The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials.
BACKGROUND
Polycystic ovary syndrome (PCOS) presents in adolescence, and obesity is a common finding. The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear.


OBJECTIVE
We investigated the effects of metformin, oral contraceptives (OCs), and/or lifestyle modification in obese adolescent women with PCOS.


METHODS
Two small, randomized, placebo-controlled clinical trials were performed.


METHODS
A total of 79 obese adolescent women with PCOS participated.


METHODS
In the single treatment trial, subjects were randomized to metformin, placebo, a lifestyle modification program, or OC. In the combined treatment trial, all subjects received lifestyle modification and OC and were randomized to metformin or placebo.


METHODS
Serum concentrations of androgens and lipids were measured.


RESULTS
Lifestyle modification alone resulted in a 59% reduction in free androgen index with a 122% increase in SHBG. OC resulted in a significant decrease in total testosterone (44%) and free androgen index (86%) but also resulted in an increase in C-reactive protein (39.7%) and cholesterol (14%). The combination of lifestyle modification, OC, and metformin resulted in a 55% decrease in total testosterone, as compared to 33% with combined treatment and placebo, a 4% reduction in waist circumference, and a significant increase in HDL (46%).


CONCLUSIONS
In these preliminary trials, both lifestyle modification and OCs significantly reduce androgens and increase SHBG in obese adolescents with PCOS. Metformin, in combination with lifestyle modification and OC, reduces central adiposity, reduces total testosterone, and increases HDL, but does not enhance overall weight reduction.
Hoeger
Kathleen
K
Department of Obstetrics and Gynecology, University of Rochester Medical Center, 601 Elmwood Avenue, Box 668, Rochester, New York 14642, USA. Kathy_hoeger@urmc.rochester.edu
Davidson
Kristen
K
Kochman
Lynda
L
Cherry
Tracy
T
Kopin
Laurie
L
Guzick
David S
DS
D000293:Adolescent; D000728:Androgens / Q000097:blood; D001521:Behavior Therapy; D002097:C-Reactive Protein / Q000378:metabolism; D002648:Child; D002784:Cholesterol / Q000097:blood; D003278:Contraceptives, Oral, Hormonal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008019:Life Style; D008055:Lipids / Q000097:blood; D008687:Metformin / Q000627:therapeutic use*; D009765:Obesity / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D010919:Placebos; D012944:Social Support; D013739:Testosterone / Q000097:blood
D000728:Androgens; D003278:Contraceptives, Oral, Hormonal; D007004:Hypoglycemic Agents; D008055:Lipids; D010919:Placebos; D013739:Testosterone; D002097:C-Reactive Protein; D008687:Metformin; D002784:Cholesterol