Patnaik Nabnita, Mishra Kumar Guru, Pradhan Nihar Ranjan
Obstetrics and Gynecology, All India Institute of Medical Sciences, Bibinagar, Hyderabad, IND.
Community and Family Medicine, All India Institute of Medical Sciences, Bibinagar, Hyderabad, IND.
Cureus. 2022 Apr 9;14(4):e23989. doi: 10.7759/cureus.23989. eCollection 2022 Apr.
Introduction has been used as an aphrodisiac in India and other countries. However, studies concerning humans have been limited. This randomized controlled trial was carried out to evaluate the effect of SA3X capsules containing 500 mg of on sexual function domain scores in sexually active men with symptoms of erectile dysfunction (ED) using the Men's Sexual Health Questionnaire (MSHQ). Materials and methods This triple-blind, placebo-controlled, parallel-group was conducted at two centres in Hyderabad and Secunderabad from May to December 2021. Patients were randomized 1:1 to SA3X therapy or placebo for one month along with an observational cohort. The change of MSHQ score and its subdomains from baseline to month 1 (primary endpoint) and one-month post-treatment (secondary outcome) was assessed using a mixed model repeated measures analysis. Additional secondary outcomes measured were the change in the International Index of Erectile Function (IIEF) and duration of penile erection. Safety was evaluated. Results The intention-to-treat population included 448 patients (152 - SA3X therapy; 146 - placebo; 150 - observational cohort). A significant increase was observed with SA3X therapy versus placebo on the total MSHQ score (17.24 vs 4.72; SE: 2.11, 1.98; P<0.001) along with the sub-domains at the end of one month of therapy. At one-month post-treatment, the increase in MSHQ score with SA3X therapy was significant (18.48 vs 3.78; SE 2.81, 1.39; P<0.001). The IIEF scores and duration of penile erection also increased significantly in the SA3X therapy group. Dysgeusia (3.94%) was the most common drug-related adverse effect. No serious adverse effects were noted. Conclusion SA3X was concluded to be safe and effective as a potential treatment for ED.
引言 在印度和其他国家，[具体物质名称]已被用作壮阳药。然而，关于人类的研究有限。本随机对照试验旨在使用男性性健康问卷（MSHQ）评估含有500毫克[具体物质名称]的SA3X胶囊对有勃起功能障碍（ED）症状的性活跃男性性功能领域评分的影响。材料和方法 本三盲、安慰剂对照、平行组试验于2021年5月至12月在海得拉巴和塞康德拉巴德的两个中心进行。患者按1:1随机分为SA3X治疗组或安慰剂组，为期一个月，并设有一个观察队列。使用混合模型重复测量分析评估MSHQ评分及其子领域从基线到第1个月（主要终点）和治疗后1个月（次要结局）的变化。测量的其他次要结局包括国际勃起功能指数（IIEF）的变化和阴茎勃起持续时间。评估了安全性。结果 意向性治疗人群包括448名患者（152名接受SA3X治疗；146名接受安慰剂治疗；150名在观察队列）。在治疗1个月结束时，SA3X治疗组与安慰剂组相比，MSHQ总分有显著增加（17.24对4.72；标准误：2.11，1.98；P<0.001），各子领域也是如此。在治疗后1个月，SA3X治疗组的MSHQ评分增加显著（18.48对3.78；标准误2.81，1.39；P<0.001）。SA3X治疗组的IIEF评分和阴茎勃起持续时间也显著增加。味觉障碍（3.94%）是最常见的药物相关不良反应。未观察到严重不良反应。结论 得出结论，SA3X作为ED的潜在治疗方法是安全有效的。
