Adherence to Pharmacotherapy in Post-Menopausal Women with Hypertension or Metabolic Syndrome: Real World Experience

Background: Adherence to medications is dependent upon a variety of factors, including individual characteristics of the patient, interactions with health care providers, and medication complexity. Even though several studies were conducted to test intervention strategies, results are uncertain. Aim: The aim of the study is to assess if a tailored combined intervention strategy improves medication adherence in a large population of post-menopausal women affected by hypertension or metabolic syndrome. Methods: We enrolled 6833 patients aged 50 to 69 years, 85.7% with hypertension, and 14.3% with metabolic syndrome. A network between patients, general practitioners, and cardiologists was established. Interventions included education, adequate information to patients, a simplified scheme of treatment, and periodic adherence assessment. These were either delivered as healthcare provider supports or using modern technology. Medication adherence was estimated by the proportion of days covered for all classes of drugs after the index date. Results: Non-adherent hypertensive women were 297 (5%), and those with metabolic syndrome were 73 (7.4%) (p Conclusions: The rate of non-adherence in both settings of postmenopausal women was 7.7%, much lower than that described in the literature. This rate was increased in patients with metabolic syndrome;probably it is related to the complexity of the therapeutic scheme or to a poor consciousness of the disease. Therefore, implementing a tailored combined intervention can improve significantly patients’ adherence to medical therapy.

Aging is a risk factor of nonalcoholic fatty liver disease in premenopausal women

AIM: To clarify the relationship between age, menopause, and nonalcoholic fatty liver disease (NAFLD) in women. METHODS: We conducted a follow-up study on non-alcoholic fatty liver disease by using abdominal ultrasonography, and investigated the relationship of age and menopause with the development of NAFLD in women. We followed 1829 women and 2572 men (response rate, 86%) selected in 2001 to represent the non-institutionalized adult population of Gifu, Japan. Data collected included self-reported medical history, lifestyle factors, and menopausal status. The postmenopausal state was defined as beginning 1 year after the cessation of menses. We diagnosed NAFLD with the aid of abdominal ultrasonography by using diagnostic criteria describedRESULTS: The prevalence of NAFLD in women increases with age, but does not alter with age in men. Furthermore, the prevalence of NAFLD in premenopausal women (6%) was lower than that in men (24%) and in postmenopausal women (15%). The associations of the postmenopausal state and hormone replacement therapy with NAFLD were statistically significant in a univariate logistic regression model. At the follow-up examination, 67 women (5%) were newly diagnosed with NAFLD. The incidence of NAFLD was 3.5% (28/802) in premenopausal women, 7.5% (4/53) in menopausal women, 6.1% (24/392) in postmenopausal women, and 5.3% (11/206) in women receiving hormone replacement therapy. The weight gain in premenopausal women was equal to that in postmenopausal women. Metabolic syndrome and weight gain were independent risk factors for NAFLD in pre-and postmenopausal women, but age was an independent risk factor in premenopausal women only. CONCLUSION: Aging is a risk factor for NAFLD in premenopausal women, independent of weight gain or influence of metabolic syndrome.

Relationship of serum GDF11 levels with bone mineral density and bone turnover markers in postmenopausal Chinese women

Growth differentiation factor 11 （GDF11） is an important circulating factor that regulates aging. However, the role of GDF11 in bone metabolism remains unclear. The present study was undertaken to investigate the relationship between serum GDF11 level, bone mass, and bone turnover markers in postmenopausal Chinese women. Serum GDF11 level, bone turnover biochemical markers, and bone mineral density （BMD） were determined in 169 postmenopausal Chinese women （47-78 years old）. GDF11 serum levels increased with aging. There were negative correlations between GDF11 and BMD at the various skeletal sites. After adjusting for age and body mass index （BMI）, the correlations remained statistically significant. In the multiple linear stepwise regression analysis, age or years since menopause, BMI, GDF11, and estradiol were independent predictors of BMD. A significant negative correlation between GDF11 and bone alkaline phosphatase （BAP） was identified and remained significant after adjusting for age and BMI. No significant correlation was noted between cross-linked N-telopeptides of type I collagen （NTX） and GDF11. In conclusion, GDF11 is an independent negative predictor of BMD and correlates with a biomarker of bone formation, BAP, in postmenopausal Chinese women. GDF11 potentially exerts a negative effect on bone mass by regulating bone formation.

