Menopause-related Symptoms Research Articles

Local Thermal Therapy Effects on Menopausal Symptoms and Bone Mineral Density

The aim of this study was to evaluate the effects of local thermal therapy with far-infrared rays (FIR) on menopausal symptoms and bone mineral density (BMD) in postmenopausal women. A prospective randomized, controlled trial was conducted in female volunteers from communities in Northern Taiwan. The intervention group (n=22) received local thermal therapy with the help of FIR from an FIR emitter, for approximately 20 minutes per day, twice a week, for 20 sessions. They received the therapy on their backs while lying in a supine position. The control group (n=21) received no treatment. The primary outcome was the change in the Perceived Perimenopausal Disturbances Scale, designed for the measurement of menopause-related symptoms (MRS) before and after completion of treatment in a 10-week period. Secondary outcome parameters included serum levels of estradiol (E2) with osteocalcin (OC), and calcaneal BMD by quantitative ultrasound. After 10 weeks of intervention, MRS determined by the scale decreased in mean total scores and mean scores for vasomotor, musculoskeletal, urologic, reproductive, and psychologic domains (p<0.05), except for reproductive (sexuality-related) symptoms. In the control group, mean total scores and scores of each domain had no significant difference between baseline and follow-up examination after 10 weeks. There was no significant difference between the quantitative ultrasound parameters in the calcaneus, serum E2, and OC levels either at the baseline or in the changes from the baseline between the intervention and control groups of women (p>0.05). Local thermal therapy with FIR results in a significant reduction of MRS in postmenopausal women. Serum E2, OC levels, and calcaneal BMD showed no significant changes between the two groups. These results suggest that FIR local thermal therapy may be a potential alternative for the management of postmenopausal symptoms.

Acupuncture for Hot Flushes in Perimenopausal and Postmenopausal Women: A Randomised, Sham-Controlled Trial

To determine the effect of acupuncture in treating hot flushes in perimenopausal or postmenopausal women. The study was a randomised single-blind sham-controlled clinical trial. Perimenopausal or postmenopausal women with moderate or severe hot flushes were randomised to receive real or sham acupuncture. Both groups underwent a 4-week run-in period before the treatment. The real acupuncture group received 11 acupuncture treatments for 7 weeks, and the control group underwent sham acupuncture on non-acupuncture points during the same period. Both groups were followed for 8 weeks after the end of treatment period. Changes from baseline in the hot flush scores at week 7, measured by multiplying the hot flush frequency and severity, were the primary outcome. Hot flush frequency, severity and menopause-related symptoms measured with the Menopause Rating Scale Questionnaire were regarded as secondary outcomes. 54 participants were randomised into the real acupuncture group (n=27) and the sham acupuncture group (n=27). The mean change in hot flush scores was -6.4±5.2 in the real acupuncture group and -5.6±9.2 in the sham group at week 7 from values at the start of the acupuncture treatment (10.0±8.1 vs 11.7±12.6), respectively (p=0.0810). No serious adverse events were observed during the whole study period. Compared to sham acupuncture, acupuncture failed to show significantly different effects on the hot flush scores but showed partial benefits on the hot flush severity. Further consideration is needed to develop appropriate strategies for distinguishing non-specific effects from observed overall effectiveness of acupuncture for hot flushes. Whether acupuncture has point-specific effects for hot flushes should be also considered in designing future researches.

Improving sleep quality in climacteric women with insomnia: A randomized, head-to-head trial between Jia-Wei-Shiau-Yau San (JWSYS) and Suan-Zao-Ren Tang (SZRT)

