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作为偏头痛预防治疗的辅助剂的开放标签安慰剂:随机临床试验

Julian Kleine-Borgmann¹, Katharina Schmidt¹, Linda Ludwig¹

¹Center for Translational Neuro- and Behavioral Sciences, Department of Neurology, University Hospital Essen, Essen, Germany.

JAMA network open

|October 8, 2025

概括

开放标签安慰剂 (OLP) 并没有减少偏头痛患者的头痛频率,但改善了他们的生活质量并减少了疼痛障碍. 需要进一步的研究来探索它们在偏头痛管理中的支持作用.

科学领域:

神经学神经学
临床试验临床试验
精神病体医学是一种精神病体医学.

背景情况:

安慰剂效应显著影响治疗结果,特别是在疼痛条件下.
开放的安慰剂 (OLP) 提供了一种无欺骗的方法来利用安慰剂效应.
偏头痛管理可以从探索新的治疗策略中受益.

研究的目的:

评估为期3个月的OLP治疗方案在控制偏头痛症状方面的有效性.
评估OLP对偏头痛患者头痛频率,药物使用,残疾和生活质量的影响.

主要方法:

一个双中心,并行组随机临床试验,涉及患有偶发性或慢性偏头痛的成年人.
参与者接受了OLP加通常治疗 (TAU) 或TAU单独治疗3个月.
主要结果:每月头痛天数的变化;次要结果:生活质量,疼痛残疾,整体改善.

主要成果:

与TAU相比,OLP没有观察到头痛或偏头痛日的显著减少.
OLP组在生活质量,与疼痛相关的残疾和整体改善方面表现出显著的改善.
两组之间没有发现疼痛强度或救援药物使用的差异.

结论:

对偏头痛的开放性安慰剂治疗没有降低头痛的频率.
在偏头痛患者中,OLP与改善生活质量和减少疼痛障碍有关.
需要进一步研究以了解OLP机制及其在支持性偏头痛护理中的作用.

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