Postmenopausal women with hyperandrogenemia:Three case reports

BACKGROUND Diagnosing hyperandrogenemia in postmenopausal women is very difficult.It occasionally manifests as excessive hair growth or with no clinical manifestations,and is therefore often misdiagnosed or missed altogether.Ovarian steroid cell tumors that cause hyperandrogenemia in women account for approximately 0.1%of all ovarian tumors.Due to the low incidence,corresponding imaging reports are rare,so ovarian steroid cell tumors lacks typical imaging findings to differ-entiate it from other ovarian tumors.Therefore,we summarized its clinical and imaging characteristics through this case series,and elaborated on the differential diagnosis of steroid cell tumors.CASE SUMMARY We report three cases of postmenopausal women with hyperandrogenemia.Only 1 patient showed virilization symptoms,the other two patients were completely asymptomatic.All patients underwent total hysterectomy+bilateral adnexe-ctomy.Histological results showed one case of Leydig cell tumor and two cases of benign,non-specific steroid cell tumor.After the operation,the androgen levels of all patients returned to normal,and there was no clinical recurrence since follow-up.CONCLUSION Although virilization caused by increased serum testosterone levels is an important clinical feature of ovarian steroid cell tumors,it is often asymptomatic.A solid,slightly hypoechoic,round or oval mass with uniform internal echo,richer blood flow in the solid part,and low resistance index are typical imaging features of ovarian steroid cell tumors.Diagnosis of ovarian steroid cell tumors after menopause is challenging,but surgery can be used for both diagnosis and clear treatment.

Adjuvant tamoxifen switched to exemestane treatment in postmenopausal women with estrogen receptor-positive early breast cancer:A pragmatic,multicenter,and prospective clinical trial in China

Objective:This post-approval safety study assessed the efficacy and safety of exemestane after 2-3 years of tamoxifen treatment among postmenopausal women with estrogen receptor-positive(ER+)early breast cancer in China.Methods:Enrolled patients had received 2-3 years of tamoxifen and were then switched to exemestane for completion of 5 consecutive years of adjuvant endocrine therapy.The primary endpoint was the time from enrollment to the first occurrence of locoregional/distant recurrence of the primary breast cancer,appearance of a second primary or contralateral breast cancer,or death due to any cause.Other endpoints included the proportion of patients experiencing each event,incidence rate per annum,relationships between human epidermal growth factor receptor 2 status and time to event,and relationship between disease history variables and time to event.Results:Overall,558 patients were included in the full analysis set:397(71.1%)completed the study,20experienced an event,and 141 discontinued[47 owing to an adverse event(AE);37 no longer willing to participate].Median duration of treatment was 29.5(range,0.1-57.7)months.Median time to event was not reached.Eventfree survival probability at 36 months was 91.4%(95%CI,87.7%-95.1%).The event incidence over the total exposure time of exemestane therapy was 3.5 events/100 person-years(20/565).Multivariate analysis showed an association between tumor,lymph node,and metastasis stage at initial diagnosis and time to event[hazard ratio:1.532(95%CI,1.129-2.080);P=0.006].Most AEs were grade 1 or 2 in severity,with arthralgia(7.7%)being the most common treatment-related AE.Conclusions:This study supports the efficacy and safety of exemestane in postmenopausal Chinese women with ER+breast cancer previously treated with adjuvant tamoxifen for 2-3 years.No new safety signals were identified in the Chinese population.

