Alexander Tsertsvadze, MD, MSc; Howard A. Fink, MD, MPH; Fatemeh Yazdi, MSc; Roderick MacDonald, MSc; Anthony J. Bella, MD; Mohammed T. Ansari, MBBS, MMedSc, MPhil; Chantelle Garritty, MSc; Karla Soares-Weiser, MD, PhD; Raymond Daniel, BA; Margaret Sampson, MLIS; Steven Fox, MD, MPH; David Moher, PhD; Timothy J. Wilt, MD, MPH
Disclaimer: The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Grant Support:Honoraria: A.J. Bella (Pfizer, Lilly, Bayer).
Potential Conflicts of Interest: None disclosed.
Requests for Single Reprints: Howard A. Fink, MD, MPH, Veterans Affairs Medical Center (11-G), One Veterans Drive, Minneapolis, MN 55417; e-mail, email@example.com.
Current Author Addresses: Dr. Tsertsvadze, Ms. Yazdi, and Mr. Daniel: Ottawa Hospital Research Institute, 501 Smyth Road, Room W0575, Box 208, Ottawa, Ontario K1H 8L6, Canada.
Dr. Fink: Veterans Affairs Medical Center (11-G), One Veterans Drive, Minneapolis, MN 55417.
Mr. MacDonald and Dr. Wilt: Veterans Affairs Medical Center (111-0), One Veterans Drive, Minneapolis, MN 55417.
Dr. Bella: University of Ottawa, Faculty of Medicine, 451 Smyth Road, Ottawa, Ontario K1H 8M5, Canada.
Dr. Ansari: Ottawa Hospital Research Institute, 501 Smyth Road, Room W0589, Box 208, Ottawa, Ontario K1H 8L6, Canada.
Ms. Garritty: Ottawa Hospital Research Institute, 501 Smyth Road, Room W0585, Box 208, Ottawa, Ontario K1H 8L6, Canada.
Dr. Soares-Weiser: PO Box 137, Enhance Reviews, Kfar-Saba 44101, Israel.
Ms. Sampson: Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada.
Dr. Fox: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850.
Dr. Moher: Ottawa Hospital Research Institute, 501 Smyth Road, Room W6112, Box 208, Ottawa, Ontario K1H 8L6, Canada.
Author Contributions: Conception and design: A. Tsertsvadze, H.A. Fink, F. Yazdi, M.T. Ansari, M. Sampson, S. Fox, D. Moher, T.J. Wilt.
Analysis and interpretation of the data: A. Tsertsvadze, H.A. Fink, R. MacDonald, A.J. Bella, K. Soares-Weiser, S. Fox, D. Moher, T.J. Wilt.
Drafting of the article: A. Tsertsvadze, H.A. Fink, A.J. Bella.
Critical revision of the article for important intellectual content: A. Tsertsvadze, H.A. Fink, A.J. Bella, M. Sampson, S. Fox, D. Moher, T.J. Wilt.
Final approval of the article: A. Tsertsvadze, H.A. Fink, R. MacDonald, A.J. Bella, M.T. Ansari, K. Soares-Weiser, M. Sampson, S. Fox, D. Moher, T.J. Wilt.
Provision of study materials or patients: C. Garritty.
Statistical expertise: A. Tsertsvadze, R. MacDonald.
Obtaining of funding: D. Moher, T.J. Wilt.
Administrative, technical, or logistic support: A. Tsertsvadze, H.A. Fink, F. Yazdi, R. MacDonald, M.T. Ansari, C. Garritty, R. Daniel, S. Fox, D. Moher, T.J. Wilt.
Collection and assembly of data: A. Tsertsvadze, H.A. Fink, F. Yazdi, R. MacDonald, A.J. Bella, M.T. Ansari, C. Garritty, K. Soares-Weiser, M. Sampson, T.J. Wilt.
Other: M. Sampson (search expertise).
Erectile dysfunction (ED) is a common male sexual disorder. The relative benefits and harms of pharmacologic therapies for ED, as well as the value of hormonal testing in men with ED, are uncertain.
To evaluate the efficacy and harms of oral phosphodiesterase-5 (PDE-5) inhibitors and hormonal treatments for ED and assess the effect of measuring serum hormone levels on treatment outcomes for ED.
English-language studies from MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, AMED, and SCOPUS through April 2009. Trial reference lists also were scanned.
Randomized, controlled trials (RCTs) of oral PDE-5 inhibitors and hormonal treatment for ED, and observational studies reporting measurement of serum hormone levels, prevalence of hormonal abnormalities, or both in men with ED.
Two independent reviewers abstracted data on study, participant, and treatment characteristics; efficacy and harms outcomes; and prevalence of hormonal abnormalities.
Data, primarily from short-term trials (≤12 weeks), indicate that PDE-5 inhibitors were more effective than placebo in improving sexual intercourse success (69.0% vs. 35.0%). The proportion of men with improved erections was significantly greater among those treated with PDE-5 inhibitors (range, 67.0% to 89.0%) than with placebo (range, 27.0% to 35.0%). The PDE-5 inhibitors were associated with increased risk for any adverse events compared with placebo (for example, relative risk with sildenafil, 1.72 [95% CI, 1.53 to 1.93]). In 4 head-to-head RCTs comparing sildenafil, vardenafil, and tadalafil, improvement of ED and adverse events did not differ among treatments. Results from 15 RCTs evaluating hormonal treatment of ED were inconsistent on whether treatment improved outcomes. Evidence was insufficient regarding whether men with ED had a higher prevalence of hypogonadism than men without ED.
Many RCTs were of low methodological and reporting quality, particularly those involving hormonal treatments or directly comparing different PDE-5 inhibitors. Most RCTs provided only short-term efficacy and harms data.
Oral PDE-5 inhibitors improved erectile functioning and had similar efficacy and safety profiles. Results on the efficacy of hormonal treatments and the value of hormone testing in men with ED were inconclusive.
Agency for Healthcare Research and Quality.
Literature search and selection.
NAION = nonarteritic anterior ischemic optic neuropathy.
Table 1. Summary of Findings of Effectiveness
Improvement in erections: sildenafil versus placebo.
CAD = coronary artery disease; CVD = cardiovascular disease; RR = relative risk.
Improvement in erections: vardenafil versus placebo.
RR = relative risk.
Improvement in erections: tadalafil versus placebo.
Table 2. Summary of Findings on AEs
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Video News Release - Guideline on the Benefits and Risks of PED-5 Inhibitor Drugs
Tsertsvadze A, Fink HA, Yazdi F, MacDonald R, Bella AJ, Ansari MT, et al. Oral Phosphodiesterase-5 Inhibitors and Hormonal Treatments for Erectile Dysfunction: A Systematic Review and Meta-analysis. Ann Intern Med. 2009;151:650-661. doi: 10.7326/0003-4819-151-9-200911030-00150
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Published: Ann Intern Med. 2009;151(9):650-661.
Endocrine and Metabolism, Guidelines, Neurology.
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