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Randomized controlled trial evaluating response to metformin versus standard therapy in the treatment of adolescents with polycystic ovary syndrome

Allen, H.F., Mazzoni, C., Heptulla, R.A., Murray, M.A., Miller, N., Koenigs, L., Reiter, E.O.·2005·Journal of Pediatric Endocrinology and Metabolism
DOI 10.1515/jpem.2005.18.8.761
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Abstract

OBJECTIVE: We evaluated the hypothesis that metformin would improve signs and symptoms of polycystic ovary syndrome (PCOS) in adolescents as compared to oral contraceptive pills (OCP) and have a favorable effect on obesity. STUDY DESIGN: Thirty-five obese, post-menarchal, non-sexually active adolescents aged 12-21 years with PCOS and hyperinsulinism were randomly assigned to receive either OCP or metformin for 6 months. RESULTS: There was a significant decrease in BMI in the two groups over time, from 40.1 to 38.6 in the OCP group, and 37.3 to 36.3 in the metformin group, p = 0.0026, but no significant difference in the degree of change between the two groups. Both groups had decreased free testosterone (OCP: 1.8 pg/ml to 0.96 pg/ml; metformin: 2.1 pg/ml to 1.6 pg/ml), p < 0.0001, and improvements in insulin resistance as evidenced by increased glucose/insulin (G/I) ratio (p < 0.005) and increased QUICK1 scores (p < 0.0005). No significant differences in response to treatment were found between the metformin and OCP groups in outcome variables. CONCLUSION: Adolescents with PCOS treated with metformin or OCP experienced similar beneficial outcomes including reduction in androgen levels, weight loss, and increased insulin sensitivity. The choice of a treatment agent for long-term use will depend on safety profiles, therapeutic goals and patient adherence.

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Crossref · 10.1515/jpem.2005.18.8.761

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  • Multiple observational studies and six RCTs evaluating the effect of metformin on a total of 275 adolescents with PCOS have demonstrated short-term beneficial effects mostly in adolescents with overweight/obesity.

    “There have been multiple observational studies and six RCTs evaluating the effect of metformin on a total of 275 adolescents with PCOS. These studies have demonstrated short-term beneficial effects mostly in adolescents with overweight/obesity [164, 180–183].”

    From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [180]

  • COCPs are associated with improvement in menstrual irregularity and acne according to a meta-analysis of metformin vs oral contraceptives in adolescents with PCOS.

    “Metformin at a dose of 1700 to 2000 mg/d is associated with greater improvement of BMI, and COCPs are associated with improvement in menstrual irregularity and acne according to a meta-analysis of metformin vs oral contraceptives in adolescents with PCOS and including four RCTs (170 adolescents) [164, 180–184].”

    From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [180]

  • COCPs improve menstrual irregularity in adolescents with PCOS.

    “COCPs improve menstrual irregularity in adolescents with PCOS [164, 180–184].”

    From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [180]

  • Metformin at a dose of 1700 to 2000 mg/d is associated with greater improvement of BMI according to a meta-analysis of metformin vs oral contraceptives in adolescents with PCOS and including four RCTs (170 adolescents).

    “Metformin at a dose of 1700 to 2000 mg/d is associated with greater improvement of BMI, and COCPs are associated with improvement in menstrual irregularity and acne according to a meta-analysis of metformin vs oral contraceptives in adolescents with PCOS and including four RCTs (170 adolescents) [164, 180–184].”

    From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [180]

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Authors
Allen, H. F., Mazzoni, C., Heptulla, R. A., Murray, M. A., Miller, N., Koenigs, L., & Reiter, E. O.
Affiliations
Tufts University (US)
ORCID
Reiter, E.O.
Venue
Journal of Pediatric Endocrinology and Metabolism
Publisher
Walter de Gruyter GmbH
Published
2005-01
Volume
18
Issue
8
Pages
761-8
ISSN
  • 0334-018X (ISSN-L)
  • 2191-0251
DOI
10.1515/jpem.2005.18.8.761
OpenAlex
W2316241706
Cited by
90
References
42
Citations by year
2025: 3 · 2023: 5 · 2022: 1 · 2021: 4 · 2020: 7 · 2019: 2 · 2018: 2 · 2017: 4 · 2016: 6 · 2015: 9 · 2014: 7 · 2013: 1 · 2012: 4
FWCI
6.97
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Pediatric Endocrinology and Metabolism (publishedVersion)
  • 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 › Dermatology › Acne and Rosacea Treatments and Effects
Keywords
polycystic ovary syndrome, adolescents, metformin, oral contraceptives, obesity, hyperinsulinism, insulin resistance, free testosterone, androgen reduction, weight loss, glucose/insulin ratio
MeSH terms
Adolescent, Adult, Androgens, Child, Contraceptives, Oral, Female, Humans, Hyperinsulinism, Hypoglycemic Agents, Insulin Resistance, Metformin, Obesity, Polycystic Ovary Syndrome, Weight Loss, Treatment Outcome

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