Effectiveness of vitamin D2 supplementation on high-sensitivity C-reactive protein and other metabolic indices in menopausal Thai women: a randomized-controlled trial.

OBJECTIVE: To investigate the effectiveness of vitamin D2 supplementation with ergocalciferol on high-sensitivity C-reactive protein (hsCRP) level and other cardio-metabolic indices in menopausal Thai women. MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled trial was conducted at the menopause clinic of a university hospital in Thailand from May 2017 to 2018. Participants were 80 postmenopausal women randomly assigned to treatment (N = 40, receiving vitamin D2 40,000 IU/week) or control (N = 40, receiving placebo) for 12 weeks. The primary outcome was hsCRP level, and secondary outcomes were cardio-metabolic profiles and 10-year risk of developing cardiovascular disease using the Framingham risk score. The changes from baseline to week-12 (Δ) of all outcomes were analyzed using a modified intention-to-treat (ITT) population. RESULTS: The vitamin D2 (N = 39) and placebo (N = 37) groups were comparable in all baseline characteristics. The hsCRP level was significantly reduced in the vitamin D2 group (Δ of -0.39 ± 1.30 mg/L, p = .024) but not in the placebo group (Δ of -0.15 ± 1.15 mg/L, p = .521). However, the Δ of hsCRP had no statistical difference between groups; neither did the Δ of other cardio-metabolic parameters. CONCLUSION: In menopausal Thai women, vitamin D2 supplementation with ergocalciferol 40,000 IU/week for 12 weeks can reduce hsCRP level; and the treatment might be superior to placebo. However, the hsCRP levels after 12 weeks between both groups were not statistically different. Clinical Trial Registration: Thai Clinical Trials Registry (TCTR20161216001).

SYNOPSISVitamin D2 supplementation in menopausal Thai women can reduce hsCRP level and might be superior to placebo.

Compliance and health consequences of menopausal hormonal therapy after surgical menopause: A retrospective study in Thailand.

AIM: To study compliance with menopausal hormonal therapy (MHT) until age ≥ 50 year and health consequences after surgical menopause. METHODS: A retrospective cohort study of 1000 consecutive surgically menopausal patients who underwent premenopausal surgery before 50 years of age from benign indications during 1996-2012 was performed. Main outcomes were number in year of MHT compliance and health consequences: hypertension (HT), diabetes mellitus (DM), dyslipidemia (DLP), ischemic heart disease (IHD)/myocardial infarction (MI), venous thromboembolism (VTE), stoke, osteopenia/osteoporosis, cognitive impairment/dementia/Alzheimer's disease (AD) /Parkinsonism and breast/other cancers. The MHT nonuser subgroup served as the control. RESULTS: Of the 1000 patients, 855 cases used MHT. The median overall follow-up time from surgery for 145 MHT nonuser patients, 435 MHT users until age <50 year and 420 MHT users until age ≥50 year was 12.0 years. Compliance until age ≥50 year was only 49.1%. For MHT users, the overall median age of stopping MHT was 47.0 year with a median MHT use of 6.0 year. After age adjustment at the time of follow-up of all subgroups by forward stepwise logistic regression analysis, the only significantly different health consequence was osteopenia (32.4%, 10.6% and 21.4% in the MHT nonusers, users until age <50 year and users until age ≥50 year, respectively [P < 0.001]). Prevalence of breast cancer, colon cancer and other cancers were not different among subgroups. CONCLUSION: The majority of patients used MHT with low compliance until age ≥50 year. In addition, MHT initiation after surgery possibly prevented osteopenia compared with MHT nonusers.

Effect of metformin on cardiovascular risk factors in middle-aged Thai women with metabolic syndrome: A randomized placebo-controlled trial.

AIM: To evaluate the effect of metformin on cardiovascular risk factors in middle-aged Thai women with metabolic syndrome that are in menopausal transition. METHODS: This study was double-blind randomized placebo-controlled trial. Metabolic syndrome was diagnosed using American Heart Association and National Heart, Lung, and Blood Institute criteria. After taking metformin 1700 mg/day for 6 months, cardiovascular risk factors were evaluated at baseline and month-6; the values of which were used to calculate delta (Δ, month-6 minus baseline values). RESULTS: Forty menopausal participants were equally, randomized into either the placebo or metformin group. The two groups had comparable metabolic parameters at baseline, except that the mean triglyceride level was higher in the metformin group than in the placebo group. The significant improvements found only in the metformin group were body mass index, fasting blood glucose, high-sensitivity C-reactive protein and 10-year risk of coronary heart disease (Framingham heart study) (P = 0.0004, P = 0.049, P = 0.035 and P = 0.029); whereas that only in the placebo group was high density lipoprotein cholesterol. However, there was no statistically significant difference in the improvement between the two groups. CONCLUSION: Metformin can improve some parameters of metabolic syndrome in middle-aged Thai women. Metformin is not superior to placebo for the improvement of cardiovascular risk factors.

