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一项单中心、随机、双盲、安慰剂对照的人体比较研究,以验证截叶铁扫帚提取物改善男性衰老综合征的功能和安全性。

A Single-Center, Randomized, Double-Blind, and Placebo-Controlled Comparative Human Study to Verify the Functionality and Safety of the Lespedeza cuneata G. Don Extract for the Improvement of Aging Male Syndrome.

作者信息

Kim Hyungjee, Seo Yu-Mi, Lee Seong, Kang Dahye, Kim Changhee

机构信息

Department of Urology, Dankook University Medical College, Cheonan, Republic of Korea.

Research Institute of Clinical Medicine, Dankook University Hospital, Cheonan, Republic of Korea.

出版信息

Urol Res Pract. 2023 Sep;49(5):316-323. doi: 10.5152/tud.2023.23065.

DOI:10.5152/tud.2023.23065
PMID:37877880
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10652066/
Abstract

OBJECTIVE

Aging male syndrome is a clinical biochemical syndrome characterized by typical aging symptoms and serum testosterone deficiency. Although it is accompanied by various health problems, directly affects life satisfaction, and requires proper management, no clear prevention or treatment other than hormone replacement therapy is currently available for this syndrome. Here, we aimed to determine the efficacy and safety of the Lespedeza cuneata extract in the management of the aging male syndrome.

METHODS

Males aged 43-70 years who provided consent for participation and had a total Aging Males' Symptom questionnaire score ≥ 37 and testosterone level ≤ 500 ng/dL were enrolled in this study. This study was conducted in a randomized, double-blind manner. Participants were randomly assigned to either the experimental or control groups and orally administered the assigned product twice a day. Efficacy was evaluated by measuring changes in Aging Males' Symptom score, Androgen Deficiency in the Aging Male questionnaire score, International Index of Erectile Function score, International Prostatic Symptom Score, blood test results, and body mass index at 8 weeks.

RESULTS

After 8 weeks, the experimental group had significantly improved symptom scores compared to the control group on the Aging Males' Symptom and Androgen Deficiency in the Aging Male questionnaires. However, no significant differences in the International Index of Erectile Function score, International Prostatic Symptom Score score, blood test results, and body mass index were observed between the experimental and control groups.

CONCLUSION

Lespedeza cuneata extract safely alleviates andropause symptoms without any significant side effects, suggesting its potential for the treatment of the aging male syndrome.

摘要

目的

老年男性综合征是一种临床生化综合征,其特征为典型的衰老症状和血清睾酮缺乏。尽管它伴有各种健康问题,直接影响生活满意度,且需要适当管理,但目前除激素替代疗法外,尚无明确的预防或治疗该综合征的方法。在此,我们旨在确定截叶铁扫帚提取物治疗老年男性综合征的有效性和安全性。

方法

本研究纳入了年龄在43至70岁之间、同意参与且老年男性症状问卷总分≥37分、睾酮水平≤500 ng/dL的男性。本研究采用随机、双盲方式进行。参与者被随机分配到实验组或对照组,每天口服指定产品两次。在第8周时,通过测量老年男性症状评分、老年男性雄激素缺乏问卷评分、国际勃起功能指数评分、国际前列腺症状评分、血液检查结果和体重指数的变化来评估疗效。

结果

8周后,与对照组相比,实验组在老年男性症状和老年男性雄激素缺乏问卷上的症状评分显著改善。然而,实验组和对照组在国际勃起功能指数评分、国际前列腺症状评分、血液检查结果和体重指数方面未观察到显著差异。

结论

截叶铁扫帚提取物可安全缓解更年期症状,且无任何明显副作用,表明其在治疗老年男性综合征方面具有潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/287a/10652066/559f45a34be6/urp-49-5-316_f002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/287a/10652066/b02d20c39ba9/urp-49-5-316_f001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/287a/10652066/559f45a34be6/urp-49-5-316_f002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/287a/10652066/b02d20c39ba9/urp-49-5-316_f001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/287a/10652066/559f45a34be6/urp-49-5-316_f002.jpg

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