Abstract
BackgroundTestosterone deficiency (TD) may induce a series of clinical symptoms.Studies have shown that testosterone supplementation may prevent these unfavourable symptoms and improve patients’ quality of life. Given the conflicting findings across studies, this systematic review aims to evaluate the effects and risks associated with testosterone supplementation in middle-aged or aging males with TD.MethodsElectronic databases (MEDLINE, EMBASE, PubMed, and Cochrane.Library were searched to December 2019. The risk of bias of individual included studies and the quality of the aggregate evidence were assessed using the GRADE approach. Our primary outcome was bone mineral density (BMD). Meta-analyses were performed. This systematic review was reported according to the PRISMA statement.ResultsA total of 52 randomized controlled trials (RCTs) were included. When compared with placebo, testosterone supplementation did not increase total BMD (short-term: 1081 participants, MD − 0.01 g/cm2, 95% CI − 0.02 g/cm2 to 0.01 g/cm2; long-term: 156 participants, MD 0.04 g/cm2, 95% CI − 0.07 g/cm2 to 0.14 g/cm2), lumbar spine, hip, or femur neck BMD. Furthermore, testosterone supplementation did not decrease the risk of falling or fracture. Lastly, it was found that testosterone supplementation did not increase the risk of cardiovascular events (1374 participants, RR 1.28, 95% CI 0.62 to 2.64), all-cause mortality (729 participants, RR 0.55, 95% CI 0.29 to 1.04), or prostatic events. However, testosterone supplementation may improve sexual function and quality of life (1328 participants, MD -1.32, 95% CI − 2.11 to − 0.52).ConclusionsThe effect of testosterone supplementation on BMD and the risk of falls or fracture remains inconclusive. However, supplementation may benefit patients in the areas of sexual function and quality of life without increasing the risk of cardiovascular events, all-cause mortality, or prostatic events. RCTs with a longer follow-up period are still required.Trial registrationWe registered our protocol in PROSPERO (CRD42018109738).
Highlights
Testosterone deficiency (TD) may induce a series of clinical symptoms
The results showed no significant difference between the groups
The results showed that when compared with placebo, testosterone supplementation decreased the risk of allcause mortality, the difference was not statistically significant (5 Randomized controlled trial (RCT) [41,42,43, 59, 67], 729 participants, Risk ratio (RR) 0.55, 95% confidence intervals (CIs) 0.29 to 1.04; Fig. 7), either in the short-term and the long-term (Fig. 7; very low quality of evidence, Table 1)
Summary
Testosterone deficiency (TD) may induce a series of clinical symptoms. Whether testosterone supplementation increases the risk of cardiovascular events remains a focus of debate. One RCT that enrolled 209 patients [11] reported that the application of testosterone gel was associated with an increased risk of cardiovascular events. In another RCT [8], the authors found that the use of testosterone did not increase the risk of carotid artery intima-media thickness or coronary artery calcium in 308 men 60 years or older with low or low-normal testosterone levels
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