MATERIALS AND METHODS: International and Thai databases were searched from inception to February 2017. Clinical trials investigating effects of PM menopausal or postmenopausal women were included. Outcomes were self-reported menopausal symptoms, serum reproductive hormones, urino-genital tract function, and bone surrogates. Methodological quality was assessed by Cochrane risk-of-bias v2.0, and a 22-parameter quality score based on the CONSORT checklist for herbal medicines.
RESULTS: Eight studies (9 articles) used data from 309 menopausal patients. Five-studies demonstrated that PM was associated with climacteric scores reduced by ~50% compared to baseline. Other PM studies using limited numbers of placebo participants suggested improved vaginal and other urogenital tract symptoms. Bone alkaline phosphatase halved (suggesting lowered bone turnover). Variable serum reproductive hormone levels suggested menopausal status differed between studies. PM active ingredients and sources were not defined. Adverse event rates (mastodynia, vaginal spotting, dizziness) were similar in all groups (PM, conjugated equine estrogen, and placebos) but serum C-reactive protein doubled. These studies had design and reporting deficiencies, high risks of biases, and low quality scores.
CONCLUSIONS: The efficacy of PM on menopausal symptoms remains inconclusive because of methodological short-comings especially placebo effects inherent in self-assessment/recall questionnaires and no PM standardization. PM efficacy and safety need a fundamental re-appraisal by: (i) cohort (retro- and prospective) studies on current users to define its traditional use for rejuvenation; (ii) tightly coupling long-term efficacy to safety of well-defined PM and multiple end-points; (iii) using study design related to current understanding of menopause progression and estrogen pharmacology (iv) robust pharmacovigilance.
Methods: This study is a review of relevant publications about the effects of raloxifene on sleep disorder, depression, venous thromboembolism, the plasma concentration of lipoprotein, breast cancer, and cognitive function among menopausal women.
Results: Raloxifene showed no significant effect on depression and sleep disorder. Verbal memory improved with administration of 60 mg/day of raloxifene while a mild cognitive impairment risk reduction by 33% was observed with administration of 120 mg/day of raloxifene. Raloxifene was associated with a 50% decrease in the need for prolapse surgery. The result of a meta-analysis showed a significant decline in the plasma concentration of lipoprotein in the raloxifene group compared to placebo (standardized mean difference, -0.43; 10 trials). A network meta-analysis showed that raloxifene significantly decreased the risk of breast cancer (relative risk, 0.572; 95% confidence interval, 0.327-0.881; P = 0.01). In terms of adverse effects of raloxifene, the odds ratio (OR) was observed to be 1.54 (P = 0.006), indicating 54% increase in the risk of deep vein thrombosis (DVT) while the OR for pulmonary embolism (PE) was 1.05, suggesting a 91% increase in the risk of PE alone (P = 0.03).
Conclusions: Raloxifene had no significant effect on depression and sleep disorder but decreased the concentration of lipoprotein. Raloxifene administration was associated with an increased risk of DVT and PE and a decreased risk of breast cancer and pelvic organ prolapse in postmenopausal women.
OBJECTIVES: To identify the risk factors associated with mortality for each gender and compare differences, if any, among ST-elevation myocardial infarction (STEMI) patients.
DESIGN: Retrospective analysis.
SETTINGS: Hospitals across Malaysia.
PATIENTS AND METHODS: We analyzed data on all STEMI patients in the National Cardiovascular Database-Acute coronary syndrome (NCVD-ACS) registry for the years 2006 to 2013 (8 years). We collected demographic and risk factor data (diabetes mellitus, hypertension, smoking status, dyslipidaemia and family history of CAD). Significant variables from the univariate analysis were further analysed by a multivariate logistic analysis to identify risk factors and compare by gender.
MAIN OUTCOME MEASURES: Differential risk factors for each gender.
RESULTS: For the 19484 patients included in the analysis, the mortality rate over the 8 years was significantly higher in females (15.4%) than males (7.5%) (P < .001). The univariate analysis showed that the majority of male patients < 65 years while females were >=65 years. The most prevalent risk factors for male patients were smoking (79.3%), followed by hypertension (54.9%) and diabetes mellitus (40.4%), while the most prevalent risk factors for female patients were hypertension (76.8%), followed by diabetes mellitus (60%) and dyslipidaemia (38.1%). The final model for male STEMI patients had seven significant variables: Killip class, age group, hypertension, renal disease, percutaneous coronary intervention and family history of CVD. For female STEMI patients, the significant variables were renal disease, smoking status, Killip class and age group.
CONCLUSION: Gender differences existed in the baseline characteristics, associated risk factors, clinical presentation and outcomes among STEMI patients. For STEMI females, the rate of mortality was twice that of males. Once they reach menopausal age, when there is less protection from the estrogen hormone and there are other risk factors, menopausal females are at increased risk for STEMI.
LIMITATION: Retrospective registry data with inter-hospital variation.
METHODS: Forty-two female Sprage-Dawley rats were randomized into 7 groups (6 in each group). The ovariectomized (OVX) and OVX + 6%, 3%, and 1.5% EBN and OVX +estrogen groups were given standard rat chow alone, standard rat chow +6%, 3%, and 1.5% EBN, or standard rat chow +estrogen therapy (0.2mg/kg per day), respectively. The sham-operation group was surgically opened without removing the ovaries. The control group did not have any surgical intervention. After 12 weeks of intervention, blood samples were taken for serum estrogen, osteocalcin, and osteoprotegerin, as well as the measurement of magnesium, calcium abd zinc concentrations. While femurs were removed from the surrounding muscles to measure bone mass density using the X-ray edge detection technique, then collected for histology and estrogen receptor (ER) immunohistochemistry.
RESULTS: Ovariectomy altered serum estrogen levels resulting in increased food intake and weight gain, while estrogen and EBN supplementation attenuated these changes. Ovariectomy also reduced bone ER expression and density, and the production of osteopcalcin and osteorotegerin, which are important pro-osteoplastic hormones that promote bone mineraliztion and density. Conversely, estrogen and EBN increased serum estrogen levels leading to increased bone ER expression, pro-osteoplastic hormone production and bone density (all P<0.05).
CONCLUSION: EBN could be used as a safe alternative to hormone replacement therapys for managing menopausal complications like bone degeneration.