Department of Research, Heisei Medical Welfare Group Research Institute, Tokyo, Japan.
Division of Policy Evaluation, Department of Health Policy, Research Institute, National Center for Child Health and Development, Tokyo, Japan.
Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD014852. doi: 10.1002/14651858.CD014852.pub2.
Stroke patients often face disabilities that significantly interfere with their daily lives. Poor nutritional status is a common issue amongst these patients, and malnutrition can severely impact their functional recovery post-stroke. Therefore, nutritional therapy is crucial in managing stroke outcomes. However, its effects on disability, activities of daily living (ADL), and other critical outcomes have not been fully explored.
To evaluate the effects of nutritional therapy on reducing disability and improving ADL in patients after stroke.
We searched the trial registers of the Cochrane Stroke Group, CENTRAL, MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1982), and AMED (from 1985) to 19 February 2024. We also searched trials and research registries (ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform) and reference lists of articles.
We included randomised controlled trials (RCTs) that compared nutritional therapy with placebo, usual care, or one type of nutritional therapy in people after stroke. Nutritional therapy was defined as the administration of supplemental nutrients, including energy, protein, amino acids, fatty acids, vitamins, and minerals, through oral, enteral, or parenteral methods. As a comparator, one type of nutritional therapy refers to all forms of nutritional therapies, excluding the specific nutritional therapy defined for use in the intervention group.
We used Cochrane's Screen4Me workflow to assess the initial search results. Two review authors independently screened references that met the inclusion criteria, extracted data, and assessed the risk of bias and the certainty of the evidence using the GRADE approach. We calculated the mean difference (MD) or standardised mean difference (SMD) for continuous data and the odds ratio (OR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I statistic. The primary outcomes were disability and ADL. We also assessed gait, nutritional status, all-cause mortality, quality of life, hand and leg muscle strength, cognitive function, physical performance, stroke recurrence, swallowing function, neurological impairment, and the development of complications (adverse events) as secondary outcomes.
We identified 52 eligible RCTs involving 11,926 participants. Thirty-six studies were conducted in the acute phase, 10 in the subacute phase, three in the acute and subacute phases, and three in the chronic phase. Twenty-three studies included patients with ischaemic stroke, three included patients with haemorrhagic stroke, three included patients with subarachnoid haemorrhage (SAH), and 23 included patients with ischaemic or haemorrhagic stroke including SAH. There were 25 types of nutritional supplements used as an intervention. The number of studies that assessed disability and ADL as outcomes were nine and 17, respectively. For the intervention using oral energy and protein supplements, which was a primary intervention in this review, six studies were included. The results for the seven outcomes focused on (disability, ADL, body weight change, all-cause mortality, gait speed, quality of life, and incidence of complications (adverse events)) were as follows: There was no evidence of a difference in reducing disability when 'good status' was defined as an mRS score of 0 to 2 (for 'good status': OR 0.97, 95% CI 0.86 to 1.10; 1 RCT, 4023 participants; low-certainty evidence). Oral energy and protein supplements may improve ADL as indicated by an increase in the FIM motor score, but the evidence is very uncertain (MD 8.74, 95% CI 5.93 to 11.54; 2 RCTs, 165 participants; very low-certainty evidence). Oral energy and protein supplements may increase body weight, but the evidence is very uncertain (MD 0.90, 95% CI 0.23 to 1.58; 3 RCTs, 205 participants; very low-certainty evidence). There was no evidence of a difference in reducing all-cause mortality (OR 0.57, 95% CI 0.14 to 2.28; 2 RCTs, 4065 participants; low-certainty evidence). For gait speed and quality of life, no study was identified. With regard to incidence of complications (adverse events), there was no evidence of a difference in the incidence of infections, including pneumonia, urinary tract infections, and septicaemia (OR 0.68, 95% CI 0.20 to 2.30; 1 RCT, 42 participants; very low-certainty evidence). The intervention was associated with an increased incidence of diarrhoea compared to usual care (OR 4.29, 95% CI 1.98 to 9.28; 1 RCT, 4023 participants; low-certainty evidence) and the occurrence of hyperglycaemia or hypoglycaemia (OR 15.6, 95% CI 4.84 to 50.23; 1 RCT, 4023 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS: We are uncertain about the effect of nutritional therapy, including oral energy and protein supplements and other supplements identified in this review, on reducing disability and improving ADL in people after stroke. Various nutritional interventions were assessed for the outcomes in the included studies, and almost all studies had small sample sizes. This led to challenges in conducting meta-analyses and reduced the precision of the evidence. Moreover, most of the studies had issues with the risk of bias, especially in terms of the absence of blinding and unclear information. Regarding adverse events, the intervention with oral energy and protein supplements was associated with a higher number of adverse events, such as diarrhoea, hyperglycaemia, and hypoglycaemia, compared to usual care. However, the quality of the evidence was low. Given the low certainty of most of the evidence in our review, further research is needed. Future research should focus on targeted nutritional interventions to reduce disability and improve ADL based on a theoretical rationale in people after stroke and there is a need for improved methodology and reporting.
