Cai Tommaso, Morgia Giuseppe, Carrieri Giuseppe, Terrone Carlo, Imbimbo Ciro, Verze Paolo, Mirone Vincenzo
Department of Urology, Santa Chiara Regional Hospital, Trento.
Arch Ital Urol Androl. 2013 Dec 31;85(4):184-9. doi: 10.4081/aiua.2013.4.184.
The relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) has recently received increased attention. The aim of this study was to evaluate the efficacy of the Alfa-5® association of Serenoa repens, Pinus massoniana Bark Extract (PMBE) and Crocus sativus (IDIProst® Gold) in improvement of patient's quality of life, when compared with Serenoa repens alone.
All patients with clinical and instrumental diagnosis of LUTS due to Benign Prostatic Hyperplasia (BPH) and ED, attending 5 Italians Urological Institutions from May to December 2012 were enrolled in this prospective, multicentre, phase 3 study. Participants were assigned to receive oral capsules of IDIProst® Gold (one capsule q24 h) or Serenoa repens 320 mg (one capsule q24h) for 3 months. Clinical and instrumental analyses were carried out at the enrollment and at the end of therapy. IPSS, IIEF-5 and SF-36 questionnaires have been used. The main outcome measure was the improvement of quality of life at the end of the whole study period.
129 (mean age 45-71 ± 4.36) men were randomly allocated to IDIProst® Gold (n = 83) or Serenoa repens (n = 46). The baseline questionnaire mean scores were 17.1 ± 6.4, 14.9 ± 3.7, 96.3 ± 1.2 for IPSS, IIEF-5 and SF-36, respectively. At the follow-up examination, statistically significant differences have been reported in terms of IPSS (11.9 vs 13.8; p < 0.001), IIEF-5 and SF-36 mean scores (19.3 vs 16.1; 99.7 vs 96.3; p < 0.003; p < 0.001). Moreover, statistically significant differences were then reported between the two visits, in terms of IPSS, IIEF-5 and SF-36 scores (p < 0.003; p < 0.001; p < 0.001), only in the IDIProst® Gold group.
In conclusions, we found that IDIProst® Gold significantly improve the quality of life of patients affected by LUTS due to BPH and ED, specifically in terms of sexual function, highlighting that a better sexual quality of life is correlated with an higher overall quality of life regardless of the urinary function.
下尿路症状(LUTS)与勃起功能障碍(ED)之间的关系近来受到更多关注。本研究旨在评估锯叶棕果实提取物、马尾松树皮提取物(PMBE)和藏红花(IDIProst® Gold)联合用药(Alfa-5®)与单独使用锯叶棕果实提取物相比,对改善患者生活质量的疗效。
2012年5月至12月,在5家意大利泌尿机构就诊的所有因良性前列腺增生(BPH)和ED导致LUTS且经临床和仪器诊断的患者被纳入这项前瞻性、多中心、3期研究。参与者被分配接受IDIProst® Gold口服胶囊(每24小时1粒)或320毫克锯叶棕果实提取物(每24小时1粒),为期3个月。在入组时和治疗结束时进行临床和仪器分析。使用了国际前列腺症状评分(IPSS)、勃起功能国际问卷-5(IIEF-5)和健康调查简表(SF-36)问卷。主要观察指标是整个研究期结束时生活质量的改善情况。
129名(平均年龄45 - 71±4.36岁)男性被随机分配至IDIProst® Gold组(n = 83)或锯叶棕果实提取物组(n = 46)。IPSS、IIEF-5和SF-36问卷的基线平均得分分别为17.1±6.4、14.9±3.7、96.3±1.2。在随访检查中,IPSS(11.9对13.8;p < 0.001)、IIEF-5和SF-36平均得分(19.3对16.1;99.7对96.3;p < 0.003;p < 0.001)方面报告有统计学显著差异。此外,仅在IDIProst® Gold组中,两次就诊之间在IPSS、IIEF-5和SF-36得分方面报告有统计学显著差异(p < 0.003;p < 0.001;p < 0.001)。
总之,我们发现IDIProst® Gold显著改善了因BPH和ED导致LUTS患者的生活质量,特别是在性功能方面,突出表明无论排尿功能如何,更好的性生活质量与更高的总体生活质量相关。