Bath Philip M, Lee Han Sean, Everton Lisa F
Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, UK, NG5 1PB.
Cochrane Database Syst Rev. 2018 Oct 30;10(10):CD000323. doi: 10.1002/14651858.CD000323.pub3.
Dysphagia (swallowing problems), which is common after stroke, is associated with increased risk of death or dependency, occurrence of pneumonia, poor quality of life, and longer hospital stay. Treatments provided to improve dysphagia are aimed at accelerating recovery of swallowing function and reducing these risks. This is an update of the review first published in 1999 and updated in 2012.
To assess the effects of swallowing therapy on death or dependency among stroke survivors with dysphagia within six months of stroke onset.
We searched the Cochrane Stroke Group Trials Register (26 June 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 6) in the Cochrane Library (searched 26 June 2018), MEDLINE (26 June 2018), Embase (26 June 2018), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (26 June 2018), Web of Science Core Collection (26 June 2018), SpeechBITE (28 June 2016), ClinicalTrials.Gov (26 June 2018), and the World Health Organization International Clinical Trials Registry Platform (26 June 2018). We also searched Google Scholar (7 June 2018) and the reference lists of relevant trials and review articles.
We sought to include randomised controlled trials (RCTs) of interventions for people with dysphagia and recent stroke (within six months).
Two review authors independently applied the inclusion criteria, extracted data, assessed risk of bias, used the GRADE approach to assess the quality of evidence, and resolved disagreements through discussion with the third review author (PB). We used random-effects models to calculate odds ratios (ORs), mean differences (MDs), and standardised mean differences (SMDs), and provided 95% confidence intervals (CIs) for each.The primary outcome was functional outcome, defined as death or dependency (or death or disability), at the end of the trial. Secondary outcomes were case fatality at the end of the trial, length of inpatient stay, proportion of participants with dysphagia at the end of the trial, swallowing ability, penetration aspiration score, or pneumonia, pharyngeal transit time, institutionalisation, and nutrition.
We added 27 new studies (1777 participants) to this update to include a total of 41 trials (2660 participants).We assessed the efficacy of swallowing therapy overall and in subgroups by type of intervention: acupuncture (11 studies), behavioural interventions (nine studies), drug therapy (three studies), neuromuscular electrical stimulation (NMES; six studies), pharyngeal electrical stimulation (PES; four studies), physical stimulation (three studies), transcranial direct current stimulation (tDCS; two studies), and transcranial magnetic stimulation (TMS; nine studies).Swallowing therapy had no effect on the primary outcome (death or dependency/disability at the end of the trial) based on data from one trial (two data sets) (OR 1.05, 95% CI 0.63 to 1.75; 306 participants; 2 studies; I² = 0%; P = 0.86; moderate-quality evidence). Swallowing therapy had no effect on case fatality at the end of the trial (OR 1.00, 95% CI 0.66 to 1.52; 766 participants; 14 studies; I² = 6%; P = 0.99; moderate-quality evidence). Swallowing therapy probably reduced length of inpatient stay (MD -2.9, 95% CI -5.65 to -0.15; 577 participants; 8 studies; I² = 11%; P = 0.04; moderate-quality evidence). Researchers found no evidence of a subgroup effect based on testing for subgroup differences (P = 0.54). Swallowing therapy may have reduced the proportion of participants with dysphagia at the end of the trial (OR 0.42, 95% CI 0.32 to 0.55; 1487 participants; 23 studies; I² = 0%; P = 0.00001; low-quality evidence). Trial results show no evidence of a subgroup effect based on testing for subgroup differences (P = 0.91). Swallowing therapy may improve swallowing ability (SMD -0.66, 95% CI -1.01 to -0.32; 1173 participants; 26 studies; I² = 86%; P = 0.0002; very low-quality evidence). We found no evidence of a subgroup effect based on testing for subgroup differences (P = 0.09). We noted moderate to substantial heterogeneity between trials for these interventions. Swallowing therapy did not reduce the penetration aspiration score (i.e. it did not reduce radiological aspiration) (SMD -0.37, 95% CI -0.74 to -0.00; 303 participants; 11 studies; I² = 46%; P = 0.05; low-quality evidence). Swallowing therapy may reduce the incidence of chest infection or pneumonia (OR 0.36, 95% CI 0.16 to 0.78; 618 participants; 9 studies; I² = 59%; P = 0.009; very low-quality evidence).
AUTHORS' CONCLUSIONS: Moderate- and low-quality evidence suggests that swallowing therapy did not have a significant effect on the outcomes of death or dependency/disability, case fatality at the end of the trial, or penetration aspiration score. However, swallowing therapy may have reduced length of hospital stay, dysphagia, and chest infections, and may have improved swallowing ability. However, these results are based on evidence of variable quality, involving a variety of interventions. Further high-quality trials are needed to test whether specific interventions are effective.
