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人参治疗勃起功能障碍。

Ginseng for erectile dysfunction.

机构信息

Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea, South.

Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Korea, South.

出版信息

Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD012654. doi: 10.1002/14651858.CD012654.pub2.

DOI:10.1002/14651858.CD012654.pub2
PMID:33871063
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8094213/
Abstract

BACKGROUND

Dietary supplements with ginseng, or ginseng alone, are widely used for a broad range of conditions, including erectile dysfunction. Ginseng is particularly popular in Asian countries. Individual studies assessing its effects are mostly small, of uneven methodological quality and have unclear results.

OBJECTIVES

To assess the effects of ginseng on erectile dysfunction.

SEARCH METHODS

We conducted systematic searches on multiple electronic databases, including CENTRAL, MEDLINE, Embase, CINAHL, AMED, and loco-regional databases of east Asia, from their inceptions to 30 January 2021 without restrictions on language and publication status. Handsearches included conference proceedings.

SELECTION CRITERIA

We included randomized or quasi-randomized controlled trials that evaluated the use of any type of ginseng as a treatment for erectile dysfunction compared to placebo or conventional treatment.

DATA COLLECTION AND ANALYSIS

Two authors independently classified studies and three authors independently extracted data and assessed risk of bias in the included studies. We rated the certainty of evidence according to the GRADE approach.

MAIN RESULTS

We included nine studies with 587 men with mild to moderate erectile dysfunction, aged from 20 to 70 years old. The studies all compared ginseng to placebo. We found only short-term follow-up data (up to 12 weeks).  Primary outcomes Ginseng appears to have a trivial effect on erectile dysfunction when compared to placebo based on the Erectile Function Domain of the International Index of Erectile Function (IIEF)-15 instrument (scale: 1 to 30, higher scores imply better function; mean difference [MD] 3.52, 95% confidence interval [CI] 1.79 to 5.25; I² = 0%; 3 studies; low certainty evidence) assuming a minimal clinically important difference (MCID) of 4.  Ginseng probably also has a trivial effect on erectile function when compared to placebo based on the IIEF-5 instrument (scale: 1 to 25, higher scores imply better function; MD 2.39, 95% CI 0.89 to 3.88; I² = 0%; 3 studies; moderate certainty evidence) assuming a MCID of 5. Ginseng may have little to no effect on adverse events compared to placebo (risk ratio [RR] 1.45, 95% CI 0.69 to 3.03; I² = 0%; 7 studies; low certainty evidence). Based on 86 adverse events per 1000 men in the placebo group, this would correspond to 39 more adverse events per 1000 (95% CI 27 fewer to 174 more). Secondary outcomes Ginseng may improve men's self-reported ability to have intercourse (RR 2.55, 95% CI 1.76 to 3.69; I² = 23%; 6 studies; low certainty evidence). Based on 207 per 1000 men self-reporting the ability to have intercourse in the placebo group, this would correspond to 321 more men (95% CI 158 more to 558 more) per 1000 self-reporting the ability to have intercourse. Ginseng may have a trivial effect on men's satisfaction with intercourse based on the Intercourse Satisfaction Domain of the IIEF-15 (scale: 0 to 15, higher scores imply greater satisfaction; MD 1.19, 95% CI 0.41 to 1.97; I²=0%; 3 studies; low certainty evidence) based on a MCID of 25% improvement from baseline. It may also have a trivial effect on men's satisfaction with intercourse based on item 5 of the IIEF-5 (scale: 0 to 5, higher scores imply more satisfaction; MD 0.60, 95% CI 0.02 to 1.18; 1 study; low certainty evidence) based on a MCID of 25% improvement from baseline. No study reported quality of life as an outcome. We found no trial evidence to inform comparisons to other treatments for erectile dysfunction, such as phosphodiesterase-5 inhibitors. We were unable to conduct any predefined subgroup analyses.

AUTHORS' CONCLUSIONS: Based on mostly low certainty evidence, ginseng may only have trivial effects on erectile function or satisfaction with intercourse compared to placebo when assessed using validated instruments. Ginseng may improve men's self-reported ability to have intercourse. It may have little to no effect on adverse events. We found no trial evidence comparing ginseng to other agents with a more established role in treating erectile dysfunction, such as phosphodiesterase-5 inhibitors.

