PACE Trial Data Released

PACE Trial Data Released

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


Section: News

There are 7 comments for this article
  1. Graham McPhee at 5:12 pm

    Had the authors of the PACE study stuck to their original agreed targets for improvement and recovery, and if they had made the sort of comments that they are now beginning to make, there would have been much less anger within the patient community. Instead they used utterly inappropriate statistical methods to define “normality” (using the mean and standard deviation on a heavily-skewed, totally unmatched comparison group) to lower their targets so that they could claim high success. Remember that their prime therapies are based on the fear avoidance theory and of the deconditioning theory of chronic fatigue syndrome: such low figures, when combined with a poorly-defined catch-all set of criteria to select the sample, completely refutes their long-held assumptions. It is their persistence in putting forward these beliefs over the last 30 years or more, despite an utter lack of rigorous evidence, that has damaged both our treatment by medical professionals, and the funding of biomedical research.

  2. Anil van der Zee at 7:45 pm

    The PACE-trial is a great example of the fact that (directive) CBT and for sure GET just do not work for ME patients. With the use of the Oxford criteria we don’t even know if the subjective improvements are actually made by ME patients or patients fatigued by other illnesses. Post Exertional Malaise was not a requirement. So the study is pretty useless.
    Stop funding these useless CBT GET studies and invest in biomedical research.
    In the long run that will be more cost effective than these fairy tale treatments.

  3. Nancy Blake at 9:59 am

    The ‘recovery’ baseline, which was lowered during the trial after the first results started coming in, defined ‘recovery’ on a six- minute walking test to a figure below that (400) which would qualify a COPD sufferer to go on a waiting list for a lung transplant.

    On a (subjective) fatigue questionnaire, on which a normally healthy person would score 100, the original ‘recovery’ target was set at 85. The score for qualifying as sick enough to enter the trial was 65. After the trial results had started coming in, the ‘recovery’ score was lowered to 60. This is what a reply above is referring to…your score could have been 65 upon entering, you could have deteriorated as a result of treatment to a score of 60 and been included in the statistics as ‘recovered’.

    The pilot study included use of an actometer, which would have given a physical measure of increased activity. This was dropped from the study itself, leaving only subjective reports of increases in activity. Professor White justifies this by reference to a study which demonstrates that physical measures tend to be different from subjective reports, so they decided to use just subjective reports. If you read that article, what it concludes is that subjective reports exaggerate the level of activity shown by the physical measurements.

    All of the above information is available through reading the original article, but of course dressed up in obfuscating language. Further information is that this is the only ‘scientific’ study funded by the DWP. Also the investigators did not acknowledge the conflict of interest which existed because of the ties some of them (including the lead investigator) had to major medical insurers.

    Professor White asserts that CBT and GET are ‘both confirmed as safe’. The trial included as ‘harms’ only death or a hospital admission. As reported both in surveys of the severely ill (housebound/bedridden, in ongoing intractable pain), and in many research reports detailing the physical damage and the physiological reasons for it, exercise causes delayed and protracted harm to people who have ME. Many have conscientiously adhered to a programme of GET when mildly or moderately ill, during and after which they have deteriorated into severe ME, and remained so for years.

    The US IOM Report states unequivocally, after studying 9000 research papers, that ME is a disease (not a psychiatric disorder) which is extremely incapacitating, and of which the defining feature is that exertion, of any type, may adversely affect many organ systems’.

    The psychiatric view is that PWME have a ‘false belief’ that they have a medical disease and that exercise will harm them. The IOM confirms that we do have a medical disease, and that exertion does harm us.

    It is quite understandable that psychiatrists who are being paid by insurers and the DWP to ‘prove’ that ME is a psychiatric disorder would do all they could to get their study to do this.

  4. Carmel C at 12:03 pm

    As an ex Advance Personal Trainer & Sports Therapist. Enjoying all sports and participating in Triathlons all over the whole of the UK. After bouts of meningitis I went on to being diagnosed with mild ME. I was given GET and pacing by the NHS. I was doing the amount of an unhealthy 80 year old. Still, this wouldn’t put me off as I wanted my health back and was told this is the best treatment. After 6 weeks of keeping it up no matter how Ill I felt, I crashed badly and ended up with severe ME and have not recovered despite 5 years passing. I am stuck in this state, sadly I am not alone, I have heard hundreds of stories telling the simular stories from other adults who had mild ME and now have it severe too because of pacing and GET

  5. Katarzyna Sinclair at 10:50 pm

    I am very surprised that the authors of the “research” were not investigated and it wasn’t removed from the medical journals. I am even more surprised that ONLINE cognitive behavioural therapy is being trialed on children with ME. Another 5 million wasted and thousands of lives damaged!

  6. Paul Mc Daid at 6:17 pm

    By far the most important thing that rarely gets discussed in articles about the PACE trial is that GET makes people worse. The PACE trial did not follow up people who dropped out of the study. Every time one of the authors says GET has been proven safe it gets harder and harder to hear.

  7. John at 10:37 pm

    QMUL is back in the news, once again for avoiding having to comply with PACE-related freed of information requests.

    I’d like to see The Print pick up this story again, as it never really ended. It affects the healthcare treatment recommendations for millions of ME/CFS patients worldwide.

    David Tuller (UC Berkeley) has provided some of the details on Virology Blog:

    http://www.virology.ws/2018/02/13/trial-by-error-qmul-and-foi-nature-and-cochrane-the-pineapple-fund/

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