OMEGA (Oxfordshire ME Group for Action) wishes to express concern about coverage surrounding the FITNET-NHS trial, which was in the national press starting 1 November 2016.

We have three main concerns:

1) The FITNET trial is meant to replicate a similar trial in the Netherlands; however, most media coverage failed to clarify that in the original trial, the long-term follow-up showed Null results. https://www.ncbi.nlm.nih.gov/pubmed/23669515 See also comment by Tom Kindlon http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61324-5/fulltext

2) Some headlines unfortunately used the word ‘cure’, even though CBT (Cognitive Behaviour Therapy ) is not claimed to be a cure. Some people with ME/CFS do find CBT helpful in coping better whilst chronically ill, but no studies to date have found it to be a cure. While we welcome anything that may help people with this debilitating condition, it is important to emphasise that children suffering with ME/CFS and their parents are extremely vulnerable and implying this programme offers a cure is irresponsible; 'it may help some patients' would be better.

3) The publicity states that ‘1 in 50’ teens have CFS, an incidence of 2%, which is unusually high. Most estimates of those affected (across all age groups) are in the range of 0.4% (1 in 200-250 people). Using a loose definition of ME/CFS means some children are likely to be included who have other milder conditions that might resolve naturally without intervention.

We also have concerns about the FITNET-NHS trial itself:

1) If one looks more closely at what is involved in the trial, it becomes clear it involves not just CBT, but leads into some form of Activity management involving regular increases in activities, which is similar to Graded exercise Therapy (GET). See http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/fitnet-nhs/ and linked pages, such as Information for parents.

2) Patient experience (our own as well as major surveys) indicates that in many instances Graded Exercise Therapy (GET) programmes encourage patients to do too much physical exercise or other activities, with regular increases on a set schedule. This can cause health to deteriorate, with sometimes catastrophic and permanent damage; none of the coverage mentioned potential for harm, and this risk is only given a passing mention in information about the trial.

3) While there are two arms for the trial (one is clinic based care, the other is support via the internet), there is no control group to test if improvement might happen without treatment. Neither are there objective measures planned to test outcomes, which, given the study is unblinded, is very concerning.

Given that the PACE trial outcomes showed null results (when reanalysed according to the original protocol, as well as at long-term followup) for both CBT and Graded Exercise Therapy as treatment options, we would urge any families considering enrolling in FITNET to consider very carefully the pros and cons of the proposed research before committing to it.

For an initial reanalysis of the PACE trial results see: http://www.virology.ws/2016/09/21/no-recovery-in-pace-trial-new-analysis-finds/

Priscilla Kew Chair, on behalf of OMEGA (Oxfordshire ME Group for Action) email: enquire.omega@gmail.com