NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
This publication is provided for historical reference only and the information may be out of date.
Diagnosis and Treatment of Erectile Dysfunction
Evidence Reports/Technology Assessments, No. 171
Investigators: Alexander Tsertsvadze, MD, MSc, Fatemeh Yazdi, MSc, Howard A Fink, MD, PhD, Roderick MacDonald, MS, Tim J Wilt, MD, Karla Soares-Weiser, MD, PhD, Anthony J Bella, MD, Dan Deforge, MD, Chantelle Garritty, MSc(c), Mohammed Ansari, MD, MSc, Margaret Sampson, MLIS, Raymond Daniel, BA, and David Moher, PhD.
Structured Abstract
Objectives:
To systematically review the evidence on efficacy and harms of pharmaceutical treatments used in the management of male erectile dysfunction (ED); to explore the clinical utility of routine hormonal blood tests (e.g. testosterone, prolactin) for identifying and treating hormonal disorders and thereby affecting therapeutic outcomes for ED.
Data Sources:
MEDLINE®, EMBASE, PsycINFO®, SCOPUS™, and Cochrane CENTRAL were searched up to June 2007. Reference lists of relevant studies were also searched.
Review Methods:
English language primary studies reporting effects of pharmaceutical treatments used to treat men with ED were eligible for inclusion. The records were screened for relevance, abstracted, and assessed for quality by two reviewers independently. The evidence was summarized qualitatively and the results of randomized controlled trials (RCTs) were pooled using meta-analyses. Subgroup and sensitivity analyses were also conducted.
Results:
The evidence needed to ascertain the clinical utility of routine hormonal blood tests was limited in terms of the amount and interpretability. Studies were heterogenous with wide variations in the prevalence of hypogonadism or hyperprolactinemia in patients with ED. Overall phosphodiesterase type 5 (PDE-5) inhibitors were superior to placebo in treating patients with ED with clinically important and statistically significant between-group differences. Adverse events however, were more frequent in PDE-5 inhibitor-treated patients. Few trials demonstrated dose-response trends in the degree of efficacy or frequency of adverse events associated with PDE-5 inhibitors. The clinical benefits conferred by use of PDE-5 inhibitors relative to placebo were observed in patients with wide spectrum of comorbidities irrespective of the origin, duration, or severity of ED. In head-to-head trials evaluating PDE-5 inhibitors, more patients preferred tadalafil to sildenafil or vardenafil. Patients treated with intracavernosal or subcutaneous injections experienced pain and priapism. The evidence for topical, intra-urethral, and hormonal treatments for male ED was insufficient and inconclusive.
Conclusions:
Evidence comparing cause-specific therapies (i.e. targeting underlying causes of ED) to symptomatic treatments (e.g. PDE-5 inhibitors, injections, hormonal treatments) for management of ED is lacking. Moreover, long-term effects of ED treatments have not been adequately explored in RCTs. Studies using comparable study populations, diagnostic criteria, and types of tests for hormonal disorders are needed to clarify the clinical utility of routine hormonal blood tests in ED patients. There is also a need for trials comparing PDE-5 inhibitors to other symptomatic treatments for ED (e.g. hormonal treatments, injections, topical applications). This review outlined current gaps in knowledge that need to be addressed in future research.
Contents
- Preface
- Acknowledgments
- Executive Summary
- 1. Introduction
- 2. Methods
- 3. Results
- Question 1. What is the Clinical Utility of Routine Blood Tests (Testosterone/Prolactin/Luteinizing Hormone/Follicle-Stimulating Hormone) in Identifying and Affecting Therapeutic Outcomes for Treatable Causes of Erectile Dysfunction (ED)?
- Prevalence of Hormonal Abnormalities in ED Patients
- The Efficacy of Hormonal Therapy in Treating Erectile Dysfunction in Patients with Hormonal Abnormalities
- Questions 2–3. What is the Evidence of the Relative Clinical Benefits and Harms of Pharmaceutical Treatments (e.g. Oral Medications) for Men Diagnosed With Erectile Dysfunction?
- Oral Treatments — Phosphodiesterase Type 5 (PDE-5) Inhibitors - Sildenafil
- Oral Treatments — Phosphodiesterase Type 5 (PDE-5) Inhibitors - Vardenafil
- Oral Treatments — Phosphodiesterase Type 5 (PDE-5) Inhibitors - Tadalafil
- Sublingual Treatments - Apomorphine
- Injection Treatments - Intracavernosal Injection
- Injection Treatments - Subcutaneous Injections
- Intra-urethral Suppositories
- Topical Treatments
- Hormonal Treatments
- Other Treatments (Off Label)
- Question 3a. What Are the harms of Pharmaceutical Treatments for Male Patients with ED?
- Specific Adverse Events Oral Medications: PDE-5 inhibitors
- Injection Treatments
- 4. Discussion
- Strength of the Evidence
- Question 1: What is the Clinical Utility of Routine Blood Tests—Testosterone, Prolactin, Luteinizing Hormone, Follicle-stimulating Hormone—in Identifying and Affecting Therapeutic Outcomes for Treatable Causes of ED?
- Questions 2–3: What are the Benefits and Harms of Pharmaceutical Treatments for ED? Oral Medications - PDE-5 Inhibitors
- Sublingual Agents - Apomorphine
- Intracavernosal Injections
- Subcutaneous Injections
- Intraurethral Suppositories
- Topical Treatments
- Hormonal Treatments
- Other Treatments (Off-label use)
- Question 2a-b: Do Specific Patient Characteristics (e.g. Origin, Severity, or Duration of ED, and Comorbid Conditions) Affect Prognosis or Treatment Success for ED Patients?
- Questions 3a: Specific Harms of Pharmaceutical Treatments in Male Patients With ED
- Methodological and Logistic Limitations of the Systematic Review
- Future Research Recommendations
- List of Acronyms/Abbreviations
- Appendixes
- Appendix A. Search Strategies
- Appendix B. Data Assessment, Data Abstraction and Quality Assessment Forms
- Appendix C. Evidence Tables
- Appendix D. Reference List of Excluded Studies
- Appendix E. Additional Acknowledgments
- Appendix F. Quality Assessment
- Appendix G. Funnel Plots
- Appendix H. Instruments Used in the Assessment of Treatment Outcomes
- Appendix I. List of Unobtained Articles
- References and Included Studies
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No. 290-02-0021. Prepared by: University of Ottawa Evidence-based Practice Center, Ottawa, Canada.
Suggested citation:
Tsertsvadze A, Yazdi F, Fink HA, MacDonald R, Wilt TJ, Soares-Weiser K, Bella AJ, Deforge D, Garritty C, Ansari M, Sampson M, Daniel R, Moher D. Diagnosis and Treatment of Erectile Dysfunction. Evidence Report/Technology Assessment No.171 (Prepared by the University of Ottawa Evidence-based Practice Centre (UO-EPC) under Contract No. 290-02-0021). AHRQ Publication No. 08(09)-E016, Rockville, MD: Agency for Healthcare Research and Quality. May 2009.
This report is based on research conducted by the University of Ottawa Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0021). The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.
This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
No investigators have any affiliations or financial involvement (e.g. employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850. www
.ahrq.gov
- Diagnosis and Treatment of Erectile DysfunctionDiagnosis and Treatment of Erectile Dysfunction
Your browsing activity is empty.
Activity recording is turned off.
See more...