Shirai Masato, Hiramatsu Ippei, Aoki Yusuke, Shimoyama Hirofumi, Mizuno Taiki, Nozaki Taiji, Fukuhara Shinichiro, Iwasa Atsushi, Kageyama Shinji, Tsujimura Akira
Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan.
Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan; Department of Urology, Juntendo University, Graduate School of Medicine, Tokyo, Japan.
Sex Med. 2018 Dec;6(4):291-296. doi: 10.1016/j.esxm.2018.07.001. Epub 2018 Aug 24.
Phosphodiesterase type 5 inhibitors (PDE5i) are first-line therapy for most men with erectile dysfunction (ED). If ineffective, vacuum erection devices, intracavernous injections, and penile prosthesis implantation are suitable as second- or third-line therapies. However, very few patients select these therapies. It is critically important to improve erectile function with oral administration of effective agents. Administration of L-citrulline or transresveratrol in animal experiments has been reported to improve erectile function, but few such experiments have been performed on humans with ED.
We aimed to investigate the efficacy of combination therapy of L-citrulline and transresveratrol in patients with ED despite their use of PDE5i.
In this randomized, double-blind, placebo-controlled crossover pilot study, men with ED (Sexual Health Inventory for Men [SHIM] score below 16) despite on-demand use of PDE5i received a placebo for 1 month or the active treatment (L-citrulline 800 mg/day and transresveratrol 300 mg/day) for another month. Patients continued on-demand use of PDE5i.
The SHIM score, Erection Hardness Score (EHS), Aging Male Symptoms Scale-sexual domain (AMS-SD), and adverse events were examined.
20 patients ages 29-78 years were enrolled, and after 6 men withdrew, 13 concluded the study without adverse events. Mean SHIM score for the active treatment increased significantly (10.96 ± 1.21) compared with baseline (8.32 ± 1.21) and placebo (8.31 ± 1.23) (both P < .05). Mean EHS score for the active treatment (2.56 ± 0.26) also increased from baseline (2.31 ± 0.26), but not significantly (P = .79). Mean AMS-SD score was not significantly different in either group.
To our knowledge, this is the first study to show that combination therapy of L-citrulline and transresveratrol is effective for ED treatment in men with added on-demand use of PDE5i. This combination supplement may be added if PDE5i is insufficient. Shirai M, Hiramatsu I, Aoki Y, et al. Oral L-citrulline and Transresveratrol Supplementation Improves Erectile Function in Men With Phosphodiesterase 5 Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study. Sex Med 2018;6:291-296.
5型磷酸二酯酶抑制剂（PDE5i）是大多数勃起功能障碍（ED）男性的一线治疗药物。若无效，真空勃起装置、海绵体内注射及阴茎假体植入可作为二线或三线治疗方法。然而，很少有患者选择这些治疗方法。通过口服有效药物改善勃起功能至关重要。动物实验中已报道给予L-瓜氨酸或白藜芦醇可改善勃起功能，但针对ED患者的此类人体实验很少。
我们旨在研究L-瓜氨酸和白藜芦醇联合治疗对尽管使用PDE5i但仍患有ED的患者的疗效。
在这项随机、双盲、安慰剂对照的交叉试验性研究中，尽管按需使用PDE5i但仍患有ED（男性性健康量表[SHIM]评分低于16分）的男性接受1个月的安慰剂治疗或另1个月的活性治疗（L-瓜氨酸800毫克/天和白藜芦醇300毫克/天）。患者继续按需使用PDE5i。
检查SHIM评分、勃起硬度评分（EHS）、老年男性症状量表-性领域（AMS-SD）及不良事件。
纳入20例年龄在29至78岁之间的患者，6例退出后，13例完成研究且无不良事件。与基线（8.32±1.21）和安慰剂（8.31±1.23）相比，活性治疗的平均SHIM评分显著提高（10.96±1.21）（P均<.05）。活性治疗的平均EHS评分（2.56±0.26）也较基线（2.31±0.26）有所提高，但差异不显著（P = .79）。两组的平均AMS-SD评分无显著差异。
据我们所知，这是第一项表明L-瓜氨酸和白藜芦醇联合治疗对按需使用PDE5i的男性ED治疗有效的研究。如果PDE5i疗效不足，可添加这种联合补充剂。白井M，平松I，青木Y等。口服L-瓜氨酸和白藜芦醇补充剂改善使用5型磷酸二酯酶抑制剂男性的勃起功能：一项随机、双盲、安慰剂对照的交叉试验性研究。性医学2018；6：291 - 296。
