Growth Hormone

Cenegenics® only prescribes human growth hormone (hGH) if a comprehensive evaluation reveals an adult growth hormone deficiency. Our prescribing protocols and analyses are based on our research and evaluation of multiple controlled studies from peer-reviewed journals. Cenegenics® engaged outside counsel to conduct a review of its prescribing protocols and believes these protocols are consistent with the law and FDA guidelines.

Our evidence-based approach incorporates hormone modulation to help patients regain and maintain metabolic and endocrine functions at the upper end of the normal range, adjusted for the patient’s age—creating the best opportunity for a healthier and more vigorous life.

The Science of hGH

A cell generator, hGH carries the singular title of “master hormone.” It is a complex protein molecule, made up of 191 amino acids that are synthesized in the anterior pituitary gland and released in pulses, mostly during sleep and after heavy resistance training. This master hormone affects all other hormones, organs, and body cells. It is necessary for repair and restorative abilities at the cellular level, beyond those of any other hormone. Also known as somatotropin, hGH aids growth, healing, immune system function, muscle mass and strength, body fat reduction, cholesterol level control, bone strength, and energy maintenance—including sexual energy and performance. Adult growth hormone deficiency does exist, significantly impairing an individual’s ability to obtain optimal physiology.

The master hormone, secreted by cells called somatrophs, acts on the liver and almost every other tissue in the body. It stimulates IGF-1 (insulin-like growth factor) production, which ultimately yields growth-promoting effects. Exercise, stress, emotional excitement, diet, and aging all affect the quantity of hGH production. By measuring levels of IGF-1, we determine the amount of the growth hormone in your body.

In youth, hGH is critical to bone, organ and all aspects of development. Having too little causes dwarfism; occasionally, a tumor of the pituitary gland produces excess growth hormone, which can result in gigantism.

Both growth hormone and its metabolite IGF-1 begin decreasing between 15 and 20 years old, continuing to decline rapidly from that point. Although growth hormone is no longer needed for growth in adulthood, it remains essential for many other vital functions.

 

Identifying hGH

The hormone was first isolated in the mid-1950s. Its structure wasn’t identified until the early ’70s. By the mid-80s, the only hGH source was collecting it post-mortem from pituitary glands. Genetic engineering has changed all that. Recombinant hGH is now available from FDA-approved pharmaceutical manufacturers.

Is hGH for everyone? Absolutely not. It should be noted that individuals with certain specific medical diagnoses should avoid growth hormone therapy for adult deficiency because it could exacerbate their illness. These contraindications include uncontrolled diabetes; unusual lung diseases such as pulmonary fibrosis, sarcoidosis, pneumoconiosis and bronchiolitis obliterans; Hermansky-Pudlak Syndrome; or systemic sclerosis. Currently, growth hormone is contraindicated in the history of cancer.

There is not sufficient medical literature to use hGH safely in these contexts—although we do believe that literature will appear in the not-too-distant future. If you have ever been diagnosed with any of these medical problems, be sure to inform your Cenegenics® physician.

Is hGH safe—are there side effects? Studies overwhelmingly point toward the safety of growth hormone therapy in hGH-dcficient adults. Per a 1999 article in the New England Journal of Medicine: “Side effects of growth hormone therapy for adult deficiency are minor, dose-related, and totally reversible.*” Also, in a cover story on growth hormone published in a 2003 issue of Newsweek, Dr. Pinchas Cohen, Director of Pediatric Endocrinology-UCLA, states “all the evidence shows that growth hormone is one of the safest drugs we have. Thousands of patients have been followed for the last 16 years.”

Of course, before starting on any hormonal therapy, a comprehensive evaluation is essential. Any program should focus on hormonal balance with careful monitoring to minimize the potential of mild side effects.

hGH therapy can lead to the following results:

DECREASED

  • body fat
  • skin wrinkling
  • hospitalization rate by 50%
  • sick days from work
  • diastolic blood pressure
  • waist/hip ratio
  • bone loss, increases with age

INCREASED

  • libido
  • lean muscle
  • bone density
  • skin thickness
  • exercise capacity
  • renal blood flow
  • feeling of well-being/improved socialization

IMPROVED

  • cholesterol profile
  • memory
  • cognitive function

STRENGTHENED

  • immune system
  • wound healing with lower infection rate

If your evaluation assessment shows an adult hGH deficiency, your personal Cenegenics® physician will help you understand and assess all the available information, as objectively as possible. Experience has shown us that the benefit of growth hormone therapy for deficient adults far outweighs the risk. Ultimately, the decision is yours.

