Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.
Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.
BACKGROUND: People with central neurological disease or injury have a much higher risk of both faecal incontinence (FI) and constipation than the general population. There is often a fine line between the two symptoms, with management intended to ameliorate one risking precipitating the other. Bowel problems are observed to be the cause of much anxiety and may reduce quality of life in these people. Current bowel management is largely empirical, with a limited research base. The review is relevant to individuals with any disease directly and chronically affecting the central nervous system (post-traumatic, degenerative, ischaemic or neoplastic), such as multiple sclerosis, spinal cord injury, cerebrovascular disease, Parkinson's disease and Alzheimer's disease. This is an update of a Cochrane Review first published in 2001 and subsequently updated in 2003, 2006 and 2014. OBJECTIVES: To assess the effects of conservative, physical and surgical interventions for managing FI and constipation in people with a neurological disease or injury affecting the central nervous system. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register (searched 27 March 2023), which includes searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP as well as handsearching of journals and conference proceedings; and all reference lists of relevant articles. SELECTION CRITERIA: We included randomised, quasi-randomised (where allocation is not strictly random), cross-over and cluster-randomised trials evaluating any type of conservative, physical or surgical intervention against placebo, usual care or no intervention for the management of FI and constipation in people with central neurological disease or injury. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed the risk of bias in eligible trials using Cochrane's 'Risk of bias' tool and independently extracted data from the included trials using a range of prespecified outcome measures. We produced summary of findings tables for our main outcome measures and assessed the certainty of the evidence using GRADE. MAIN RESULTS: We included 25 studies with 1598 participants. The studies were generally at high risk of bias due to lack of blinding of participants and personnel to the intervention. Half of the included studies were also at high risk of bias in terms of selective reporting. Outcomes were often reported heterogeneously across studies, making it difficult to pool data. We did not find enough evidence to be able to analyse the effects of interventions on individual central neurological diseases. Additionally, very few studies reported on the primary outcomes of self-reported improvement in FI or constipation, or Neurogenic Bowel Dysfunction Score. Conservative interventions compared with usual care, no active treatment or placebo Thirteen studies assessed this comparison. The interventions included assessment-based nursing, holistic nursing, probiotics, psyllium, faecal microbiota transplantation, and a stepwise protocol of increasingly invasive evacuation methods. Conservative interventions may result in a large improvement in faecal incontinence (standardised mean difference (SMD) -1.85, 95% confidence interval (CI) -3.47 to -0.23; 3 studies; n = 410; low-certainty evidence). We interpreted SMD ≥ 0.80 as a large effect. It was not possible to pool all data from studies that assessed improvement in constipation, but the evidence suggested that conservative interventions may improve constipation symptoms (data not pooled; 8 studies; n = 612; low-certainty evidence). Conservative interventions may lead to a reduction in mean time taken on bowel care (data not pooled; 5 studies; n = 526; low-certainty evidence). The evidence is uncertain about the effects of conservative interventions on condition-specific quality of life and adverse events. Neurogenic Bowel Dysfunction Score was not reported. Physical therapy compared with usual care, no active treatment or placebo Twelve studies assessed this comparison. The interventions included massage therapy, standing, osteopathic manipulative treatment, electrical stimulation, transanal irrigation, and conventional physical therapy with visceral mobilisation. Physical therapies may make little to no difference to self-reported faecal continence assessed using the St Mark's Faecal Incontinence Score, where the minimally important difference is five, or the Cleveland Constipation Score (MD -2.60, 95% CI -4.91 to -0.29; 3 studies; n = 155; low-certainty evidence). Physical therapies may result in a moderate improvement in constipation symptoms (SMD -0.62, 95% CI -1.10 to -0.14; 9 studies; n = 431; low-certainty evidence). We interpreted SMD ≥ 0.5 as a moderate effect. However, physical therapies may make little to no difference in Neurogenic Bowel Dysfunction Score as the minimally important difference for this tool is 3 (MD -1.94, 95% CI -3.36 to -0.51; 7 studies; n = 358; low-certainty evidence). We are very uncertain about the effects of physical therapies on the time spent on bowel care, condition-specific quality of life and adverse effects (all very low-certainty evidence). Surgical interventions compared with usual care, no active treatment or placebo No studies were found for surgical interventions that met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: There remains little research on this common and, for patients, very significant issue of bowel management. The available evidence is almost uniformly of low methodological quality. The clinical significance of some of the research findings presented here is difficult to interpret, not least because each intervention has only been addressed in individual trials, against control rather than compared against each other, and the interventions are very different from each other. Understanding whether there is a clinically-meaningful difference from the results of available trials is largely hampered by the lack of uniform outcome measures. This is due to an absence of core outcome sets, and development of these needs to be a research priority to allow studies to be compared directly. Some studies used validated constipation, incontinence or condition-specific measures; however, others used unvalidated analogue scales to report effectiveness. Some studies did not use any patient-reported outcomes and focused on physiological outcome measures, which is of relatively limited significance in terms of clinical implementation. There was evidence in favour of some conservative interventions, but these findings need to be confirmed by larger, well-designed controlled trials, which should include evaluation of the acceptability of the intervention to patients and the effect on their quality of life.
