在遗传性无氧试验中量化安慰剂效应:对无氧评估和评分 (SARA) 评分尺度的元分析 评分变化
Emilien Petit1, Adonis Beaubois-Gandoin1, Alexandra Durr1
1Institut du Cerveau-Paris Brain Institute-ICM, CNRS, Inria, Inserm, AP-HP, Groupe Hospitalier Sorbonne Université, Sorbonne Université, Paris, France.
概括
在遗传性动力衰竭试验中,对SARA得分的安慰剂效应是可测量的,并受地理区域和干预类型的影响. 随着试验持续时间的延长,观察到安慰剂反应下降的趋势.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 遗传性缩症是使人衰弱的神经系统疾病.
- 临床试验的评估和评分尺度 (SARA) 是临床试验的主要结果指标.
- 了解SARA得分中的安慰剂效应对于试验设计至关重要.
研究的目的:
- 系统地审查和量化SARA得分的变化在遗传性无氧临床试验的安慰剂臂内.
- 分析影响这些试验中安慰剂效应的因素.
主要方法:
- 系统性审查和随机效应对遗传性无氧试验中安慰剂组数据的元分析.
- 来自PubMed和clinicalTrials.gov.gov的数据来源
- 共变量分析包括试验持续时间,大陆,干预类型和出版日期.
主要成果:
- 包括34项试验,共计37个评估点.
- 观察到实质性的异质性 (I2 = 94%).
- 对安慰剂的反应因大陆 (欧洲最小,亚洲最大) 和干预类型 (用设备最强) 显著不同. 随着试验持续时间的增加,人们注意到安慰剂效应下降的趋势.
结论:
- 在遗传性无氧试验中,对SARA得分存在可测量的安慰剂效应.
- 地理区域和干预类型显著调节安慰剂效应.
- 试验持续时间可能会影响安慰剂反应的程度.
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