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Prostaglandin E1 for treatment of erectile dysfunction

  • Review
  • Intervention

Authors


Abstract

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 methods

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 1873 participants, 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) . 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.

Authors' 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.

摘要

背景

前列腺素E1治療勃起功能障礙

勃起功能障礙(Erectile dysfunction ,ED),為無法達到或維持性生活所需的勃起狀態,是最常見的男性性功能障礙。ED對許多男人和他們的伴侶都可能產生生活品質的巨大影響。

目標

本系統性回顧分析的目的是評估和總結PGE1治療勃起功能障礙的有效性及安全性。

搜尋策略

我們檢索了Cochrane MS Group Trials Register (2003年6月),Cochrane Central Register of Controlled Trials (Issue 2,2003年),MEDLINE(1966年1月2003年6月),EMBASE(1988年1月2003年6月)文章的參考文獻列表。我們還進行手工檢索及聯繫試驗者和製藥公司。

選擇標準

在沒有顯著干擾及雙盲設計下,比較PGE1和安慰劑治療不同原因造成ED的所有隨機對照試驗都被考慮在內。主要研究指標為:(1)病人和伴侶自我評估滿意度;(二)生活品質(三)安全評估。無論是平行試驗或交叉設計試驗都被列入考慮。

資料收集與分析

所有審查委員各自選取要收錄的文章,並評估試驗品質和擷取數據。我們也聯繫研究作者以獲得更多資訊。

主要結論

本回顧分析收錄了包含1873人的4項試驗,其中造成ED的病因各異。研究設計包含兩個平行設計及兩個交叉設計試驗。但只有後者提供了足夠的數據可供統合分析。追蹤發現,在“至少有一次成功性交”的成果方面,PGE1是有效的(Peto Odds Ratio, OR 7.22, 95% CI. 5.68 – 9.18)。其中一個交叉研究報告說,在至少接受一次PGE1的患者中有63.6%患者可以有至少一次成功的性交(P < 0.01 每一劑量與安慰劑相比)。在其他的交叉研究中,每3個治療組中只有1組自我評價的結果是良好的(55.5%:回答“良好”或“優秀”)。不良反應最常見於治療組,且最常發生於劑量增加時。明顯的不良反應包括陰莖疼痛(Peto OR 7.39,95% CI. 5.40 – 10.12)和輕微尿道損傷(Peto OR 3.79, 95% CI. 1.88 – 7.65)。

作者結論

PGE1對許多不同原因造成的ED患者是有效的。不良反應並不嚴重,且與劑量成正比。如果能夠比較不同病因、不同給藥方式、及較長時間的追蹤,並更加強調病人/伴侶相互關係及生活品質的話,對使用PGE1治療ED的效果應該能得到更好的詮釋。

翻譯人

本摘要由新光醫院鍾禎智翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

前列腺素E1幫助了許多患有性交勃起功能障礙的男性。勃起功能障礙(ED)意指無法達到或維持性生活所需的勃起狀態。其中最常見的治療即是一種天然的前列腺素PGE1。給藥方式有將PGE1注入陰莖,或將藥丸塞入陰莖末端(進入尿道)。本回顧分析發現,使用PGE1的男性能得到較滿意的性經驗。高劑量能得到更好的效果,但也會增加不良反應。常見的不良反應為疼痛,比起注射,患者可能更偏好經尿道給藥的方式。

Plain language summary

Prostaglandin E1 helps many men suffering from erectile dysfunction to have sexual intercourse

Men who experience erectile dysfunction (ED) are unable to achieve an erection sufficient for satisfactory sexual intercourse. One of the most common treatment is with prostaglandin E1 (PGE1), a naturally occurring PGE used to treat this dysfunction. Men either inject PGE1 into their penis or insert a pellet containing the drug into the end of the penis (into the urethra). The review of trials found that men using PGE1 reported more satisfactory sexual experiences. Higher doses gave greater benefits but also increased the adverse effects. The most common adverse effect is some pain, and men may prefer the urethral medication rather than injections.