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PubMedDate not supplied

Effects of REM sleep and ambient temperature on hot flash-induced sleep disturbance.

OBJECTIVE: To determine whether hot flashes produce sleep disturbance in postmenopausal women. DESIGN: This study was performed in a university medical center laboratory with 18 postmenopausal women with hot flashes, six with no hot flashes, and 12 cycling women, all healthy and medication free. Polysomnography, skin and rectal temperatures, and skin conductance to detect hot flashes were recorded for four nights. Nights 2, 3, and 4 were run at 30 degrees C, 23 degrees C, and 18 degrees C in randomized order. RESULTS: During the first half of the night, the women with hot flashes had significantly more arousals and awakenings than the other two groups and the 18 degrees C ambient temperature significantly reduced the number of hot flashes, from 2.2 +/- 0.4 to 1.5 +/- 0.4. These effects did not occur in the second half of the night. In the first half of the night, most hot flashes preceded arousals and awakenings. In the second half, this pattern was reversed. CONCLUSIONS: In the second half of the night, rapid eye movement sleep suppresses hot flashes and associated arousals and awakenings. This may explain previous discrepancies between self-reported and laboratory-reported data in postmenopausal women with hot flashes.

Cold Temperature↗
PubMed2004

Effect of zolpidem on sleep in women with perimenopausal and postmenopausal insomnia: a 4-week, randomized, multicenter, double-blind, placebo-controlled study.

BACKGROUND: Although most adults in the United States obtain less sleep than they need, women report more sleep deprivation throughout their lifetime than do men. The prevalence of self-reported sleep difficulty increases as women make the transition from the premenopausal to the postmenopausal period. OBJECTIVE: The purpose of this study was to assess the clinical efficacy and safety of zolpidem as a treatment for insomnia in perimenopausal and postmenopausal women. METHODS: Women who were perimenopausal or postmenopausal for >or=6 months, who had developed insomnia in conjunction with menopausal symptoms, and who had difficulty maintaining sleep or had nonrestorative sleep for >or=6 months were eligible for this 4-week, multicenter study. Sleep maintenance difficulty had to occur an average of >or=3 nights per week and had to be accompanied by >or=2 nocturnal hot flashes, hot flushes, or night sweats. Patients were randomized in a double-blind fashion to 1 of 2 treatment groups--zolpidem 10 mg or placebo. Capsules were provided in weekly blister cards, and patients were instructed to take 1 capsule each night at bedtime. Patients recorded estimates of their sleep quality and quantity and daytime functioning on daily morning and evening questionnaires, and made weekly global assessments of sleep. RESULTS: The study included 141 women (mean age +/- SD, 50.8 +/- 4.5 years; age range, 39-60 years). Increases in reported total sleep time were significantly greater in the zolpidem group than in the placebo group (P < 0.01) for each treatment week. Wake time after sleep onset and number of awakenings decreased significantly in the zolpidem group compared with the placebo group (P < 0.05). Each week, approximately twice as many patients in the zolpidem group as in the placebo group reported improved sleep (P < 0.001 for each week). The improvement in sleep-related difficulty with daytime functioning was significantly greater in the zolpidem group than in the placebo group (P < 0.05). The effects of zolpidem did not diminish with the duration of treatment. CONCLUSIONS: Zolpidem 10 mg/d was effective and well tolerated in the treatment of menopause-related insomnia in perimenopausal and postmenopausal women.

Adult↗
PubMed1998

Raloxifene effects on vasomotor and other climacteric symptoms in postmenopausal women.

