Factors associated with the age of natural menopause and menopausal symptoms in Chinese women

Objective

To investigate the factors associated with the age of natural menopause and menopausal symptoms in a large population of Chinese middle-aged women.

Study design

In this cross-sectional study, a total of 20,275 women (40–65 years) attending health screening in Jiangsu Province of China were enrolled. A structured questionnaire was used to collect data of demographics, menopausal status, chronic diseases, reproductive history, etc. Also we evaluated the severity of menopausal symptoms by Kupperman menopause index (KMI).

Main outcome measure

Menopausal age and scorings of Kupperman menopause index.

Results

The overall median age at natural menopause was 50 years. Lower educational level, poor economic status, lower body mass index (BMI), age at menarche less than 14 years, nulliparity and smoking were associated with earlier onset of natural menopause (P < 0.05). The most frequently symptoms in postmenopausal women were sexual problems (57.05%), muscle/joint pain (53.29%) and insomnia (51.02%), while fatigue, insomnia and muscle/joint pain were predominant symptoms in pre- and peri-menopausal women. After adjusting for confounding factors, logistic regression analysis revealed that women with poor educational background, low income, divorce, higher BMI, higher parity, smoking and chronic diseases presented higher KMI scores (P < 0.05).

Conclusion

The study provided an estimate of median age at natural menopause in Chinese women. The main factors contributing to earlier onset of menopause and severity of menopausal symptoms were lower educational level, poor economic status, and smoking. Thus, this study provides important insights for physicians to prevent and treat menopause related symptoms.     

A health survey of Beijing middle-aged registered nurses during menopause

ObjectiveTo collect health information of Beijing middle-aged registered nurses during menopause.MethodsWe distributed self-administered questionnaires to 2100 registered nurses aged 40–55 from 20 hospitals in Beijing. The objects of interest were selected by cluster sampling.ResultsA total of 1686 questionnaires met the criteria and were used for statistical analysis. The average natural menopause age was 48.68 ± 3.61 years old. We determined that 37.83% of the objects had modified Kupperman Menopausal Index (KMI) scores ≥15. The top three menopause symptoms were fatigue (82.72%), irritability (70.24%), and arthralgia/myalgia (69.55%); hot flashes ranked eleventh (30.83%).ConclusionsA total of 37.83% Beijing middle-aged registered nurses had menopause syndrome, and the top three symptoms were fatigue, irritability, and arthralgia/myalgia.     

Anti-mullerian hormone (AMH) is associated with natural menopause in a population-based sample: The CARDIA Women's Study

ObjectiveAMH is associated with menopausal timing in several studies. In contrast to prior studies that were restricted to women with regular cycles, our objective was to examine this association in women with either regular or irregular menstrual cycles.MethodsCARDIA is a longitudinal, population-based study that recruited adults ages 18–30 when it began in 1985–1986. AMH was measured in serum stored in 2002–2003. Natural menopause was assessed by survey in 2005–2006 and 2010–2011.ResultsAmong 716 premenopausal women, median [25th, 75th] AMH was 0.77 [0.22–2.02] ng/dL at a median age of 42 [39–45] years. Twenty-nine percent of the women (n = 207) reported natural menopause during 9 years of follow up. In fully adjusted discrete-time hazard models, a 0.5 ng/dL AMH decrement was associated with higher risk of menopause (p < 0.001). Hazard ratios varied with time since AMH measurement. The HR (95% CI) for menopause was 8.1 (2.5–26.1) within 0–3 years and 2.3 (1.7–3.3) and 1.6 (1.3–2.1) for 3–6 and 6–9 years, respectively. When restricted to women with regular menses, results were similar (e.g., HR = 6.1; 95% CI: 1.9–20.0 for 0–3 years).ConclusionAMH is independently associated with natural menopause. AMH appears most useful in identifying women at risk of menopause in the near future (within 3 years of AMH measurement).     

