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Latest Anti-Aging Elixirs Lack Proof of Safety and Efficacy
by Richard Sherer
Geriatric Times January/February 2003 Vol. IV Issue 1
Hard on the heels of the latest journal article, the e-mails poured in: "The first 100 percent natural neutraceutical capsule clinically proven to reverse the aging process." "Lose weight while you sleep." "As seen on NBC, CBS, CNN and even Oprah. As reported on in the New England Journal of Medicine. Reverses aging while burning fat, without dieting or exercise. Forget aging and dieting forever. And it's Guaranteed!"
The search for weapons in the battle against the aging process is not new. Juan Ponce de Leon led a troop of soldiers around the wild new land that became Florida nearly 500 years ago in a futile search for the Fountain of Youth. Next to the philosopher's stone that would turn lead into gold, the most important goal of alchemy was to find the fabled elixir of life--a quest that has found new impetus on the Internet and in medical journals.
Today's elixir is human growth hormone (HGH), and it is being touted on the Internet, in direct mail advertising, and in a seemingly endless series of conferences and meetings, some of which lure physicians with the offer of continuing medical education credits. Some conferences offer an opportunity to hear well-known scientists discuss the latest breakthroughs in anti-aging medicine.
"Many bright people in their 70s and 80s cast around for almost anything to make them functional again," explained John E. Morley, M.D., in an interview with Geriatric Times. Morley, who is professor of internal medicine and geriatrics at St. Louis University, went on to say, "You can go back to [Charles Édouard] Brown-Séquard in France in the 19th century, who injected himself with genital gland extracts and became an 'authority' on aging. The power of positive thought as you get older is extraordinarily strong. Belief is important in making things appear to be working. It's the placebo effect."
A conference sponsored by the American Academy of Anti-Aging Medicine listed Nobel Laureate Louis Ignarro, Ph.D., among its featured speakers. Ignarro, who received the Nobel Prize for medicine in 1998 for his work in identifying nitric oxide as the signaling molecule in the cardiovascular system, did not return this reporter's phone call or e-mail requesting an interview. Later, the Web site promoting the conference had been reposted without his picture.
According to Stephen H. Miller, M.D., M.P.H., executive vice president of the American Board of Medical Specialties, anti-aging medicine is not a recognized medical specialty. "We have never accredited them, and … I'm unaware of the completion of an application," said Miller in an interview with GT. "They have not applied for recognition, at least not in the last five years. What the criteria are, I have no idea.
"It's part of a children's story," he added. "I'm thinking of Alice in Wonderland, where one character avers that 'words mean what I choose them to mean.'"
The popularity of HGH among anti-aging proponents received a boost with the recent publication of a 26-week, double-blind, placebo-controlled, parallel-group trial involving men and women between the ages of 65 and 88 years who were recruited between June 1992 and July 1998. The study, published in JAMA in November 2002, was supported by grants from the National Institutes of Health and the General Clinical Research Center.
Among study findings, researchers reported that growth hormone replacement increased lean body mass (LBM) and reduced fat mass in both men and women. The study also found that growth hormone used in combination with testosterone improved cardiovascular endurance in men. Despite these findings, the researchers emphasized the high incidence of side effects associated with these treatments, including diabetes and glucose intolerance, edema in women, and carpal tunnel symptoms and arthralgias in men.
The researchers cautioned, "Because adverse effects were frequent (importantly, diabetes and glucose intolerance), GH interventions in the elderly should be confined to controlled studies"--a statement not quoted in the widely distributed promotional materials for HGH.
"The bottom line," said Morley, "is that growth hormone does not appear to improve anything worth improving. There is some small improvement in muscle mass. But there are no studies that show that it actually enhances life. And all of the studies so far show an unacceptable level of side effects. With growth hormone, the fact is that for the person who is taking it, the answer most probably is that they shouldn't."
Morley also noted that many of the products being touted by anti-aging specialists are not tested. "For example, take testosterone. A lot of what's advertised is basically not effective. You've got a 50-50 chance of buying nothing. Often what is being advertised is not what's there. One product increases testosterone by 1 nanogram; that has no meaning at all. But that's very common.