Prevalence of type 2 diabetes mellitus compared between lean and overweight/obese patients with polycystic ovarian syndrome: a 5-year follow-up study.

PURPOSE: To investigate the prevalence of type 2 diabetes mellitus (T2DM) at the 5-year follow-up after polycystic ovarian syndrome (PCOS) diagnosis compared between lean and overweight/obese groups. METHODS: This retrospective cohort study included 400 prediabetes PCOS women who attended our clinic. Participants were divided into either the lean group (body mass index [BMI]: < 23 kg/m2) or the overweight/obese group (BMI: ≥ 23 kg/m2). Patient demographic, clinical characteristics, metabolic profiles, and laboratory values were collected and compared between groups at baseline and during follow-up for 5 years. RESULTS: At the end of the follow-up, overweight/obese group had a higher risk for developing T2DM than lean group (11.5% vs. 0.5%, p < 0.001). Lean group had a lower incidence of hypertension (3% vs. 38.5%, p < 0.001) and dyslipidemia (35% vs. 53.5%, p < 0.001) than overweight/obese group. The factors found to be independently associated with increased risk for developing T2DM were BMI ≥ 23 kg/m2 (odds ratio [OR]: 1.075, p = 0.047), non-use of oral combined contraceptive pills (OR: 0.312, p = 0.028), and impaired fasting glucose at baseline (OR: 38.167, p < 0.001). CONCLUSIONS: Overweight/obese PCOS patients were found to be at significantly higher risk for developing T2DM than lean PCOS patients. Higher BMI, IFG at baseline, and non-use of oral contraceptive pills found to be independent predictors of T2DM in PCOS.

Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice.

BACKGROUND: Dienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL). To date, there is no data on patient-reported outcomes reflecting the real-world practice in Asia where endometriosis is a relevant health, social and economic burden. This non-interventional, multi-center, prospective study aims to investigate the influence of dienogest on HRQoL. METHODS: Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented. RESULTS: Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by - 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (- 6.2 points mean change) compared to patients with low baseline EAPP severity (- 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months. CONCLUSION: The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated. TRIAL REGISTRATION: Name of registry: Clinical Trials Clinicaltrials.gov registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.

Effect of iron supplementation during early pregnancy on the development of gestational hypertension and pre-eclampsia.

OBJECTIVE: To investigate the association between iron supplementation during early pregnancy and the presence of de novo hypertension after 20 weeks' gestation (either gestational hypertension or pre-eclampsia). STUDY DESIGN: Retrospective cohort study. METHODS: This study retrospectively reviewed the medical records of non-anemic pregnant women who received first antenatal care at the Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand, during the June 2009-December 2010 study period. All included women had blood pressure and urine albumin level data that were recorded at each antenatal visit. The study population was divided into one of the two following groups: iron supplementation starting at gestational age (GA) < 16 weeks (study group) or GA ≥ 16 weeks (control group). A comparison of the proportion of de novo hypertension arising after 20 weeks' gestation was then performed between groups. RESULTS: Four hundred non-anemic pregnant women were included, with 200 patients allocated to each groups. The overall incidence of de novo hypertension after 20 weeks' gestation was 10% (40/400), with significantly higher prevalence in the study group than that in the control group [13.5% (27/200) vs. 6.5% (13/200); relative risk: 2.14, 95%, CI 1.22-3.73; p = 0.008]. None of the women in this study developed anemia at time of delivery. There was no significant difference between groups for GA at delivery, birth weight, or birth asphyxia. CONCLUSION: In our study population, iron supplementation before 16 weeks' GA was significantly associated with increased risk of developing de novo hypertension after 20 weeks' gestation.

Postoperative desogestrel for pelvic endometriosis-related pain: a randomized controlled trial.

