万艾可治疗勃起功能障碍的疗效和安全性

目的 :评估万艾可 (Viagra○R)治疗男性勃起功能障碍 (ED)的有效性和安全性。　方法 :本试验为双盲、随机(安慰剂 :西地那非 ,1:3)、安慰剂对照、剂量可调整 (2 5、5 0和 10 0mg)、持续 12周的临床研究。共有 84名受试者参与本研究。　结果 :对主要疗效指标 (IIEF问题 3、4)的分析结果显示 ,万艾可对ED病人达到和维持勃起能力的改善作用显著优于安慰剂 (P <0 .0 0 0 1) ,万艾可的临床总有效率为 86 % ,显著高于安慰剂 (37% ) ;对心理性、器质性和混合性ED的有效率分别为 83%、79%和 81% (安慰剂组分别为 5 0 %、33%和 30 % )。同时 ,对次要疗效指标评估 (IIEF其余 13个问题、记事表和总评题 )亦显示 ,万艾可改善性生活的作用明显优于安慰剂 ;万艾可组性交成功率平均为71.8% ,显著高于安慰剂组 (17.0 % ) ;有 87.3%的万艾可组受试者认为研究药物改善了其勃起功能 ,显著高于安慰剂组 (36 .8% )。无 1名受试者因不良事件而中断研究 ,万艾可组的不良事件发生率 (33.3% )较安慰剂组高(19.0 % ) ,但绝大多数为轻度、一过性的。　结论 :口服万艾可是一种可治疗各种病因导致的勃起功能障碍安全有效的药物 ,按需服用时能很好耐受。     

枸橼酸西地那非治疗男子多发性硬化症患者ED

多发性硬化(MS)可导致勃起功能障碍(ED),枸橼酸西地那非对于此类患者的治疗效果怎样呢?Fowler CJ等人进行了相关研究。一共有217个患者接受了西地那非(25～100mg；n=104)或者安慰剂(n=113)治疗,为期12周。疗效根据国际勃起功能指数问卷(IIEF)中的获得勃起(Q3)和维持勃起(Q4)问题,以及总评题(GEQ)进行评价,同时也评估生活质量。12周后,西地那非组的IIEF Q3和Q4的平均分值比安慰剂组高(P＜0．0001),西地那非组有89%(92/103)的患者报     

前列腺素E1乳膏治疗勃起功能障碍的疗效和安全性

目的 :评估前列腺素E1(PGE1)乳膏治疗男性勃起功能障碍 (ED)的有效性和安全性。　方法 :按 1∶1(安慰剂∶乳膏 )双盲、随机、安慰剂对照的临床研究 ,共有 4 2例符合标准的各种病因的ED病人入选。研究结束时 ,根据受试者对勃起功能国际指数 (IIEF) 2次回答的得分差值、临床疗效评估 (记事表 )及总体疗效评估 (总评题 )、不良事件登记和实验室检查等 ,对受试者用药的有效性和安全性进行综合分析。　结果 :主要疗效评估显示 :使用本研究药物后病人阴茎勃起程度达到显效和有效改善的 ,在乳膏组与安慰剂组分别为 6 3.16 %和 9.5 2 % (P <0 .0 1) ;同时总体疗效评估 (乳膏组与安慰剂组分别为 73.6 8%和 19.0 5 % ,P <0 .0 1)的分析结果 ,也支持主要疗效评估。 2例中止试验 (4 .76 % ) ,不良事件发生乳膏组 6例 (30 .0 0 % )、安慰剂组 1例 (4 .76 % ) ,均为轻度、一过性的 ,以泌尿生殖道刺激症状为主。结论 :PGE1乳膏是一种可治疗各种病因导致ED的安全有效的药物 ,按需使用时能很好耐受     

