R Visvanathan1, C Piantadosi, K Lange, V Naganathan, P Hunter, I D Cameron, I Chapman. 1. Professor Renuka Visvanathan, University of Adelaide and The Queen Elizabeth Hospital, Department of Medicine and The Aged and Extended Care Services, Address: Level 8B, The Queen Elizabeth Hospital, Woodville South, SA 5011, Telephone No: 08-82226887, Fax No: 08-82228593, e-mail: renuka.visvanathan@adelaide.edu.au.
Abstract
OBJECTIVE: In a pilot single centre study we found that treatment of undernourished older, community dwelling people for one year withoral testosterone (placebo-controlled) and a nutritional supplement (no control) was associated with a significant reduction in hospitalizations. A larger, multicentre study was conducted to investigate further this potentially important finding. DESIGN: One year, randomized, placebo-controlled, multi-centre, double-blind, trial. SETTING: Community. PARTICIPANTS: 53 undernourished men and women aged 65 years and older. INTERVENTION: Oral testosterone undecanoate (40 mg/day women, 160 mg/day men) and high energy oral nutritional supplement (2108-2416 kJ/day) or placebo medication and low energy (142-191 kJ/day) "placebo" oral nutritional supplementation. MEASUREMENTS: Hospital admissions, falls and other variables were assessed. RESULTS:53 subjects were recruited (64% male and mean age 77 years), which was substantially less than planned. Sixteen subjects (30%) were admitted to hospital at least once, with a total of 29 admissions. Eight subjects (32%) in the placebo arm were admitted to hospital, whilst in the intervention group also there were eight (29%) subjects admitted to hospital during the study period. There was no difference in the number of hospitalisations (P = 0.842), length of hospitalization (P=0.645) or quality of life [mental health P=0.195 and physical health P=0.451) between the treatment arms. CONCLUSIONS: In undernourished older people, treatment with testosterone and a nutritional supplementation did not reduce the number and length of hospitalisations or improve quality of life.
RCT Entities:
OBJECTIVE: In a pilot single centre study we found that treatment of undernourished older, community dwelling people for one year with oral testosterone (placebo-controlled) and a nutritional supplement (no control) was associated with a significant reduction in hospitalizations. A larger, multicentre study was conducted to investigate further this potentially important finding. DESIGN: One year, randomized, placebo-controlled, multi-centre, double-blind, trial. SETTING: Community. PARTICIPANTS: 53 undernourished men and women aged 65 years and older. INTERVENTION: Oral testosterone undecanoate (40 mg/day women, 160 mg/day men) and high energy oral nutritional supplement (2108-2416 kJ/day) or placebo medication and low energy (142-191 kJ/day) "placebo" oral nutritional supplementation. MEASUREMENTS: Hospital admissions, falls and other variables were assessed. RESULTS: 53 subjects were recruited (64% male and mean age 77 years), which was substantially less than planned. Sixteen subjects (30%) were admitted to hospital at least once, with a total of 29 admissions. Eight subjects (32%) in the placebo arm were admitted to hospital, whilst in the intervention group also there were eight (29%) subjects admitted to hospital during the study period. There was no difference in the number of hospitalisations (P = 0.842), length of hospitalization (P=0.645) or quality of life [mental health P=0.195 and physical health P=0.451) between the treatment arms. CONCLUSIONS: In undernourished older people, treatment with testosterone and a nutritional supplementation did not reduce the number and length of hospitalisations or improve quality of life.
Authors: L P Fried; C M Tangen; J Walston; A B Newman; C Hirsch; J Gottdiener; T Seeman; R Tracy; W J Kop; G Burke; M A McBurnie Journal: J Gerontol A Biol Sci Med Sci Date: 2001-03 Impact factor: 6.053
Authors: Stephanie T Page; John K Amory; F Dubois Bowman; Bradley D Anawalt; Alvin M Matsumoto; William J Bremner; J Lisa Tenover Journal: J Clin Endocrinol Metab Date: 2004-11-30 Impact factor: 5.958
Authors: John K Amory; Howard A Chansky; Kari L Chansky; Matthew R Camuso; Chris T Hoey; Bradley D Anawalt; Alvin M Matsumoto; William J Bremner Journal: J Am Geriatr Soc Date: 2002-10 Impact factor: 5.562