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Comparison of Clinical, Metabolic and Hormonal Effects of Metformin Versus Combined Therapy of Metformin With Myoinositol Plus D-Chiro-Inositol in Women With Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial
Open accessAbstract
Objective To compare the effects of metformin alone versus combined therapy of metformin with myoinositol (MI) plus D-chiro-inositol (DCI) in women with polycystic ovary syndrome (PCOS). Materials and methods This is a prospective, non-blinded randomized controlled trial conducted in newly diagnosed PCOS women aged 18 to 45 years. Group I received metformin 500 mg twice a day orally for 6 months while group II received metformin 500 mg twice a day orally along with MI 550 mg plus DCI 150 mg twice daily orally for six months. The primary outcome was a change in clinical, metabolic and hormonal parameters of the two groups from baseline to the end of six months of treatment. Results A total of 72 patients were randomized into two groups of 36 patients each. Statistically, a significant difference was seen in terms of mean global acne score (p=0.004) and cycle regularity (p=0.034) after six months of treatment in group II. A significant difference in values of luteinizing hormone (LH) (p=0.002), luteinizing hormone/follicle-stimulating hormone (LH/FSH) ratio (p=0.007), mean cholesterol (p=0.040), mean high-density lipoprotein (HDL) (p=0.049), mean low-density lipoprotein (LDL) (p=0.0001) and postprandial insulin (p=0.005) was also seen in group II at the end of treatment duration. No significant difference was seen between the two groups in terms of mean FSH, mean testosterone, mean dehydroepiandrosterone sulfate (DHEAS), mean triglyceride, mean fasting and postprandial blood sugar, fasting insulin and homeostatic model assessment of insulin resistance (HOMA-IR) index. Conclusion Combined therapy with metformin and MI plus DCI in women with PCOS and insulin resistance seems promising with the need for further studies with a greater sample size to evaluate the efficacy of this treatment.
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In one study of 72 women, 1.1 g MI + 0.3 g DCI + 1 g metformin vs metformin alone for 6 months showed improvements in menstrual irregularity, cholesterol, HDL, LDL, and postprandial insulin, with low certainty; no differences for hirsutism, androgens, anthropometry, or glucose, with low certainty.
“One study (n = 72) (28) suggests there were improvements in menstrual irregularity (38.9% vs 63.9%, P = .034), cholesterol (31.58 mg/dL ± 23.99 vs 146.75 mg/dL ± 36.37, P = .040), HDL (47.25 mg/dL ± 15.92 vs 41.53 mg/dL ± 6.38, P = .049), LDL (85.89 mg/dL ± 19.84 vs 106.16 mg/dL ± 22.78, P = .0001), and postprandial insulin (35.30 mIU/L ± 18.94 vs 57.82mIU/L ± 37.52, P = .005) with 1.1 g MI + 0.3”
From Inositol for Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis to Inform the 2023 Update of the International Evidence-based PCOS Guidelines (2024) · cites this paper as [28]
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Experimental — accuracy not yet measuredOne included trial evaluated MI + DCI + metformin.
“One trial evaluated MI + DCI + metformin (28) and 1 MI + metformin (30).”
From Inositol for Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis to Inform the 2023 Update of the International Evidence-based PCOS Guidelines (2024) · cites this paper as [28]
Twelve included studies used metformin at doses of 1000 mg to 2000 mg daily alone or in combination with FA as a comparator.
“Twelve used metformin at doses of 1000 mg to 2000 mg daily alone or in combination with FA as a comparator (26, 28, 30, 33, 39, 41, 42, 49-54, 56).”