Association of Bisphenol A Exposure with Circulating Sex Hormone Concentrations in Men and Postmenopausal Women

A total of 1 116 middle-aged and elderly men and 1 442 postmenopausal women were recruited in this study. Whether bisphenol A exposure was associated with circulating sex hormone concentrations was studied. Univariate analysis revealed that the urinary bisphenol A concentration was negatively correlated with the serum levels of luteinizing hormone （B=-0.061, P〈0.0001） and follicle-stimulating hormone （B=-0.086, P〈0.0001） in men, and with the serum levels of follicle-stimulating hormone （B=-0.037, P=0.018） and sex hormone-binding globulin （B=-0.043, P=0.006） in women. However, no significant association was observed between the serum levels of urinary bisphenol A and circulating sex hormone after adjustment for the potential confounders.

Association of the MTHFR C677T polymorphism and bone mineral density in postmenopausal women:a meta-analysis

Osteoporosis is a condition characterized by low bone mineral density （BMD） and micro-architectural changes in the bone tissue.The risk of osteoporosis is partly determined by genetic factors.The role of C677T polymorphism of methylenetetrahydrofolate reductase （MTHFR） gene has been investigated in postmenopausal osteoporosis.However,the relationship between MTHFR polymorphism and BMD is still controversial.We carried out a meta-analysis of 5,833 subjects to evaluate the association of MTHFR and BMD in postmenopausal women.Databases of MEDLINE,Web of Science,Scopus and CNKI were retrieved for all publications relating to MTHFR polymorphism and BMD in postmenopausal women.Five eligible studies were selected for meta-analysis.All these articles studied the association of MTHFR polymorphism and BMD of the femoral neck and lumbar spine in postmenopausal women.Our analysis suggested that postmenopausal women with the TT genotype had lower femoral neck BMD than the women with the CC/CT genotype,and the weighted mean difference （WMD） was-0.01 g/cm 2 [95% confidence interval （CI）：（-0.01,-0.01）,P 0.01].However,BMD of the lumbar spine of postmenopausal women with the TT genotype was not significantly different from that of women with the CC/CT genotype.In the random effects model,the WMD between the TT and TC/CC genotype was-0.01 g/cm 2 [95% CI：（-0.04,0.01）,P=0.32].The C677T polymorphism of the MTHFR gene is associated with BMD of the femoral neck in postmenopausal women.Women with the TT genotype of the MTHFR gene have lower BMD,suggesting that the TT genotype may be a risk factor for postmenopausal osteoporosis.

Bone density, microarchitecture and stiffness in Caucasian and Caribbean Hispanic postmenopausal American women

Hispanic Americans of Caribbean origin are a fast-growing subset of the US population, but there are no studies on bone density, microstructure and biomechanical integrity in this minority group. In this study, we aimed to compare Caucasian and Caribbean Hispanic postmenopausal American women with respect to these characteristics. Thirty-three Caribbean Hispanics were age-matched to thirty-three Caucasian postmenopausal women. At the lumbar spine, the Hispanic women had significantly lower areal bone mineral density （aBMD）. At the radius by high-resolution peripheral quantitative computed tomography （HR-pQCT）, there were minimal differences between Hispanic and Caucasian women. At the tibia, Hispanic women had lower trabecular volumetric bone density and trabecular number, and higher trabecular separation. Individual trabecula segmentation （ITS） analyses indicated that at the tibia, Hispanic women not only had significantly lower bone volume fraction, but also had significantly lower rod bone volume fraction, plate trabecular number, rod trabecular number and lower plate-plate, plate-rod and rod-rod junction densities compared to Caucasian women. The differences in bone quantity and quality contributed to lower whole bone stiffness at the radius, and both whole bone and trabecular bone stiffness at the tibia in Hispanic women. In conclusion, Hispanic women had poorer bone mechanical and microarchitectural properties than Caucasian women, especially at the load-bearing distal tibia.

