Nguyen Sabine, Rajfer Jacob, Shaheen Magda
Department of Health and Life Sciences, Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.
Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Transl Androl Urol. 2018 Apr;7(2):266-273. doi: 10.21037/tau.2018.03.22.
The earliest sign of an ongoing change in a man's erectile function (EF) is the increase in his refractory period. This is due to the onset of an aging related apoptosis of the corporal smooth muscle cells (CSMC) as a result of oxidative stress (ROS) within the CSMC itself. In response, the CSMC begin to upregulate the inducible nitric oxide synthase (iNOS) enzyme presumably to achieve high levels of nitric oxide (NO) used to combat ROS. Treatment of aged rats for 2 months with the nutraceutical Revactin, known to stimulate the iNOS-NO-cGMP pathway in CSMC, resulted in (I) an increase in CSMC content with a decrease in corporal fibrosis, (II) decrease in systemic ROS, and (III) improvement in EF. To determine whether Revactin could be used in the clinical setting, a pilot safety study was conducted.
Fifty-four middle aged men (mean age 57.8±10.7; range, 33-77 years) were recruited for this safety study. Patients were given Revactin twice daily (total daily dose of 500 mg of ginger root, muira puama, and Paullinia cupana and 1,600 mg of L-citrulline) and were asked to complete the IIEF-15 questionnaire [domains: EF, orgasmic function (OF), sexual desire (SD), intercourse satisfaction (IS), overall satisfaction (OS)] at baseline (B), 1 month (M1), 2 months (M2) and 3 months (M3) and report any side effects. Those on erectogenic medications at B were requested to stop taking them during the trial. Data were analyzed using Wilcoxon paired test and Friedman rank test for trend.
Revactin was safe with only 5 patients reporting treatment side effects (e.g., dyspepsia, heartburn, migraine) and none considered severe. For those who stayed on the regimen (M1 =32; M2 =22; M3 =16), there was an increase in median domain scores for EF, OF, SD, IS, and OS over 3 months compared to baseline median scores but statistical significance was found only in the EF, IS, and OS median domain scores. Trend analysis indicated significant trend in EF, OS & IS (P<0.05). For the EF domain, the median scores were: M1 =21, M2 =22, M3 =19 relative to the B =16, 15.5, and 14.5, respectively (P<0.05). Overall, approximately 50% of the patients reported a significant improvement in EF (P<0.05). The major reason for trial discontinuation (M1 =22, M2 =9 and M3 =6) was non-compliance with pro-erectile medications.
Revactin, a combination of 3 nutraceuticals packaged with L-citrulline, appears to have the same excellent safety profile known for each of its individual four components. The early improvement in EF seen in about 50% of these patients may be due to the elevated levels of cGMP produced via this iNOS-cGMP pathway. Further longitudinal studies with Revactin appear warranted.
男性勃起功能（EF）持续变化的最早迹象是其不应期延长。这是由于阴茎海绵体平滑肌细胞（CSMC）内氧化应激（ROS）导致与衰老相关的细胞凋亡开始。作为反应，CSMC开始上调诱导型一氧化氮合酶（iNOS），可能是为了产生高水平的一氧化氮（NO）来对抗ROS。用营养保健品Revactin对老年大鼠进行2个月的治疗，已知Revactin可刺激CSMC中的iNOS-NO-cGMP途径，结果显示：（I）CSMC含量增加，阴茎纤维化减少；（II）全身ROS减少；（III）EF改善。为了确定Revactin是否可用于临床，进行了一项初步安全性研究。
54名中年男性（平均年龄57.8±10.7岁；范围33-77岁）被纳入该安全性研究。患者每天服用两次Revactin（每日总剂量为500毫克姜根、育亨宾树皮和巴西可可，以及1600毫克L-瓜氨酸），并被要求在基线（B）、1个月（M1）、2个月（M2）和3个月（M3）时完成IIEF-15问卷[领域：EF、性高潮功能（OF）、性欲（SD）、性交满意度（IS）、总体满意度（OS）]，并报告任何副作用。在B时服用勃起功能药物的患者被要求在试验期间停止服用。使用Wilcoxon配对检验和Friedman秩检验进行趋势分析。
Revactin是安全的，只有5名患者报告有治疗副作用（如消化不良、胃灼热、偏头痛），且无一例被认为严重。对于坚持治疗方案的患者（M1 =32；M2 =22；M3 =16），与基线中位数分数相比，3个月内EF、OF、SD、IS和OS的中位数领域分数有所增加，但仅在EF、IS和OS中位数领域分数中发现统计学意义。趋势分析表明EF、OS和IS有显著趋势（P<0.05）。对于EF领域，中位数分数分别为：M1 =21，M2 =22，M3 =19，而B分别为16、15.5和14.5（P<0.05）。总体而言，约50%的患者报告EF有显著改善（P<0.05）。试验中断的主要原因（M1 =22，M2 =9和M3 =6）是未遵守促勃起药物治疗。
Revactin是一种由3种营养保健品与L-瓜氨酸组合而成的产品，似乎具有其四种成分各自所具有的同样出色的安全性。约50%的这些患者中早期出现的EF改善可能是由于通过该iNOS-cGMP途径产生的cGMP水平升高。对Revactin进行进一步的纵向研究似乎是有必要的。