摘要

背景

人参或单独用人参制成的膳食补充剂被广泛用于治疗多种疾病,包括勃起功能障碍。人参在亚洲国家尤其受欢迎。评估其效果的个别研究大多规模较小,方法学质量参差不齐,结果也不明确。

目的

评估人参对勃起功能障碍的影响。

检索方法

我们对多个电子数据库(包括 CENTRAL、MEDLINE、Embase、CINAHL、AMED 和东亚局部数据库)进行了系统检索,检索时间截至 2021 年 1 月 30 日,无语言和发表状态限制。手工检索还包括会议论文集。

选择标准

我们纳入了随机或半随机对照试验,评估了任何类型的人参作为勃起功能障碍治疗与安慰剂或常规治疗相比的效果。

数据收集和分析

两名作者独立对研究进行分类,三名作者独立提取数据,并对纳入研究的偏倚风险进行评估。我们根据 GRADE 方法评估证据的确定性。

主要结果

我们纳入了 9 项研究,共 587 名年龄在 20 至 70 岁之间的轻至中度勃起功能障碍男性。这些研究均将人参与安慰剂进行比较。我们仅发现了短期随访数据(最长 12 周)。主要结局 基于国际勃起功能指数问卷(IIEF-15)的勃起功能域(量表:1 到 30,分数越高表示功能越好;平均差值 [MD] 3.52,95%置信区间 [CI] 1.79 到 5.25;I² = 0%;3 项研究;低确定性证据),人参与安慰剂相比,可能对勃起功能障碍仅有微小影响,假设最小临床重要差异(MCID)为 4。基于 IIEF-5 量表(量表:1 到 25,分数越高表示功能越好;MD 2.39,95%CI 0.89 到 3.88;I² = 0%;3 项研究;中等确定性证据),人参与安慰剂相比,可能对勃起功能也仅有微小影响,假设 MCID 为 5。与安慰剂相比,人参可能对不良事件几乎没有影响(风险比 [RR] 1.45,95%CI 0.69 到 3.03;I² = 0%;7 项研究;低确定性证据)。根据安慰剂组中每 1000 名男性出现 86 例不良事件,这相当于每 1000 名男性增加 39 例不良事件(95%CI 27 例更少到 174 例更多)。次要结局 基于 IIEF-15 的自我报告性交能力域(量表:0 到 15,分数越高表示满意度越高;MD 2.55,95%CI 1.76 到 3.69;I² = 23%;6 项研究;低确定性证据),人参与安慰剂相比,可能改善男性的自我报告性交能力,假设 MCID 为 25%的基线改善。在安慰剂组中,有 207 名男性自我报告能够进行性交,这将相当于有 321 名男性(95%CI 158 名更多到 558 名更多)能够进行性交。人参可能对 IIEF-15 的性交满意度域(量表:0 到 15,分数越高表示满意度越高;MD 1.19,95%CI 0.41 到 1.97;I² = 0%;3 项研究;低确定性证据)有微小影响,假设 MCID 为 25%的基线改善。它也可能对 IIEF-5 项目 5(量表:0 到 5,分数越高表示满意度越高;MD 0.60,95%CI 0.02 到 1.18;1 项研究;低确定性证据)有微小影响,假设 MCID 为 25%的基线改善。没有研究报告生活质量作为结局。我们没有发现任何试验证据可以比较人参与其他勃起功能障碍治疗药物的疗效,如磷酸二酯酶-5 抑制剂。我们无法进行任何预先设定的亚组分析。

作者结论

基于大多为低确定性证据,与安慰剂相比,人参可能对勃起功能或性交满意度仅有微小影响,使用验证工具评估时。人参可能会改善男性的自我报告性交能力。它可能对不良事件几乎没有影响。我们没有发现任何试验证据可以比较人参与其他更有治疗勃起功能障碍作用的药物,如磷酸二酯酶-5 抑制剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/90a9a35002bc/tCD012654-CMP-001.04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/d1ea836aa366/nCD012654-FIG-01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/0d82c6984ef6/tCD012654-FIG-02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/ea8f4af33cc9/tCD012654-FIG-03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/44eabac59fe4/tCD012654-CMP-001.01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/59467fd72580/tCD012654-CMP-001.02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/0820d7f25c8a/tCD012654-CMP-001.03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/90a9a35002bc/tCD012654-CMP-001.04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/d1ea836aa366/nCD012654-FIG-01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/0d82c6984ef6/tCD012654-FIG-02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/ea8f4af33cc9/tCD012654-FIG-03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/44eabac59fe4/tCD012654-CMP-001.01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/59467fd72580/tCD012654-CMP-001.02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/0820d7f25c8a/tCD012654-CMP-001.03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bf/8094213/90a9a35002bc/tCD012654-CMP-001.04.jpg

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