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Submitted on November 23, 2004
Accepted on May 2, 2005
University Departments of Obstet. Gynecology and Vascular Biochemistry, Level 3 (Level 4) Q.E.B., Royal Infirmary, Glasgow G31 2ER, UK
* To whom correspondence should be addressed. E-mail: gqta13{at}udcf.gla.ac.uk.
Context: metformin treatment of women with polycystic ovary syndrome (PCOS) is widespread, following studies with diverse patient populations. No comparative examination of weight changes or metabolite responses to different doses has been reported.
Objective: to determine whether different doses of metformin (1500 or 2550 mg per day) would have different effects upon body weight, circulating hormones, markers of inflammation and lipid profiles.
Design: prospective cohorts randomized to 2 doses of metformin.
Setting: university teaching hospital with patients from gynaecology / endocrinology clinics
Patients: obese (Ob, BMI 30 to <37; n = 42) and morbidly obese (Mob, BMI 
37; n = 41) women with PCOS.
Intervention: patients were randomized to 2 doses of metformin, and parameters assessed after 4 and 8 months.
Main Outcome Measures: changes in body mass, circulating hormones, markers of inflammation and lipid profiles.
Results. Intention to treat analyses showed significant weight loss in both dose groups. Only the Ob sub-group showed a dose relationship (1.5 Kg and 3.6 Kg in 1500 mg and 2550 mg groups respectively, P = 0.04). The Mob group showed similar reductions (3.9 and 3.8 Kg) in both groups. Suppression of androstenedione was significant with both metformin doses, but with no clear dose relationship. Generally beneficial changes in lipid profiles were not related to dose.
Conclusion. Weight loss is a feature of protracted metformin therapy in obese women with PCOS, with greater weight reduction potentially achievable with higher doses. Further studies are required to determine whether other aspects of the disorder may benefit from the higher dose of metformin.
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