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Department of Medicine (V.J., S.L.A.), University of Hull, Michael White Centre for Diabetes and Endocrinology, Hull Royal Infirmary, Hull HU3 2RW, United Kingdom; Department of Clinical Biochemistry and Immunology (E.S.K., S.H.), Hull Royal Infirmary, Hull HU3 2JZ, United Kingdom; and Department of Medicine (P.E.J.), York Hospital, York YO31 8HE, United Kingdom
Address all correspondence and requests for reprints to: Dr. V. Jayagopal, Department of Medicine, University of Hull, Michael White Centre for Diabetes and Endocrinology, Hull Royal Infirmary, Anlaby Road, Hull HU3 2RW, United Kingdom. E-mail: V.Jayagopal{at}hull.ac.uk.
The objective of this study was to evaluate and compare the effect of treatment with orlistat vs. metformin on the hormonal and biochemical features of patients with polycystic ovarian syndrome (PCOS).
Twenty-one Caucasian women with PCOS [mean (±SEM) age 27 ± 0.9 yr and body mass index 36.7 ± 3.3 kg/m2] participated in this prospective, randomized, open-labeled study. All subjects had an 8-wk run-in period of dietary modification and then randomized to receive either metformin (500 mg three times daily) or orlistat (120 mg three times daily) for 3 months. Weight, blood pressure, and fasting blood samples were taken at screening, randomization, and on completion. Insulin resistance (IR) was calculated using the homeostasis model of assessment (HOMA)-IR method [HOMA-IR = (insulin x glucose)/22.5].
The results are expressed as mean ± SEM. When compared with baseline, treatment with both orlistat [93.5 ± 11.5 ng/dl (3.24 ± 0.4 nmol/liter) vs. 114.5 ± 11.5 ng/dl (3.97 ± 0.4 nmol/liter), P = 0.039] and metformin [97.2 ± 11.5 ng/dl (3.37 ± 0.4 nmol/liter) vs. 120.0 ± 8.7 ng/dl (4.16 ± 0.3 nmol/liter), P = 0.048] produced a significant reduction in total testosterone. Treatment with orlistat produced a 4.69% reduction in weight (99.0 ± 6.0 vs. 94.6 ± 6.1 kg, P = 0.002), and this reduction was more significant than the reduction produced by metformin (4.69 vs. 1.02%, P = 0.006). There was no significant reduction seen after either treatment group for fasting insulin, HOMA-IR, SHBG, or any of the lipid parameters studied.
In this study, orlistat produced a significant reduction in weight and total testosterone. The reduction in total testosterone was similar to that seen after treatment with metformin. Therefore, orlistat may prove to be a useful adjunct in the treatment of PCOS.
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