BackgroundJia-Wei-Shiau-Yau San (JWSYS) was reported to reduce various menopausal-related symptoms, and Suan-Zao-Ren Tang (SZRT) is a frequently prescribed Chinese herbal formula for insomnia. We performed a double-blind, randomized trial to compare the efficacy of SZRT with that of JWSYS for insomnia in climacteric women. MethodsA total of 60 subjects 40–60 years of age with a history of insomnia at least 1 month were recruited from the Taipei City Hospital. The participants were instructed to take 4g 3 times per day of either SZRT (n=30) or JWSYS (n=30) for a period of 4 weeks. The primary outcome measures were the mean component scores of the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome parameter was the global score on the World Health Organization Quality of Life questionnaire – Taiwan brief version. ResultsOf the initial 60 intent-to-treat participants, 54 completed the 4-week study. The mean domain and individual scores of PSQI decreased significantly under both treatments, reflecting improved daytime vitality and concentration ability. Mixed model analysis showed that SZRT was more effective in improving habitual sleep efficiency and prolonging sleep duration, while JWSYS was more effective in improving sense of well-being. Both formulas were associated with good compliance and safety. Serum cholesterol decreased slightly after 4 weeks of SZRT treatment. ConclusionSZRT appears to be more effective than JWSYS for improving sleep efficiency and duration, but the latter seems to be more effective in improving well-being. The potential effect of SZRT on serum total cholesterol level deserves further study.

Menopausal symptoms assessment among middle age women in Kushtia, Bangladesh

BackgroundThere are few menopausal study data available in South East Asia especially in Bangladesh. This study was conducted in a well populated town named Kushtia, which is located in the western part of Bangladesh.ObjectivesThis study was aimed to document the menopausal-related symptoms among middle age women of Kushtia region of Bangladesh.MethodsBy using modified MRS (Menopause Rating Scale) questionnaire, 509 women aged 40-70 years were interviewed to document symptoms commonly associated with menopause.FindingsThe mean age of menopause was 51.14 years. The most prevalent symptoms reported include, feeling tired (92.90%); headache (88.80%); joint and muscular discomfort (76.20%); physical and mental exhaustion (60.90%) and sleeplessness (54.40%) which are followed by depressive mood (37.30%); irritability (36%); dryness of vagina (36%); hot flushes and sweating (35.80%); anxiety (34.20%). However, noted less frequent symptoms were sexual problem (31.20%); cardiac discomfort (19.10%) and bladder problem (12.80%).ConclusionsThe prevalence of menopausal symptoms found in this study correspond to other studies on Asian women however the prevalence of classical menopausal symptoms of hot flushes and sweating were lower compared to studies on Caucasian women.

Effects of diphenyl diselenide on lipid profile and hepatic oxidative stress parameters in ovariectomized female rats

Ovarian hormone decline after menopause is linked to many pathophysiological reactions. Female rats submitted to ovariectomy are employed as a model of post-menopausal condition. This study investigated the effects of diphenyl diselenide (PhSe)(2) on body weight gain, intra-abdominal fat deposition, plasma lipid profile and hepatic oxidative stress in ovariectomized rats. Female adult Wistar rats were ovariectomized (OVX rats) or sham-operated and divided into four groups: (i) sham-operated, (ii) (PhSe)(2), (iii) OVX and (iv) OVX + (PhSe)(2). (PhSe)(2) (5 mg/kg; 5 ml/kg, p.o.) was administered once a day for 30 days to groups (ii) and (iv). After that, rats were anaesthetized for blood sample gathering and submitted to euthanasia. (PhSe)(2) (5 mg/kg) was effective in preventing the rise in body weight gain and intra-abdominal fat deposition induced in OVX rats. Although (PhSe)(2) was not effective in avoiding the increase in plasma total cholesterol and non-HDL levels induced in OVX rats, (PhSe)(2) reduced plasma triglycerides and augmented HDL levels in OVX rats. (PhSe)(2) also increased hepatic ascorbic acid levels, reduced glutathione content, glutathione S-transferase activity and restored catalase activity in liver of OVX rats. These findings suggest that (PhSe)(2) could be a promising alternative to minimize menopause related symptoms.

Status Epilepticus Associated with Borage Oil Ingestion

The use of herbal and complementary medicine is common. Many herbal products are known to produce serious adverse effects. Borage oil is derived from the seeds of the borage plant (Borago officinalis) an abundant source of gamma-linolenic acid (GLA), and Borage oil has been promoted as a treatment for rheumatoid arthritis, atopic dermatitis, diabetic neuropathy, and menopause-related symptoms. We report a case of status epilepticus in a patient who consumed borage oil for one week.

Defining bioidentical hormones for menopause-related symptoms.

