A Randomized Controlled Trial of Testosterone Undecanoate for Improving Quality of Life of the Elderly Male Patients with Chronic Disease in Advanced Stage_Chinese Journal of Evidence-Based Medicine

Authors：

SHU Defen , DONG Birong

Department of Gerontology; West China Hospital; Sichuan University; Chengdu 610041; China;

Corresponding author：

Keywords：

Testosterone undecanoate; Quality of life; Elderly male patient; Chronic disease; Exhaustion

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Objective 　To study the effectiveness, safety and tolerance of testosterone undecanoate （TU） in improving exhaustion and quality of life （QOL） of the elderly male patients with chronic disease in advanced stage.
Methods 　Using a simple randomized controlled trial design, eighty patients were randomized into two groups. The treatment group took routine therapy and TU and the control group with routine therapy alone.
Results 　1. Baseline characteristics in both groups were similar. 2. The PADAM grade decreased, and the QOL scale increased in the treatment group （P〈0.05 ）. 3. Serum total testosterone in the treatment group rose, upper arm circumference and right hand grip improved （P〈0.05 ）. 4. There were no significant differences in adverse effects between both groups.
Conclusions 　TU can improve the clinical health status in the elderly male patients with chronic disease in advanced stage and increase serum testosterone level, there is a satisfactory tolerances and few adverse reactions.

Citation： SHU Defen,DONG Birong. A Randomized Controlled Trial of Testosterone Undecanoate for Improving Quality of Life of the Elderly Male Patients with Chronic Disease in Advanced Stage. Chinese Journal of Evidence-Based Medicine, 2005, 05(8): 599-604. doi: Copy

1.	黄志明, 韩银发, 李铮. 睾酮补充治疗是否增加患者良性前列腺增生风险的研究[J]. 中国男科学杂志, 2002; 16(5): 364～366, 369.
2.	Ferrini RL, Barrett-Connor E. Sex hormones and age: a cross-sectional study of testosterone and estradiol and their bioavailable fractions in community-dwelling men[J]. Am J Epidemio, 1998; 147(8): 750-754.
3.	Gray A, Feldman HA, Mckinlay JB, Longcope C. Age, disease and changing sex hormone levels in middle-aged men: results of the Massachusetts Male Aging Study[J]. J Clin Endocrinol Metab, 1991; 73(5): 1016-1025.
4.	Barrett-connor E, Von Mühlen DG, Kritz-silverstein D. Bioavaolable testosterone and depressed mood in older men: The Rancho Bernardo Study[J]. J Clin Endocrinol Metab, 1999; 84(2): 573-577.
5.	Wang C, Swerdloff RS, Iranmanesh A, Dobs A, Snyder PJ, Cunningham G, Matsumoto AM, Weber T, Berman N. The Testosterone Gel Study Group, Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. Testosterone Gel Study Group[J]. J Clin Endocrinol Metab, 2000; 85(8): 2839-2853.
6.	Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Lenrow DA, Holmes JH, Dlewati A, Santanna J, Rosen CJ, Strom BL. Effect of testosterone treatment on body composition and muscle strength in men over 65 years of age[J]. J Clin Endocrinol Metab, 1999; 84(8): 2647-2653.
7.	Wittert GA, Chapman IM, Haren MT, Mackintosh S, Coates P, Morley JE. Oral testosterone supplementation increases muscle and decreases fat mass in healthy elderly males with low-normal gonadal status[J]. ournals of Gerontology Series A-Biological Sciences & Medical Sciences, 2003; 58(7): 618-625.
8.	Storer TW, Magliano L, Woodhouse L, Lee ML, Dzekov C, Dzekov J, Casaburi R, Bhasin S. Testosterone dose-dependently increases maximal voluntary strength and leg power, but does not affect fatigability or specific tension[J]. J Clin Endocrinol Metabo, 2003; 88(4): 1478-1485.
9.	Pope HG Jr, Cohane GH, Kanayama G, Siegel AJ, Hudson JI. Testosterone gel supplementation for men with refractory depression: a randomized, placebo-controlled trial[J]. Am J Psychiatry, 2003; 160(1): 105-111.
10.	Cavallini G, Caracciolo S, Vitali G, Modenini F, Biagiotti G. Carnitine versus androgen administration in the treatment of sexual dysfunction, depressed mood, and fatigue associated with male aging[J]. Urology, 2004; 63(4): 641-646.
11.	Leibenluft E, Schmidt PJ, Turner EH, Danaceau MA, Ashman SB, Wehr TA, Rubinow DR. Effects of leuprolide-induced hypogonadism and testosterone replacement on sleep, melatonin, and prolactin secretion in men[J]. J Clin Endocrinol Metab, 1997; 82(10): 3203-3207.
12.	Ly LP, Jimenez M, Zhuang TN, Celermajer DS, Conway AJ, Handelsman DJ. A double-blind, placebo-controlled, randomized clinical trial of transdermal dihydrotestosterone gel on muscular strength, mobility, and quality of life in older men with partial androgen deficiency[J]. J Clin Endocrinol Metab, 2001; 86(9): 4078-4088.
13.	Bergamini E. Tstosterone and sugar transport in levator ani muscle of rat[J]. Biochim Biophys Acta, 1969; 193(1): 193-202.
14.	Park NC, Yan BQ, Chung JM, Lee KM. Oral testosterone undecanoate (Andriol) supplement therapy improves the quality of life for men with testosterone deficiency[J]. Aging Male, 2003; 6(2): 86-93.
15.	Liu PY, Yee B, Wishart SM, Jimenez M, Jung DG, Grunstein RR, Handelsman DJ. The short-term effects of high-dose testosterone on sleep, breathing, and function in older men[J]. J Clin Endocrinol Metab, 2003; 88(8): 3605-3613.
16.	Huang ZM, Han YF, Li Z. The study of whether testosterone supplement therapy improving the risk of benign prostatic hyperplasia[J]. Chinese Male Science Journal, 2002; 16(5): 364-366, 369.
17.	Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls[J]. Clin Endocrinol (Oxf), 1994; 40(3): 341-349.
18.	Gooren LJ. A ten-year safety study of the oral androgen testosterone undecanoate[J]. J Androl, 1994; 15(3): 212-215.

