Original Article
International Journal of Obesity (2008) 32, 692–699; doi:10.1038/sj.ijo.0803777; published online 11 December 2007
Effect of hypocaloric diet plus sibutramine treatment on hormonal and metabolic features in overweight and obese women with polycystic ovary syndrome: a randomized, 24-week study
D Florakis1, E Diamanti-Kandarakis2, I Katsikis1, G P Nassis3, A Karkanaki1, N Georgopoulos4 and D Panidis1
- 1Second Department of Obstetrics and Gynecology, Division of Endocrinology and Human Reproduction, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece
- 2First Department of Medicine, Endocrine Section, Medical School, Laiko Hospital, University of Athens, Athens, Greece
- 3Department of Sports Medicine and Biology of Physical Activity, University of Athens, Athens, Greece
- 4Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology, University of Patras Medical School, Patra, Greece
Correspondence: Dr D Florakis, Second Department of Obstetrics and Gynecology, Division of Endocrinology and Human Reproduction, Medical School, Aristotle University of Thessaloniki, 49 Konstandinoupoleos Street, 54642 Thessaloniki, Greece. E-mail: gnassis@phed.uoa.gr
Received 11 July 2007; Revised 21 October 2007; Accepted 5 November 2007; Published online 11 December 2007.
Abstract
Objective:
To examine the effect of hypocaloric diet plus sibutramine on body composition, hormonal and metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS).
Design:
Open-label, randomized study at an outpatient clinic.
Patients:
A total of 59 overweight and obese (18–39 years old) women with PCOS.
Measurements:
All patients were placed in a hypocaloric diet plus sibutramine (10 mg per day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg per day, group S) or hypocaloric diet only (group D) for the subsequent 6 months. Body composition, hormonal and metabolic features and insulin sensitivity (oral glucose tolerance test, OGTT) were evaluated at baseline and at 3 and 6 months of treatment.
Results:
Body weight reduced in both groups but the reduction was greater with sibutramine (-15.4
1.1 vs –11.11.9% in groups S and D, respectively, P<0.05). At 6 months, a greater percent of patients lost more than 10% of initial body weight in group S than D (81 vs 52.9%). In both groups, all women with abnormal OGTT at baseline presented normal glucose tolerance after 6 months. Free androgen index (FAI), glucose area under the curve and fasting triglyceride (TG) concentration were reduced after 6 months in group S only (P<0.05). No changes in cardiovascular risk factors, prolactin and hepatic enzymes levels were observed in both groups.
Conclusion:
A hypocaloric diet and a diet plus sibutramine both result in significant weight loss in overweight and obese women with PCOS. Patients who received sibutramine showed a greater weight loss and improvement in hyperandrogenemia and insulin sensitivity after 6 months of treatment. The amelioration of insulin resistance in this group could not be totally explained by weight loss. Total testosterone, FAI and TG levels reduction could be a possible mechanism. Finally, sibutramine increased compliance to diet and it was well tolerated from these patients.
Keywords:
sibutramine, hyperandrogenemia, insulin sensitivity, polycystic ovary syndrome
