Off-label Use of Testosterone and Growth-hormone Preparations

By: 
Michael S. Irwig, MD, FACE and Maria Fleseriu, MD, FACE

An all-too-common scenario is that a middle-aged man or woman goes to a “men’s health” or anti-aging clinic to seek treatment for decreased sexual desire, fatigue, or weight gain. Blood tests may be ordered for those patients who may be prescribed testosterone and/or human-growth hormone in addition to other hormones. In most cases, the individual actually does not have a medical disease that requires testosterone or growth hormone. This article will highlight the risks (not to mention costs) of taking off-label and unnecessary testosterone and growth hormone.

Low testosterone in men

Testosterone levels vary throughout the day and can drop to low levels even in healthy men with no signs or symptoms. This is why at least two confirmed tests that show low levels of testosterone are needed to diagnose male hypogonadism, the term for low production of testosterone. Common causes of low testosterone are obesity, inadequate sleep or opiate pain medications. Less common conditions are diseases related to the testicles or pituitary gland, which sits at the base of the brain.

"Before taking either testosterone or growth hormone, patients should be under the care of an endocrinologist who can perform a careful evaluation and recommend treatment only if medically indicated."

Treatment with testosterone

Testosterone treatment should be reserved only for men with consistently low testosterone levels. For men who are obese, weight loss is recommended, as weight loss does not have any bad side effects and can help improve overall health, energy, blood pressure and cholesterol levels. Weight loss usually increases and may normalize testosterone levels.

Risks of testosterone therapy

Testosterone replacement causes the body’s own factory of testosterone (the testicles) to stop working and can result in smaller testicles that stop making sperm—a concern for men interested in having a biological child. Other possible side effects of testosterone include acne, high blood pressure, drop in good cholesterol (high density lipoprotein (HDL)) and high red blood cell count. Long-term side effects of testosterone have not been well studied, so other possible risks may exist.

Growth hormone

Growth hormone is a protein produced in the anterior pituitary gland; its secretion, controlled mainly by hypothalamic (brain) hormones, is usually in pulses, higher at night and stimulated by exercise, trauma and sleep. Production of growth hormone starts to decrease around middle age and declines thereafter.

Symptoms of growth-hormone deficiency — decreased muscle mass, increased fat tissue, fatigue, decreased concentration — can mimic aging, thus explaining increased interest in growth hormone as “the fountain of youth.” Since growth hormone levels vary throughout the day, sporadic measurement is not useful. Insulin growth factor-1 (IGF-1) is an integrated measurement of growth hormone secretion, but values must be adjusted for age. Low values can suggest growth hormone deficiency. However, values can be falsely low in patients with obesity and those taking oral estrogen.

Growth hormone replacement in adults remains controversial and may be offered only to patients with confirmed growth hormone deficiency after rigorous growth-hormone stimulation testing. The decision to treat should be individualized after thoughtful clinical judgement with a careful evaluation of benefits and risks of treatment.

Treatment with growth hormone

Unfortunately, growth hormone and growth hormone “stimulants” are increasingly used off-label among athletes trying to improve athletic performance and older adults to slow or reverse aging. Although the body’s growth hormone and IGF-1 secretion decrease with aging, older adults with age-adjusted low IGF-1 levels and no history of pituitary or hypothalamic disease do not benefit from growth hormone administration. Some studies have found a change in body composition but no significant improvements in cholesterol, triglycerides, bone density or capacity for exercise. Furthermore, if taken but not needed, growth hormone treatment in older adults can lead to a variety of side effects, including but not limited to fluid retention, headaches, joint pain, breast enlargement, hyperglycemia or diabetes and carpal tunnel syndrome. Additionally, growth hormone treatment is very expensive, likely thousands of dollars per month depending on dose, without calculating the costs of possible associated complications.

The use of growth hormone to enhance performance in athletes or for anti-aging is illegal in the United States and has neither a scientific nor ethical basis.

Conclusion

Before taking either testosterone or growth hormone, patients should be under the care of an endocrinologist who can perform a careful evaluation and recommend treatment only if medically indicated.