Testosterone Therapy: Randomized Trials Suggest Modest Benefits in Some Patients — Physician’s First Watch

Medical News |
February 18, 2016

Testosterone Therapy: Randomized Trials Suggest Modest Benefits in Some Patients

By Allan S. Brett, MD

Dr. Brett is editor-in-chief of NEJM Journal Watch General Medicine, from which this story was adapted. Full coverage is available to subscribers at the link below.

Testosterone therapy improved sexual and physical function modestly in symptomatic older men with low testosterone levels — but the proportion of men who benefited was low — in the NIH-supported "Testosterone Trials" (TT) published in the New England Journal of Medicine.

Some 790 symptomatic older men with serum testosterone levels averaging <275 ng/dL were randomized to receive testosterone gel or placebo for 1 year. Qualifying symptoms were decreased libido (for the Sexual Function Trial), difficulty walking or climbing stairs (Physical Function Trial), or fatigue (Vitality Trial).

For primary endpoints, results with active treatment versus placebo were as follows:

  • Sexual function scores improved significantly both in the Sexual Function Trial and among all TT participants, but improvement was only about 0.6 points on a 12-point scale.

  • A small increase in the proportion of men whose 6-minute walk distance improved by ≥50 meters was not significant in the Physical Function Trial but was significant among all TT participants.

  • The proportion of men who improved by ≥4 points on a 52-point fatigue scale did not increase significantly either in the Vitality Trial or among all TT participants.

Frequencies of adverse events with testosterone and placebo were generally similar, but testosterone recipients were more likely to develop polycythemia and increased prostate-specific antigen levels.

Comment: Although the results could justify testosterone treatment in men who meet the study's fairly restrictive enrollment criteria, patients should understand that benefits were rather limited and long-term safety remains unclear.

Reader Comments (7)

Jack Hajjar ,MD Physician, Anesthesiology, NYC

I totally agree with you,treating low T,is very individualized,
Men who have low T's are higher risk of mortality from all causes,this has been published in many European studies.

James Recht, MD Physician, Psychiatry

The cited study does not support the use of testosterone supplementation. It simply describes a correlation between low endogenous sex hormones and development of dementia. This observation in no way implies that testosterone treatment would reduce that risk.

Scott Rex, MD Physician, Family Medicine/General Practice, Long Island, NY

Well stated.
How much time are we going to spend in the next two weeks
talking to patients about testosterone levels and why we do not recommend supplements!
Monetary-motivated; since advertising was allowed in the NEJM

CHRISTIAN ALLAN Physician, Obstetrics/Gynecology

"Trials suggest modest benefits"....trials really suggest no real benefits and of course don't address risks, costs, etc.
Unfortunately the header has been picked up by news outlets and many will be mislead into thinking this is a useful therapy.

victor kantariya Physician, Family Medicine/General Practice

"Low Testosterone Levels Linked to Alzheimer Disease in Older Men" ( J Alzheimers Dis. 2010). Based on present data ,the magnitude of risk reduction is quite substantial, 1nM/L increase in serum bioavailable testosterone level might reduce the risk of AD at 1 year by 78%. Victor Kantariya, MD

DANIEL SANCHEZ Physician, Family Medicine/General Practice

Previous studies have shown inconsistent serum testosterone levels with topical replacement therapy. It would be interesting to see a similar trial with a more reliable delivery method.

William DeMedio MD Physician, Family Medicine/General Practice

It is strange how the title of this synopsis seems to support use of HRT in men, while the last small line does not. It makes me realize why this newsletter is free, and this is not very becoming of a "transparent", "peer reviewed", and "independent" journal. It seems money is what does the talking today in medicine, like most else.

Please don't edit out this comment, thanks.

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