盐酸曲唑酮治疗勃起功能障碍的随机对照研究

目的　为了观察盐酸曲唑酮治疗阴茎勃起障碍的疗效和安全性。方法　入选 6 5例轻、中度阴茎勃起功能障碍 (ED)患者 ,随机分 2组 :盐酸曲唑酮组 5 0mg每日一次口服 ,逐日增加至 15 0mg后维持 ;对照组给安慰剂。治疗前与治疗后 4周 ,以勃起功能国际指标评分问卷 (IIEF 5 )得分之和作为判断标准。结果　显效 3例(10 % ) ,有效 9例 (30 % ) ,总有效率为 4 0 % ,无效 18例 (6 0例 ) ;对照组有效 6例 (16 .7% ) ,曲唑酮组治疗前后比较差异有显著性 (P <0 .0 5 )。副作用为头晕、嗜睡。结论　本研究初步证明曲唑酮治疗轻、中度勃起功能障碍有一定疗效     

西地那非治疗勃起功能障碍的临床疗效

目的 :观察西地那非对不同年龄和病因勃起功能障碍 (ED)病人的疗效。　方法 :88例ED病人口服不同剂量的西地那非 4～ 2 2周 ,以国际勃起功能指数 5 (IIEF 5 )评分为评估标准判断疗效 ,设对照组作比较。　结果 :西地那非治疗ED病人的总疗效率为 80 .7% ,IIEF 5值上升幅度与西地那非疗效呈正相关。不同年龄ED病人的疗效无明显差异。神经性ED病人的显效率和IIEF 5值与心因性病人差异显著。　结论 :西地那非治疗ED是安全有效的 ,IIEF 5可作为评判ED疗效的可靠指标。     

持续气道正压通气对睡眠呼吸暂停综合征合并勃起功能障碍的治疗

目的 :探讨经鼻持续气道正压通气 (nCPAP)对睡眠呼吸暂停综合征 (SAS)合并勃起功能障碍 (ED)患者勃起功能的影响。　方法 :SAS合并ED患者 2 7例 ,随机分为治疗组 15例和对照组 12例 ,治疗组使用BIPAP呼吸机以nCPAP治疗 1个月 ,比较两组治疗前后睡眠呼吸暂停低通气指数 (AHI)、最低SaO2 和勃起功能国际问卷 5 (IIEF 5 )评分的变化。　结果 :两组患者治疗前AHI、最低SaO2 、勃起功能、IIEF 5评分无明显差异 ,治疗组在治疗后比治疗前、对照组均有明显改善 ,差异均有显著性 (P <0 .0 5 )。而对照组在治疗前后上述指标无明显变化 (P >0 .0 5 )。结论 :nCPAP可改善SAS合并ED患者的勃起功能。     

美蓝染色法提高静脉性勃起功能障碍手术疗效观察

目的 :探讨美蓝染色法提高静脉性勃起功能障碍 (ED)手术疗效。　方法 :78例静脉性ED在美蓝染色标识下切除和结扎回漏静脉 ,采用国际勃起功能指数 5 (IIEF 5 )得分对手术效果进行评估。　结果 :阴茎背深静脉切除 +属支结扎 2 6例 ,有效 2 0例 ( 76.9% ) ;背深静脉切除 +阴茎脚静脉结扎 3 2例 ,有效 2 5例 ( 78.1% ) ;背深静脉切除 +尿道海绵体分离和阴茎头静脉结扎 13例 ,有效 5例 ( 3 8.5 % ) ;单纯脚静脉结扎 7例 ,有效 3例 ( 4 2 9% )。术后随访 1～ 12个月、13～ 2 4个月和 2 5～ 3 6个月的总有效率分别为 67 9%、4 1.0 %和 3 3 .3 %。IIEF 5得分从术前的 ( 4 .8± 0 .5 )分分别提高到 ( 19.5± 0 .5 )分、( 18.6± 0 .5 )分和 ( 18.6± 0 .6)分 ,P值均 <0 .0 0 1。　结论 :阴茎海绵体注射美蓝染色可以提高静脉性ED的手术疗效。     

