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PACE trial misrepresents their own results again

Debunked: the myth that CBT and GET are effective for ME/CFS

PACE trial psychiatrists professors Chalder, Sharpe and White, responded to the article by immunologist Professor Cohen Tervaert agreeing with him "that chronic fatigue syndrome (CFS), regarded as another name for ME, is a disabling and much misunderstood illness" even though their own trial was based on the assumption that ME patients suffer from the false beliefs that they have a disabling disease when in reality they only suffer from symptoms and not from a (physical) disease because their fear of exercise (aka fear avoidance beliefs) after a viral illness leads to deconditioning (bad physical stamina). In an effort to manage symptoms people avoid activity; this leads to a downward spiral causing all their symptoms according to the proponents of this (biopsychosocial) model for which objective evidence has never been presented, perhaps because it doesn't exist. CBT and GET were designed to address and reverse these and by doing so cure people. The biopsychosocial model however is at odds with the abnormal physiological findings in ME yet an important part of the model is ignoring evidence even if they have produced it themselves. For example, they disproved deconditioning in 2001 and fear avoidance behaviour in 2005 thereby disproving their own biopsychosocial model, professor White co-authored this study just like a 2004 study which found that exercise caused immunological abnormalities in ME/CFS but not in healthy controls and these were still present in the blood 3 days later.
The PACE trial authors reiterate that their treatments are effective and safe and that 22% recovered even though part of their definition of recovery was feeling (very) much better which represents improvement but not recovery.

After an extensive number of changes made to their definition of recovery during the trial, a fatigue score of 18 (out of 33) and a physical functioning score of 60 to 65 (inclusive) (out of 100) represented being ill and recovered at the same time so that 13.3% of participants were already classed as partially recovered at trial entry before receiving any treatment! Even though a score of 65 or less represents an "abnormal level of physical function" according to the PACE trials own recovery paper and severe disability according to the literature. 

In a properly conducted study these 13.3% should have been excluded to avoid the false impression that a treatment is effective when it's not.

After receiving 'effective' treatment, patients were still ill enough to re-enter the trial based on both subjective primary outcomes. The objective outcomes showed no significant improvements; the results of the 6-minute walk test showed that ME/CFS patients remained ill enough for a lung transplant and the number of patients claiming different forms of disability benefits increased/doubled. No one classified as recovered achieved actual recovery, whereby symptoms are eliminated and patients return to premorbid levels of functioning.

In up to 82.2% (CBT) and 79.8% (GET) of patients their health was made worse, confirming the outcomes of numerous patient surveys that CBT and GET are ineffective and harmful in a (very) large percentage of patients.

If CBT and GET had really been effective there would have been no need for an extensive number of changes to the recovery criteria made during an unblinded trial, making the definition much less accurate to the point that people who were still (severely) ill were classed as recovered.

The time has now come for the PACE trial authors to stop misrepresenting their own results; acknowledge the inefficacy and harmfulness of CBT and GET to prevent further unnecessary suffering inflicted on patients by physicians/therapists, which is the worst of all harms, yet totally preventable.

Mark Vink, (Family Physician). is the author of the 2016 Review of the PACE trial for which he was nominated for the John Maddox Prize for Standing up for Science.
 

 

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