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Submitted on December 17, 2004
Accepted on April 6, 2005
Division of Endocrinology, Dept. of Internal Medicine, and Centre for Applied Biomedical Research (C.R.B.A.), S. Orsola-Malpighi Hospital, University of Bologna, Italy (A.G., L.P., R. De I., U. P., R.P.); Reproductive Endocrinology Center, University of Bologna, Italy (B.C., G.E.C., M.F.); Department of Endocrinological and Metabolic Sciences and Centre for Excellence for Biomedical Research, University of Genova, Genova, Italy (A.B.); and Endocrine Section of First Department of Internal Medicine, Athens University School of Medicine, Laiko General Hospital, Athens, Greece (E. D-K)
* To whom correspondence should be addressed. E-mail: renato.pasquali{at}unibo.it.
Context: Somatostatin reduces LH, GH and insulin, and somatostatin receptors are present at ovary level; somatostatin analogs are thus potential candidates for the treatment of the polycystic ovary syndrome (PCOS).
Objective: To evaluate the effect of octreotide-LAR, a long-acting somatostatin analog, in anovulatory abdominal obese women with PCOS.
Design: Single-blind, placebo-controlled study, lasting for 7 months.
Setting: Ambulatory patients.
Patients: Twenty PCOS subjects enrolled. Eighteen completed the study.
Interventions: Low-calorie diet (first month); low-calorie diet plus octreotide-LAR (10 mg) (n = 10 subjects) or placebo (n = 10 subjects), one im injection every 28 days (further 6 months).
Main Outcome Measures: Clinical features, computerized tomography measurement of fat distribution, androgens, GH, IGF-1, IGF binding proteins (IGFBPs), fasting and glucose-stimulated insulin and ovulation.
Results: Octreotide had no further effect in reducing body fat and in improving fat distribution than placebo. Conversely, octreotide determined a further 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 a greater reduction in testosterone (P = 0.061) and androstenedione (P = 0.069) was observed in women treated with octreotide-LAR respect to 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 hypocaloric dieting abdominal obese PCOS women to improve hyperandrogenism and the insulin-IGF-1 system. Restoration of ovulatory menstrual cycles appears to be another advantage of this treatment.
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A. Gambineri, L. Patton, A. Vaccina, M. Cacciari, A. M. Morselli-Labate, C. Cavazza, U. Pagotto, and R. Pasquali Treatment with Flutamide, Metformin, and Their Combination Added to a Hypocaloric Diet in Overweight-Obese Women with Polycystic Ovary Syndrome: A Randomized, 12-Month, Placebo-Controlled Study J. Clin. Endocrinol. Metab., October 1, 2006; 91(10): 3970 - 3980. [Abstract] [Full Text] [PDF]
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 R. Pasquali and A. Gambineri Insulin-sensitizing agents in polycystic ovary syndrome. Eur. J. Endocrinol., June 1, 2006; 154(6): 763 - 775. [Abstract] [Full Text] [PDF]
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