To determine the effectiveness and cost effectiveness of advice on optimised bowel care plus abdominal massage on PwMS compared to advice on optimised bowel care only. A process evaluation investigated the mediating factors that impacted upon effectiveness and possible implementation.
Fifty to 80% of people with multiple sclerosis (PwMS) report constipation which impacts on their quality of life and can lead to hospitalisation if impaction occurs.
A randomised controlled trial with process evaluation and health economic component was undertaken in 12 secondary care hospitals in the UK recruiting 189 PwMS who had ‘bothersome’ constipation. Following individualised training abdominal massage was undertaken daily by the participant or a carer for 6 weeks. Advice on good bowel management as per the MS Society Care and Advice Booklet was provided to both groups. All participants received weekly telephone calls from the research clinician to support the intervention.
189 participants were randomised and intention to treat analysis performed. Participants had a mean age of 52 years (SD 10.83), 81% (n=154) were female, 11% (n=21) were wheel chair dependent. 15 from the Intervention Group and 5 from the Control Group withdrew or were lost to follow up.
The NBD Score at Week 24 demonstrated no significant difference between Groups (mean difference -1.64 95% CI -3.32 to 0.04, p=0.0558); secondary outcomes recorded in the bowel diary demonstrated a significant mean difference in change between the groups of 0.62 (95% CI 0.03 to 1.21, p=0.039) in the frequency of stool evacuation and on the number of times participants felt they emptied their bowels completely (mean difference 1.08 95% CI 0.41 to 1.76, p=0.002) with the Intervention Group showing greater effect. Laxative use at Week 24 was twice as likely to be lower in the Intervention Group than the Control Group (OR = 2.37, 95% CI 0.87, 6.46), p = 0.092).
25 health care providers and 6 stakeholders were interviewed (providing a total of 88 interviews). 15/20 participant interviewees reported benefits e.g. less difficulty passing stool and feeling they had emptied their bowel completed, feeling less bloated and improved appetite, with 17/20 continuing with the massage. A cost utility analysis was conducted from an NHS and patient cost perspective. The mean incremental cost for the Intervention Group compared to the Control Group was £132.96. The incremental gain in Quality Adjusted Life Years (QALYs) was 0.0024. The incremental cost per QALY gained was £55,400.
Abdominal massage is a non-invasive, non-pharmacological intervention that may be clinically effective in some PwMS.
Principal Investigator: Professor Doreen McClurg
External Collaborators: Coggrave M - National Spinal Centre, Donnan P, University of Dundee, Emmanuel A - University College London NHS Foundation Trust, Mason H - Glasgow Caledonian University, Norrie J - University of Aberdeen , Norton C -King's College London, Smith P - Spinal Injuries Association, Treweek S - University of Aberdeen