Jones Sarah, Man William D-C, Gao Wei, Higginson Irene J, Wilcock Andrew, Maddocks Matthew
NIHR Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College, London, UK.
Cochrane Database Syst Rev. 2016 Oct 17;10(10):CD009419. doi: 10.1002/14651858.CD009419.pub3.
This review is an update of a previously published review in the Cochrane Database of Systematic Reviews Issue 1, 2013 on Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease.Patients with advanced progressive disease often experience muscle weakness, which can impact adversely on their ability to be independent and their quality of life. In those patients who are unable or unwilling to undertake whole-body exercise, neuromuscular electrical stimulation (NMES) may be an alternative treatment to enhance lower limb muscle strength. Programmes of NMES appear to be acceptable to patients and have led to improvements in muscle function, exercise capacity, and quality of life. However, estimates regarding the effectiveness of NMES based on individual studies lack power and precision.
Primary objective: to evaluate the effectiveness of NMES on quadriceps muscle strength in adults with advanced disease. Secondary objectives: to examine the safety and acceptability of NMES, and its effect on peripheral muscle function (strength or endurance), muscle mass, exercise capacity, breathlessness, and health-related quality of life.
We identified studies from searches of the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), and Database of Abstracts of Reviews of Effects (DARE) (the Cochrane Library), MEDLINE (OVID), Embase (OVID), CINAHL (EBSCO), and PsycINFO (OVID) databases to January 2016; citation searches, conference proceedings, and previous systematic reviews.
We included randomised controlled trials in adults with advanced chronic respiratory disease, chronic heart failure, cancer, or HIV/AIDS comparing a programme of NMES as a sole or adjunct intervention to no treatment, placebo NMES, or an active control. We imposed no language restriction.
Two review authors independently extracted data on study design, participants, interventions, and outcomes. We assessed risk of bias using the Cochrane 'Risk of bias' tool. We calculated mean differences (MD) or standardised mean differences (SMD) between intervention and control groups for outcomes with sufficient data; for other outcomes we described findings from individual studies. We assessed the evidence using GRADE and created a 'Summary of findings' table.
Eighteen studies (20 reports) involving a total of 933 participants with COPD, chronic respiratory disease, chronic heart failure, and/or thoracic cancer met the inclusion criteria for this update, an additional seven studies since the previous version of this review. All but one study that compared NMES to resistance training compared a programme of NMES to no treatment or placebo NMES. Most studies were conducted in a single centre and had a risk of bias arising from a lack of participant or assessor blinding and small study size. The quality of the evidence using GRADE comparing NMES to control was low for quadriceps muscle strength, moderate for occurrence of adverse events, and very low to low for all other secondary outcomes. We downgraded the quality of evidence ratings predominantly due to inconsistency among study findings and imprecision regarding estimates of effect. The included studies reported no serious adverse events and a low incidence of muscle soreness following NMES.NMES led to a statistically significant improvement in quadriceps muscle strength as compared to the control (12 studies; 781 participants; SMD 0.53, 95% confidence interval (CI) 0.19 to 0.87), equating to a difference of approximately 1.1 kg. An increase in muscle mass was also observed following NMES, though the observable effect appeared dependent on the assessment modality used (eight studies, 314 participants). Across tests of exercise performance, mean differences compared to control were statistically significant for the 6-minute walk test (seven studies; 317 participants; 35 m, 95% CI 14 to 56), but not for the incremental shuttle walk test (three studies; 434 participants; 9 m, 95% CI -35 to 52), endurance shuttle walk test (four studies; 452 participants; 64 m, 95% CI -18 to 146), or for cardiopulmonary exercise testing with cycle ergometry (six studies; 141 participants; 45 mL/minute, 95% CI -7 to 97). Limited data were available for other secondary outcomes, and we could not determine the most beneficial type of NMES programme.
AUTHORS' CONCLUSIONS: The overall conclusions have not changed from the last publication of this review, although we have included more data, new analyses, and an assessment of the quality of the evidence using the GRADE approach. NMES may be an effective treatment for muscle weakness in adults with advanced progressive disease, and could be considered as an exercise treatment for use within rehabilitation programmes. Further research is very likely to have an important impact on our confidence in the estimate of effect and may change the estimate. We recommend further research to understand the role of NMES as a component of, and in relation to, existing rehabilitation approaches. For example, studies may consider examining NMES as an adjuvant treatment to enhance the strengthening effect of programmes, or support patients with muscle weakness who have difficulty engaging with existing services.
