.2% placebo). In this group, the mean reduction in moderate and severe hot flushes from baseline was approximately 50% after 2, 70% after 4, 90% after 8, and 95% after 12 weeks. There were no differences between active treatments and placebo regarding adverse events. Micro-dose E2 (0.014 mg/d) was clinically and statistically significantly more effective than placebo in reducing the number of moderate and severe hot flushes, with a 41% responder rate, supporting the concept of the lowest effective dose. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00206622

A multicenter, prospective, randomized, double-blind, placebo-controlled study to investigate the efficacy of a continuous-combined hormone therapy preparation containing 1 mg estradiol valerate/2 mg dienogest on hot flushes in postmenopausal women

Objectives To evaluate the effects of an estrogen-reduced, continuous-combined hormone therapy preparation (HT) containing 1 mg estradiol valerate (1EV) and 2 mg dienogest (2DNG) on the number of moderate and severe hot flushes. Methods This study compared the effects of an oral continuous-combined HT containing 1 mg EV and 2 mg DNG (1EV/2DNG) with those of placebo. The planned treatment duration was 12 weeks. Data were obtained from 324 postmenopausal women. The primary efficacy variable was the individual relative change of the mean number of moderate and severe hot flushes per week. Weeks 5–12 of treatment were compared with the 2 weeks preceding the treatment phase. Results Moderate and severe hot flushes were reduced by 80.8 ± 30.9% in the 1EV/2DNG group and by 41.5 ± 39.4% in the placebo group. This difference was statistically significant ( p < 0.0001; Wilcoxon's rank sum test). The incidence of all types of hot flushes (mild + moderate + severe) was reduced by 75.2 ± 30.2% under 1EV/2DNG and by 35.3 ± 37.0% under placebo. In the subset of non-hysterectomized women, exposure to 1EV/2DNG led to 2.4 ± 6.2 days with bleeding in the reference period of 84 days of treatment, versus 0.3 ± 1.3 days in the placebo group. The safety profile of 1EV/2DNG was very similar to that of placebo. Conclusions Continuous-combined HT preparation with 1 mg EV and 2 mg DNG induced a significant reduction of moderate and severe hot flushes compared to placebo ( p < 0.0001). Thus, this low-estrogen preparation is an effective and safe option for HT.

Desvenlafaxine succinate (DVS) results in a sustained reduction in number of moderate-to-severe hot flushes (HFs)

