Fang Jinghuan, Zhou Muke, Yang Mi, Zhu Cairong, He Li
Department of Neurology, West China Hospital, Sichuan University, Chengdu, China.
Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008554. doi: 10.1002/14651858.CD008554.pub3.
Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), is a progressive neurodegenerative disease without effective therapies. Several studies have suggested that repetitive transcranial magnetic stimulation (rTMS) may have positive benefit in ALS. However, the efficacy and safety of this therapy remain uncertain. This is the first update of a review published in 2011.
To determine the clinical efficacy and safety of rTMS for treating ALS.
On 30 July 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL (2012, issue 7 in The Cochrane Library), MEDLINE (1966 to July 2012), EMBASE (1980 to July 2012), CINAHL (1937 to July 2012), Science Citation Index Expanded (January 1945 to July 2012), AMED (January 1985 to July 2012). We searched the Chinese Biomedical Database (1979 to August 2012). We also searched for ongoing studies on clinicaltrials.gov (August 2012).
Randomised and quasi-randomised controlled trials assessing the therapeutic efficacy and safety of rTMS for patients with a clinical diagnosis of ALS.Comparisons eligible for inclusion were:1. rTMS versus no intervention;2. rTMS versus sham rTMS;3. rTMS versus physiotherapy;4. rTMS versus medications;5. rTMS + other therapies or drugs versus sham rTMS + the same therapies or drugs;6. different methods of application of rTMS such as high-frequency (> 1Hz) compared to low-frequency (≤ 1Hz) rTMS.
Two authors independently selected papers, assessed risk of bias and extracted data. We resolved disagreements through discussion. We contacted study authors for additional information.
Three randomised, placebo-controlled trials with a total of 50 participants were included in the review. All three trials compared rTMS with sham TMS. All the trials were of poor methodological quality and were insufficiently homogeneous to allow the pooling of results. Moreover, the high rate of attrition further increased the risk of bias. None of the trials provided detailed data on the ALS Functional Rating Scale-Revised (ALSFRS-R) scores at six months follow-up which was pre-assigned as our primary outcome. One trial contained data in a suitable form for quantitative analysis of our secondary outcomes. No difference was seen between rTMS and sham rTMS using the ALSFRS-R scores and manual muscle testing (MMT) scores at 12 months follow-up in this trial. Additionally, none of the trials reported any adverse events associated with the use of rTMS. However, in view of the small sample size, the methodological limitations and incomplete outcome data, treatment with rTMS cannot be judged as completely safe.
AUTHORS' CONCLUSIONS: There is currently insufficient evidence to draw conclusions about the efficacy and safety of rTMS in the treatment of ALS. Further studies may be helpful if their potential benefit is weighed against the impact of participation in a randomised controlled trial on people with ALS.
肌萎缩侧索硬化症(ALS),也被称为运动神经元病(MND),是一种进展性神经退行性疾病,目前尚无有效治疗方法。多项研究表明,重复经颅磁刺激(rTMS)可能对ALS有益。然而,这种疗法的疗效和安全性仍不确定。这是对2011年发表的一篇综述的首次更新。
确定rTMS治疗ALS的临床疗效和安全性。
2012年7月30日,我们检索了Cochrane神经肌肉疾病专业组注册库、Cochrane图书馆2012年第7期的CENTRAL、MEDLINE(1966年至2012年7月)、EMBASE(1980年至2012年7月)、CINAHL(1937年至2012年7月)、科学引文索引扩展版(1945年1月至2012年7月)、AMED(1985年1月至2012年7月)。我们检索了中国生物医学数据库(1979年至2012年8月)。我们还在clinicaltrials.gov上检索了正在进行的研究(2012年8月)。
评估rTMS对临床诊断为ALS患者的治疗效果和安全性的随机和半随机对照试验。符合纳入标准的比较包括:1. rTMS与无干预;2. rTMS与假rTMS;3. rTMS与物理治疗;4. rTMS与药物治疗;5. rTMS + 其他疗法或药物与假rTMS + 相同疗法或药物;6. rTMS的不同应用方法,如高频(>1Hz)与低频(≤1Hz)rTMS比较。
两位作者独立选择论文、评估偏倚风险并提取数据。我们通过讨论解决分歧。我们联系研究作者获取更多信息。
本综述纳入了三项随机、安慰剂对照试验,共50名参与者。所有三项试验均将rTMS与假TMS进行比较。所有试验的方法学质量都很差,且同质性不足,无法合并结果。此外,高失访率进一步增加了偏倚风险。没有一项试验提供了预先设定为主要结局的六个月随访时的修订版ALS功能评定量表(ALSFRS-R)评分的详细数据。一项试验包含了适合对我们的次要结局进行定量分析的数据形式。在该试验中,12个月随访时,使用ALSFRS-R评分和徒手肌力测试(MMT)评分,rTMS与假rTMS之间未见差异。此外,没有一项试验报告了与使用rTMS相关的任何不良事件。然而,鉴于样本量小、方法学局限性和结局数据不完整,不能判定rTMS治疗完全安全。
目前尚无足够证据就rTMS治疗ALS的疗效和安全性得出结论。如果权衡其潜在益处与参与随机对照试验对ALS患者的影响,进一步的研究可能会有所帮助。