Health-related and socio-demographic correlates of physical activity level amongst urban menopausal women in Nigeria

ObjectivesTo investigate the physical activity (PA) level of Nigerian women aged 40–60 years and examine possible association between the PA level and some health-related and socio-demographic variables.MethodsThis is a cross-sectional study of 547 women in which a purposive sampling method was used to recruit participants in urban centers of three states from three geopolitical zones in Nigeria. The International Physical Activity Questionnaire (IPAQ)-short form, was used to assess PA level. A self-administered 13-item semi-structured questionnaire was used to obtain health-related (menopausal status, perceived health status, health problems, menopausal symptoms) and socio-demographic (age, marital status, educational level, occupation, personal income) information from participants. Chi-square and logistic-regression analysis were used to assess association between PA level and these variables.ResultsThe mean age of participants was 49.21 ± 5.2 years, comprising 184 (33.6%) premenopausal, 129 (23.6%) perimenopausal and 234 (42.8%) postmenopausal women. Most of the women in the three menopausal groups reported moderate PA level. No significant association was observed between PA level and menopausal status (P = 0.348), health problems (P = 0.079) or any of the menopausal symptoms and age-group (P = 0.381) of the women. PA level had a direct significant association with perceived health status (P = 0.001) and educational level (P = 0.000).ConclusionMenopausal women in Nigeria reported a moderate PA level. Self-perception of good health, having secondary/post-secondary education, were directly associated with not being of a low PA level.     

Depressive symptoms in Taiwanese women during the peri- and post-menopause years: Associations with demographic,health, and psychosocial characteristics

ObjectiveThe purpose of this study was to evaluate the prevalence of depressive symptoms in peri- and post-menopausal Taiwanese women, and to investigate the relation between depressive symptoms and demographic variables, chronic disease status, health habits, stress management, menopausal symptoms, and attitudes toward menopause and aging.Study designCross-sectional study, using a purposive sample of 566 women between 45 and 60 years of age from a medical center and residential community in Southern Taiwan.Main outcome measuresDemographic and health habits questionnaire, Women's Health Initiative Symptom Scale, Attitudes Toward Menopause and Aging Scale, and Center for Epidemiological Studies-Depression Scale (CES-D).ResultsThe prevalence of depressive symptoms (CES-D score ≧ 16) was 38.7% in peri- and post-menopausal Taiwanese women. Bivariate correlations and analyses of variance indicated that higher CES-D scores were related to lower family income, younger age, smoking for a greater number of years, consuming more alcohol, having multiple chronic diseases, not exercising regularly, consulting with a specialist for stress management, having more severe menopausal symptoms, and more negative attitudes toward menopause and aging. A stepwise multiple regression analysis indicated that the key predictors, accounting for 33.7% of the variance, were menopausal symptoms, attitudes toward menopause and aging, family income, and chronic disease status.ConclusionsResults highlight the importance of considering psychosocial factors, life style, and chronic disease management in providing health guidance for peri- and post-menopausal women to enhance their quality of life and reduce the risk of depressive symptoms.     

Sexuality of Chinese women around menopause

ObjectiveTo study the sexual activities and prevalence of sexual dysfunctions in midlife Chinese women and their correlations with demographic factors, sexual dissatisfaction and interpersonal difficulty.Study designThis is a cross-sectional survey of a convenience sample of women aged 40–60, who requested gynecological checkup or attend social activities at Women's Club.Main outcome measuresSexual activities, sexual dysfunctions, sexual dissatisfaction, demographic factors and interpersonal difficulty were assessed by self-administered questionnaire.ResultsAmong 371 eligible subjects, 22.4% and 39.6% women had low intimacy and coitus frequency (0 to <12 acts in one year), respectively. The odds ratios for low coital frequency in the natural menopausal and surgical menopausal subgroups were 3.00 and 5.09, respectively (95% confidence interval: 1.73–5.19 and 1.77–14.69, respectively). Overall, 77.2% women had at least one type of sexual dysfunctions; this proportion was highest in the surgically menopausal subgroup (88.9%) followed by the naturally menopausal subgroup (79.3%), the perimenopausal subgroup (78.2%) and the premenopausal subgroup (72.2%) (p = 0.003). No lubrication (42.9%) was the commonest sexual dysfunction and predominantly affected naturally and surgically menopaused women (p = 0.001). Sexual dysfunction was the major contributor to sexual dissatisfaction (0.80), followed by interpersonal difficulty (0.2). Arousal disorder was the pivot of interaction between sexual dissatisfaction, menopausal status and low coital frequency.ConclusionsChinese women had fewer intimate contacts and less coitus when menopause progressed. No lubrication was the commonest sexual dysfunction and predominantly affected menopaused women. Our model showed that sexual dysfunction is the main contributor to sexual dissatisfaction.     

