A multicenter, randomized, open, controlled trial to evaluate the efficacy of Honglilai Vaginal Cream and Premarin Vaginal Cream for Genitourinary Syndrome of Menopause in different subgroups of Chinese postmenopausal women.

AIM: In a randomized, multicenter, open, controlled trial, we compared the effects of Honglilai Vaginal Cream and Premarin Vaginal Cream in different age subgroups and menopausal year subgroups (trial registration numbers: 02003L00493). METHODS: Postmenopausal women with Genitourinary Syndrome of Menopause (GSM) were divided into Honglilai group (n = 319) and Premarin group (n = 116), while subgroups were divided according to their different characteristics of age and menopausal years. Honglilai Vaginal Cream (0.625 mg/g) or Premarin Vaginal Cream (0.625 mg/g) once daily for 3 weeks. RESULTS: In the subgroup of participates >60 years, there were no significant differences of Vaginal Cell Maturation Index (VMI) between the two groups after treatment (p = .171). In the subgroup of 50-59 years, the VMI of Honglilai group was significantly lower than Premarin group (Honglilai group: 74.37 ± 22.76; Premarin group: 80.06 ± 16.15; p = .02). There were no significant differences of Vaginal symptom scores between Honglilai group and Premarin group in every sub-group (p > .05). CONCLUSIONS: Honglilai Vaginal Cream had comparable efficacy with Premarin Vaginal Cream in Chinese women older than 60 years.

General and Central Obesity Are Associated With Increased Severity of the VMS and Sexual Symptoms of Menopause Among Chinese Women: A Longitudinal Study.

Background: Strong evidence has linked overweight and obesity to increased risks of cardiovascular disease and all-cause mortality in Chinese populations. Menopause is considered associated with increased obesity and central body fat distribution. However, the correlation between obesity and menopausal symptoms has not been well studied. Objective: To examine the associations between obesity or abdominal obesity and menopausal symptoms as women progressed from premenopausal to postmenopausal status. Design: This study included 430 midlife Chinese women who had experienced natural menopause and were followed up for 10 years. Physical examinations and questionnaires should be completed annually. The questionnaires include the Menopause-Specific Quality of Life questionnaire, the Hospital Anxiety and Depression Scale, and other physical and behavioral factors. Results: Among women who were not obese (n=345) or not abdominal obese (n=372) at baseline, 5.8% and 31.7% became obese or abdominal obese at the recent follow-up visit, respectively. Women at the recent follow-up visit had an increased body mass index (BMI) by 0.14%, and the waist-to-hip ratio (WHR) increased by 5.2% compared with the data at baseline. In multivariate analysis, more frequent hot flashes, moderate/severe bothered vasomotor symptoms (VMS), mild bothered sexual functioning, and less anxiety symptoms were significantly associated with obesity. Increasing age, moderate/severe bothered VMS, and less anxiety symptoms were independently associated with abdominal obesity. Multivariable analysis also showed that less education level is independently associated with both obesity and abdominal obesity. Conclusion: Our findings suggest that the proportion of obesity and abdominal obesity increased gradually during menopause. The increase of abdominal obesity is more rapidly than obesity in middle-aged women. Both obesity and abdominal obesity are related with severe or frequent VMS and anxiety symptoms in Chinese women. Although the proportion of obese women in China is lower than in western countries, the problem of abdominal obesity and related complications cannot be ignored.

Menopause-specific quality of life during ovarian aging among Chinese women: A prospective cohort study.

OBJECTIVE: To describe the menopause-specific quality of life of Chinese urban women at midlife. STUDY DESIGN: Prospective cohort study. MAIN OUTCOME MEASURES: This study included 920 natural menopausal midlife Chinese women who were followed up for 10 years. The Menopause-Specific Quality of Life (MENQOL) questionnaire, which has four domains (vasomotor, psychosocial, physical, and sexual functioning symptoms), and other measures of physical and behavioral factors, were administered. Generalized estimating equations were used to assess the associations. RESULTS: The mean MENQOL scores in the four domains were 1.75 ± 1.32, 2.13 ± 1.16, 2.33 ± 1.11, and 2.20 ± 1.83, respectively. The occurrence of vasomotor symptoms (VMS) persisted in >50% of women in the perimenopausal and early postmenopausal stages. However, the prevalence of moderate/severe bothersome VMS was relatively low. More than 75% of the women presented with mild physical or psychological symptoms, whereas less than 5% of them had moderate/severe symptoms. Sexual problems were highly frequent and bothersome, and their occurrence increased with advancing menopausal stage and age. The prevalence of bothersome sexual symptoms and moderate/severe sexual symptoms ranged from 31.89 and 1.58% in premenopausal women to 78.09 and 39.35% in late postmenopausal women, respectively. Menopausal status, depressive symptoms, and poor health status were significantly associated with the four menopausal domains. CONCLUSION: VMS are among the menopausal symptoms most frequently rated as severe. Sexual problems become more prevalent with advancing age. Clinicians should have a broad understanding of changes that occur during the transition to maximize women's health.

