从有效性到有效性:评估迷幻的随机对照试验,以获得可靠的基于证据的政策和实践
1Instituto Phaneros, São Paulo, Brazil.
Pharmacology research & perspectives
|April 15, 2025
概括
对迷幻疗法的监管审查面临挑战. 对药物辅助疗法的随机对照试验 (RCT) 的证据值得信赖,但对于独立的迷幻药物来说,证据不那么值得信赖.
科学领域:
- 精神药理学和基于证据的医学
- 监管科学和临床试验设计
背景情况:
- 美国食品和药物管理局 (FDA) 在审查MDMA辅助治疗PTSD时发现了挑战.
- 预计其他迷幻化合物 (如用于抑郁症的 псилоцибин) 也会出现类似的问题.
- 两个成功的第三阶段随机对照试验 (RCT) 的黄金标准对这些新型治疗提出了困难.
研究的目的:
- 在迷幻疗法的背景下审查RCT的假设和局限性.
- 批判性地评估RCT证据的可靠性,以对心理治疗的不同监管途径进行批判性评估.
- 防止有效疗法被拒绝或批准可能有害的疗法.
主要方法:
- 对心理治疗的证据评估中的认识论和方法论挑战的审查.
- 分析基于证据的医学中RCT的黄金标准地位的假设.
- 检查关于RCT和现实世界有效性的内部有效性和推断谬误.
主要成果:
- 在RCT中对"成功"的定义存在分歧,特别是在同时进行心理治疗时,挑战了内部有效性.
- 为了预测现实世界的有效性,RCT的有效性可靠性因监管方法而异.
- 独立的迷幻药物的证据不如药物辅助心理治疗的证据值得信赖,因为因果关系和外部有效性不同.
结论:
- 对于迷幻疗法的RCT证据的可靠性应在独立药物中被评为低,在药物辅助疗法中被评为高.
- 不同的因果关系主张和外部有效性需要对支持因素进行仔细的,特定于背景的评估.
- 如果不能区分,可能会导致有害后果,包括拒绝有效治疗或医疗逆转批准的药物.
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