本综述是对2013年第1期《Cochrane系统评价数据库》中一篇关于神经肌肉电刺激治疗晚期疾病成人肌肉无力的综述的更新。晚期进行性疾病患者常出现肌肉无力,这会对其独立生活能力和生活质量产生不利影响。对于那些无法或不愿意进行全身运动的患者,神经肌肉电刺激(NMES)可能是增强下肢肌肉力量的替代治疗方法。NMES方案似乎为患者所接受,并已使肌肉功能、运动能力和生活质量得到改善。然而,基于个别研究对NMES有效性的估计缺乏力度和精确性。
主要目的:评估NMES对晚期疾病成人股四头肌力量的有效性。次要目的:研究NMES的安全性和可接受性,及其对外周肌肉功能(力量或耐力)、肌肉质量、运动能力、呼吸困难和健康相关生活质量的影响。
我们通过检索Cochrane对照试验中心注册库(CENTRAL)、Cochrane系统评价数据库(CDSR)、效果评价文摘数据库(DARE)(Cochrane图书馆)、医学期刊数据库(MEDLINE,OVID平台)、荷兰医学文摘数据库(Embase,OVID平台)、护理及健康照护领域数据库(CINAHL,EBSCO平台)和心理学文摘数据库(PsycINFO,OVID平台),检索截至2016年1月的研究;进行引文检索、会议论文检索和以往的系统评价。
我们纳入了针对患有晚期慢性呼吸系统疾病、慢性心力衰竭、癌症或艾滋病毒/艾滋病的成人的随机对照试验,比较NMES方案作为唯一或辅助干预与不治疗、安慰剂NMES或积极对照的效果。我们未设语言限制。
两位综述作者独立提取关于研究设计、参与者、干预措施和结局的数据。我们使用Cochrane“偏倚风险”工具评估偏倚风险。对于有足够数据的结局,我们计算干预组与对照组之间的平均差(MD)或标准化平均差(SMD);对于其他结局,我们描述个别研究的结果。我们使用GRADE方法评估证据,并创建了“结果总结”表。
18项研究(20篇报告),共933名患有慢性阻塞性肺疾病(COPD)、慢性呼吸系统疾病、慢性心力衰竭和/或胸段癌症的参与者符合本次更新的纳入标准,自本综述的上一版本以来又增加了7项研究。除一项将NMES与阻力训练进行比较的研究外,所有研究均将NMES方案与不治疗或安慰剂NMES进行比较。大多数研究在单一中心进行,因缺乏参与者或评估者的盲法以及研究规模较小而存在偏倚风险。使用GRADE方法比较NMES与对照,股四头肌力量的证据质量为低,不良事件发生情况的证据质量为中等,所有其他次要结局证据质量为极低到低。我们主要由于研究结果之间的不一致以及效应估计的不精确性而降低了证据质量等级。纳入的研究报告NMES后未出现严重不良事件,肌肉酸痛发生率较低。与对照组相比,NMES使股四头肌力量有统计学意义的改善(12项研究;781名参与者;SMD 0.53,95%置信区间(CI)0.19至0.87),相当于约1.1千克的差异。NMES后还观察到肌肉质量增加,尽管可观察到的效应似乎取决于所使用的评估方式(8项研究,314名参与者)。在运动表现测试中,与对照组相比,6分钟步行试验的平均差有统计学意义(7项研究;317名参与者;35米,95%CI 14至56),但递增往返步行试验(三项研究;434名参与者;9米,95%CI -35至52)、耐力往返步行试验(四项研究;452名参与者;64米,95%CI -18至146)或使用自行车测力计进行的心肺运动试验(六项研究;141名参与者;45毫升/分钟,95%CI -7至97)无统计学意义。其他次要结局的数据有限,我们无法确定最有益的NMES方案类型。
尽管我们纳入了更多数据进行新的分析,并使用GRADE方法对证据质量进行了评估,但本综述的总体结论与上次发表时没有变化。NMES可能是治疗晚期进行性疾病成人肌肉无力的有效方法,可被视为康复计划中使用的一种运动治疗方法。进一步的研究很可能对我们对效应估计的信心产生重要影响,并可能改变估计值。我们建议进行进一步研究,以了解NMES作为现有康复方法的组成部分及其与之相关的作用。例如,研究可考虑将NMES作为辅助治疗以增强方案的强化效果,或为难以参与现有服务的肌肉无力患者提供支持。