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The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review

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By M. Vink

Abstract

The main findings reported in the PACE trial were that cognitive behavioral therapy (CBT) and graded exercise therapy (GET) were moderately effective treatments for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and fear avoidance beliefs constituted the strongest mediator of both therapies. These findings have been challenged by patients and, more recently, a number of top scientists, after public health expert Tuller, highlighted methodological problems in the trial.

As a doctor who has been bedridden with severe ME for a long period, I analyzed the PACE trial and its follow-up articles from the perspectives of a doctor and a patient. During the PACE trial the eligibility criteria, both subjective primary outcomes, and most of the recovery criteria were altered, creating an overlap of the eligibility and recovery criteria; consequently, 13% of patients were considered “recovered,” with respect to 1 or 2 primary outcomes, as soon as they entered the trial. In addition, 46% of patients reported an increase in ME/CFS symptoms, 31% reported musculoskeletal and 19% reported neurological adverse events. Therefore the proportion negatively affected by CBT and GET would be between 46% and 96%, most likely estimated at 74%, as shown in a large survey recently conducted by the ME Association. Medication with such high rates of adverse events would be withdrawn with immediate effect.

There was no difference in long-term outcomes between adaptive pacing therapy, CBT, GET and specialist medical care, and none of them were effective, invalidating the biopsychosocial model and use of CBT and GET for ME/CFS. The discovery that an increase in exercise tolerance did not lead to an increase in fitness means that an underlying physical problem prevented this; validates that ME/CFS is a physical disease and that none of the treatments studied addressed this issue.

Source: Vink M (2016) The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review. J Neurol. Neurobiol 2(3): doi http://dx.doi.org/10.16966/2379- 7150.124  (Full article)

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One thought on “The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review”

  1. dfwmom says:

    It is a relief to see doctors beginning to question the PACE trial. I actually had a doctor try to tell my teenager that, with enough exercise and talk therapy, the should recover from CFS before she became an adult. That would be wonderful!! But, it didn’t happen. By following her doctor’s advice, she became worse. And, even worse than that, the doctor blamed her, because she said if she had been doing it right, she would have gotten better.

    It is high time that people start challenging this Snake Oil theory of medicine. A jog around the block does NOT magically cure CFS. And, we should continue to put pressure on The Lancet. The PACE trial is a study in corruption in the medical industry and the medical publishing industry, and if it is not challenged, the corruption will continue and get even worse.

    Corrupt, inaccurate medical studies can KILL people, if they convince the doctors to use the wrong treatments on patients.

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