Climacteric symptoms and quality of life in yoga practitioners

BackgroundYoga is among the most commonly studied complementary therapies for managing climacteric symptoms. However, it is unclear whether yoga practices in premenopause can affect the occurrence of symptoms when women reach menopause.ObjectiveTo assess climacteric symptoms and quality of life in regular yoga practitioners and to determine whether yoga practices before menopause may avoid or mitigate climacteric-related symptoms.DesignThis study of 108 women between 40 and 65 years old included 28 women who started to practice yoga in premenopause and had already practiced for at least five years, and as controls 30 physical activity practitioners (PA) who had practiced for at least five years, and 50 sedentary women.Main outcome measuresClimacteric symptoms were evaluated with the Kupperman Menopausal Index (KMI) and the Women's Health Questionnaire (WHQ). Moreover, we measured the quality of life with the WHQ.ResultsThe KMI showed that 39.3% of yoga practitioners had no menopausal symptoms, and none reported severe symptoms. The WHQ indicated a few symptoms and a good quality of life for yoga practitioners (3.56; 3.35–3.80). In addition, we found that the yoga group had significantly less moderate and severe symptoms (p = 0.002) compared with the sedentary group. We also observed that yoga practitioners had less vasomotor symptoms and memory/concentration disorders than PA practitioners (p = 0.010 and p = 0.047) and sedentary women (p = 0.001 and p = 0.001) and also used fewer drugs than the PA (p < 0.001) and the sedentary groups (p = 0.001).ConclusionsYoga practitioners who started to practice in premenopause had satisfactory results on the frequency and intensity of climacteric symptoms and quality of life. Although further research is required to support our findings, we conclude that yoga practice may represent an efficient non-pharmacological approach to manage and prevent climacteric symptoms.     

Reducing depression during the menopausal transition with health coaching: Results from the healthy menopausal transition randomised controlled trial

ObjectiveTo determine if health coaching (HC) decreases the incidence of depression, reduces the severity of symptoms, and increases quality of life during the menopausal transition (MT).Research design and methodsParallel, single-blinded, randomised controlled trial of 6 sessions of phone-delivered HC compared with usual care. Participants were 351 community-dwelling women free of major depression going through the MT, of whom 180 were assigned the intervention and 171 usual care. The primary outcome of interest was the incidence of clinically significant depressive symptoms over 52 weeks. Other study measures included the Hospital Anxiety and Depression Scale, quality of life (SF-12), the Menopause Rating Scale (MRS), diet, body mass index, alcohol use, smoking and physical activity. We considered that women with Patient Health Questionnaire (PHQ-9) scores between 5 and 14 (inclusive) had sub-threshold depressive symptoms.ResultsNine women developed clinically significant symptoms of depression during the study—2 had been assigned HC (odds ratio, OR = 0.26, 95%CI = 0.05, 1.29; p = 0.099). Intention-to-treat showed that, compared with usual care, the intervention led to a greater decline in depressive scores, most markedly for participants with sub-threshold depressive symptoms. Similar, but less pronounced, benefits were noticed for anxiety scores and the mental component summary of the SF-12. The intervention led to a decline in MRS scores by week 26 and subtle improvements in body mass, consumption of vegetables and smoking.ConclusionsHC addressing relevant risk factors for depression during the MT improves mental health measures. Our findings indicate that women with sub-threshold depressive symptoms may benefit the most from such interventions, and suggest that HC could play a useful role in minimizing mental health disturbance for women going through the MT.     

