Coon Joanna Thompson, Ernst Edzard
Department of Complementary Medicine, School of Postgraduate Medicine and Health Sciences, University of Exeter, Exeter, United Kingdom.
Drug Saf. 2002;25(5):323-44. doi: 10.2165/00002018-200225050-00003.
Panax ginseng C. A. Meyer is a perennial herb native to Korea and China and has been used as an herbal remedy in eastern Asia for thousands of years. Modern therapeutic claims refer to vitality, immune function, cancer, cardiovascular diseases, improvement of cognitive and physical performance and sexual function. A recent systematic review of randomised controlled trials found that the efficacy of ginseng root extract could not be established beyond doubt for any of these indications. In order to obtain a balanced assessment of the therapeutic value of P. ginseng it is also necessary to consider the safety profile. In view of the extremely widespread use of P. ginseng it seems important to ask whether this herbal medicine involves health risks for the consumer. This review was conducted as a systematic attempt to document and evaluate all the available safety data on P. ginseng root extracts. Systematic searches were performed in five electronic databases and the reference lists of all papers located were checked for further relevant publications. All articles containing original data on adverse events and drug interactions with P. ginseng were included. Information was also requested from 12 manufacturers of ginseng preparations, the spontaneous reporting schemes of the WHO and national drug safety bodies. No language restrictions were imposed. Data from clinical trials suggest that the incidence of adverse events with ginseng monopreparations is similar to that with placebo. The most commonly experienced adverse events are headache, sleep and gastrointestinal disorders. The possibility of more serious adverse events is indicated in isolated case reports and data from spontaneous reporting schemes; however, causality is often difficult to determine from the evidence provided. Combination products containing ginseng as one of several constituents have been associated with serious adverse events and even fatalities. Interpretation of these cases is difficult as ingredients other than P. ginseng may have caused the problems. Possible drug interactions have been reported between P. ginseng and warfarin, phenelzine and alcohol. Collectively, these data suggest that P. ginseng monopreparations are rarely associated with adverse events or drug interactions. The ones that are documented are usually mild and transient. Combined preparations are more often associated with such events but causal attribution is usually not possible.
人参（Panax ginseng C. A. Meyer）是一种多年生草本植物，原产于韩国和中国，在东亚作为草药使用已有数千年历史。现代治疗宣称涉及活力、免疫功能、癌症、心血管疾病、认知和身体机能改善以及性功能等方面。最近一项对随机对照试验的系统评价发现，对于上述任何一种适应症，人参根提取物的疗效都无法得到确凿证实。为了对人参的治疗价值进行全面评估，还需要考虑其安全性。鉴于人参的使用极为广泛，询问这种草药是否会给消费者带来健康风险似乎很重要。本综述旨在系统地记录和评估关于人参根提取物的所有现有安全数据。我们在五个电子数据库中进行了系统检索，并检查了所有找到论文的参考文献列表以获取更多相关出版物。所有包含人参不良事件和药物相互作用原始数据的文章均被纳入。我们还向12家参制剂制造商、世界卫生组织的自发报告计划以及国家药品安全机构索取了信息。未设语言限制。临床试验数据表明，人参单一制剂不良事件的发生率与安慰剂相似。最常出现的不良事件是头痛、睡眠和胃肠道紊乱。个别病例报告和自发报告计划的数据显示存在更严重不良事件的可能性；然而，根据所提供的证据往往难以确定因果关系。含有人参作为几种成分之一的复方产品与严重不良事件甚至死亡有关。由于除人参外的其他成分可能导致了这些问题，因此对这些病例的解读很困难。据报道，人参与华法林、苯乙肼和酒精之间可能存在药物相互作用。总体而言，这些数据表明人参单一制剂很少与不良事件或药物相互作用相关。已记录的那些通常是轻微和短暂的。复方制剂更常与此类事件相关，但通常无法确定因果关系。
