Department of Clinical and Theoretical Mental Health, Semmelweis University, Faculty of Medicine, Budapest, Hungary.
Eur Neuropsychopharmacol. 2012 Nov;22(11):782-6. doi: 10.1016/j.euroneuro.2012.03.002. Epub 2012 Apr 11.
It is widely believed that in randomized controlled trials of antidepressants the difference between drug and placebo response rates is rather small (around 20%), leading to a common perception that antidepressants have limited efficacy.
The aim of the present paper was to present an alternative calculation and interpretation of antidepressant-placebo difference in the treatment response to antidepressant in drug trials which may shed a new light on the efficacy of antidepressants.
We have previously highlighted several controversial points concerning the calculation of antidepressant and placebo response rates in randomised controlled trials, which may influence views concerning the efficacy of drugs, and demonstrated several factors which may lead to overestimation of the placebo effect and underestimation of antidepressant efficacy. The traditional interpretation of antidepressant-placebo difference in randomized controlled trials on major depression has been also challenged previously from at least five points of view but all leading to a conclusion that currently prevailing opinions concerning relative placebo and antidepressant response rates overestimate placebo response, and thereby underestimate efficacy of antidepressant drugs. In our present paper we propose another method for calculating placebo and antidepressant response rates which may shed new light on an overlooked aspect of the efficacy of these drugs.
We contend that opinions on the effectiveness of antidepressants should be reconsidered, and comparisons with placebo should be more carefully applied. Interpretation of the placebo response is of crucial importance for establishing the efficacy of antidepressive medications, and psychiatry should not become the hostage of placebo.
人们普遍认为,在抗抑郁药的随机对照试验中,药物和安慰剂的反应率差异相当小(约 20%),这导致了一种普遍的看法,即抗抑郁药的疗效有限。
本文旨在提出一种替代的计算和解释抗抑郁药治疗反应中抗抑郁药与安慰剂差异的方法,这可能为抗抑郁药的疗效提供新的视角。
我们之前曾强调过几个关于随机对照试验中抗抑郁药和安慰剂反应率计算的争议点,这些问题可能会影响人们对药物疗效的看法,并证明了几个可能导致高估安慰剂效应和低估抗抑郁药疗效的因素。从至少五个方面来看,传统的抗抑郁药与安慰剂在治疗重度抑郁症的随机对照试验中的差异的解释也受到了挑战,但所有这些都得出了一个结论,即目前关于相对安慰剂和抗抑郁药反应率的普遍观点高估了安慰剂反应,从而低估了抗抑郁药的疗效。在我们目前的论文中,我们提出了另一种计算安慰剂和抗抑郁药反应率的方法,这可能为这些药物疗效的一个被忽视的方面提供新的视角。
我们认为,应该重新考虑对抗抑郁药有效性的看法,并更仔细地应用与安慰剂的比较。对安慰剂反应的解释对于确定抗抑郁药物的疗效至关重要,而精神病学不应该成为安慰剂的俘虏。