• Sharanbasappa Durg, Shivakumar Badamaranahalli Shivaram, and Sachin Bavage.
• Independent Researcher, Bidar 585402, Karnataka, India. Electronic address: sharanabasappadurg@yahoo.com.
• Phytomedicine. 2018 Nov 15; 50: 247-256.

BackgroundWithania somnifera Dunal, commonly known as Indian ginseng, has been in use since ancient times as anti-stress agent, aphrodisiac, for impotence and infertility treatment.PurposeTo evaluate the efficacy and safety of W. somnifera treatment in infertile men.Study DesignAn evidence-based systematic review and meta-analysis using Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.MethodsPublished 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/).ResultsFour 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.ConclusionDue 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.Copyright © 2017 Elsevier GmbH. All rights reserved.

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