Kley Rudolf A, Tarnopolsky Mark A, Vorgerd Matthias
Department of Neurology, University Hospital Bergmannsheil, Ruhr University Bochum, Bochum, Germany.
Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD004760. doi: 10.1002/14651858.CD004760.pub4.
Progressive muscle weakness is a main symptom of most hereditary and acquired muscle diseases. Creatine improves muscle performance in healthy individuals. This is an update of our 2007 Cochrane review that evaluated creatine treatment in muscle disorders. Previous updates were in 2009 and 2011.
To evaluate the efficacy of creatine compared to placebo for the treatment of muscle weakness in muscle diseases.
On 11 September 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL (2012, Issue 9 in The Cochrane Library), MEDLINE (January 1966 to September 2012) and EMBASE (January 1980 to September 2012) for randomised controlled trials (RCTs) of creatine used to treat muscle diseases.
RCTs or quasi-RCTs of creatine treatment compared to placebo in hereditary muscle diseases or idiopathic inflammatory myopathies.
Two authors independently applied the selection criteria, assessed trial quality and extracted data. We obtained missing data from investigators.
A total of 14 trials, including 364 randomised participants, met the selection criteria. The risk of bias was low in most studies. Only one trial had a high risk of selection, performance and detection bias. No new studies were identified at this update.Meta-analysis of six trials in muscular dystrophies including 192 participants revealed a significant increase in muscle strength in the creatine group compared to placebo, with a mean difference of 8.47%; (95% confidence intervals (CI) 3.55 to 13.38). Pooled data of four trials including 115 participants showed that a significantly higher number of participants felt better during creatine treatment compared to placebo with a risk ratio of 4.51 (95% CI 2.33 to 8.74). One trial in 37 participants with idiopathic inflammatory myopathies also showed a significant improvement in functional performance. No trial reported any clinically relevant adverse event.In metabolic myopathies, meta-analyses of three cross-over trials including 33 participants revealed no significant difference in muscle strength. One trial reported a significant deterioration of activities of daily living (mean difference 0.54 on a 1 to 10 scale; 95% CI 0.14 to 0.93) and an increase in muscle pain during high-dose creatine treatment in McArdle disease.
AUTHORS' CONCLUSIONS: High quality evidence from RCTs shows that short- and medium-term creatine treatment increases muscle strength in muscular dystrophies. There is also evidence that creatine improves functional performance in muscular dystrophy and idiopathic inflammatory myopathy. Creatine is well tolerated in these people. High quality but limited evidence from RCTs does not show significant improvement in muscle strength in metabolic myopathies. High-dose creatine treatment impaired activities of daily living and increased muscle pain in McArdle disease.
进行性肌无力是大多数遗传性和获得性肌肉疾病的主要症状。肌酸可改善健康个体的肌肉功能。这是我们2007年Cochrane系统评价的更新版，该评价评估了肌酸治疗肌肉疾病的效果。之前的更新时间为2009年和2011年。
评估与安慰剂相比，肌酸治疗肌肉疾病中肌无力的疗效。
2012年9月11日，我们检索了Cochrane神经肌肉疾病组专业注册库、CENTRAL（2012年第9期，Cochrane图书馆）、MEDLINE（1966年1月至2012年9月）和EMBASE（1980年1月至2012年9月），以查找关于肌酸治疗肌肉疾病的随机对照试验（RCT）。
在遗传性肌肉疾病或特发性炎性肌病中，将肌酸治疗与安慰剂进行比较的RCT或半随机对照试验。
两位作者独立应用入选标准，评估试验质量并提取数据。我们向研究者获取了缺失数据。
共有14项试验，包括364名随机参与者，符合入选标准。大多数研究的偏倚风险较低。只有一项试验存在选择、实施和检测偏倚的高风险。此次更新未发现新的研究。对包括192名参与者的6项肌营养不良试验进行的Meta分析显示，与安慰剂相比，肌酸组的肌肉力量显著增加，平均差异为8.47%；（95%置信区间（CI）3.55至13.38）。对包括115名参与者的4项试验的汇总数据显示，与安慰剂相比，肌酸治疗期间感觉好转的参与者数量显著更多，风险比为4.51（95%CI 2.33至8.74）。一项针对37名特发性炎性肌病参与者的试验也显示功能表现有显著改善。没有试验报告任何临床相关不良事件。在代谢性肌病中，对包括33名参与者的3项交叉试验进行的Meta分析显示肌肉力量无显著差异。一项试验报告在麦卡德尔病中，高剂量肌酸治疗期间日常生活活动显著恶化（1至10分制下平均差异为0.54；95%CI 0.14至0.93）且肌肉疼痛增加。
来自RCT的高质量证据表明，短期和中期肌酸治疗可增加肌营养不良患者的肌肉力量。也有证据表明肌酸可改善肌营养不良和特发性炎性肌病的功能表现。这些人群对肌酸耐受性良好。来自RCT的高质量但有限的证据未显示代谢性肌病患者的肌肉力量有显著改善。高剂量肌酸治疗损害了麦卡德尔病患者的日常生活活动并增加了肌肉疼痛。
