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对声的安慰剂效应:随机对照试验的系统审查和元分析

Rameen K Walters, Frederick G Durrant¹, Shaun A Nguyen¹

¹Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology

|February 16, 2024

概括

安慰剂治疗在改善患者报告的耳症状方面表现出有效性,特别是在耳障碍库存 (THI) 和视觉模拟声量表 (VAS-L) 中. 然而,这些安慰剂效应的实质性不如活性治疗观察到的效应.

科学领域:

耳鼻喉科耳鼻喉科耳鼻喉科
临床心理学临床心理学
基于证据的医学基于证据的医学.

背景情况:

耳是一个普遍的疾病,影响全球数百万人.
在声治疗中量化安慰剂效应对于解释临床试验结果至关重要.
了解安慰剂反应有助于区分真正的治疗效果与非特异性治疗益处.

研究的目的:

在 tinnitus 的随机临床试验 (RCT) 中系统地评估和量化安慰剂效应.
分析口服和入耳内安慰剂干预对患者报告的耳严重程度的影响.
为了比较安慰剂效应的大小与 tinnitus 管理中的积极治疗结果.

主要方法:

在CINAHL,PubMed和Scopus数据库中进行了全面的文献搜索 (截至2022年10月).
包括包括涉及有耳的成年受试者的RCT,比较口服或入耳性安慰剂治疗与活性干预措施.
提取的数据包括从治疗前到治疗后标准化耳评估得分 (例如,耳障碍目录,视觉模拟尺度) 的变化.

主要成果:

包含953项选研究的23个RCT被纳入了元分析.
在安慰剂组中,在耳障碍清单 (THI) 得分中观察到5.6的统计学显著平均差异 (MD) (p < 0.001).
安慰剂干预表明,视觉模拟大声度 (VAS-L) 显著的0.8的MD (p = 0.05),但不是烦 (VAS-An) 或意识 (VAS-Aw).

结论:

安慰剂治疗对患者报告的耳结局产生了可衡量的影响,特别是在噪音和整体障碍方面.
观察到的安慰剂效应,虽然在THI和VAS-L等指标上显著,但与活性,非安慰剂耳治疗的效应相比,其明显性较小.
这些发现强调了在设计和解释对耳干预的临床试验时考虑安慰剂反应的重要性.

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