Effects and safety of Pueraria mirifica on lipid profiles and biochemical markers of bone turnover rates in healthy postmenopausal women.

OBJECTIVE: To evaluate the effect of Pueraria mirifica on lipid profiles and biochemical markers of bone turnover rates in healthy postmenopausal women and to evaluate the safety of Pueraria mirifica on endometrium; breast tissue; and hematologic, hepatic, and renal systems. DESIGN: This was a randomized, double-blind, placebo-controlled study in a university hospital of healthy postmenopausal women aged 45 to 60 years old. Women were enrolled voluntarily and randomly received 20, 30, or 50 mg Pueraria mirifica in capsules or identical placebo once daily for 24 weeks. Outcome measures were lipid profiles, bone-specific alkaline phosphatase level, endometrial thickness, endometrial histology, breast ultrasonography, complete blood count, liver function test, and renal function test. RESULTS: After 24 weeks of treatment, 71 women were evaluated. Of the 71 women, 51 randomly received varying doses of Pueraria mirifica and 20 received placebo. Pueraria mirifica and placebo significantly increased triglyceride levels by 15% from baseline levels (P<0.05). The Pueraria mirifica group showed a significant decrease in bone-specific alkaline phosphatase levels after 24 weeks of treatment compared with the placebo group; from 0.22+/-0.18 U/L to 0.13+/-0.01 U/L in the Pueraria mirifica group and from 0.20+/-0.10 U/L to 0.20+/-0.14 U/L in the placebo group. Endometrial thickness did not change after treatment in both groups (P>0.05). No endometrial proliferation or hyperplasia was reported after 24 weeks of treatment in both groups. There were no significant differences in adverse effects on breast tissue, complete blood count, and liver and renal function tests between the Pueraria mirifica and placebo groups in this study. CONCLUSION: Pueraria mirifica at a dose of 20, 30, and 50 mg/d for a 24-week period demonstrated an estrogen-like effect on bone turnover rate. Pueraria mirifica did not demonstrate an estrogen-like effect on endometrial thickness and endometrial histology. Mild adverse effects occurred after Pueraria mirifica and placebo treatment.

Effect of Pueraria mirifica on vaginal health.

OBJECTIVE: To evaluate the effect of Pueraria mirifica on vaginal symptoms, vaginal health index, vaginal pH, and vaginal cytology in healthy postmenopausal women. DESIGN: A randomized, double-blind, placebo-controlled study. Healthy postmenopausal women, age 45 to 60 years old, were enrolled voluntarily and randomly received 20, 30, or 50 mg of Pueraria mirifica in capsules or placebo in identical capsules once daily for 24 weeks. RESULTS: After 24 weeks of treatment, 71 women were evaluated. Fifty-one of 71 randomly received one of the three doses of Pueraria mirifica, and the remaining 20 received placebo. The mean vaginal dryness symptom in the Pueraria mirifica group decreased after 12 weeks of treatment. Pueraria mirifica increased vaginal maturation index (parabasal:intermediate:superficial cells) from 46:43:11 to 11:65:24 after 24 weeks of treatment. There was no significant difference of adverse effects between the Pueraria mirifica and placebo groups in this study. CONCLUSIONS: Pueraria mirifica was proven to exhibit estrogenicity on vaginal tissue, to alleviate vaginal dryness symptoms and dyspareunia, to improve signs of vaginal atrophy, and to restore the atrophic vaginal epithelium in healthy postmenopausal women.

Transvaginal color Doppler sonographic assessment of uterus and ovaries in postmenopausal women: the effect of local estrogen treatment.