Circulating osteoprotegerin and asymptomatic carotid atherosclerosis in postmenopausal non diabetic women

PurposeOsteoprotegerin (OPG) is a bone metabolism regulator but it is also involved in vascular calcification. Its role in the development of atherosclerosis is still a subject of debate. Postmenopausal women seem to have an increased risk for cardiovascular disease. The aim of the study is to evaluate the relationship between serum OPG and asymptomatic carotid atherosclerosis in postmenopausal non-diabetic women.Material/methodsCarotid artery examination was performed in 100 postmenopausal women without diabetes mellitus and overt cardiovascular disease, using B-mode ultrasonography to determine the carotid intima-media thickness (CIMT) and the presence of plaques. Serum OPG was measured in all study participants and its relationship with clinical, biochemical and vascular parameters was evaluated.ResultsCIMT correlated with age (r = 0.45, p < 0.001), years since menopause (r = 0.30, p = 0.003), abdominal circumference (r = 0.25, p = 0.01) and OPG (r = 0.23, p = 0.02). Carotid plaques correlated with age (p < 0.001), obesity (p = 0.03), abdominal circumference (p = 0.03) and CIMT (p < 0.001), but not with serum OPG (p = 0.86). In regression analyses the independent predictors for CIMT were age (β = 0.717, p < 0.001), OPG (β = 0.214, p = 0.02), and years since menopause (β = −0.334, p = 0.04) and for the presence of carotid plaques were obesity (p = 0.04, OR = 3.90), CIMT (p < 0.001, OR = 6408.86) and smoking (p = 0.02, OR = 687.93).ConclusionOPG is associated with cardiovascular risk factors, CIMT, but not with the presence of asymptomatic carotid plaques in non diabetic postmenopausal women. OPG may be a marker of cardiovascular risk.     

Effects of aripiprazole adjunctive to standard antidepressant treatment on the core symptoms of depression: A post-hoc,pooled analysis of two large,placebo-controlled studies

BackgroundAlthough antipsychotic agents have a long history of use in depression, their effectiveness in treating core symptoms of depression such as loss of interest has been questioned. Adjunctive aripiprazole is beneficial for the treatment of patients with major depressive disorder but its effects on specific symptoms have not been reported. The objective of this study was to examine the effects of aripiprazole on core symptoms of depression.MethodsThis is a post-hoc, pooled analysis of two trials of aripiprazole augmentation of standard antidepressants (ADT) in patients with major depression. Patients with an inadequate response to ADT received adjunctive aripiprazole (n = 373) or placebo (n = 368) for 6 weeks. Change on four subscales of the 17-item Hamilton Depression Rating Scale (HAM-D17) that capture core depression symptoms was determined and change on individual HAM-D items also was assessed. The magnitude of within-group change for the subscales and individual items was expressed as effect size (ES) and between-group significance tested with ANCOVA. The magnitude of change was also examined comparing the response rates for aripiprazole and placebo on HAM-D17 and the four subscales. Change on three composite subscales — anxiety, insomnia and drive was also examined.ResultsWithin-group change on the four core subscales was substantial (ES = 1.1–1.2) and similar to that for the 17-item HAM-D total score. Between-group comparisons indicated mean change and response rates were significantly greater with adjunctive aripiprazole than placebo for each core subscale (all p < 0.01). Individual HAM-D17 items showing the greatest change from baseline with adjunctive aripiprazole: depressed mood (within-group ES = 1.03) work and activities (ES = 0.86), guilt (ES = 0.77) and psychic anxiety (ES = 0.67) are the same symptoms identified by each of the core subscales and each of these items differed significantly from change on that item with placebo (p < 0.01). On three composite scales, adjunctive aripiprazole was significantly more effective than placebo with respect to mean change for anxiety, insomnia and drive (all p < 0.001).ConclusionsAripiprazole augmentation of standard ADT results in significant, clinically meaningful changes in the core symptoms of depression. It is also associated with significant change in anxiety, insomnia, and drive components of the 17-item HAM-D.     