In the last decade, the use of bioidentical hormones (BHs) to treat menopause-related symptoms has become increasingly popular. However, the many different definitions of BHs have led to a great deal of confusion often making it difficult for health care providers to discuss this area with patients. The purpose of this paper was to produce a concise definition of bioidentical hormones, based on a review of the literature. Searches, using systematic review methodology, were conducted from inception to June 2010 in PubMed, EMBASE, IPA, The Journal of International Compounding and the Internet to identify definitions of bioidentical hormones. There were no restrictions on type, date or language of publication. Included papers/website included those that contained a definition of BHs. Definitions were extracted, similarities and differences summarized, and these were then examined to produce a concise definition. Sixty-three definitions were found. Based on the analysis of similarities and differences, the following definition, comprised of three components (term being defined; category to which term belongs; distinctive characteristics of term) was produced: "Bioidentical hormones are chemical substances that are identical in molecular structure to human hormones." This definition clearly and concisely explains the meaning of BHs which should lead to a common understanding of the term and limit confusion among health care providers, the general public and the scientific community.

Postmenopausal hormone therapy and venous thromboembolism

Introduction Hormone therapy (HT) is the most effective treatment to counteract menopauserelated symptoms. Because venous thromboembolism (VTE) is the main harmful effect of HT among young postmenopausal women, reducing VTE risk appears to be a relevant strategy to improve the benefit/risk profile of HT among postmenopausal women. Methods This article is a review of recent findings regarding the VTE risk among women using HT. Results Recent data confirmed the safety of the transdermal route of estrogens administration in postmenopausal women requiring treatment. In addition, epidemiological data showed that use of concomitant progestins could increase VTE risk compared with progesterone use. Finally, results of a meta-analysis showed that the VTE risk increased with doses of oral estrogens. Conclusion The route of estrogen administration, the type of concomitant progestogens and the dose of estrogens are three important determinants of the thrombotic risk among postmenopausal women using HT.

Cardioprotective effects of aqueous Schizandra chinensis fruit extract on ovariectomized and balloon-induced carotid artery injury rat models: Effects on serum lipid profiles and blood pressure

The fruit from Schizandra chinensis, a member of the Magnoliaceae family, has been used to treat menopause-related symptoms. We have previously reported that an aqueous extract of Schizandra chinensis fruit (ScEx) caused vascular relaxation via the production of endothelial nitric oxide. Estrogen-like molecules are known to play a protective role in cardiovascular diseases through several mechanisms, but the cardioprotective effects of ScEx have not been clearly demonstrated. Therefore, we investigated the vasculoprotective effects of ScEx on ovariectomized (OVX) and balloon-induced carotid artery injury rat models. An aqueous extract of Schizandra chinensis (ScEx) was examined for its cardioprotective effects. To test the arterial response to injury, we applied the balloon-induced carotid artery model to OVX Sprague-Dawley (SD) rats. Rats were subcutaneously administered vehicle, 17β-estradiol (E2; 0.02 or 0.2mg/kg/day), or ScEx (0.2 or 2.0mg/kg/day) over the course of the study. Vessel morphology was assessed two weeks after injury. To identify the cardioprotective effects after ScEx treatment, we measured serum lipid profiles and blood pressure levels in the OVX- and sham-operated normotensive and spontaneously hypertensive rats (SHR). Serum lipid profiles were measured in OVX rats after five weeks of treatment with vehicle, E2 (0.5mg/kg/day), or ScEx (0.5 or 5.0mg/kg/day). Tail systolic blood pressure in OVX SHR was measured weekly. In the balloon-induced carotid artery injury model, treatment with E2 (0.2mg/kg/day) or ScEx (2.0mg/kg/day) reduced the intimal area and the intima-to-media ratio compared to control animals. Injection of ScEx or E2 reduced body weight gain but did not inhibit the decrease in uterine weight. Treatment with ScEx (5.0mg/kg/day) or E2 (0.5mg/kg/day) in OVX SD rats reduced total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), TC/high-density lipoprotein cholesterol (HDL-C), and TC-(HDL-C)/HDL-C compared to control animals. In OVX rats, treatment with ScEx or E2 also significantly reduced LDL-C compared with the OVX control rats, and systolic blood pressure was significantly attenuated compared to OVX control and the sham control rats. ScEx treatment restored endothelial function in rats that underwent balloon-induced carotid artery injury, and it reduced serum cholesterol levels in OVX rats. Similar to E2, ScEx exhibited hypotensive effects in OVX SHR. Therefore, ScEx and E2 exhibited similar cardioprotective effects, thereby suggesting that ScEx is a potential candidate to replace estradiol in the prevention and treatment of cardiovascular diseases.

