The effects of growth hormone and/or testosterone in healthy elderly men: a randomized controlled trial.
BACKGROUND
Declines in GH and testosterone (Te) secretion may contribute to the detrimental aging changes of elderly men.


OBJECTIVE
To assess the effects of near-physiological GH with/without Te administration on lean body mass, total body fat, midthigh muscle cross-section area, muscle strength, aerobic capacity, condition-specific quality of life (Age-Related Hormone Deficiency-Dependent Quality of Life questionnaire), and generic health status (36-Item Short-Form Health Survey) of older men.


METHODS
A 6-month, randomized, double-blind, placebo-controlled trial was performed on 80 healthy, community-dwelling, older men (age, 65-80 yr).


METHODS
Participants were randomized to receive 1) placebo GH or placebo Te, 2) recombinant human GH (rhGH) and placebo Te (GH), 3) Te and placebo rhGH (Te), or 4) rhGH and Te (GHTe). GH doses were titrated over 8 wk to produce IGF-I levels in the upper half of the age-specific reference range. A fixed dose of Te (5 mg) was given by transdermal patches.


RESULTS
Lean body mass increased with GHTe (P = 0.008) and GH (P = 0.004), compared with placebo. Total body fat decreased with GHTe only (P = 0.02). Midthigh muscle (P = 0.006) and aerobic capacity (P < 0.001) increased only after GHTe. Muscle strength changes were variable; one of six measures significantly increased with GHTe. Significant treatment group by time interactions indicated an improved Age-Related Hormone Deficiency-Dependent Quality of Life questionnaire score (P = 0.007) in the GH and GHTe groups. Bodily pain increased with GH alone, as determined by the Short-Form Health Survey (P = 0.003). There were no major adverse effects.


CONCLUSIONS
Coadministration of low dose GH with Te resulted in beneficial changes being observed more often than with either GH or Te alone.
Giannoulis
Manthos G
MG
Department of Diabetes and Endocrinology, GKT School of Medicine, King's College London, St. Thomas' Hospital, London SE1 7EH, UK.
Sonksen
Peter H
PH
Umpleby
Margot
M
Breen
Louise
L
Pentecost
Claire
C
Whyte
Martin
M
McMillan
Carolyn V
CV
Bradley
Clare
C
Martin
Finbarr C
FC
D000368:Aged; D000369:Aged, 80 and over; D001823:Body Composition / Q000187:drug effects / Q000502:physiology*; D004311:Double-Blind Method; D018737:Hand Strength / Q000502:physiology; D019382:Human Growth Hormone / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008297:Male; D018482:Muscle, Skeletal / Q000187:drug effects* / Q000502:physiology*; D010809:Physical Fitness / Q000502:physiology*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000009:adverse effects / Q000494:pharmacology*
D019382:Human Growth Hormone; D013739:Testosterone; D007334:Insulin-Like Growth Factor I