ACP Releases Guidelines for Treatment of Age-Related Low Testosterone

In an effort to improve care, the American College of Physicians (ACP) has released new guidelines for testosterone treatment in adult men with age-related low testosterone.

Published in the Annals of Internal Medicine, the guidelines have already received endorsement from the American Academy of Family Physicians and are based on a systematic review of more than 30 randomized controlled trials published between 1980 and May 2019.

"Physicians are often asked by patients about low 'T' and are skeptical about the benefits of testosterone treatment," said Robert McLean, MD, MACP, president of the ACP. "The evidence shows that men with age-related low testosterone may experience slight improvements in sexual and erectile function. The evidence does not support prescribing testosterone for men with concerns about energy, vitality, physical function, or cognition."

The new peer-reviewed guidelines, which were created by the ACP Clinical Guidelines Committee through a review of 38 randomized controlled trials, are designed for use by all clinicians and headlined by 4 new recommendations. Labeled 1a, 1b, 1c, and 2, the recommendations are based on a review of clinical outcomes in the aforementioned trials use the GRADE system and included evaluations of sexual function, physical function, quality of life, energy and vitality, depression, cognition, and multiple forms of adverse events.

Recommendation 1a is a suggestion that clinicians should discuss whether to initiate treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual dysfunction. This discussion should include potential benefits, arms, costs, and patient’s preferences.

The guideline noted recommendation 1a is classified as a conditional recommendation with low-certainty evidence. The rationale for 1a, according to the guideline, is based concurrent evidence indicating patients may see small improvement in sexual functioning with treatment but little evidence of improvement of physical function, depressive symptoms, energy, or cognition.

Recommendation 1b suggests clinicians should be reevaluating symptoms within 12 months and periodically thereafter. Treatment should be discontinued by clinicians in men with age-related low testosterone with sexual dysfunction who see no improvement in sexual function.

Similar to 1a, recommendation 1b is classified as a conditional recommendation with low-certainty evidence. The rationale behind the recommendation is most studies lacked follow-up beyond 12 months—making the longer term benefits or harm of treatment unknown.

Recommendation 1c is the ACP’s suggestion that clinicians should consider intramuscular rather than transdermal formulations when initiation testosterone treatment to improve sexual function in men with age-related low testosterone due to lower costs and similarly safety and efficacy. The ACP noted direct evidence for this recommendation but there were no substantial differences noted in effectiveness benefits or harms between the applications and intramuscular testosterone was notably cheaper ($156.32 versus $2135.32 per person per year).

The final recommendation, titled recommendation 2, suggests clinicians should only prescribe testosterone treatment in men with age-related low testosterone for treating sexual function issues and not initiate treatment to improve energy, vitality, physical function, or cognition. Rationale for this recommendation was evidence indicating little to no benefits for common concerns of aging.

In addition to the 4 recommendations, the “Testosterone Treatment in Adult Men with Age-Related Low Testosterone" also featured clinical considerations and talking points with patients. Considerations included the fact safety monitoring varied across trials and that no clear differences in sexual function outcomes were observed based on baseline treatment levels, and also suggesting the use of caution in applying the recommendations for patients with comorbid conditions. The guideline does not address screening or diagnosis of hypogonadism or monitoring of testosterone levels.

This guideline, titled “Testosterone Treatment in Adult Men With Age-Related Low Testosterone: A Clinical Guideline From the American College of Physicians,” is published online in the Annals of Internal Medicine.