From Inositol for Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis to Inform the 2023 Update of the International Evidence-based PCOS Guidelines (2024) · cites this paper as [28]
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References 21 · Cited by 22
Research works printed but not linked: 14
- Azziz R, Woods KS, Reyna R, Key TJ, Knochenhauer ES, Yildiz BO. The prevalence and features of the polycystic ovary syndrome in an unselected population. J Clin Endocrinol Metab. 2004, 89:2745-9. 10.1210/jc.2003-032046 · DOI
- Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004, 81.19-25. 10.1016/j.fertnstert.2003.10.004 · DOI · Paper page
- Stumvoll M, Nurjhan N, Perriello G, Dailey G, Gerich JE. Metabolic effects of metformin in non-insulin-dependent diabetes mellitus. N Engl J Med. 1995, 333:550-4. 10.1056/NEJM199508313330903 · DOI · Paper page
- Moran LJ, Hutchison SK, Norman RJ, Teede HJ. Lifestyle changes in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2011, CD007506. 10.1002/14651858.CD007506.pub2 · DOI · Paper page
- Baillargeon JP, Iuorno MJ, Nestler JE. Insulin sensitizers for polycystic ovary syndrome. Clin Obstet Gynecol. 2003, 46:325-40. 10.1097/00003081-200306000-00011 · DOI
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- Harborne L, Fleming R, Lyall H, Sattar N, Norman J. Metformin or antiandrogen in the treatment of hirsutism in polycystic ovary syndrome. J Clin Endocrinol Metab. 2003, 88:4116-23. 10.1210/jc.2003-030424 · DOI
- Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010, 16:543-52. 10.2119/molmed.2010.00107 · DOI
- Randeva HS, Tan BK, Weickert MO, Lois K, Nestler JE, Sattar N, Lehnert H. Cardiometabolic aspects of the polycystic ovary syndrome. Endocr Rev. 2012, 33:812-41. 10.1210/er.2012-1003 · DOI
- Benelli E, Del Ghianda S, Di Cosmo C, Tonacchera M. A combined therapy with myo-inositol and D-chiro-inositol improves endocrine parameters and insulin resistance in PCOS young overweight women. Int J Endocrinol. 2016, 2016:3204083. 10.1155/2016/3204083 · DOI · Paper page
- Nestler JE. Insulin regulation of human ovarian androgens. Hum Reprod. 1997, 12 Suppl 1:53-62. 10.1093/humrep/12.suppl_1.53 · DOI
- Nestler JE, Unfer V. Reflections on inositol(s) for PCOS therapy: steps toward success. Gynecol Endocrinol. 2015, 31:501-5. 10.3109/09513590.2015.1054802 · DOI · Paper page
- Facchinetti F, Bizzarri M, Benvenga S, et al.. Results from the International Consensus Conference on myo-inositol and D-chiro-inositol in obstetrics and gynecology: the link between metabolic syndrome and PCOS. Eur J Obstet Gynecol Reprod Biol. 2015, 195:72-6. 10.1016/j.ejogrb.2015.09.024 · DOI
- Chirania K, Misra S, Behera S. A randomised clinical trial comparing myoinositol and metformin in PCOS. Int J Reprod Contracept Obstet Gynecol. 2017, 6:1814-20. 10.18203/2320-1770.ijrcog20171563 · DOI · Paper page
Metadata
- Authors
- Bahadur, A., Arora, H., Ravi, A. K., Naithani, M., Bahurupi, Y., Chaturvedi, J., Ajmani, M., & Mundhra, R.
- Affiliations
- All India Institute of Medical Sciences Rishikesh (IN)
- Corresponding author
- Mundhra, Rajlaxmi
- ORCID
- Venue
- Cureus
- Published
- 2021-06-07
- Volume
- 13
- Issue
- 6
- Pages
- e15510-e15510
- ISSN
- 2168-8184 (ISSN-L)
- PMC
- PMC8263823
- OpenAlex
- W3169139421
- Cited by
- 22
- References
- 21
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 7 · 2023: 8 · 2022: 1
- FWCI
- 3.45
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- cc-by
- Locations
- Cureus (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Reproductive Medicine › Reproductive Biology and Fertility
- Keywords
- polycystic ovary syndrome, metformin, myo-inositol, D-chiro-inositol, insulin resistance, combination therapy, acne, menstrual cycle regularity, luteinizing hormone, lipid profile, HOMA-IR
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