Orr Guy, Weiser Mark, Polliack Michael, Raviv Gil, Tadmor Daphne, Grunhaus Leon
Department of Psychiatry, Sheba Medical Center, Tel-Hashomer, Israel.
J Clin Psychopharmacol. 2006 Aug;26(4):426-30. doi: 10.1097/01.jcp.0000227701.33999.b3.
Post Traumatic Stress Disorder (PTSD) is known to be associated with Erectile Dysfunction (ED). Sildenafil citrate was shown to be effective treatment for ED among different clinical populations. However, to date, no placebo-controlled trial has assessed sildenafil's effectiveness for treating ED in PTSD patients. The goal of the present study was to address this question using a double-blind placebo controlled crossover design.
A four-week double-blind crossover trial of sildenafil (50 mg up to 100 mg per usage) versus placebo was conducted on 21 outpatients diagnosed with chronic PTSD accompanied by ED. Erectile function was assessed biweekly using the International Inventory of Erectile Function (IIEF). Depressive symptoms, PTSD symptoms and subjective well-being scores were assessed as well.
Analysis of IIEF scores revealed a main effect of treatment phase (E = 33.361, df =2, P < 0.000). Pairwise comparisons showed that sildenafil IIEF scores (mean = 45.19 +/- 15.05) were significantly higher compared to baseline scores (mean = 20.00 +/- 12.32, P = 0.000) and placebo scores (mean = 33.04 +/- 12.99). Compared to placebo, a significant improvement was also observed during the sildenafil phase in erectile function, orgasmic function and sexual desire. There was no significant change in depression, PTSD symptoms or subjective well-being.
The results of this study suggest that sildenafil citrate treatment for ED in PTSD patients was accompanied with improvement of ED symptoms and was found to be significantly better than placebo. Nevertheless, this effect should be considered marginal since patients still meet the criteria of ED after treatment. Larger, parallel group studies are warranted.
创伤后应激障碍（PTSD）已知与勃起功能障碍（ED）相关。枸橼酸西地那非已被证明在不同临床人群中对ED是有效的治疗方法。然而，迄今为止，尚无安慰剂对照试验评估西地那非对PTSD患者ED的治疗效果。本研究的目的是使用双盲安慰剂对照交叉设计来解决这个问题。
对21名被诊断为伴有ED的慢性PTSD门诊患者进行了为期四周的西地那非（每次用量50毫克至100毫克）与安慰剂的双盲交叉试验。每两周使用国际勃起功能指数（IIEF）评估勃起功能。还评估了抑郁症状、PTSD症状和主观幸福感得分。
IIEF评分分析显示治疗阶段有主要效应（E = 33.361，自由度 = 2，P < 0.000）。两两比较表明，西地那非IIEF评分（平均值 = 45.19 ± 15.05）显著高于基线评分（平均值 = 20.00 ± 12.32，P = 0.000）和安慰剂评分（平均值 = 33.04 ± 12.99）。与安慰剂相比，在西地那非治疗阶段，勃起功能、性高潮功能和性欲也有显著改善。抑郁、PTSD症状或主观幸福感没有显著变化。
本研究结果表明，枸橼酸西地那非治疗PTSD患者的ED伴随着ED症状的改善，且被发现明显优于安慰剂。然而，由于患者治疗后仍符合ED标准，应认为这种效果是有限的。有必要进行更大规模的平行组研究。
