Nassir Ghaemi S, Shirzadi Arshia A, Filkowski Megan
Tufts Medical Center, Boston, Massachusetts, USA.
Medscape J Med. 2008;10(9):211. Epub 2008 Sep 10.
Publication bias, especially the lack of publication of negative treatment studies, is known to be a major problem in the medical literature. In particular, it appears that the pharmaceutical industry is not routinely making data from negative studies available through the published scientific literature. In this paper, we review the case of studies with lamotrigine in bipolar disorder, describing evidence of lack of efficacy in multiple mood states outside of the primary area of efficacy (prophylaxis of mood episodes). In particular, the drug has very limited, if any, efficacy in acute bipolar depression and rapid-cycling bipolar disorder, areas in which practicing clinicians, as well as some academic leaders, have supported its use. The negative unpublished data now made available on lamotrigine provide an important context for clinical practice and research, and also raise important scientific and public policy concerns about having access to studies showing inefficacy with psychotropic medications.
众所周知，发表偏倚，尤其是阴性治疗研究未得到发表，是医学文献中的一个主要问题。特别是，制药行业似乎没有常规地通过已发表的科学文献提供阴性研究的数据。在本文中，我们回顾了拉莫三嗪治疗双相情感障碍的研究案例，描述了在主要疗效领域（预防情绪发作）之外的多种情绪状态下缺乏疗效的证据。特别是，该药物在急性双相抑郁和快速循环型双相情感障碍中的疗效非常有限（如果有疗效的话），而执业临床医生以及一些学术带头人曾在这些领域支持使用该药物。现在可获取的关于拉莫三嗪的未发表阴性数据为临床实践和研究提供了重要背景，同时也引发了关于获取显示精神药物无效的研究的重要科学和公共政策问题。
