A randomized trial of modafinil for the treatment of fatigue and excessive daytime sleepiness in individuals with chronic traumatic brain injury
A randomized trial of modafinil for the treatment of fatigue and excessive daytime sleepiness in individuals with chronic traumatic brain injury
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DOI：
10.1097/01.htr.0000308721.77911.ea
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发表时间：
2008-01-01
影响因子：
2.4
通讯作者：
Gerber, Don
中科院分区：
文献类型：
--
作者：
Jha, Amitabh;Weintraub, Alan;Gerber, Don
背景：本研究探讨莫达非尼治疗外伤性脑损伤（TBI）患者的疲劳和日间过度嗜睡的疗效。方法：一项单中心、双盲、安慰剂对照的交叉试验，其中53名TBI患者被随机分配接受高达400毫克的莫达非尼，或等量的无效安慰剂片。主要入选标准为脑外伤后至少1年严重到需要住院康复。主要结局指标为疲劳（疲劳严重程度量表，FSS）和白天嗜睡（Epworth嗜睡量表，ESS）。结果：在调整基线评分和周期效应后，在第4周（-0.5 +/- 1.88;P = 0.80）或第10周（-1.4 +/- 2.75;P = 0.61），莫达非尼和安慰剂在FSS方面的改善没有统计学上的显著差异。对于ESS，在第4周，莫达非尼组的平均变化显著大于安慰剂组（-1.2 +/- 0.49;P = 0.02），但在第10周则没有（-0.5 +/- 0.87;P = 0.56）。莫达非尼是安全且耐受性良好的，尽管莫达非尼组的失眠发生率明显高于安慰剂组（P = 0.03）。结论：虽然发现了零星的统计学显著差异，但在第4周或第10周的12个结果中，莫达非尼都没有明显的有益模式。莫达非尼治疗和安慰剂治疗之间没有一致和持续的临床显著差异。
Background: This study examines the efficacy of modafinil in treating fatigue and excessive daytime sleepiness in individuals with traumatic brain Injury (TBI). Methods: A single-center, double-blind, placebo-controlled cross-over trial, where 53 participants with TBI were randomly assigned to receive up to 400 mg of modafinil, or equal number of inactive placebo tablets. Main eligibility criteria were being at least 1 year post-TBI severe enough to require inpatient rehabilitation. The primary outcome measures were fatigue (Fatigue Severity Scale, FSS) and daytime sleepiness (Epworth Sleepiness Scale, ESS). Results: After adjusting for baseline scores and period effects, there were no statistically siginficant differences between improvements seen with modafinil and placebo in the FSS at week 4 (-0.5 +/- 1.88; P = .80) or week 10 (-1.4 +/- 2.75; P = .61). For ESS, average changes were significantly greater with modafinil than placebo at week 4 (-1.2 +/- 0.49; P = .02) but not at week 10 (-0.5 +/- 0.87; P = .56). Modafinil was safe and well tolerated, although insomnia was reported significantly more often with modafinil than placebo (P = .03). Conclusions: While there were sporadic statistically significant differences identified, a clear beneficial pattern from modafinil was not seen at either week 4 or week 10 for any of the 12 outcomes. There was no consistent and persistent clinically significant difference between treatment with modafinil and placebo.