ObjectiveDVS, a nonhormonal therapy, has been shown in clinical trials to significantly reduce the frequency and severity of moderate-to-severe hot flushes in postmenopausal women. The objective of this analysis was to compare the long-term effect of DVS with placebo in treating menopausal HFs.DesignThis was a 52-week, multicenter, randomized, double-blind, placebo-controlled trial.Materials and methodsTableReduction of number of moderate and severe HFs, observed dataAdjusted Mean Change from Baseline (SE)WeekDVS 100 mgPlaceboP-value vs. placebo4−6.92 (0.34)−5.31 (0.44)0.00312−7.80 (0.36)−6.04 (0.49)0.00313–16−7.69 (0.34)−5.70 (0.45)<0.00117–20−7.70 (0.36)−5.56 (0.49)<0.00121–24−7.76 (0.37)−5.53 (0.50)<0.00125–28−8.01 (0.35)−6.29 (0.47)0.00329–32−8.20 (0.35)−6.59 (0.49)0.00733–36−8.00 (0.35)−6.61 (0.47)0.01537–40−8.12 (0.36)−6.79 (0.49)0.02141–44−8.36 (0.35)−6.69 (0.47)0.00345–48−8.39 (0.36)−6.85 (0.48)0.00749–52−8.26 (0.37)−6.93 (0.49)0.024 Open table in a new tab ResultsThe frequency of moderate-to-severe HFs was significantly reduced from baseline with DVS 100 mg at all time points up to week 52 (all comparisons P<0.001). The decreases in number of moderate-to-severe hot flushes with DVS were significantly greater than those observed in the placebo group at all time points up to week 52 (all comparisons P<0.05; Table).ConclusionsIn this analysis, the significant decrease from baseline seen with DVS 100 mg was maintained and was significantly better than placebo for the full 52-week duration of the trial. ObjectiveDVS, a nonhormonal therapy, has been shown in clinical trials to significantly reduce the frequency and severity of moderate-to-severe hot flushes in postmenopausal women. The objective of this analysis was to compare the long-term effect of DVS with placebo in treating menopausal HFs. DVS, a nonhormonal therapy, has been shown in clinical trials to significantly reduce the frequency and severity of moderate-to-severe hot flushes in postmenopausal women. The objective of this analysis was to compare the long-term effect of DVS with placebo in treating menopausal HFs. DesignThis was a 52-week, multicenter, randomized, double-blind, placebo-controlled trial. This was a 52-week, multicenter, randomized, double-blind, placebo-controlled trial. Materials and methodsTableReduction of number of moderate and severe HFs, observed dataAdjusted Mean Change from Baseline (SE)WeekDVS 100 mgPlaceboP-value vs. placebo4−6.92 (0.34)−5.31 (0.44)0.00312−7.80 (0.36)−6.04 (0.49)0.00313–16−7.69 (0.34)−5.70 (0.45)<0.00117–20−7.70 (0.36)−5.56 (0.49)<0.00121–24−7.76 (0.37)−5.53 (0.50)<0.00125–28−8.01 (0.35)−6.29 (0.47)0.00329–32−8.20 (0.35)−6.59 (0.49)0.00733–36−8.00 (0.35)−6.61 (0.47)0.01537–40−8.12 (0.36)−6.79 (0.49)0.02141–44−8.36 (0.35)−6.69 (0.47)0.00345–48−8.39 (0.36)−6.85 (0.48)0.00749–52−8.26 (0.37)−6.93 (0.49)0.024 Open table in a new tab ResultsThe frequency of moderate-to-severe HFs was significantly reduced from baseline with DVS 100 mg at all time points up to week 52 (all comparisons P<0.001). The decreases in number of moderate-to-severe hot flushes with DVS were significantly greater than those observed in the placebo group at all time points up to week 52 (all comparisons P<0.05; Table). The frequency of moderate-to-severe HFs was significantly reduced from baseline with DVS 100 mg at all time points up to week 52 (all comparisons P<0.001). The decreases in number of moderate-to-severe hot flushes with DVS were significantly greater than those observed in the placebo group at all time points up to week 52 (all comparisons P<0.05; Table). ConclusionsIn this analysis, the significant decrease from baseline seen with DVS 100 mg was maintained and was significantly better than placebo for the full 52-week duration of the trial. In this analysis, the significant decrease from baseline seen with DVS 100 mg was maintained and was significantly better than placebo for the full 52-week duration of the trial.

Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women

To evaluate in a 12-month, prospective, randomized, double-blind, placebo-controlled study whether pure administration of the phytoestrogen genistein (54 mg/d) might reduce the number and severity of hot flushes in postmenopausal women with no adverse effect on the endometrium. A total of 389 participants met the main study criteria and were randomly assigned to receive the phytoestrogen genistein (n=198) or placebo (n=191). About 40% of participants in both groups did not suffer from hot flushes, and the evaluation was performed in a subgroup of 247 participants (genistein, n=125; placebo, n=122). Reductions from baseline in the frequency and severity of hot flushes were the principal criteria of efficacy. Endometrial thickness was evaluated by ultrasonography. The maturation value was also used to determine hormonal action on the vaginal cells. There were no significant differences in age, time since menopause, body mass index, and vasomotor symptoms between groups at baseline (4.4 +/- 0.33 hot flushes per day in the genistein group and 4.2 +/- 0.35 hot flushes per day in the control group). The effect was already evident in the first month and reached its peak after 12 months of genistein therapy (-56.4% reduction in the mean number of hot flushes). Furthermore, there was a significant difference between the two groups at each evaluation time (1, 3, 6, and 12 months). No significant difference was found in mean endometrial thickness and maturation value score between the two groups, either at baseline or after 12 months. The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on endometrium.

