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Guideline Summary
Guideline Title
Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline from the American College of Physicians.
Bibliographic Source(s)
Qaseem A, Snow V, Denberg TD, Casey DE Jr, Forciea MA, Owens DK, Shekelle P, Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2009 Nov 3;151(9):639-49. [202 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Erectile dysfunction

Guideline Category
Assessment of Therapeutic Effectiveness
Management
Treatment
Clinical Specialty
Endocrinology
Family Practice
Internal Medicine
Urology
Intended Users
Advanced Practice Nurses
Nurses
Pharmacists
Physician Assistants
Physicians
Guideline Objective(s)
  • To present the available evidence in the hormonal testing and pharmacologic management of erectile dysfunction
  • To synthesize the evidence for the following key questions:
    • What is the clinical utility of routine hormonal blood tests—testosterone and prolactin—in identifying and affecting therapeutic outcomes for treatable causes of erectile dysfunction (ED)?
    • What are the benefits of pharmaceutical treatments for patients with ED?
    • What are the harms of the pharmaceutical treatments for patients with ED?
Target Population

Men with erectile dysfunction

Interventions and Practices Considered
  1. Hormonal diagnostic testing
  2. Pharmacologic therapies include phosphodiesterase-5 (PDE-5) inhibitors, such as sildenafil, vardenafil, tadalafil, mirodenafil, and udenafil, and hormonal treatment.

Note: This guideline addresses only the utility of hormonal testing and treatment of erectile dysfunction. Such treatments as vacuum constriction devices, intraurethral suppositories, intracavernosal injections, and psychotherapy were not included in the evidence review and are not addressed in this guideline.

Major Outcomes Considered
  • Prevalence of erectile dysfunction
  • Improvement in erections
  • Successful sexual intercourse
  • Quality of life

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

The databases used for the literature search included MEDLINE (1966 to May 2007), EMBASE (1980 to week 22 of 2007), Cochrane Central Register of Controlled Trials (second quarter of 2007), PsycINFO (1985 to June 2007), AMED (1985 to June 2007), and SCOPUS (2006). The literature search was limited to studies published in English and scanning of reference lists of retrieved publications. The literature search was updated by searching for articles on MEDLINE and EMBASE published between May 2007 and April 2009.

Two persons independently reviewed abstracts and relevant full-text articles regarding study, study population, and treatment characteristics. Disagreements were discussed and resolved by consensus. The reviewers excluded reviews, pooled analysis, editorials, commentaries, and letters. To assess the relative benefits and harms of pharmacologic treatments for erectile dysfunction (ED), eligible studies included randomized, controlled trials (RCTs) of pharmacologic ED treatments in men aged 18 years or older with ED. To assess the clinical value of routine hormonal blood tests in men with ED, eligible studies were those reporting prevalence of hypogonadism, hyperprolactinemia, or both in men with ED and RCTs comparing hormone treatment alone or in combination versus control in men with ED. For adverse events, data abstracted included the number of patients with any adverse event, specific adverse events, withdrawals due to adverse events, serious adverse events, and serious cardiovascular adverse events. To assess the risks for nonarteritic anterior ischemic optic neuropathy (NAION) in men receiving phosphodiesterase-5 (PDE-5) inhibitors, eligible studies included RCTs; nonrandomized, controlled trials; and observational studies. Treatments not generally prescribed by primary care physicians, such as vacuum constriction devices, intraurethral suppositories, intracavernosal injections, or psychotherapy, were considered beyond the scope of this guideline.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

This guideline rates the evidence and recommendations by using a slightly modified version of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system (see "Rating Scheme for the Strength of the Recommendations" field, below).

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations
American College of Physicians' Guidelines Grading System*
Quality of Evidence Strength of Recommendation
  Benefits Clearly Outweigh Risks and Burden OR Risks and Burden Clearly Outweigh Benefits Benefits Finely Balanced with Risks and Burden
High Strong Weak
Moderate Strong Weak
Low Strong Weak
Insufficient evidence to determine net benefits or risks

*Adopted from the classification developed by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) workgroup.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

This guideline was approved by the American College of Physicians Board of Regents on July 11, 2009.

Recommendations

Major Recommendations

The strength of the evidence (high, moderate, low, insufficient evidence to determine benefits or risks) and strength of recommendations (strong, weak) are defined at the end of the "Major Recommendations" field.

