The American Urological Association has released a white paper warning physicians that current evaluation standards for testosterone levels are significantly problematic, HCP Live reported Dec. 15.
“Significant intra-individual fluctuations in serum T levels, biological variation of T action on end organs, the wide range of T levels in human serum samples and technical limitations of currently available assays have led to poor reliability of T measurements in the clinical laboratory setting,” the paper’s abstract reads.
While the paper acknowledges the importance of laboratory tests, it calls into question the various levels that certain organizations classify as “low” testosterone (commonly known as low T), noting that there is no consensus among providers and regulatory bodies as to what that cutoff should be.
And even if there were a consensus, the problem would remain that some men above certain levels experience the symptoms associated with low T, such as fatigue or loss of libido, while others below those levels experience no symptoms whatsoever. “Rigid use of the 300 ng/dL threshold [set by the Food and Drug Administration] would lead to treatment for many men with no physical symptoms of hypogonadism and no treatment for men with higher total testosterone levels who still suffered persistent signs and symptoms of androgen deficiency,” Andrew Smith explained in the HCP report on the white paper.
These thresholds are further complicated by the fact that they’re often developed based on studies in which the participants are all geriatric men.
Guidelines on what constitutes low T effect not only on treatment, but also insurance reimbursement — a factor the paper’s authors consider. “No patient should be denied coverage for treatment based solely on payer defined cutoff points if need for such treatment is established by a health professional,” they write.
The recommendation made by the paper’s authors is that symptoms be weighed just as heavily as test results in clinical diagnoses of low T.
Rising visibility of problems associated with low T has researchers across the globe scrambling to gather data and provide solutions.
But some doctors are warning that standards should still be kept high in these efforts.
A professor from the University of Texas Health Science Center recently warned against reading too much into a new — and much reported-on — French study showing that men who like spicy foods have higher testosterone levels.
“I don’t think it’s causal in any way,” said Dr. Robert Tan, “that you can say that someone who has preference for spicy food has high testosterone.”