西地那非治疗合并勃起功能障碍的早泄病人的临床观察

目的 :评价枸橼酸西地那非对合并勃起功能障碍 (ED)的早泄病人的临床疗效和安全性。　方法 :45例诊断为合并ED早泄病人 ,以西地那非片可调整用药方案治疗 1～ 3个月。以阴道内射精潜伏期及配偶性交满意度来评价早泄治疗效果 ,并评估ED的总体疗效和治疗满意度 ,比较治疗前后的国际勃起功能指数评分 5 (IIEF 5 )。　结果 :早泄改善者共 2 7例 ,有效率为 6 0 %。勃起功能改善者共 40例 ,改善率为 88.88%。 2 7例早泄有效者均为 5 0mg西地那非改善了勃起功能的病人 ,且满意率为81.48%;18例早泄无效者中ED治疗满意率仅为 5 .5 6 %。在早泄有效者和无效者间比较其治疗前、后IIEF 5评分及增加值 ,差异均有显著性 (P <0 .0 0 1)。不良反应共 9例(2 0 %) ,均为轻度或中度 ,未经特殊处理即自行缓解。　结论 :对合并ED的早泄病人 ,枸橼酸西地那非片能安全有效地改善其勃起功能 ,如获得满意疗效多能使病人早泄得到改善。     

视听性刺激与性教育在西地那非治疗勃起障碍中的应用

目的探讨视听性刺激与性教育对服用西地那非无效的勃起障碍(ED)患者疗效。方法128例服药无效的ED患者,随机分为两组,治疗组64例接受夫妻性教育并服用西地那非100mg后接受视听性刺激诱导勃起。对照组给予常规门诊性教育,指导服药后的性刺激。治疗8周后后对性功能情况再次进行IIEF评分,评定疗效与安全性。结果完成治疗并进行有关检查者120例,治疗组61例,对照组59例。治疗组显效率、总有效率分别为31.12%、81.96%；对照组则为13.33%、62.71%,统计学处理两组有非常显著性差异(P＜0.01)。结论对服用西地那非无效的ED患者,采取性教育和视听刺激诱导勃起,使患者掌握正确的性刺激方法,可明显改善勃起功能,疗效明显优于传统的门诊服药指导。     

西地那非显著提高ED患者的勃起功能和勃起硬度

为了确定勃起硬度[根据勃起硬度等级评分(EHGS)]与：(1)勃起功能[根据国际勃起功能评分的勃起功能域(IIEF EF)]；(2)足够插入的勃起硬度的频率(由IIEF Q2评价)；(3)性交尝试成功率(根据患者事件日志)之间的关系。Mulhall JP等研究了大量关于枸橼酸西地那非治疗ED的双盲、安慰剂对照临床实验的数据。汇集6549名     

Safety and efficacy of vardenafil in patients with erectile dysfunction: Result of a bridging study in Japan

AIM: Vardenafil is a selective and highly potent phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED. The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED. METHODS: This was a prospective, double blind, randomized clinical trial designed to evaluate the efficacy and safety of vardenafil. Following a 4-week treatment-free observation period, 283 eligible patients were randomized to 12 weeks treatment with vardenafil 5 mg, 10 mg, 20 mg, or placebo. Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function (IIEF). RESULTS: All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF questionnaire, either at 12 weeks or at the 'last observation carried forward' (LOCF, P < 0.0001). Q3 scores were improved to 4.06 with vardenafil 5 mg, 4.53 with vardenafil 10 mg, and 4.64 with vardenafil 20 mg, versus 3.17 with placebo. Comparable scores for Q4 were 3.47, 4.15 and 4.31 versus 2.31 for placebo. Up to 86% of patients achieved improved erections as assessed by the global assessment question (GAQ). Reported adverse event rates were 35.3%, 45.3% and 54.5% with vardenafil 5 mg, 10 mg and 20 mg, respectively, versus 21.1% in the placebo group. No serious adverse drug reactions were reported. The most common treatment-emergent adverse events were transient headache, flushing and rhinitis, which were mostly mild. CONCLUSION: Vardenafil is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED. The results of our trial show that up to nearly 90% of patients achieve improved erections with the administration of vardenafil.     

