Antidepressant-placebo differences for specific adverse events in major depressive disorder: A systematic review.
Antidepressant-placebo differences for specific adverse events in major depressive disorder: A systematic review.
复制标题
抗抑郁药与安慰剂在重度抑郁症特定不良事件方面的差异：系统评价。
DOI：
10.1016/j.jad.2020.02.013
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发表时间：
2020
影响因子：
6.6
通讯作者：
Schaffer,Ayal
中科院分区：
文献类型：
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作者：
Sinyor,Mark;Cheung,ChristianP;Abraha,HabenY;Lanctôt,KristaL;Saleem,Mahwesh;Liu,CelinaS;Li,Abby;Juda,Ari;Levitt,AnthonyJ;Cheung,AmyH;Schaffer,Ayal
研究背景已知患者在接受安慰剂治疗时会发生不良事件（AE），这是所谓反安慰剂效应的一部分。然而，证据是有限的可能性，具体的不良事件发生与抗抑郁药治疗是或不是由于nocebo effects.MethodsThis study identified 56安慰剂对照，随机对照试验（RCT）的抗抑郁药单药治疗成人重度抑郁症，报告不良事件发生率足够详细的比较。Poisson回归分析比较了根据研究人群加权的抗抑郁药类别的AE发生率，以确定与安慰剂的区别。还计算了“反安慰剂指数”（0定义为最低比率，1或更高表示安慰剂组中AE的相同或更高比率）。ResultsMany AE在抗抑郁药类别和安慰剂之间没有统计学差异，包括精神症状恶化，所有形式的疼痛，体重增加和呼吸道症状。然而，在多种抗抑郁药类别中，抗抑郁药组中的一些AE显著高于安慰剂组。这些主要是神经、性和抗胆碱能作用。尽管抗抑郁药和安慰剂之间存在统计学差异，但几起AE的反安慰剂指数为中度（≥0.5）。例如，SSRIs组的头晕与安慰剂组有显著差异（OR 1.50，95%CI 1.13-1.99），但反安慰剂指数为0.67.LimitationsThis study depends on multiple RCT with intense design differences. Conclusions本研究确定了几种可能是抗抑郁药生理学结果的不良事件，许多可能代表反安慰剂效应。这些结果应该为临床决策和与患者的讨论提供信息。
BackgroundAdverse events (AEs) are known to occur while patients are treated with placebos, part of the so-called nocebo effect. Yet evidence is limited regarding the likelihood that specific AEs occurring with antidepressant treatment are or are not due to nocebo effects.MethodsThis study identified 56 placebo-controlled, randomized controlled trials (RCTs) of antidepressant monotherapy for adults with major depressive disorder that reported AE rates in sufficient detail for comparison. Poisson regression analyses compared rates of AEs according to antidepressant class weighted by study population to determine which separated from placebo. A “nocebo index” was also calculated (with 0 defined as the lowest rate and 1 or higher indicating the same or greater rate of an AE in the placebo group).ResultsNumerous AEs did not differ statistically between antidepressant classes and placebo including worsening psychiatric symptoms, all forms of pain, weight gain and respiratory symptoms. Nevertheless, a number of AEs were significantly more common in antidepressants than placebos across multiple antidepressant classes. These were predominantly neurological, sexual and anticholinergic effects. Several AEs that separated statistically between antidepressants and placebos nevertheless had moderate nocebo indices (≥0.5). For example, dizziness in SSRIs separated significantly from placebo (OR 1.50, 95%CI 1.13–1.99) but had a nocebo index of 0.67.LimitationsThis study relied on multiple RCTs with subtle design differences.ConclusionsThis study identified several AEs that are likely the physiological result of antidepressants and many that likely represent nocebo effects. These results should inform clinical decision making and discussions with patients.