Effect of sibutramine on weight reduction in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
To examine the efficacy of sibutramine together with brief lifestyle modification for weight reduction in obese women with polycystic ovary syndrome (PCOS).


METHODS
Investigator-initiated, multicenter, double-blind, randomized, parallel-group clinical trial.


METHODS
Departments of Obstetrics and Gynecology in primary care, referral centers, and private practice.


METHODS
Forty-two patients with confirmed PCOS were included in the study, and 34 patients completed the study.


METHODS
Sibutramine 15 mg once daily together with brief lifestyle modification was compare with placebo together with brief lifestyle modification.


METHODS
The primary endpoint was to assess weight loss. Secondary endpoints included the efficacy of sibutramine for treatment of menstrual pattern and cardiovascular risk factors.


RESULTS
After 6 months the sibutramine group had lost 7.8 +/- 5.1 kg compared with a weight loss of 2.8 +/- 6.2 kg in the placebo group. Sibutramine treatment resulted in significant decreases in apolipoprotein B, apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C levels.


CONCLUSIONS
Sibutramine in combination with lifestyle intervention results in significant weight reduction in obese patients with PCOS. In addition to the weight loss, sibutramine seems to have beneficial effects on metabolic and cardiovascular risk factors.
Lindholm
Åsa
Å
Department of Obstetrics and Gynecology, Sunderby Hospital, Luleå, Sweden. Electronic address: asa.lindholm@nll.se.
Bixo
Marie
M
Department of Clinical Science, Obstetrics and Gynecology, University Hospital, Umeå, Sweden.
Björn
Inger
I
Department of Clinical Science, Obstetrics and Gynecology, University Hospital, Umeå, Sweden; Läkarhuset Björnen, Piteå, Sweden.
Wölner-Hanssen
Pål
P
Department of Obstetrics and Gynecology, Lund University Hospital, Lund, Sweden.
Eliasson
Mats
M
Department of Internal Medicine, Sunderby Hospital, Luleå, Sweden.
Larsson
Anders
A
Department of Clinical Chemistry, University Hospital, Uppsala, Sweden.
Johnson
Owe
O
Department of Internal Medicine, University Hospital, Umeå, Sweden.
Poromaa
Inger Sundström
IS
Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
D000293:Adolescent; D000328:Adult; D001067:Appetite Depressants / Q000494:pharmacology / Q000627:therapeutic use*; D001835:Body Weight / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000209:etiology; D003503:Cyclobutanes / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008019:Life Style; D008599:Menstruation Disturbances / Q000097:blood / Q000188:drug therapy; D009765:Obesity / Q000097:blood / Q000188:drug therapy*; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000188:drug therapy*; D011446:Prospective Studies; D012307:Risk Factors; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D015431:Weight Loss / Q000187:drug effects
D001067:Appetite Depressants; D003503:Cyclobutanes; D012738:Sex Hormone-Binding Globulin; C058254:sibutramine