OBJECTIVE: To determine the effectiveness of desogestrel for relieving endometriosis-related pain. METHODS: A double-blinded randomized placebo-controlled trial was conducted in 40 patients who had endometriosis with moderate-to-severe dysmenorrhea or chronic pelvic pain undergoing laparoscopic conservative surgery. After surgery, patients were randomized to desogestrel or placebo group. Outcomes included changes in visual analog scale (VAS) of dysmenorrhea, pelvic pain and dyspareunia, patient satisfaction, and adverse effects. RESULTS: Forty patients were randomized to desogestrel group (n = 20) and placebo group (n = 20). At month 6, the desogestrel group had significantly lower median VAS of overall pelvic pain, dysmenorrhea and noncyclic pelvic pain. Comparing with the placebo group, the desogestrel group had greater reduction in VAS of overall pain, dysmenorrhea and pelvic pain, but comparable reduction in VAS of dyspareunia. No patient in the desogestrel group but 4 patients in the placebo group still had moderate-to-severe pelvic pain at 6 months postoperatively. The proportion of patients who rated the treatment as very satisfied was higher in the desogestrel group than in the placebo group. There was no serious adverse event during the study period. CONCLUSIONS: Desogestrel is effective and acceptable for postoperative therapy for patients with moderate-to-severe pain related to endometriosis.

Measures of body adiposity and visceral adiposity index as predictors of metabolic syndrome among Thai women with PCOS.

AIM: To evaluate the relationship between measures of body adiposity and visceral adiposity index (VAI) and risk of metabolic syndrome (MS) and to identify the optimal cut-off points of each measurement in Thai polycystic ovary syndrome (PCOS). METHODS: A cross-sectional study was completed physical examination, fasting plasma glucose, lipid profiles of 399 PCOS and 42 age-matched normal controls. Body mass index (BMI), waist-to-hip ratio (WHR), waist-to-height ratio (WHtR) and VAI were calculated. Associations between different measures and MS were evaluated and the receiver-operating characteristic (ROC) curve was performed to determine appropriate cut-off points for identifying MS. RESULTS: Percentage of MS in PCOS was 24.6%, whereas none MS in controls. Previously recommended cut-off values for body adiposity and VAI were significantly associated with MS. ROC curve analysis of the only PCOS showed newly obtained optimal cut-off points for BMI and VAI of ≥28 kg/m(2) (AUC = 0.90) and >5.6 (AUC = 0.94), respectively. Values found to be more accurate than the original ones. VAI was the best predictor, followed by BMI and WHtR. CONCLUSION: All body adiposity and VAI parameters can predict the risk of MS. Optimal values for Thai PCOS were ≥28 kg/m(2) for BMI, ≥0.85 for WHR, ≥0.5 for WHtR and >5.6 for VAI.

Correlation of clinical and biochemical hyperandrogenism in Thai women with polycystic ovary syndrome.

AIM: The aim of this study was to determine the correlation of clinical hyperandrogenism and biochemical hyperandrogenism (hyperandrogenemia) in Thai women with polycystic ovary syndrome (PCOS). METHODS: This cross-sectional study was conducted at Siriraj Hospital, Thailand. Subjects were 145 women with PCOS who were diagnosed in accordance with the revised Rotterdam 2003 criteria and registered during January to July 2008. Clinical hyperandrogenism was assessed using the modified Ferriman-Gallwey score for hirsutism, the American Academy of Dermatology criteria for severity of acne, and the Ludwig scale for androgenic alopecia and virilization. Biochemical hyperandrogenism was determined from serum concentration of total testosterone (TT), dehydroepiandrosterone sulfate and free testosterone (FT). RESULTS: The participants had a mean age of 25.5 ± 6.5 years and a body mass index of 26.2 ± 6.9 kg/m(2) . The most common presenting symptom was oligomenorrhea or amenorrhea. The most common expression of clinical hyperandrogenism was acne (56.6%). Most of the participants (84.8%) had high serum-FT. There was a statistically significant correlation between clinical and biochemical hyperandrogenism in the following pairs: hirsutism and FT (r = 0.3, P < 0.001); hirsutism and TT (r = 0.26, P < 0.001); and acne and TT (r = 0.26, P = 0.002). The others had little or no correlations. CONCLUSION: Clinical hyperandrogenism is not a good predictor for biochemical hyperandrogenism in Thai women with PCOS. A modified Ferriman-Gallwey score cut-off point of 8 has low sensitivity but high specificity for hyperandrogenemia; therefore, it is useful for the diagnosis but not useful for the exclusion of hyperandrogenemia in Thai women with PCOS.

