F Orio1,2, G Muscogiuri3, F Giallauria4, S Savastano5, P Bottiglieri6, D Tafuri7, P Predotti6, G Colarieti8, A Colao5, S Palomba9. 1. Endocrinology, Department of Sports Science and Wellness, "Parthenope" University Naples, Naples, Italy. francescoorio@virgilio.it. 2. Fertility Techniques SSD, University Hospital "S. Giovannni di Dio e Ruggi d'Aragona" Salerno, Salerno, Italy. francescoorio@virgilio.it. 3. I.O.S. & COLEMAN Srl, Naples, Italy. 4. Department of Clinical Medicine, Cardiovascular and Immunological Sciences, Cardiac Rehabilitation Unit, "Federico II" University of Naples, Naples, Italy. 5. Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Naples, Italy. 6. Unit of Cardiology, University Hospital "S. Giovanni di Dio e Ruggi d'Aragona" Salerno, Salerno, Italy. 7. Department of Sports Science and Wellness, "Parthenope" University Naples, Naples, Italy. 8. Fertility Techniques SSD, University Hospital "S. Giovannni di Dio e Ruggi d'Aragona" Salerno, Salerno, Italy. 9. Obstetrics and Gynecology Unit, ASMN- IRCCS of Reggio, Reggio Emilia, Italy.
Abstract
BACKGROUND: Although oral contraceptives (OCs) are one the most widespread therapy in young polycystic ovary syndrome (PCOS) women andphysical exercise represents a crucial first step in the treatment of overweight and obese PCOS, no studies were performed to compare the effects on cardiovascular risk (CVR) of OCs and physical exercise in PCOS. OBJECTIVE: To compare the effects of OCs administration and physical exercise on the CVR, clinical, hormonal and metabolic parameters in PCOS women. METHODS:One hundred and fifty PCOS women were enrolled and were randomized to OCs (3 mg drospirenone plus 30 μg ethinyloestradiol), structured exercise training programme (SETP) or polyvitamin tablets. The intervention phase study was of 6 months. Primary outcome was intima-media thickness (IMT) and flow-mediated dilation (FMD). Secondary outcomes were clinical, hormonal and metabolic changes. RESULTS: A significant reduction of IMT and a significant increase of FMD were observed in the SETP group after treatment. Compared to baseline, in the SETP group, a significant improvement in anthropometric measures, insulin sensitivity indexes, lipid profile, cardiopulmonary function, inflammatory markers and frequency of menses was observed. Oral contraceptives use was associated with a significant decrease of hyperandrogenism and a significant improvement of frequency of menses. Further, OCs use had a neutral effect on CVR risk factors. CONCLUSION:OCs effectively treat hyperandrogenism and menstrual disturbances, while SETP is more effective in improving cardiometabolic profile and cardiopulmonary function in PCOS.
RCT Entities:
BACKGROUND: Although oral contraceptives (OCs) are one the most widespread therapy in young polycystic ovary syndrome (PCOS) women and physical exercise represents a crucial first step in the treatment of overweight and obese PCOS, no studies were performed to compare the effects on cardiovascular risk (CVR) of OCs and physical exercise in PCOS. OBJECTIVE: To compare the effects of OCs administration and physical exercise on the CVR, clinical, hormonal and metabolic parameters in PCOS women. METHODS: One hundred and fifty PCOS women were enrolled and were randomized to OCs (3 mg drospirenone plus 30 μg ethinyloestradiol), structured exercise training programme (SETP) or polyvitamin tablets. The intervention phase study was of 6 months. Primary outcome was intima-media thickness (IMT) and flow-mediated dilation (FMD). Secondary outcomes were clinical, hormonal and metabolic changes. RESULTS: A significant reduction of IMT and a significant increase of FMD were observed in the SETP group after treatment. Compared to baseline, in the SETP group, a significant improvement in anthropometric measures, insulin sensitivity indexes, lipid profile, cardiopulmonary function, inflammatory markers and frequency of menses was observed. Oral contraceptives use was associated with a significant decrease of hyperandrogenism and a significant improvement of frequency of menses. Further, OCs use had a neutral effect on CVR risk factors. CONCLUSION: OCs effectively treat hyperandrogenism and menstrual disturbances, while SETP is more effective in improving cardiometabolic profile and cardiopulmonary function in PCOS.
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