Objectives: 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.
Design: A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind. Setting: The trial took place in 12 UK hospitals. Intervention: 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. Main outcome measures: The primary outcome was the difference between the intervention and control groups in change in the NBD score from baseline to week 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.
The mean age was 52 years standard deviation 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 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 No adverse events were reported.
Limitations include unequal randomisation, dropout and the possibility of ineffective massage technique. Conclusion: The increment in the primary outcome favoured the intervention group, but it was small and not statistically significant.
