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Submitted on May 2, 2005
Accepted on November 23, 2005
Departments of Diabetes & Endocrinology, (MGG, LB, CP, MU, PHS), Ageing and Health (FCM), GKT School of Medicine, King's College London, St. Thomas' Hospital London SE1 7EH, United Kingdom; Health Psychology Research, (CM, CB), Psychology Department, Royal Holloway, University of London, Egham, Surrey, TW20 0EX, United Kingdom
* To whom correspondence should be addressed. E-mail: finbarr.martin{at}gstt.
Context: Declines of growth hormone (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 (LBM), fat body mass (FBM), mid-thigh muscle cross-section area, muscle strength, aerobic capacity (VO2max), condition-specific quality of life (A-RHDQoL) and generic health status (SF-36) of older men.
Design, settings, and participants: A six months randomized double blind, placebo controlled trial in eighty healthy community dwelling older men (age, 65-80 yr).
Interventions: Participants were randomized to receive either (i) placebo GH or placebo Te (Pl), (ii) recombinant human GH (rhGH) and placebo Te (GH), (iii) Te and placebo rhGH (Te) or (iv) rhGH and Te (GHTe). GH doses were titrated over 8 weeks to produce IGF-I levels in the upper half of the age-specific reference range. Fixed dose Te (5 mg) was given by transdermal patches.
Results: LBM increased with GHTe (P = 0.008) and with GH (P = 0.004), compared with placebo. FBM decreased with GHTe only (P = 0.02). Mid-thigh muscle (P = 0.006) and VO2max (P < 0.001) increased only after GHTe. Muscle strength changes were variable, one of six measures significantly increasing with GHTe. Significant treatment-group-by-time interactions indicated an improved A-RHDQoL score (P = 0.007) in the GH and GHTe groups. SF-36. Bodily Pain increased with GH alone (P = 0.003). There were no major adverse effects.
Conclusion: Co-administration of low dose GH with Te resulted in beneficial changes being observed more often than with either GH or Te alone.
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