Márcia Gaspar Nunes

Endometrial effects of bazedoxifene acetate, a novel selective estrogen receptor modulator, in postmenopausal women.

OBJECTIVE: To assess the endometrial effects of bazedoxifene acetate in healthy postmenopausal women. METHODS: The endometrial effects of bazedoxifene 2.5, 5.0, 10, 20, 30, and 40 mg/d were evaluated in a 2-part, 6-month, double-blind, randomized, active- and placebo-controlled study among a total of 497 healthy postmenopausal women. Conjugated estrogens (0.625 mg)/medroxyprogesterone acetate (2.5 mg) served as the active control. Patients underwent transvaginal ultrasonography to measure double-wall endometrial thickness and endometrial biopsy at baseline and at 6 months of treatment. The incidence of amenorrhea was assessed from self-reported daily diaries. RESULTS: Bazedoxifene treatment at 2.5–20 mg/d resulted in mean changes from baseline in endometrial thickness that were no different than those seen with placebo treatment. Changes in endometrial thickness for the bazedoxifene 30 and 40 mg groups were significantly smaller than for placebo. The change from baseline in endometrial thickness was significantly and inversely related to dose (P ≤ .001). None of the endometrial biopsy specimens demonstrated endometrial hyperplasia. Subjects in the 2.5–20 mg bazedoxifene groups experienced amenorrhea rates of 57–74%, comparable with the 59% seen in placebo. Over 90% of subjects treated with bazedoxifene 30 or 40 mg/d were amenorrheic at 6 months. CONCLUSION: Bazedoxifene at dosages up to 40 mg/d was well tolerated and did not stimulate the endometrium. The significant decreases in endometrial thickness and decreased uterine bleeding observed with doses of 30 and 40 mg/d as compared with placebo suggest endometrial antagonism, representing a novel characteristic not previously associated with any selective estrogen receptor modulator. LEVEL OF EVIDENCE: I

Efeitos da isoflavona e dos estrogênios conjugados eqüinos sobre a qualidade de vida na pós-menopausa

PuRPOse: to analyze the isoflavone and estrogen effects on the postmenopausal quality of life. MethOds: this is a randomized and double-blind study with 79 postmenopausal patients, 12 months of amenorrhea, 40 years old or more and body mass index (BMI) above 30 kg/m2. The participants were randomly divided into two treatment groups: GECP received orally two capsules, every 12 hours, one contained 0.625 mg conjugated equine estrogen and another placebo (n=33); GECS received two capsules of 150 mg extract of soy, with 60 mg isoflavone (n=32). Both treatments were administered for six months. The Quality Menopause Specific Questionnaire of Life was applied before and after one, three and six months of treatment. The parameters of gynecological cancer risk were evaluated. ANOVA and the Tukey test were used for data analysis. Results: there was a reduction in the values of the vasomotor parameters after six months of treatment, 1.6±0.8 and 2.4±1.6, compared to before therapy, 4.0±2.2 and 4.2±2.3 in GECP and GECS, respectively. The psychological aspects showed reduction in values after six months of therapy, 2.5±1.2 and 2.9±1.4, compared to before treatment, 3.6±1.6 and 4.1±1.9 in GECP and GECS, respectively. Similar results were obtained on the physical aspects and in the sexual symptoms. COnClusiOns: isoflavones may positively act on life quality of postmenopausal women. This effect was similar to conjugated equine estrogen.

Efeitos dos fitoestrogênios sobre alguns parâmetros clínicos e laboratoriais no climatério

Purpose: to evaluate the estrogenic effects of soy phytoestrogens in postmenopausal patients. Method: we selected postmenopausal patients from the Climacteric Service of the Gynecology Department of the Federal University of Sao Paulo - Escola Paulista de Medicina. The patients were divided into two groups: GI (n=40) received daily 100 mg isoflavone (3 x 33.3 mg/day); and GCtr (n=40) received daily placebo. We included in this study the Kuppermann menopausal index, physical examination and the biochemical determination of total and fractions of cholesterol, triglycerides, estradiol, FSH e LH. We also performed sonographic examination to measure endometrial thickness. To compare baseline and after treatment values of both groups, the nonparametric Kruskal-Wallis test was used for the Kuppermann index, while the t test was performed for other data. Results: evaluation of the Kupperman Menopausal Index, 80% patients of GI showed a decrease in the total score, while the improvement of symptoms in GCtr was 12,5%. The analysis of total cholesterol levels showed that 35 patients of GI had levels above 200 mg/dL, and only 13 of GCtr presented similar levels. The body mass index reduction occurred in GI and the control group showed no changes. We also verified that echo endometrial thickness and FSH levels were similar to baseline values. However the values of estrogen increased after isoflavone treatment. Conclusion: we concluded that 100 mg/day isoflavone may be an alternative treatment for attenuating the climacteric symptoms in 80% of isoflavone users and that it reduced total cholesterol.

The ACTH test in the diagnosis of hirsutism

The ACTH test has been used to confirm the diagnosis of adrenal insufficiency and the classic and the non-classic adrenal hyperplasia due to the 3-HSD, 21 OH e 110H deficiencies. This article reviews the historical aspects of the use of ACTH in the diagnosis of hirsutism and points out its mains indications. In spite of new biological molecular advances in the diagnosis of adrenal enzymatic deficiencies, the use of the ACTH test can help the physician to predict both genothipus and fenothipus in populations with hyperandrogenic manifestations due to non-classical or late-onset congenital adrenal hyperplasia.