背景:患有中枢神经系统疾病或损伤的人群比一般人群更容易出现粪便失禁(FI)和便秘。这两种症状之间常常存在细微差别,旨在改善一种症状的管理方法可能会导致另一种症状恶化。肠道问题是导致这些人焦虑的主要原因之一,并可能降低他们的生活质量。目前的肠道管理主要基于经验,其研究基础有限。本综述与任何直接和慢性影响中枢神经系统的疾病有关(创伤后、退行性、缺血性或肿瘤性),例如多发性硬化症、脊髓损伤、脑血管疾病、帕金森病和阿尔茨海默病。这是一篇发表于 2001 年的 Cochrane 综述的更新版,随后分别于 2003 年、2006 年和 2014 年进行了更新。
目的:评估保守、物理和手术干预措施在管理患有影响中枢神经系统的神经疾病或损伤的人群中 FI 和便秘的效果。
检索方法:我们检索了 Cochrane 尿控专题注册库(2023 年 3 月 27 日检索),包括对 Cochrane 中心对照试验注册库(CENTRAL)、MEDLINE、MEDLINE In-Process、MEDLINE Epub Ahead of Print、ClinicalTrials.gov、WHO ICTRP 的检索,以及对期刊和会议论文集的手工检索;以及所有相关文章的参考文献列表。
纳入标准:我们纳入了评估任何类型的保守、物理或手术干预与安慰剂、常规护理或无干预在管理患有中枢神经系统疾病或损伤的人群中 FI 和便秘的随机、半随机(分配不是严格随机的)、交叉和整群随机试验。
数据收集和分析:至少两名综述作者使用 Cochrane 的“偏倚风险”工具独立评估合格试验的偏倚风险,并使用一系列预设的结局测量指标独立提取纳入试验的数据。我们针对主要结局指标生成了证据概要表格,并使用 GRADE 评估证据的确定性。
主要结果:我们纳入了 25 项研究,涉及 1598 名参与者。这些研究由于对干预措施的参与者和人员缺乏盲法,往往存在高度偏倚风险。一半的纳入研究在选择性报告方面也存在高度偏倚风险。由于研究之间的结果报告存在异质性,使得数据难以合并。我们没有足够的证据来分析干预措施对个别中枢神经系统疾病的影响。此外,很少有研究报告自我报告的 FI 或便秘改善或神经源性肠道功能障碍评分的主要结局。
保守干预与常规护理、无积极治疗或安慰剂比较:十三项研究评估了这种比较。干预措施包括基于评估的护理、整体护理、益生菌、车前子、粪便微生物群移植,以及逐步采用越来越具侵入性的排空方法。保守干预可能会显著改善粪便失禁(标准化均数差(SMD)-1.85,95%置信区间(CI)-3.47 至-0.23;3 项研究;n=410;低质量证据)。我们将 SMD≥0.80 解释为大效应。由于研究报告便秘改善的所有数据无法合并,但证据表明保守干预可能改善便秘症状(数据未合并;8 项研究;n=612;低质量证据),因此无法合并所有数据。保守干预可能会减少排便护理的平均时间(数据未合并;5 项研究;n=526;低质量证据)。证据不确定保守干预对特定疾病的生活质量和不良事件的影响。神经源性肠道功能障碍评分未报告。
物理治疗与常规护理、无积极治疗或安慰剂比较:十二项研究评估了这种比较。干预措施包括按摩疗法、站立、整骨治疗、电刺激、经肛门灌洗和常规物理治疗联合内脏按摩。物理治疗可能对使用 St Mark's Faecal Incontinence Score 评估的粪便失禁无明显改善,该评分的最小重要差异为 5,或 Cleveland Constipation Score(MD-2.60,95%CI-4.91 至-0.29;3 项研究;n=155;低质量证据)。物理治疗可能会适度改善便秘症状(SMD-0.62,95%CI-1.10 至-0.14;9 项研究;n=431;低质量证据)。我们将 SMD≥0.5 解释为中度效应。然而,物理治疗可能对神经源性肠道功能障碍评分无明显改善,因为该工具的最小重要差异为 3(MD-1.94,95%CI-3.36 至-0.51;7 项研究;n=358;低质量证据)。我们对物理治疗对排便护理时间、特定疾病的生活质量和不良影响的影响的证据非常不确定(所有证据均为极低质量)。
手术干预与常规护理、无积极治疗或安慰剂比较:未发现符合本综述纳入标准的手术干预研究。
作者结论:在管理肠道方面,这是一个非常常见且对患者来说非常重要的问题,但目前关于这一问题的研究几乎都是基于低质量的研究。现有的研究结果很难解释,部分原因是每项干预措施仅在个别试验中得到解决,而不是相互比较,而且干预措施彼此之间差异很大。由于缺乏核心结局集,很大程度上阻碍了理解可用试验结果是否存在临床意义上的差异。这需要将开发重点放在研究上。一些研究使用了经过验证的便秘、失禁或特定疾病的措施;然而,其他研究则使用未经验证的模拟量表来报告有效性。一些研究没有使用任何患者报告的结局,而是侧重于生理结局测量,这在临床实施方面意义相对有限。有一些保守干预的证据,但这些发现需要通过更大、精心设计的对照试验来证实,这些试验应该包括对患者接受干预的可接受性及其对生活质量的影响的评估。
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