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    6/22/2009

    Metformin effects on ovarian ultrasound appearance and steroidogenic function in normal-weight normoinsulinemic women with polycystic ovary syndrome: a randomized double-blind placebo-controlled clinical trial

    Metformin effects on ovarian ultrasound appearance and steroidogenic function in normal-weight normoinsulinemic women with polycystic ovary syndrome: a randomized double-blind placebo-controlled clinical trial

    Daniela Romualdi, M.D.a, Maddalena Giuliani, M.D.a, Francesca Cristello, M.D.a, Anna Maria Fulghesu, M.D.c, Luigi Selvaggi, M.D.a, Antonio Lanzone, M.D.ab, Maurizio Guido, M.D., Ph.D.aCorresponding Author Informationemail address

    Received 1 October 2008; received in revised form 14 January 2009; accepted 19 January 2009. published online 06 March 2009.
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    Objective

    To investigate metformin effects on the endocrine-metabolic parameters and ovarian morphology in normoinsulinemic women with polycystic ovary syndrome (PCOS).

    Design

    Randomized double-blind study.

    Setting

    Operative Division of Endocrinological Gynecology, Università Cattolica del Sacro Cuore.

    Patient(s)

    Twenty-eight normal-weight normoinsulinemic PCOS women.

    Intervention(s)

    Patients were randomized to receive metformin 500 mg twice a day (group A, 15 subjects) or placebo (group B, 13 subjects) for 6 months. Ultrasonographic pelvic exams, hormonal and lipid features, and oral glucose tolerance test were performed at baseline and after 3 and 6 months of treatment.

    Main Outcome Measure(s)

    Hormonal and glycoinsulinemic assessment, ovarian ultrasound appearance.

    Result(s)

    Glycoinsulinemic assessment remained unvaried in both groups. About 70% of patients in group A experienced a restoration of menstrual cyclicity. Metformin significantly decreased testosterone levels at 3 and 6 months) and 17-hydroxyprogesterone levels at 6 months, and improved hirsutism score at 6 months. No clinical or hormonal modifications occurred in group B. Metformin, but not placebo, reduced ovarian volume and stromal/total area ratio at 3 and 6 months.

    Conclusion(s)

    Metformin seems to improve the menstrual pattern and ultrasonographic ovarian features in normoinsulinemic PCOS women. These effects seem to be, at least in part, independent of the insulin-lowering properties of the drug.

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