Effects of standardized phytoestrogen on Taiwanese menopausal women.

OBJECTIVE: To investigate the effects of standardized soy extract on climacteric symptoms, lipid profiles, bone markers, and serum isoflavone concentration in healthy Taiwanese postmenopausal women. MATERIALS AND METHODS: A multicenter, open-labeled, randomized, prospective, comparative study design was used. A total of 130 outpatients who had undergone natural menopause were randomly administered either 70 mg or 35 mg soy extract daily for 24 weeks. RESULTS: The evidence suggests that the soy extract treatment that was administered to both groups for 1 month could help reduce climacteric scores (reductions of 19.66% [p<0.01] and 18.85% [p<0.01] in the 35 mg and 70 mg groups compared with baseline, respectively), and the efficacy was more potent after 6 months of treatment. Soy isoflavone significantly reduced the total cholesterol (reductions of 4.50% [p<0.01] and 3.06% [p<0.05] in the 35 mg and 70 mg groups, respectively) and low density lipoprotein cholesterol levels (reductions of 4.67% [p<0.05] and 5.09% [p<0.05] in the 35 mg and 70 mg groups, respectively) in patients with total cholesterol > 200 mg/dL after 6 months of treatment. In patients with high bone turnover (urinary deoxypyridinoline/creatinine > 7.4 nM/mM), soy extract treatment reduced the deoxypyridinoline/creatinine level by 10.53% (p<0.05) and 11.58% (p<0.05) in the 35 mg and 70 mg groups, respectively. Serum levels of isoflavone increased in both groups after 6 months of treatment. CONCLUSION: Soy extract is highly efficacious at relieving menopausal symptoms and demonstrates a positive effect on the cardiovascular system and skeleton.

The effects of intravenous zoledronic acid in Chinese women with postmenopausal osteoporosis.

The aim of this study was to assess the efficacy and safety of a once-yearly zoledronic acid treatment for Chinese women with postmenopausal osteoporosis in Taiwan and Hong Kong. This post hoc subpopulation analysis, from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly Pivotal Fracture Trial, enrolled 323 Chinese women with osteoporosis who were randomly given either annual infusions of zoledronic acid or placebo for 3 consecutive years. The incidence of fractures and changes in bone mineral density (BMD) were measured; adverse events (AEs) and tolerability were recorded and assessed. The results of this study at 36 months demonstrate that there was a significantly reduced risk of morphometric vertebral fracture and clinical vertebral fracture in subjects treated with zoledronic acid (P < 0.05). In addition, there were significant increases of BMD by 4.9%, 4.3%, and 7.0% in the total hip, femoral neck, and trochanter, respectively, in the zoledronic acid group compared with the placebo group (P < 0.001 for all comparisons). The incidences of AEs were comparable between the two groups. Thus, once-yearly zoledronic acid treatment showed bone protection effects by reducing the risk of vertebral fracture and increasing BMD in Chinese women with postmenopausal osteoporosis.

Who can pass the ISCD professional certification course? The 8-yr experience in Taiwan.

The International Society for Clinical Densitometry (ISCD) launched the professional certification course in early 1996 and was introduced to Taiwan by the Taiwanese Osteoporosis Association in 2002. Disclosing the associated factors of passing the certification examination would be valuable to advance the teaching skill of faculties and clinical excellence of professionals. From June 2002 to July 2009, 732 attendees (male/female=621/111) of 12 professional certification courses (11 courses delivered in Chinese) were enrolled for analysis. All subjects were asked to complete a questionnaire including demographics and professional experience at the time of course registration. After certification examination, subjects were dichotomized as either pass or fail group for analyzing the determinants of pass rate statistically. The average pass rate of the 12 examinations was 75.3% (n=551). In univariate analysis, the age (p<0.001) and hospital level (p<0.001) showed significant differences between the pass and fail groups. However, in the multivariate logistic analysis, only the age (odds ratio [OR]=0.907, 95% confidence interval [CI]: 0.867-0.949, p<0.001) and clinical experience (attending physician vs resident: OR=3.210, 95% CI: 1.215-8.485, p=0.019) were the independent determinants for passing the course. Professionals who are relatively younger or attending physicians have higher pass rate of ISCD course in Taiwan. The fact that only limited predisposing factors might influence the pass rate reflects the efficient design of course delivering. For any knowledge level of professionals who have interest in the excellence of osteoporosis diagnosis and management, the ISCD course is recommended.

The effects of continuous combined oral estradiol and norethisterone on pulsatility index in internal carotid and uterine arteries in early postmenopausal Taiwanese women---a preliminary study.