Do peripartum and postmenopausal women with primary liver cancer have a worse prognosis? A nationwide cohort in Taiwan

BACKGROUND While primary liver cancer(PLC)is one of the most common cancers around the world,few large-scale population-based studies have been reported that evaluated the clinical survival outcomes among peripartum and postmenopausal women with PLC.AIM To investigate whether peripartum and postmenopausal women with PLC have lower overall survival rates compared with women who were not peripartum and postmenopausal.METHODS The Taiwan National Health Insurance claims data from 2000 to 2012 was used for this propensity-score-matched study.A cohort of 40 peripartum women with PLC and a reference cohort of 160 women without peripartum were enrolled.In the women with PLC with/without menopause study,a study cohort of 10752 menopausal females with PLC and a comparison cohort of 2688 women without menopause were enrolled.RESULTS Patients with peripartum PLC had a non-significant risk of death compared with the non-peripartum cohort[adjusted hazard ratios(aHR)=1.40,95%confidence intervals(CI):0.89-2.20,P=0.149].The survival rate at different follow-up durations between peripartum PLC patients and those in the non-peripartum cohort showed a non-significant difference.Patients who were diagnosed with PLC younger than 50 years old(without menopause)had a significant lower risk of death compared with patients diagnosed with PLC at or older than 50 years(postmenopausal)(aHR=0.64,95%CI:0.61-0.68,P<0.001).The survival rate of women<50 years with PLC was significantly higher than older women with PLC when followed for 0.5(72.44%vs 64.16%),1(60.57%vs 51.66%),3(42.92%vs 31.28%),and 5 year(s)(37.02%vs 21.83%),respectively(P<0.001).CONCLUSION Peripartum females with PLC have no difference in survival rates compared with those patients without peripartum.Menopausal females with PLC have worse survival rates compared with those patients without menopause.

THE CHANGES OF BONE VOLUME AND TURNOVER IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS：A REPORT OF 293 BONE BIOPSIES

bone biopsies of ooteoporosis in postmenopausal women were analyzed. The results showed that the mean ttabecular bone volume was(10.6 ± 5. 47)%, which is 29'3% less than the low value of normal range(15%).There were 186 (63. 5%)cases in normal turnover,75(25.6 %)cases in high turnover,and 32 (10.9%)tases in low turnover.In comparison with the normal turnover group ,the osteoid volume and surface,mineralization surface, corrected mineralization rate,osteoclast number, and bone formation rate were elevated (P<0.01), but mineralization lag time was reduced (P< 0' 01) in the high turnover group,and all the above parameters in the low turnover group were opposite (P <0.05 0. 01).In comparison with the 3 agegroups (51￣60, 60￣70,>70),the bone volume and osteoid volume dropped as the age increased. Both high and low turnover situations appeared in the 51￣60 age group,waied had the highest ratio in the 61￣70 age group and the lowest ratio in the >70 age group. All these changes of bone volume and turnover reflect the heterogeneity of etiology and complicacy of pathogenesis in this disease.Bone biopsy is not only to distinguish osteoPOrosis from ostcomalacla, but also to determine the turnover type and direct clinical treatment.

Impact of Consumption of Olive and Argane Oils on Anthropometric Profile of Postmenopausal Women in Morocco

Worldwide, large studies have shown that the menopause is mainly associated with substantial changes in body composition that result in an increase in waist circumference, fat accumulation and specially weight gain. This overweight could be exacerbated by fat intake. Thus, this study was planned to evaluate the impact of the consumption of olive and argane oils on anthropometric profile and body composition of postmenopausal women. The nutritional intervention was conducted over a period of eight weeks, involving daily consumption of 25 mL of argane oil The anthropometric profile （weight, height and body mass index or olive oil in 151 postmenopausal women （55.49 ± 6.18 years old）. （BMI）） and body composition （fat mass （FM） and lean mass （LM）） were determined at 0 week （baseline）, and after the 4th and 8th weeks of nutritional intervention. Results clearly demonstrated that argane oil or olive oil consumption did not affect the anthropometric parameters and the body composition of postmenopausal women. Thus, argane and/or olive oils＇ regular diet does not lead to weight gain, and postmenopausal women could benefit from their impact on health for a better quality of life and to overcome all menopause associated problems. A longer period of nutritional intervention is required to confirm the trend down that was recorded.