Insomnia symptoms in relation to menopause among middle-aged Chinese women: Findings from a longitudinal cohort study.

OBJECTIVE: Our study aims to investigate the differences in insomnia between Chinese and Western women during menopause to fill the gaps in the research on menopause in Chinese women, and to examine the premenopausal factors predictive of moderate to severe insomnia during menopause. STUDY DESIGN: This is a longitudinal cohort study conducted in an urban Chinese community with a total of 458 participants. MAIN OUTCOME MEASURES: Presence of insomnia symptoms (trouble falling asleep, waking up early); vasomotor symptoms; anxiety and depression assessed by the Hospital Anxiety and Depression Scale; and menopausal stages. RESULTS: Multivariable analysis showed that compared with that in premenopause, the prevalence of trouble falling asleep was significantly higher in menopausal transition (P = 0.029) and postmenopause (P < 0.001), and the prevalence of early-morning awakenings also significantly increased in menopausal transition (P = 0.003) and postmenopause (P = 0.011). In multivariable analysis anxiety (P = 0.022) and depression (P = 0.005) were independently and significantly positively associated with trouble falling asleep. Anxiety (P < 0.001), depression (P = 0.018), and levels of follicle stimulating hormone (P-0.031) were independently and significantly positively associated with trouble falling asleep. Women who experienced insomnia in premenopause had a significantly higher risk of moderate to severe insomnia in menopausal transition (P = 0.003) and postmenopause (P = 0.047) than those who did not. CONCLUSION: This study showed that the prevalence of sleep disturbance significantly increased during and after menopause. Women with anxiety and depression had a higher risk of insomnia. Difficulty in sleep initiation in the premenopausal period was a strong predictor of moderate to severe insomnia at menopausal transition and postmenopause.

Relationships Between Vasomotor Symptoms and Mood in Midlife Urban Chinese Women: Observations in a Prospective Study.

CONTEXT: During the menopausal transition, there is a greater likelihood of the prevalence of various bothersome symptoms, including vasomotor symptoms (VMS) and mood symptoms. OBJECTIVE: To investigate the association among bothersome VMS and symptoms of anxiety and depression in Chinese women during perimenopause and early in menopause. DESIGN, PATIENTS, SETTING, AND INTERVENTIONS: This study included 430 midlife Chinese women who had experienced natural menopause and were followed up for 10 years. A structured questionnaire was provided annually, comprising the VMS Bother Score (range 1-8) from the Menopause-Specific Quality of Life questionnaire, the Hospital Anxiety and Depression Scale, and other physical and behavioral factors. RESULTS: Among the 430 women evaluated, 78.8% had experienced VMS during long-term follow-up. The overall level of VMS bother score was relatively low (1.92 ± 1.32). Both anxiety and depressive symptoms were significantly associated with VMS bother. After adjusting for potential covariates, the association between anxiety or depression symptoms and VMS bother remained highly significant. Menopausal stage, body mass index, general health, follicle-stimulating hormone, and estradiol were independent contributors to VMS. In time-lagged (1-year) models, VMS bother scores significantly predicted the risk of symptoms of both anxiety and depression the following year. In contrast, anxiety symptoms, rather than depressive symptoms, could predict VMS bother the following year. CONCLUSION: The prevalence of VMS in our cohort was higher than has been previously reported; however, the overall level of bother was relatively low. This study demonstrated a strong relationship between VMS bother and mood symptoms in Chinese women progressing from perimenopause through natural menopause.

Changes in ultrasound uterine morphology and endometrial thickness during ovarian aging and possible associated factors: findings from a prospective study.

