Efficacy and safety of DT56a compared to hormone therapy in Greek post-menopausal women.

BACKGROUND: Hormone therapy (HT) is the treatment of choice for the alleviation of menopausal symptoms; concerns, however, about its concomitant long-term health risks have limited its use. DT56a is a unique enzymatic isolate of soybeans. The purpose of our study was to evaluate the efficacy and safety of DT56a, compared to HT, in symptomatic post-menopausal women. SUBJECTS AND METHODS: Eighty-nine post-menopausal women were studied prospectively. Women with climacteric symptoms were randomly assigned to receive eitherDT56a (no.=27) or oral low dose continuous combined HT (no.=26). Symptomatic women not wishing to receive any treatment served as controls (no.=36). Menopausal symptoms as assessed through the Kupperman index, serum lipids and lipoproteins, calcium, as well as bone mineral density (BMD), endometrial thickness, and mammography were assessed at baseline and at 12 months. RESULTS: Patients receiving HT and DT56a showed a significant and independent decrease in menopausal symptoms (mean difference in Kupperman score, DT56a group: -3.98, HT group -5.601, no treatment group +1.76, p-value <0.001). Lumbar spine BMD T-score was significantly lower in women receiving no treatment, as opposed to the two treatment arms which showed no significant change (No treatment, baseline: -0.60, final: -0.85, p=0.001; HT, baseline: -84, final -0.99, p=0.79; DT56a, baseline -0.51, final: -0.76, p=0.75). No differences in femoral bone density, ET or mammography classification were detected in any of the treatment arms. Likewise, serum lipids or lipoproteins did not differ between the three groups. CONCLUSIONS: DT56a decreased menopausal symptoms significantly and in the same degree as HT.

Comparing classic and newer phenotypes in Greek PCOS women: the prevalence of metabolic syndrome and their association with insulin resistance.

OBJECTIVE: Recently, it has been debated whether the new polycystic ovary syndrome (PCOS) phenotypes, according to the Rotterdam criteria, share the same metabolic risk with the classic ones (National Institutes of Health 1990). Our study sought to compare the prevalence of metabolic syndrome (MS) and glucose homeostasis disorders in Greek women with classic and new PCOS phenotypes. MATERIALS AND METHODS: Two hundred and sixty-six Greek PCOS women were recruited and divided into groups according to two of the three Rotterdam criteria that they fulfilled. Two subgroups were formed; the first represented the classic phenotypes and the second the new phenotypes. The clinical, biochemical, and ultrasound characteristics of both groups were explored. All subjects were evaluated for MS and underwent a 2-h glucose tolerance test to assess insulin resistance (IR) as measured by the homeostasis model assessment (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), and MATSUDA indices. RESULTS: 62.4% of PCOS women were classified as classic NIH phenotypes of which 32 women had MS (prevalence 19.6%). Only 4 patients categorized in the newer phenotypic groups had MS (prevalence 4.1%). Among the subjects with classic phenotypes, 11.7% exhibited impaired glucose tolerance (3-fold higher percentage compared to patients with newer phenotypes). Regarding IR indices, HOMA-IR was significantly higher and QUICKI significantly lower for classic phenotypes. CONCLUSIONS: Greek PCOS women with classic phenotypes are at increased risk for MS and impaired glucose homeostasis compared to women with newer phenotypes. A subclassification of PCOS permits the earlier recognition and closer surveillance of women whose metabolic profile indicates potential risks for adverse health outcomes.

Augmentation of cortical bone mineral density in women with polycystic ovary syndrome: a peripheral quantitative computed tomography (pQCT) study.

BACKGROUND: Women with polycystic ovary syndrome (PCOS) may have increased cortical bone mineral density (BMD) and probably higher bone material quality as well as better resistance in the compression strength of the tibia, measured by peripheral quantitative computed tomography (pQCT), in comparison with that of age-matched healthy subjects. METHODS: Thirty women with PCOS, (15 lean and 15 obese) and 15 age-matched healthy controls were enrolled in this study. The clinical, biochemical and ultrasound characteristics of the two groups were evaluated. Using pQCT, the following parameters were measured: volumetric cortical density (CBD) and volumetric trabecular density (TBD) BMD, total bone cross-sectional area (ToA), cortical area (CoA), cortical thickness (CRT-THK-C) and finally the strength-strain index (SSI). RESULTS: The geometrical parameters (CoA, ToA, CRT-THK-C), the SSI as well as the TBD were increased in the PCOS women; however, these differences did not achieve statistical significance between lean PCOS women, obese PCOS women, and controls. Conversely, CBD was significantly higher in PCOS women compared with controls (P < 0.000) and furthermore in lean PCOS women compared with obese ones (P < 0.01040). CONCLUSIONS: The PCOS women of our study seem to have a higher quality of bone material in the distal tibia and probably a better resistance of bone in the compression strength without alterations in bone mass and geometry (especially the lean PCOS women), indicating that our oligomenorrheic and hyperandrogonemic PCOS women may be protected from the development of osteoporosis and fracture risk later in life.