#376 Testosterone supplementation for cis-gender men: Let’s (andro-)pause for a moment (Update)
CLINICAL QUESTION
What are the benefits and harms of testosterone supplementation in healthy cis-gender men or those with age-related low testosterone?
BOTTOM LINE
Compared to placebo, testosterone may increase lean body mass by ~1.6kg in older men but has no consistent, meaningful impact on sexual function, strength, fatigue, or cognition. Testosterone does not increase prostate events, myocardial infarction or stroke, but pulmonary embolism (0.9% versus 0.5% placebo) and atrial fibrillation (3.5% versus 2.4% placebo) may be increased.
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EVIDENCE
- 16 systematic reviews from last five years1-16 and main randomized, placebo-controlled trials (RCTs). Statistically significant unless indicated.
- Sexual function: Most comprehensive systematic review1 (men ≥40 years with normal/low testosterone and sexual dysfunction). Highest quality RCTs:
- Sexual function scale (range 6-30, higher=normal function): 6 RCTs, 2016 patients
- Mean difference: 2.4 at ≤12 months, not clinically different.
- Others similar.2-4
- Sexual function scale (range 6-30, higher=normal function): 6 RCTs, 2016 patients
- Strength: Most comprehensive review5 (11 RCTs, 814 men, 66-77 years old, normal/low testosterone). Over 3-12 months, highest quality RCTs:
- Lean body mass: 1.6 kg higher with testosterone. Other reviews similar.6-10
- Hand grip strength, physical performance tests: No difference.5
- Leg strength: Inconsistent.5
- Fatigue: One systematic review with limitations.11 Largest RCT: 464 patients, age 65+, low testosterone and self-reported “low vitality”:17
- Proportion with clinical improvement on fatigue score: No difference.
- Cognition: Three systematic reviews with limited reporting.11-13
- Two largest RCTs: No difference.18,19
- Quality of life: Best systematic review (7 RCTs, 1043 participants, most: testosterone <12nmol/L).11
- Symptom scale: Not clinically different.
- Others similar.1,2,3,6
- Harms: Largest RCT on cardiovascular effects of testosterone 1.62% gel in 5204 men, 55% with cardiovascular disease or at high risk.20 Baseline testosterone=8nmol/L. At 33 months:
- All-cause mortality, major cardiovascular events, prostate cancer, invasive prostatic procedures: No difference.
- Atrial fibrillation: 3.5% versus 2.4% (placebo), number needed to harm=93.
- Pulmonary embolism: 0.9% versus 0.5% (placebo) (no statistics provided).
- Systematic reviews:1,14 Similar.
CONTEXT
- Low testosterone: < 10nmol/L.21
- Guidelines:21,22
- Asymptomatic: Not recommended.22
- Age-related low testosterone and sexual dysfunction: May discuss testosterone.22
- Best initial screening: Total testosterone (morning draw: 7-11am).21
- Best formulation is uncertain: Direct comparisons of different formulations lacking.1
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Good summary
Low testosterone: < 10nmol/L.
Testosterone replacement not needed in most pts with testosterone deficiency
This means we have to adjust how we discuss this with men who want to get testing done especially if asymptomatic.
very effective summary
Clear and balanced insights on testosterone therapy—valuable for guiding discussions with patients seeking treatment for age-related low testosterone
Good information!
Good information