Insulin Resistance in Polycystic Ovary Syndrome Improved by Chinese Medicine Dingkun Pill (定坤丹): A Randomized Controlled Clinical Trial (original) (raw)

Abstract

Objective

To assess the efficacy and safety of the Chinese medicine Dingkun Pill (定坤丹, DKP) on insulin resistance in women with polycystic ovary syndrome (PCOS).

Methods

A total of 117 women with PCOS were randomly assigned to Group A (38 women), Group B (40 women), or Group C (39 women) in a randomization sequence with SAS software and a 1:1:1 allocation ratio using random block sizes of 6, and were given 7 g of oral DKP daily (Group A), 1 tablet of Diane-35 orally daily (Group B), or 7 g of oral DKP daily plus 1 tablet of Diane-35 orally daily (Group C). Patients took all drugs cyclically for 21 consecutive days, followed by 7 drug-free days. The treatment course for the 3 groups was continued for 3 consecutive months. Oral glucose tolerance tests (OGTT) were performed before treatment and again after 2 and 3 months of therapy, respectively, and homeostasis model assessment for insulin resistance (HOMA-IR) and quantitative insulin sensitivity check index (QUICKI) were calculated.

Results

Of 117 women with PCOS, 110 completed the entire course of therapy: 35 in Group A, 36 in Group B, and 39 in Group C. After treatment, all three groups showed significant decreases in fasting glucose: at 1 h glucose decreased significantly in Group A (by 0.5 ± 1.4 mmol/L, _P_=0.028) and Group C (by 0.5 ± 1.2 mmol/L, _P_=0.045); while showing a tendency to increase in Group B (by 0.4 ± 1.9 mmol/L, _P_=0.238). HOMA-IR decreased significantly in Group C [by 0.5 (−2.2 to 0.5) mIU mmol/L2, _P_=0.034]. QUICKI was significantly increased in Groups A and C (by 0.009 ± 0.02, _P_=0.033 and by 0.009 ± 0.027, _P_=0.049, respectively), while no change was observed in Group B. Repeated-measure ANOVA showed that the absolute changes in all parameters (except for glucose at 1 h), including glucose and insulin levels at all time-points during OGTT and in HbA1c, HOMA-IR, and QUICKI, were not significantly different among the 3 groups after treatment (_P_>0.05).

Conclusion

DKP or DKP combined with Diane-35 produce a slight improvement in insulin sensitivity compared with Diane-35 alone in PCOS patients (Trial Registration: ClinicalTrials.gov, NCT03264638).