Effects of Soymilk on Serum Insulinemic Status and High Sensitivity C-Reactive Protein Levels in Healthy Postmenopausal Women of Bangladesh

Background: Postmenopausal women are at increased risk for cardiac diseases because many risk factors are aggravated by menopause. Isoflavones are phytoestrogens present in natural sources, and they may modulate risk factors favorably, involving mechanisms similar to estrogen. The study aimed to assess the effects of soymilk on serum insulinemic status and hs-C reactive protein (CRP) levels of postmenopausal women of Bangladesh. Methods: Thirty-six women (aged 50 ± 5 years, M ± SD) participated in a randomized, un-blind, open-ended, crossover study design for 52 days. During the study period, the patients made four visits (before and after the intervention including the washout period). The soymilk group consumed 350 mL of milk twice a day for 21 days;the milk contained ~30 mg of isoflavones. Fasting blood glucose (FBG), postprandial glucose (PPG), HbA1c, serum insulin, and hs-CRP were measured on day 0, day 21, day 31, and day 51 with a 10-day washout period. Paired t-test was performed to determine the effects of soymilk on the CVD risks among postmenopausal women and a student t-test was performed for group comparison. Statistical tests were considered significant at p value of ≤0.05. Results: The mean (±SD) BMI of the postmenopausal women was 25.14 ± 3.55 kg/m2. In the consumption of soymilk no significant changes were found in glycemic, insulinemic, and hs-CRP levels between and within the groups. After crossover, a significant change was observed in FBG (5.18 ± 0.49 vs 5.56 ± 0.43, p = 0.005) in the soymilk group. No significant changes were observed in other parameters within or between the groups. However, FBG and hs-CRP levels were found to improve but not significantly at the end of 51 days. Conclusions: Soy isoflavones did not improve serum insulinemic status and hs-C reactive protein (CRP) levels among Bangladeshi postmenopausal women. Further studies need to be elucidated by considering a follow-up study with a large sample size.

Effect of mistletoe combined with carboxymethyl cellulose on dry eye in postmenopausal women

AIM： To investigate the protective effect of mistletoe combined with carboxymethyl cellulose eye drops on dry eye in postmenopausal women.METHODS： Sixty postmenopause female patients diagnosed of dry eye were assigned randomly to mistletoe combined with carboxymethyl cellulose eye drops treatment group（n=30） and control group treated with normal saline eye drops（n=30）. The subjective symptoms of ocular surface, Ocular Surface Disease Index（OSDI）, tear film function tests, tear protein and corneal morphology by confocal scanning microscopy were analyzed before treatment and at 1, 2, 4 and 8 wk after treatment respectively. To ensure the safety of the trial, all patients were examined with systolic pressure, diastolic pressure, glutamic-pyruvic transaminase, glutamic oxaloacetic transaminase, urine creatinine, and blood urea nitrogen at 8 wk after treatment.RESULTS： There were no obvious differences between two groups before the treatment（P〉0.05）. In two months after the treatment, the symptoms of ocular surface, OSDI, tear protein, and tear film function were only slightly changed in normal saline eye drops group. However, all indices were improved after the treatment of mistletoe combined with carboxymethyl cellulose eye drops group（P〈0.05）. In addition, the average amount of corneal epithelium basal cells and inflammatory cells of mistletoe treated group were 3174±379 and 38±25 cells/mm2, significantly decreased as compared to the control group with 4309±612 and 158± 61 cells/mm2, respectively. In the control group, althoughnerves still maintained straight under corneal epithelium, the number of nerves were significantly decreased, as compared with normal female. In the mistletoe treated group, the number of nerves was only slightly reduced, compared with normal female.CONCLUSION： Mistletoe combined with carboxymethyl cellulose eye drops can alleviate the symptoms and signs of dry eye symptoms.

