title: 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.
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).
  
  
  METHODS
  Open-label, randomized study at an outpatient clinic.
  
  
  METHODS
  A total of 59 overweight and obese (18-39 years old) women with PCOS.
  
  
  METHODS
  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 -11.1+/-1.9% 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.
  
  
  CONCLUSIONS
  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.
authors: Second Department of Obstetrics and Gynecology, Division of Endocrinology and Human Reproduction, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece. gnassis@phed.uoa.gr
authors: D
authors: D
authors: Florakis
authors: E
authors: E
authors: Diamanti-Kandarakis
authors: I
authors: I
authors: Katsikis
authors: G P
authors: GP
authors: Nassis
authors: A
authors: A
authors: Karkanaki
authors: N
authors: N
authors: Georgopoulos
authors: D
authors: D
authors: Panidis
mesh_terms: D000293:Adolescent; D000328:Adult; D000728:Androgens / Q000097:blood; D000886:Anthropometry / Q000379:methods; D001067:Appetite Depressants / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D050218:Body Fat Distribution; D001835:Body Weight; D003131:Combined Modality Therapy; D003503:Cyclobutanes / Q000627:therapeutic use*; D004038:Diet, Reducing; D005260:Female; D006801:Humans; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D008055:Lipids / Q000097:blood; D008099:Liver / Q000201:enzymology; D009765:Obesity / Q000097:blood / Q000503:physiopathology / Q000628:therapy*; D050177:Overweight / Q000097:blood / Q000503:physiopathology / Q000628:therapy; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000503:physiopathology / Q000628:therapy*; D011388:Prolactin / Q000097:blood; D011446:Prospective Studies; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D000728:Androgens; D001067:Appetite Depressants; D001786:Blood Glucose; D003503:Cyclobutanes; D007328:Insulin; D008055:Lipids; D011388:Prolactin; C058254:sibutramine