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Division of Endocrinology, Department of Internal Medicine, and Center for Applied Biomedical Research, S. Orsola-Malpighi Hospital (A.G., L.P., R.D.I., U.P., R.P.), and Reproductive Endocrinology Center (B.C., G.E.C., M.F.), University of Bologna, 40138 Bologna, Italy; Department of Endocrinological and Metabolic Sciences and Center for Excellence for Biomedical Research, University of Genova (A.B.), 16132 Genova, Italy; and Endocrine Section, First Department of Internal Medicine, Athens University School of Medicine, Laiko General Hospital (E.D.-K.), 17562 Athens, Greece
Address all correspondence and requests for reprints to: Dr. Renato Pasquali, Division of Endocrinology, Department of Internal Medicine, S. Orsola-Malpighi Hospital, Via Massarenti 9, 40138 Bologna, Italy. E-mail: renato.pasquali{at}unibo.it.
Context: Somatostatin reduces LH, GH, and insulin, and somatostatin receptors are present at the ovarian level; somatostatin analogs are thus potential candidates for treatment of the polycystic ovary syndrome (PCOS).
Objective: The purpose of this study was to evaluate the effect of octreotide-LAR, a long-acting somatostatin analog, in anovulatory abdominal obese women with PCOS.
Design: A single-blind, placebo-controlled study was performed, lasting for 7 months.
Setting: The patients were ambulatory throughout the study.
Patients: Twenty PCOS subjects were enrolled. Eighteen completed the study.
Interventions: A low-calorie diet was given during the first month, a low-calorie diet plus octreotide-LAR (10 mg; n = 10 subjects) or placebo (n = 10 subjects) was then given, with one im injection every 28 d (for 6 months).
Main Outcome Measures: The main outcome measures were clinical features, computerized tomography measurement of fat distribution, androgens, GH, IGF-I, IGF-binding proteins (IGFBPs), fasting and glucose-stimulated insulin, and ovulation.
Results: Octreotide had no additional effect in reducing body fat or improving fat distribution than placebo. Conversely, octreotide produced an additional decrease in fasting (P = 0.018) and glucose-stimulated (P = 0.038) insulin levels, an increase in IGFBP-2 (P = 0.042) and IGFBP-3 (P = 0.047), and an improvement in hirsutism (P = 0.004). Moreover, a trend toward greater reductions in testosterone (P = 0.061) and androstenedione (P = 0.069) was observed in women treated with octreotide-LAR compared with those given placebo. All women treated with octreotide ovulated at the end of the study compared with only one of those receiving placebo (P < 0.001).
Conclusions: Octreotide-LAR may be usefully applied to hypocalorically dieting, abdominal obese PCOS women to improve hyperandrogenism and the insulin-IGF-I system. Restoration of ovulatory menstrual cycles appears to be another advantage of this treatment.
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