Wang Sheng-Min, Han Changsu, Lee Soo-Jung, Jun Tae-Youn, Patkar Ashwin A, Masand Prakash S, Pae Chi-Un
a Department of Psychiatry , The Catholic University of Korea College of Medicine , Seoul , Republic of Korea.
b International Health Care Center, Seoul St. Mary's Hospital, College of Medicine , The Catholic University of Korea , Seoul , Republic of Korea.
Expert Rev Clin Pharmacol. 2018 Jan;11(1):15-25. doi: 10.1080/17512433.2017.1377070. Epub 2017 Sep 14.
Countless antidepressant randomized trials were conducted and showed statistically significant benefits of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) over placebo. Meanwhile, critics are increasing regarding the efficacy of antidepressants in the treatment of MDD because at least a proportion of clinical trials could be hampered by various biases. In contrast, number of failed trials is increasing in the recent years which have made developing psychiatric medications progressively more time-consuming and expensive. Areas covered: Biases and related issues in clinical trials for antidepressants can be identified as an important common contributing factor to the two paradoxical phenomenon. This review identifies possible biases that can occur before, during, and after clinical trials of antidepressant. Expert commentary: Recent studies not only may over-estimate efficacy of antidepressants, but also may exaggerate placebo response because of various biases. Sponsorship and publication biases have been one of the targets of the criticism and ethical debate. Thus, initiating new trend of research by re-organizing academic-industry partnership will be the most important task in the next five years.
进行了无数次抗抑郁药物随机试验，结果显示选择性5-羟色胺再摄取抑制剂（SSRI）和5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRI）相对于安慰剂具有统计学上的显著疗效。与此同时，对于抗抑郁药物治疗重度抑郁症（MDD）的疗效，批评声越来越多，因为至少有一部分临床试验可能受到各种偏差的影响。相比之下，近年来失败试验的数量不断增加，这使得开发精神科药物的时间越来越长，成本越来越高。涵盖领域：抗抑郁药物临床试验中的偏差及相关问题可被视为导致这两种矛盾现象的一个重要共同因素。本综述确定了抗抑郁药物临床试验之前、期间和之后可能出现的偏差。专家评论：由于各种偏差，近期研究不仅可能高估了抗抑郁药物的疗效，还可能夸大了安慰剂反应。赞助和发表偏差一直是批评和伦理辩论的目标之一。因此，在未来五年内，通过重新组织学术-产业合作关系开启新的研究趋势将是最重要的任务。
