PHILADELPHIA, Jan. 16, 2007 -- A review of published data on use of human growth hormone (GH) by healthy elderly people found that the synthetic hormone was associated with small changes in body composition but not in body weight or other clinically important outcomes.
Further, people who took GH had increased rates of unhealthy side effects such as soft tissue swelling, joint pain, carpal tunnel syndrome, and, in men, abnormal breast development. They were also somewhat more likely to develop diabetes.
The review, "The Safety and Efficacy of Growth Hormone in the Healthy Elderly," was published in the Jan. 16, 2007, issue of Annals of Internal Medicine and is available on the Web at www.annals.org on that day.
"Growth hormone has been widely promoted as an anti-aging therapy," said Hau Liu, MD, a research fellow in endocrinology and health policy at Stanford University and an author of the review.
"But the scant clinical experience of GH in the healthy elderly suggests that although GH may minimally alter body composition, it does not improve other clinically relevant outcomes such as bone density, cholesterol levels, stamina, and longevity in this population.
"And it's associated with high rates of adverse events.
"So, on the basis of available evidence, we cannot recommend growth hormone use for anti-aging in the healthy elderly."
Human growth hormone, a protein produced by the pituitary gland, helps regulate growth during childhood and metabolism in adults.
In the United States, the FDA has approved the drug, now produced synthetically, to treat children with short stature and some other growth problems caused by childhood diseases.
The FDA has approved GH to treat adults with growth hormone deficiency syndrome. Its use for anti-aging falls into a grey area. The FDA prohibits drug companies from marketing GH for off-label uses such as anti-aging.
Yet thousands of adults use GH as an anti-aging drug. One estimate is that 20,000 to 30,000 adults used it for anti-aging purposes in the United States in 2004.
The Web is replete with ads for all kinds of products said to contain GH, from pills, sprays, injections, secretagogues, homeopathic formations, and GH releasers and enhancers. GH, often in conjunction with vitamins, testosterone and other hormones, is said to increase muscle strength and mass, decrease body fat, improve mood and motivation, increase exercise capacity, increase bone density and (wink, wink) make wives and girlfriends happy.
Despite these enticing claims, careful review of existing evidence does not support the prescription of GH for anti-aging purposes.
Growth hormone is among the most expensive of all hormones used for replacement therapy. One physician estimated that a year's supply for an adult with GH-deficiency caused by pituitary disease would cost between $7,500 and $10,000 per year. Estimates of the cost of GH for anti-aging purposes range from $1,000 per month to $2,000 per month.
"Everyone is looking for the fountain of youth," Liu said. "We wanted to see if there is any validity behind some of the claims made about growth hormone's anti-aging properties.
"Our biggest surprise was the general lack of research that had been done in this area. When we reviewed the scientific evidence, we found that there were really only about 500 patients involved in rigorous controlled trials. And only a few more than 200 actually received growth hormone.
"Think about all the scientific claims made on anti-aging Web sites based on this small population of patients. The FDA typically doesn't approve a drug until it's been tested in thousands of patients.
"In our review, we found that growth hormone increased lean body mass or muscle mass by slightly more than two kilograms (that's a little over four pounds) and decreased fat mass by about two kilograms. But it had no other beneficial effects that we could see.
"If you went to a gym pretty regularly, you might get that change without breaking into too much of a sweat, and you wouldn't spend $1,000 to $2,000 a month on something that appears to have modest or minimal benefit and the probability of bad side effects," said Liu.
NOTE: Offices of Annals of Internal Medicine and the American College of Physicians are closed on Monday, Jan. 15, 2007, reopening on Jan. 16. Please call for embargoed article and interviews on Jan. 11 or Jan. 12 or Tuesday, Jan. 16. Also, this article is the subject of a video news release. Coordinates follow.
Annals of Internal Medicine (www.annals.org) is one of the most widely cited peer-reviewed medical journals in the world. The journal has been published for 80 years and accepts only 7 percent of the original research studies submitted for publication.
Annals of Internal Medicine is published by the American College of Physicians (www.acponline.org), the largest medical specialty organization and the second-largest physician group in the United States.
ACP members include 120,000 internal medicine physicians (internists), related subspecialists, and medical students. Internists specialize in the prevention, detection, and treatment of illness in adults.
NOTES TO EDITORS:
1. To reach Dr. Liu, call: Louis Bergeron, Stanford Office of Communications, 650-723-0272.
2. This article is the subject of a video news release from the American College of Physicians.
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