Ratio of ovarian stroma and total ovarian area by ultrasound in prediction of hyperandrogenemia in reproductive-aged Thai women with polycystic ovary syndrome: a diagnostic test.

AIM: To evaluate the performance of ovarian stromal area to total ovarian area (S/A) ratio for the prediction of biochemical hyperandrogenism in Thai women with polycystic ovary syndrome (PCOS). METHODS: A cross-sectional study was performed in 222 reproductive-aged Thai women with PCOS attending the Gynecologic Endocrinology Unit (GEU), Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital from May 2007 to January 2009. The patients were interviewed for medical history and examined for anthropometry and clinical hyperandrogenism. Venous blood samples were obtained for androgen profiles. An ovarian ultrasonogram was obtained via transvaginal or transrectal ultrasonography. RESULTS: The prevalences of clinical and biochemical hyperandrogenism were 48.6% and 81.1%, respectively. The S/A ratio at a cut-off point of 0.33 had modest predictability for hyperandrogenism, namely, 0.537 area under the receiver-operator curve, 36.6% sensitivity, 72.1% specificity, 83.8% positive predictive value (PPV) and 20.9% negative predictive value (NPV). The combination of clinical hyperandrogenism and S/A ratio improved the predictability for biochemical hyperandrogenism, with sensitivity, specificity, PPV and NPV of 72.1%, 58.1%, 87.8% and 33.3%, respectively. CONCLUSION: The S/A ratio alone is not a good predictor for biochemical hyperandrogenism in Thai PCOS women attending GEU for menstrual dysfunction. The combination of S/A ratio and clinical hyperandrogenism has better performance than the S/A ratio alone to predict biochemical hyperandrogenism.

No association between CYP17 -34T/C polymorphism and insulin resistance in Thai polycystic ovary syndrome.

AIM: To investigate the association of CYP 17 -34T/C polymorphism with insulin resistance (IR) in Thai polycystic ovary syndrome (PCOS). METHODS: A cross-sectional study was performed on 210 Thai women diagnosed with PCOS. Polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) was used to analyze CYP17 polymorphism at -34T/C. Student's t-test was used to compare the mean of normally distributed variables between A1/A1 and A2/X. Chi-squared or Fisher's exact tests and OR were used to analyze the association at P < 0.05. RESULTS: Out of 210 cases, PCR-RFLP was successful in 199. Mean patient age was 24.4 ± 4.7 years, with body mass index 25.2 ± 6.3 kg/m(2) . There were 65 and 134 women in the A1/A1 genotype group and A2/X genotype group, respectively. The A2/X genotype group was statistically significantly younger and had a strong trend toward overweight/obesity compared with the A1/A1 genotype group. The prevalence of IR according to different methods varied from 15.4% to 70.8% and was not different between the two groups. On subgroup analysis, in the overweight/obese PCOS group, the A2/X genotype was not associated with any indices of IR. CONCLUSION: No significant association between CYP17-34T/C polymorphism and IR was found in Thai PCOS women, although the A2/X genotype group was statistically significantly younger than the A1/A1 genotype group.

Summary of the 2023 Thai Menopause Society Clinical Practice Guideline on Menopausal Hormone Therapy.

The Thai Menopause Society is an academic organization consisting of healthcare professionals engaged in menopause medicine. The position statement was first issued in 1994 and updated in 2003 and 2023. Herein, we reviewed the important updates of the 2023 position statement on menopausal hormone therapy (MHT) as an international reference for healthcare professionals in Thailand. An advisory panel of clinicians and research experts in the field of menopause reviewed the recommendation of published International Consensus Statements and updated the evidence using the MEDLINE database through PubMed. The evidence-based information and relevant publications were assessed, and a consensus on recommendations was subsequently achieved using the level of evidence to determine the recommendation strength and evidence quality. MHT remains the most effective treatment for vasomotor symptoms and genitourinary syndromes of menopause even after 20 years. Additionally, it is effective in preventing bone loss and fractures in postmenopausal women. The cardiovascular risk of MHT increased in women who initiated MHT after 60 years of age. Hormone therapy should be individualized following the hormone type, dose, administration route, use duration, and progestogen inclusion. The necessary pretreatment evaluation and appropriate follow-up recommendations were added for improved MHT standard care. The updated 2023 Clinical Practice Guideline on MHT is useful for gynecologists, general physicians, endocrinologists, and other healthcare professionals in treating menopausal women receiving hormone therapy in Thailand.