OBJECTIVE: The aim of the study was to provide reference values for sonographic measurements of uterine morphology, quantify changes in uterine morphology across the menopausal transition, and identify possible factors associated with sonographic findings in uterine morphology. METHODS: This is a longitudinal cohort study conducted in middle-aged Chinese women. Using transvaginal ultrasound, we measured morphologic parameters of the uterus (volume and endometrial thickness) under standardized conditions every year for over a decade. RESULTS: Uterine volume begins to decrease before the final menstrual period and declines rapidly thereafter. Compared with a baseline measurement taken in the year of the final menstrual period, uterine volume decreased by 20% and 35% at the first year and second year of postmenopause, respectively. The rate of decrease was slower in the third year. Compared with endometrial thickness in the year of the final menstrual period, the figures for 2 and 3 years before the final menstrual period were 5% and 10% higher, while they decreased by 9% and 18% at the first and second year after the final menstrual period. Similarly, the endometrial thickness became relatively stable 3 years after the final menstrual cycle. These observations were fairly consistent across all women without uterine fibroids. Endometrial thickness was significantly positively associated with body mass index (P = 0.049) after adjusting for time and menopausal stage. CONCLUSIONS: The figures for uterine volume and endometrial thickness decrease around menopause using ultrasound measurments with large reductions in the first and second year after the final menstrual period. A higher body mass index is associated with increased endometrial thickness.

Symptoms of anxiety and depression among Chinese women transitioning through menopause: findings from a prospective community-based cohort study.

OBJECTIVE: To determine the prevalence of symptoms of anxiety and depression in Chinese women during and after menopause, and the associated risk factors. DESIGN: Prospective community-based cohort study. SETTING: An urban community in Beijing, People's Republic of China. PATIENT(S): Four hundred and thirty women who had transitioned through natural menopause. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Symptoms of anxiety and depression. RESULT(S): Symptoms of depression were more common than symptoms of anxiety. The prevalence of symptoms of depression rose from 14.5% during premenopause, to 18.2% during the menopausal transition, and 19.6% in the postmenopause period. The prevalence of symptoms of anxiety rose from 3.1% premenopause, to 7.0% during the menopausal transition, and 7.4% in the postmenopause period. Compared with women in the premenopausal stage, perimenopausal and postmenopausal women were more likely to have symptoms of anxiety and depression, but these differences were not statistically significant. Multivariable analysis showed that poor health status, trouble falling asleep, and early awakening were independently associated with symptoms of anxiety, and that a higher body mass index, poor health, low education status, and night sweats were independently associated with symptoms of depression. CONCLUSION(S): Symptoms of depression were more prevalent than symptoms of anxiety. Our findings suggest that symptoms of anxiety and depression are more common during and after menopause than in premenopausal women. These findings highlight the importance of screening and evaluation of women undergoing the menopausal transition for symptoms of anxiety and depression, especially those with risk factors.

A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule () and Hormone Therapy in Perimenopausal Women.

OBJECTIVE: To evaluate the efficacy and safety of Heyan Kuntai Capsule (, HYKT) and hormone therapy (HT) on perimenopausal syndromes (PMSs). METHODS: From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol (E2) below 30 ng/L, and follicle stimulating hormone (FSH) above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index (KMI) scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life (MENQOL) scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment RESULTS: After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline (P <0.01) and there was no significant difference between groups (P >0.05), except that KMI of HYKT group was higher after 3-month treatment (P <0.05). After treatment, hot flush and insomnia scores were both improved significantly in two groups (P <0.01); and HT had a better performance than HYKT in improving hot flush (P <0.05). MENQOL were significantly improved in both groups after treatment (P <0.01); but there was no significant difference between two groups (P >0.05). The incidence of adverse event in the HYKT group was much lower than that in the HT group (P <0.01). CONCLUSIONS: HYKT could effectively relieve PMSs and improve patients quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.

Clinical characteristics of 138 Chinese female patients with idiopathic hypogonadotropic hypogonadism.

