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[抗抑郁药治疗中的安慰剂效应:对抑郁症药物治疗科学评估和临床应用的启示]

[Placebo effect in the treatment with antidepressants : Implications for the scientific evaluation and clinical use of pharmaceutical treatments of depression].

作者信息

Rief Winfried, Kube Tobias

机构信息

Klinische Psychologie und Psychotherapie, Philipps-Universität Marburg, Gutenbergstraße 18, 35032, Marburg, Deutschland.

Klinische Psychologie und Psychotherapie, Rheinland-Pfälzische Technische Universität Kaiserslautern-Landau, Landau, Deutschland.

出版信息

Nervenarzt. 2025 Mar;96(2):128-137. doi: 10.1007/s00115-024-01784-5. Epub 2024 Dec 12.

DOI:10.1007/s00115-024-01784-5
PMID:39668233
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11876280/
Abstract

BACKGROUND

Blinded placebo treatment arms in clinical trials often achieve up to 80% of the clinical improvements of the verum groups. Apparently, the majority of the effects found in the antidepressant groups in clinical trials are due to factors that are not specific to antidepressant treatment. This article reviews the factors that contribute to the high effectiveness of placebo interventions for antidepressants.

METHODS

A narrative literature review is presented with particular emphasis on placebo effects in antidepressant clinical trials.

RESULTS

There is a particularly strong placebo effect in depression compared to other mental disorders. The magnitude of this effect can be modulated by helpful versus nonhelpful instructions, by patient participation in the decision-making process but also by personal attention, especially if the clinician is perceived as competent and warmhearted. The occurrence of subtle side effects can also reinforce placebo effects. Placebo effects are not only reflected in subjective patient-reported outcome variables but are also evident in neurochemical changes in the body.

CONCLUSION

Clinicians essentially contribute to the effectiveness of antidepressant treatment through their own behavior. At the same time, the relatively small overall difference between verum and placebo treatments for depression leads to the necessity of a critical evaluation of the cost-benefit ratio, adapted to the individual case. Study designs for the evaluation of antidepressants are required that better reflect the complex interactions between the genuine drug effects and placebo effects.

摘要

背景

临床试验中使用盲法安慰剂治疗组往往能达到阳性药物治疗组临床改善效果的80%。显然,临床试验中抗抑郁药治疗组所发现的大部分疗效是由非抗抑郁药治疗特异性的因素所致。本文综述了有助于安慰剂干预对抑郁症产生高效应的因素。

方法

进行叙述性文献综述,特别强调抗抑郁药临床试验中的安慰剂效应。

结果

与其他精神障碍相比,抑郁症中存在特别强烈的安慰剂效应。这种效应的大小可通过有益与无益的指导、患者参与决策过程以及个人关注(尤其是当临床医生被认为有能力且热心时)来调节。轻微副作用的出现也可增强安慰剂效应。安慰剂效应不仅反映在患者报告的主观结局变量中,在身体的神经化学变化中也很明显。

结论

临床医生本质上通过自身行为对抗抑郁治疗的有效性做出贡献。同时,抑郁症阳性药物治疗与安慰剂治疗之间总体差异相对较小,这就需要根据具体情况对成本效益比进行批判性评估。需要设计出能更好反映真实药物效应与安慰剂效应之间复杂相互作用的抗抑郁药评估研究方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e53/11876280/b88e6e159fa8/115_2024_1784_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e53/11876280/b88e6e159fa8/115_2024_1784_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e53/11876280/b88e6e159fa8/115_2024_1784_Fig1_HTML.jpg

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本文引用的文献

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Nat Ment Health. 2023 Nov;1(11):876-886. doi: 10.1038/s44220-023-00140-x. Epub 2023 Oct 19.
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Use of Quantile Treatment Effects Analysis to Describe Antidepressant Response in Randomized Clinical Trials Submitted to the US Food and Drug Administration: A Secondary Analysis of Pooled Trial Data.利用分位数治疗效果分析描述向美国食品和药物管理局提交的随机临床试验中的抗抑郁反应:汇总试验数据的二次分析。
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Cognitive behavior therapy vs. control conditions, other psychotherapies, pharmacotherapies and combined treatment for depression: a comprehensive meta-analysis including 409 trials with 52,702 patients.认知行为疗法与抑郁症的对照条件、其他心理疗法、药物疗法及联合治疗的比较:一项纳入409项试验、52702例患者的综合荟萃分析
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Consistently Modest Antidepressant Effects in Clinical Trials: the Role of Regulatory Requirements.临床试验中持续存在的抗抑郁药疗效不显著:监管要求的作用。
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Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial.开放标签安慰剂治疗单相抑郁:一项随机对照试验的结果。
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Expectation-induced placebo effect on acute sadness in women with major depression: An experimental investigation.期待诱导的安慰剂效应对女性重性抑郁急性悲伤的影响:一项实验研究。
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