Recommendation 1: The American College of Physicians recommends that clinicians initiate therapy with a phosphodiesterase-5 (PDE-5) inhibitor in men who seek treatment for erectile dysfunction and who do not have a contraindication to PDE-5 inhibitor use (Grade: strong recommendation; high-quality evidence).

Treatment with an oral PDE-5 inhibitor demonstrated statistically significant and clinically relevant improvements in sexual intercourse and erectile function in patients with erectile dysfunction (ED). Improvement in erectile functioning was related to higher doses for sildenafil and vardenafil. However, higher doses were associated with a greater risk for an adverse effect. Nitrate therapy is a contraindication for therapy with oral PDE-5 inhibitors.

Recommendation 2: The American College of Physicians recommends that clinicians base the choice of a specific PDE-5 inhibitor on the individual preferences of men with erectile dysfunction, including ease of use, cost of medication, and adverse effects profile (Grade: weak recommendation; low-quality evidence).

The evidence is insufficient to compare the efficacy and adverse effects of different PDE-5 inhibitors for the treatment of ED because only few head-to-head trials are available. Therefore, individual preferences, ease of use, and cost of medication are reasonable criteria to help select a treatment.

Recommendation 3: The American College of Physicians does not recommend for or against routine use of hormonal blood tests or hormonal treatment in the management of patients with erectile dysfunction (Grade: insufficient evidence to determine net benefits and harms).

The prevalence of low testosterone varies from 12.5% to 36% in studies of men with ED. However, the evidence is inconclusive about the effectiveness of hormonal treatment in the management of patients with ED, even in patients with low testosterone levels. Trials comparing testosterone (in oral, injection, gel, patch, and cream forms) with placebo in hypogonadal men with ED were small, were of low quality, or reported inconsistent effects on erectile function. Clinicians should individualize decisions to measure hormone levels on the basis of the clinical presentation (for example, decreased libido, premature ejaculation, and fatigue) and physical findings (for example, testicular atrophy and muscle atrophy) that suggest hormonal abnormality.

Definitions:

Grade of Recommendation

American College of Physicians' Guidelines Grading System*
Quality of Evidence Strength of Recommendation
  Benefits Clearly Outweigh Risks and Burden OR Risks and Burden Clearly Outweigh Benefits Benefits Finely Balanced with Risks and Burden
High Strong Weak
Moderate Strong Weak
Low Strong Weak
Insufficient evidence to determine net benefits or risks

*Adopted from the classification developed by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) workgroup.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Phosphodiesterase-5 (PDE-5) Inhibitor Versus Placebo

  • High-quality evidence from randomized controlled trials (RCTs) showed that PDE-5 inhibitors improved successful sexual intercourse. The weighted mean percentage of successful sexual intercourse attempts was 69% (range, 52% to 85%) for sildenafil versus 35.5% (range, 19% to 68%) for placebo, 68% (range, 50% to 88%) for vardenafil versus 35% (range, 20% to 40%) for placebo, and 69% (range, 50% to 85%) for tadalafil versus 33% (range, 23% to 52%) for placebo. In trials enrolling men with a wide spectrum of diseases, corresponding values were 69% versus 36%, 68% versus 35%, and 69% versus 33%.
  • High-quality evidence indicated that all 5 agents (sildenafil, vardenafil, tadalafil, mirodenafil, and udenafil) improved erections (range, 73% to 88%) compared with placebo (range, 26% to 32%). Men assigned to PDE-5 inhibitors experienced improved erections compared with placebo in trials limited to patients with specific medical conditions, such as diabetes, depression, cardiovascular disease, prostate cancer, multiple sclerosis, colorectal cancer, schizophrenia, liver failure, and renal failure.

PDE-5 Inhibitor Versus Non–PDE-5 Inhibitor

Sildenafil was more effective than non–PDE-5 inhibitor treatments, such as sublingual apomorphine, psychotherapy, continuous positive airway pressure, phentolamine, and alfuzosin, in improving erectile function, frequency of penile penetration or erectile maintenance, and percentage of successful intercourse attempts.

PDE-5 Inhibitor Plus Non–PDE-5 Inhibitor Versus PDE-5 Inhibitor

Sildenafil combined with other erectile dysfunction therapies (such as psychotherapy, dihydroergotamine, cabergoline, atorvastatin, quinapril, and alfuzosin) resulted in greater improvements in erectile function and frequency of penile penetration or maintenance of erection than did sildenafil alone.

