Erectile Dysfunction, Diagnosis and Treatment: Evidence Report
Systematic review of the efficacy and harms of pharmaceuticals used to manage male erectile dysfunction; and exploration of routine hormonal blood tests for identification and treatment.
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.
Diagnosis and Treatment of Erectile Dysfunction
Evidence-based Practice Center: University of Ottawa EPC
Topic Nominators: American College of Physicians