Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK.
Nursing, Midwifery and Allied Health Professionals Research Unit, University of Stirling, Stirling, UK.
Health Technol Assess. 2018 Oct;22(58):1-134. doi: 10.3310/hta22580.
Between 50% and 80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD) (i.e. constipation and faecal incontinence) that affects quality of life and can lead to hospitalisation.
To determine the clinical effectiveness and cost-effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared with advice only. A process evaluation investigated the factors that affected the clinical effectiveness and possible implementation of the different treatments.
A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind.
The trial took place in 12 UK hospitals.
PwMS who had 'bothersome' NBD.
Following individualised training, abdominal massage was undertaken daily for 6 weeks (intervention group). Advice on good bowel management as per the Multiple Sclerosis Society advice booklet was provided to both groups. All participants received weekly telephone calls from the research nurse.
The primary outcome was the difference between the intervention and control groups in change in the NBD score from baseline to week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EuroQol-5 Dimensions, five-level version (EQ-5D-5L).
A total of 191 participants were finalised, 189 of whom were randomised (two participants were finalised in error) (control group, = 99; intervention group, = 90) and an intention-to-treat analysis was performed. The mean age was 52 years (standard deviation 10.83 years), 81% ( = 154) were female and 11% ( = 21) were wheelchair dependent. Fifteen participants from the intervention group and five from the control group were lost to follow-up. The change in NBD score by week 24 demonstrated no significant difference between groups [mean difference total score -1.64, 95% confidence interval (CI) -3.32 to 0.04; = 0.0558]; there was a significant difference between groups in the change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21; = 0.039) and in the number of times per week that participants felt that they emptied their bowels completely (mean difference 1.08, 95% CI 0.41 to 1.76; = 0.002), in favour of the intervention group. Of participant interviewees, 75% reported benefits, for example less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost-utility analysis conducted from a NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of -0.002 quality-adjusted life-years (QALYs) (95% CI -0.029 to 0.027 QALYs). In the same imputed sample with bootstrapping, the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI -£372.62 to £415.68). No adverse events were reported. Limitations include unequal randomisation, dropout and the possibility of ineffective massage technique.
The increment in the primary outcome favoured the intervention group, but it was small and not statistically significant. The economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QALYs, a low-cost version of the intervention might be considered worthwhile by some patients.
Research is required to establish possible mechanisms of action and modes of massage delivery.
Current Controlled Trials ISRCTN85007023 and NCT03166007.
This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 58. See the NIHR Journals Library website for further project information.
50%至 80%的多发性硬化症患者（PwMS）经历神经源性肠功能障碍（NBD）（即便秘和粪便失禁），这会影响生活质量，并可能导致住院。
确定腹部按摩加对肠症状的建议与仅建议相比，对 PwMS 的临床效果和成本效益。一项过程评估调查了影响不同治疗效果和可能实施的因素。
一项随机对照试验，具有过程评估和健康经济学组成部分。结果分析是盲法进行的。
试验在英国的 12 家医院进行。
有“麻烦”NBD 的 PwMS。
在接受个性化培训后，干预组每天进行 6 周的腹部按摩。两组均按照多发性硬化症协会建议手册提供良好的肠道管理建议。所有参与者每周都会接到研究护士的电话。
主要结果是干预组和对照组在第 24 周时 NBD 评分的变化差异。次要结果通过排便日记、依从性日记、便秘评分系统、患者资源问卷和 EuroQol-5 维度，五个层次版本（EQ-5D-5L）进行测量。
共有 191 名参与者完成了最终分析，其中 189 名被随机分组（两名参与者错误地完成了最终分析）（对照组，n=99；干预组，n=90），并进行了意向治疗分析。平均年龄为 52 岁（标准差 10.83 岁），81%（n=154）为女性，11%（n=21）为轮椅依赖者。干预组中有 15 名参与者和对照组中有 5 名参与者失访。第 24 周时 NBD 评分的变化显示组间无显著差异[总分差值-1.64，95%置信区间（CI）-3.32 至 0.04；=0.0558]；两组间每周排便频率的变化（平均差值 0.62，95%CI 0.03 至 1.21；=0.039）和每周参与者感觉完全排空肠道的次数（平均差值 1.08，95%CI 0.41 至 1.76；=0.002）存在显著差异，干预组更有利。在接受采访的参与者中，75%的人报告了好处，例如排便更困难、更完全排空、更少腹胀、改善食欲等，85%的人继续进行按摩。从英国国家医疗服务体系和患者成本的角度进行的成本效用分析发现，在带有自举的插补样本中，干预相对于常规护理的增量结果效应为 -0.002 质量调整生命年（QALY）（95%CI -0.029 至 0.027 QALY）。在带有自举的相同插补样本中，干预相对于常规护理的增量成本效应为 56.50 英镑（95%CI -372.62 至 415.68 英镑）。没有报告不良事件。局限性包括随机分配不均、辍学和按摩技术无效的可能性。
主要结果的增量有利于干预组，但很小且无统计学意义。经济分析确定干预组处于主导地位。考虑到主要结果的微小改善，但不是在 QALY 方面，一些患者可能会认为低成本版本的干预是值得的。
需要研究可能的作用机制和按摩方式。
当前对照试验 ISRCTN85007023 和 NCT03166007。
本项目由英国国家卫生研究院健康技术评估计划资助，将在；第 22 卷，第 58 期。有关该项目的更多信息，请访问 NIHR 期刊库网站。