Associations between the number of natural teeth in postmenopausal women and hormone replacement therapy

ObjectivesIncreasing research suggests that periodontal status is associated with hormone replacement therapy in postmenopausal women. This study was performed to assess the relationship between the number of natural teeth and ever use of hormone replacement therapy in postmenopausal women using nationally representative Korean data.MethodsData from the Korea National Health and Nutrition Examination Survey between 2010 and 2012 were used, and the analysis in this study was confined to a total of 4869 respondents over 19 years old who had gone through menopause and who had no missing data for the reproductive factors and outcome variables in that study. The total number of natural teeth was then calculated after excluding third molars. The time of day when tooth brushing was done was recorded as representative oral health behavior. Multiple logistic regression analyses were used to assess association between the number of natural teeth and the use of hormone replacement therapy.ResultsAmong participants who had ever used hormone replacement therapy, the proportions (percentage and standard error) with no teeth, 1–9 teeth, 10–19 teeth, 20–27 teeth, and 28 teeth were 5.0 ± 2.4%, 6.7 ± 1.4%, 12.5 ± 1.7%, 18.9 ± 1.0%, and 20.7 ± 1.6%, respectively (P < 0.05). The adjusted odds ratio and 95% confidence interval for having fewer than 20 teeth <20 was 0.624 [0.464–0.840] for the individuals using hormone replacement therapy, after adjustments.ConclusionsThe analysis revealed that the use of hormone replacement therapy by postmenopausal women showed positive effects for retention of natural teeth. Lack of hormone replacement therapy may be considered to be an independent risk indicator for tooth loss in Korean postmenopausal women.     

Psychometric assessment of female overactive bladder syndrome and antimuscarinics-related effects

ObjectivesTo investigate the characteristics of psychological distress (PD), personality traits, and family support in women with overactive bladder syndrome (OAB), and the effects of antimuscarinic treatment.Study designWomen with and without OAB (age- and body mass index [BMI]-matched control group) were prospectively enrolled; they recorded bladder diaries, underwent urodynamic studies, and completed PD, personality traits, and filled family support questionnaires before and after antimuscarinic treatment. OAB women underwent treatment with tolterodine or solifenacin for 12 weeks. The control group completed questionnaires.Main outcome measuresThe differences in PD, personality traits, and family support scores between both groups, and the changes after antimuscarinic treatment in OAB women.ResultsEighty-five women with OAB (tolterodine, n = 42; solifenacin, n = 43) and 65 without OAB completed the studies. Linear regression analysis with age and BMI adjustment revealed: coefficients of OAB were significant (all P < 0.05) for somatic complaints (mean: 0.87 vs. 0.63, coefficient = 0.21), obsessive–compulsive symptoms (0.69 vs. 0.44, coefficient = 0.25), anxiety symptoms (0.42 vs. 0.27, coefficient = 0.14), General Symptom Index (GSI, 0.48 vs. 0.33, coefficient = 0.14), neuroticism (9.23 vs. 5.17, coefficient = 3.73), and extroversion–introversion (13.64 vs. 15.25, coefficient = −1.73). Anxiety symptoms (0.42 vs. 0.36) and GSI (0.48 vs. 0.39) improved after antimuscarinics (all P < 0.05). High Overactive Bladder Symptom Score questionnaire score (coefficient = −0.39), low hostility score (coefficient = 2.11), and high additional symptoms score (coefficient = −1.46) were associated with good therapeutic effect (all P < 0.05).ConclusionsOAB women experience more PD, neuroticism, and introversion than asymptomatic women, and antimuscarinics could improve PD.     

