Raw data from Queen Mary’s controversial PACE trial has now been made public
PACE was a five year trial conducted by researchers from Queen Mary University of London and King’s College London to investigate the effectiveness of treatments for ME and Chronic Fatigue Syndrome (CFS).
£5 million of public money was used to fund the trial. In 2011, it was announced, in the medical journal The Lancet, that Cognitive Behaviour Therapy (CBT), with graded exercise therapy, was an effective treatment for CFS. It was presumed that the raw data must have indicated that psychotherapy and exercise could significantly reduce symptoms patients suffer. A Freedom of Information request asked for the release of the data and now, after QM’s appeal that the material couldn’t be successfully anonymised was rejected, the data has now become available.
In October 2015, David Tuller, who has a doctorate in public health, has been a health reporter and lectures about public health at Berkley University, wrote an analysis of the trial and highlighted some serious scientific flaws. He pointed out that the definition of ‘recovery’ was so poor that a patient could have shown to have worsened on two or four measurements and leave having ‘recovered’ a year later.
Writing for the Guardian, Professor Peter White, co-investigator of the PACE trial, discussed the definition that was used,
“…by recovery we mean recovery from a patient’s present episode of illness – which is not necessarily the same as being cured, as someone might fall ill again.”
The Print spoke to Alem Matthees, who requested the release of anonymised raw data from the trial, about the “recovery” controversy,
“The revised ‘recovery’ criteria overlapped with trial entry criteria for severe disabling fatigue, and one-third of those who met all the revised ‘recovery’ criteria still met broad criteria for chronic fatigue syndrome.”
Now the data is available it can be compared to that which was published in The Lancet in 2011. Only 21 percent of patients were shown as improvers in the graded exercise group compared to the 61 percent that was originally published. 20 percent of patients improved with the use of CBT and medical care but 59 percent was the figure which featured in the journal. Of those who only received medical care, only 10 percent improved in comparison to the 45 percent that was previously stated. Those receiving exercise in addition to medical care did not improve significantly more than those not receiving extra care.
Professor White still maintains that the treatment recommended by the trial will improve the health of a patient,
“Whichever way the data is viewed, patients get better results from CBT and GET – both confirmed as safe – than they do from pacing or medical care alone.”
Having finally been able to view the data himself, Mr. Matthees had this to say,
“…considering that CBT and GET do not lead to meaningful improvements to any objective outcomes, these therapies should not be promoted as “rehabilitative”.
“Perhaps most disappointing of all has been the effort required, and the prejudice faced, when trying to resolve the controversy over ‘recovery’ in the PACE trial.”
Image: JPD/Wikimedia Commons