The efficacy and safety of tadalafil: an update

OBJECTIVE: To provide an update on the efficacy and safety of tadalafil, a phosphodiesterase-5 inhibitor, in the treatment of erectile dysfunction (ED). PATIENTS AND METHODS: In all, 2102 men (mean age 56 years) with mild-to-severe ED of various causes were randomized to placebo or tadalafil, taken as needed with no food restrictions, at fixed 'on-demand' doses of 10 or 20 mg in 11 randomized, double-blind, placebo-controlled trials lasting 12 weeks. The three co-primary outcomes were changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF) and the proportion of 'yes' responses to questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included a Global Assessment Question (GAQ). RESULTS: Compared with placebo, tadalafil gave significantly better outcomes. Patients receiving either dose of tadalafil had a significant mean improvement of 6.5 and 8.6, respectively, in the IIEF erectile function domain score from baseline (P < 0.001 vs placebo). At both doses the mean success rate for intercourse attempts (SEP-Q3) was 58% and 68%, respectively, compared with 31% in the placebo group (P < 0.001), and 71% and 84% reported improved erections at the endpoint (GAQ), vs 33% on placebo (P < 0.001). Tadalafil was effective up to 36 h after dosing and was effective regardless of disease severity and causes, and in patients of all ages. The most frequent adverse events were headache, dyspepsia, back pain and myalgia. CONCLUSION: Tadalafil was an effective and well-tolerated treatment for ED.     

The efficacy and safety of tadalafil in United States and Puerto Rican men with erectile dysfunction

PURPOSE: We evaluate the efficacy and safety of tadalafil, taken as needed, in men with mild to severe erectile dysfunction (ED) and assess sexual intercourse attempt patterns. MATERIALS AND METHODS: In this multicenter, double-blind, placebo controlled, parallel study conducted in the United States and Puerto Rico 207 men with ED were randomized to placebo or 20 mg tadalafil for 12 weeks. The primary efficacy variables were changes from baseline in the mean International Index of Erectile Function erectile function domain score and mean per patient percentage of "yes" responses to Sexual Encounter Profile (SEP) diary questions 2 (successful penetration) and 3 (successful intercourse). The Global Assessment Question was a secondary end point and post hoc analyses on sexual intercourse attempt patterns were conducted. RESULTS: Men treated with tadalafil compared with placebo reported greater mean changes from baseline on the erectile function domain score (9.3 vs 0.3 with placebo, p <0.001) and on the mean per patient percentage of successful penetration (SEP question 2, 31.6% vs 2.3% with placebo, p <0.001) and successful intercourse attempts (SEP question 3, 43.6% vs 3.5% with placebo, p <0.001). The per treatment group percentage of successful intercourse attempts during treatment was higher for tadalafil than placebo (67.6% vs 24.1%, respectively, p <0.001) and most successful intercourse attempts occurred between 4 and 36 hours after taking tadalafil. Of the men treated with tadalafil 82.8% reported improved erections versus 19.6% taking placebo (Global Assessment Question, p <0.001). The most common treatment emergent adverse events were headache (15.7% vs 6.3% with placebo), back pain (8.8% vs 0%), and dyspepsia (7.5% vs 0%). CONCLUSIONS: Tadalafil (20 mg) significantly improved erectile function and patients did not closely temporally link sexual intercourse attempts with taking tadalafil. Tadalafil was also well tolerated in both groups of men with mild to severe ED.     

Efficacy and safety of fixed-dose oral sildenafil in the treatment of erectile dysfunction of various etiologies

OBJECTIVES: To determine the efficacy and safety of fixed-dose oral sildenafil in patients with erectile dysfunction (ED) of various etiologies. METHODS: In a 12-week, double-blind, randomized, placebo-controlled, fixed-dose study, 514 men (mean age 56 years) with ED were randomized to receive 25, 50, or 100 mg of sildenafil or placebo. The primary etiology of ED was determined to be organic in 32% of men, psychogenic in 25%, or mixed in 43%. Sildenafil or placebo was taken in the home setting approximately 1 hour before sexual activity, not more than once daily. Efficacy was determined by responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) of the 15-item International Index of Erectile Function (IIEF). Other measures of efficacy included the five sexual function domains of the IIEF, a global efficacy question, event log data, and a partner questionnaire. RESULTS: Sildenafil significantly increased patients' ability to achieve and maintain erections (P <0.0001), with efficacy increasing with increasing dose. Significant improvements were also observed in the IIEF domains for erectile function, orgasmic function, intercourse satisfaction, and overall sexual satisfaction (P <0.0001). The proportion of subjects who felt that treatment with sildenafil improved their erections was significantly greater (67% to 86%) than that with placebo treatment (24%, P <0.0001). The proportion of successful attempts at sexual intercourse also increased significantly with sildenafil treatment (P <0.001). Partner responses corroborated patient reports. Sildenafil was well tolerated at the three doses studied. CONCLUSIONS: Oral sildenafil is an effective, well-tolerated treatment for ED of various etiologies.     

Efficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian men

AIM: Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of on-demand tadalafil for the treatment of ED in South-East Asian men. METHODS: This was a randomized, double-blind, placebo-controlled study of men with mild to severe ED of various etiologies randomized to receive placebo (n = 122), tadalafil 10 mg (n = 120), or tadalafil 20 mg (n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). RESULTS: Men from China, Singapore, and the Philippines participated in this trial (n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes (P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF-EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per-patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group (P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group (P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. CONCLUSIONS: Tadalafil was an effective and well-tolerated treatment for South-East Asian men with ED.     

补肾益寿胶囊治疗ED的临床观察

目的 :观察中药补肾益寿胶囊治疗男性勃起功能障碍的疗效。　方法 :泌尿男科门诊患勃起功能障碍的病人 5 1例 ,随机分成A、B 2组。A组为治疗组 (2 6例 ) ,口服补肾益寿胶囊治疗 ,30d为 1个疗程。B组 (2 5例 )为对照组 ,口服相同剂型的安慰剂。　结果 :A、B 2组的有效率分别为 6 5 .4%和 2 4.0 %。经 χ2 检验 ,有显著性差异 (P <0 .0 0 5 )。　结论 :中药补肾益寿胶囊治疗勃起功能障碍有一定疗效。     

Long-term efficacy and safety of oral Viagra (sildenafil citrate) in men with erectile dysfunction and the effect of randomised treatment withdrawal

The long-term efficacy and safety of oral Viagra (sildenafil citrate), a selective phosphodiesterase 5 inhibitor, and the effect of withdrawing treatment were evaluated in men with erectile dysfunction (ED). In 233 men with ED of psychogenic or mixed organic/psychogenic aetiology, 16 weeks of open-label, flexible-dose sildenafil treatment (10-100 mg) was followed by eight weeks of double-blind, fixed-dose, randomised withdrawal to placebo or continued treatment with sildenafil. Sildenafil was taken as needed (not more than once daily) approximately 1 h prior to sexual activity. The main outcome measures were a global efficacy question, a sexual function questionnaire, an event log of erections, and adverse event recording. In the open-label phase, 200 of 216 patients (93%) reported improved erections with sildenafil; 28 patients (12%) discontinued treatment. In the double-blind phase, the significant improvements in the frequency and duration of erections were maintained in the sildenafil group but returned to pre-treatment values in patients on placebo (P values < 0.0001 versus placebo). The most frequent adverse events in the sildenafil group during the double-blind phase were flushing (7%), headache (6%), and dyspepsia (5%). Of the 192 patients enrolled in the 1-y extension, 90% completed the study; only two patients (1%) were withdrawn due to lack of efficacy. In men with ED of psychogenic or mixed aetiology, oral sildenafil is effective and well-tolerated both at the initiation of therapy and during long-term treatment. For most patients, sildenafil treatment must be continued for improvements in erectile function to be maintained.     

Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction: a randomized double-blind, parallel, placebo-controlled clinical study