OBJECTIVE: To evaluate the clinical features of Chinese women with idiopathic hypogonadotropic hypogonadism (IHH). METHODS: We retrospectively reviewed the clinical characteristics, laboratory and imaging findings, therapeutic management and fertility outcomes of 138 women with IHH. All patients had been treated and followed up at an academic medical centre during 1990-2016. RESULTS: Among the 138 patients, 82 patients (59.4%) were diagnosed with normosmic IHH and 56 patients (40.6%) were diagnosed with Kallmann syndrome (KS). The patients with IHH experienced occasional menses (4.3%), spontaneous thelarche (45.7%) or spontaneous pubarche (50.7%). Women with thelarche had a higher percentage of pubarche (P < 0.001) and higher gonadotropin concentrations (P < 0.01). Olfactory bulb/sulci abnormalities were found during the magnetic resonance imaging (MRI) of all patients with KS. Most patients with IHH had osteopenia and low bone age. Among the 16 women who received gonadotropin-releasing hormone treatment, ovulation induction or assisted reproductive technology, the clinical pregnancy rate was 81.3% and the live birth rate was 68.8%. CONCLUSIONS: The present study revealed that the phenotypic spectrum of women with IHH is broader than typical primary amenorrhoea with no secondary sexual development, including occasional menses, spontaneous thelarche or pubarche. MRI of the olfactory system can facilitate the diagnosis of KS. Pregnancy can be achieved after receiving appropriate treatment.

Meteorin-Like Shows Unique Expression Pattern in Bone and Its Overexpression Inhibits Osteoblast Differentiation.

The present study was performed to identify and characterize genes involved in osteoblasts function. Firstly, we constructed and sequenced a human osteoblast full-length cDNA library to screen for genes whose functions have not been reported and further identify these candidate genes through detecting the relationship with the activator protein-1 (AP-1) transcription factor complex using a dual luciferase reporter system. Only one gene, namely METRNL (Meteorin, glial cell differentiation regulator-like) has been screened out. We performed immunohistochemistry to analyze expression patterns in bone and established a stable transfection MG63 cell line of METRNL-EGFP fusion protein overexpression to analyze the function of METRNL in mineralized nodule formation. Immunohistochemistry showed METRNL expression in hypertrophic chondrocytes and osteoblasts lining trabecular bone surfaces. Overexpression of METRNL inhibited mineralized nodule formation by the MG63 osteosarcoma cell line. Thus, the identified gene, METRNL, which is associated with AP-1 transcription factor complex activity, has a unique expression pattern in bone. In addition, the anomalous expression of METRNL may inhibit bone cell differentiation.

Comparison of follicle-stimulating hormone, estradiol, ovarian volume, and antral follicle count, based on the Stages of Reproductive Aging Workshop system, among community-based women in China.

OBJECTIVE: This study aims to describe changes in follicle-stimulating hormone (FSH), estradiol (E2), ovarian volume (OV), and antral follicle count (AFC), and to examine their relationships at the same menopause stage, based on the Stages of Reproductive Aging Workshop (STRAW) system, among Chinese women in community settings. METHODS: Prospective longitudinal study design was used to analyze the sex hormone levels, OV, and AFC of 327 community women aged 30 to 65 years. They were followed up at 1 year. RESULTS: Significant differences in FSH, E2, and OV were observed at baseline and on follow-up (all P<0.001). Significant differences in E2 were observed between baseline and follow-up for women in premenopause (-2.743, P=0.006) and late postmenopause (-5.213, P<0.001). There were significant differences in FSH between baseline and follow-up in early menopausal transition (MT) (-2.430, P=0.015) and late MT (-3.737, P<0.001). There were significant differences in OV between baseline and follow-up in late MT (-3.805, P<0.001) and early postmenopause (-4.341, P<0.001). There were significant differences in AFC between baseline and follow-up in premenopause (-2.046, P=0.041). CONCLUSIONS: These results suggest the existence of significant associations between FSH, E2, OV, AFC, and menopause status, supporting the use of the STRAW system among community-based women in China. Further study of the MT is recommended to confirm the appropriateness of the STRAW system for Chinese women.

Pattern of moderate-to-severe symptoms of premenstrual syndrome in a selected hospital in China.