OBJECTIVE: The objective was to evaluate the effect of local estrogen treatment on the uterus and ovaries using transvaginal color Doppler sonography. MATERIALS AND METHODS: A 12-week randomized open-label study of postmenopausal women taking local estrogen treatment and controls was conducted. The study group was treated with either a 25-mum estradiol vaginal tablet or 1g of conjugated estrogen cream intravaginally each day for 2 weeks followed by twice a week for 10 weeks. The control group did not receive any type of hormone replacement therapy. All women underwent transvaginal ultrasonography and color Doppler imaging of the uterine arteries both before starting local estrogen treatment and after treatment. The uterine volume, ovarian volume, endometrial thickness, and uterine arterial blood flow of the two groups were evaluated. Statistical analysis was performed using paired and unpaired Student's t-test. A p value of <0.05 was considered statistically significant. RESULTS: Of the 53 postmenopausal women recruited to this study, 26 women received local estrogen treatment for treatment of urogenital symptoms and 27 untreated women constituted the control group. The mean age was 54.85+/-5.51 years. The uterine and ovarian volumes were not significantly different before and after treatment in either of the groups. The endometrial thickness did not change in the local estrogen treatment group (4.00+/-1.60 and 4.30+/-1.20mm) or in the control group (3.90+/-1.40 and 3.70+/-1.50mm). The mean resistance indices in the local estrogen treatment group before and after treatment (1.01+/-0.10 and 0.96+/-0.10) were not significantly different from those of the control group (0.96+/-0.15 and 0.97+/-0.10). The mean pulsatility index after 12 weeks of treatment was lower than before treatment, although not statistically significantly (3.69+/-1.32 and 4.27+/-1.49; p>0.05), and the mean pulsatility indices did not differ between the study and the control groups. CONCLUSION: The volumes of the uterus and the ovaries, including endometrial thickness, were not affected and did not show any significant influence of the 12-week local estrogen treatment. The uterine arterial blood flow did not significantly change after treatment.

Transvaginal Doppler sonography: is there a role for this modality in the evaluation of women with postmenopausal bleeding?

OBJECTIVE: The aim of this study was to determine whether transvaginal sonography (TVS) and transvaginal Doppler sonography (TDS) can discriminate between normal and abnormal endometrium. MATERIALS AND METHODS: Patients who had vaginal bleeding an year after menopause and were not on HRT or tamoxifen were preoperatively examined by TVS and TDS on the same day of curettage. The endometrial thickness as well as the pulsatility index (PI) and resistance index (RI) of uterine arteries were recorded. RESULTS: Final pathology analysis revealed that 55/81 (67.9%) had normal endometrial tissue and 26/81 (32.1%) had an abnormality (endometrial hyperplasia, polyp or cancer). The mean endometrial thickness was greater in the abnormal group (9.4 mm versus 3.8 mm, P < 0.05). The mean PI of normal and abnormal endometrium were 2.85 and 1.53. The mean RI of normal and abnormal endometrium were 1.04 and 0.68. Univariate analysis found that PI < 2 and RI < 0.9 were correlated with abnormal endometrium (P < 0.05). Multivariate analysis revealed significance only for the endometrial thickness. CONCLUSIONS: TDS cannot distinguish between normal and abnormal endometrium. Using TVS only would result in a significant reduction of endometrial biopsy or curettage.

Effect of estradiol valerate and levonorgestrel on vaginal health.

OBJECTIVES: To evaluate the effect of the combined hormone replacement therapy (HRT) estradiol valerate/levonorgestrel on vaginal symptoms, vaginal health index, vaginal pH, and vaginal cytology. STUDY DESIGN: A prospective, open-label study involving 32 postmenopausal women was performed in Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. All the subjects received sequential oral estrogen-progestogen hormone replacement therapy, which contains 2 mg estradiol valerate and 0.15 mg levonorgestrel, for 6 months. The results in terms of vaginal health index, vaginal pH, and vaginal cytology before and after treatment were analyzed. RESULTS: The mean age of these postmenopausal women was 52.56 +/- 3.33 years (range: 46-60 years). The mean time since the last menstrual period was 3.41 +/- 2.95 years (range: 1-15 years). The vaginal health index, which indicates vaginal health by means of scores for vaginal moistness, vaginal fluid volume, vaginal elasticity, vaginal mucosa, and vaginal pH rose significantly in all the women. The mean vaginal pH became significantly lower. The vaginal cytology showed an estrogenic effect on the karyopyknotic index (KPI) and the maturation value (MV) after 3 and 6 months of treatment. CONCLUSION: During estradiol valerate and levonorgestrel treatment, there were demonstrable improvements in the objective signs of vaginal atrophy: atrophic vaginal epithelium became thicker and vaginal pH lower, and the morphology of the vaginal cells was better.

Alleviation of the climacteric symptoms with oral sequential hormone replacement therapy.

