Sign the petition to suspend graded exercise trials
“The increased migraines caused by the graded exercise therapy course meant increased use of painkillers. It affected family relationships as I became increasingly disabled in my day to day life and had to be cared for. Socially I could not interact or go out as I had become too physically ill.”
We want to stop more clinical trials from using graded exercise therapy – especially the MAGENTA trial.
MAGENTA is a trial of graded exercise therapy for children with myalgic encephalomyelitis (ME, also known as ME/CFS – myalgic encephalomyelitis/chronic fatigue syndrome), conducted in the UK. A feasibility trial on 100 children began last year and is likely to lead to a much larger trial.
Modern research show abnormalities in ME patients’ energy production systems including research demonstrating that cellular metabolism is dramatically slowed. This indicates that ME patients cannot generate the resources to exercise as MAGENTA and other graded exercise studies recommend. Telling a child with an energy metabolism disorder that if she is more active, she will gain the ability to do so without damage is like telling a diabetic that if she consumes more sugar, she will be able to eat cake. It is like advising someone on the verge of bankruptcy that their problems will be solved if they spend more and more money at a time.
The MAGENTA researchers justify a trial in children on the basis of the 2011 PACE trial, which has been featured on Retraction Watch and is notorious for its flaws. It has so many problems that a group of over 40 scientists and clinicians — including specialists in child medicine — have published an open letter saying that PACE’s “major flaws… have raised serious concerns about the validity, reliability and integrity of the findings”. These flaws include but are not limited to:
- setting recovery criteria below entry criteria (patients could worsen and still researchers would label treatment as successful)
- setting recovery criteria so low that a patient with late-stage congestive heart failure would have been considered recovered
- started off with objective measures (activity meters) which would have provided crucial evidence of whether their therapies were effective, but dropped their use before trial’s end and did not report their findings
- provided promotional material about their therapies to trial participants during the trial, introducing more bias into a trial that already relied on self-reported improvements only
- showed no evidence of effectiveness on long-term follow-up
- altered the definition of recovery halfway through the trial; utilizing original measures show a mild, placebo-like effect
“It is, of course, completely unacceptable that any study should justify itself based on the uninterpretable findings of the PACE trial. The MAGENTA trial should be halted until the PACE authors have done what the First-Tier Tribunal ordered them to do–release their raw data and allow others to analyze it according to the outcomes specified in the PACE trial protocol.” — Vincent Racaniello, Professor of Microbiology and Immunology, Columbia University
None of this information appears in MAGENTA’s participant information sheets, raising serious concerns about whether the children in the trial, and their parents or carers have given genuine informed consent.
Please help us stop MAGENTA, and all trials of graded exercise therapy.