Evaluation of clinical, ultrasonographic and hysteroscopic parameters in the differentiation of endometrial polyps and cancer of endometrium

Study Objective: To evaluate the diagnostic accuracy of transvaginal ultrasound and office hysteroscopy in the differentiation between endometrial polyps and endometrial adenocarcinoma. Design: This is a prospective 100 women longitudinal study, 24 to 80 years, submitted to hysteroscopic polypectomy (n = 80) or surgery due to endometrial adenocarcinoma (n = 20), from january 2010 to December 2011. Clinical, ultrasonographic and hysteroscopic parameters were analyzed and compared with histopathologic find. Statistical analysis were performed utilizing the Tukey, Kruskal-Wallis, Dunn and Mann-Whitney test, with a confidence interval of 95% and p\0, 05 statiscally significant. Setting: Botucatu Medical School. Intervention: Prospective analysis of clinical, ultrasonographic and hysteroscopic parameters in patients with diagnosis suspected of endometrial polyps and adenocarcinoma of endometrium were performed. According to the diagnosis, hysteroscopic polypectomy or pan hysterectomy with lymph node sampling was realized. After the surgery and histopathological study, statistical analysis of parameters was performed and the results were compared between groups. It was Research Ethics Committee approved. Measurements and Main Results: There were no differences between age, BMI, menopause, TH use and associated diseases among groups. The main symptom of endometrial cancer was the postmenopausal bleeding, affecting 84,2% of women against 34,8% of polypectomy group. The majority of women with endometrial polyps were asymptomatic. Transvaginal ultrasonography showed no ability to differentiate cases of endometrial cancer compared with the cases of endometrial polyps, considering the presence of endometrial thickness and blood flow on color Doppler. Office hysteroscopy showed significant changes in 75% of the adenocarcinoma cases, especially the presence of diffuse hypervascularity with atypical vessels. Conclusion: Still remains an inability to establish clinical parameters and reliable ultrasound imaging to differentiate endometrial polyps and cancer of endometrium. Attention should be given to hysteroscopic exams presenting diffuse endometrial hypervascularization with architectural distortion of the vessels. The recommendation of our service remains the systematic removal of all endometrial polyps.

Endometrial and vaginal effects of low-dose estradiol delivered by vaginal ring or vaginal tablet

Aims The major aims of the study were to compare the safety of a continuous low-dose estradiol-releasing vaginal ring (ESTring) to that of a vaginal estradiol tablet (Vagifem®) on the endometrium and the relief of subjective symptoms and signs of urogenital estrogen deficiency. Quality of life and acceptability of treatment delivery were also assessed. Study design A prospective, randomized study in which women were assigned in a 2: 1 ratio to ESTring and Vagifem and followed for 12 months. The primary endpoint was endometrial safety, based on the results of ultrasound measurement of endometrial thickness and a progestogen challenge test at baseline and week 48. Efficacy was determined by subjective assessment of urogenital estrogen deficiency symptoms at baseline and weeks 3, 12, 24, 36 and 48 and assessment of signs of vaginal epithelial atrophy by the clinician at baseline, 12 and 48 weeks. In addition, pelvic floor strength, vaginal cytological evaluation and pH, bacteruria and patient acceptability were assessed. Quality of life was assessed using a menopause-specific quality-of-life questionnire and a 2-day bladder diary at baseline and 12 and 48 weeks. The comparability of the two groups was assessed using ANOVA, χ(2) or Fisher's exact tests. Results A total of 126 women were randomized to ESTring and 59 to Vagifem. There was no statistical difference between the groups in the alleviation of symptoms and signs of urogenital estrogen deficiency. Maturation indices increased in both groups, from generally atrophic at baseline to proliferative or highly proliferative at 48 weeks. After 48 weeks of treatment, there was no statistically significant difference in endometrial thickness between the two groups. A statistically smaller proportion of bleeding/spotting occurred in the ESTring group (n = 0) compared to the Vagifem users (n = 4). Estradiol and total estrone serum levels increased during treatment in both groups but remained within the normal postmenopausal range. General health status in both groups was unchanged but the urogenital component of health burden was significantly improved in both groups. Bladder diary variables showed no differences between treatment groups. Conclusion Equivalent endometrial safety and efficacy in the relief of the symptoms and signs of urogenital estrogen deficiency were demonstrated for the 12 months' use of a low-dose estradiol-releasing vaginal ring and a vaginal estradiol tablet.

