[Testosterone--a "fountain of youth" for ageing men? Brief assessment of the efficacy and safety of androgen substitution in healthy men].
BACKGROUND
Testosterone levels decline gradually with age in men. A number of manifestations such as reduced libido or depression have been attributed to subphysiological testosterone levels. Hence, testosterone supplementation has been proposed in these cases.


OBJECTIVE
To assess the efficacy and safety of testosterone supplementation therapy in hypogonadal healthy men.


METHODS
Non-systematic review of randomised controlled trials (RCTs), systematic reviews/meta-analyses and HTA reports investigating testosterone supplementation in hypogonadal healthy men.


RESULTS
Five systematic reviews/meta-analyses and seven additional RCTs were included. The evidence suggests a consistent but weak positive effect on sexual function, lean body mass and vertebral bone mass. However, the clinical significance of these findings remains unclear and some clinically relevant outcomes were not included in these studies. On the other hand, testosterone substitution was associated with an increase in prostata-related adverse events, increased hematocrit and allergic skin reactions due to testosterone patches.


CONCLUSIONS
The efficacy of testosterone supplementation for healthy hypogonadal men remains unclear. Only sexual function may improve in men with unequivocally reduced testosterone levels after supplementation therapy, but the clinical significance of this finding remains unclear. Long-term experience (i.e. more than three years) with effects and side effects is lacking.
Perleth
Matthias
M
Abteilung Fachberatung Medizin, Gemeinsamer Bundesausschuss, Auf dem Seidenberg 3a, 53721 Siegburg. matthias.perleth@g-ba.de
D000368:Aged; D000375:Aging / Q000187:drug effects*; D002986:Clinical Trials as Topic; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011785:Quality Assurance, Health Care; D012449:Safety; D013739:Testosterone / Q000502:physiology / Q000627:therapeutic use*
D013739:Testosterone