FDA regulations are a distinct facet of hGH therapy. The FDA established strict regulations, limiting how (hGH) can be prescribed, manufactured, distributed, and sold. The FDA actually licenses and oversees companies manufacturing hGH. These manufacturers must register and verify their methods and product, uniformity, bioavailability, safety, and demonstrated effectiveness. Therefore, by federal law, any claim that a product contains hGH would require its production be overseen and approved by the FDA, meeting standards for quality and content. These patent parameters make hGH manufacturing complex and expensive. Therefore, hGH-deficient patients must avoid the lure of “cheaper” hGH.

Drug-dispensing Web sites sprawl across the Internet, promising deep discounts and “anti-aging hGH.” However, the government has drawn a clear line regarding steroid and hGH prescription and use, albeit via online or direct purchase. That’s evidenced by the flurry of grand jury indictments, followed by the Department of Justice and FDA raids on online drug networks linked to indiscriminate doctors and “anti-aging” healthcare centers.

Cenegenics®—as a medical facility for age management, not part of the anti-aging trend—always has been compliant with the letter and intention of the law. We believe in the traditional approach of patients seeing their doctors and undergoing comprehensive exams to determine the appropriate therapy. Our physicians only prescribe hGH on label for proven adult hGH deficiency.

The FDA has warned that the high price of hGH creates an incentive for disreputable persons to counterfeit the drug or to use improper methods or shortcuts to manufacture raw hGH. Not only are these products illegal, but they also pose inherent risks of being contaminated, counterfeit, subpotent, or superpotent.

There is one other point to consider. Often these advertisements promote over-the-counter pills, elixirs, sprays, and creams, claiming to have valued amounts of hGH. Since hGH must be dispensed by prescription only, none of these products could contain the hormone. Furthermore, many of these products rely on topical, sublingual or nasal administration. Federal law weighs heavily against purported “oral” and other forms of hGH. Firstly, these products don’t contain any significant amount of hGH, and secondly, they are illegal without a prescription for adult deficiency and without a statement of their exact content disclosure or production origin.

All the published benefits of using the master hormone for proven adult deficiencies are based on injected hGH. None of its prized benefits have been objectively measured with oral tablets, capsules, or sprays. There are no published physiologic studies demonstrating any appreciable improvements in systemic hGH/IGF-1 levels delivered orally or by sprays. However, we have recently begun using sermorelin, a GnRH analogue that stimulates the body to secrete hGH and increase IGF-1 levels. While early, patients seem to notice a benefit and we have seen a rise in IGF-1 levels.

The 191 amino acids in this large, fragile polypeptide hormone (hGH) are in exact sequence with a specific 3-dimensional shape, which fits cell receptors like a key in a lock. Even if the chemical formula remains the same, a change in shape blocks hGH activity. Once dissolved in a solution, the cross-linkages maintaining the shape break quite easily and can become unstable. Claims that hGH can be absorbed in the oral mucosa and transported to the pituitary gland are nonsense. The hormone doesn’t act nor does it offer any beneficial effect at the pituitary level, but is secreted by the gland (normal source of hGH in young adults) to affect organ systems throughout the body. Such statements of a “stimulating dose” working by absorption into the pituitary’s feedback system are marketing attempts, intended to deceive scientifically unsophisticated consumers.

The only safe, accurately assembled hGH is one using recombinant DNA technology, which requires elaborate, precise methods. Using hGH from any other source—even other animals—doesn’t work in humans. Animal molecules have been shown to be species-specific and are unable to mimic the human molecule. There is absolutely no naturally occurring plant source of hGH.

Bottom line: The only current method for adult hGH-deficient patients to administer this hormone is via injection with a prescription under the supervision of a licensed physician and through an FDA-approved hGH manufacturer and pharmacy, or via the use of injectable sermorelin.

 

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