Archives of Gynecology and Obstetrics

, Volume 297, Issue 6, pp 1557–1563 | Cite as

Effect of Diane-35, alone or in combination with orlistat or metformin in Chinese polycystic ovary syndrome patients

  • Xiangyan Ruan
  • Jinghua Song
  • Muqing Gu
  • Lijuan Wang
  • Husheng Wang
  • Alfred O. Mueck
Gynecologic Endocrinology and Reproductive Medicine



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.


Diane-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).


  1. 1.
    Goodman NF, Cobin RH, Futerweit W et al (2015) American association of clinical endocrinologists, American college of endocrinology, and androgen excess and PCOS society disease state clinical review: guide to the best practices in the evaluation and treatment of polycystic ovary syndrome—PART 2. Endoc Pract 21:1415–1426CrossRefGoogle Scholar
  2. 2.
    Lizneva D, Suturina L, Walker W et al (2016) Criteria, prevalence, and phenotypes of polycystic ovary syndrome. Fertil Steril 106:6–15CrossRefPubMedGoogle Scholar
  3. 3.
    Ali AT (2015) Polycystic ovary syndrome and metabolic syndrome. Ceska Gynekol 80:279–289PubMedGoogle Scholar
  4. 4.
    Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group (2004) Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril 81:19–25Google Scholar
  5. 5.
    Royal College of Obstetricians and Gynecologists (2014) Polycystic ovary syndrome, long-term consequences (Green-top Guideline No. 33). Accessed 05 Nov 2014
  6. 6.
    Conway G, Dewailly D, Diamanti-Kandarakis E et al (2014) The polycystic ovary syndrome: a position statement from the European society of endocrinology. Eur J Endocrinol 171:1–29CrossRefGoogle Scholar
  7. 7.
    Buzney E, Sheu J, Buzney E et al (2014) Polycystic ovary syndrome: a review for dermatologists, Part II. Treatment. J Am Acad Dermatol 71:859.e1–859.e15CrossRefGoogle Scholar
  8. 8.
    Ruan X, Kubba A, Aguilar A et al (2017) Use of cyproterone acetate/ethinylestradiol in polycystic ovary syndrome: rationale and practical aspects. Eur J Contracept Reprod Health Care 22:183–190CrossRefPubMedGoogle Scholar
  9. 9.
    Williams T, Mortada R, Porter S (2016) Diagnosis and treatment of polycystic ovary syndrome. Am Fam Physician 94:106–113PubMedGoogle Scholar
  10. 10.
    Wang YW, He SJ, Feng X et al (2017) Metformin: a review of its potential indications. Drug Des Devel Ther 11:2421–2429CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Ladson G, Dodson WC, Sweet SD et al (2011) The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study. Fertil Steril 95:1059–1066CrossRefPubMedGoogle Scholar
  12. 12.
    Kumar P, Arora S (2014) Orlistat in polycystic ovarian syndrome reduces weight with improvement in lipid profile and pregnancy rates. J Hum Reprod Sci 7:255–261CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Alqahtani S, Qosa H, Primeaux B et al (2015) Orlistat limits cholesterol intestinal absorption by Niemann-pick C1-like 1 (NPC1L1) inhibition. Eur J Pharmacol 762:263–269CrossRefPubMedGoogle Scholar
  14. 14.
    Ahn SM, Kim H, Ji E et al (2014) The effect of orlistat on weight reduction in obese and overweight Korean patients. Arch Pharm Res 37:512–519CrossRefPubMedGoogle Scholar
  15. 15.
    Wu H, Ruan X, Jin J et al (2015) Metabolic profile of Diane-35 versus Diane-35 plus metformin in Chinese PCOS women under standardized life-style changes. Gynecol Endocrinol 31:548–551CrossRefPubMedGoogle Scholar
  16. 16.
    Yang YM, Choi EJ (2015) Efficacy and safety of metformin or oral contraceptives, or both in polycystic ovary syndrome. Ther Cin Risk Manag 11:1345–1353Google Scholar
  17. 17.
    Vilmann LS, Thisted E, Baker JL et al (2012) Development of obesity and polycystic ovary syndrome in adolescents. Horm Res Paediatr 78:269–278CrossRefPubMedGoogle Scholar
  18. 18.
    Naderpoor N, Shorakae S, Joham A et al (2015) Obesity and polycystic ovary syndrome. Minerva Endocrinol 40:37–51PubMedGoogle Scholar
  19. 19.
    Baptiste CG, Battista MC, Trottier A et al (2010) Insulin and hyperandrogenism in women with polycystic ovary syndrome. J Steroid Biochem Mol Biol 122:42–52CrossRefPubMedGoogle Scholar
  20. 20.
    Tosi F, Bonora E, Moghetti P (2017) Insulin resistance in a large cohort of women with polycystic ovary syndrome: a comparison between euglycaemic-hyperinsulinaemic clamp and surrogate indexes. Hum Reprod 13:1–7Google Scholar
  21. 21.
    Nestler JE, Powers LP, Matt DW et al (1991) A direct effect of hyperinsulinemia on serum sex hormone-binding globulin levels in obese women with the polycystic ovary syndrome. J Clin Endocrinol Metab 72:83–89CrossRefPubMedGoogle Scholar
  22. 22.
    Feng W, Jia YY, Zhang DY et al (2016) Management of polycystic ovarian syndrome with Diane-35 or Diane-35 plus metformin. Gynecol Endocrinol 32:147–150CrossRefPubMedGoogle Scholar
  23. 23.
    Panidis D, Tziomalos K, Papadakis E et al (2014) The role of orlistat in combination with lifestyle changes in the management of overweight and obese patients with polycystic ovary syndrome. Clin Endocrinol (Oxf) 80:432–438CrossRefGoogle Scholar
  24. 24.
    Gallo MF, Lopez LM, Grimes DA et al (2014) Combination contraceptives: effects on weight. Cochrane Database Syst Rev 29:CD003987Google Scholar
  25. 25.
    Glintborg D, Altinok ML, Mumm H et al (2014) Body composition is improved during 12 months’ treatment with metformin alone or combined with oral contraceptives compared with treatment with oral contraceptives in polycystic ovary syndrome. J Clin Endocrinol Metab 99:2584–2591CrossRefPubMedGoogle Scholar
  26. 26.
    de Bastos M, Stegeman BH, Rosendaal FR et al (2014) Combined oral contraceptives: venous thrombosis. Cochrane Database Syst Rev 3:CD010813Google Scholar
  27. 27.
    Sandset PM (2014) Combined oral contraceptives increase risk of venous thrombosis according to oestrogen dose and type of progestogen. Evid Based Med 19:194CrossRefPubMedGoogle Scholar
  28. 28.
    Okoroh EM, Hooper C, Atrash HK et al (2012) Is polycystic ovary syndrome anther risk factor for venous thromboembolism? United States 2003–2008. Am J Obstet Gynecol 207(377):e1–e8Google Scholar
  29. 29.
    Bird ST, Hartzema AG, Brophy JM et al (2013) Risk of venous thromboembolism in women with polycystic ovary syndrome: a population-based matched cohort analysis. CMAJ 185:E115–E120CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Department of Gynecological EndocrinologyBeijing Obstetrics and Gynecology Hospital, Capital Medical UniversityBeijingChina
  2. 2.Department of Women’s HealthUniversity Hospitals of TuebingenTuebingenGermany
  3. 3.Department of Obstetrics and GynecologyBeijing Anzhen Hospital, Capital Medical UniversityBeijingChina

Personalised recommendations