Introduction and Objectives: Raloxifene, a novel selective estrogen receptor modulator (SERM), is under investigation for the prevention of osteoporosis in postmenopausal women. Like traditional estrogen replacement therapy, raloxifene has beneficial effects on bone and on serum lipids whereas, in contrast to estrogen's adverse effects in the breast and uterus, raloxifene is an estrogen antagonist in the breast and is nonstimulatory in the uterus. This study examines the effects of raloxifene 60 mg/day compared with placebo on: 1) the incidence of vasomotor symptoms: hot flashes (flushing) and sweating (including night sweats), 2) the severity and time course of hot flashes, and 3) the relation of hot flashes to baseline subject characteristics and study discontinuations. Additionally, the study explores the effects of raloxifene 60 mg/day compared with placebo on other climacteric symptoms that affect the quality of life of postmenopausal women, such as depression, insomnia, mood lability and genitourinary complaints.Methods: Integrated data from five randomized, placebo-controlled studies involving 1,165 healthy, postmenopausal women, with up to 30 months of study drug exposure, were analyzed. The incidence and severity of hot flashes and other climacteric symptoms were compared in patients treated with placebo or raloxifene (60 mg/day) via open-ended, non-directed subject self-assessment questionnaires. Data were analyzed for subgroup-by-therapy interactions using many baseline subject characteristics such as age, body mass index, smoking, alcohol, and years post-menopause, as well as preexisting conditions such as hot flashes, sweating, insomnia, depression, and history of hysterectomy. The overall incidence of other climacteric symptoms were reported as adverse events.Results: The increase in overall incidence of hot flashes in raloxifene-treated (24.6%) and placebo-treated (18.3%) subjects was modest, but statistically significant. However, this difference was significant only during the first 6 months of therapy, raloxifene (20.1%) compared with placebo (14.4%). After 6 months of treatment, there was no statistically significant difference in the incidence of hot flashes between the two treatment groups. The majority of hot flashes in raloxifene-treated subjects were subject-assessed as "mild-to-moderate" in severity (89%). The incidence of hot flashes reported as "severe" did not differ significantly in raloxifene- or placebo-treated subjects. Subgroup analyses revealed the overall incidence of hot flashes to be highest for both raloxifene and placebo-treated subjects, in younger (age < 55 years) women (P =.004), in women who had previously experienced hot flashes (P =.031), and in women having had hysterectomies (P <.001). Within each of these subgroups, there was no statistical difference in the incidence of hot flashes between the raloxifene and placebo groups. Between the two treatment groups, there was no difference in the overall incidence of subject discontinuations from study due to hot flashes. The occurrence of the other common vasomotor symptom, sweating (which includes night sweats), was not statistically different for the raloxifene- or placebo-treated subjects.Genitourinary complaints are often symptoms related to vaginal dryness, such as dyspareunia and decreased libido, as well as other symptoms of vaginitis and leukorrhea. No statistically significant differences occurred for raloxifene- or placebo-treated subjects in reports of these genitourinary symptoms. Similarly, for the other common climacteric symptoms; depression, insomnia, and mood lability, no significant differences in incidence between the raloxifene and placebo treatment groups were observed.Conclusions: Raloxifene (60 mg/day) treatment modestly increased the incidence of hot flashes compared with placebo, however, this difference was only statistically significant during the first 6 months of treatment. There were no differences in the severity of hot flashes between treatment groups, and this symptom did not adversely affect subjects' study participation. In both the raloxifene and placebo treatment groups, young postmenopausal women (age < 55), those with baseline hot flashes, and those with histories of hysterectomy were most likely to experience hot flashes. Raloxifene therapy did not affect the occurrence of other climacteric symptoms commonly affecting the quality of life of women after menopause.

Journal Article↗
PubMedDate not supplied

Age and symptom experience at menopause in the Selska Valley, Slovenia.

OBJECTIVE: To assess age and symptom experience at menopause in a high-altitude population in the Selska Valley of Slovenia. DESIGN: In four mountain villages, all houses were approached and 80% of eligible residents were interviewed. Additional women were interviewed for comparison in the valley below. Age at interview ranged from 32.7 to 85.5 years, with a mean of 58.2 years. The majority of women (62%) were aged 40 to 65 years. RESULTS: Of the 58 women interviewed, 7 had undergone menopause by hysterectomy (12%). Recalled age at natural menopause ranged from 42 to 54, with a mean of 50.3 (SD 2.9). By probit analysis, median age at natural menopause was 52.03. Fifty-five percent of participants reported ever having experienced a hot flash, although only 24% reported hot flashes during the 2 weeks before being interviewed. When the sample was limited to women aged 40 to 65, frequency of hot flashes in the 2 weeks before the interview was 39%. For all participants, the most frequent complaint was lack of energy (66%), followed by backaches (59%), and joint stiffness (53%). CONCLUSIONS: In contrast to expectations, age at menopause was not earlier and hot flash frequency was not significantly lower at higher elevations.

