Department of Pharmacy, School of Medicine and Surgery, University of Napes Federico II, Via D. Montesano 49, 80131, Naples, Italy.
Working Group "Pharmacognosy and Phytotherapy" of the Italian Pharmacological Society, Viale Abruzzi 32, 20131, Milan, Italy.
Drugs. 2018 Apr;78(6):643-673. doi: 10.1007/s40265-018-0897-3.
Erectile dysfunction (ED) is a common condition that significantly affects quality of life and interpersonal relationships.
Our objective was to perform a systematic review and meta-analysis to evaluate the efficacy of herbal dietary supplements in the treatment of ED.
We searched five databases to identify randomized controlled trials (RCTs) that evaluated the clinical efficacy of herbal medicines in ED. Quality was assessed and risk of bias was estimated using the Jadad score and the Cochrane risk-of-bias tool.
In total, 24 RCTs, including 2080 patients with ED, were identified. Among these, 12 evaluated monopreparations (five ginseng [n = 399], three saffron [n = 397], two Tribulus terrestris [n = 202], and one each Pinus pinaster [n = 21] and Lepidium meyenii [n = 50]), seven evaluated formulations (n = 544), and five investigated dietary supplements in combination with pure compounds (n = 410). Ginseng significantly improved erectile function (International Index of Erectile Function [IIEF]-5 score: 140 ginseng, 96 placebo; standardized mean difference [SMD] 0.43; 95% confidence interval [CI] 0.15-0.70; P < 0.01; I = 0), P. pinaster and L. meyenii showed very preliminary positive results, and saffron and T. terrestris treatment produced mixed results. Several herbal formulations were associated with a decrease of IIEF-5 or IIEF-15, although the results were preliminary. The quality of the included studies varied, with only seven having a prevalent low risk of bias. The median methodological quality Jadad score was three out of a maximum of five. Adverse events were recorded in 19 of 24 trials, with no significant differences between placebo and verum in placebo-controlled studies.
Encouraging evidence suggests that ginseng may be an effective herbal treatment for ED. However, further, larger, and high-quality studies are required before firm conclusions can be drawn. Promising (although very preliminary) results have also been generated for some herbal formulations. Overall, more research in the field, adhering to the CONSORT statement extension for reporting trials, is justified before the use of herbal products in ED can be recommended.
勃起功能障碍（ED）是一种常见病症，严重影响生活质量和人际关系。
我们旨在进行系统评价和荟萃分析，以评估草药膳食补充剂治疗 ED 的疗效。
我们检索了五个数据库，以确定评估草药治疗 ED 的临床疗效的随机对照试验（RCT）。使用 Jadad 评分和 Cochrane 偏倚风险工具评估质量和偏倚风险。
共纳入 24 项 RCT，包括 2080 例 ED 患者。其中，12 项研究评估了单一组分（人参[399 例]、西红花[397 例]、刺蒺藜[202 例]、油松[21 例]和玛咖[50 例]），7 项研究评估了配方（544 例），5 项研究调查了膳食补充剂与纯化合物联合应用（410 例）。人参可显著改善勃起功能（国际勃起功能指数[IIEF]-5 评分：人参 140 分，安慰剂 96 分；标准化均数差[SMD]0.43；95%置信区间[CI]0.15-0.70；P<0.01；I²=0），油松和玛咖显示出初步的积极结果，而西红花和刺蒺藜的治疗结果则喜忧参半。几种草药配方与 IIEF-5 或 IIEF-15 评分降低相关，尽管结果初步，但仍有一定的效果。纳入研究的质量差异较大，仅有 7 项研究的偏倚风险普遍较低。Jadad 评分最高得分为 5 分，中位数为 3 分。24 项试验中有 19 项记录了不良反应，安慰剂对照研究中安慰剂和阳性药物之间无显著差异。
有令人鼓舞的证据表明，人参可能是一种有效的 ED 草药治疗方法。然而，需要进一步开展更大规模和高质量的研究，才能得出更确定的结论。一些草药配方也产生了有前景（尽管非常初步）的结果。总体而言，在推荐 ED 使用草药产品之前，有理由在该领域开展更多符合 CONSORT 扩展声明报告试验的研究。
