Randomized controlled trials (RCTs) are considered to represent the gold standard of scientific studies and paved the way for evidence-based medicine (EBM). Besides the initial aim to improve the quality of patient care, EBM is used in the meanwhile for political and economic decision-making and legal issues as well. A review of the literature was performed, followed by a search using links and references of the detected articles. Additionally, homepages for German institutions of public health were screened. Substantial limitations of RCTs and EBM health care could be identified. Based on the selected literature, 80% of the medical treatments have low evidence. RCTs are expensive and are mainly performed by the industry nowadays. A publication bias for positive results exists. Some RCTs are of low external validity. Many studies have a low fragility index. Nonetheless, negative RCTs could be of benefit for the patients. The results of RCTs, gained in a distinct patient population, are partially generalized. RCTs should be analyzed critically before adopting the results to daily clinical routine. It is not really justified to use RCTs and EBM for political and economic decision-making and legal issues as seen today.

随机对照试验（RCT）被认为代表了科学研究的黄金标准，并为循证医学（EBM）铺平了道路。除了提高患者护理质量的最初目标外，EBM 同时还用于政治和经济决策以及法律问题。对文献进行审查，然后使用检测到的文章的链接和参考文献进行搜索。此外，还对德国公共卫生机构的主页进行了筛查。可以确定随机对照试验和循证医学医疗保健的重大局限性。根据所选文献，80%的医学治疗证据不足。随机对照试验费用昂贵，目前主要由业界进行。存在对阳性结果的发表偏倚。一些随机对照试验的外部效度较低。许多研究的脆弱性指数较低。尽管如此，阴性随机对照试验可能对患者有益。在不同患者群体中获得的随机对照试验结果具有部分概括性。在将结果应用于日常临床常规之前，应对随机对照试验进行严格分析。正如今天所看到的，将随机对照试验和循证医学用于政治和经济决策以及法律问题确实是不合理的。