Adult↗
PubMed2000

Soy isoflavones: are they useful in menopause?

In October 1999, the US Food and Drug Administration authorized the use on food labels of health claims associated with soy protein and the reduced risk of coronary heart disease. Several studies have indicated that a total daily intake of 25 g of soy protein paired with a low-fat diet resulted in clinically important reductions of total cholesterol and low-density lipoprotein (LDL) cholesterol levels. Soybeans are a rich source of isoflavones, a class of phytoestrogens found predominantly in legumes and beans. Soy isoflavones are heterocyclic phenols with structural similarity to estradiol-17beta and selective estrogen receptor modulators. Actions at the cellular level depend on the target tissue, receptor status of the tissue, and the level of endogenous estrogen. Studies of soy-based diets evaluating the relation between soy consumption and serum lipid concentrations revealed that soy consumption significantly decreased total cholesterol, LDL cholesterol, and triglyceride levels. However, the soy isoflavones do not increase high-density lipoprotein cholesterol or triglyceride levels. The effects of soy protein on other target tissues reflect estrogenlike agonist and antagonist effects. Epidemiological studies suggest a protective effect of soy protein on breast tissue as evidenced by the lower rates of breast cancer in East Asian countries where soy is a predominant part of the diet. Data available from human studies on the effect of isoflavones on osteoporosis are limited, and additional studies are needed to support a role in osteoporosis prevention. Thus far, there is no evidence for a stimulatory effect of isoflavones on the endometrium. A few studies reveal a minimal effect of soy on hot flashes, with soy reducing hot flashes 45% and placebo causing a 30% reduction compared with an approximate 70% reduction in hot flashes with estrogen replacement therapy. Evidence from laboratory studies reveals neither a positive nor a negative effect of soy isoflavones on cognition. To date, no adverse effects of short- or long-term use of soy proteins are known in humans. The only adverse effects known are those reported in animals (infertility in sheep and quails grazing on phytoestrogen-rich pastures). In conclusion, soy isoflavones are biologically active compounds. Current data are insufficient to draw definitive conclusions regarding the use of isoflavones as an alternative to estrogen for hormone replacement in postmenopausal women. Although epidemiological and basic laboratory studies allude to the possible protective effects of soy isoflavones at specific target tissues, randomized, placebo-controlled clinical trials are necessary to address these important issues.

Animals↗
PubMedDate not supplied

Vasomotor symptom prevalence and language of menopause in Japan.

OBJECTIVE: To characterize the prevalence of vasomotor symptoms affecting menopausal women in Japan, the relationship between vasomotor symptoms and menopause status as defined by menstrual patterns versus self-assigned kōnenki (climacteric) status, and the salience and specificity of hot flash terminology. DESIGN: Participants were healthy Japanese women, aged 45 to 55 years, living in Kyoto and Fukushima prefectures, divided into menopause groups based on menstrual patterns and self-assigned kōnenki groups. Women recalled 82 general health symptoms during the previous 2 weeks, and provided detailed descriptions of hot flash symptom terms. RESULTS: Hot flash prevalence ranged from 3.0% (hotto furasshu) to 17.1% (hoteri) depending on the individual term used, and was 22.1% when all hot flash terms were combined. Prevalence of vasomotor symptoms was 25.7%, but peaked at 52.6% among late perimenopausal women. Hot flash prevalence was 13.2% among premenopausal women, but zero among self-assigned pre-kōnenki women. The three major hot flash terms (kaa, nobose, and hoteri) vary in their physical location, characteristics, and cultural salience. CONCLUSIONS: Vasomotor symptom prevalence rates in Japan have increased over the past 20 years but are still lower than in most Western populations, and vary according to hot flash term, and between menopause and self-assigned kōnenki status. Kōnenki status appears to be a better predictor of hot flashes than menopause status. Japanese women's language, including self-assessed kōnenki stage and hot flash terminology, seems to be more fine-grained than Western biomedical terms of menopause status and hot flash, and may offer insight into subtle differences in experiences and underlying physiology of menopause.