Exercise beyond menopause: Dos and Don'ts.

With a significant number of women belonging to the status of menopause and beyond, it is imperative to plan a comprehensive health program for them, including lifestyle modifications. Exercise is an integral part of the strategy. The benefits are many, most important being maintenance of muscle mass and thereby the bone mass and strength. The exercise program for postmenopausal women should include the endurance exercise (aerobic), strength exercise and balance exercise; it should aim for two hours and 30 minutes of moderate aerobic activity each week. Every woman should be aware of her target heart rate range and should track the intensity of exercise employing the talk test. Other deep breathing, yoga and stretching exercises can help to manage the stress of life and menopause-related symptoms. Exercises for women with osteoporosis should not include high impact aerobics or activities in which a fall is likely. The women and the treating medical practitioner should also be aware of the warning symptoms and contraindications regarding exercise prescription in women beyond menopause. The role of exercise in hot flashes, however, remains inconclusive. Overall, exercising beyond menopause is the only noncontroversial and beneficial aspect of lifestyle modification and must be opted by all.

A Pilot, 8-Week, Placebo Lead-In Trial of Quetiapine Extended Release for Depression in Midlife Women

Perimenopausal and early postmenopausal women have shown an increased risk for developing depression (new onset or recurrent); concomitant vasomotor and other menopause-related complaints significantly affect quality of life and overall functioning. This study examined the effects of quetiapine extended release (XR) in midlife women with major depressive disorder who also reported significant menopause-related symptoms. Forty eligible women with major depressive disorder entered a 2-week, placebo lead-in phase, followed by an 8-week open trial with quetiapine XR, flexible dose, 150-300 mg/d. The primary outcome measure (depressive symptoms) was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) scores. Other measures included menopause symptoms (Greene Climacteric Scale total scores and subscores) and the impact of hot flashes on functioning (Hot Flash-Related Daily Interference Scale). Weight, cholesterol, triglycerides, and glucose levels were monitored. Data from 24 subjects (modified intent-to-treat, last observation carried forward; quetiapine XR mean dose, 191 [SD, 55] mg/d) showed improvement in depressive and menopause-related symptoms, that is, reduction in MADRS, GCS, and Hot Flash-Related Daily Interference Scale scores (P < 0.01 for all comparisons). Seventeen subjects were considered responders (>50% reduction in MADRS scores); 15 achieved remission (MADRS<10). Main adverse effects included drowsiness and dry mouth. Based on these preliminary results, quetiapine XR should be further examined in larger, controlled trials for the management of depressed, symptomatic midlife women.

Effect of hormone metabolism genotypes on steroid hormone levels and menopausal symptoms in a prospective population-based cohort of women experiencing the menopausal transition

This study evaluated whether genes involved in the metabolism of steroid hormones are associated with hormone levels or menopausal symptoms. We used a population-based prospective sample of 436 African American (AA) and European American (EA) women who were premenopausal at enrollment and were followed longitudinally through menopause. We evaluated the relationship between steroid hormone metabolism genotypes at COMT, CYP1A2, CYP1B1, CYP3A4, CYP19, SULT1A1, and SULT1E1 with hormone levels and menopausal features. In EA women, SULT1E1 variant carriers had lower levels of dehydroepiandrosterone sulfate, and SULT1A1 variant carriers had lower levels of estradiol, dehydroepiandrosterone sulfate, and testosterone compared with women who did not carry these variant alleles. In AA women, CYP1B1*3 genotypes were associated with hot flashes (odds ratio [OR], 0.62; 95% CI, 0.40-0.95). Interactions of CYP1A2 genotypes were associated with hot flashes across menopausal stage (P = 0.006). Interactions of CYP1B1*3 (P = 0.02) and CYP1B1*4 (P = 0.03) with menopausal stage were associated with depressive symptoms. In EA women, SULT1A1*3 was associated with depressive symptoms (OR, 0.53; 95% CI, 0.41-0.68) and hot flashes (OR, 2.08; 95% CI, 1.64-2.63). There were significant interactions between SULT1A1*3 and hot flashes (P < 0.001) and between SULT1A1*2 and depressive symptoms (P = 0.007) on menopausal stage, and there were race-specific effects of SULT1A1*2, SULT1A1*3, CYP1B1*3, and CYP3A4*1B on menopause. Our results suggest that genotypes are associated with the occurrence of menopause-related symptoms or the timing of the menopausal transition.