OBJECTIVE: This study analyzed whether continuous combined oral estradiol and norethisterone had any effect on the pulsatility index (PI) of the internal carotid and uterine arteries in Taiwanese early postmenopausal women. MATERIALS AND METHODS: A group of 40 healthy postmenopausal women with no history of hormone therapy (HT) participated in this study and were randomly subdivided into two groups: HT treatment group (n = 20) and placebo group (n = 20). PI was evaluated with color Doppler ultrasound at the beginning of the study and after 4 months of HT (2 mg 17beta-estradiol + 1 mg norethisterone acetate) or placebo. RESULTS: There was no significant change in the PI of the internal carotid and the uterine arteries after 4 months of HT. CONCLUSION: This HT regimen showed no significant negative impact on vascular resistance in Taiwanese early postmenopausal women. Results are compatible with the updated recommendations on HT stating that there is little cardiovascular risk when HT is initiated within a few years of the menopause.

A clinical trial of 3 doses of transdermal 17beta-estradiol for preventing postmenopausal bone loss: a preliminary study.

BACKGROUND: It is well documented that a daily oral dose of 0.625 mg of conjugated equine estrogen or 1-2 mg of 17beta-estradiol is needed to prevent postmenopausal bone loss. Recent studies have indicated that a lower dose of estrogen maybe as effective in maintaining bone mass. The purpose of this study was to evaluate the effects of 3 dosages of transdermally administered 17beta-estradiol gel in postmenopausal women stratified by oophorectomy and natural menopause. METHODS: One hundred and twenty postmenopausal women were randomly selected to form 4 groups. Three groups of women were treated with a transdermal administration of estradiol gel at a daily dosage of 1.25, 2.5 and 5.0 g (containing 0.75, 1.5, and 3 mg of 17beta-estradiol/day), respectively. The 4th group of women, receiving estriol 2 mg/day p.o., was studied concurrently as a control. Bone mineral density was measured by quantitative computed tomography of the vertebrae from T12 to L3 at baseline, then at 6-month intervals for 1 year. RESULTS: Women in all groups receiving 17beta-estradiol gel obtained a significant increase in bone mass, with the exception of the 1.25 g/day group, which showed a minimal increment at the 6-month period, compared with the control group. Comparisons of the increments in bone mass after estrogen therapy for both natural and surgical menopausal subjects found that there was a more prominent response in surgical menopausal women receiving a dosage of 2.5 g/day. CONCLUSION: Estradiol gel at the dosage of 1.25 g/day, equivalent to 17beta-estradiol 0.75 mg/day, effectively prevented bone loss in postmenopausal women after a 12-month treatment period. The therapeutic effect of estradiol gel on bone mass was more prominent in the surgical menopausal groups at the dosage of 2.5 g/day. The atrophic ovaries may therefore play a crucial role in the subsequent decades of postmenopausal women.

Effect of continuous administration of conjugated estrogen plus medroxyprogesterone acetate (Premelle) in postmenopausal women in Taiwan.

BACKGROUND: To compare the metabolic effects on lipids and acceptability and safety of, and compliance with, a continuous administration of conjugated estrogen plus medroxyprogesterone acetate (Premelle) versus a placebo in non-hysterectomized postmenopausal women. METHODS: Sixty-six generally healthy, female, early post-menopausal women, from 45-60 years of age, were randomized for an administration of conjugated estrogen plus medroxyprogesterone acetate (Premelle, Premarin 0.625 mg plus medroxyprogesterone acetate 2.5 mg/tablet orally) or a placebo for 6 months. The changes in each patient's lipid profiles from baseline, the frequency of hot flushes, bleeding occurrences, and climacteric symptoms, were evaluated. Safety was monitored by means of physical examination, Papanicolau smear, transvaginal ultrasonography, and laboratory check-up. Adverse events were also recorded. RESULTS: The difference before and after treatment in serum LDL-C and total cholesterol (TC) was statistically significant in the Premelle group (LDL-C, p = 0.006, TC, p = 0.040). No statistically significant difference in the change from baseline was observed in the levels of LDL-C and TC in the placebo treatment group. There was a statistically significant change from baseline in menopausal symptoms, which were evaluated by the Greene Climacteric Scales in the Premelle group. There was no clinically significant finding in the physical examination, vital signs, laboratory data, or endometrial thickness in either treatment group. The difference in the number of patients who reported an adverse event was not statistically significant between the 2 treatment groups. CONCLUSIONS: This study demonstrated that Premelle was effective in decreasing LDL-C and total cholesterol levels, and also showed an improvement in some menopausal symptoms, such as vasomotor and sexual dysfunction symptoms. No significant bleeding was observed with Premelle, which was well tolerated in this study. The results of this study could support the use of Premelle tablets as a convenient alternative hormone therapy.

Effect of peer review and trial of labor on lowering cesarean section rates.