"The first thing a person should do is discuss with a physician if he or she is a candidate for testosterone replacement. There are a number of products on the market, but there is no evidence that they will increase life or result in quality of life improvement. With testosterone, there is a very small subset of people whose conditions will improve."
In an editorial in The Journal of Gerontology: Medical Sciences, which Morley edits, Morley and Alfred Fisher, M.D., reviewed the current catalogue of anti-aging nostrums and products on the market. Most, they wrote, are "unlikely to rejuvenate, but are couched in pseudoscientific terminology to appeal to those desperate to find the mythical fountain of youth."
For example, they wrote, controlled trials of vitamin E supplementation in humans "showed a reduction in morbidity and mortality from atherosclerosis in the Cambridge Heart Antioxidant Study, but failed to find a beneficial effect in the Primary Prevention Project, the Alpha-Tocopherol and Beta-Carotene Cancer Prevention Study, the Heart Outcomes Prevention Evaluation Study and the Italian Gizzi-Prevenicone Study." Morley and Fisher also noted that vitamin E "has been shown to have some benefit in delaying Alzheimer's ... but only after the data were statistically manipulated to account for baseline mental status."
At present, "There is little evidence that free radical scavengers have positive antiaging effects."
Morley and Fisher explained that caloric restriction "has been shown to extend lifespan in a variety of animal species," but "an important negative effect of caloric restriction is a reduction in bone mineral density." The authors also warned against "the anorexia of aging" and added, "caloric restriction could lead over time to an increase in the number of 'fat frail' in the older population."
Although estrogen replacement in women "can prevent the unpleasant effects of menopause and delay the rapid decline in bone mineral density," the authors noted, "the Heart Estrogen Replacement Study and Women's Health Initiative Memory Study have suggested that estrogen replacement may increase early cardiovascular deaths in some women."
Testosterone replacement offers some promise, the editorial suggested. "There are, however, minimal safety studies demonstrating the long-term effects of testosterone."
The authors stated that there is not enough evidence "to support the use of DHEA [dehydroepiandrosterone] or pregnenolone as anti-aging hormones," despite their popularity with "anti-aging aficionados."
"DHEA may be reasonable in some women," Morley told GT, "But there [are] no data to support it. The data [are] poor in all these areas. None of these other things are proven to be useful. They all need more work."
Studies of herbal products also "need to be viewed with caution," Fisher and Morley wrote. They noted that garlic supplementation "has minimal effects on lowering cholesterol and no effect on blood pressure. Garlic supplements containing 1.3% allicin have not been shown to prevent cancer."
The researchers from the NIH study compared the results of hormone enhancements and physical exercise: "In the men in our study, the magnitude of the increases in LBM and decreases in fat following GH + testosterone treatment were similar to those reported after 6 months of exercise training 3 times per week." They also commented, "An increase of the magnitude observed would be expected after 6 to 8 weeks of regular resistance exercise."
Strongly endorsing that view, Morley told GT, "resistance exercise is amazing," and "none of these other things has been proven useful." In his editorial with Fisher, they expanded on that view: "Perhaps the best anti-aging medicine is exercise. Resistance exercise seems to be particularly useful as it not only improves strength but also enhances cognition and decreases depression."
Yet the sellers of anti-aging products continue to push their wares. There is virtually no restriction on them, as long as their claims are sufficiently vague. "These things sort of break down into two categories," said Richard Cleland, senior attorney in the division of advertising practices at the Federal Trade Commission. "There are products that have a vague marketing position of calling themselves anti-aging versus products that discuss specific ailments associated with aging products. Our cases tend to focus on the latter. We tend to give priority to those cases and those instances where marketers are claiming that they can prevent or mitigate age-related diseases," he told GT.
One typical anti-aging Web site promotes a product that was "developed in our own laboratories by our chemists and clinically tested by doctors in studies to determine a reversal in the aging process." It refers to its product as a "secretagogue" that stimulates release of growth hormone. The product can escape notice of the regulatory authorities by not citing a specific disease.
Fisher and Morley acknowledged the appeal of anti-aging products, but pointed out, "There is clearly little evidence-based medicine to support most of the generally touted approaches. While research needs to go forward, it is important that gerontologists do not provide support for the large number of inappropriate antiaging therapies."