Effects of acupuncture, applied relaxation, estrogens and placebo on hot flushes in postmenopausal women: an analysis of two prospective, parallel, randomized studies

Objective To assess if transdermal or oral estrogens, acupuncture and applied relaxation decrease the number of menopausal hot flushes/24 h and improve climacteric symptoms, as assessed by the Kupperman index, more than transdermal placebo treatment.Setting An outpatient clinic at a Swedish university hospital.Methods A total of 102 postmenopausal women were recruited to two studies performed in parallel. In Study I, the women were randomized between transdermal placebo or estrogen treatment and, in Study II, between oral estrogens, acupuncture or applied relaxation for 12 weeks. Climacteric symptoms were measured with daily logbooks on hot flushes. Women completed the assessment questionnaire for the Kupperman index at baseline and after 12 weeks.Results The number of flushes/24 h decreased significantly after 4 and 12 weeks in all groups except the placebo group. Both at 4 and 12 weeks, acupuncture decreased the number of flushes more (p < 0.05; p < 0.01, respectively) than placebo. At 12 weeks, applied relaxation decreased the number of flushes more (p < 0.05) than placebo. The Kupperman index score decreased in all groups except the placebo group. The decrease in score was significantly greater in all treatment groups than in the placebo group (p < 0.01).Conclusion Acupuncture and applied relaxation both reduced the number of hot flushes significantly better than placebo and should be further evaluated as alternatives to hormone therapy in women with menopausal vasomotor complaints.

Feasibility and acceptability of restorative yoga for treatment of hot flushes: A pilot trial

Objective To determine the feasibility and acceptability of a restorative yoga intervention for the treatment of hot flushes in postmenopausal women. Methods A pilot trial in 14 postmenopausal women experiencing ≥4 moderate to severe hot flushes per day or ≥30 moderate to severe hot flushes per week. The intervention consisted of eight restorative yoga poses taught in a 3-h introductory session and 8 weekly 90-min sessions. Feasibility was measured by recruitment rates, subject retention and adherence. Acceptability was assessed by subject interview and questionnaires. Efficacy measures included change in frequency and severity of hot flushes as recorded on a 7-day diary. Results Recruitment was accomplished as planned. The majority of study subjects (93%) completed the trial. Of those who completed the trial, 92% attended seven or more of the eight yoga sessions. The majority of the subjects were satisfied with the study and 75% continued to practice yoga 3 months after the study. Mean number of hot flushes per week decreased by 30.8% (95% CI 15.6-45.9%) and mean hot flush score decreased 34.2% (95% CI 16.0-52.5%) from baseline to week 8. No adverse events were observed. Conclusions This pilot trial demonstrates that it is feasible to teach restorative yoga to middle-aged women without prior yoga experience. The high rates of subject retention and satisfaction suggest that yoga is an acceptable intervention in this population. Our results indicate that a larger, randomized controlled trial to explore the efficacy of restorative yoga for treatment of menopausal symptoms would be safe and feasible.

Gabapentin shows efficacy comparable to estrogen for the treatment of hot flushes in postmenopausal women,

Gabapentin shows efficacy comparable to estrogen for the treatment of hot flushes in postmenopausal women,

The effect of tibolone in postmenopausal women receiving tamoxifen after surgery for breast cancer: a randomised, double‐blind, placebo‐controlled trial

