Adverse Effects of Testosterone Therapy in Adult Men: A Systematic Review and Meta-Analysis
Abstract
CONTEXT: The risks of testosterone therapy in men remain poorly understood. OBJECTIVE: The aim of this study was to conduct a systematic review and meta-analyses of testosterone trials to evaluate the adverse effects of testosterone treatment in men. DATA SOURCES: We searched MEDLINE, EMBASE, and Cochrane CENTRAL from 2003 through August 2008. Review of reference lists and contact with experts further identified candidate studies. STUDY SELECTION: Eligible studies were comparative, randomized, and nonrandomized and reported the effects of testosterone on outcomes of interest (death, cardiovascular events and risk factors, prostate outcomes, and erythrocytosis). Reviewers, working independently and in duplicate, determined study eligibility. DATA EXTRACTION: Reviewers working independently and in duplicate determined the methodological quality of studies and collected descriptive, quality, and outcome data. DATA SYNTHESIS: The methodological quality of the 51 included studies varied from low to medium, and follow-up duration ranged from 3 months to 3 yr. Testosterone treatment was associated with a significant increase in hemoglobin [weighted mean difference (WMD), 0.80 g/dl; 95% confidence interval (CI), 0.45 to 1.14] and hematocrit (WMD, 3.18%; 95% CI, 1.35 to 5.01), and a decrease in high-density lipoprotein cholesterol (WMD, -0.49 mg/dl; 95% CI, -0.85 to -0.13). There was no significant effect on mortality, prostate, or cardiovascular outcomes. CONCLUSIONS: The adverse effects of testosterone therapy include an increase in hemoglobin and hematocrit and a small decrease in high-density lipoprotein cholesterol. These findings are of unknown clinical significance. Current evidence about the safety of testosterone treatment in men in terms of patient-important outcomes is of low quality and is hampered by the brief study follow-up.
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Testosterone lowers HDL cholesterol in men.
“testosterone lowers HDL cholesterol in men, which may partly explain why we did not find an increase in HDL cholesterol in men in this systematic review and meta-analysis.”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [42]
A systematic review and meta-analysis of testosterone trials including randomized controlled trials found no significant effect of testosterone supplementation on overall survival.
“In contrast, a systematic review and meta-analysis of T trials, including RCTs demonstrated no significant effect of T supplementation on overall survival.”
From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [124]
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- Authors
- Fernández-Balsells, M. M., Murad, M. H., Lane, M., Lampropulos, J. F., Albuquerque, F., Mullan, R. J., Agrwal, N., Elamin, M. B., Gallegos-Orozco, J. F., Wang, A. T., Erwin, P. J., Bhasin, S., & Montori, V. M.
- Affiliations
- Mayo Clinic (US)
- Boston University (US)
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2010-06
- Volume
- 95
- Issue
- 6
- Pages
- 2560-2575
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2099814945
- Cited by
- 713
- References
- 15
- Citations by year
- 2026: 9 · 2025: 24 · 2024: 29 · 2023: 29 · 2022: 37 · 2021: 18 · 2020: 39 · 2019: 32 · 2018: 46 · 2017: 48 · 2016: 56 · 2015: 71 · 2014: 84 · 2013: 66 · 2012: 58
- FWCI
- 8.45
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Instituto de Salud Carlos III
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Keywords
- testosterone replacement therapy, adverse effects, adult male, erythrocytosis, hemoglobin, hematocrit, HDL cholesterol, cardiovascular events, mortality, treatment safety
- MeSH terms
- Adult, Cardiovascular Diseases, Data Interpretation, Statistical, Humans, Male, Mortality, Polycythemia, Prostatic Neoplasms, Research Design, Risk Factors, Testosterone, Urologic Diseases, Randomized Controlled Trials as Topic, Treatment Outcome
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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