Consumption of a Flaxseed-Rich Food Is Not More Effective Than a Placebo in Alleviating the Climacteric Symptoms of Postmenopausal Women

Our objective in this work was to test the effects of daily intake of bread produced with partially defatted ground flaxseed on the climacteric symptoms and endometrial thickness of postmenopausal women. A double-blind, placebo-controlled, randomized clinical trial was performed with 38 women who had been postmenopausal for 1-10 y and consumed 2 slices of bread containing 25 g of flaxseed (46 mg lignans) or wheat bran (<1 mg lignans; control) every day for 12 consecutive weeks. The outcome variables were the daily number of hot flashes, the Kupperman Menopausal Index (KMI), and endometrial thickness. The plasma lipid profile (total cholesterol and HDL, LDL, and VLDL cholesterol fractions and triglycerides) and the hormones estradiol, follicle-stimulating hormone, thyroid-stimulating hormone, and free thyroxine also were measured. Food intake was evaluated by means of 2 24-hrecalls, before and after the treatment. Twenty patients in the study group and 18 in the control group completed the study. The general characteristics did not differ between the 2 groups at the start of the study. Both had significant, but similar, reductions in hot flashes and KMI after 3 mo of treatment. Moreover, endometrial thickness was not affected in either group. Our findings clearly show that although flaxseed is safe, its consumption at this level (46 mg lignans/d) is no more effective than placebo for reducing hot flashes and KMI. J. Nutr. 140: 293-297, 2010.

Raloxifene therapy does not affect uterine blood flow in postmenopausal women: a transvaginal Doppler study

AZEVEDO, George Dantas de et al. Raloxifene therapy does not affect uterine blood flow in postmenopausal women: a transvaginal Doppler study. Maturitas, Amsterdam, v.47, n.3, p.195-200, 2004

Efficacy and safety of a soy isoflavone extract in postmenopausal women: A randomized, double-blind, and placebo-controlled study

Objective: To investigate the efficacy of soy isoflavone on climacteric symptoms in postmenopausal women.Design: In this double-blind, randomized, placebo-controlled study, a total of 80 women (mean age =55.1 years), who reported 5 or more hot flush episodes per day, were randomized to receive either 250 mg of standardized soy extract (Glycine max AT) a total of 100 mg/day of isoflavone (n=40) or placebo (n=40). Exclusion criteria included: contra-indication for hormone therapy (HT), chronic gastrointestinal diseases, and users of HT within the preceding 6-months. For 10-months, climacteric symptoms were evaluated using a score card and the menopausal Kupperman index. Compliance and safety were also assessed. At baseline and the end of the study, lipid and hormonal profiles, as well as vaginal, mammographic and ultrasonographic parameters were measured. The t-test, Wilcoxon test and ANOVA were used in the statistical analysis.Results: At baseline, the mean number of hot flushes was 9.6 +/- 3.9 per day in the isoflavone group and 10.1 +/- 4.9 in the placebo group (p>0.05). After 10 months, there was a significant reduction in frequency of hot flushes among isoflavone users when compared to those on placebo (3.1 +/- 2.3 and 5.9 +/- 4.3, respectively) (p<0.001). Kupperman index mean values showed a significant reduction in both groups. However, soy isoflavone was significantly superior to placebo, in reducing hot flush severity (69.9% and 33.7%, respectively) (p<0.001). Endometrial thickness, mammography, vaginal cytology, lipids and hormonal profile did not change in both groups. No serious adverse event related to isoflavone treatment was reported.Conclusions: the soy isoflavone extract exerted favorable effects on vasomotor symptoms and good compliance, providing a safe and effective alternative therapeutic for postmenopausal women. (C) 2007 Elsevier B.V.. All rights reserved.

