ME Association Comment
The MAGENTA trial (Managed Activity Graded Exercise in Teenagers and Pre-Adolescents) investigated the safety and effectiveness of graded exercise therapy (GET) in children and teenagers with mild or moderate ME/CFS.
The trial started in 2016 with a feasibility study, and compared GET with an activity management (AM) protocol. It was funded by the National Institute for Health Research (NIHR) as part of a research fellowship award for paediatric ME/CFS totalling £864,736.
We have obviously waited a long time for this trial into the safety and effectiveness of using GET in children with ME/CFS to be completed and the results announced. The key findings are:
- GET is not an effective treatment for ME/CFS.
- GET is not a cost effective treatment for ME/CFS.
- GET can cause harm in ME/CFS.
These negative results add further support to the decision by NICE in the 2021 Guideline on ME/CFS to no longer recommend GET as a treatment. Hopefully, MAGENTA represents the final final nail in the coffin of GET and there won’t be any more precious research funds being used to carry out clinical trials into GET in either adults or children.
Dr Charles Shepherd,
Trustee and Hon. Medical Adviser to the ME Association.
Member of the 2018-2021 NICE Guideline Committee.
Member of the 2002 Independent Working Group on ME/CFS.
European Journal of Paediatrics:
Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial
Published: 02 March 2024
Abstract
The MAGENTA pragmatic parallel groups randomized controlled trial compared graded exercise therapy (GET) with activity management (AM) in treating paediatric myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). Children aged 8-17 years with mild/moderate ME/CFS and presenting to NHS specialist paediatric services were allocated at random to either individualised flexible treatment focussing on physical activity (GET, 123 participants) or on managing cognitive, school and social activity (AM, 118 participants) delivered by NHS therapists.
The primary outcome was the self-reported short-form 36 physical function subscale (SF-36-PFS) after 6 months, with higher scores indicating better functioning. After 6 months, data were available for 201 (83%) participants who received a mean of 3.9 (GET) or 4.6 (AM) treatment sessions. Comparing participants with measured outcomes in their allocated groups, the mean SF-36-PFS score changed from 54.8 (standard deviation 23.7) to 55.7 (23.3) for GET and from 55.5 (23.1) to 57.7 (26.0) for AM giving an adjusted difference in means of −2.02 (95% confidence interval −7.75, 2.70).
One hundred thirty-five participants completed the mean SF-36-PFS at 12 months, and whilst further improvement was observed, the difference between the study groups remained consistent with chance. The two study groups showed similar changes on most of the secondary outcome measures: Chalder Fatigue, Hospital Anxiety and Depression Scale: Depression, proportion of full-time school attended, a visual analogue pain scale, participant-rated change and accelerometer measured physical activity, whether at the 6-month or 12-month assessment. There was an isolated finding of some evidence of an improvement in anxiety in those allocated to GET, as measured by the Hospital Anxiety and Depression Scale at 6 months, with the 12-month assessment, and the Spence Children’s Anxiety scale being aligned with that finding.
There was weak evidence of a greater risk of deterioration with GET (27%) than with AM (17%; p = 0.069). At conventional UK cost per QALY thresholds, the probability that GET is more cost-effective than AM ranged from 18 to 21%. Whilst completion of the SF-36-PFS, Chalder Fatigue Scale and EQ-5D-Y was good at the 6-month assessment point, it was less satisfactory for other measures, and for all measures at the 12-month assessment.
Conclusion: There was no evidence that GET was more effective or cost-effective than AM in this setting, with very limited improvement in either study group evident by the 6-month or 12-month assessment points.
What is New:
- Graded exercise therapy delivered in an out-patient setting is neither more effective nor more cost-effective than activity management for paediatric ME/CFS.
- Physical function did not improve greatly in either group over the 12 months in this pragmatic study conducted in the UK NHS.