TY - JOUR
T1 - The Efficacy and Adverse Events of Testosterone Replacement Therapy in Hypogonadal Men
T2 - A Systematic Review and Meta-Analysis of Randomized, Placebo-Controlled Trials
AU - Ponce, Oscar J.
AU - Spencer-Bonilla, Gabriela
AU - Alvarez-Villalobos, Neri
AU - Serrano, Valentina
AU - Singh-Ospina, Naykky
AU - Rodriguez-Gutierrez, Rene
AU - Salcido-Montenegro, Alejandro
AU - Benkhadra, Raed
AU - Prokop, Larry J.
AU - Bhasin, Shalender
AU - Brito, Juan P.
N1 - Publisher Copyright:
Copyright © 2018 Endocrine Society.
PY - 2018/5/1
Y1 - 2018/5/1
N2 - Context: The efficacy and safety of testosterone replacement therapy (TRT) in hypogonadal men remain incompletely understood. Objective: To conduct a systematic review and meta-analysis of randomized clinical trials (RCTs) to determine the effects of TRT on patient important outcomes and adverse events in hypogonadal men. Data Sources: We searched Ovid Medline, Ovid Embase, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus, from inception to 2March 2017. Study Selection: Randomized clinical trials assessing the efficacy and adverse events of TRT of at least 12 weeks compared with placebo in adult men with hypogonadism, defined by morning total testosterone #300 ng/dL and at least one symptom or sign of hypogonadism. Data Extraction: Reviewers working independently and in duplicate assessed the quality of RCTs and collected data on patient characteristics, interventions, and outcomes. Results: We found four RCTs (including 1779 patients) at low risk of bias. Compared with placebo, TRT was associated with a small but significant increase in sexual desire or libido [standardized mean difference (SMD): 0.17; 95% confidence interval (CI), 0.01, 0.34; n = 1383], erectile function (SMD: 0.16; 95% CI, 0.06, 0.27; n = 1344), and sexual satisfaction (SMD: 0.16; 95% CI, 0.01, 0.31; n = 676) but had no effect on energy or mood. TRT was associated with an increased risk of developing erythrocytosis (relative risk: 8.14; 95% CI, 1.87, 35.40; n = 1579) compared with placebo but had no significant effect on lower urinary tract symptoms. Conclusion: In hypogonadal men, TRT improves sexual desire, erectile function and sexual satisfaction; however, it increases the risk of erythrocytosis.
AB - Context: The efficacy and safety of testosterone replacement therapy (TRT) in hypogonadal men remain incompletely understood. Objective: To conduct a systematic review and meta-analysis of randomized clinical trials (RCTs) to determine the effects of TRT on patient important outcomes and adverse events in hypogonadal men. Data Sources: We searched Ovid Medline, Ovid Embase, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus, from inception to 2March 2017. Study Selection: Randomized clinical trials assessing the efficacy and adverse events of TRT of at least 12 weeks compared with placebo in adult men with hypogonadism, defined by morning total testosterone #300 ng/dL and at least one symptom or sign of hypogonadism. Data Extraction: Reviewers working independently and in duplicate assessed the quality of RCTs and collected data on patient characteristics, interventions, and outcomes. Results: We found four RCTs (including 1779 patients) at low risk of bias. Compared with placebo, TRT was associated with a small but significant increase in sexual desire or libido [standardized mean difference (SMD): 0.17; 95% confidence interval (CI), 0.01, 0.34; n = 1383], erectile function (SMD: 0.16; 95% CI, 0.06, 0.27; n = 1344), and sexual satisfaction (SMD: 0.16; 95% CI, 0.01, 0.31; n = 676) but had no effect on energy or mood. TRT was associated with an increased risk of developing erythrocytosis (relative risk: 8.14; 95% CI, 1.87, 35.40; n = 1579) compared with placebo but had no significant effect on lower urinary tract symptoms. Conclusion: In hypogonadal men, TRT improves sexual desire, erectile function and sexual satisfaction; however, it increases the risk of erythrocytosis.
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U2 - 10.1210/jc.2018-00404
DO - 10.1210/jc.2018-00404
M3 - Review article
AN - SCOPUS:85046641951
SN - 0021-972X
VL - 103
SP - 1745
EP - 1754
JO - Journal of Clinical Endocrinology and Metabolism
JF - Journal of Clinical Endocrinology and Metabolism
IS - 5
ER -