Independent Researcher, Bidar 585402, Karnataka, India.
Independent Researcher, Bengaluru 560040, Karnataka, India.
Phytomedicine. 2018 Nov 15;50:247-256. doi: 10.1016/j.phymed.2017.11.011. Epub 2017 Nov 29.
Withania somnifera Dunal, commonly known as Indian ginseng, has been in use since ancient times as anti-stress agent, aphrodisiac, for impotence and infertility treatment.
To evaluate the efficacy and safety of W. somnifera treatment in infertile men.
An evidence-based systematic review and meta-analysis using Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.
Published literature was searched in PubMed/MEDLINE, EMBASE, Scopus, the Cochrane Library, and DHARA. Grey literature was assessed from the WHO International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/) and the US National Institutes of Health (https://clinicaltrials.gov/).
Four clinical trials (comprising 5 publications: observational, n = 4; randomized controlled trial [RCT], n = 1) were included in the study. As only one RCT included, meta-analysis of RCT was not performed; however, systematically reviewed data demonstrated statistical (p ≤ .002 versus baseline) increase in sperm concentration (167%), semen volume (59%), and sperm motility (57%) in oligospermic males after 90 days of W. somnifera treatment, as well, serum testosterone (17%) and luteinizing hormone (34%) levels. Meta-analysis of observational (versus pre-treatment) studies showed that W. somnifera treatment significantly improved semen parameters (semen volume: mean difference [MD], 0.28 ml; 95% confidence interval [CI], 0.12 to 0.43; p = .0004; sperm concentration: MD, 13.57 million/ml; 95% CI, 11.12 to 16.01; p < .00001; sperm motility: MD, 8.50%; 95% CI, 7.36 to 9.63; p < .00001) with 14% of pregnancy outcome success rate in normozoospermic men. Meta-analysis findings also evidenced significant improvement in serum hormonal profile, oxidative biomarkers and antioxidant vitamins in seminal plasma. No adverse effects were reported in infertile men taking W. somnifera treatment.
Due to a small number of eligible studies, the available data, though promising, are too limited to provide novel and sufficiently robust evidence of the benefits of W. somnifera in male infertility. Additional RCTs of high quality with a larger sample size are warranted to further strength clinical use of W. somnifera in treating male factor infertility. Future research also needs to elucidate the molecular mechanism(s) of W. somnifera as well its active principles in male infertility.
印度人参（Withania somnifera Dunal），俗称冬樱花，自古以来一直被用作抗应激剂、壮阳药，用于治疗阳痿和不育。
评估印度人参治疗男性不育的疗效和安全性。
采用系统评价和荟萃分析的首选报告项目（PRISMA）指南进行基于证据的系统评价和荟萃分析。
在 PubMed/MEDLINE、EMBASE、Scopus、Cochrane 图书馆和 DHARA 中搜索已发表的文献。从世界卫生组织国际临床试验注册平台（http://apps.who.int/trialsearch/）和美国国立卫生研究院（https://clinicaltrials.gov/）评估灰色文献。
本研究纳入了 4 项临床试验（包括 5 篇文献：观察性研究，n=4；随机对照试验 [RCT]，n=1）。由于只有一项 RCT，因此未进行 RCT 的荟萃分析；然而，系统评价数据显示，在接受印度人参治疗 90 天后，寡精子症男性的精子浓度（167%）、精液量（59%）和精子活力（57%）以及血清睾酮（17%）和促黄体生成激素（34%）水平均有统计学意义（p≤.002 与基线相比）。对观察性研究（与治疗前相比）的荟萃分析表明，印度人参治疗可显著改善精液参数（精液量：平均差值[MD]，0.28 ml；95%置信区间[CI]，0.12 至 0.43；p=.0004；精子浓度：MD，1357 万/ml；95%CI，1112 至 1601；p<.00001；精子活力：MD，8.50%；95%CI，7.36 至 9.63；p<.00001），且正常精子男性的妊娠成功率为 14%。荟萃分析结果还表明，印度人参可显著改善血清激素谱、精液中的氧化生物标志物和抗氧化维生素。接受印度人参治疗的不育男性未报告不良反应。
由于合格研究数量较少，尽管有希望，但现有数据还太局限，无法为印度人参治疗男性不育提供新的、足够有力的证据。需要进行更多高质量、更大样本量的 RCT，以进一步加强印度人参治疗男性因素不育的临床应用。未来的研究还需要阐明印度人参的分子机制及其在男性不育中的活性成分。