吞咽困难(吞咽问题)在中风后很常见,与死亡或依赖风险增加、肺炎发生、生活质量差以及住院时间延长有关。为改善吞咽困难而提供的治疗旨在加速吞咽功能恢复并降低这些风险。这是对1999年首次发表并于2012年更新的综述的更新。
评估吞咽治疗对中风发作后六个月内患有吞咽困难的中风幸存者的死亡或依赖情况的影响。
我们检索了Cochrane中风小组试验注册库(2018年6月26日)、Cochrane图书馆中的Cochrane对照试验中央注册库(CENTRAL;2018年第6期)(2018年6月26日检索)、MEDLINE(2018年6月26日)、Embase(2018年6月26日)、护理及相关健康文献累积索引(CINAHL)(2018年6月26日)、科学引文索引核心合集(2018年6月26日)、SpeechBITE(2016年6月28日)、ClinicalTrials.Gov(2018年6月26日)以及世界卫生组织国际临床试验注册平台(2018年6月26日)。我们还检索了谷歌学术(2018年6月7日)以及相关试验和综述文章的参考文献列表。
我们试图纳入针对吞咽困难且近期中风(六个月内)患者的干预措施的随机对照试验(RCT)。
两位综述作者独立应用入选标准、提取数据、评估偏倚风险、使用GRADE方法评估证据质量,并通过与第三位综述作者(PB)讨论解决分歧。我们使用随机效应模型计算比值比(OR)、平均差(MD)和标准化平均差(SMD),并为每个结果提供95%置信区间(CI)。主要结局是试验结束时的功能结局,定义为死亡或依赖(或死亡或残疾)。次要结局包括试验结束时的病死率、住院时间、试验结束时吞咽困难患者的比例、吞咽能力、渗透误吸评分或肺炎、咽部通过时间、住院机构化和营养状况。
我们在本次更新中新增了27项新研究(1777名参与者),共纳入41项试验(2660名参与者)。我们评估了吞咽治疗总体以及按干预类型划分的亚组的疗效:针灸(11项研究)、行为干预(9项研究)、药物治疗(3项研究)、神经肌肉电刺激(NMES;6项研究)、咽部电刺激(PES;4项研究)、物理刺激(3项研究)、经颅直流电刺激(tDCS;2项研究)和经颅磁刺激(TMS;9项研究)。基于一项试验(两个数据集)的数据,吞咽治疗对主要结局(试验结束时的死亡或依赖/残疾)没有影响(OR 1.05,95%CI 0.63至1.75;306名参与者;2项研究;I² = 0%;P = 0.86;中等质量证据)。吞咽治疗对试验结束时的病死率没有影响(OR 1.00,95%CI 0.66至1.52;766名参与者;14项研究;I² = 6%;P = 0.99;中等质量证据)。吞咽治疗可能缩短了住院时间(MD -2.9,95%CI -5.65至-0.15;577名参与者;8项研究;I² = 11%;P = 0.04;中等质量证据)。研究人员通过亚组差异检验未发现亚组效应的证据(P = 0.54)。吞咽治疗可能降低了试验结束时吞咽困难患者的比例(OR 0.42,95%CI 0.32至0.55;1487名参与者;23项研究;I² = 0%;P = 0.00001;低质量证据)。试验结果通过亚组差异检验未发现亚组效应的证据(P = 0.91)。吞咽治疗可能改善吞咽能力(SMD -0.66,95%CI -1.01至-0.32;1173名参与者;26项研究;I² = 86%;P = 0.0002;极低质量证据)。我们通过亚组差异检验未发现亚组效应的证据(P = 0.09)。我们注意到这些干预措施的试验之间存在中度到高度的异质性。吞咽治疗并未降低渗透误吸评分(即未降低放射学误吸)(SMD -0.37,95%CI -0.74至-0.00;303名参与者;11项研究;I² = 46%;P = 0.05;低质量证据)。吞咽治疗可能降低胸部感染或肺炎的发生率(OR 0.36,95%CI 0.16至0.78;618名参与者;9项研究;I² = 59%;P = 0.009;极低质量证据)。
中度和低质量证据表明,吞咽治疗对死亡或依赖/残疾结局、试验结束时的病死率或渗透误吸评分没有显著影响。然而,吞咽治疗可能缩短了住院时间、减少了吞咽困难和胸部感染,并可能改善了吞咽能力。然而,这些结果基于质量参差不齐的证据,涉及多种干预措施。需要进一步的高质量试验来检验特定干预措施是否有效。