Effects of acupuncture on hot flashes in perimenopausal and postmenopausal women-a multicenter randomized clinical trial

The aim of this study was to evaluate the effectiveness of acupuncture plus usual care for relief of hot flashes and menopause-related symptoms compared with usual care alone in perimenopausal or postmenopausal women. A multicenter, randomized, controlled trial was conducted. Perimenopausal or postmenopausal women with average hot flash scores of 10 or higher during the week before the screening visit were enrolled and randomly divided into two groups. The treatment group received 12 sessions of acupuncture and maintained usual care for 4 weeks, whereas the control group underwent usual care alone. Hot flash scores were calculated by multiplying frequency by severity of hot flashes recorded in a daily diary. The primary outcome was the mean change in the average 24-hour hot flash score at week 4 from baseline. The secondary outcome was the mean change in menopause-related symptoms as estimated by the Menopause Rating Scale questionnaire at week 4. Follow-up assessment at week 8 was conducted in the treatment group only. The mean change in the average 24-hour hot flash score was -16.57 in the treatment group (n = 116) and -6.93 in the control group (n = 59), a difference of 9.64 (P < 0.0001). The total Menopause Rating Scale score, as well as the subscale scores for the psychological, somatic, and urogenital dimensions of menopause, showed significant improvement in the acupuncture group compared with the control group (P < 0.001). The mean change in the treatment group in the primary outcome was -17.58 at week 8. Our results suggest that acupuncture in addition to usual care is associated with marked clinical improvement in hot flashes and menopause-related symptoms in perimenopausal or postmenopausal women.

Estrogen and progestogen use in postmenopausal women

To update for both clinicians and the lay public the evidence-based position statement published by The North American Menopause Society (NAMS) in July 2008 regarding its recommendations for menopausal hormone therapy (HT) for postmenopausal women, with consideration for the therapeutic benefit-risk ratio at various times through menopause and beyond. An Advisory Panel of clinicians and researchers expert in the field of women's health was enlisted to review the July 2008 NAMS position statement, evaluate new evidence through an evidence-based analysis, and reach consensus on recommendations. The Panel' s recommendations were reviewed and approved by the NAMS Board of Trustees as an official NAMS position statement. Also participating in the review process were other interested organizations who then endorsed the document. Current evidence supports a consensus regarding the role of HT in postmenopausal women, when potential therapeutic benefits and risks around the time of menopause are considered. This paper lists all these areas along with explanatory comments. Areas that vary from the 2008 position statement are noted. A suggested reading list of key references published since the last statement is also provided. Recent data support the initiation of HT around the time of menopause to treat menopause-related symptoms; to treat or reduce the risk of certain disorders, such as osteoporosis or fractures in select postmenopausal women; or both. The benefit-risk ratio for menopausal HT is favorable for women who initiate HT close to menopause but decreases in older women and with time since menopause in previously untreated women.

The use of complementary and alternative medicine by women experiencing menopausal symptoms in Bologna

BackgroundThe present study describes Complementary and Alternative Medicine (CAM) use amongst Italian women transitioning through menopause. Popularity and perceived effectiveness of CAM treatments, use of pharmaceutical medications, characteristics of CAM users, the extent of communication between medical practitioners and women about their use of CAM, and variables associated with CAM use were also investigated.MethodsWomen, aged 45-65 years attending Family Planning and Women's Health clinics or Menopause Centres in Bologna were invited to complete a voluntary, anonymous, self administered questionnaire, which was used in a previous study in Sydney. The questionnaire was translated and adapted for use amongst Italian women. Data on general demographic and health characteristics, menopause related symptoms and the use of CAM and pharmaceutical treatments during the previous 12 months were collected.ResultsIn total, 1,203 women completed the survey, of which 1,106 were included in the final sample. Of women who had symptoms linked with menopause and/or used remedies to alleviate symptoms, 33.5% reported to have used CAM. Among these, 23.5% had consulted one or more practitioners and 24% had used at least one CAM product.Approximately nine out of ten respondents reported medical practitioners did not seek information about their use of CAM; while one third of CAM users did not disclose the use of CAM to their physician. Nevertheless, medical practitioners were the most popular source of information. From the multivariate analysis, variables associated with CAM use were: professional employment, time since the last natural menses, use of CAM for conditions other than menopause, and presence of some severe symptoms.ConclusionsThe relatively high prevalence of CAM use by women transitioning through menopause should encourage research initiatives into determining which CAM treatments are the safest and effective. The increasing and likely concomitant use of CAM with HRT and other pharmaceuticals underlines the need for the implementation of a surveillance system to report and monitor possible drug-herb adverse events. The discrepancy between women preferring to seek information about CAM from their medical doctor and the difficulties noted in communication between doctor and patient should encourage educational initiatives on CAM by health-care agencies and institutions.

