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Assessing the 'true' effect of active antidepressant therapy v. placebo in major depressive disorder: use of a mixture model.

机译:评估主动抗抑郁疗法与安慰剂在严重抑郁症中的“真实”效果:使用混合模型。

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BACKGROUND: There is controversy about the implications of relatively small average drug-placebo differences observed in randomised controlled trials of antidepressant medications. AIMS: To investigate whether efficacy is better understood as a large effect in a subgroup of patients. METHOD: The mixture model was used to identify patient subgroups (patients benefiting or not benefiting from treatment) to directly model the skewness of Montgomery-Asberg Depression Rating Scale (MADRS) scores at week 8. RESULTS: The MADRS scores improved by 15.9 points (95% CI 15.2-16.6) among patients who benefited from treatment. The proportion of patients who benefited from escitalopram and not from placebo treatment was 19.5%, corresponding to a number needed to treat of 5. CONCLUSIONS: This model gave a considerably better fit to the data than the analysis of covariance model in which all patients were assumed to benefit from treatment. The small average antidepressant-placebo difference obscures a much larger effect in a clinically meaningful subgroup of patients.
机译:背景:关于抗抑郁药的随机对照试验中观察到的相对较小的平均药物-安慰剂差异的影响存在争议。目的:研究是否能更好地将疗效理解为对亚组患者的重大影响。方法:混合模型用于确定患者亚组(受益或不受益于治疗的患者),以直接模拟第8周蒙哥马利-阿斯伯格抑郁量表(MADRS)评分的偏度。结果:MADRS评分提高了15.9分(受益于治疗的患者中95%CI 15.2-16.6)。受益于依他普仑而非安慰剂治疗的患者比例为19.5%,对应于需要治疗的人数5。结论:与所有患者均接受协方差分析的模型相比,该模型对数据的拟合度更好。假定将从治疗中受益。较小的平均抗抑郁药-安慰剂差异会在临床上有意义的患者亚组中掩盖更大的作用。

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