Graded exercise therapy compared to activity management for paediatric [CFS/ME]: pragmatic randomized controlled trial, 2024, Gaunt, Crawley et al.

Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial
Gaunt, Daisy M.; Brigden, Amberly; Harris, Shaun R. S.; Hollingworth, William; Jago, Russell; Solomon-Moore, Emma; Beasant, Lucy; Mills, Nicola; Sinai, Parisa; Crawley, Esther; Metcalfe, Chris

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.

CONCLUSIONS
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.

TRIAL REGISTRATION
The study protocol was registered at www. isrctn.com (3rd September 2015; ISRCTN 23962803) before the start of enrolment to the initial feasibility phase.

Link | PDF (European Journal of Pediatrics) [Open Access]

 

@dave30th: improving science one blog post and letter at a time.

 

[36] Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis (2023)

 

That is pretty strong evidence. The chances that the difference is purely due to chance is one in fourteen. So the chance that it is real is thirteen fourteenths. That isn't good enough to be sure of a beneficial result but it is perfectly good enough to conclude that GET most likely makes people worse.

So again a bit back to front. What they mean is that we can be more than 80% confident that it isn't cost-effective.

 

Maybe to activity management in the form of 'pacing up' - two legs good and all that?

 

Maybe it just shows the expected - when you compare two therapy programmes the results always look the same, because they don't reflect any particular therapy.

 

Let's hope this was her last hurrah and she is no longer the grant magnet she's been for years. Someone with her record of corrections and controversy at this point should really not be conducting research.

 

Poor Esther. She and her colleagues must be pulling their hair out. Although surely they must have realized long ago they weren't getting the results they wanted. I hope this puts a cork in her ability to attract so much funding. Maybe after this people will stop believing the nonsense she tells everyone.

 

I'll have to see exactly what they did here. I can't remember--in this case did they also fold the feasibility trial subjects into the full trial?

 

Must they?
New Clinical Guidelines favour activity management, not GET.
Trial shows activity management as good as GET. Spot on. Jobs for the girls continue.

 

(1st column is GET; 2nd AM)

 

It feels like we've been waiting for this trial for at least a decade... (2015ish?).

Anyway. I thought it might be useful to tie together a few older threads:

MAGENTA (Managed Activity Graded Exercise iN Teenagers and pre-Adolescents) - Esther Crawley
https://www.s4me.info/threads/magen...gers-and-pre-adolescents-esther-crawley.4808/

Esther Crawley (2019) Physical activity patterns among children and adolescents with mild-to-moderate CFS / ME [baseline accelerometer MAGENTA data]
https://www.s4me.info/threads/esthe...-me-baseline-accelerometer-magenta-data.9141/

David Tuller: Trial By Error: So What's Happening with the MAGENTA Trial?
https://www.s4me.info/threads/david...-whats-happening-with-the-magenta-trial.5788/

 

Am I reading this wrongly ?
The baseline figures for school attendance show ACM group as potentially being " more well " in that school attendance is much higher 74 v 56 . The difference at baseline is striking .
At the end of the trial this has tanked to 42 ( GET has 47).

There are lots of factors as to why school attendance is not a brilliant metric , but to have attendance almost halved seems to me to indicate the same problems GET invoked.

How many drop outs ?

ETA I agree with @Jonathan Edwards .
This keeps the money flowing , and with long COVID likely coming under existing " specialists" umbrellas , this is justification for continuance .

The queen is dead, long live the queen