数字安慰剂效应及其对通用焦虑症状的调节者的规模:系统性审查和元分析
Takashi Hosono1,2, Rinka Tsutsumi1, Yuki Niwa1
1Graduate School of Pharmaceutical Sciences, The University of Osaka, 1-6 Yamadaoka, Suita, Osaka, 5650871, Japan.
Journal of medical Internet research
|October 7, 2025
概括
数字疗法 (DTx) 在通用焦虑障碍 (GAD) 试验中显示出小到中等的安慰剂效应. 了解患者类型和基线值等调节因素是有效的DTx开发的关键.
科学领域:
- 数字健康干预措施 数字健康干预措施
- 精神病学研究精神病学研究
- 临床试验方法论 临床试验方法论
背景情况:
- 数字疗法 (DTx) 正在成为传统药物治疗的替代品或补充品.
- 精神疾病,特别是泛性焦虑症 (GAD),是DTx发展的关键目标.
- 在GAD药物治疗中显著的安慰剂效应需要严格评估使用数字安慰剂的DTx疗效.
研究的目的:
- 系统地识别使用数字安慰剂作为GAD的比较剂的随机对照试验 (RCT).
- 描述这些RCT及其数字安慰剂的特点.
- 量化数字安慰剂效应的大小,并确定其GAD治疗中的调节者.
主要方法:
- 在PubMed,Web of Science和Scopus数据库中的系统文献搜索 (2024年7月).
- 对已识别的RCT及其数字安慰剂特征进行系统审查.
- 超分析,包括子组分析和超回归,以评估效应大小和调节者.
主要成果:
- 审查了54个RCT;32个RCT (5311名参与者) 纳入了元分析.
- 观察到一个小到中等的数字安慰剂效应 (Hedges g=0.28).
- 目标人群,安慰剂方法和基线值显著缓和了数字安慰剂效应.
结论:
- 对于GAD评估得分,存在统计学上显著的数字安慰剂效应.
- 影响数字安慰剂效应的关键调节者包括目标人群,安慰剂方法和基线值.
- 对于DTx试验的研究方案应纳入这些已识别的调节者,以更准确地评估疗效.
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