Causes of primary amenorrhea: a report of 295 cases in Thailand.

AIMS: The aim of this study was to determine the prevalence of etiologic causes of primary amenorrhea in Thailand. METHODS: A retrospective study was performed using 295 complete medical records of women with primary amenorrhea who attended the Gynecologic Endocrinology Clinic, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand from September 1992 to February 2009. RESULTS: The three most common causes of primary amenorrhea were Müllerian agenesis (39.7%), gonadal dysgenesis (35.3%), and hypogonadotropic hypogonadism (9.2%). Amongst 88 cases of gonadal dysgenesis, 59 cases (67.0%) incurred abnormal karyotype including 45X (n=21), mosaic (n=31), and others (n=7). CONCLUSIONS: The present study has currently been the largest case series of primary amenorrhea. Müllerian agenesis is the most prevalent cause in our study, while gonadal dysgenesis is the most common cause in the largest-scale study in the USA. Hence, racial, genetic and environmental factors could play roles in the cause of primary amenorrhea.

Quality of life in Thai women with various types of abnormal uterine bleeding.

OBJECTIVE: To determine the quality of life (QoL) in Thai women with various types of abnormal uterine bleeding (AUB). METHODS: A cross-sectional study was conducted on 353 AUB patients between November 2010 and January 2012. They were grouped according to the duration of symptom: <6 months (acute AUB, n = 122), ≥6 months (chronic AUB, n = 138), and postmenopausal bleeding (PMB, n = 93); and the bleeding pattern: hypermenorrhea (n = 24) and irregular bleeding (n = 236). QoL was determined using the 36-Item Short-Form Health Survey (SF-36) Thai version. RESULTS: The acute AUB and chronic AUB groups had a mean age of 43.84 ± 4.87 and 43.81 ± 6.55 years; they were younger than the PMB group (55.62 ± 7.55 years) (P < 0.001). Medical diseases were more prevalent in the PMB than in the acute and chronic groups (66.7% vs. 27.9% and 35.5%, respectively, P < 0.001). Some subscales of the SF-36 were significantly lower in the women with AUB than in those with normative values, in those with chronic AUB or PMB than in those with acute AUB, and in those with hypermenorrhea rather than in those with irregular bleeding. CONCLUSION: Thai women with any AUB types have a poorer QoL than general Thai women. QoL tends to be poorer in women with symptoms longer than 6 months or with hypermenorrhea.

The effectiveness of desogestrel for endometrial protection in women with abnormal uterine bleeding-ovulatory dysfunction: a non-inferiority randomized controlled trial.

Women with chronic abnormal uterine bleeding-ovulatory dysfunction (AUB-O) are at increased risk of endometrial neoplasia. We conducted a non-inferiority randomized controlled trial to determine the effectiveness of two cyclic-progestin regimens orally administered 10 d/month for 6 months on endometrial protection and menstruation normalization in women with AUB-O. There were 104 premenopausal women with AUB-O randomized to desogestrel (DSG 150 µg/d, n = 50) or medroxyprogesterone acetate (MPA 10 mg/d, n = 54) group. Both groups were comparable in age (44.8 ± 5.7 vs. 42.5 ± 7.1 years), body mass index (24.8 ± 4.7 vs. 24.9 ± 4.7 kg/m2), and AUB characteristics (100% irregular periods). The primary outcome was endometrial response rate (the proportion of patients having complete pseudodecidualization in endometrial biopsies during treatment cycle-1). The secondary outcome was clinical response rate (the proportion of progestin withdrawal bleeding episodes with acceptable bleeding characteristics during treatment cycle-2 to cycle-6). DSG was not inferior to MPA regarding the endometrial protection (endometrial response rate of 78.0% vs. 70.4%, 95% CI of difference - 9.1-24.4%, non-inferiority limit of - 10%), but it was less effective regarding the menstruation normalization (acceptable bleeding rate of 90.0% vs 96.6%, P = 0.016).Clinical trial registration: ClinicalTrials.gov (NCT02103764, date of approval 18 Feb 2014).

Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN.