Aim:To assess the efficacy and safety of tadalafil in comparison to a placebo,when taken on demand for 12 weeksby East/Southeast Asian men with erectile dysfunction(ED).Methods:This multicenter,randomized,double-blind,parallel group,placebo-controlled study was conducted at 17 centers across East and Southeast Asia between August2002 and February 2003.Men more than 18 years of age with mild to severe ED of various etiologies were randomizedto receive a placebo or 20 mg of tadalafil taken as needed(maximum once daily).Efficacy assessments included theInternational Index of Erectile Function,the Sexual Encounter Profile diary and Global Assessment Questions.Results:Tadalafil significantly improved erectile function as compared to the placebo(P<0.001).At the endpoint,the pa-tients receiving 20 mg of tadalafil reported a greater mean per patient percentage of successful intercourse attempts(Sexual Encounter Profile question 3:70.9% compared to 33.5% in the placebo)and a greater proportion of improvederections(Global Assessment Question:86.2% compared to 30.1%).Most(≥3%)treatment emergent adverseevents were mild or moderate.The most common treatment emergent adverse events were headache,back pain,dizziness and dyspepsia.Conclusion:Tadalafil was an effective and well-tolerated treatment for ED in East andSoutheast Asian men.(Asian J Androl 2006 Nov;8:685-692)     

伐地那非治疗勃起功能障碍的多中心、随机、双盲、对照研究

目的　观察伐地那非治疗勃起功能障碍的安全性和有效性。　方法　采用多中心、随机、双盲、安慰剂对照的方法 ,在国内 7家中心对 6 2 4例勃起功能障碍者口服伐地那非的勃起功能改善情况进行临床观察。患者随机按 1∶1∶1∶1进入安慰剂组及伐地那非 5、10、2 0mg组 ,每组各 15 6例 ,完成 4周洗脱期和 12周治疗期。患者按需在性交前 1h服用 1片研究药物。每日最多服用 1次研究药物。观察治疗 12周后国际勃起功能指数 (IIEF)问卷中有关勃起功能部分 (问题 1～ 5和 15 )的得分 ,患者日记中有关插入的成功率及成功保持勃起的成功率。　结果　共有 6 0 2例 (96 .5 % )进入安全性评估和意向性分析 ,各组分别为安慰剂组 14 8例 (94 .9% )、5mg组 15 1例 (96 .8% )、10mg组 15 0例 (96 .2 % )、2 0mg组 15 3例 (98.1% )。完全符合方案人群共 4 6 8例 (75 .0 % ) ,各组分别为 :安慰剂组 12 0例 (76 .9% )、5mg组 118例 (75 .6 % )、10mg组 10 6例 (6 8.0 % )、2 0mg组 12 4例 (79.5 % )。意向性分析人群的IIEF勃起功能部分 (问题 1～ 5 ,15 )得分的统计结果 ,用药 12周后 ,伐地那非 5mg组、10mg组和 2 0mg组的平均得分基线分别为 13.3分、14 .1分和 13.6分 ,分别增加到 2 2 .2分、2 2 .8分和 2 3.6分 ,与安慰剂组     

Study of the efficacy of Korean Red Ginseng in the treatment of erectile dysfunction

Aim： To examine the treatment efficacy of Korean Red Ginseng （KRG） in impotent men with erectile dysfunction （ED）. Methods： A total of 60 patients presenting mild or mild to moderate ED were enrolled in a double-blind, placebo-controlled study in which the efficacies of KRG and a placebo were compared. The patients received either 1 000 mg （3 times daily） of KRG or a placebo. Results： The five-item version of the International Index of Erectile Function （IIEF-5） score after the treatment was significantly higher in the KRG group compared with that before the treatment （from 16.4±2.9 to 21.0±6.3, P 〈 0.0001）. In contrast, there was no difference before and after the treatment in the placebo group （from 17.0±3.1 to 17.7±5.6, P 〉 0.05）. In the KRG group, 20 patients （66.6%）, reported improved erection, significant in the global efficacy question （P 〈 0.01）; in the placebo group there was no significance. Scores on questions 2 （rigidity）, 3 （penetration）, 4 and 5 （maintenance）, were significantly higher for KRG than those for the placebo when those questions were answered after 12 weeks of each treatment （P 〈 0.01）. When the score in the KRG group was compared to the placebo group after the treatment, there was a significant improvement in total score （IIEF-5 score） in questions 3 and 5 for the KRG-treated group （P 〈 0.001 and P 〈 0.0001, respectively）. The levels of serum testosterone, prolactine and cholesterol after the treatment were not statistically significant different between the KRG and the placebo group （P 〉 0.05）. Conclusion： Our data show that KRG can be an effective alternative to the invasive approaches for treating male ED.