Department of Psychology, University of Pennsylvania, 3720 Walnut St, Philadelphia, PA 19104, USA.
JAMA. 2010 Jan 6;303(1):47-53. doi: 10.1001/jama.2009.1943.
Antidepressant medications represent the best established treatment for major depressive disorder, but there is little evidence that they have a specific pharmacological effect relative to pill placebo for patients with less severe depression.
To estimate the relative benefit of medication vs placebo across a wide range of initial symptom severity in patients diagnosed with depression.
PubMed, PsycINFO, and the Cochrane Library databases were searched from January 1980 through March 2009, along with references from meta-analyses and reviews.
Randomized placebo-controlled trials of antidepressants approved by the Food and Drug Administration in the treatment of major or minor depressive disorder were selected. Studies were included if their authors provided the requisite original data, they comprised adult outpatients, they included a medication vs placebo comparison for at least 6 weeks, they did not exclude patients on the basis of a placebo washout period, and they used the Hamilton Depression Rating Scale (HDRS). Data from 6 studies (718 patients) were included.
Individual patient-level data were obtained from study authors.
Medication vs placebo differences varied substantially as a function of baseline severity. Among patients with HDRS scores below 23, Cohen d effect sizes for the difference between medication and placebo were estimated to be less than 0.20 (a standard definition of a small effect). Estimates of the magnitude of the superiority of medication over placebo increased with increases in baseline depression severity and crossed the threshold defined by the National Institute for Clinical Excellence for a clinically significant difference at a baseline HDRS score of 25.
The magnitude of benefit of antidepressant medication compared with placebo increases with severity of depression symptoms and may be minimal or nonexistent, on average, in patients with mild or moderate symptoms. For patients with very severe depression, the benefit of medications over placebo is substantial.
抗抑郁药物是治疗重度抑郁症的最佳手段，但对于轻度抑郁患者，与服用安慰剂相比，它们在药理学上的效果几乎没有证据支持。
评估药物治疗相对于轻度抑郁患者服用安慰剂的疗效差异在各种初始症状严重程度下的表现。
从 1980 年 1 月至 2009 年 3 月，通过 PubMed、PsycINFO 和 Cochrane Library 数据库进行检索，同时检索了荟萃分析和综述的参考文献。
选择了经美国食品和药物管理局批准的抗抑郁药物治疗重度或轻度抑郁障碍的随机安慰剂对照试验。如果研究作者提供了必要的原始数据，研究对象为成年门诊患者，包括至少 6 周的药物与安慰剂对照，没有根据安慰剂洗脱期排除患者，且使用汉密尔顿抑郁量表（HDRS），则将其纳入研究。共纳入了 6 项研究（718 例患者）。
从研究作者处获取了个体患者水平的数据。
药物与安慰剂之间的差异与基线严重程度密切相关。在 HDRS 评分低于 23 的患者中，药物与安慰剂之间差异的 Cohen d 效应大小估计小于 0.20（一种小效应的标准定义）。随着基线抑郁严重程度的增加，药物优于安慰剂的估计值增加，并在基线 HDRS 评分为 25 时超过了国家临床卓越研究所定义的临床显著差异的阈值。
与安慰剂相比，抗抑郁药物的益处大小随抑郁症状严重程度的增加而增加，在轻度或中度症状的患者中平均可能很小或不存在。对于重度抑郁患者，药物治疗相对于安慰剂的益处是显著的。