The efficacy of the oral hormone replacement therapy (HRT) preparation estradiol valerate/levonorgestrel (EV/LNG, Klimonorm) in the alleviation of the menopausal complaints of peri- and postmenopausal Thai women was studied in a prospective, open, uncontrolled phase IV clinical trial. Of the 50 peri- or postmenopausal women screened, 39 completed the study. From them 31 were postmenopausal and 8 perimenopausal. The participants received EV/LNG over a period of 6 cycles. The Menopause Rating Scale II (MRS II) was used to assess the effect of EV/LNG on the menopausal symptoms. The changes in the main parameters of the MRS II during the treatment with EV/LNG showed that the general score decreased by 34.9 per cent after 3 months and was kept at the same value after 6 months of treatment. The somato-vegetative complaints decreased by 32.5 per cent after 3 months and by 35 per cent after 6 months. The psychological complaints decreased by 34.1 per cent after 3 months and by 32.9 per cent after 6 months. The urogenital complaints decreased by 29.3 per cent after 3 months, and remained at the same level after 6 months of treatment. In conclusion, the 6-months administration of the oral HRT preparation estradiol valerate/levonorgestrel caused a considerable alleviation of the climacteric symptoms in menopausal women.

Lower urinary tract symptoms in Thai women attending the menopause clinic: prevalence and associated factors.

OBJECTIVE: To determine the prevalence of lower urinary tract symptoms and associated factors in women attending the menopause clinic. METHOD: Nine hundred and fifty-six women attending the menopause clinic, Ramathibodi Hospital were interviewed regarding their general health issues and lower urinary tract symptoms by means of an anonymous questionnaire. Demographic data, obstetric history, and underlying diseases were analysed by using Student t-test, Chi-square and Fisher exact test. P < 0.05 was considered as a level of significance. RESULTS: A total of 956 women, mean age 52.89 +/- 5.80 years, completed the questionnaire. The prevalence of stress incontinence, nocturia, urgency, frequency, and urge incontinence were 58.3%, 40.3%, 33.9%, 22.7%, and 6.6%, respectively. Lower urinary tract symptoms was found to be associated with marital status, coexisting medical diseases, menopausal status, previous term delivery, and vaginal delivery (P < 0.05). CONCLUSIONS: Lower urinary tract symptoms was a common problem among women attending the menopause clinic. Marital status, coexisting medical diseases, menopausal status, parity, and mode of delivery were associated with this problem.

Effect of combined oral estrogen/progestogen preparation (Kliogest) on bone mineral density, plasma lipids and postmenopausal symptoms in HRT-naïve Thai women.

BACKGROUND: Kliogest is commonly prescribed for the relief of acute postmenopausal symptoms and prevention of postmenopausal bone loss. However, there have been few data on its effect in Asian women. METHODS: This 1-year, single-center, randomized, double-blind and placebo-controlled study evaluated the efficacy and safety of Kliogest in hormone replacement therapy (HRT)-naïve Thai women. The subjects were 120 healthy Thai women aged between 45 and 65 years, with intact uterus, and who had been amenorrheic for at least 1 year. RESULTS: Kliogest increased spine (+ 6%, p < 0.01) and hip (+2%, p < 0.01) bone mineral density (BMD), and lowered plasma total cholesterol (TC) (-16%, p < 0.05) and low density lipoprotein cholesterol (LDL-C) (-16%, p < 0.05) concentrations. However, Kliogest also resulted in a decrease in high density lipoprotein cholesterol (HDL-C) concentration (-18%, p < 0.05). Compared to placebo, the reduction in menopausal symptoms by Kliogest was not statistically significant. The frequency and severity of treatment-related uterine bleeding decreased with the duration of Kliogest treatment. Furthermore, there was a fairly strong relationship between the change in serum estrone concentration and the average monthly weighted bleeding scores over the first 6 months (Spearman's correlation r = 0.54; p < 0.001), which became weaker over the entire treatment period (Spearman's correlation r = 0.27; p < 0.01). Although there was a small to moderate relationship between baseline estrone concentration and both lumbar (r = 0.23, p < 0.02) and hip (r = 0.20, p < 0.05) BMD, there was no significant relationship between Kliogest-induced change in estrone concentration and change in lumbar and hip BMD. CONCLUSIONS: Continuous treatment with Kliogest for 1 year reversed the potential postmenopausal bone loss in HRT-naïve Thai postmenopausal women. However, its effect on cardiovascular risk is uncertain. Furthermore, Kliogest is safe but appears to have no significant effect on climacteric symptoms in the patients in the present study.