To assess the effects of tibolone on climacteric symptoms, endometrium and serum lipid/lipoproteins in postmenopausal women receiving tamoxifen after surgery for breast cancer. Double-blind, randomised, placebo-controlled, multicentre pilot study. Hospital outpatient clinic. Seventy postmenopausal women receiving tamoxifen following surgery for early breast cancer. Women received 20 mg/day oral tamoxifen plus either 2.5 mg/day oral tibolone or placebo for 12 months. Frequency and severity of hot flushes (diary cards); intensity of hot flushes and sweats (Landgren scale); interference of hot flushes and sweats with normal life; frequency and intensity of other climacteric symptoms; endometrial thickness and histology; vaginal bleeding; breast cancer recurrence and serum lipid/lipoproteins. Daily card data showed no change in the daily number of hot flushes with either tibolone or placebo (P= 0.219) after three months. There was a significant reduction in the severity of flushes with tibolone compared with placebo (-0.4 vs 0.2, P= 0.031). The Landgren scale showed a mean change in the number of hot flushes of -0.6 with tibolone and +1.1 with placebo after 12 months (P= 0.022). Endometrial biopsies were normal and vaginal bleeding was similar in both groups. A significant decrease in triglycerides (-23% vs 1.4%) and HDL (-12% vs 19%) was seen with tibolone compared with placebo after 12 months. Tibolone prevented an increase in hot flushes in postmenopausal women given tamoxifen following surgery for breast cancer without untoward effects on the endometrium. Beneficial effects on serum lipid profile were noted.

Effect of pure genistein on bone markers and hot flushes

Objective To evaluate the effect of 90 mg of daily genistein on markers of bone turnover and menopausal symptoms.Design This was a cross-over, placebo-controlled study involving 100 postmenopausal women. Subjects were randomly assigned to daily genistein or placebo for 6 weeks and crossed over to the alternative preparation for the following 6 weeks. Pure genistein was processed and encapsulated in accordance with British Pharmacopoeia standards. Each capsule contained 90 mg of pure genistein while the placebo contained just the eccipients.Results In women with significant hot flushes (score (intensity × number) ≥ 9), genistein reduced symptoms by 30% compared to baseline and the difference compared to placebo was statistically significant. No effect was observed on biochemical markers of bone turnover, possibly due to the short duration of each arm of the study. Genistein reduced osteocalcin, a marker of bone formation, by 3.6% compared to baseline and 0.31% compared to placebo (p = 0.81 and 0.40, respectively). Genistein increased cross-link telopeptide, a marker of bone resorption, by 1.8% compared to baseline and 0.29% compared to placebo; both differences were not statistically significant (p = 0.078 and 0.88, respectively).Conclusion Pure genistein at a dose of 90 mg per day appears to reduce the number of hot flushes in postmenopausal women but the effect is mild.

Predictors of hot flushes in postmenopausal women who receive raloxifene therapy

In a previous report, we described the results of a randomized, controlled trial that evaluated the potential of raloxifene to induce or exacerbate hot flushes. Here, we provide additional analyses that were undertaken to identify potential predictors of hot flushes and to assess the clinical usefulness of various therapeutic strategies for the reduction of hot flushes in postmenopausal women who receive raloxifene therapy. In this randomized, double-blind, placebo-controlled study, 487 unselected postmenopausal women were assigned randomly to receive treatment for 8 months with raloxifene, which was administered either at a dose of 60 mg/d every other day for 2 months followed by 60 mg/d (slow-dose escalation) or 60 mg/d throughout (raloxifene), or placebo. Data on the number, duration, intensity, and severity of hot flushes and awakenings because of night sweats were collected. Logistic regression models were used to examine the predictive value of various demographic and menopausal factors on the development or worsening of hot flushes. At baseline, 40.4% of all randomly assigned patients had hot flushes. The mean number of hot flushes (3-5 per week) was low. Fewer years postmenopause, surgical menopause, and previous estrogen or estrogen/progestin therapy were significant predictors of hot flushes at baseline but were not predictive of incident hot flushes during treatment with raloxifene. Of the women who received raloxifene therapy who had pre-existing hot flushes at baseline, 36% women had none at the end point. Early postmenopause and surgical menopause were significant predictors of a biologically relevant increase in hot flushes (>/=14 flushes/week). Early postmenopause, previous estrogen/progestin therapy, high body mass index, and greater duration of hot flushes at baseline were significant predictors of the need for symptomatic treatment. After 2 months of treatment, women in early postmenopause had significantly more hot flushes with raloxifene therapy than with slow-dose escalation ( P = .042), whereas there was no significant difference between raloxifene therapy and slow-dose escalation among women in later postmenopause. In the 50 patients who requested symptomatic treatment during the study, phytohormones or veralipride did not reduce the number of hot flushes markedly. A shorter time since menopause and surgical menopause are important predictors of hot flushes both before and during treatment with raloxifene. Previous estrogen/progestin therapy also increases the risk of hot flushes at baseline. For women in early postmenopause, slow-dose escalation of raloxifene therapy may be a suitable therapeutic strategy for the reduction of the risk of hot flushes.

