Systematic Review: The Safety and Efficacy of Growth Hormone in the Healthy Elderly

16 January 2007 | Volume 146 Issue 2 | Pages 104-115

Background: Human growth hormone (GH) is widely used as an antiaging therapy, although its use for this purpose has not been approved by the U.S. Food and Drug Administration and its distribution as an antiaging agent is illegal in the United States.

Purpose: To evaluate the safety and efficacy of GH therapy in the healthy elderly.

Data Sources: The authors searched MEDLINE and EMBASE databases for English-language studies published through 21 November 2005 by using such terms as growth hormone and aging.

Study Selection: The authors included randomized, controlled trials that compared GH therapy with no GH therapy or GH and lifestyle interventions (exercise with or without diet) with lifestyle interventions alone. Included trials provided GH for 2 weeks or more to community-dwelling participants with a mean age of 50 years or more and a body mass index of 35 kg/m² or less. The authors excluded studies that evaluated GH as treatment for a specific illness.

Data Extraction: Two authors independently reviewed articles and abstracted data.

Data Synthesis: 31 articles describing 18 unique study populations met the inclusion criteria. A total of 220 participants who received GH (107 person-years) completed their respective studies. Study participants were elderly (mean age, 69 years [SD, 6]) and overweight (mean body mass index, 28 kg/m² [SD, 2]). Initial daily GH dose (mean, 14 µg per kg of body weight [SD, 7]) and treatment duration (mean, 27 weeks [SD, 16]) varied. In participants treated with GH compared with those not treated with GH, overall fat mass decreased (change in fat mass, –2.1 kg [95% CI, –2.8 to –1.35] and overall lean body mass increased (change in lean body mass, 2.1 kg [CI, 1.3 to 2.9]) (P < 0.001), and their weight did not change significantly (change in weight, 0.1 kg [CI, –0.7 to 0.8]; P = 0.87). Total cholesterol levels decreased (change in cholesterol, –0.29 mmol/L [–11.21 mg/dL]; P = 0.006), although not significantly after adjustment for body composition changes. Other outcomes, including bone density and other serum lipid levels, did not change. Persons treated with GH were significantly more likely to experience soft tissue edema, arthralgias, carpal tunnel syndrome, and gynecomastia and were somewhat more likely to experience the onset of diabetes mellitus and impaired fasting glucose.

Limitations: Some important outcomes were infrequently or heterogeneously measured and could not be synthesized. Most included studies had small sample sizes.

Conclusions: The literature published on randomized, controlled trials evaluating GH therapy in the healthy elderly is limited but suggests that it is associated with small changes in body composition and increased rates of adverse events. On the basis of this evidence, GH cannot be recommended as an antiaging therapy.

Editors' Notes Context Human growth hormone (GH) is widely sold and used as an antiaging agent. Contributions The researchers reviewed all clinical trials of GH to determine if it is safe and effective in the healthy elderly. They found that GH had no important effects on body composition but led to frequent adverse effects, most notably soft tissue edema and arthralgias. Cautions Clinical trials of GH have been small, and they may not have been able to detect important differences. Implications Published data about GH use in the elderly is limited, but available evidence suggests that risks far outweigh benefits when it is used as an antiaging treatment in healthy older adults. —The Editors

 

Author and Article Information

From Stanford University, Stanford, California, and Veterans Affairs Palo Alto Health Care System, Palo Alto, California.

Acknowledgments: The authors thank Christopher Stave, MLS, Information Services Librarian, Lane Medical Library, Stanford University, for his assistance with the literature review.

Grant Support: Dr. Liu was supported by the U.S. Agency for Healthcare Research and Quality, National Research Service Award, grant number HS000028-19. Dr. Nayak was supported by a U.S. Department of Veterans Affairs Ambulatory Care Fellowship. Drs. Garber and Hoffman were supported in part by the U.S. Department of Veteran Affairs. Dr. Garber was also supported by a grant from the National Institute of Aging (AG17253, Center for Demography and Economics of Health and Aging). Dr. Roberts was supported by a fellowship stipend from Genentech, Inc.

Potential Financial Conflicts of Interest: Consultancies: A.R. Hoffman (Genentech, Teva, LG Life Sciences); Honoraria: A.R. Hoffman (Genentech); Stock ownership or options (other than mutual funds): A.R. Hoffman (Ambrx); Grants received: B. Roberts (Genentech), A.R. Hoffman (Genentech).

Requests for Single Reprints: Hau Liu, MD, MBA, MPH, Stanford University, 117 Encina Commons, Stanford CA, 94305-6019; e-mail, hauliu{at}stanford.edu.

Current Author Addresses: Drs. Liu, Bravata, and Garber: Stanford University, 117 Encina Commons, Stanford, CA 94305.

Dr. Olkin: Department of Health Research and Policy, Stanford University, Sequoia 126, Stanford, CA, 94305.

Dr. Nayak: University of Pittsburgh, 200 Meyran Avenue, Suite 200, Pittsburgh, PA, 15213.

Dr. Roberts: Stanford University, 300 Pasteur Drive, Stanford, CA 94305.

Dr. Hoffman: Veterans Affairs Palo Alto Health Care System, Endocrinology, 3801 Miranda Avenue, Palo Alto, CA 94304.

Author Contributions: Conception and design: H. Liu, D.M. Bravata, A.M. Garber, A.R. Hoffman.

Analysis and interpretation of the data: H. Liu, D.M. Bravata, I. Olkin, A.M. Garber, A.R. Hoffman.

Drafting of the article: D.M. Bravata.

Critical revision of the article for important intellectual content: H. Liu, D.M. Bravata, I. Olkin, S. Nayak, A.M. Garber, A.R. Hoffman.

Final approval of the article: H. Liu, D.M. Bravata, I. Olkin, S. Nayak, B. Roberts, A.M. Garber, A.R. Hoffman.

Provision of study materials or patients: H. Liu.

Statistical expertise: H. Liu, D.M. Bravata, I. Olkin.

Obtaining of funding: H. Liu.

Administrative, technical, or logistic support: S. Nayak, A.M. Garber.

Collection and assembly of data: H. Liu, S. Nayak, B. Roberts.

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