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, multicentre, 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.
- randomized controlled trial