Synthetic conjugated estrogens reduced the frequency and severity of hot flushes in postmenopausal women

Synthetic conjugated estrogens reduced the frequency and severity of hot flushes in postmenopausal women

Non-hormonal therapy for hot flushes in postmenopausal women

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: Primary Objective: To examine the effectiveness of non‐hormonal pharmacological treatments for relieving hot flushes in postmenopausal women. In separate comparisons, we will assess non‐hormonal treatments for their effectiveness in the relief of hot flushes: Non‐hormonal treatments versus placebo Non‐hormonal treatments versus hormonal replacement therapy Non‐hormonal treatments versus no‐treatment control group Secondary Objectives: To determine the adverse effects of non‐hormonal treatments. To evaluate the impact on quality of life of non‐hormonal treatments versus no‐treatment control, placebo or hormonal replacement therapy.

Raloxifene is not associated with biologically relevant changes in hot flushes in postmenopausal women for whom therapy is appropriate

Objectives Raloxifene is approved for the treatment and prevention of postmenopausal osteoporosis. Previous studies have described a raloxifene-associated increase in hot flushes, reported as adverse events. This study was undertaken to provide a detailed evaluation of the potential of raloxifene to induce or exacerbate hot flushes in postmenopausal women. Study design In this double-blind, placebo-controlled, parallel group multicenter study, 487 postmenopausal women were randomized to receive 8 months of treatment with either raloxifene (RLX) at the recommended dose of 60 mg/day, or by slow-dose escalation for the first 2 months, followed by the standard dose for the rest of the study (SDE), or placebo (PL). The frequency, duration, intensity, severity, and impact of hot flushes were measured. Results With 3-5 hot flushes per week, the mean number at baseline was low. During treatment, it increased by <1 hot flush/week in both active treatment groups and decreased by <1 hot flush/week with PL. The high proportion (∼60%) of asymptomatic patients at baseline had increased further by the end of treatment in all groups. The proportion of women whose pre-existing hot flushes abated during treatment was significantly greater with SDE ( P = .005) and PL ( P = .050), but not with RLX, when compared with the proportion with treatment-emergent flushes. There were no statistically significant between-group differences in the distribution of the number of hot flushes after 2 months of treatment. At end point, there were no significant differences between SDE and either RLX or PL, but the difference between RLX and PL was statistically significant ( P = .035). There were no significant between-group differences in the hot flush impact scores, in treatment satisfaction, and in the proportion of patients requesting symptomatic treatment to alleviate hot flushes. Conclusion In a postmenopausal population meeting the criteria for the prescription of RLX, the overall effect of the drug on hot flushes is low. Previous studies using adverse event reports have overestimated the importance of hot flushes in postmenopausal women during treatment with RLX. Slow-dose escalation seems to decrease the number of symptomatic patients further and may be a useful strategy in women reporting flushes when starting RLX.

Effect of Soy-Derived Isoflavones on Hot Flashes, Endometrial Thickness, and the Pulsatility Index of the Uterine and Cerebral Arteries

