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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.
Int J Obes (Lond). 2008 Apr; 32(4):692-9.IJ

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 -11.1+/-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.

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.

Authors+Show Affiliations

Second Department of Obstetrics and Gynecology, Division of Endocrinology and Human Reproduction, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece. gnassis@phed.uoa.grNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

18071341

Citation

Florakis, D, et al. "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." International Journal of Obesity (2005), vol. 32, no. 4, 2008, pp. 692-9.
Florakis D, Diamanti-Kandarakis E, Katsikis I, et al. 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. Int J Obes (Lond). 2008;32(4):692-9.
Florakis, D., Diamanti-Kandarakis, E., Katsikis, I., Nassis, G. P., Karkanaki, A., Georgopoulos, N., & Panidis, D. (2008). 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. International Journal of Obesity (2005), 32(4), 692-9.
Florakis D, et al. 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. Int J Obes (Lond). 2008;32(4):692-9. PubMed PMID: 18071341.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Florakis,D, AU - Diamanti-Kandarakis,E, AU - Katsikis,I, AU - Nassis,G P, AU - Karkanaki,A, AU - Georgopoulos,N, AU - Panidis,D, Y1 - 2007/12/11/ PY - 2007/12/12/pubmed PY - 2008/8/23/medline PY - 2007/12/12/entrez SP - 692 EP - 9 JF - International journal of obesity (2005) JO - Int J Obes (Lond) VL - 32 IS - 4 N2 - 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 -11.1+/-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. 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. SN - 1476-5497 UR - https://www.unboundmedicine.com/medline/citation/18071341/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_ L2 - https://doi.org/10.1038/sj.ijo.0803777 DB - PRIME DP - Unbound Medicine ER -