AIM: Premenstrual syndrome (PMS) is a commonly encountered complaint among women. It may affect women's quality of life and reduce their occupational productivity. This study aims to describe the symptoms of moderate-to-severe PMS and to examine the onset, stability, and severity of PMS among Chinese women. METHODS: A descriptive study included 142 women with self-reported PMS, aged 18-45 years, who were recruited by the Outpatient Department of Gynecological Endocrinology, Peking Union Medical College Hospital. Premenstrual symptoms were retrospectively assessed by using screening questionnaires modified with the DSM-IV. In total, 126 eligible subjects were asked to record their daily symptoms during two consecutive menstrual cycles by using a premenstrual syndrome diary (PMSD). RESULTS: Of 126 eligible subjects, 67 filled in the PMSD for two cycles. The median of total scores of PMSD peaked on the day before menses and dropped after the beginning of the menses. Mood swings were the most common moderate-to-severe symptom prospectively reported by the subjects. The symptoms of PMS were relatively consistent across the two cycles. CONCLUSIONS: Women with moderate-to-severe PMS were vulnerable to psychological symptoms. Further studies are needed to understand the correlations between hormonal changes and the experience of symptoms related to the menstrual cycle.

[Evaluation the efficacy and safety of estradiol and drospirenone tablets in the treatment of menopausal symptoms among postmenopausal Chinese healthy women:a randomized, multi-center, double-blind, placebo-controlled clinical study].

OBJECTIVE: To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq) in treatment of menopausal symptoms among postmenopausal Chinese healthy women. METHODS: Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned into estradiol and drospirenone (observation group, n = 183) or placebo group (n = 61) by the ratio of 3:1 for 16 weeks in this randomized multi-center double-blind placebo-controlled study. During the trial, the follow-up visits were conducted at week 4, 8, 12, 16 of treatment and 2 weeks after treatment respectively. Height, weight, vital signs, hot flushes, other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit, while the clinical global impression scale was assessed at 16 weeks as well. RESULTS: It showed that hot flushes were reduced significantly more in observation group than that in placebo group (P < 0.01), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by -0.6 ± 0.5 in observation group and -0.4 ± 0.4 in placebo group from baseline respectively, which reached significant difference (P < 0.05). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by -0.6 ± 0.8 in observation group and -0.3 ± 0.6 in placebo group from baseline respectively, which had no significant difference (P > 0.05). After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P < 0.01). During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48.9% (87/178) in observation group and 10.7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183). The level of serum potassium was in the normal range in observation group mostly.Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related. CONCLUSION: Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmenopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.

Serum lipid profile changes during the menopausal transition in Chinese women: a community-based cohort study.

OBJECTIVE: The aim of this study was to examine the changes in serum lipid profile related to the stages of the menopausal transition as defined by prospective menstrual pattern. METHODS: A total of 593 healthy women aged 35 to 64 years were followed annually for up to 3 years (average, 1.6 y), and 1,549 observations were provided. Blood samples were collected from all participants. Serum total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol, TC/HDL-C, estradiol, and follicle-stimulating hormone were assessed. Menopause status was defined by the menstrual change criteria of the Stages of Reproductive Aging Workshop. RESULTS: After adjusting for age, body mass index, physical activity, and antihypertensive medication use, TC, TG, and TC/HDL-C increased to peak in the late perimenopause (increased by 7.1 mg/dL in TC, 12.3 mg/dL in TG, and 0.19 in TC/HDL-C; all P < 0.05) compared with the premenopause status group. We did not find any statistically significant difference between the premenopause and postmenopause status groups in all lipid profile variables. Among postmenopausal women, only TG decreased by 8.2 mg/dL in the late postmenopause (P < 0.01). In contrast, there is no significant change in HDL-C among the different menopause status groups. CONCLUSIONS: Our data suggest that the menopausal transition instead of menopause per se is associated with serum lipid profile in community-based women in China. Late perimenopause status is significantly associated with accelerated increase in TC, TG, and TC/HDL-C. HDL-C seemed to have no relationship with menopause status.

Evaluating therapeutic effect in symptoms of moderate-to-severe premenstrual syndrome with Vitex agnus castus (BNO 1095) in Chinese women.

OBJECTIVES: To assess therapeutic effect of an extract of Vitex agnus castus (VAC, BNO 1095) in premenstrual syndrome (PMS) in Chinese women. DESIGN: It was a prospective, randomised, double-blind, placebo-controlled study carried out in China. Eligible patients were treated with VAC extract or placebo for three cycles. Symptoms were documented with PMS diary (PMSD), a daily rating scale with 17 items. Main efficacy variable was the reduction percentage of 17 symptom score documented in PMSD during the luteal phase of the third treatment cycle. RESULTS: A total of 67 patients were enrolled and randomly assigned to VAC group or placebo group. Of these, 64 patients completed the study (31 vs. 33). All the 17 symptoms showed a significantly greater improvement with VAC than placebo (P < 0.05) except lower abdominal cramping (P > 0.05). CONCLUSION: Vitex agnus castus is more effective than placebo in the treatment of moderate-to-severe PMS in Chinese women, especially in symptoms of negative effect and insomnia.

