Testosterone and Rehabilitation

ABSTRACT & COMMENTARY

Source: Bakhshi V, et al. Testosterone improves rehabilitation outcomes in ill older men. J Am Geriatr Soc 2000; 48:550-553.

As men age, there is a decrease in muscle strength, mass, and endurance. These changes may be attributed to declining levels of bioavailable testosterone. By age 80, testosterone production rate has declined by 50%. Chronic illness also depresses testosterone concentrations. In fact, hypogonadism is more common than hypothyroidism in individuals with systemic illnesses. However, the effect of illness-associated hypogonadism on morbidity in elderly men has not been systematically studied.

Bakhshi and colleagues hypothesized that men, admitted to a Geriatric Evaluation and Management (GEM) unit for rehabilitation, would have a greater improvement in strength and physical functional status after receiving testosterone supplementation than placebo. Community-dwelling men aged 65 years or older who were admitted or transferred to the GEM and met inclusion and exclusion criteria were eligible for the study. Over a 13-month period, only 17 patients met inclusion/exclusion criteriaand two refused to participate. The remaining 15 patients were enrolled and randomized to receive a weekly intramuscular injection of either placebo or testosterone enanthate 100 mg until discharge or for a maximum of eight weeks. All subjects received rehabilitation therapy treatments appropriate for their needs.

Bakhshi et al primary outcome measures were the Functional Independence Measure (FIM) and grip strength. The FIM is a standardized self-report measure of functional status during medical rehabilitation. The secondary measure consisted of the Geriatric Depression Scale, short form administered by a therapist blinded to the intervention.

Six patients (age 78.3 ± 5.6 vs 75.7 ± 5.3 years) were randomized to receive a weekly intramuscular injection of placebo (sterile saline) and nine to receive a weekly intramuscular injection of testosterone enanthate 100 mg. All subjects tolerated the treatment well and no one dropped out of the study. However, one subject in the testosterone group died unexpectedly two weeks after admission to the study. This patient was excluded from statistical analysis.

There were no statistically significant differences between groups in any measured baseline variable. At time of discharge from the GEM, FIM scores of the testosterone-treated subjects had improved compared to baseline (93.6 ± 25.4 vs 70.7 ± 28.7; P = 0.012). Grip strength also improved in the testosterone-treated group (68.7 ± 32.1 vs 55.3 ± 25 pounds; P = 0.033). There was no statistically significant improvement on either measure in the placebo group. The GDS-SF score improved in both the placebo and testosterone groups. However, there was a greater improvement in the testosterone group than in the placebo group: mean change of the GDS-SF score was 0.6 ± 0.5 in the placebo group vs. 3.5 ± 1.9 in the testosterone group (P = 0.013). The length of stay on the GEM was not significantly different between the placebo and testosterone groups.

COMMENT BY CLAUDIA A. ORENGO, MD, PhD

Bakhshi et al have presented a placebo-controlled, randomized pilot study of 15 ill older men admitted to a GEM. Bakhshi et al found that functional status and grip strength scores improved in the testosterone-treated subjects, whereas they did not change significantly in the placebo group. They also found a significant improvement in depressive symptoms in the testosterone group, more so than in the placebo group. These preliminary results suggest that testosterone supplementation in debilitated older men may improve rehabilitation outcomes.

The study is limited by various factors. The study has a small sample size with confounding variables. In addition, all the subjects were older male veterans; therefore, the results may not be generalizable to the community- dwelling older men.

Overall, this study provides useful information regarding improving rehabilitation outcomes by testosterone supplementation in ill older men. Often, community-dwelling men are admitted to hospitals because of acute or subacute illnesses and rapidly become deconditioned. The overall morbidity of these men increases dramatically due to the effects of deconditioning and declines in functional status. Patients require rehabilitation to recover lost strength and functional status. This study demonstrates that weekly testosterone supplementation can improve rehabilitation outcomes. Although the study has a small sample size and reports modest improvement in grip strength and FIM, testosterone supplementation in ill older men should be explored. Investigating the effects of testosterone supplementation in ill older men selected for hypogonadism may show more robust clinically significant results. Future studies should investigate if testosterone supplementation decreases length of stay or recovery time. Also, the safety of chronic testosterone supplementation should be investigated.

Clinically, one might consider a short course of testosterone treatment in chronically ill, hypogonadal older men not only to improve functional outcomes but also to improve the quality of life of older men.