Leon A C, Shear M K, Portera L, Klerman G L
Cornell University Medical College, Department of Psychiatry, New York, NY 10021.
Psychopharmacol Bull. 1993;29(2):163-7.
A data-analytic strategy is proposed for identifying the symptom-specific effects of each medication in a clinical trial. The within-group effect size is a standardized ratio of the pre-post change relative to the stability of change for each treatment group. Advantages of using this descriptive approach are illustrated by examining antidepressant effects of alprazolam, imipramine, and placebo in a clinical trial for patients meeting criteria for both panic disorder and depression. There was a significant difference between active medication and placebo on the Hamilton Rating Scale for Depression (HAM-D) total, but no difference between the anti-depressant effects of the active medications despite their diverse psychopharmacologic properties. Examination of effect sizes for each HAM-D item revealed distinct symptom-specific effects of each active medication in this study sample. Although these descriptive findings cannot be used for inferential conclusions, they can be used to guide the design of future trials.
本文提出了一种数据分析策略，用于在临床试验中识别每种药物的症状特异性效应。组内效应量是每个治疗组前后变化相对于变化稳定性的标准化比率。通过在一项针对符合惊恐障碍和抑郁症标准患者的临床试验中检查阿普唑仑、丙咪嗪和安慰剂的抗抑郁作用，说明了使用这种描述性方法的优势。在汉密尔顿抑郁量表（HAM-D）总分上，活性药物与安慰剂之间存在显著差异，但尽管活性药物具有不同的精神药理特性，它们的抗抑郁作用之间没有差异。对每个HAM-D项目的效应量进行检查，揭示了本研究样本中每种活性药物独特的症状特异性效应。虽然这些描述性结果不能用于推断结论，但它们可用于指导未来试验的设计。
