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). 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 (À15.4±1.1 vs -11.1±1.9% in groups S and D, respectively, Po0.05). 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 (Po0.05). 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.

Obesity and reproductive function

“…With this search we identified eight studies. Six of the studies investigated reproductive function after treatment with medical therapies including metformin, orlistat, sibutramine, and myoinositol [58][59][60][61][62][63] . One study outlined the strategy of an ongoing trial evaluating the costs and effects of a structured lifestyle program in overweight and obese subfertile women in Norway, but no results were available 64 .…”

Ovarian function and obesity—Interrelationship, impact on women's reproductive lifespan and treatment options

“…Its primary mechanism of action is increased satiety, although some evidence also suggests increased energy expenditure could play a role in sibutramine-induced weight loss (Poston and Foreyt, 2004). Data from the recent studies on the use of sibutramine in obese patients with PCOS clearly show that treatment with this drug for 6 months together with lifestyle intervention, results in weight reduction and may also decrease hyperandrogenaemia and IR (Sabuncu et al, 2003;Florakis et al, 2008;Lindholm et al, 2008). Treatment with orlistat, a potent inhibitor of gastric and pancreatic carboxyl-ester lipase which impairs digestion of dietary fats, combined with hypo-caloric diet apart from decreasing body weight also led to a reduction of serum insulin and androgen levels in obese PCOS patients (Jayagopal et al, 2005;Diamanti-Kandarakis et al, 2007a;Panidis et al, 2008).…”

The use of sibutramine in the management of obesity and related disorders: An update

“…101 In two small studies in overweight or obese women with PCOS (total n = 101), sibutramine (10-15 mg/day for six months) reduced body weight and BMI more than lifestyle modification alone. 102,103 Triglyceride levels and markers of androgen excess decreased more in the sibutramine group but menstrual frequency did not differ significantly between groups. 102,103 In one of these studies insulin sensitivity was also increased.…”

“…102,103 Triglyceride levels and markers of androgen excess decreased more in the sibutramine group but menstrual frequency did not differ significantly between groups. 102,103 In one of these studies insulin sensitivity was also increased. 102 In another study in 40 obese women with PCOS, sibutramine (10 mg/day) reduced body weight, BMI and markers of androgen excess to a similar extent as oral ethinyl estradiol plus cyproterone acetate (35 µg/2 mg).…”

“…102,103 In one of these studies insulin sensitivity was also increased. 102 In another study in 40 obese women with PCOS, sibutramine (10 mg/day) reduced body weight, BMI and markers of androgen excess to a similar extent as oral ethinyl estradiol plus cyproterone acetate (35 µg/2 mg). 104 However, only sibutramine reduced WHR and improved insulin sensitivity.…”