Hormonal Therapy Versus Placebo

In 1 low-quality trial, gel testosterone (50 to 100 mg) but not patch testosterone modestly improved the frequency of successful sexual intercourse compared with placebo.

Potential Harms

Phosphodiesterase-5 (PDE-5) Inhibitor Versus Placebo

  • High-quality evidence showed that men receiving PDE-5 inhibitors are more likely to have at least one adverse event compared with placebo. However, the incidence for more serious adverse events was less than 2%, with no difference between PDE-5 inhibitors and placebo. The most common adverse effects were headache, flushing, rhinitis, and dyspepsia. Less common adverse effects were visual disturbances, myalgia, nausea, diarrhea, vomiting, dizziness, and chest pain.
  • In one large study, PDE-5 inhibitors were associated with an increased risk for possible nonarteritic anterior ischemic optic neuropathy (NAION) (absolute risk, 2.4 cases per 10,000 men per year; relative risk, 1.34 [confidence interval 1.17 to 1.55]).
  • Trials evaluated for this guideline did not report priapism. Prolonged erection and priapism were reported infrequently during postmarketing surveillance.

Contraindications

Contraindications

Concurrent use, regularly or intermittently, of nitrates in any form (for example, nitroglycerin and isosorbide dinitrate) is a contraindication for oral phosphodiesterase-5 (PDE-5) inhibitor therapy.

Qualifying Statements

Qualifying Statements
  • Clinical practice 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 American College of Physicians (ACP) clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication, or once an update has been issued.
  • The authors of this article are responsible for its contents, including any clinical or treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Mobile Device Resources
Patient Resources
Staff Training/Competency Material
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Qaseem A, Snow V, Denberg TD, Casey DE Jr, Forciea MA, Owens DK, Shekelle P, Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2009 Nov 3;151(9):639-49. [202 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2009 Nov 3
Guideline Developer(s)
American College of Physicians - Medical Specialty Society
Source(s) of Funding

American College of Physicians

Guideline Committee

Clinical Efficacy Assessment Subcommittee of the American College of Physicians

Composition of Group That Authored the Guideline

Authors: Amir Qaseem, MD, PhD, MHA; Vincenza Snow, MD; Thomas D. Denberg, MD, PhD; Donald E. Casey Jr., MD, MPH, MBA; Mary Ann Forciea, MD; Douglas K. Owens, MD, MS; and Paul Shekelle, MD, PhD

Subcommittee Members: Paul Shekelle, MD, PhD (Chair); Roger Chou, MD; Paul Dallas, MD; Thomas D. Denberg, MD, PhD; Mary Ann Forciea, MD; Robert H. Hopkins Jr., MD; Linda Humprey, MD, MPH; David B. Nash, MD, MBA; Douglas K. Owens, MD, MS; and Donna Sweet, MD

Financial Disclosures/Conflicts of Interest

Grants received: V. Snow (Bristol-Myers Squibb, Centers for Disease Control and Prevention, Novo Nordisk, Merck Vaccines, Boehringer Ingelheim, Wyeth, Sanofi Pasteur); P. Shekelle (Pfizer). Royalties: P. Shekelle (Up-to-Date). Any financial and nonfinancial conflict of interest of the group members were declared, discussed, and resolved.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the Annals of Internal Medicine Web site External Web Site Policy.

Print copies: Available from the American College of Physicians (ACP), 190 N. Independence Mall West, Philadelphia PA 19106-1572.

Availability of Companion Documents

The following is available:

  • Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline from the American College of Physicians. Continuing medical education (CME) course. Available from the Annals of Internal Medicine Web site External Web Site Policy.

A collection of Recommendation Summaries for all current American College of Physicians Clinical Guidelines is available for Personal Digital Assistant (PDA) download from the American College of Physicians (ACP) Web site External Web Site Policy.

Patient Resources

The following is available:

  • Summaries for patients. Hormonal testing and pharmacologic treatment of erectile dysfunction. Ann Intern Med. 2009 November 3; 151(9): I-44. Electronic copies: Available from the Annals of Internal Medicine Web site External Web Site Policy.

Print copies: Available from the American College of Physicians (ACP), 190 N. Independence Mall West, Philadelphia PA 19106-1572.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on October 24, 2010.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

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