Amir Qaseem, MD, PhD, MHA; Carrie A. Horwitch, MD, MPH; Sandeep Vijan, MD, MS; Itziar Etxeandia-Ikobaltzeta, PhD; Devan Kansagara, MD, MCR; for the Clinical Guidelines Committee of the American College of Physicians *
Note: Clinical guidelines are “guides” only and may not apply to all patients and all clinical situations. Thus, they are not intended to override clinicians' judgment. All ACP clinical guidelines are considered automatically withdrawn or invalid 5 years after publication, or once an update has been issued.
Acknowledgment: The CGC thanks the following members of the ACP Guidelines Public Panel for their review and comments on the paper from a patient's perspective: Cynthia Appley, Larry Curley, Ray Haeme, Billy Oglesby, James Pantelas, Missy Carson Smith, and Lelis Vernon. They also thank Farah Sultan, MD, MS, for her contributions to the supplemental rapid review on values and preferences of men treated with testosterone.
Financial Support: Financial support for the development of this guideline comes exclusively from the ACP operating budget.
Disclosures: Dr. Horwitch is a fiduciary officer for the Washington State Medical Association. Dr. Lin is an employee of Kaiser Permanente. Dr. McLean is an employee of Northeast Medical Group. Authors not named here have disclosed no conflicts of interest. Authors followed the policy regarding conflicts of interest described at www.annals.org/article.aspx?articleid=745942. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-0882. All financial and intellectual disclosures of interest were declared and potential conflicts were discussed and managed. Dr. Wilt was recused from chairing and from authorship and voting because of a moderate-level conflict (author of supporting evidence review). A record of disclosures of interest and management of conflicts of interest is kept for each CGC meeting and conference call and can be viewed at www.acponline.org/clinical_information/guidelines/guidelines/conflicts_cgc.htm.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Corresponding Author: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, email@example.com.
Current Author Addresses: Dr. Qaseem: 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Horwitch: 1100 Ninth Avenue C8-GIM, Seattle, WA 98101.
Dr. Vijan: 2800 Plymouth Road, Building 16, Room 344E, Ann Arbor, MI 48109.
Dr. Etxeandia-Ikobaltzeta: 1, Santa Margarita Hospital Street rear, ground floor 2, Office 1, Room 2, 20303 Irun, Gipuzkoa, Spain.
Dr. Kansagara: 3710 Southwest U.S. Veterans Hospital Road, Portland, OR 97239.
Author Contributions: Conception and design: A. Qaseem, I. Etxeandia-Ikobaltzeta, D. Kansagara, M.A. Forciea, R.A. Mustafa.
Analysis and interpretation of the data: A. Qaseem, S. Vijan, C.J. Crandall, I. Etxeandia-Ikobaltzeta, D. Kansagara, M.A. Forciea, L.A. Hicks, J. Tufte.
Drafting of the article: A. Qaseem, C.A. Horwitch, I. Etxeandia-Ikobaltzeta, D. Kansagara, M.A. Forciea.
Critical revision for important intellectual content: A. Qaseem, S. Vijan, I. Etxeandia-Ikobaltzeta, D. Kansagara, C.J. Crandall, M.A. Forciea, L.A. Hicks, J.S. Lin, R.A. Mustafa.
Final approval of the article: A. Qaseem, C.A. Horwitch, S. Vijan, I. Etxeandia-Ikobaltzeta, D. Kansagara, C.J. Crandall, N. Fitterman, M.A. Forciea, L.A. Hicks, J.S. Lin, M.F. Maroto, R.M. McLean, R.A. Mustafa, J. Tufte.
Statistical expertise: A. Qaseem.
Obtaining of funding: A. Qaseem.
Administrative, technical, or logistic support: A Qaseem, I. Etxeandia-Ikobaltzeta.
Collection and assembly of data: I. Etxeandia-Ikobaltzeta, D. Kansagara.
The American College of Physicians (ACP) developed this guideline to provide clinical recommendations based on the current evidence of the benefits and harms of testosterone treatment in adult men with age-related low testosterone. This guideline is endorsed by the American Academy of Family Physicians.
The ACP Clinical Guidelines Committee based these recommendations on a systematic review on the efficacy and safety of testosterone treatment in adult men with age-related low testosterone. Clinical outcomes were evaluated by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system and included sexual function, physical function, quality of life, energy and vitality, depression, cognition, serious adverse events, major adverse cardiovascular events, and other adverse events.
The target audience includes all clinicians, and the target patient population includes adult men with age-related low testosterone.
ACP suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function (conditional recommendation; low-certainty evidence). The discussion should include the potential benefits, harms, costs, and patient's preferences.
ACP suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter. Clinicians should discontinue testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function (conditional recommendation; low-certainty evidence).
ACP suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar.
ACP suggests that clinicians not initiate testosterone treatment in men with age-related low testosterone to improve energy, vitality, physical function, or cognition (conditional recommendation; low-certainty evidence).
Grading the certainty of evidence and strength of recommendations of ACP clinical guidelines by using GRADE.
ACP = American College of Physicians; GRADE = Grading of Recommendations Assessment, Development and Evaluation.
Summary of the ACP guideline on testosterone treatment in adult men with age-related low testosterone.
ACP = American College of Physicians. A downloadable version of this figure is available as a Supplement at Annals.org.
B Patrick Harpole MD
January 9, 2020
I have been administering intramuscular testosterone cyprionate for about 10 years.Charge is $50 for 300 mgs which is $600 a year. Most insurance carriers cover.This is just one of the errors the author wrote.
January 18, 2020
Testosterone replacement issues in aging
I am a 66 year old retired pharmacist. There is no comment in the article about the pharmaceutical suppression of testosterone by statin therapy. Statin therapy is so widely used to suppress cholesterol, that the existence of such therapy should be factored in when considering other possible causes of testosterone depression beyond just aging. There are numerous studies that have correlated statin therapy to decreased free testosterone due to cholesterol being the pre-cursor structure to the steroid formation of testosterone. In the past few months, I have started on replacement testosterone therapy since I was borderline low (and on atorvastatin 20mg QD), and while I have found that the testosterone is not having a significant impact on my physical well-being, other possible benefits of the drug besides increased libido should be considered. I have much more restful sleep and deep sleep with very vivid dreams. I also do not awaken as often during the night, my skin texture and hair seem to be smoother and more refined and my red blood cell has increased marginally which may increase my stamina. Thus, for rational patients, this therapy may offer some subtle but meaningful secondary benefits. I agree with the prior comment that the price estimate for therapy in this article seems to be exaggerated. By using a Good RX coupon, you can buy 30 days of transdermal gel for a cash (non-insurance) price around $100.
Thank you for considering my comments.
Qaseem A, Horwitch CA, Vijan S, et al, for the Clinical Guidelines Committee of the American College of Physicians. Testosterone Treatment in Adult Men With Age-Related Low Testosterone: A Clinical Guideline From the American College of Physicians. Ann Intern Med. 2020;172:126–133. [Epub ahead of print 7 January 2020]. doi: https://doi.org/10.7326/M19-0882
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Published: Ann Intern Med. 2020;172(2):126-133.
Published at www.annals.org on 7 January 2020
Endocrine and Metabolism, Guidelines, High Value Care.
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