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References

  1. Goodman NF, Cobin RH, Futterweit W, Glueck JS, Legro RS, Carmina E. 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. Endocr Pract 2015;21:1415–1426.
    Article PubMed Google Scholar
  2. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod 2004;19:41–47.
  3. Escobar-Morreale HF. Polycystic ovary syndrome: definition, aetiology, diagnosis and treatment. Nat Rev Endocrinol 2018;14:270–284.
    Article PubMed Google Scholar
  4. Ranasinha S, Joham AE, Norman RJ, Shaw JE, Zoungas S, Boyle J, et al. The association between polycystic ovary syndrome (PCOS) and metabolic syndrome: a statistical modelling approach. Clin Endocrinol 2015;83:879–887.
    Article CAS Google Scholar
  5. Fazleen NE, Whittaker M, Mamun A. Risk of metabolic syndrome in adolescents with polycystic ovarian syndrome: a systematic review and meta-analysis. Diabetes Metab Syndr 2018;12:1083–1090.
    Article PubMed Google Scholar
  6. Chen L, Tan Y, Chen SP. Effect of clomiphene citrate and Dingkun Dan on ovulation induction and clinical pregnancy of polycystic ovary syndrome. Chin J Mater Med (Chin) 2017;42:4035–4039.
    Google Scholar
  7. Namavar Jahromi B, Dabaghmanesh MH, Parsanezhad ME, Fatehpoor F. Association of leptin and insulin resistance in PCOS: a case-controlled study. Int J Reprod Biomed (Yazd, Iran) 2017;15:423–428.
    Article Google Scholar
  8. Teede HJ, Hutchison SK, Zoungas S. The management of insulin resistance in polycystic ovary syndrome. Trends Endocrinol Metab 2007;18:273–279.
    Article CAS PubMed Google Scholar
  9. Jonard S, Robert Y, Cortet-Rudelli C, Pigny P, Decanter C, Dewailly D. Ultrasound examination of polycystic ovaries: is it worth counting the follicles? Hum Reprod 2003;18:598–603.
    Article CAS PubMed Google Scholar
  10. Hatch R, Rosenfield RL, Kim MH, Tredway D. Hirsutism: implications, etiology, and management. Am J Obstet Gynecol 1981;140:815–830.
    Article CAS PubMed Google Scholar
  11. Hacivelioglu S, Gungor AN, Gencer M, Uysal A, Hizli D, Koc E, et al. Acne severity and the Global Acne Grading System in polycystic ovary syndrome. Int J Gynaecol Obstet 2013;123:33–36.
    Article PubMed Google Scholar
  12. Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, et al. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab 2000;85:2402–2410.
    Article CAS PubMed Google Scholar
  13. Pasquali R. Metabolic syndrome in polycystic ovary syndrome. Front Horm Res 2018;49:114–130.
    Article PubMed Google Scholar
  14. Abbott DH, Bacha F. Ontogeny of polycystic ovary syndrome and insulin resistance in utero and early childhood. Fertil Steril 2013;100:2–11.
    Article CAS PubMed PubMed Central Google Scholar
  15. Johansson J, Stener-Victorin E. Polycystic ovary syndrome: effect and mechanisms of acupuncture for ovulation induction. Evid Based Complement Alternat Med 2013;2013:762615.
    Article PubMed PubMed Central Google Scholar
  16. Wang LH, Wang X, Yu XZ, Xu WT. Potent therapeutic effects of Shouwu Jiangqi Decoction on polycystic ovary syndrome with insulin resistance in rats. Chin J Integr Med 2016;22:116–123.
    Article CAS PubMed Google Scholar
  17. Shorakae S, Ranasinha S, Abell S, Lambert G, Lambert E, De Courten B, et al. Inter-related effects of insulin resistance, hyperandrogenism, sympathetic dysfunction and chronic inflammation in PCOS. Clin Endocrinol 2018;89:628–633.
    Article CAS Google Scholar
  18. Dickerson EH, Cho LW, Maguiness SD, Killick SL, Robinson J, Atkin SL. Insulin resistance and free androgen index correlate with the outcome of controlled ovarian hyperstimulation in non-PCOS women undergoing IVF. Hum Reprod 2010;25:504–509.
    Article CAS PubMed Google Scholar
  19. Diamanti-Kandarakis E, Papavassiliou AG. Molecular mechanisms of insulin resistance in polycystic ovary syndrome. Trends Mol Med 2006;12:324–332.
    Article CAS PubMed Google Scholar
  20. Jayasena CN, Franks S. The management of patients with polycystic ovary syndrome. Nat Rev Endocrinol 2014;10:624–636.
    Article PubMed Google Scholar
  21. ACOG Practice Bulletin No. 194: polycystic ovary syndrome. Obstet Gynecol 2018;131:e157–e171.
  22. Role of metformin for ovulation induction in infertile patients with polycystic ovary syndrome (PCOS): a guideline. Fertil Steril 2017;108:426–441.
  23. De Medeiros SF. Risks, benefits size and clinical implications of combined oral contraceptive use in women with polycystic ovary syndrome. Reprod Biol Endocrin 2017;15:93.
    Article CAS Google Scholar
  24. Luque-Ramirez M, Alvarez-Blasco F, Botella-Carretero JI, Martinez-Bermejo E, Lasuncion MA, Escobar-Morreale HF. Comparison of ethinyl-estradiol plus cyproterone acetate versus metformin effects on classic metabolic cardiovascular risk factors in women with the polycystic ovary syndrome. J Clin Endocrinol Metab 2007;92:2453–2461.
    Article CAS PubMed Google Scholar
  25. Meyer C, Mcgrath BP, Teede HJ. Effects of medical therapy on insulin resistance and the cardiovascular system in polycystic ovary syndrome. Diabetes Care 2007;30:471–478.
    Article CAS PubMed Google Scholar
  26. Fruzzetti F, Perini D, Lazzarini V, Parrini D, Gambacciani M, Genazzani AR. Comparison of effects of 3 mg drospirenone plus 20 μ g ethinyl estradiol alone or combined with metformin or cyproterone acetate on classic metabolic cardiovascular risk factors in nonobese women with polycystic ovary syndrome. Fertil Steril 2010;94:1793–1798.
    Article CAS PubMed Google Scholar

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Acknowledgments

We are grateful to all the women who participated in our study, and wish to thank the Clinical Laboratory Department of Peking Union Medical College Hospital.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China
    Yan Deng, Wei Xue, Yan-fang Wang, Shi-yang Zhu, Xiao Ma & Ai-jun Sun
  2. Technology Center for Protein Sciences, School of Life Sciences, Tsinghua University, Beijing, 100084, China
    Xiao-hui Liu
  3. Department of Obstetrics and Gynecology, The Second Hospital of Hebei Medical University, Hebei, 050000, China
    Hong-ling Zuo
  4. Department of Obstetrics and Gynecology, Third Xiangya Hospital, Central South University, Changsha, 410013, China
    Jian-fa Jiang
  5. Department of Obstetrics and Gynecology, Beijing Chaoyang Hospital Affiliated of Capital Medical University, Beijing, 100020, China
    Ting-ping Zheng

Authors

  1. Yan Deng
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  2. Wei Xue
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  3. Yan-fang Wang
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  4. Xiao-hui Liu
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  5. Shi-yang Zhu
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  6. Xiao Ma
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  7. Hong-ling Zuo
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  8. Jian-fa Jiang
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  9. Ting-ping Zheng
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  10. Ai-jun Sun
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Correspondence toAi-jun Sun.

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Deng, Y., Xue, W., Wang, Yf. et al. Insulin Resistance in Polycystic Ovary Syndrome Improved by Chinese Medicine Dingkun Pill (定坤丹): A Randomized Controlled Clinical Trial.Chin. J. Integr. Med. 25, 246–251 (2019). https://doi.org/10.1007/s11655-018-2947-1

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