Table 2

Meta-analysis of adverse events associated with the use of any testosterone compared with placebo

OutcomeNo. of RCTsTreatment durationEvent/no. treatedOR
(95% CI)*
I 2
Cardiovascular death1812 weeks to 36 monthsPlacebo: 4/1851
TRT: 9/2088
2.15 (0.72 to 6.45)11%
Myocardial infarction1512 weeks to 36 monthsPlacebo: 10/1613
TRT: 6/1915
0.43 (0.15 to 1.19)34%
Prostate cancer1312 weeks to 36 monthsPlacebo: 11/1649
TRT: 12/1877
0.97 (0.43 to 2.23)0%
Stroke812 weeks to 36 monthsPlacebo: 8/1103
TRT: 8/1104
0.99 (0.37 to 2.65)29%
Heart disease340 weeks to 12 monthsPlacebo: 5/120
TRT: 5/131
0.89 (0.24 to 3.26)0%
Erythrocytosis412 weeks to 12 monthsPlacebo: 0/78
TRT: 4/110
2.44 (0.26 to 22.53)0%
Diabetes0
Serious adverse events1812 weeks to 36 monthsPlacebo: 181/1902
TRT: 168/2138
0.88 (0.70 to 1.11)0%
Withdrawals due to adverse events4812 weeks to 36 monthsPlacebo: 150/2551
TRT: 221/2840
1.31 (0.98 to 1.73)13%
  • *Random-effects models.

  • RCT, randomised controlled trial; TRT, testosterone replacement therapy.