REFERENCES

References:

1. Barthelmess EK, Naz RK. Polycystic ovary syndrome: current status and future perspective. Front Biosci (Elite Ed). 2014 Jan 1;6:104-19.

2. Sinopol® package insert, February 2019.

3. Rago R, Marcucci I, Leto G, et al. Effect of myo-inositol and alpha-lipoic acid on oocyte quality in polycystic ovary syndrome non-obese women undergoing in vitro fertilization: a pilot study. J Biol Regulators Homeostatic Agents 2015;29(4):1-11.

4. Cappelli V, Musacchio MC, Bulfoni A, et al. Natural molecules for the therapy of hyperandrogenism and metabolic disorders in PCOS. Eur Rev Med Pharmacol Sci 2017; 21(2 Suppl):15-29.

5. Bellver J, Rodríguez-Tabernero L,  Robles A, et al. Polycystic ovary syndrome throughout a woman’s life. J Assist Reprod Genet 2018;35:25 -39.

6. Carbonelli MG, Di Renzo L, Bigioni M, et al. α-Lipoic Acid Supplementation: A Tool for Obesity Therapy? Curr Pharmaceut Design 2010;16:840-846.

7. PCOS Awareness Association. What is Polycystic Ovarian Syndrome (PCOS) [online] [cited 2019 July 29]. Available from URL:
https://www.pcosaa.org/symptoms.

8. Sirmans SM, Pate KA. Epidemiology, diagnosis, and management of polycystic ovary syndrome. Clin Epidemiol 2014:6 1 -13.

9. Genazzani AD, Shefer K, Della Casa D, et al. Modulatory effects of alpha‑lipoic acid (ALA) administration on insulin sensitivity in obese PCOS patients.
J Endocrinol Invest 2018;41:583 -590.

10. Gunalan E, Yaba A, Yımaz B. The effect of nutrient supplementation in the management of polycystic ovary syndrome-associated metabolic dysfunctions:
A critical review. J Turk Ger Gynecol Assoc 2018;19:220-32.

11. De Cicco S, Immediata V, Romualdi D, et al. Myoinositol combined with alpha-lipoic acid may improve the clinical and endocrine features of polycystic ovary syndrome through an insulin-independent action. Gynecol Endocrinol 2017;33(9):698 -701. 

12.  Sharif E, Rahman S, Zia Y, et al. The frequency of polycystic ovary syndrome in young reproductive females in Qatar. Int J Women’s Health 2017:9 1 -10. 

13. Iezzi ML, Varriale G, Rorge N, et al. Polycystic ovary syndrome in adolescence: new therapeutic approach with inositol and alpha-lipoic acid. Int J Curr Res 2017;9(7):54006-54011.

14. Bellver J, Rodríguez-Tabernero L, Robles A, et al. Polycystic ovary syndrome throughout a woman’s life. J Assist Reprod Genet 2018;35:25 -39.

15. Data on file, iNova Pharmaceuticals.

16. Sinopol® him approved package insert, October 2019.

17. Canepa P, Dal Lago A, De Leo C, et al. Combined treatment with myo-inositol, alpha-lipoic acid, folic acid and vitamins significantly improves sperm parameters of sub-fertile men: a multi-centric study. Eur Rev Med Pharmacol Sci 2018;22:7078-7085.

18. Konrad D, Somwar R, Sweeney G, et al. The Antihyperglycemic Drug a-Lipoic Acid Stimulates Glucose Uptake via Both GLUT4 Translocation and GLUT4 Activation. Potential Role of p38 Mitogen-Activated Protein Kinase in GLUT4 Activation. Diabetes 2001;50:1464–1471.

19. Agarwal A, Virk G, Ong C, et al. Effect of Oxidative Stress on Male Reproduction. World J Mens Health 2014;32(1):1-17.

Proprietary name (and dosage form): SINOPOL® Granules. Composition: Each sachet contains: Myo-inositol 1 000 mg, Alpha Lipoic Acid 400 mg and Folic Acid 200 µg.  Complementary Medicine: Health Supplement. D34.12 Multiple Substance formulation. This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use. Studies as part of the references were not conducted on Sinopol®. Proprietary name (and dosage form): SINOPOL® him Granules. Composition: Each sachet contains: Myo-inositol 500 mg, Alpha Lipoic Acid 400 mg, Coenzyme Q1O 100 mg,
Zinc 7,5 mg, Vitamin B2 1,4 mg, Vitamin B6 1,4 mg, Selenium 41,5 μg and Vitamin B12 2,5 μg. Complementary Medicine: Health Supplement. D34.12 Multiple Substance formulation. This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use. Studies as part of the references were not conducted on Sinopol® Him sachets; efficacy is proven on active ingredients. Name and business address of applicant: iNova Pharmaceuticals (Pty) Limited. Co. Reg. No. 1952/001640/07, 15e Riley Road, Bedfordview. Tel. No. 011 087 0000. www.inovapharma.co.za. For full prescribing information, refer to the package insert. Further information is available on request from iNova Pharmaceuticals. IN4010/20