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.

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.

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.

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.

[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.

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.

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.

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.

[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.

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.

Impact of menopause on quality of life in community-based women in China.

OBJECTIVE: To assess the impact of menopause, age, and other factors on quality of life (QOL). DESIGN: Generally healthy women aged 35 to 64 years were recruited from a general community in Beijing, People's Republic of China. An instrument including the Chinese version of the Menopause-Specific Quality of Life Questionnaire was used to obtain data. RESULTS: A gradual decline of QOL was seen from pre- to peri- and postmenopausal women in the same age group. Statistically impaired QOL was associated with the peri- and postmenopausal women in vasomotor and physical domains but only with the postmenopausal women in psychosocial and sexual domains. Early postmenopausal women presented the worse QOL in vasomotor, psychosocial and physical domains. The gradually declining sexual QOL was related to the advance of menopause. Age had a negative impact on QOL in vasomotor and sexual domains. Women who assessed their own health as common (fair) or weak (poor) reported worse QOL than those who decribed themselves as healthy. Women with a higher body mass index reported more vasomotor symptoms. CONCLUSIONS: Menopause might have a negative impact on QOL independent of age in community-based women in China. There seemed to be a potential model of the relationship of menopause status to change in QOL, but this needs supporting evidence from longitudinal studies. The association of QOL with age and other factors also should be considered.

Social and behavior factors related to aged Chinese women with osteoporosis.

BACKGROUND: Women aged >or=65 years are screened routinely for osteoporosis in the developed world and identifying risk factors for osteoporosis should be highlighted in developing countries such as the People's Republic of China. In the present study, possible factors related to the occurrence of primary osteoporosis in aged Chinese women were explored. METHODS: On appointed attendance at a menopausal outpatient clinic, generally healthy Chinese women aged >or=65 years were requested to complete a self-administered questionnaire. Bone mineral density at the left femur region was assessed using dual-energy X-ray absorptiometry, by which subjects were categorized as osteoporotic (group A), osteopenic (group B) or normal (group C). If a prevalent spinal fracture was affirmed, patients in group B were reclassified into group A. Non-conditional logistic regression analysis was applied to the calculate odds ratio (OR) of being in group A against the other two groups in terms of social and behavior factors (including education, past occupation, work quality, marriage status, income, self-rated health status, amount of daily physical activity, cigarette smoking, time watching television, and consumption of milk, soy products and tea). RESULTS: Three hundred and twenty-four participants were eligible (77 in group A, 137 in group B, 110 in group C). There were significant differences in age, height, weight, menopausal age and years since menopause among groups. Compared with subjects with amount of daily physical activity <0.5 h in group A, the OR for women in group C was 0.357 (95% confidence interval (CI) 0.144-0.889) for 0.5-1 h, 0.314 (95% CI 0.126-0.780) for 1-2 h and 0.278 (95% CI 0.080-0.968) for >2 h of daily physical activity. When adjusted for age and weight, however, the difference was not significant. Other factors did not reach statistical significance. CONCLUSION: The development of osteoporosis in aged women was affected by both menopause and aging. The known related factors could help to identify susceptible subjects in aged Chinese women for either further assessment or treatment.

Incidence of osteonecrosis of the jaw in women with postmenopausal osteoporosis in the health outcomes and reduced incidence with zoledronic acid once yearly pivotal fracture trial.

BACKGROUND: The authors determined incidence of osteonecrosis of the jaw (ONJ) in a large, prospective three-year clinical trial of zoledronic acid in women with postmenopausal osteoporosis (PMO). METHODS: A total of 7,714 women with PMO received intravenous zoledronic acid 5 mg or a placebo. No spontaneous reports of ONJ were received. An independent, blinded adjudication committee searched the trial's adverse event database by using 60 terms. On an ongoing basis, the committee reviewed the identified events, and it defined ONJ as exposed bone in the maxillofacial area with delayed healing for more than six weeks despite appropriate care. RESULTS: One participant who received a placebo and one participant who received zoledronic acid experienced delayed healing associated with infection. Both conditions resolved after antibiotic therapy, débridement or both. CONCLUSION: The occurrence of ONJ is rare in a PMO population, and delayed healing of lesions can occur with and without bisphosphonate use over three years. CLINICAL IMPLICATIONS: The low incidence of ONJ must be assessed in the context of the clinical benefit of zoledronic acid therapy in reducing hip, vertebral and nonvertebral fractures in this at-risk population. There is no evidence to suggest that healthy patients with osteoporosis who are receiving bisphosphonates require any special treatment beyond routine dental care or to support altering standard treatment practices.

A potential mechanism of breakthrough bleeding associated with progestin: involvement in alteration of endometrial endothelial cells.

OBJECTIVE: To explore the potential mechanism of breakthrough bleeding associated with progestin with in vitro methods. METHODS: The isolation and culture of human endometrial endothelial cells (HEECs) was performed with the method established in our laboratory. The content and activity of urokinase-type plasminogen activator (uPA) and the content of plasminogen activator inhibitor-1 (PAI-1) in cell supernatants after incubated with different concentrations of progesterone (0-5 micromol/L) and 17beta-estradiol (0, 0.1, or 1 nmol/L) were measured by method of ELISA. Apoptosis rate of HEECs was measured by flow cytometry. Viable cell count was measured by MTT. RESULTS: The increased level of progesterone (0.5-5 micromol/L) combined with 17beta-estradiol elevated content and activity of uPA while the production of PAI-1 remained unchanged. The apoptosis of HEECs was inhibited along with the increment of total viable cell counts at higher concentrations of progesterone with 17beta-estradiol. CONCLUSION: The inhibition of apoptosis and increased content and activity of uPA may contribute to the occurrence of irregular bleeding associated with progestin use to some extent

Genistein inhibits proliferation of human endometrial endothelial cell in vitro.

