American College of Physician committee systematically reviewed 38 randomized controlled clinical trials involving testosterone supplementation in patients with age-related hypogonadism. Subjects’ mean age was 66 years, with average baseline total testosterone measures ≤300 ng/dL. Authors reached consensus on the following soft recommendations:
Physicians should be open to initiating testosterone therapy in adults with age-related hypogonadism only from the sexual dysfunction perspective. The decision to treat should be reached after a complete patient-physician discussion that includes pharmacological options, benefits, safety, and cost.
ACP recommends the intramuscular route of testosterone administration due to its low cost and similar efficacy and safety to other modes of therapy. They do not advise starting testosterone supplementation for other symptoms – apart from sexual dysfunction – such as reduced physical capacity, cognition, stamina, and vitality.
GT
Also see:
Annals of Internal Medicine
ACP Testosterone GUIDELINES
January 2020
Recommendation 1a:
ACP suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function (conditional recommendation; low-certainty evidence). The discussion should include the potential benefits, harms, costs, and patient’s preferences.
Recommendation 1b:
ACP suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter. Clinicians should discontinue testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function (conditional recommendation; low-certainty evidence).
Recommendation 1c:
ACP suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar.
Recommendation 2:
ACP suggests that clinicians not initiate testosterone treatment in men with age-related low testosterone to improve energy, vitality, physical function, or cognition (conditional recommendation; low-certainty evidence).
Background
A gradual, age-associated decline in serum total testosterone levels begins in men in their mid-30s and continues at an average rate of 1.6% per year. This condition is referred to as age-related low testosterone and is accompanied by clinical symptoms associated with androgen deficiency. No well-defined, universally accepted threshold of testosterone levels exists below which symptoms of androgen deficiency and adverse health outcomes occur.
The incidence of low testosterone in the United States is reported to be approximately:
- Sexual function
- Physical function
- Quality of life
- Energy and vitality
- Depression
- Cognition
- Serious adverse events
- Major adverse cardiovascular events, and
- Other adverse events.
The evidence review identified 38 randomized controlled trials that met the inclusion criteria to evaluate the benefits and harms of testosterone treatment. The mean age across all studies was 66 years, and follow-up ranged from 6-36 months.
Participants in most studies had a mean baseline total testosterone level of ≤300 ng/dL (20 studies), although several studies included men with higher baseline testosterone levels. Outcomes did not vary substantially in studies that had different baseline testosterone levels or evaluated different testosterone formulations.
- 20% in men older than 60 years
- 30% in those older than 70 years
- 50% in those older than 80 years
Uncertainty exists as to whether nonspecific signs and symptoms associated with age-related low testosterone, such as sexual dysfunction, decreases in energy and muscle mass, mood disturbances, changes in bone mineral density, cardiovascular disease, depression, decreased libido, erectile dysfunction, decreased volume of ejaculate, loss of body and facial hair, weakness, and mortality, are a consequence of age-related low testosterone or whether they are a result of other factors, such as chronic illnesses or concomitant medications.
The ACP Clinical Guidelines Committee based these recommendations on a systematic review on the efficacy and safety of testosterone treatment in adult men with age-related low testosterone. Clinical outcomes were evaluated by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system and included:
- Sexual function
- Physical function
- Quality of life
- Energy and vitality
- Depression
- Cognition
- Serious adverse events
- Major adverse cardiovascular events, and
- Other adverse events.
The evidence review identified 38 randomized controlled trials that met the inclusion criteria to evaluate the benefits and harms of testosterone treatment. The mean age across all studies was 66 years, and follow-up ranged from 6-36 months.
Participants in most studies had a mean baseline total testosterone level of ≤300 ng/dL (20 studies), although several studies included men with higher baseline testosterone levels. Outcomes did not vary substantially in studies that had different baseline testosterone levels or evaluated different testosterone formulations.