BACKGROUND: In an attempt to lower cesarean section rates, a cesarean surveillance system and a selective trial of labor were introduced in a tertiary hospital in Taiwan. METHODS: From 1997 to 2000, 2 physicians were appointed as consultants for the pre-cesarean surveillance, and a trial of labor after a cesarean section was employed concurrently. We organized a weekly departmental Cesarean Indication Conference on Mondays. Comparisons of the cesarean rates between 1993-96 and 1997-2000 were made using the chi-square test. Comparisons of the proportion of overall cesarean sections contributed by each indication for both 1993 and 2000 were also made by chi-square test. RESULTS: A comparison of the 4-year periods before and after 1997 showed that the total cesarean rate had decreased from 37.0 to 30.7% (p < 0.001), primary cesarean rate from 21.3 to 17.8% (p < 0.001), and repeat cesarean rate from 15.7 to 12.9% (p < 0.001). No uterine rupture occurred. Among the 54 indications for primary cesareans, compared between 1993 and 2000, the proportion rates for dystocia, fetal distress, preeclampsia, induction failure, gestational diabetes, and elderly primigravidahad decreased substantially. CONCLUSIONS: The efficient way to lower the repeat cesarean rate is trial of labor, and the way to reduce the number of primary cesareans is in practicing of the guidelines for various indications. The cesarean surveillance system can solidify these guidelines, leading to a lower cesarean rate and an avoidance of inappropriate indications.

Osteoporosis: prevalence in Taiwanese women.

The aim of this study is to understand the current status of bone mineral density (BMD) among Taiwanese women and to determine the relationship between bone mass, weight, height and body mass index (BMI), and the proportion of osteoporosis sufferers, based on World Health Organization standards, in each age group. A total of 4689 women underwent lumbar vertebrae (L2-L4) BMD measurements, and 3529 women underwent femoral neck bone mineral density measurements. BMD was measured using dual-energy X-ray absorptiometry. Standards were based on the BMD of the 20- to 40-year-old age group, as were relationships between height, weight, BMI, and BMD. Pearson correlation revealed a positive relationship between body weight, BMI, and BMD in the femoral neck; other correlations were insignificant. The defined BMD value for a diagnosis of osteoporosis was 0.827 g/cm(2) for lumbar vertebrae and 0.605 g/cm(2) for the femoral neck. The proportion of osteoporosis calculated for each age group in the lumbar vertebrae group was: 40-49 years old, 8.25%; 50-59 years old, 8.62%; 60-69 years old, 14.14%; 70-79 years old, 14.25%; >80 years old, 16.07%. For the femoral neck group, the values were: 40-49 years old, 5.24%; 50-59 years old, 5.28%; 60-69 years old, 11.17%; 70-79 years old, 17.30%; >80 years old, 24%. The total proportion of osteoporosis in the lumbar vertebrae was 10.08%, and in the femoral neck, 7.45%. The BMD of Taiwanese women shows a positive relationship to body weight and BMI in the femoral neck group but not in the lumbar vertebrae group. The proportion of osteoporosis by age group in this cohort was lower than that among Western women.

Effects of period-free hormone replacement therapy in postmenopausal women in Taiwan.

BACKGROUND: To compare the effects of continuous combined hormone replacement therapy (Kliogest) and placebo on climacteric symptoms, bone turnover markers, serum lipid profiles and the safety of Kliogest. METHODS: This is a 4-month, single-centre, double-blind, placebo-controlled clinical study. Fifty-six healthy volunteer women with intact uterus, between six months and three years after a natural menopause, were recruited and randomised into two groups to have blood and urine laboratory test for assessment of bone resorption marker of deoxypyridinoline, bone formation marker of bone specific alkaline phosphatase, lipid profile including total cholesterol, high-density lipoprotein, low-density lipoprotein and triglyceride, and menopausal symptoms. Information was taken at initial visit and 1, 2 and final follow-up after taking medication. RESULTS: Continuous Kliogest treatment resulted in significant reduction in menopausal symptoms, as scored by Integrated Greene Climacteric Scale and in the psychological, somatic and vasomotor subscales scores (p = 0.009). Kliogest reversed the negative trends in lipoprotein profiles by lowering total cholesterol (p < 0.001), low-density lipoprotein cholesterol (p < 0.001), and triglyceride (p = 0.004), but decreasing high-density lipoprotein cholesterol (p = 0.002). A significant reduction in bone resorption marker, deoxypyridinoline, was also observed in the Kliogest group (p < 0.001). There was no report of serious adverse events, endometrial hyperplasia or cancer in the Kliogest treated patients. CONCLUSIONS: Four-month treatment with Kliogest resulted in an improvement in menopausal symptoms and lipid profiles as well as reduction in bone loss.