“During the graded exercise therapy course I began to have episodes of paralysis below the waist. Because of this, my paediatrician stopped the therapy. I have never been able to return to my level of health prior to graded exercise. It rendered me housebound and triggered off a number of new symptoms as well as worsening the severity of my old symptoms and worsening my overall health, mobility and cognitive ability to severe. I went from mild/moderate ME to severe ME following graded exercise therapy.”
— patient response to an ME Association survey
- MAGENTA is a trial of graded exercise therapy in children aged 8-17, diagnosed with ME according to the NICE guidelines.
- The trial is led by a team of researchers from the University of Bristol. A feasibility trial on 100 children began last year in three UK centres at Bath, Cambridge and Newcastle, funded by the NHS National Institute for Health Research. It is is likely to lead to a much larger trial involving hundreds of children.
- MAGENTA’s plan for the feasibility trial is justified only by the PACE trial, which has been featured on Retraction Watch for its numerous flaws.
- In clinical trials on children (under-18s), both the child and their parents/carers must give consent for the child to take part. MAGENTA’s participant-information sheets and consent forms do not mention the controversy over PACE, the many problems with the trial’s analyses, or the harms following graded exercise therapy reported by hundreds of patients in surveys. This raises questions about whether the patients and their parents/carers gave properly informed consent in the feasibility trial, or would be able to do so in the larger trial.