Females in Asian countries seem to have fewer and milder menopausal symptoms than those in Western countries. Dietary differences could be responsible. The traditional Asian diet is rich in substances of vegetable origin that resemble estrogen structurally. Soy, a dietary staple, is a source of isoflavones, including genistine and daidzine, the metabolic products of which appear to have weak estrogenic as well as antiestrogen activity. This randomized, double-blind, placebo-controlled trial examined the effects of soy-derived isoflavones in 62 postmenopausal women 45 to 60 years of age who were in good general health. Actively treated women received two 1-g tablets daily containing a total of 72 mg of soy-derived isoflavones and were followed up along with placebo recipients for 6 months. Endometrial thickness was measured by ultrasound, and Doppler studies were done of blood flow in the uterine, internal carotid, and middle cerebral arteries on either side. The number of daily hot flushes decreased significantly by approximately 40% in both groups after 30 days and did not change appreciably after that time. There were no significant between-group differences or variations over time for the pulsatility index (PI) in the uterine arteries or for endometrial thickness. None of the participants had uterine bleeding during 6 months of follow up. In addition, there were no differences in the PI of the internal carotid or middle cerebral arteries. Soy-derived isoflavones had no apparent advantage over placebo in reducing hot flushes in postmenopausal women in this randomized 6-month trial. There were no substantial differences in endometrial thickness or blood flow in the uterine, internal carotid, or middle cerebral arteries between the actively treated and placebo groups.

Effect of soy-derived isoflavones on hot flushes, endometrial thickness, and the pulsatility index of the uterine and cerebral arteries

Objective To determine the effect of soy-derived isoflavones on hot flushes, endometrial thickness, and the vascular reactivity of uterine and cerebral arteries. Design Double-blind, randomized, placebo-controlled trial. Setting Healthy volunteers in an academic research environment. Patient(s) Sixty-two postmenopausal women aged 45–60 years attending the Outpatient Menopause Clinic of our gynecological departments. Intervention(s) The patients were administered 72 mg of soy-derived isoflavones or placebo under double-blind conditions. The daily number of hot flushes was recorded in a diary. Endometrial thickness was measured by means of transvaginal ultrasound; the uterine, internal carotid, and middle cerebral arteries were evaluated using Doppler ultrasound. Main outcome measure(s) The daily number of hot flushes, endometrial thickness, and arterial pulsatility index (PI). Result(s) Both treatments led to a 40% reduction in the number of hot flushes. Soy-derived isoflavones had no effect on endometrial thickness or the PI of the uterine and cerebral arteries. Conclusion(s) The daily administration of 72 mg of soy-derived isoflavones is no more effective than placebo in reducing hot flushes in postmenopausal women. It also has no effect on endometrial thickness or the PI of the uterine and cerebral arteries.

Gabapentin for the management of hot flushes: a case series.

To audit the effectiveness of the anticonvulsant gabapentin on hot flushes in postmenopausal women. This was an open case series involving 11 postmenopausal women who were willing to take gabapentin for the relief of their hot flushes and were willing to keep a diary recording the number and intensity of their hot flushes, both before and during treatment. Gabapentin was started at a dose of 300 mg, to be taken at night, and the women were instructed to increase the dose up to 1,200 mg, according to symptom behavior. Eleven women agreed to participate for on average 53.22 days (range, 2-79 days), but two discontinued participation-one before starting treatment and one after 2 days-so there are complete data sets for nine women. Gabapentin was found to be extremely effective in reducing hot flush activity (P < 0.001; Fig. 1). A significant reduction in symptoms was observed with a dose of 300 mg/day (P < 0.001). Scores on the Green Climacteric Scale were significantly improved from a mean of 25.72 (range, 12-42) to 19.25 (range, 13-31; P < 0.001). Palpitations (P = 0.001), panic attacks (P = 0.0001), mood (P = 0.023), muscle and joint pains (P = 0.021), and paresthesias and loss of sensation in the extremities (P = 0.001) were also shown to improve with treatment. In the present case series, gabapentin was well tolerated and could be a valuable alternative for the treatment of hot flushes in women with contraindications to hormonal replacement therapy. It would be particularly beneficial for women in whom aches and pains and paresthesias are also a significant feature of the climacteric syndrome.

Randomised, Controlled Comparison of Transdermal Estradiol with Oral Conjugated Estrogens for the Relief of Hot Flushes

Objective and Design: This multicentre, double-blind, randomised, controlled trial evaluated the efficacy of continuous low-dose transdermal estradiol (E2-TDS) compared with oral conjugated equine estrogens (CEE) in decreasing the frequency and severity of hot flushes in postmenopausal women.