The MAGENTA trial (short for Managed Activity Graded Exercise in Teenagers and Pre-Adolescents) was a trial investigating the effectiveness and value for money of Graded Exercise Therapy in children compared to "activity management". It ran from September 2015 to August 2016 with a planned sample size of 100. The results are expected to be published in 2017.
Funding[edit | edit source]
Protocol[edit | edit source]
The protocol of the trial was published in BMJ Open in July 2016.
Criticism[edit | edit source]
The trial has been criticised on several points.
- It makes no use of objective outcome measures, instead opting to interview children and parents "in order to judge how well the treatment is working".
- It told potential participants that there were no risks in participating in the trial, although there is evidence that GET may cause harm to patients.
- The feasibility for the trial is based on the PACE trial, the results of which are contested.
James Coyne has urged patents not to enroll their children in the trial. He has highlighted the lack of information given to patients about potential harm, the consent procedure and the lack of published data on previous studies.
References[edit | edit source]
- ISRCTN Registry - The MAGENTA trial (ISRCTN23962803)
- Brigden, Amberly; Beasant, Lucy; Hollingworth, William; Metcalfe, Chris; Gaunt, Daisy; Mills, Nicola; Jago, Russell; Crawley, Esther (2016-07-04), "Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol", BMJ open, 6 (7): –011255, doi:10.1136/bmjopen-2016-011255, ISSN 2044-6055, PMC , PMID 27377634
- WAMES - MAGENTA trial – PACE for children
- 23 Sep 2016, PLoS Blogs - "Before you enroll your child in the MAGENTA chronic fatigue syndrome study: Issues to be considered", James Coyne.
- Stop GET - What is MAGENTA?
- #MEAction - Stop Graded Exercise Therapy Trials for ME/CFS
- Parliament Petitions - Suspend all trials of graded exercise therapy in children and adults with ME/CFS
- Before you enroll your child in the MAGENTA chronic fatigue syndrome study: Issues to be considered -PLOS Blogs