Further research is needed to determine the
risks and advantages of testosterone supplementation for older men, according
to an article published in the Medical Journal of Australia.
Professor David Handelsman, Director of the
ANZAC Research Institute at Concord Hospital, University of Sydney, reviewed
two recent research articles on prescribing testosterone for older men.
One of the reviewed research articles
reported the European Male Ageing Study into the relationships of nonspecific
physical and mental symptoms to serum testosterone levels, the results of which
have been interpreted in a way that is likely to encourage testosterone usage
in older men. The second article reported the early termination of a clinical
trial for excess adverse cardiovascular effects associated with testosterone supplementation,
and discourages the use of testosterone.
Prof Handelsman said that, taken together,
these two studies could be construed as pressing the accelerator and the brakes
at the same time on testosterone prescribing for older men ... with probably the
usual effect of spinning wheels. However, several reflections arise for
Australian clinical practice.
"Australia's national guidelines for
testosterone use, developed in 2000 and adopted by the Pharmaceutical Benefits
Scheme as the criteria for subsidised testosterone prescriptions, are
vindicated," Prof Handelsman said.
"They aim to restrict testosterone
prescribing for age-related androgen deficiency without hindering it for
pathologically based androgen deficiency.
"The European Male Ageing Study definition of
'late-onset hypogonadism', which is reliant on a single measurement of serum
testosterone, is not suitable for implementation in practice.
"Serial serum testosterone levels in older
men are sufficiently variable to require the results of at least two blood
samples taken weeks apart to establish a sustained low level of serum
"It is evident that bans need to be
reinforced on direct-to-public advertising of testosterone supplementation.
"Without this protection, an avalanche of misguided
testosterone prescribing awaits us.
"Testosterone prescribing for older men is
best restricted to clinical trials where ethical oversight ensures appropriate
design and warnings to participants.
"Age alone may not prove a valid indication,
but this should not limit essential further research within the framework of
placebo-controlled clinical trials aiming to define the benefits and risks of
testosterone use in patients with the comorbidities of aging, such as obesity,
diabetes, metabolic syndrome, and other chronic conditions."
The Medical Journal of Australia
publication of the Australian Medical Association.