Female↗
PubMedDate not supplied

The effect of varying low-dose combinations of norethindrone acetate and ethinyl estradiol (femhrt) on the frequency and intensity of vasomotor symptoms.

OBJECTIVE: To determine whether there is a significant reduction in frequency and severity of hot flashes in symptomatic postmenopausal women who are administered continuously different dose combinations of norethindrone acetate and ethinyl estradiol. DESIGN: Two randomized clinical trials (Study 1 and Study 2) were conducted in which study participants recorded in daily diaries the frequency of their hot flashes. Study 2 participants also recorded the number of mild, moderate, or severe hot flashes they experienced. In Study 1, a total of 219 postmenopausal women reporting vasomotor symptoms were placed randomly into groups to receive either a placebo or 1 of 4 treatments (0.2 mg/1 microg; 0.5 mg/2.5 microg; 1 mg/5 microg; or 1 mg/10 microg norethindrone acetate/ethinyl estradiol). In Study 2, a total of 266 highly symptomatic postmenopausal women were placed randomly to receive either a placebo or 1 of 3 treatment groups [0.5 mg/2.5 microg; 1 mg/5 microg; or 1 mg/10 microg norethindrone acetate (NA)/ethinyl estradiol (EE)]. Total duration of treatment was 16 weeks in Study 1 and 12 weeks in Study 2. Study 1 subjects had to have at least 10 hot flashes during the week before randomization. Study 2 subjects had to have at least 56 moderate to severe hot flashes during the week before randomization. RESULTS: In both studies, there was a dose-related decrease in hot flash frequency with the highest dose (1 mg NA/10 microg EE) group that had the greatest response. Significant differences from placebo (p < 0.05, Dunnett's test) occurred within 4 weeks in Study 1 for hot flash frequency with a percent reduction in frequency ranging from 33% for placebo to 84% for both the 1 mg NA/10 microg EE and 1 mg NA/5 microg EE dose groups. Likewise, Study 2 significant reductions in hot flash frequency occurred by Week 2 for 1 mg NA/10 microg EE, Week 3 for 1 mg NA/5 microg EE, and Week 5 for 0.5 mg NA/2.5 microg EE (p < 0.05, Dunnett's test). This dose effect was also apparent with regard to severity. In addition, more subjects had clinically meaningful reductions in hot flash frequency or elimination as the dose combinations increased. CONCLUSION: There were significant reductions in hot flash frequency and severity with continuous treatment with norethindrone acetate and ethinyl estradiol combinations. The time at which significant reductions were observed, as well as the magnitude of the response, were dose dependent. The opportunity for lower-dose options of a new continuous-combined hormone replacement therapy provides therapeutic flexibility for women who are recently menopausal.

Adult↗
PubMed2006

Melatonin effects on luteinizing hormone in postmenopausal women: a pilot clinical trial NCT00288262.

BACKGROUND: In many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes in reproductive hormones such as luteinizing hormone (LH). Melatonin's effects on human reproductive endocrinology are uncertain. It is thought that the same hypothalamic pulse generator may both trigger the pulsatile release of GnRH and LH and also cause hot flashes. Thus, if melatonin suppressed this pulse generator in postmenopausal women, it might moderate hot flashes. This clinical trial tested the hypothesis that melatonin could suppress LH and relieve hot flashes. METHODS: Twenty postmenopausal women troubled by hot flashes underwent one week of baseline observation followed by 4 weeks of a randomized controlled trial of melatonin or matched placebo. The three randomized treatments were melatonin 0.5 mg 2.5-3 hours before bedtime, melatonin 0.5 mg upon morning awakening, or placebo capsules. Twelve of the women were admitted to the GCRC at baseline and at the end of randomized treatment for 24-hour sampling of blood for LH. Morning urine samples were collected twice weekly to measure LH excretion. Subjective responses measured throughout baseline and treatment included sleep and hot flash logs, the CESD and QIDS depression self-ratings, and the SAFTEE physical symptom inventory. RESULTS: Urinary LH tended to increase from baseline to the end of treatment. Contrasts among the 3 randomized groups were statistically marginal, but there was relative suppression combining the groups given melatonin as contrasted to the placebo group (p < 0.01 one-tailed, Mann-Whitney U = 14). Similar but not significant results were seen in blood LH. There were no significant contrasts among groups in hot flashes, sleep, depression, or side-effect measures and no significant adverse effects of any sort. CONCLUSION: The data are consistent with the hypothesis that melatonin suppresses LH in postmenopausal women. An effect related to the duration of nocturnal melatonin elevation is suggested. Effects of melatonin on reproductive endocrinology should be studied further in younger women and in men. Larger studies of melatonin effects on postmenopausal symptoms would be worthwhile.