Treatment of moderate to severe premenstrual syndrome with Vitex agnus castus (BNO 1095) in Chinese women.

OBJECTIVES: To assess efficacy of the extract of Vitex agnus castus (VAC, BNO 1095) in the treatment of Chinese women suffering from moderate to severe premenstrual syndrome (PMS). METHODS: It was a prospective randomised double-blind placebo-controlled study conducted in Chinese women. Eligible patients were randomly assigned into VAC or placebo group. Symptoms were documented with a daily rating scale with four symptom factors (negative affect, water retention, food cravings and pain). RESULTS: Sixty-seven patients were enrolled and randomly assigned to receive one tablet of VAC or placebo once a day. The premenstrual syndrome diary (PMSD) sum score decreased from 29.38 +/- 7.63 score points at baseline to 4.28 +/- 5.76 at the 3rd cycle in the treatment group, while it decreased from 28.76 +/- 8.23 to 11.79 +/- 11.78 in the placebo group. All the four symptom factor scores were significantly reduced by the 3rd treatment cycle. There was significant difference in PMSD sum score, score of negative affect and water retention between two groups at cycle 3 (P < 0.05). PMSD sum scores decreased 60% was defined as efficacy, and the efficacy rate in treatment group was significantly higher than that in placebo group at the 3rd treatment cycle. CONCLUSION: Vitex agnus castus extract BNO 1095 shows effective in treating moderate to severe PMS in Chinese women, especially in symptoms of negative affect and water retention.

Assess the discrimination of Achilles InSight calcaneus quantitative ultrasound device for osteoporosis in Chinese women: compared with dual energy X-ray absorptiometry measurements.

Since the implementation of quantitative ultrasound (QUS) technology may become a part of future clinical decision making to identify osteoporosis and prevent fractures, this study was initiated to evaluate the correlations of QUS parameters and axial bone mineral density (BMD) using dual energy X-ray absorptiometry (DXA) and to assess the discrimination of QUS measurements for osteoporosis and osteopenia defined by WHO criteria. 106 native Chinese women (aged 50.2±10.9 SD, 21-74 years) were involved. Each subject received both QUS measurements at left calcaneus with Achilles InSight and DXA measurements with DPX-L at lumbar spine (L(2-4)), total hip and femoral neck. Achilles InSight provided the stiffness index (SI) which derived from Broadband Ultrasound Attenuation (BUA) and Speed of Sound (SOS), and the T-scores of SI were calculated. We found that the QUS parameter SI was statistically significant but medium correlated (r=0.458-0.587) with DXA at the lumbar spine, total hip and femoral neck (P<0.0001 for all correlations). With ROC analysis, the area under the ROC curve of diagnosis of osteoporosis and osteopenia were 0.933 and 0.796, respectively. To identify osteoporosis, when the T-score threshold of SI was defined as -1.4, the sensitivity was 100%, and the specificity was 73.7%. Our study confirmed that QUS measurements performed with Achilles InSight were capable to identify osteoporosis defined by axial BMD using DXA in Chinese women.

[Safety of promestriene capsule used in postmenopausal atrophic vaginitis].