Body Composition, Gynecologic-Obstetric Variables, and Prolactin Levels in Patients with Breast Cancer

Objective: The aim of this study was to determine body composition, gynecological, and obstetric data, sex hormones, and prolactin serum levels in pre- (PREW) and postmenopausal women (PMW) with breast cancer (BC) and compare them with a control group (CG) of healthy women. Methodology: BC patients without treatment or use of hormone replacement therapy, or hormonal birth control, and without data of metastasis were included. CG was matched for age, BMI, and menstrual cycle status. FSH, LH, E2, progesterone, testosterone, and prolactin (PRL) were measured using radioimmunoassay kits. Comparisons between BC and CG were made with “t” tests, and with the Mann-Whitney U-test;χ2 test was used to compare the qualitative variables between the groups. Results: Seventy-two patients with BC, and 74 CG women were evaluated. Both groups presented overweight data, BMI (kg/mt2) = 27.21 ± 5.51 vs. 28.40 ± 4.66, p = ns, for BC patients and CG, respectively. In PREW, the age at menarche was later in BC patients compared to the CG (13.3 ± 1.36 years vs. 12.41 ± 1.27 years, p = 0.005). The PMW with BC presented a higher age at menarche and menopause compared to the women of the CG (13.51 ± 1.48 vs. 12.91 ± 1.41, p = 0.09, and 49.03 ± 2.86 vs. 45.5 ± 8.78, p = 0.03, respectively). PRL levels were significantly higher in PMW with BC, in comparison with the CG;median and minimum and maximum values (min-max) were: 14.7 ng/mL (3.6 - 52.7) vs. 5.9 ng/mL (1.9 - 33.3), p = 0.005). A higher percentage of PMW with BC (26.0% vs. 7.1%, χ2 = 5.57, p = 0.01) presented hyperprolactinemia (PRL serum levels > 20 ng/mL), compared to the GC. Conclusions: The higher levels of PRL in PMW with BC compared with CG, suggest a proliferative effect of this hormone in the affected breast tissue. This study demonstrates the need to use biological markers such as PRL to determine the risk of BC in PMW.

Effect of gender on the reliability of COVID-19 rapid antigen test among elderly

Defining con-founders that affect the reliability of diagnostic tests for coronavirus disease 2019 is vital to breaking the chain of infection.The elderly population is a higher risk group for the emerging virus.However,gender seems to exert a critical role in modifying the infection risk among women owing to hormonal changes.The menopause transition is an exceptional period for older women where the protective and immunomodulatory effects of the estrogen hormone are lost.Accordingly,attention should be given to postmenopausal women since they will have an increased risk compared to their pre-menopausal peers.

Difference in symptom manifestation between postmenopausal and premenopausal women in acute uncomplicated cystitis:A multi-institutional pilot study

Objectives:We aimed to prospectively compare lower urinary tract symptoms in premenopausal and postmenopausal women with acute uncomplicated cystitis before and after antibiotic therapy.Materials and methods:This study included adult women with acute uncomplicated cystitis who visited 4 institutions between 2019 and 2020.After registration,we administered oral antibiotics and prospectively documented the changes in lower urinary tract symptoms from the first visit to a follow-up visit at 1 week using the Core Lower Urinary Tract Symptoms Score(CLSS)questionnaire.Results:After treatment,pyuria disappeared in 60 of the 66 patients(14 premenopausal and 46 postmenopausal).The CLSS total score(range)changed from 13(3-29)to 4(0-18)with a significant improvement in all CLSS items.At baseline,nocturia,urgency,and urgency incontinence were more prominent in postmenopausal women than in premenopausal women.In contrast,baseline urethral pain and quality of life index were more severe in premenopausal women than in postmenopausal women.After treatment,the CLSS total score was still higher in postmenopausal women,as reflected by the relatively higher scores for nocturia and urgency,irrespective of the comparable scores for urethral pain and the quality of life index in the 2 groups.Conclusions:Our results suggest that if storage symptoms persist,they should be carefully interpreted according to menopausal status.

