疗效与效果：随机对照试验和日常实践中治疗轻中度抑郁症的治疗结果的直接比较。

Efficacy versus effectiveness: a direct comparison of the outcome of treatment for mild to moderate depression in randomized controlled trials and daily practice.

机构信息

Department of Psychiatry, Leiden University Medical Center/Rivierduinen, Leiden, The Netherlands.

出版信息

Psychother Psychosom. 2012;81(4):226-34. doi: 10.1159/000330890. Epub 2012 May 11.

DOI:10.1159/000330890

PMID:22584117

Abstract

BACKGROUND

Results from randomized controlled trials (RCTs) are considered to give the most reliable information on treatment outcome (efficacy). Yet, the generalizability of efficacy results to daily practice (effectiveness) might be diminished by the design of RCTs. The STARD trial approached daily practice as much as possible, but still has some properties of an RCT. In this study, we compare results from treatment of major depressive disorder (MDD) in routine clinical practice to those of RCTs and STARD.

METHODS

Effectiveness in routine clinical practice was compared with efficacy results from 15 meta-analyses on antidepressant, psychotherapeutic and combination treatment and results from STAR*D. Data on daily practice patients and treatments were derived from a routine outcome monitoring (ROM) system. Treatment outcome was defined as proportion of remitters (MADRS ≤10) and within-group effect size.

RESULTS

From ROM, 598 patients suffering from a MDD episode according to the MINI-plus were included. Remission percentages were lower in routine practice than in meta-analyses for all treatment modalities (32 vs.40-74%). Differences were less explicit for antidepressants (21 vs. 34-47%) than for individual psychotherapy (27 vs. 34-58%; effect size 0.85 vs. 1.71) and combination therapy (21 vs. 45-63%), since only 60% of the meta-analyses for antidepressants showed significant differences with ROM, while for psychotherapy and combination treatment almost all meta-analyses showed significant differences. No differences in effectiveness were found between routine practice and STAR*D (antidepressants 27 vs. 28%; individual psychotherapy 27 vs. 25%; combination treatment 21 vs. 23%, respectively).

CONCLUSIONS

Effectiveness of treatment for mild-to-moderate MDD in daily practice is similar to STAR*D and significantly lower than efficacy results from RCTs.

摘要

背景

随机对照试验（RCT）的结果被认为提供了关于治疗效果（疗效）的最可靠信息。然而，由于 RCT 的设计，疗效结果在日常实践中的普遍性（有效性）可能会降低。STARD 试验尽可能接近日常实践，但仍具有 RCT 的一些特征。在这项研究中，我们将常规临床实践中治疗重度抑郁症（MDD）的结果与 RCT 和 STARD 的结果进行比较。

方法

将常规临床实践中的有效性与 15 项关于抗抑郁药、心理治疗和联合治疗的荟萃分析的疗效结果以及 STAR*D 的结果进行比较。常规实践中患者和治疗的数据来自常规结果监测（ROM）系统。治疗结果定义为缓解者的比例（MADRS≤10）和组内效应大小。

结果

从 ROM 中，根据 MINI-plus 纳入了 598 名患有 MDD 发作的患者。在所有治疗方式中，常规实践中的缓解率均低于荟萃分析（32% vs. 40-74%）。对于抗抑郁药（21% vs. 34-47%），个体心理治疗（27% vs. 34-58%；效应大小 0.85 vs. 1.71）和联合治疗（21% vs. 45-63%），差异不太明显，因为只有 60%的抗抑郁药荟萃分析显示与 ROM 存在显著差异，而对于心理治疗和联合治疗，几乎所有荟萃分析都显示出显著差异。常规实践与 STAR*D 之间未发现治疗效果的差异（抗抑郁药 27% vs. 28%；个体心理治疗 27% vs. 25%；联合治疗 21% vs. 23%）。