Subjective cognitive complaints at menopause associated with declines in performance of verbal memory and attentional processes

Background Subjective cognitive complaints are commonly reported during the menopause transition. Whether they are indicative of actual cognitive impairment is unknown.Objectives To assess subjective attention and memory complaints in a general population sample across the stages of menopause; to assess relationships between subjective complaints and objective measures of cognitive performance; to examine potential menopause-related, hormonal, psychosocial and cognitive predictors of subjective complaints.Methods Multivariate and univariate analyses of cross-sectional data from 120 pre-, peri- and postmenopausal women.Results Attention problems were more evident in the perimenopausal and hormone therapy groups. Subjective cognitive problems were associated with declines in verbal memory, and with declining performance on reaction time measures of attention, with small-to-medium effect sizes. Predictors of subjective complaints included menopause-related symptoms, psychosocial variables, psychological symptoms and objective cognitive performance.Conclusion A link has been demonstrated between the subjective and objective aspects of cognitive function in association with the menopausal transition. It is suggested that greater recognition be given to cognitive symptoms as forming part of the constellation of menopause-related symptoms.

Eszopiclone improves insomnia and depressive and anxious symptoms in perimenopausal and postmenopausal women with hot flashes: a randomized, double-blinded, placebo-controlled crossover trial

Menopause-associated insomnia is commonly associated with other symptoms (hot flashes, depression, anxiety). Given frequent symptom cooccurrence, therapies targeting sleep may provide an important approach to treatment during midlife. Peri/postmenopausal women (40-65 years old) with sleep-onset and/or sleep-maintenance insomnia cooccurring with hot flashes and depressive and/or anxiety symptoms were randomized to eszopiclone 3 mg orally or placebo in a double-blinded, crossover 11 week trial. Changes in the Insomnia Severity Index (ISI) scale and secondary outcomes (diary-based sleep parameters, depression/anxiety, hot flashes, quality of life) were analyzed using repeated-measure linear models. Of 59 women, 46 (78%) completed the study. Eszopiclone reduced ISI scores by 8.7 + or - 1.4 more points than placebo (P < .0001). Eszopiclone improved (P < .05) all sleep parameters, depressive symptoms, anxiety symptoms, quality of life, and nighttime but not daytime hot flashes. Eszopiclone treats insomnia and cooccurring menopause-related symptoms. Our results provide evidence that hypnotic therapies may improve multiple domains of well-being during midlife.

P860 Incidence of menopause-related symptoms – a study from a suburban area of Mumbai, India

P860 Incidence of menopause-related symptoms – a study from a suburban area of Mumbai, India

Effects of a Combination ofHypericum perforatumandVitex agnus-castuson PMS-Like Symptoms in Late-Perimenopausal Women: Findings from a Subpopulation Analysis