1. 黄志明, 韩银发, 李铮. 睾酮补充治疗是否增加患者良性前列腺增生风险的研究[J]. 中国男科学杂志, 2002; 16(5): 364～366, 369.
2. Ferrini RL, Barrett-Connor E. Sex hormones and age: a cross-sectional study of testosterone and estradiol and their bioavailable fractions in community-dwelling men[J]. Am J Epidemio, 1998; 147(8): 750-754.
3. Gray A, Feldman HA, Mckinlay JB, Longcope C. Age, disease and changing sex hormone levels in middle-aged men: results of the Massachusetts Male Aging Study[J]. J Clin Endocrinol Metab, 1991; 73(5): 1016-1025.
4. Barrett-connor E, Von Mühlen DG, Kritz-silverstein D. Bioavaolable testosterone and depressed mood in older men: The Rancho Bernardo Study[J]. J Clin Endocrinol Metab, 1999; 84(2): 573-577.
5. Wang C, Swerdloff RS, Iranmanesh A, Dobs A, Snyder PJ, Cunningham G, Matsumoto AM, Weber T, Berman N. The Testosterone Gel Study Group, Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. Testosterone Gel Study Group[J]. J Clin Endocrinol Metab, 2000; 85(8): 2839-2853.
6. Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Lenrow DA, Holmes JH, Dlewati A, Santanna J, Rosen CJ, Strom BL. Effect of testosterone treatment on body composition and muscle strength in men over 65 years of age[J]. J Clin Endocrinol Metab, 1999; 84(8): 2647-2653.
7. Wittert GA, Chapman IM, Haren MT, Mackintosh S, Coates P, Morley JE. Oral testosterone supplementation increases muscle and decreases fat mass in healthy elderly males with low-normal gonadal status[J]. ournals of Gerontology Series A-Biological Sciences & Medical Sciences, 2003; 58(7): 618-625.
8. Storer TW, Magliano L, Woodhouse L, Lee ML, Dzekov C, Dzekov J, Casaburi R, Bhasin S. Testosterone dose-dependently increases maximal voluntary strength and leg power, but does not affect fatigability or specific tension[J]. J Clin Endocrinol Metabo, 2003; 88(4): 1478-1485.
9. Pope HG Jr, Cohane GH, Kanayama G, Siegel AJ, Hudson JI. Testosterone gel supplementation for men with refractory depression: a randomized, placebo-controlled trial[J]. Am J Psychiatry, 2003; 160(1): 105-111.
10. Cavallini G, Caracciolo S, Vitali G, Modenini F, Biagiotti G. Carnitine versus androgen administration in the treatment of sexual dysfunction, depressed mood, and fatigue associated with male aging[J]. Urology, 2004; 63(4): 641-646.
11. Leibenluft E, Schmidt PJ, Turner EH, Danaceau MA, Ashman SB, Wehr TA, Rubinow DR. Effects of leuprolide-induced hypogonadism and testosterone replacement on sleep, melatonin, and prolactin secretion in men[J]. J Clin Endocrinol Metab, 1997; 82(10): 3203-3207.
12. Ly LP, Jimenez M, Zhuang TN, Celermajer DS, Conway AJ, Handelsman DJ. A double-blind, placebo-controlled, randomized clinical trial of transdermal dihydrotestosterone gel on muscular strength, mobility, and quality of life in older men with partial androgen deficiency[J]. J Clin Endocrinol Metab, 2001; 86(9): 4078-4088.
13. Bergamini E. Tstosterone and sugar transport in levator ani muscle of rat[J]. Biochim Biophys Acta, 1969; 193(1): 193-202.
14. Park NC, Yan BQ, Chung JM, Lee KM. Oral testosterone undecanoate (Andriol) supplement therapy improves the quality of life for men with testosterone deficiency[J]. Aging Male, 2003; 6(2): 86-93.
15. Liu PY, Yee B, Wishart SM, Jimenez M, Jung DG, Grunstein RR, Handelsman DJ. The short-term effects of high-dose testosterone on sleep, breathing, and function in older men[J]. J Clin Endocrinol Metab, 2003; 88(8): 3605-3613.
16. Huang ZM, Han YF, Li Z. The study of whether testosterone supplement therapy improving the risk of benign prostatic hyperplasia[J]. Chinese Male Science Journal, 2002; 16(5): 364-366, 369.
17. Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls[J]. Clin Endocrinol (Oxf), 1994; 40(3): 341-349.
18. Gooren LJ. A ten-year safety study of the oral androgen testosterone undecanoate[J]. J Androl, 1994; 15(3): 212-215.

Chinese Journal of Evidence-Based Medicine

A Randomized Controlled Trial of Testosterone Undecanoate for Improving Quality of Life of the Elderly Male Patients with Chronic Disease in Advanced Stage

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