Effects of escitalopram on menopause-specific quality of life and pain in healthy menopausal women with hot flashes: A randomized controlled trial

ObjectiveTo evaluate the effects of escitalopram 10–20 mg/day on menopause-related quality of life and pain in healthy menopausal women with hot flashes.Study designA double-blind, placebo-controlled randomized trial of escitalopram 10–20 mg/day vs. identical placebo was conducted among 205 women ages 40–62 years with an average of ≥4 daily hot flashes recruited at 4 clinical sites from July 2009 to June 2010.Main outcome measuresThe primary trial outcomes, reported previously, were the frequency and severity of vasomotor symptoms at 8 weeks. Here, we report on the pre-specified secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and the pain intensity and interference scale (PEG).ResultsOutcome data were collected on 97% of randomized women and 87% of women took at least 70% of their study medication. Treatment with escitalopram resulted in significantly greater improvement in total MENQOL scores (mean difference at 8 weeks of −0.41; 95% confidence interval (CI) −0.71 to −0.11; p < 0.001), as well as Vasomotor, Psychosocial, and Physical domain scores with the largest difference seen in the Vasomotor domain (mean difference −0.75; 95% CI −1.28 to −0.22; p = 0.02). There was no significant treatment group difference for the Sexual Function domain. Escitalopram treatment resulted in statistically significant improvements in PEG scores compared to placebo (mean treatment group difference at 8 weeks of −0.33; 95% CI −0.81 to 0.15; p = 0.045).ConclusionsTreatment with escitalopram 10–20 mg/day in healthy women with vasomotor symptoms significantly improved menopause-related quality of life and pain.     

Efficacy and cost-effectiveness of a clinic-based counseling intervention tested in an ethnically diverse sample of pregnant smokers

ObjectiveRates of cigarette smoking are higher among women who receive obstetric care through publicly funded prenatal clinics. This study compared smoking outcomes for pregnant women (n = 105) who were randomized to receive either usual care (standard cessation advice from the health care provider) or an intervention conducted in the prenatal clinic consisting of 1.5 h of counseling plus telephone follow-up delivered by a masters prepared mental health counselor.MethodsSubjects were 105 low income, predominantly Hispanic, pregnant patients in an urban prenatal clinic. Smoking outcomes were assessed at end of pregnancy and 6 months post-partum.ResultsAt follow-up, 28.3% and 9.4% of participants in the experimental intervention and 9.6% and 3.8% of patients in usual care were abstinent at end of pregnancy (p = .015) and 6 months post-partum, respectively (p = .251). Cost of the intervention was $56 per patient and cost to produce a non-smoker at end of pregnancy was $299.ConclusionsThis model for intervention was cost-effective and was associated with significantly lower smoking rates at end of pregnancy.Practical implicationsIf these findings are replicated, prenatal clinics could offer the option for intensive smoking cessation treatment by training mental health counselors to deliver one extended smoking cessation counseling session.     

Determinants of vitamin D status in healthy men and women aged 40–80 years

ObjectivesTo determine the contribution of life style and health related factors on vitamin D status in middle-aged and older men and women.Study designA cross-sectional single-center study in 400 male subjects (40–80 years) and 402 postmenopausal female subjects (56–73 years), conducted in a University Medical Center in the central part of the Netherlands (52 degrees northern latitude).Main outcome measuresMedical history, vitamin D, calcium and alcohol intake, physical activity, Body Mass Index, Blood pressure, smoking, total fat body mass and total lean body mass were measured using DEXA. Laboratory analysis included 25-hydroxyvitamin D (25OHD) and sex hormones.ResultsThirty-six percent of men and 51% of women had 25OHD less than 50 nmol/L. In summertime men had significant higher 25OHD as compared to women (81.5 vs 53.3 nmol/L, P = .000) but this difference disappeared come winter. In a saturated model, male gender (B = .16, P = .008), and season (summer vs winter B = .30, P = .000) remained statistically significant. In men, physical activity and season explained 21% of the variance. In women, household physical activity (B = .13, P = .03), sport physical activity (B = .02, P = .02) and estradiol (B = ?.003, P = .048) remained in the model,.ConclusionIn healthy middle-aged and older men and postmenopausal women, male gender and season were important predictors of vitamin D status. In men, physically activity and season, explained 21% of the variance in vitamin D status. In women, physical activity and estradiol explained 9.3% of the variance in vitamin D.     

Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial

ObjectiveVaginal atrophy is one of the main concerns of postmenopausal women. The aim of the present study was to investigate the effect of fennel vaginal cream on vaginal atrophy in postmenopausal women in Ahvaz, Iran.Materials and methodsThis double-blind randomized controlled trial was conducted on 60 postmenopausal women (45–65 years of age) in Ahvaz, Iran. The study participants were randomly divided into one of two groups, receiving either a placebo (n = 30) or fennel 5% vaginal cream (n = 30) administered as one application per day (5 g/day) for 8 weeks.Main outcomeThe vaginal pH and maturation vaginal index (MVI) were measured at baseline and 8 weeks after the intervention, while the vaginal atrophy symptoms was measured at baseline and at 2, 4, and 8 weeks after the intervention. The data were analyzed using the independent t-test, chi-square test, paired sample t-test, and the generalized estimating equation.ResultsThe number of superficial cells increased significantly in the fennel group after 8 weeks compared to the control group (76.1 ± 15.3 vs. 11.8 ± 8, p < 0.001). The number of intermediate and parabasal cells decreased significantly in the fennel group compared to the control group (p < 0.001). The vaginal pH decreased significantly at the 8-week follow-up in the fennel group compared to the control group (100% vs. 7.4%, p < 0.001). All women in the fennel group had an MVI of 65–100 at the 8-week follow-up, whereas almost half (40.7%) of the women in the control group had an MVI of 50–64 (p < 0.001).ConclusionAccording to results of this study, fennel is an effective means to manage the symptoms of vaginal atrophy in postmenopausal women and is devoid of side effects. Larger studies are necessary to confirm the positive impact of fennel for vaginal conditions occurring among postmenopausal women.     

Effects of a continuous-combined regimen of low-dose hormone therapy (oestradiol and norethindrone acetate) and tibolone on the quality of life in symptomatic postmenopausal women: A double-blind,randomised study

ObjectiveThis study compared the effects of a continuous-combined regimen of low-dose hormone therapy (LD-HT) versus tibolone and supplemental calcium/vitamin D3 (control) on quality of life (QoL) in symptomatic postmenopausal women.DesignThis study was a prospective, randomised, double-blind, comparative trial with a control group.SettingThe study was conducted in a climacteric outpatient clinic in the University Hospital of Federal University of Juiz de Fora, Brazil.PopulationA total of 174 postmenopausal women under 60 years of age who attended the climacteric outpatient clinic between June 2009 and June 2011 were recruited. These women complained of moderate or intense vasomotor symptoms and exhibited no contraindications for the use of hormone therapy.InterventionsThe patients were randomised into three groups: (1) daily treatment with 2.5 mg tibolone (n = 64), (2) 50 mg calcium carbonate + 200 IU vitamin D3 (Ca/Vit D3, n = 54) or (3) 1 mg oestradiol + 0.5 mg norethindrone acetate (E2/NETA, n = 56) for 12 weeks.Primary outcome measuresThe primary outcome was the evaluation of QoL using the Women's Health Questionnaire (WHQ) in all subjects at baseline and after 4, 8 and 12 weeks of treatment.ResultsA total of 130 women in the following groups completed the study: tibolone (n = 42), Ca/Vit D3 (n = 44) and E2/NETA (n = 44). An improved QoL based on the WHQ was observed at T0 (80.12 ± 14.04, 77.73 ± 15.3, 77.45 ± 15.4) and T12 (57.0 ± 15.5, 55.7 ± 16.7, 58.4 ± 12.6) for the tibolone, E2 + NETA and Ca/Vit D3 groups, respectively (p values <0.05). The three groups exhibited significantly different scores at T12 for sexual behaviour and vasomotor symptoms. The tibolone group exhibited better sexual function compared with the E2/NETA and Ca/Vit D3 groups (4.2 ± 26, 5.6 ± 2.8, 5.4 ± 2.8, respectively, p values <0.05). LD-HT was superior to tibolone and Ca/Vit D3 treatment for improvements in vasomotor symptoms (3.2 ± 1.5, 4.0 ± 1.8, 4.3 ± 2.0, respectively, p values <0.05). Adverse effects were few and mild.ConclusionsAn improved QoL was observed in the three study groups. Tibolone primarily improved sexual function, and E2/NETA exhibited a superior response for vasomotor symptoms.     

