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Marc R. Blackman; John D. Sorkin; Thomas Munzer; Michele F. Bellantoni; Jan
Busby-Whitehead; Thomas E. Stevens; Jocelyn Jayme; Kieran G. O'Connor; Colleen
Christmas; Jordan D. Tobin; Kerry J. Stewart; Ernest Cottrell; Carol St. Clair;
Katharine M. Pabst; S. Mitchell Harman
JAMA. 2002; 288(18):2282-2292.
The purpose of this study was to evaluate the effects of recombinant human
growth hormone (rhGH) and/or sex steroids on body composition, strength,
endurance and adverse outcomes in healthy elderly persons. Changes in body
composition and function during aging may result in part from the interactive
effects of decreases in both growth hormone and sex steroids.
Study
participants included 57 women and 74 men between the ages of 65 and 88,
recruited between 1992 and 1998. All were healthy as verified by a screening
history and physical examination, routine blood work and urinalysis. All were
nonsmokers, drank less than 30g/d of alcohol and took no medications that would
interfere with the study.
This was a 26 week, randomized, double blind,
placebo controlled trial. Participants were randomized to receive rhGH plus a
sex steroid; rhGH plus a placebo sex steroid; sex steroid plus a placebo rhGH;
or a placebo rhGH plus a placebo sex steroid. Participants were initially
admitted to a clinical facility for 3 days of testing to establish baseline
measurements. They were instructed in the self administration of the study
medications and told maintain their normal diet and levels of physical activity
during the trail period.
The sex steroids and placebos were
self-administered by the female study participants via tablets and transdermal
patches. The male participants received biweekly intramuscular injections of
either testosterone or saline from a nurse. Subcutaneous injections of growth
hormone were self-administered by both men and women three times per week. After
the first year of the study, the standard dose of rhGH was reduced due to the
high incidence of adverse effects experienced by participants.
Participants were seen weekly for assessment of adverse effects and measurement
of body weight, temperature, blood pressure and pulse, and every 4 weeks for a
detailed assessment and testing. Medication doses were reduced as necessary
based on adverse effects. Four women and two men dropped out before the end of
the study, two thirds of which were due to adverse effects.
Adverse
effects in participants treated with GH included soft tissue edema, joint pain
and carpal tunnel symptoms and were more common in men than in women. Men were
also more likely to develop glucose intolerance and diabetes, consistent with
previous findings that men are more responsive to GH. Administering sex steroids
with GH did not increase the incidence of soft tissue effects or glucose
intolerance. About 10% of the men receiving GH developed mild gynecomastia
(breast enlargement).
Both men and women who received GH, with or without
sex steroids, increased lean body mass and decreased fat mass. Men taking GH
plus sex steroid increased muscle strength marginally and increased maximum
oxygen uptake during treadmill tests. Women showed no significant change in
strength or cardiovascular endurance.
The findings of this study suggest
that GH and sex steroid supplementation can potentially exert beneficial effects
on body composition in healthy elderly men and women and possibly improve muscle
strength and cardiovascular endurance capacity in men. The beneficial effects of
GH for men appeared to be augmented by taking it in combination with
testosterone. However, GH supplementation can lead to a number of adverse
effects, most importantly glucose intolerance and diabetes. The researchers
suggest that further research is needed into the safety and efficacy of GH and
GH supplementation for the elderly should be confined to controlled studies.
