Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial

Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial
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DOI:
10.1016/j.jns.2003.11.005
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发表时间:
2004-03-15
影响因子:
4.4
通讯作者:
Fieschi, C
Fieschi, C
中科院分区:
医学3区
文献类型:
--
作者:
Tomassini, V;Pozzilli, C;Fieschi, C

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乙酰肉碱(ALCAR)可改善慢性疲劳综合征患者的疲劳,但目前还没有关于ALCAR治疗多发性硬化症(MS)疲劳的试验。为了比较ALCAR和金刚烷胺的疗效,36名表现疲劳的MS患者参加了一项随机、双盲、交叉研究。金刚烷胺是最广泛用于治疗多发性硬化症相关疲劳的药物之一。患者接受金刚烷胺(100 mg,每日两次)或Alcar(1g,每日两次)治疗3个月。经过3个月的洗涤期后,他们接受了为期3个月的替代治疗。根据研究的主要终点疲劳严重程度量表(FSS),对患者在基线和每3个月进行一次评级。次要结果变量为:疲劳影响量表(FIS)、贝克抑郁量表(BDI)和社会经验检查表(SEC)。6名患者因不良反应而退出研究(5名患者服用金刚烷胺,1名患者服用Alcar)。统计分析显示,与金刚烷胺相比,ALCAR对疲劳严重程度评分有显著影响(p=0.039)。对任何次要结果变量都没有显著影响。这项研究的结果表明,ALCAR在治疗MS相关性疲劳方面比金刚烷胺耐受性更好,也更有效。(C)2003爱思唯尔B.V.保留所有权利。
Treatment with acetyl L-carnitine (ALCAR) has been shown to improve fatigue in patients with chronic fatigue syndrome, but there have been no trials on the effect of ALCAR for treating fatigue in multiple sclerosis (MS). To compare the efficacy of ALCAR with that of amantadine, one of the drugs most widely used to treat MS-related fatigue, 36 MS patients presenting fatigue were enrolled in a randomised, double-blind, crossover study. Patients were treated for 3 months with either amantadine (100 mg twice daily) or ALCAR (1 g twice daily). After a 3-month washout period, they crossed over to the alternative treatment for 3 months. Patients were rated at baseline and every 3 months according to the Fatigue Severity Scale (FSS), the primary endpoint of the study. Secondary outcome variables were: Fatigue Impact Scale (FIS), Beck Depression Inventory (BDI) and Social Experience Checklist (SEC). Six patients withdrew from the study because of adverse reactions (five on amantadine and one on ALCAR). Statistical analysis showed significant effects of ALCAR compared with amantadine for the Fatigue Severity Scale (p = 0.039). There were no significant effects for any of the secondary outcome variables. The results of this study show that ALCAR is better tolerated and more effective than amantadine for the treatment of MS-related fatigue. (C) 2003 Elsevier B.V. All rights reserved.