Howland Robert H
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, PA, USA.
J Psychosoc Nurs Ment Health Serv. 2011 Sep;49(9):11-4. doi: 10.3928/02793695-20110809-01. Epub 2011 Aug 17.
Publication bias and outcome reporting bias contribute to distorted perceptions of drug efficacy and the underreporting of adverse events. To demonstrate these biases, this article describes how the clinical profile of the antidepressant agent agomelatine (Valdoxan(®)) has been presented in the literature. Agomelatine has been systematically assessed in 10 short-term placebo-controlled studies and three long-term placebo-controlled relapse prevention studies. Five published trials demonstrated clinically modest but statistically significant benefits over placebo. Five unpublished trials did not find agomelatine more effective than placebo, but in two of these studies the active comparison drug (fluoxetine [Prozac(®)] or paroxetine [Paxil(®)]) was more effective than placebo. Agomelatine was more effective than placebo in one of three relapse prevention studies, but only the positive study was published. Based on what is evident in the entire published and unpublished dataset, agomelatine does not have a tremendously superior sleep and sexual effects profile. The risk of liver toxicity is also not prominently highlighted in the published literature.
发表偏倚和结果报告偏倚导致对药物疗效的认知扭曲以及不良事件报告不足。为了证明这些偏倚,本文描述了抗抑郁药阿戈美拉汀(Valdoxan®)在文献中的呈现方式。阿戈美拉汀已在10项短期安慰剂对照研究和3项长期安慰剂对照预防复发研究中进行了系统评估。五项已发表的试验显示,与安慰剂相比,在临床上有适度但具有统计学意义的益处。五项未发表的试验未发现阿戈美拉汀比安慰剂更有效,但在其中两项研究中,活性对照药物(氟西汀[Prozac®]或帕罗西汀[Paxil®])比安慰剂更有效。在三项预防复发研究中的一项中,阿戈美拉汀比安慰剂更有效,但只有阳性研究被发表。根据整个已发表和未发表数据集的明显情况,阿戈美拉汀在睡眠和性功能方面并没有极其优越的表现。已发表的文献中也没有突出强调肝毒性风险。