Background: Erectile dysfunction (ED), the inability to achieve or maintain an erection sufficient for satisfactory sexual activity, is one of the most common sexual dysfunctions in men. ED may have a dramatic impact on the quality of life of many men and their partners.
Objectives: The aim of this systematic review was to evaluate and summarise the effectiveness and safety of PGE1 in the treatment of erectile dysfunction.
Search strategy: We searched the Cochrane MS Group Trials Register (June 2003), the Cochrane Central Register of Controlled Trials (issue 2, 2003), MEDLINE (January 1966 - June 2003), EMBASE (January 1988 - June 2003) and reference lists of articles. We also undertook handsearching and contacting trialists and pharmaceutical companies.
Selection criteria: All unconfounded, double blind, randomised controlled trials comparing PGE1 and placebo treatment in participants with ED of different aetiology were considered. Primary outcomes were: (a) patient and partner satisfaction measured by means of a self-assessment; (b) quality of life and (c) safety assessment. Both parallel group and cross-over design trials were considered for inclusion.
Data collection and analysis: All the reviewers independently selected articles for inclusion, assessed the trials' quality and extracted the data. Study authors were contacted for additional information.
Main results: Four trials involving 1.873 people, heterogeneous with respect to aetiology of ED, were included. Study design was two cross-over and two parallel group trials. Only the latter provided adequate data for meta-analyses. PGE1 was effective during follow-up in the "at least one successful intercourse" outcome (Peto Odds Ratio, OR 7.22, 95% CI. 5.68-9.18) and "number of successful intercourse/number of PGE1 administrations" (Peto Odds Ratio, OR 6.46, 95% CI. 5.95-7.01). One cross-over study reported "at least one successful intercourse" in 63.6% of participants with at least one dose of PGE1 (P < 0.01 for each active dose versus placebo). In the other cross-over study, only one of three treatment groups conducted a self-evaluation (55.5%: "good" or "excellent" response). Adverse effects were most frequent in the treated groups and occurred more often and intensely as doses increased. Penile pain (Peto OR 7.39, 95% CI. 5.40-10.12) and minor urethral trauma (Peto OR 3.79, 95% CI. 1.88-7.65) were predominant.
Reviewers' conclusions: PGE1 was beneficial for many participants with ED of different aetiology. Adverse effects were proportional to dosage, albeit never serious. The use of PGE1 in ED could have been better interpreted if its effectiveness were compared by aetiology and with different forms of administrations, a longer follow-up were considered and more emphasis given to patient/partner relationships and quality of life.