Bioequivalence and safety study of letrozole tablet in healthy Chinese postmenopausal women volunteers

Letrozole is an orally active aromatase inhibitor for the treatment of postmenopausal women with breast cancer. A single-dose, randomized, open-label, two-way crossover study was designed to compare the bioequivalence and safety of two formulations of letrozole （2.5 mg/tablet）, including a newly developed generic formulation （test） and a branded formulation （reference） in a group of healthy Chinese postmenopausal women volunteers under fasting conditions. Blood samples were obtained before study drug administration and at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 144.00, 192.00 and 240.00 h after drug administration. Letrozole levels in plasma were analyzed using a liquid chromatography-tandem mass spectrometry （LC-MS/MS） method. The safety profile was evaluated by adverse events （AEs） record, and assessed by physical examination, vital signs, spontaneous reporting, and clinical laboratory results. A total of 30 healthy Chinese postmenopausal women were enrolled in this study however, only 29 subjects were included in bioequivalence assessments due to serious adverse events （SAEs） in 1 subject. The 90% CIs for the ln-transformed ratios of C max , AUC 0–t , and AUC 0–∞ were 99.55%–115.17%, 97.35%–103.50%, and 97.29%–103.96%, respectively. All values met the predetermined criteria for assuming bioequivalence. One subject （3.3%） experienced SAE who received the reference formulation and 10 subjects （33.3%） reported a total of 13 mild AEs （4 reported from 4 subjects who received the test formulation, and 9 reported from 6 subjects who received the reference formulation）. In this single-dose （2.5 mg） study, we found that the test and reference formulations of letrozole tablet met the regulatory definition for assuming bioequivalence in healthy Chinese postmenopausal women. Both formulations were generally well tolerated in the population studied. Chinese Clinical Trials registration number： ChiCTR-TRC-11001457.

Estrogen receptor alpha gene polymorphism associated with type 2 diabetes mellitus and the serum lipid concentration in Chinese women in Guangzhou

Background Estrogen might play an important role in type 2 diabetes mellitus pathogenesis. A number of polymorphisms have been reported in the estrogen receptor alpha （ERα） gene （also named ESR1）, including the XbaⅠ and PvuⅡ restriction enzyme polymorphisms of ESR1, which may be involved in disease pathogenesis. The aim of this study was to determine whether ER0t gene polymorphisms are associated with type 2 diabetes mellitus and serum lipid level. Methods Two hundred and ninety-nine patients with type 2 diabetes mellitus were compared with three hundred and forty-one health controls of Guangzhou in China, both were male and postmenopausal female residents at 51--70 years. ESR1 genotyping was performed using polymerase chain reaction （PCR） and PvulI and XbaI restriction fragment length polymorphism （PCR-RFLP） analysis. Results ESR1 allelic frequencies of P, p and X, x alleles were 0.408, 0.592; 0.360, 0.640 in the type 2 diabetes mellitus group and 0.318, 0.682; 0.328, 0.672 in the control group, respectively. In case-control study, there was significant difference in PvuⅡ, but not XbaⅠ, allele frequency between the type 2 diabetes mellitus and control groups （P=0.001 and P=0.122）. When the group was separated into men and women, the difference was significant in women （P〈0.001） but not in men （P=0.854） with the PvulI genotype, and the effect of PvulI variant on the development of type 2 diabetes mellitus was improved with aging. In addition, PvulI genotype was associated with blood glucose [fasting blood glucose （FBG）, postprandial blood glucose （PBG）] and serum lipid [total cholesterol （TC） and low density lipoprotein （LDL）-c] concentration in healthy women. Conclusions PvuII polymorphism of ESRI increases susceptibifity to type 2 diabetes mellitus in Chinese Guangzhou women. ESR1 variants may also impact serum lipid metabolism, which might provide a mechanism connecting ESR1 to type 2 diabetes.

Effect of Half-dose and Standard-dose Conjugated Equine Estrogens Combined with Natural Progesterone or Dydrogesterone on Components of Metabolic Syndrome in Healthy Postmenopausal Women： A Randomized Controlled Trial