OBJECTIVE: To investigate the safety and efficacy of promestriene capsule used in the treatment of postmenopausal atrophic vaginitis. METHODS: Fifty-three women at age of 45 - 75 years (more than one year history of menopause) diagnosed with postmenopausal atrophic vaginitis were enrolled in self-control study. They all had typicalsymptoms of postmenopausal vaginitis. Promestriene was given by continuous therapy for 20 days, then maintenance therapy for for 8 weeks (1 pill two times per week used). The level of follicle stimulation hormone (FSH) and estradiol (E(2)) in serum was and thickness of endometrium were detected before and after treatment. The routine biochemical test was used as index to monitoring the safety. The vaginal mature index (VMI), the atrophic vaginitis evaluating score and vaginal healthy evaluating score were evaluated for therapeutic effect. In the mean time, adverse effect was recorded. RESULTS: (1) SAFETY: during promestriene treatment, no case with adverse effect was observed. Before treatment, the mean level of FSH and E(2) was (71 +/- 3) U/L and (41 +/- 18) pmol/L, the mean thickness of endometrium was (2.4 +/- 0.9) mm. After treatment, the mean level of FSH and E(2) was (67 +/- 22) U/L and (43 +/- 37) pmol/L, the mean thickness of endometrium was (2.5 +/- 1.3) mm. No significant difference was observed (P > 0.05). (2) Therapeutic effect: VMI were 42 +/- 15 before and 54 +/- 8 after treatment. The atrophic vaginitis evaluating score were 3.4 +/- 1.7 before and 1.5 +/- 1.4 after treatment. Vaginal healthy evaluating score were 7.8 +/- 2.4 before and 12.0 +/- 2.4 after treatment. They all showed significant difference (P < 0.01). (3) Adverse effect: six cases with vaginal bleeding, 3 cases with breast nodules and 1 case with cervical polyp was observed, however, it was uncertain whether those events were associated with promestriene use. CONCLUSION: The premestriene capsule was safe and effective in the treatment of postmenopausal atrophic vaginitis.

Effect of estrogen on gene expression of fatty acid synthase in periosteum.

BACKGROUND: Estrogen deficiency contributes to postmenopausal osteoporosis. Periosteum might be a potential target of estrogen, but the underlying mechanism at gene level is far from being elucidated. The objective of this study was to investigate the correlation between estrogen and fatty acid synthase (FAS) expression in periosteum. METHODS: Human periosteum cells were cultured in vitro. Expressed genes in the substrated cDNA library were verified using semi-quantitative PCR and real-time PCR. The expression of FAS in periosteum of ovarectomized (OVX) SD rats was investigated. RESULTS: FAS gene was most significantly expressed in the subtracted cDNA library of periosteal cells screened by semi-quantitative PCR. Low FAS expression was verified by real-time PCR in the estrogen exposed human periosteum rather than in the control. The estradiol levels were (20.81 +/- 12.62) pg/ml, (19.64 +/- 4.35) pg/ml and (13.47 +/- 1.84) pg/ml in the sham group, the control, and the OVX group, respectively. The estradiol levels in the OVX group was significantly lower (P = 0.0386). The FAS gene expression in periosteum in the OVX group, sham group, and control group was 3.09 +/- 1.97, 1.33 +/- 0.47 and 1.51 +/- 1.32, respectively. The gene expression in the OVX group was significantly higher (P = 0.0372). CONCLUSION: Estrogen modulates FAS gene expression in in vitro human perisoteum as well as in in vivo rat periosteum.

Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China.

OBJECTIVES: To investigate the efficacy and safety of VAC BNO 1095 extract in Chinese women suffering from moderate to severe premenstrual syndrome (PMS). METHODS: Prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting three cycles, Eligible patients were randomly assigned into treatment or placebo groups and had treatment with VAC extract or placebo for up to three cycles. Efficacy was assessed using the Chinese version PMS-diary (PMSD) and PMTS. RESULTS: Two hundred and seventeen women were eligible to enter the treatment phase (TP) and were randomly assigned into the treatment group (108) or the placebo group (109), 208 provided the efficacy data (treatment 104, placebo 104), and 202 completed the treatment phase (treatment 101, placebo 101). The mean total PMSD score decreased from 29.23 at baseline (0 cycle) to 6.41 at the termination (3rd cycle) for the treatment group and from 28.14 at baseline (0 cycle) to 12.64 at the termination (3rd cycle) for the placebo group. The total PMSD score of 3rd cycle was significantly lower than the baseline in both groups (p<0.0001). The difference in the mean scores from the baseline to the 3rd cycle in the treatment group (22.71+/-10.33) was significantly lower than the difference in the placebo group (15.50+/-12.94, p<0.0001). Results of PMTS were similar, the total scores for PMTS were significantly lower between the two groups (p<0.01) and within each group (p<0.01). The score was decreased from 26.17+/-4.79 to 9.92+/-9.01 for the treatment group, and from 27.10+/-4.76 to 14.59+/-10.69 for the placebo group. A placebo effect of 50% was found in the present study. No serious adverse event (SAE) occurred in both groups. CONCLUSION: Vitex agnus castus (VAC BNO 1095 corresponding to 40mg herbal drug) is a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to severe PMS.