中风患者常面临严重影响日常生活的残疾问题。这些患者普遍存在营养状况不良的问题,营养不良会严重影响中风后的功能恢复。因此,营养疗法对于管理中风结果至关重要。然而,其对残疾、日常生活活动(ADL)和其他关键结果的影响尚未得到充分探索。
评估营养疗法对降低中风后患者残疾和改善 ADL 的作用。
我们检索了 Cochrane 卒中组试验登记处、CENTRAL、MEDLINE(从 1946 年开始)、Embase(从 1974 年开始)、CINAHL(从 1982 年开始)和 AMED(从 1985 年开始),检索截止日期为 2024 年 2 月 19 日。我们还检索了试验和研究登记处(ClinicalTrials.gov、世界卫生组织国际临床试验注册平台)和文章的参考文献列表。
我们纳入了比较营养疗法与安慰剂、常规护理或中风后患者的一种营养疗法的随机对照试验(RCT)。营养疗法定义为通过口服、肠内或肠外途径给予补充营养素,包括能量、蛋白质、氨基酸、脂肪酸、维生素和矿物质。作为对照,一种营养疗法是指所有形式的营养疗法,不包括干预组中定义使用的特定营养疗法。
我们使用 Cochrane 的 Screen4Me 工作流程来评估初始搜索结果。两名综述作者独立筛选符合纳入标准的参考文献,提取数据,并使用 GRADE 方法评估偏倚风险和证据的确定性。我们计算了连续数据的均数差(MD)或标准化均数差(SMD)和二分类数据的比值比(OR),置信区间(CI)为 95%。我们使用 I 统计量评估异质性。主要结局是残疾和 ADL。我们还评估了步态、营养状况、全因死亡率、生活质量、手和腿部肌肉力量、认知功能、身体表现、中风复发、吞咽功能、神经损伤以及并发症(不良事件)的发展等次要结局。
我们确定了 52 项符合纳入标准的 RCT,涉及 11926 名参与者。36 项研究在急性期进行,10 项在亚急性期进行,3 项在急性期和亚急性期进行,3 项在慢性期进行。23 项研究纳入了缺血性中风患者,3 项纳入了出血性中风患者,3 项纳入了蛛网膜下腔出血(SAH)患者,23 项纳入了缺血性或出血性中风包括 SAH 患者。使用了 25 种营养补充剂作为干预措施。评估残疾和 ADL 作为结局的研究数量分别为 9 项和 17 项。对于本综述中主要干预措施的口服能量和蛋白质补充剂,有 6 项研究纳入其中。以下是针对(残疾、ADL、体重变化、全因死亡率、步态速度、生活质量和并发症(不良事件)发生情况)的七个结局的结果:定义“良好状态”为 mRS 评分为 0 至 2 时,口服能量和蛋白质补充剂对降低残疾没有证据表明有差异(OR 0.97,95% CI 0.86 至 1.10;1 RCT,4023 名参与者;低质量证据)。口服能量和蛋白质补充剂可能会改善 ADL,表现为 FIM 运动评分的增加,但证据非常不确定(MD 8.74,95% CI 5.93 至 11.54;2 RCT,165 名参与者;极低质量证据)。口服能量和蛋白质补充剂可能会增加体重,但证据非常不确定(MD 0.90,95% CI 0.23 至 1.58;3 RCT,205 名参与者;极低质量证据)。没有证据表明降低全因死亡率有差异(OR 0.57,95% CI 0.14 至 2.28;2 RCT,4065 名参与者;低质量证据)。关于步态速度和生活质量,没有研究被确定。关于并发症(不良事件)的发生率,没有证据表明感染(包括肺炎、尿路感染和败血症)、腹泻的发生率有差异(OR 0.68,95% CI 0.20 至 2.30;1 RCT,42 名参与者;极低质量证据)。与常规护理相比,干预组腹泻的发生率更高(OR 4.29,95% CI 1.98 至 9.28;1 RCT,4023 名参与者;低质量证据),发生高血糖或低血糖的几率更高(OR 15.6,95% CI 4.84 至 50.23;1 RCT,4023 名参与者;低质量证据)。
我们不确定营养疗法(包括本综述中确定的口服能量和蛋白质补充剂及其他补充剂)对降低中风后患者残疾和改善 ADL 的作用。纳入研究评估了各种营养干预措施对结局的影响,且几乎所有研究的样本量都较小。这导致了进行荟萃分析的困难,并降低了证据的准确性。此外,大多数研究都存在偏倚问题,特别是在缺乏盲法和信息不明确方面。关于不良事件,与常规护理相比,口服能量和蛋白质补充剂与更多的不良事件相关,如腹泻、高血糖和低血糖。然而,证据质量低。鉴于我们综述中大多数证据的确定性低,需要进一步研究。未来的研究应侧重于基于理论依据的针对中风后患者的靶向性营养干预,以降低残疾和改善 ADL,同时需要改进方法和报告。