Reproductive tract development and puberty in two lines of Nellore heifers selected for postweaning weight

The objective was to evaluate reproductive tract development (ovary and uterus) and onset of puberty in two lines of Nellore heifers (Bos indicus) selected for postweaning weight. A total of 123 heifers, including 46 from the control Nellore line (NeC) and 77 from the selection Nellore line (NeS) were used. Every 18 to 21 days from 12 to 24 months of age, average ovarian area (OVA), endometrial thickness (ETh), and diameter of the largest follicle in each ovary were evaluated (using transrectal ultrasonography), and body weight, hip height, and body condition score were measured. There were no differences between NeS and NeC heifers for ETh or OVA (P < 0.05). Genetic selection for higher postweaning weight had no negative influence on the onset of puberty, with 52% and 48% of NeC and NeS heifers, respectively, pubertal at 24 months of age (P = 0.49). Heifers that reached puberty at the end of the study were heavier (NeC, 296.9 vs. 276.7 kg; NeS, 343.5 vs. 327.9 kg; P < 0.01) and younger (NeC, 23.4 vs. 24.2 mo; NeS, 22.7 vs. 24.0 months; P < 0.01) than those that did not. Furthermore, heifers that were heavier at weaning reached puberty earlier. Pubertal heifers had a greater OVA (4.15 vs. 3.14 cm2; P < 0.01) and ETh (12.15 vs. 9.93 mm; P < 0.01) than nonpubertal heifers. Taken together, OVA and ETh had positive effects (P < 0.01) on the onset of puberty and were suitable indicator traits of heifer sexual precocity in pasture management systems. However, selection for weight did not alter ovarian or endometrial development, or manifestation of puberty at 24 months of age. Among the growth traits studied, weaning weight and weight at puberty had significant positive effects on manifestation of first estrus. © 2013 Elsevier Inc.

Correlação ultrassonográfica e histeroscópica no diagnóstico de pólipos endometriais em mulheres na pós-menopausa

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Puberdade em novilhas Nelore provenientes de duas linhas de seleção para peso

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Dose-dependent change in biomarkers during neoadjuvant endocrine therapy with fulvestrant: results from NEWEST, a randomized Phase II study

NEWEST (Neoadjuvant Endocrine Therapy for Women with Estrogen-Sensitive Tumors) is the first study to compare biological and clinical activity of fulvestrant 500 versus 250 mg in the neoadjuvant breast cancer setting. We hypothesized that fulvestrant 500 mg may be superior to 250 mg in blocking estrogen receptor (ER) signaling and growth. A multicenter, randomized, open-label, Phase II study was performed to compare fulvestrant 500 mg (500 mg/month plus 500 mg on day 14 of month 1) versus fulvestrant 250 mg/month for 16 weeks prior to surgery in postmenopausal women with ER+ locally advanced breast cancer. Core biopsies at baseline, week 4, and surgery were assessed for biomarker changes. Primary endpoint: change in Ki67 labeling index (LI) from baseline to week 4 determined by automated computer imaging system (ACIS). Secondary endpoints: ER protein expression and function; progesterone receptor (PgR) expression; tumor response; tolerability. ER and PgR were examined retrospectively using the H score method. A total of 211 patients were randomized (fulvestrant 500 mg: n = 109; 250 mg: n = 102). At week 4, fulvestrant 500 mg resulted in greater reduction of Ki67 LI and ER expression versus 250 mg (-78.8 vs. -47.4% [p < 0.0001] and -25.0 vs. -13.5% [p = 0.0002], respectively [ACIS]); PgR suppression was not significantly different (-22.7 vs. -17.6; p = 0.5677). However, H score detected even greater suppression of ER (-50.3 vs. -13.7%; p < 0.0001) and greater PgR suppression (-80.5 vs. -46.3%; p = 0.0018) for fulvestrant 500 versus 250 mg. At week 16, tumor response rates were 22.9 and 20.6% for fulvestrant 500 and 250 mg, respectively, with considerable decline in all markers by both ACIS and H score. No detrimental effects on endometrial thickness or bone markers and no new safety concerns were identified. This provides the first evidence of greater biological activity for fulvestrant 500 versus 250 mg in depleting ER expression, function, and growth.

