Tejani Aaron M, Wasdell Michael, Spiwak Rae, Rowell Greg, Nathwani Shabita
Clinical Research and Drug Information, Fraser Health Authority, 3935 Kincaid Street, Burnaby, BC, Canada, V5G 2X6.
Cochrane Database Syst Rev. 2010 Feb 17(2):CD007280. doi: 10.1002/14651858.CD007280.pub2.
Fatigue is reported to occur in up to 92% of patients with multiple sclerosis (MS) and has been described as the most debilitating of all MS symptoms by 28% to 40% of MS patients.
To assess whether carnitine (enteral or intravenous) supplementation can improve the quality of life and reduce the symptoms of fatigue in patients with MS-related fatigue and to identify any adverse effects of carnitine when used for this purpose.
A literature search was performed using Cochrane MS Group Trials Register (21 May 2009), Cochrane Central Register of Controlled Trials (CENTRAL) "The Cochrane Library 2009, issue 2, MEDLINE (PubMed) (1966-21 May 2009), EMBASE (1974-21 May 2009). Reference lists of review articles and primary studies were also screened. A hand search of the abstract book of recent relevant conference symposia was also conducted. Personal contact with MS experts and a manufacturer (Source Naturals, United States) of carnitine formulation was contacted to determine if they knew of other clinical trials. No language restrictions were applied.
Full reports of published and unpublished randomized controlled trials and quasi-randomized trials of any carnitine intervention in adults with a clinical diagnosis of fatigue associated with multiple sclerosis were included.
Data from the eligible trials was extracted and coded using a standardized data extraction form and entered into RevMan 5. Discrepancies were to be resolved by discussion with a third reviewer however this was not necessary. The quality items to be assessed were method of randomization, allocation concealment, blinding (participants, investigators, outcome assessors and data analysis), intention-to-treat analysis and completeness of follow up.
The search identified one randomized cross-over trial. In this study patients were exposed to both acetyl L-carnitine (ALCAR(tm)) 2 grams daily and amantadine 200 mg daily in adult patients with relapsing-remitting and secondary progressive MS. The effects of carnitine on fatigue are not clear based on the one included crossover RCT. There was no difference between carnitine and amantadine for the number of patients withdrawing from the study due to an adverse event (relative risk ratio 0.20; 95% confidence interval 0.03 to 1.55. Mortality, serious adverse events, total adverse events, and quality of life were not reported.
AUTHORS' CONCLUSIONS: There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators.
据报道,高达92%的多发性硬化症(MS)患者会出现疲劳,28%至40%的MS患者将其描述为所有MS症状中最使人衰弱的症状。
评估补充肉碱(肠内或静脉内)是否可以改善生活质量并减轻与MS相关疲劳患者的疲劳症状,并确定肉碱用于此目的时的任何不良反应。
使用Cochrane MS组试验注册库(2009年5月21日)、Cochrane对照试验中央注册库(CENTRAL)“2009年第2期Cochrane图书馆”、MEDLINE(PubMed)(1966年至2009年5月21日)、EMBASE(1974年至2009年5月21日)进行文献检索。还筛选了综述文章和原始研究的参考文献列表。还对手工检索近期相关会议专题讨论会的摘要集。与MS专家和肉碱制剂制造商(美国Source Naturals)进行个人联系,以确定他们是否知道其他临床试验。未设语言限制。
纳入了对临床诊断为与多发性硬化症相关疲劳的成年人进行任何肉碱干预的已发表和未发表的随机对照试验及半随机试验的完整报告。
使用标准化数据提取表提取符合条件的试验数据并进行编码,然后输入RevMan 5。如有差异,将通过与第三位审阅者讨论来解决,但实际并无此必要。要评估的质量项目包括随机化方法、分配隐藏、盲法(参与者、研究者、结果评估者和数据分析)、意向性分析和随访完整性。
检索到一项随机交叉试验。在这项研究中,复发缓解型和继发进展型MS的成年患者每天接受2克乙酰L-肉碱(ALCAR(tm))和每天200毫克金刚烷胺治疗。基于纳入的一项交叉随机对照试验,肉碱对疲劳的影响尚不清楚。因不良事件退出研究的患者数量,肉碱与金刚烷胺之间无差异(相对风险比0.20;95%置信区间0.03至1.55)。未报告死亡率、严重不良事件、总不良事件和生活质量。
没有足够的证据表明,用于治疗与MS相关疲劳的肉碱比安慰剂或活性对照药具有治疗优势。