Background： Menopausal hormone therapy （MHT） has been proven to have beneficial effects on several components of metabolic syndrome. However, the effects vary according to different regimens, dosages, and duration of MHT. The aim of the study was to evaluate the effect of standard-dose 0.625 mg conjugated equine estrogen （CEE） and half-dose 0.3 mg CEE daily with different progestogens in a continuous sequential regimen on postmenopausal metabolic parameters in generally healthy postmenopausal women. Methods： A prospective, open-label, randomized controlled clinical trial was conducted between February 2014 and December 2015. Totally 123 Chinese postmenopausal women with climacteric symptoms were included in this study and were randomly assigned to three groups： Group A received CEE 0.3 mg/micronized progesterone （MP） 100 mg daily; Group B received CEE 0.625 mg/MP 100 mg daily; and Group C received CEE 0.625 mg/dydrogesterone 10 mg daily. Drugs were given in a continuous sequential pattern. The duration of treatment was 12 months. Clinical, anthropometrical, and metabolic variables were measured. Data were analyzed according to intention-to-treat analysis, using Student＇s t-test and analysis of variance. Results： A total of 107 participants completed the 12-month follow-up and were included in the data analysis. At 12 months of treatment, high-density lipoprotein cholesterol and apolipoprotein A significantly increased, and low-density lipoprotein cholesterol, fasting glucose, and glycosylated hemoglobin significantly decreased in Groups B and C, compared with baseline （all P 〈 0.05）. Among the three groups, only Group C showed significantly increased triglycerides compared with baseline （ 1.61 ± 0.80 mmol/L vs. 1.21 ± 0.52 mmol/L, P 0.026）. Each group showed a neutral effect on total cholesterol, lipoprotein A, apolipoprotein B, and fasting insulin levels. No cardiovascular and venous thromboembolic events occurred in the three groups. Conclusions： Among Chinese postmenopausal women, half-dose CEE was not sufficient to induce a favorable lipid and carbohydrate profile compared with standard-dose CEE. Adding natural MP may counterbalance the TG-increasing effect of CEE.

Effects of vibration therapy on bone mineral density in postmenopausal women with osteoporosis

Background Jaw osteonecrosis possibly associated with the administration of bisphosphonates is expected to be treated with a non-pharmacologic approach. This study aimed to determine whether noninvasive, mechanically mediated vibration would inhibit the decline in bone mineral density （BMD） that follows menopause, enhance the BMD of the lumbar and femoral neck, and reduce chronic back pain in postmenopausal women with osteoporosis. Methods A total of 116 postmenopausal women with osteoporosis participated in this study, and they were divided into groups A （66 patients） and B （50）. Group A received vibration treatment （Subjects vertically stand on the vibration platform, with a vibration frequency of 30 Hz, amplitude of 5 mm; they received the treatment five times per week, ten minutes each time and totally for six months）, whereas women of group B served as controls without any treatment. L2-4 BMD, bilateral femoral neck BMD, and body mass index （BMI） were recorded before the treatment or at the third and sixth months of the treatment respectively. After the ending of the treatment, the change of BMD in each group was compared and analyzed. Chronic back pain was evaluated by visual analogue scale （VAS） at baseline and the third and sixth months of the treatment. Results Of the 116 women, 94 including 51 women from group A （（61.23±8.20） years） and 43 women from group B （（63.73±5.45） years）, completed the study. There were no significant differences in baseline characteristics including age, BMI, menopausal years, lumbar BMD, femoral neck BMD, and VAS between the two groups. The lumbar BMD of the 51 women in group A increased by 1.3% （P=0.034） after vibration treatment for 3 months and by 4.3% at the sixth month （P=0.000）. The lumbar BMD in group B was decreased at the third month, but there was not statistical significance （P〉0.05） At the sixth month, it was decreased by 1.9% （P 〈0.05）. The femoral neck BMD of the 51 women in group A was slightly increased after vibration treatment for 3 months, but without statistical significance （P 〉0.05）. At the sixth month, the BMD was increased by 3.2% （P 〈0.05）. In group B, the BMD was not decreased significantly （P=0.185） at the third month, but decreased significantly at the sixth month （1.7%） （P 〈0.05） compared with the baseline. Chronic back pain （VAS） reduced more significantly in group A at the third and the sixth months （P 〈0.05） after vibration therapy in comparison with the baseline. The BMI was not significantly changed in the two groups during the period of follow-up. Conclusions Vibration therapy appears to be useful in reducing chronic back pain and increasing the femoral neck and lumbar BMD in postmenopausal women with osteoporosis.