Changes in cell proliferation, but not in vascularisation are characteristic for human endometrium in different reproductive failures--a pilot study

Reproductive failure, determined as recurrent spontaneous abortions (RSA) or recurrent implantation failure (RIF) in women is not well understood. Several factors, including embryo quality, and cellular and molecular changes in endometrium may contribute to the insufficient feto-maternal interaction resulting in reproductive failure. Prior clinical studies suggest an inadequate endometrial growth and development of the endometrium, leading to a lesser endometrial thickness.

Is vaginal hyaluronic acid as effective as vaginal estriol for vaginal dryness relief?

In a multicenter, randomized, controlled, open-label, parallel- group trial hyaluronic acid vaginal gel (Hyalofemme) was compared to estriol vaginal cream (Ovestin) in women with vaginal dryness due to various causes. A total of 144 supposedly postmenopausal women below age 70 years were randomized in a 1:1 ratio to either receive hyaluronic acid vaginal gel (5 g per application) or estriol vaginal cream (0.5 g cream per application = 0.5 mg estriol) every 3 days for a total of ten applications, respectively. Exclusion criteria included vaginal infections, conventional contraindications to estrogens, use of vaginal products other than the investigational compounds, being unmarried, pregnant, or breastfeeding. The aim of the study was to test for non-inferiority of hyaluronic acid vaginal gel compared to estriol vaginal cream. The primary efficacy end point was the percentage (%) improvement in vaginal dryness, with the secondary end points being the percentage (%) improvements in vaginal itching, burning, and dyspareunia. Efficacy was assessed by using a visual analog scale (VAS) (0-10; 0 = absent, 10 = intolerable) at baseline (V0), during telephone contact after the third administration (V1), and at the final visit after the tenth administration (V2). Safety parameters included vaginal pH, endometrial thickness, and a vaginal smear for vaginal microecosystem assessment. Adverse events were recorded according to international guidelines. 133 women completed the study. At baseline, participants' characteristics did not differ significantly. Mean age was 54 years, time since menopause was 5 years on average, and cause of menopause was mostly natural. However, mean menstrual cycle days were also reported, although according to inclusion criteria only postmenopausal women were eligible for the study. At V1, an improvement in vaginal dryness was reported by about 49 % of women using hyaluronic acid vaginal gel, and by 53 % of women using estriol vaginal cream (p = 0.31). At V2, the percentage improvement rates were 84 and 89 % (p = 0.13), respectively. Improvement rates for vaginal itching, burning, and dyspareunia at V2 were about 86, 85, and 57 % for hyaluronic acid vaginal gel, and 82, 87, and 62 % for estriol vaginal cream (p[0.05), respectively. After treatment, vaginal pH was significantly lower in estriol-treated women compared to those having received hyaluronic acid. Endometrial thickness did not differ between groups. In the majority of women, the vaginal microenvironment remained unaffected by treatment. However, the proportion of women whose abnormal vaginal microecological results became normal was higher in women using estriol vaginal cream. Adverse events (suspected to be) related to the investigational compounds were minor and included vaginal infection and genital itching. The authors concluded that hyaluronic acid vaginal gel was not inferior to estriol vaginal cream in women presenting with vaginal dryness. They suggest using hyaluronic acid vaginal gel not only as an alternative treatment to vaginal estrogens, but also to consider its general use in women presenting with vaginal dryness of any cause.

Raloxifene therapy does not affect uterine blood flow in postmenopausal women: a transvaginal Doppler study

AZEVEDO, George Dantas de et al. Raloxifene therapy does not affect uterine blood flow in postmenopausal women: a transvaginal Doppler study. Maturitas, Amsterdam, v.47, n.3, p.195-200, 2004

Raloxifene therapy does not affect uterine blood flow in postmenopausal women: a transvaginal Doppler study

AZEVEDO, George Dantas de et al. Raloxifene therapy does not affect uterine blood flow in postmenopausal women: a transvaginal Doppler study. Maturitas, Amsterdam, v.47, n.3, p.195-200, 2004