认知行为疗法,莫达菲尼尔及其组合治疗多发性硬化症疲劳 (COMBO-MS) 的比较有效性:一个随机的,统计学家盲目的平行臂试验
Tiffany J Braley1, Dawn M Ehde2, Kevin N Alschuler2
1Sleep Disorders Centers, University of Michigan, Ann Arbor, MI, USA; Division of Multiple Sclerosis and Clinical Neuroimmunology, University of Michigan, Ann Arbor, MI, USA; Department of Neurology, University of Michigan, Ann Arbor, MI, USA.
The Lancet. Neurology
|October 18, 2024
概括
认知行为疗法 (CBT) 和modafinil在减少多发性硬化症疲劳方面表现出类似的有效性,超过12周. 结合疗法没有提供与单个治疗MS疲劳相比增强的益处.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 康复医学 康复医学 康复医学
背景情况:
- 疲劳是多发性硬化症 (MS) 中的主要致残症状.
- 对于MS疲劳的现有干预措施提供部分好处.
- 对于MS疲劳的行为和药物治疗的综合效应仍然未被评估.
研究的目的:
- 为了比较认知行为疗法 (CBT),modafinil及其组合治疗多发性硬化症 (MS) 患者疲劳的有效性.
- 为了评估MS疲劳的治疗反应特征.
主要方法:
- 一个随机的,分析师盲目的,平行臂的比较有效性试验.
- 患有多发性硬化和显著疲劳的成年人 (疲劳严重程度评分≥4) 被分配给CBT,modafinil或组合治疗12周.
- 主要结局是修改疲劳影响量表 (MFIS) 评分从基线到12周的变化.
主要成果:
- 所有三组 (CBT,莫达菲尼尔,组合疗法) 在12周内都显示MFIS得分有临床意义的降低.
- 在组合治疗组和单个治疗组 (CBT或modafinil) 之间没有观察到MFIS得分降低的显著差异.
- 常见的不良事件包括失眠和焦虑,特别是在含莫达菲尼尔的组.
结论:
- 莫达菲尼尔,CBT和它们的组合同样降低了12周多发性硬化症疲劳的影响.
- 与单一治疗相比,组合疗法没有为MS疲劳提供更好的结果.
- 需要进一步的研究来探索睡眠卫生和嗜睡对治疗疗效的影响.
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