Effect of Diane-35, alone or in combination with orlistat or metformin in Chinese polycystic ovary syndrome patients
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To evaluate the effect of Diane-35, alone or in combination with orlistat or metformin, on androgen and body fat percentage parameters in Chinese overweight and obese polycystic ovary syndrome (PCOS) patients with insulin resistance.
A total of 240 PCOS women were randomly allocated to receive Diane-35 alone (D group), Diane-35 plus orlistat (DO group), Diane-35 plus metformin (DM group), or Diane-35 plus orlistat plus metformin (DOM group). Serum TT, DHEA-S, androstenedione, SHBG, FT, FAI, body fat, and body fat percentage were assessed at baseline and after 12 weeks of treatment.
Significant changes in serum TT, SHBG, and FAI were observed in all treatment groups compared with baseline. DHEA-S and androstenedione significantly decreased in the DO, DM, and DOM groups after treatment. FT only significantly decreased in the DOM group. Body fat and body fat percentage significantly decreased in the DO and DOM groups. Compared with the D group, DHEA-S significantly decreased in the DO, DM, and DOM groups (F = 4.081, p = 0.008); SHBG significantly increased in the DOM group (F = 3.019, p = 0.031); and FAI significantly decreased in the DO group (χ2 = 12.578, p = 0.006). There were significant differences between groups in body fat percentage (χ2 = 23.590, p < 0.001). Side-effects were less with orlistat than metformin.
Diane-35 in combination with orlistat or metformin is more effective in reducing androgen than Diane-35 alone. Orlistat is more effective in reducing body fat percentage than metformin. In addition, orlistat has mild side-effects and is better tolerated compared with metformin.
KeywordsDiane-35 Orlistat Metformin Polycystic ovary syndrome
The authors especially thank Prof. Xingming Li for his assistance in statistical analysis of the data.
Author contribution statement
XR: Project development, manuscript writing; JS: data collection, data analysis; MG: data collection; LW: data collection; HW: data collection; AOM: manuscript editing
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
This study was supported by Capital Characteristic Clinic Project of China (Z161100000516143); Beijing Capital Foundation for Medical Science Development and Research (2016-2-2113); Clinical Technique Innovation Project of Beijing Municipal Administration of Hospitals (XMLX201710); Beijing Municipality Health Technology High-level Talent (2014-2-016); Foreign technical and administrative talent introduction project in 2017, State Administration of Foreign Experts Affairs, the P. R. of China (20171100004).
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