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To: University of South Australia Vice Chancellor David Lloyd and MECFS South Australia president, Penelope McMillan

Stop dangerous and unscientific Xbox study in South Australia

Stop dangerous and unscientific Xbox study in South Australia

Dear MECFS Association (South Australia) president, Penelope McMillan, and University of South Australia Vice Chancellor, David Lloyd,

Please stop the trial on a "strategy to increase physical activity levels in adults with CFS/ME" because:

- the risk of harm is not adequately addressed
- the study does not have a set criteria, and diagnostic uncertainty renders the study worthless especially as 2 in 5 patients are misdiagnosed with chronic fatigue syndrome in Australia
- the small size of trial and it's design render it unscientific
- this "lifestyle intervention" study will not add to understanding of the illness

The lead investigator, Dr Ferrar, demonstrates a lack of understanding of the cellular and muscle problems in people with chronic fatigue syndrome and ME, as she said there is “indisputable research concerning the health benefits of physical activity” when asked about graded exercise therapy.

This study promotes further prejudice against people diagnosed with chronic fatigue syndrome and ME. It furthers the belief that exercise can improve people with chronic fatigue syndrome, ignoring expert metabolic and immune evidence as well as recent medical literature.

The University overstated the support of patient organisations.

There is concern that there is not an accurate description of the trial and the risks for participants, so participants cannot make an informed decision about joining the trial.

The USA's National Institute of Medicine's 'Report Guide for Clinicians' states: "A central characteristic of the disease—the fact that exertion of any sort (physical, cognitive, or emotional)—can adversely affect patients in multiple organ systems." https://www.ncbi.nlm.nih.gov/pubmed/25695122

We do not need further research to tell us it is harmful.

It is disappointing that the South Australian MECFS Association would put people's health at risk by endorsing this trial and helping recruit participants.

Why is this important?

This is important because Australia needs sound biomedical research into treatments in order to improve the health of people with ME and chronic fatigue syndrome.

The University of South Australia would not join other institutions in criticising the flawed and harmful PACE trial of GET and CBT. Instead, they plan further work in the field.
"We acknowledge that this study has raised some controversy in the field, and is rightly the subject of academic debate and further inquiry. The references you have provided by Professor Coyne and Dr Tuller are part of an ongoing debate that we consider a healthy part of the search for answers to ME/CFS. Research such as the current project should continue in the hope that it may contribute to positive outcomes for patients in the longer term."

Dr Ferrar, the physiotherapist running the trial said: "I welcome any discussions with them in order to improve the proposed project" but has failed to respond to questions on the lack of measures, why some measurements will only be taken at the beginning of the trial. Dr Ferrar said that they'll be presenting the data, not that the data would be openly accessible. Dr Ferrar would not say who the clinicians involved are.

People participating in the trial get a free xbox, which may influence the subjective results of trial.

Prof Coyne described the trial as "scientifically unsound, likely to contribute misinformation to the existing scientific literature, and has unresolved safety concerns".

The study has been updated since it was first registered, by including references to 'pacing' however the focus is still a push on increasing physical activity.

Aims
1. To determine the feasibility and acceptability of pacing plus active video gaming as a management strategy to increase physical activity levels in adults with CFS/ME
2. To explore if pacing plus active video gaming is an effective management strategy to increase physical activity for people with ME/CFS
3 To explore whether pacing plus conventional physical activity differs in effectiveness to pacing plus active video gaming compared to pacing alone
4. To explore the relationship between allostatic load and physical activity in people with CFS/ME
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370224&isReview=true

People have publicly expressed concern:
"As the parent of a severely affected child, I am well aware of the setbacks and so harm that can be caused from just a brief period of trying to play a computer game. Many other parents will tell the same story of their children with ME. Gaming drives adrenaline and uses a lot of energy, which easily results in over exertion, particulary for a child. Gaming is a really bad idea and clearly the brainchild of brainless people with no understanding of ME whatsoever."

"Patient experience, Ramsay’s original treatment recommendations, and the US IOM report all concur that this ia a disease in which complete rest from the inception gives the best prognosis, that protracted programmes of exercise push mildly or moderately ill patients into permanent severe or very severe ME with complete disability and severe, intractable and unremitting pain, and that this is a disease, not a psychiatric disorder, in which ‘exertion of any kind, physical, cognitive or emotional, may adversely affect many organ systems’.

It is also known that in ME/CFS the aerobic muscle metabolism is not functioning, so that even slight exertion makes use of the anaerobic metabolism, with the damaging effects consequent on that.

The idea that an ‘increase in activity’ is in any way a desirable goal for a person with ME/CFS is like suggesting that a diabetic increase their sugar consumption, or a lung cancer sufferer increase how much smoking they do. It is based on a completely perverse misunderstanding of the illness.

Exertion is toxic to a person with ME/CFS …it poisons their whole system.

It follows that without exception, any person who has ME/CFS will be damaged by participation in this research; that any possibility of a longer term recovery or even improvement will be utterly wiped out.

http://www.positivehealth.com/article/cfs-me/lost-in-translation-the-me-polio-connection-and-the-dangers-of-exercise"

"I sure hope Australian M.E. patients refuse to sign up for this “study”, which is likely to harm uninformed patients and further pollute the research literature.

Even the PACE People have been forced to admit that therapy and exercise don’t work. It’s right there in their own abstract [1] for the PACE long term followup:

“There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up.”

[1] http://www.ncbi.nlm.nih.gov/pubmed/26521770"

From comments at https://meaustralia.net/2016/06/02/south-australian-xbox-increasing-activity-trial-to/

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Reasons for signing

  • Clearly not a fruitful avenue for research in view of mounting international evidence that increasing activity in many cases will make true ME sufferers (those who suffer PEM) worse, not better. First do no harm!
  • Decades of documented evidence of harm caused by encouraging moderately to severely affected patients into increased activity indicates the need for extreme caution. Participants must give informed consent, knowing they may be rendered housebound or bed bound, temporarily or permanently, as a result of participation.
  • Because rare research funding for CFS/ME should be spent on scientific studies that use recognised international criteria for recruiting participants and should not make participants symptoms worse.

Updates

2018-03-12 06:38:26 -0400

100 signatures reached

2018-03-12 00:15:47 -0400

50 signatures reached

2018-03-11 15:37:49 -0400

25 signatures reached

2018-03-11 05:22:26 -0400

10 signatures reached