It has been suggested that some of the symptoms typically attributed to menopause may be more related to premenstrual syndrome (PMS) than menopause, as perimenopausal women appear to be more prone to PMS-like symptoms, or at least to tolerate them less well. The objective of this study was to evaluate the effectiveness of a phytotherapeutic intervention comprising a combination of Hypericum perforatum (St. John's wort) and Vitex agnus-castus (chaste tree/berry) in the management of PMS-like symptoms in perimenopausal women. A double-blind, randomized, placebo-controlled parallel trial was conducted over 16 weeks on menopause-related symptoms. Data on PMS-like symptoms were collected at 4-weekly intervals from a small subgroup of late-perimenopausal women (n = 14) participating in this study. The primary endpoint was PMS scores measured on the Abrahams Menstrual Symptoms Questionnaire, comprising the subclusters of PMS-A (anxiety), PMS-D (depression), PMS-H (hydration), and PMS-C (cravings). Herbal combination therapy or placebo tablets were administered twice daily. At the end of the 16-week treatment phase, analyses of covariance showed the herbal combination to be superior to placebo for total PMS-like scores (p = 0.02), PMS-D (p = 0.006), and PMS-C clusters (p = 0.027). The active treatment group also showed significant reductions in the anxiety (p = 0.003) and hydration (p = 0.002) clusters, using paired-samples t tests. Results of trend analyses showed significant treatment group effects across the five phases for total PMS and all subscales, all in the clinically expected direction. No significant trends were evident in the placebo group. These results suggest a potentially significant clinical application for this phytotherapeutic combination in PMS-like symptoms among perimenopausal women. Further research is warranted through a randomized, controlled trial dedicated to investigation of these symptoms.

P01-292 Midlife women with major depressive disorder: Effects of quetiapine extended-release on mood, sleep and menopause-related symptoms

Background:Recent studies suggest that the menopausal transition may constitute a period of greater risk for the development of new onset/recurrent depressive episodes. In addition, the presence of vasomotor and other menopause-related complaints may adversely affect quality of life and overall functioning. With the long-term safety of hormone therapies being questioned, non-hormonal strategies are needed for the management of symptomatic midlife women. This report is a preliminary analysis of a study investigating the effects of quetiapine extended-release (Seroquel XR) in symptomatic perimenopausal and postmenopausal women with major depressive disorder (MDD).Methods:Peri and postmenopausal women, age 40 to 60 years, suffering from MDD and reporting menopause-related symptoms were recruited into a 2-week, placebo lead-in phase, followed by an open trial (8 weeks) with quetiapine extended-release, flexible dose, 150-300 mg/day. The primary outcome measure (i.e. changes in depressive symptoms) was assessed via Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Other measures included: Hamilton Depression Rating Scale (HAM-D), menopause-related symptoms (Greene Climacteric Scale - GCS), Clinical Global Impression (CGI-S), sleep characteristics (Pittsburgh Sleep Quality Index - PSQI) and the impact of hot flashes on daily functioning (Hot Flash-Related Daily Interference Scale (HFRDIS).Results:Thirty-nine women (mean age 49.3±4.3 years) were enrolled in the placebo lead-in phase. Of those, 25 were considered eligible for the 8-week trial with quetiapine extended-release. This interim analysis (LOCF) included 18 women who completed 4 to 8 weeks of treatment with quetiapine extended-release (median MADRS total scores at baseline = 28 ±6.1; median final dose of quetiapine extended-release=200 mg/day). At the end of the study, 13 out of 18 (72.2%) participants achieved remission (total MADRS scores &lt; 10). Overall, subjects showed significant reduction in total MADRS (p&lt; 0.001) and HAM-D scores (p&lt; 0.001). Treatment with quetiapine extended-release improved menopause-related symptoms, as shown by a decrease in Greene Climacteric Scale total scores (p&lt; 0.001) and sub-scores for psychological (p&lt; 0.001), vasomotor (p=0.001), and somatic (p=0.001) complaints (Wilcoxon tests). Quetiapine extended-release did affect menopause-related sexual dysfunction (changes in CGS sexual sub-scores, p=0.06). There was a substantial reduction in overall burden associated with vasomotor symptoms, i.e., decreased HFRDIS scores (p&lt; 0.001). Lastly, sleep efficiency, perceived sleep quality, and daily sleep disturbances improved significantly after treatment with quetiapine extended-release (p&lt; 0.001 for all PSQI sub-scores).Discussion:This is the first study examining the efficacy of Seroquel XR for the treatment of Major Depressive Disorder in a population of symptomatic peri and postmenopausal women. Treatment with Seroquel XR not only reduced depressive symptomatology but also improved vasomotor symptoms and sleep complaints. Larger randomized, placebo-controlled studies are warranted to better explore the efficacy and predictors of response with quetiapine extended-release for this specific population.