Sermorelin in Patients with Normal Hormone Levels
Patients with normal growth hormone levels should not receive sermorelin therapy, as there is no evidence supporting its use outside of documented growth hormone deficiency, and current guidelines restrict growth hormone-related therapies to patients with confirmed hormonal deficiencies.
Approved Indications for Sermorelin
Sermorelin is specifically indicated for:
- Diagnostic testing: A single intravenous dose of 1 μg/kg bodyweight serves as a provocative test to diagnose growth hormone deficiency in children, providing more specific results with fewer false positives compared to other provocative tests 1
- Treatment of confirmed GH deficiency: Subcutaneous sermorelin 30 μg/kg bodyweight daily at bedtime may be effective in prepubertal children with documented idiopathic growth hormone deficiency 1
Why Normal Hormone Levels Preclude Sermorelin Use
Growth hormone therapy and its analogues are reserved exclusively for patients with confirmed deficiencies through appropriate testing:
- Patients must demonstrate growth hormone deficiency through stimulation testing unless there is a proven genetic or structural lesion 2, 3
- In children, persistent growth failure must be documented (height below 3rd percentile AND height velocity below 25th percentile for ≥3 months in infants or ≥6 months in older children) before considering any GH-related therapy 4
- Adults require confirmation of GH deficiency through appropriate GH-stimulation tests using validated cut-points specific to each test 3
Lack of Evidence for Normal Hormone Patients
No clinical data support the use of sermorelin or other growth hormone therapies in individuals with normal hormone levels:
- Studies of sermorelin have exclusively enrolled children with documented idiopathic growth hormone deficiency 1, 5
- Even in significantly short children with normal GH levels, only 5 of 7 patients showed adequate growth response to GH-RH therapy, and treatment was discontinued in 2 patients after 12 months due to inadequate response 5
- Current endocrinology guidelines emphasize that establishing a correct diagnosis of GHD is essential before consideration of any GH-related therapy 3
Unapproved and Inappropriate Uses
The use of growth hormone or its analogues in patients without documented deficiency constitutes off-label use without supporting evidence:
- Unapproved uses of GH related to sports performance enhancement and anti-aging are explicitly discouraged in clinical guidelines 3
- The final decision to treat requires thoughtful clinical judgment with careful evaluation of benefits and risks specific to the individual, which cannot be justified without documented deficiency 2
Clinical Pitfalls to Avoid
- Do not prescribe sermorelin for "optimization" or "wellness" purposes in patients with normal hormone levels—this lacks evidence and exposes patients to unnecessary risks 3
- Normal growth hormone responses to sermorelin testing cannot exclude GH deficiency due to hypothalamic deficits, but this does not justify treatment in those with normal baseline function 1
- Avoid treating based solely on symptoms like fatigue or decreased muscle mass without documented hormonal deficiency through appropriate stimulation testing 2, 3