OBJECTIVE: To explore the effect of genistein on proliferation of human endometrial endothelial cells (HEECs) and glandular epithelium. METHODS: In vitro HEECs and human endometrial cancer-1B cell (HEC-1B) were cultured with 0, 1, 10, 50, 100, and 200 micromol/L of genistein alone or indicated concentrations of genistein combined with 0.2 or 1 nmol/L 17beta-estradiol (17beta-E2). Cell proliferation was determined by [3H]-thymidine incorporation and cell cycle was measured by flow cytometry. RESULTS: After 96 hours of treatment, genistein inhibited the proliferation of HEECs in a dose-dependent manner. The stimulation index reduced from 100% (without genistein treatment) to about 1% (200 micromol/L genistein). HEECs were arrested at G1/0 and G2/M phase when treated with genistein for 96 hours. When the concentration of genistein was 200 micromol/L, the percentages of HEECs at G1/0, G2/M, and S phase were 96.0%, 2.1%, and 1.9%, respectively. However, when HEECs were treated without genistein, the percentages of HEECs at G1/0, G2/M, and S phase were 76.7%, 8.5%, and 14.7%, respectively. 17beta-E2 could not influence the effects of genistein on the proliferation of HEECs. Meanwhile, genistein could suppress the proliferation of HEC-1B. If the stimulation index of HEC-1B was defined as 100% when HEC-1B was treated with different doses of 17beta-E2 (without genistein), it was 67%, 19%, as well as 32% when cell was supplemented with 200 micromol/L genistein combined with 0, 0.2, or 1 nmol/L 17beta-E2, respectively. CONCLUSION: Genistein at the concentration of 200 micromol/L can sufficiently inhibit the proliferation of HEECs and endometrial glandular epithelium simultaneously in vitro.

[Cost-effectiveness analysis of two therapeutic methods for prolactinoma].

OBJECTIVE: To evaluate the therapeutic responses to transsphenoidal surgery and medical therapy in terms of normalization of prolactin (PRL), mortality, morbidity and the cost-effectiveness of PRL normalization in order to establish an individualized therapeutic protocol for the patients with prolactinoma. METHODS: A retrospective study was undertaken of a consecutive series of patients with prolactinoma who were followed for at least 1 year after transsphenoidal surgery or medical treatment. The clinical characteristics and the long-term outcomes (normalization of PRL, morbidity or mortality) were assessed. Utilizing the principle of medical economics and data from the two types of treatment, we worked out a Markov chain and calculated the lowest cost of two kinds of therapeutic protocols. RESULTS: (1) The success rate of normalizing serum PRL through surgical treatment in microadenoma was 85% (22/26), and that of medical treatment was 95% (19/20). There was no statistical difference between the two therapies (P > 0.05). The success rate of normalizing serum PRL through surgical treatment in macroadenoma was 45% (19/42), and that of medical treatment was 5/5. There was a statistical difference between the two therapies (P < 0.05). (2) According to the Markov model, it would cost a microprolactinoma patient 25,129.25 yuan to normalize serum PRL by surgical treatment. This is comparable to the cost of medical treatment which would be 24,943.99 yuan. Whereas for a macroprolactinoma patient surgery would cost 35,208.20 yuan and medical treatment would cost 25,344.38 yuan. CONCLUSIONS: Medical therapy is superior to surgical treatment in regard to complication rate and cost-effectiveness for macro- and extra big prolactinomas. Transsphenoidal surgery remains an option for patients with microadenomas. Markov model is an effective way to predict the treatment cost for patients with hyperprolactinoma at different ages and with different causes.

[Effect of age on body composition in healthy Beijing women].

OBJECTIVE: To observe the effect of age and menstrual status on body composition in healthy Beijing women. METHODS: We measured body composition with dual-energy X-ray (GE Lunar Prodigy) in 316 healthy Beijing females aged 20 to 74 years (5-7 cases per age). Parameters provided by the software were as following: total body bone mineral content, lean mass, fat mass and fat percentage (%fat). Local regions measured included arm, leg, trunk, android region and gynoid region. Body mass index (BMI), fat mass index (FMI), free fat mass index (FFMI) and A/G were calculated. Volunteers were assigned to 6 groups according age by every ten years a group. RESULTS: BMC peaked during the 4th decade, LM peaked during the 5th decade, with a decline of 18.1% and 5.2% respectively at age 74 years. Total body fat mass and %fat showed a general increase with aging throughout the studied age range. Total body fat mass increased from 16+/-5 kg at age 20-29 years to 24+/-6 kg at age 70-74 years, while %fat increased from 31.3% to 39.5%. All local region %fat increased with aging at different extents. Android region %fat showed the largest raise extent (32.2%). BMI increased gradually from 21.1 kg/m2 at age 20-29 years to 26.1 kg/m2 at age 70-74 years. FMI changed more obviously than FFMI. A/G increased from 0.85 at age 20-29 years to 1.02 at age 70-74 years. Different menstrual status in women of 40-59 years had obvious effect on A/G and BMC (P<0.05), while it had no significant effect on BMI, body weight and waist circumference (P>0.05). CONCLUSIONS: Aging and menstrual status have evident effect on body composition distribution in healthy Beijing women.

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.