The impact of combined nutraceutical supplementation on quality of life and metabolic changes during the menopausal transition: a pilot randomized trial.

PURPOSE: The aim of this study was to assess the efficacy of a combined nutraceutical supplement on symptoms and early metabolic alterations during the menopausal transition. This pilot randomized study was conducted at the service for menopause disorders of the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. METHODS: Ninety women in menopausal transition who attended our service with menopausal symptoms were enrolled in the study. Sixty patients, randomly assigned to the treatment group, were prescribed one daily tablet of a combined nutraceutical compound with phytoestrogen substances, vitamins, micronutrients and passion flower herbal medicine for 6 months. Thirty patients did not receive any treatment and comprised the control group. The intensity of perimenopausal symptoms was assessed by the modified Kuppermann Index (KI) at enrollment and at 3 and 6 months of treatment. At baseline and at the end of the study, patients underwent a clinical evaluation, a pelvic ultrasound and analysis of blood samples. RESULTS: In the nutraceutical supplemented group, a significant reduction in menopausal symptoms was demonstrated according to the KI after 3 and 6 months of supplementation (p < 0.01). The within-group analysis of different KI parameters in the treated group showed a significant improvement in hot flushes (p < 0.001), insomnia (p < 0.01), fatigue (p < 0.01) and irritability (p < 0.01). Metabolic parameters did not change significantly in the nutraceutical supplemented group. In the control group, total cholesterol level showed a significant increase (p < 0.05). CONCLUSIONS: Combined nutraceutical supplementation provides an effective and safe solution for early symptoms occurring during menopausal transition.

Glucocorticoid therapy as a significant risk factor for osteoporosis and fractures in an Italian postmenopausal population.

OBJECTIVE: To analyze the potential effects of glucocorticoid treatment without an osteoporosis prevention strategy and to precociously identify patients at high risk of osteoporosis and fragility fractures in the postmenopausal period. METHODS: A total of 382 postmenopausal patients, 177 exposed and 205 not exposed to glucocorticoid therapy, were studied using a standard questionnaire. Epidemiological as well as clinical data that included the most recent absorptiometry test results were examined. RESULTS: Osteoporosis and fractures were frequent in the postmenopausal glucocorticoid-treated patients. Fragility fractures occurred more frequently in glucocorticoid-treated patients (vertebral fractures represented 45% of all fractures) than in the non-glucocorticoid-treated patients. In particular, the highest fracture percentage was found in 50- to 65-year-old glucocorticoid-treated patients, a subset of patients showing a prevalence of osteoporosis similar to that of non-exposed menopausal subjects older than 65. Glucocorticoid therapy increases the risk of fragility fractures fivefold and doubles the risk of osteoporosis in menopausal patients. CONCLUSIONS: Glucocorticoid treatments put menopausal patients at a high risk of incurring fragility fractures even in the early postmenopausal period. The management of strategies for fracture prevention must take into consideration early intervention in patients undergoing or about to undergo glucocorticoid treatment.

Role of ultrasound in advanced peritoneal malignancies.

INTRODUCTION: Ovarian cancer is the seventh most common cancer among women in the developed world, and most women with ovarian cancer are diagnosed at an advanced stage of disease, when large intraperitoneal dissemination has already occurred. An accurate preoperative assessment of the tumor dissemination is pivotal for adequate counseling among risks and benefits of an aggressive surgical procedure, often required to achieve a complete cytoreduction. When performed by an experienced sonographer, ultrasound has an invaluable role in the primary diagnosis of gynecological cancer, in the assessment of tumor extent in the pelvis and abdominal cavity; however, there is a paucity of data on its use in the evaluation of the extent of disease of such patients. EVIDENCE ACQUISITION: The search retrieved 208 articles in the best matching results list. Selection by abstract and full-text, yielded 15 publications that contained information on the role of ultrasound examination in the assessment of diffused peritoneal malignancies. EVIDENCE SYNTHESIS: Sonographic appearance of metastatic nodules in peritoneum and omentum were firstly analyzed in preliminar descriptive studies, together with a systematic method to scan the abdomen and pelvis in in the staging of diffused gynecological malignancies. To date, three prospective studies mainly focused on the specific role of ultrasound (without comparison with other imaging modalities) in the evaluation of intra-abdominal tumor extension in ovarian cancer patients. In these studies, authors were in agreement to conclude that ultrasound has a very reliable role in the staging of ovarian cancer. In particular, ultrasound examination showed a high sensitivity (range 81.4-91%) and specificity (range 88-96%) in the diagnosis of peritoneal carcinomatosis, as well as in omental involvement (sense 67-94%, specificity 90%). In a recent prospective study ultrasound shows similar accuracy of CT scan in the staging of ovarian cancer patients (71% vs. 75%) when compared with surgical results. CONCLUSIONS: Even if ultrasound is a largely diffuse and practice imaging technique, there is a paucity of data in literature on its use in the evaluation of the extent of disease in ovarian cancer patiens. Nevertheless, this review has demonstrated that ultrasound has a high accuracy in staging advanced ovarian cancer patients. In certain settings, ultrasound has already replaced CT scan in the pre-operative evaluation of pelvic and abdominal disease. Finally, ultrasound allows to perform a biopsy in patients with peritoneal carcinomatosis obtaining an adequate specimen for histologic diagnosis.

Impact of aromatase inhibitor treatment on vertebral morphology and bone mineral density in postmenopausal women with breast cancer.

OBJECTIVE: The aim of this study was to evaluate the impact of aromatase inhibitor (AI) treatment on vertebral morphology by vertebral fracture assessment in postmenopausal women with early-stage breast cancer. METHODS: A clinical cross-sectional study was conducted. A group of 156 postmenopausal women with breast cancer (mean [SD] age, 60.4 [10.1] y; mean [SD] time since menopause, 11.7 [9.2] y) was included in the study. Eighty-two women received AI treatment, whereas 74 women did not. Women underwent extensive medical history check and risk factor assessment together with vertebral morphology and bone mineral density (BMD) evaluation. RESULTS: In the studied population, the prevalence of vertebral fractures identified by vertebral fracture assessment was 16.6%. Multivariate analysis showed that AI treatment was significantly associated with vertebral fractures (adjusted P < 0.04). Women receiving AI treatment had a higher prevalence of vertebral fractures than women not treated with AIs (25.6% vs. 4%). The risk of vertebral fractures in women treated with AIs was significantly higher than in non-AI-treated women (adjusted odds ratio, 4.7; P < 0.005). Vertebral fractures of the highest grade were identified at the lumbar spine. Women treated with AIs had a significantly lower BMD than women not treated with AIs (P < 0.01). Reduction of BMD was significantly associated with length of therapy, whereas there was no association between length of treatment and risk of vertebral fractures. CONCLUSIONS: AI treatment severely impacts vertebral morphology. Our study demonstrates a high prevalence of asymptomatic vertebral fractures in women treated with AIs.