Several clinical trials in women with endometriosis demonstrated that dienogest reduces endometrial lesions and improves health-related quality of life (HRQoL). To assess HRQoL in dienogest-treated patients in real-world setting, we conducted a prospective, non-interventional study in 6 Asian countries. Women aged ≥18 years with clinical or surgical diagnosis of endometriosis, presence of endometriosis-associated pelvic pain (EAPP) and initiating dienogest therapy were enrolled. The primary objective was to evaluate HRQoL using the Endometriosis Health Profile-30 (EHP-30) questionnaire. The secondary objectives included analysis of EAPP, satisfaction with dienogest, endometriosis symptoms and bleeding patterns. 887 patients started dienogest therapy. Scores for all EHP-30 scales improved with the largest mean changes at month 6 and 24 in scale pain (-28.9 ± 27.5 and - 34 ± 28.4) and control and powerlessness (-23.7 ± 28.2 and - 28.5 ± 26.2). Mean EAPP score change was -4.6 ± 3.0 for both month 6 and 24 assessments. EAPP decrease was similar in surgically and only clinically diagnosed patients. From baseline to month 24, rates of normal bleeding decreased (from 85.8% to 17.5%) while rates of amenorrhea increased (from 3.5% to 70.8%). Majority of patients and physicians were satisfied with dienogest. Over 80% of patients reported symptoms improvement. 39.9% of patients had drug-related treatment-emergent adverse events, including vaginal hemorrhage (10.4%), metrorrhagia (7.3%) and amenorrhea (6.4%). In conclusion, dienogest improves HRQoL and EAPP in the real-world setting in women with either clinical or surgical diagnosis of endometriosis. Dienogest might be a promising first-line treatment option for the long-term management of debilitating endometriosis-associated symptoms.NCT02425462, 24 April 2015.

Clinical responses to the combination of estradiol and drospirenone in symptomatic postmenopausal Thai women.

OBJECTIVES: To investigate the efficacy and tolerability of the oral hormone replacement therapy (HRT) containing 1 mg estradiol (E2) plus 2 mg drospirenone (DRSP) in Thai women with postmenopausal symptoms. MATERIAL AND METHOD: Fifty-five Thai women with postmenopausal symptoms participated in this multicenter, open-label, non-comparative Phase IV study. The primary endpoint was the reduction of hot flushes after 12 weeks of treatment. Secondary endpoints included changes infrequency and intensity of menopausal symptoms as well as safety assessments after 4, 8, and 12 weeks of treatment. RESULTS: Treatment with 1 mg E2 plus 2 mg DRSP reduced the frequency of hot flushes in 94.6% of women at the end of the 12-week treatment period. In 60% of women, the frequency of hot flushes was reduced to 10% or less, compared to baseline findings and 49.1% of women had no remaining hot flushes. Other postmenopausal symptoms such as vaginal dryness, urinary incontinence, dysuria, and dyspareunia improved The most common adverse events were vaginal bleeding or spotting and breast tenderness. CONCLUSION: The oral HRT of 1 mg E2 plus 2 mg DRSP was effective and well tolerated by Thai women suffering from postmenopausal symptoms.

Initial response of endothelial cells to acute stimulation with a lipid component: increase cyclooxygenase activity by induction of COX-2 through activation of tyrosine kinase.

OBJECTIVE: To study the initial response of endothelial cells acutely stimulated with a lipid component in the aspect of cyclooxygenase (COX) function which needed for prostacyclin synthesis, an endogenous antiatherogenic agent secreted from endothelial cells. MATERIAL AND METHOD: 25 hydroxycholesterol (25OHC) was used as a representative lipid component for stimulating human umbilical vein endothelial cell (HUVEC) obtained from umbilical cords of healthy newborns with informed consent of their mothers. HUVEC were treated with 25OHC (0.1, 1 or 10 microgram/mL) at times 6, or 24 h. COX activity was measured from amount of 6-keto-PGF(1 alfa) production in the presence of exogenous arachidonic acids (10 micromolar; 10 min) by enzyme immunoassay. The amount of COX-1 and COX-2 protein were detected by Western blot. Cell viability was assessed by using MTT assay. RESULTS: 25OHC induced COX-2 protein production with increasing the activity of COX enzyme in HUVEC without change in amount of COX-1 protein. The induction of COX-2 or increasing in COX activity depended on concentration of 25OHC and time to exposure which seemed to be inhibited by genistein, a specific tyrosine kinase inhibitor. CONCLUSION: Acute stimulation of HUVEC with 25OHC, an atherosclerotic lipid component, increases the activity of COX by inducing COX-2 expression in a manner that depended on concentration and time. The induction of COX-2 expression might possibly mediated through activation protein tyrosine kinase. These responses may be an initial defensive mechanism of endothelial cells from lipid component attack.