Efficacy and safety of paliperidone extended-release in schizophrenia patients with prominent affective symptoms

BackgroundThis post-hoc analysis evaluated the effects of paliperidone extended-release (ER) in patients with schizophrenia and prominent affective symptoms.MethodsPooled data from three 6-week, randomized, double-blind, placebo-controlled studies were analyzed. Subjects received fixed doses of paliperidone ER 3–12 mg/day or placebo. Prominent affective symptoms were defined as depressive (Positive and Negative Syndrome Scale [PANSS] depression item score of ≥ 5 [moderately severe]) and/or manic (PANSS grandiosity score of ≥ 4 [moderate], plus a score of ≥ 4 [moderate] on at least 1 PANSS item for excitement, hostility, uncooperativeness, or poor impulse control). Assessments included PANSS, Clinical Global Impressions-Severity (CGI-S), Personal and Social Performance (PSP) scale, and adverse events (AEs).ResultsAmong 193 patients with prominent affective symptoms, 140 received paliperidone ER and 53 received placebo. Paliperidone ER showed significant mean (SD) improvements vs. placebo in PANSS total (? 20.5 [23.8] vs. ? 6.3 [27.2]; p < 0.001, respectively) and all factor scores (p < 0.01). Significant mean (SD) improvements were observed in PSP (7.2 [15.8] vs. 0.4 [14.6]; p = 0.004) and CGI-S (? 0.9 [1.2] vs. ? 0.3 [1.2]; p < 0.001) scores. Most common AEs with paliperidone ER vs. placebo: headache (16.4% vs. 13.2%), insomnia (7.9% vs. 9.4%), akathisia (7.1% vs. 1.9%), sedation (7.1% vs. 3.8%).LimitationsThese studies were not designed to examine patients with prominent affective symptoms. Authors' clinical judgment was used to define prominent affective symptoms, using relevant PANSS items.ConclusionsPaliperidone ER was well tolerated and associated with significantly greater improvements in symptomatology, functioning, and overall clinical status vs. placebo in patients with schizophrenia and prominent affective symptoms.     

Low-dose 17-β-estradiol cream for vaginal atrophy in a cohort without prolapse: Serum levels and vaginal response including tissue biomarkers associated with tissue remodeling

ObjectivesDescribe the effect of 50 mcg vaginal 17-β-estradiol (E2) cream on vaginal maturation, serum estrogen levels, atrophic symptoms, and biomarkers of oxidative stress and tissue remodeling in postmenopausal women without prolapse.MethodsSeventeen women, 65 years or older, applied intravaginal E2 cream nightly for eight weeks, then twice weekly for eight weeks. Vaginal biopsies, serial blood draws, and atrophic symptoms were obtained at baseline, eight, and sixteen weeks. Changes in atrophic symptoms, vaginal maturation indices (VMI), and serum E2 were measured. Immunohistochemical staining characterized levels of transforming growth factor-beta (TGF-β), nuclear factor kappa B (NFKB), inducible nitric oxide synthase (iNOS), endothelial nitric oxide synthase (eNOS), and thrombospondin (TSP).ResultsSerum E2 levels (pg/ml) were unchanged from baseline (mean (SD)) 7.7 (3.3) to eight 9.7 (5.7) and sixteen 8.7 (5.8) (p = 0.24) weeks. VMI (mean (SD)) improved from baseline 34.2 (18.3) to eight 56.7 (13.1) and sixteen 54.5 (11.3) (p < 0.001) weeks with no difference between eight and sixteen weeks. Vaginal dryness (p = 0.03) and itching (p = 0.02) improved. Tissue biomarker levels did not change (TGF-β p = 0.35, NFKB p = 0.74, eNOS p = 0.80, iNOS p = 0.24, TSP p = 0.80).DiscussionVaginal E2 improved atrophic symptoms and VMI without elevating serum E2. Tissue remodeling biomarkers did not change.