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Adverse Effects of the Common Treatments for Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis
Open accessAbstract
CONTEXT: Polycystic ovary syndrome (PCOS) is common among women of childbearing age and the available pharmacological therapies have different side-effect profiles. OBJECTIVE: We summarized the evidence about the side effects of oral contraceptive pills, metformin, and anti-androgens in women with PCOS. DATA SOURCE: Sources included Ovid Medline, OVID EMBASE, OVID Cochrane Library, Web of Science, Scopus, PsycInfo, and CINAHL from inception through April 2011. STUDY SELECTION: We included comparative observational studies enrolling women with PCOS who received the agents of choice for at least 6 months and reported adverse effects. DATA EXTRACTION: Using a standardized, piloted, and Web-based data extraction form and working in duplicate, we abstracted data from each study and performed meta-analysis when possible. DATA SYNTHESIS: We found 22 eligible studies of which 20 were randomized. No study reported severe side effects (eg, lactic acidosis, thromboembolic episodes, liver toxicity, cancer incidence, or pregnancy loss). Meta-analysis demonstrated no significant change in weight in oral contraceptive pills or flutamide users. Indirect evidence from populations without PCOS demonstrated no increased risk of lactic acidosis with metformin, only case reports of liver toxicity with flutamide (no comparative evidence), and increased relative risk difference of venous thromboembolism with oral contraceptive pills but very low absolute risk. Evidence on mortality, cardiovascular mortality, and cancer was inconclusive. CONCLUSIONS: Drugs commonly used to treat PCOS appear to be associated with very low risk of severe adverse effects although data are extrapolated from other populations.
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“Flutamide has been associated with severe side effects such as liver toxicity [191, 207].”
From Polycystic Ovary Syndrome: Pathophysiology, Presentation, and Treatment With Emphasis on Adolescent Girls (2019) · cites this paper as [207]
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“Extended-release preparations may also decrease the gastrointestinal side effects.2,66”
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Metadata
- Authors
- Domecq, J. P., Prutsky, G., Mullan, R. J., Sundaresh, V., Wang, A. T., Erwin, P. J., Welt, C., Ehrmann, D., Montori, V. M., & Murad, M. H.
- Affiliations
- Mayo Clinic (US)
- University of Minnesota (US)
- Massachusetts General Hospital (US)
- University of Chicago (US)
- Corresponding author
- Murad, Mohammad Hassan
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2013-12
- Volume
- 98
- Issue
- 12
- Pages
- 4646-4654
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- PMC
- PMC5399491
- OpenAlex
- W1979724250
- Cited by
- 115
- References
- 71
- Citations by year
- 2026: 14 · 2025: 9 · 2024: 9 · 2023: 10 · 2022: 14 · 2021: 2 · 2020: 7 · 2019: 6 · 2018: 5 · 2017: 8 · 2016: 11 · 2015: 10 · 2014: 8 · 2013: 2
- FWCI
- 12.48
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD065029)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
- Keywords
- polycystic ovary syndrome, adverse drug reactions, oral contraceptives, metformin, androgen receptor antagonists, flutamide, lactic acidosis, venous thromboembolism, hepatotoxicity, weight change, cardiovascular mortality, cancer risk
- MeSH terms
- Androgen Antagonists, Contraceptives, Oral, Female, Flutamide, Humans, Hypoglycemic Agents, Metformin, Polycystic Ovary Syndrome, Risk Factors, Evidence-Based Medicine, Venous Thromboembolism
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