Controversies regarding the use of human growth hormone (HGH) as treatment method have centered around the claims, products, and businesses related to the use of growth hormone as an anti-aging therapy. Most of these controversies fall into two categories:
- Claims of exaggerated, misleading, or unfounded assertions that growth hormone treatment safely and effectively slows or reverses the effects of aging.
- The sale of products that fraudulently or misleadingly purport to be growth hormone or to increase the user's own secretion of natural human growth hormone to a beneficial degree.
A study was published in The New England Journal of Medicine in 1990 by Rudman et al., which showed fat loss, muscle mass increase and maintenance of healthy skin from the administration of growth hormone in twelve elderly men. Despite the fact the authors at no time claimed that GH had reversed the aging process itself, their results were misinterpreted as indicating that GH is an effective anti-aging agent.
Additionally, companies selling dietary supplements have websites selling products that claim to be linked to GH in the advertising text, with medical-sounding names described as "HGH Releasers". Typical ingredients include amino acids, minerals, vitamins, and/or herbal extracts, the combination of which are described as causing the body to make more GH with corresponding beneficial effects. In the United States, because these products are marketed as dietary supplements it is illegal for them to contain GH, which is a drug. Also, under United States law, products sold as dietary supplements cannot have claims that the supplement treats or prevents any disease or condition, and the advertising material must contain a statement that the health claims are not approved by the FDA. The FTC and the FDA do enforce the law when they become aware of violations.
As a result of the reactions to the 1990 article and its frequent citation by proponents of HGH as an anti-aging agent, in 2003 the NEJM published two articles that came out strongly and clearly stating that there was insufficient medical and scientific evidence to support use of HGH as anti-aging drug. One article was written by the Journal's then-current editor in chief, Jeffrey M. Drazen, M.D. and was entitled, "Inappropriate Advertising of Dietary Supplements". It focused mostly on the advertising of dietary supplements. The other article was written by the editor-in-chief at the time the 1990 article was published, Mary Lee Vance, M.D., and was entitled, "Can Growth Hormone Prevent Aging?"; it focused more on the medical issues around whether there was sufficient evidence to use HGH as an anti-aging agent.
There has never been an adequately large randomized controlled trial to prove definitively that HGH provides significant anti-aging benefits and that there are no significant adverse drug reactions; there have been many small studies which are described below.
Some scientific articles have demonstrated that HGH supplementation does not significantly increase muscle strength or aerobic exercise capacity in healthy individuals. While it is possible that there are some advantages, such as an increase in lean body mass, it is also evident that benefits are being exaggerated by some for commercial gain and ineffective products are being sold to unsuspecting consumers.
Some recent small clinical studies have shown that low-dose GH treatment for elderly patients with GH deficiency changes the body composition by increasing muscle mass, decreasing fat mass, increasing bone density and muscle strength, improves cardiovascular parameters (i.e. decrease of LDL cholesterol), and affects the quality of life without significant side effects. It must be emphasized that these studies were small—only tens of patients - and the results were therefore stated tentatively; in the words of one of the cited sources: "Clearly more studies are needed before GH replacement for the elderly becomes established. Safety issues will require close scrutiny, but the data available so far are sufficiently positive to undertake large multicentre, placebo-controlled trials, particularly looking at endpoints associated with prevention of frailty and loss of independence."
Side-effects of high doses and long-term use
Some of the side effects reportedly seen in previously healthy mature patients after taking high HGH doses include:
- Edema (retention of fluids) in extremities
- Arthralgia (joint pain)
- Carpal tunnel syndrome
- Hypertension.
- Diabetes and other glucose metabolism imbalances
- Gynecomastia (enlargement of male mammary glands)
Chronic use of HGH is not well studied. However, in Europe a study called "SAGhE" was undertaken to study these long-term effects of HGH in children. It found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) who were treated with recombinant human growth hormone during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France. The FDA issued a Safety Alert reporting this result.
- Rudman D, Feller AG, Nagraj HS et al. (July 1990). "Effects of human growth hormone in men over 60 years old". The New England Journal of Medicine 323 (1): 1–6. doi:10.1056/NEJM199007053230101. PMID 2355952.
- Liu H, Bravata DM, Olkin I, Nayak S, Roberts B, Garber AM, Hoffman AR (January 2007). "Systematic review: the safety and efficacy of growth hormone in the healthy elderly". Ann. Intern. Med. 146 (2): 104–15. PMID 17227934.
- "No proof that growth hormone therapy makes you live longer, study finds". PhysOrg.com. 2007-01-16. Retrieved 2009-03-16.
- Stephen Barrett, M.D. Growth Hormone Schemes and Scams
- Kuczynski, Alex (1998-04-12). "Anti-Aging Potion or Poison?". New York Times.
- Singleton ER (2010-06-04). "Atlas Operations, Inc.". Warning Letter. U.S. Food and Drug Administration. Retrieved 2011-08-28.
- H Liu, DM Bravata, I Olkin et al. (May 2008). "Systematic review: the effects of growth hormone on athletic performance". Annals of Internal Medicine 148 (10): 747–58. PMID 18347346.
- "'HGH' Pills and Sprays: Human Growth Hype?" (SHTML). FTC Consumer Alert. Federal Trade Commission. June 2005. Retrieved 2006-11-19.
- Alexopoulou O, Abs R, Maiter D (2010). "Treatment of adult growth hormone deficiency: who, why and how? A review". Acta Clinica Belgica 65 (1): 13–22. PMID 20373593.
- Ahmad AM, Hopkins MT, Thomas J, Ibrahim H, Fraser WD, Vora JP (June 2001). "Body composition and quality of life in adults with growth hormone deficiency; effects of low-dose growth hormone replacement". Clinical Endocrinology 54 (6): 709–17. doi:10.1046/j.1365-2265.2001.01275.x. PMID 11422104.
- Savine R, Sönksen P (2000). "Growth hormone - hormone replacement for the somatopause?". Hormone Research 53 (Suppl 3): 37–41. doi:10.1159/000023531. PMID 10971102.
- Liu, H., et al. (2007). "The safety and efficacy of growth hormone in the healthy elderly: A systematic review". Annals of Internal Medicine.