HGH and the FDA
Human Growth Hormone (HGH) has been the subject of controversy and legal limitations because the use of it has been abused by many clinics and companies across the country. Before prescribing HGH or starting someone on Human Growth Hormone Therapy, a clinician must carefully consider how, when, and on what basis to prescribe the drug. Typically, the Food and Drug Administration has broad authority to oversee the efficacy and safety of drugs but does not generally oversee the practice of medicine by regulating off-label use of drugs by individual physicians. However, federal law treats HGH differently than other drugs and limits the distribution of HGH to indicated uses and imposes criminal sanctions on those who violate the law. The FDA has clearly stated that it is unlawful to use HGH for anti-aging purposes, for the purpose of muscle building, or for the enhancement of athletic performance.
Diagnosis and Provocative Testing
The safest course for consumers interested in Human Growth Hormone Therapy is to consult a physician who prescribes HGH only for FDA approved uses and for adults with growth hormone deficiency. Guidelines further state that adult growth hormone deficiency syndrome (AGHD or GHD) must be confirmed through provocative testing. Provocative testing is achieved through pituitary stimulation in a controlled environment. The Insulin Tolerance Test (ITT) and other stimulation tests were developed to help identify only those individuals with the poorest ability to secrete growth hormone as candidates for Human Growth Hormone Therapy.
The ITT test has been the stimulation test used by most endocrinologists to diagnose growth hormone deficiency in adults. The Insulin Tolerance Test (ITT), however, has inherent danger of serious risks that include seizures or unconsciousness due to neuroglycopenia. It is also contraindicated in patients with known or who are at risk for coronary artery disease or in patients with a history of seizures. Many physicians and experts feel that the GH stimulation tests are hard to reproduce reproducibility and very labor intensive. There is little data available that indicates whether stimulation tests can reliably separate growth hormone deficient individuals from normal subjects.
For these reasons along with a growing criticism surrounding the validity, reliability, and safety of ITT, many investigators and clinicians now reject stimulation tests as the gold standard for diagnosing adult growth hormone deficiency.
Growth Hormone Deficiency Testing at transformyou
In spite of all the controversy over the best method to diagnose GHD, the FDA and HGH manufacture have maintained their positions that stimulation testing is necessary and required for the accurate diagnosis of adults with growth hormone deficiency. For this reason, transformyou has implemented pituitary stimulation testing as a prerequisite for diagnosing GHD in our patients.
The Glucagon stimulation test is currently our provocative test of choice for the diagnosis of GHD. It is readily available and simple to perform. Studies to date have suggested it is accurate and reproducible, though further validation studies will be necessary for this test to supplant the ITT as the gold standard. It is much safer than the ITT, with hypoglycemia being very uncommon. The only contraindications are in the malnourished or those who have not eaten in the previous 48 hours.
The entire test takes a total of 2-3 hours from glucagon injection to final blood draw, with GH levels being measured at 0, 90, 135, and 180 minutes. An increase in growth hormone above a certain level due to the glucagon injection is considered to be indicative of pituitary sufficiency and NOT consistent with a diagnosis of adult-onset growth hormone deficiency.
Growth Hormone Releasing Hormones / Peptides and IGF-1 Testing
Patients who are interested in Sermorelin, Ipamorelin, Tesamorelin, CJC 1295, GHRP-2, GHRP-6 or IGF-1 therapy alone without HGH do not need to undergo a stimulation test. In this case, a regular blood test which also includes an IGF-1 score is needed first to determine treatment options.
transformyou offers all consultations completely free of charge with no obligation. If you have questions about a possible growth hormone deficiency, it is recommended that you take advantage of this consultation and get all your questions answered. Call 480-839-4131 to schedule an appointment today. All patients always work directly with one of our licensed physicians to ensure patient safety and confidentiality.
It is important to remember that any program or treatment we offer at transformyou carrying the phrase 'Anti-Aging’ is not intended to stop or prevent one from aging. Rather, our services and products are designed to help individuals effectively manage and navigate the aging process, yielding the best possible levels of health and wellness.