Spivak L G, Platonova D V, Enikeev D V, Rapoport L M, Vinarov A Z, Demidko Yu L
Department of Urology, Medical Faculty, I.M. Sechenov First MSMU of Minzdrav of Russia, Moscow, Russia.
Urologiia. 2018 May(2):54-61.
Erectile dysfunction (ED) is a common condition. Pharmacological management of ED involves medications produced by chemical synthesis. Despite high efficiency, their use is often accompanied by some side effects. Considering this, herbal preparations with sufficient efficacy and greater safety have received much attention.
To compare the efficacy and safety of two herbal preparations (EFFEX Tribulus and Tribestan) based on Tribulus Terrestris herb dry extract in patients with ED.
A total of 173 patients were enrolled in the study, of whom 87 (group I) and 86 (group II) received EFFEX Tribulus and Tribestan, respectively. The mean age of patients was 42.2+/-11.5 years in group I and 42.8+/-11.2 years in group II. One hundred fifty two patients completed the study. The follow-up was 13 weeks (the herbal preparation dose was titrated at week five after the treatment initiation). The effectiveness of treatment was assessed on five follow-up visits using the IIEF, AMS, MSF, GAQ questionnaires, and a complex of diagnostic and laboratory studies.
At visit five compared to visit 1, the mean IIEF erectile function domain score increased by 5.7+/-4.6 and 5.2+/-4.3 points in group I and II, respectively. In both groups, all other IIEF domain scores demonstrated a statistically significant increase. The AMS scores decreased from 32.93+/-10.04 to 25.02+/-7.62 points in group I and 31.78+/-10.37 to 24.55+/-7.31 points in group II. The SMF scores increased from 22.36+/-4.85 to 27.16+/-4.80 points in group I and from 22.13+/-3.69 to 26.10+/-5.69 points in group II. Besides, the use of the herbal preparations was associated with a decrease in the serum cholesterol level, more pronounced with increasing patient age (correlation coefficient -0.06, p=0.41).
The herbal preparations EFFEX Tribulus and Tribestan have a similar efficacy and safety profiles.
勃起功能障碍（ED）是一种常见病症。ED的药物治疗涉及化学合成药物。尽管这些药物疗效高，但使用时往往伴有一些副作用。考虑到这一点，具有足够疗效且安全性更高的草药制剂受到了广泛关注。
比较两种基于刺蒺藜草干提取物的草药制剂（EFFEX刺蒺藜和Tribestan）对ED患者的疗效和安全性。
共有173例患者纳入本研究，其中87例（I组）和86例（II组）分别接受EFFEX刺蒺藜和Tribestan治疗。I组患者的平均年龄为42.2±11.5岁，II组为42.8±11.2岁。152例患者完成了研究。随访时间为13周（治疗开始后第5周调整草药制剂剂量）。在五次随访中，使用IIEF、AMS、MSF、GAQ问卷以及一系列诊断和实验室研究评估治疗效果。
与第1次随访相比，第5次随访时，I组和II组的IIEF勃起功能领域平均得分分别增加了5.7±4.6分和5.2±4.3分。在两组中，所有其他IIEF领域得分均有统计学显著增加。I组的AMS得分从32.93±10.04降至25.02±7.62分，II组从31.78±10.37降至24.55±7.31分。I组的SMF得分从22.36±4.85增至27.16±4.80分，II组从22.13±3.69增至26.10±5.69分。此外，使用草药制剂与血清胆固醇水平降低有关，随着患者年龄增加更为明显（相关系数-0.06，p = 0.41）。
草药制剂EFFEX刺蒺藜和Tribestan具有相似的疗效和安全性。