Journal Article↗
PubMed2006

Symptoms and treatment in cancer therapy-induced early menopause.

Young women with breast cancer often experience early menopause as a result of the therapy for their malignant disease. The sudden occurrence of menopause resulting from chemotherapy, oophorectomy, radiation, or gonadal dysgenesis frequently results in hot flashes that begin at a younger age and may occur at a greater frequency and intensity than hot flashes associated with natural menopause. Hormone therapy relieves symptoms effectively in 80%-90% of women who initiate treatment. This therapy, however, is generally contraindicated in estrogen-dependent cancers, such as breast cancer, because of the potentially increased risk for recurrence. Many agents have been investigated as potential means for alleviating hot flashes in survivors of breast cancer, such as progestagens, clonidine, gabapentin, and anti-depressants. Several complementary and alternative medicines frequently used by patients have also been studied. These include black cohosh, phytoestrogens, homeopathy, vitamin E, acupuncture, and behavior strategies. To support the use of one of more of these nonpharmacological or pharmacological options in the treatment of hot flashes in breast cancer patients, more evidence from well-controlled clinical trials is needed. In particular, soundly based scientific research with complementary and alternative medicine therapies is lacking. Pharmacological treatments appear to be more beneficial than nonpharmacological treatments. This article reviews the current literature to assess the epidemiology and diagnosis of hot flashes and the nonpharmacological and pharmacological options for the treatment of hot flashes, in breast cancer patients in particular. When specific treatment options have not been evaluated in breast cancer patients specifically, published data on the management of hot flashes with this modality in healthy postmenopausal women are described.

Breast Neoplasms↗
PubMed2006

Serotonergic agents as an alternative to hormonal therapy for the treatment of menopausal vasomotor symptoms.

Hot flashes represent one of the most common complaints among women undergoing menopause. Despite their prevalence, the pathophysiology leading to hot flashes is only partly understood. Short-term estrogen remains the most effective treatment for hot flashes, but because of safety concerns many women are reluctant to use this treatment. Several non-hormonal pharmacologic treatments have been evaluated in randomized, prospective clinical trials. Placebo-controlled clinical trials have suggested that agents from the selective serotonin reuptake inhibitor/serotonin and norepinephrine reuptake inhibitor (SSRI/SNRI) family reduce hot flashes by 50-60%. Successful treatment of hot flashes with these compounds may also be associated with improvements in sleep, mental health, and vitality. Adverse events may cause 10-20% of individuals to withdraw from treatment. The agents should be stopped with caution to prevent a discontinuation syndrome. Given the available data, the North American Menopause Society and the American College of Obstetricians and Gynecologists have recommended that women with moderate to severe, menopause-related hot flashes, with concerns or contraindications to estrogen-containing treatments, should consider prescription progestogens, venlafaxine, paroxetine, fluoxetine, or gabapentin. Prescribing clinicians are urged to discuss the potential benefits, adverse effects, and new information that may become available for each of the treatment options. Caution should also be exercised when prescribing strong cytochrome P450 2D6 inhibitors, such as paroxetine or fluoxetine, to women who are taking tamoxifen. Further studies are required to evaluate the optimal agent and duration of SSRI/SNRI treatment in menopausal women.

Antineoplastic Agents, Hormonal↗