Prevalence of metabolic syndrome in reproductive-aged polycystic ovary syndrome Thai women.

OBJECTIVE: To determine the prevalence of metabolic syndrome (MS) in reproductive-aged polycystic ovary syndrome (PCOS) Thai women. MATERIAL AND METHOD: A Cross sectional study was done at the Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital of 250 PCOS Thai women who were diagnosed using Revised Rotterdam 2003 criteria, and who did not take medications affecting sex hormones or lipid metabolism, and attended the Gynecologic Endocrinology Unit between May 2007 and January 2009. Patents were interviewed and examined for weight, height, waist circumference, and blood pressure. Venous blood sample of each patient was drawn after 12-hour fasting. Prevalence of MS determined using the definitions of National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III), International Diabetes Federation (IDF), and National Heart Lung and Blood Institutes/American Heart Association (NHLBI/AHA). RESULTS: Mean +/- SD of age, body mass index (BMI), and waist circumference (WC) were 25.4 +/- 5.8 years, 26.2 +/- 7.6 kg/M2, and 82.3 +/- 16.3 cm, respectively. Prevalence of MS by the definitions of NCEP ATP III, IDF and NHLBI/AHA was 18.0%, 21.2%, and 21.2%, respectively. Of non-MS women, > 40% already had one to two criteria of IDF definition. Among MS women, 100% had central obesity, 50.9% had high blood pressure, 28.3% had impaired fasting blood glucose, 62.3% had hypertriglyceridemia, and 92.5% had high-density lipoprotein cholesterol < 50 mg/dL. The prevalence of MS increased from 10.3% in women aged < 20 years to 50.0% in those aged > or = 40 years (p of trend = 0.003), and from 0.0% in women with BMI < 23 kg/M2 to 54.5% in those with BMI > or = 30 kg/M2 (p of trend < 0.001). CONCLUSION: The prevalence of MS in reproductive-aged PCOS Thai women was 18.0% by NCEP ATP III and 21.2% by IDF and NHLBI/AHA. The prevalence varies only little with definitions of diagnostic criteria. The prevalence increases with age and body mass index. Slightly more than 40% of the non-MS PCOS Thai women already had one to two criteria of MS.

Vaginal atrophy and sexual dysfunction in current users of systemic postmenopausal hormone therapy.

OBJECTIVE: To determine the prevalence of vaginal atrophy and sexual dysfunction in current users of systemic postmenopausal hormone therapy (pHT). MATERIAL AND METHOD: A cross-sectional study was conducted in 97 current users of pHT at Siriraj Menopause Clinic from 2005 to 2007. Subjective symptoms of vaginal atrophy and sexual dysfunction were assessed by interviewing. Objective signs of vaginal atrophy were assessed using pelvic examination, vaginal pH, and maturation value (MV). RESULTS: The prevalence of vaginal atrophy in current users of systemic pHT determining from patient's symptoms, pelvic examination, vaginal pH, and MV were 44.3%, 15.5%, 21.6% and 8.8%, respectively. The prevalence of sexual dysfunction varied from 48.7% to 71.6% depending on types of dysfunction. There was poor association between the subjective symptoms and signs, and the objective indicators of vaginal atrophy. Among various regimens of pHT, tibolone had the lowest prevalence of subjective atrophic symptoms; estrogen-only pHT had the lowest prevalence of objective atrophic signs; and raloxifene had the highest prevalence of atrophic symptoms and signs, and sexual dysfunction. There was statistically significant association between regimens of pHT and objective indicators for vaginal atrophy (p = 0.004 for pH, and 0.000 for MV). CONCLUSION: Current users of systemic pHT still have vaginal atrophy and sexual dysfunction which relates to regimens of pHT. The prevalence of vaginal atrophy varies depending on the assessment methods. The subjective method gives higher prevalence than the objective one does. Since the subjective symptoms of vaginal atrophy would have more adverse effect on quality of life than the objective signs do, the authors suggest that patients' complaints be used to assess factors affecting vaginal atrophy in further research.