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November 13, 2002 — Growth hormone supplementation, with or without hormone replacement therapy (HRT) or testosterone, increases lean body mass and decreases fat in older women and men, but also increases the risk of complications such as diabetes and glucose intolerance, according to an article in the November 13 issue of The Journal of the American Medical Association, a theme issue on aging. According to background information in the article, previous studies have shown that growth hormone administration can improve the body composition of older men and women, but the effects of growth hormone in combination with sex steroids (testosterone and HRT) and their influence on muscle strength and cardiovascular endurance are unknown. Marc R. Blackman, M.D., of the National Institutes of Health in Bethesda, Md., and colleagues evaluated the effects of 26 weeks of growth hormone and sex steroids (women, transdermal estradiol plus oral medroxyprogesterone; men, testosterone enanthate), alone and in combination, on body composition, strength, cardiovascular endurance and adverse outcomes, in healthy, older men (n=74) and women (n=57) aged 65 to 88 years, recruited between June 1992 and July 1998. The study was a randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to receive four different treatments: growth hormone (GH) and sex steroids (for women, HRT and for men, testosterone) (n=35), GH plus a placebo sex steroid (n=30), sex steroid plus placebo GH (n=35), or placebo GH plus placebo sex steroid (n=31). The researchers found that lean body mass (LBM) increased the most in men and women taking GH plus sex steroids, with an increase of 4.3 kg of LMB in men, and an increase of 2.1 kg of LBM in women. Men and women taking GH and GH plus sex steroids also lost a statistically significant amount of fat.
Strength was not significantly affected by GH, sex steroids or GH plus sex steroids for women, but the strength of men taking GH plus testosterone increased marginally. Cardiovascular endurance (maximum aerobic capacity [VO2 max]) was measured by the maximum amount of oxygen used until exhaustion or other end points were reached while using a treadmill. VO2 max increased significantly only in men taking GH plus testosterone. Changes in strength and cardiovascular endurance were directly related to changes in LBM.
The researchers also found that there were several adverse effects in men and women participating in the study. Diabetes or glucose intolerance occurred in 18 GH-treated men vs. seven men not receiving GH. Additionally, peripheral edema, or swelling of the arms or legs, was reported in 39 percent of women taking GH, and in 38 percent of women taking GH and sex steroids compared to no reports of edema in women taking placebo. Carpal tunnel syndrome symptoms were reported in 32 percent of men taking GH and testosterone, and joint pains were evident in 41 percent of men taking GH, with no reports of carpal tunnel symptoms or joint pains in men taking placebo.
The authors conclude: "Our findings suggest that GH and sex steroid supplementation in a selected group of healthy aged women and men can exert potentially beneficial effects on body composition, and possibly improve muscle strength and cardiovascular endurance capacity in men. However, GH supplementation may lead to various adverse effects, most importantly diabetes and glucose intolerance. The beneficial effects of GH appeared to be augmented by co-administration of testosterone but not HRT. These data support the rationale for further, larger-scale investigations of the efficacy, safety, and clinical and functional utility of more physiologic hormone replacement. However, at this time, GH interventions in elderly individuals should be confined to controlled research studies."
Editor's Note: This work was supported in part by grants from the National Institute on Aging, National Institutes of Health. Genentech Inc. provided the recombinant human GH and Novartis Pharmaceuticals provided the transdermal estradiol.
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