A Study of Chronic Fatigue Syndrome Therapies Is Debunked (Again)

A new analysis of a 2013 paper that supported dubious treatments for the disease finds that its conclusions were “not justified by the data.”



Two widely prescribed treatments for chronic fatigue syndrome — cognitive behavior therapy, and a steady increase in activity known as “graded exercise therapy” — failed to lead to any recovery in patients. That’s the stark conclusion of a new reanalysis of data from the so-called PACE trial, the largest study of treatments for the illness, also known as myalgic encephalomyelitis, or ME/CFS.

The claims made by the PACE trial research were "highly misleading to clinicians and patients," the new analysis concluded.

The claims made by the PACE trial research were “highly misleading to clinicians and patients,” the new analysis concluded.

The PACE trial’s main results were published in The Lancet in 2011 and the journal Psychological Medicine in 2013. In the latter paper, the authors claimed that 22 percent of those who received either treatment “recovered,” about three times the rate in the study’s two other groups. The trial’s results have been hugely influential around the world. In the United States, the Centers for Disease Control and Prevention as well as major medical centers like the Mayo Clinic and Kaiser Permanente have long promoted the therapies, as Undark reported in a recent investigation.

But the trial has been mired in controversy for years. According to a growing chorus of well-regarded scientists and other experts, it suffered from egregious and disqualifying flaws. In the PACE trial protocol, the authors outlined four criteria that participants needed to meet in order to be considered “recovered.” In the 2013 paper, they dramatically weakened all four criteria, making it far easier to reach the “recovery” thresholds. In a bizarre paradox, some participants even qualified as “recovered” on two of the four criteria — measures of fatigue and physical function — at the start of the study, before undergoing any treatment at all.

For years, the PACE authors rejected requests from patients to release their raw trial data, which would have allowed others to calculate the results per the original protocol definition of “recovery.” Last summer, a British court ordered Queen Mary University of London — the home base of the lead PACE investigator, psychiatrist Peter White — to make the data from the $6 million trial available to the public. An independent group of researchers, using this newly released information, published the reanalysis last week in the journal Fatigue: Biomedicine, Health & Behavior.

In contrast to the results reported in the 2013 paper, the reanalysis found only single-digit rates of “recovery” for all four groups in the study. Moreover, there were no statistically significant benefits for cognitive behavior therapy (CBT) and graded exercise therapy (GET), the two interventions long promoted by the PACE investigators. “The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments,” concluded the reanalysis.

Dr. White and his PACE colleagues did not respond to e-mails seeking comment. Neither did Robin Murray, a professor of psychiatric research at King’s College London and the U.K. editor of Psychological Medicine.

NOTE: The author of this post has played an advocacy role in working with physicians and patient groups to challenge the efficacy of graded exercise and cognitive behavior therapies for the treatment of chronic fatigue syndrome.

CORRECTION: A previous version of this article stated that a new analysis of a 2013 paper had concluded that the chronic fatigue syndrome therapies examined in that paper provided “no benefit.” However, the new analysis focused only on claims of “recovery,” and did not examine whether the therapies provided other benefits. The article’s subhead also originally referred to a 2011 study, but the 2011 article in The Lancet was a different PACE-related paper that was not the subject of the new reanalysis.

David Tuller is a lecturer in public health and journalism at the University of California, Berkeley, where he receives support from a Kaiser Permanente grant to the Graduate School of Journalism.

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82 comments / Join the Discussion

    Our body charged with positive electron and control system work normally.

    If our body contact with negative charge, Our body may get negative electron.

    If our body charged with negative electron, our control system(gene expression or control)

    may changed and abnormal condition.

    If negative charged part is partially charged, mental disorder or digest problem or immune problem

    etc.. If most of our body charged with negative charged, several disorder occur and CFS.

    I can read the positive charge and negative charge from people, material, photo, earth, sound etc..

    Gene expression or body control signal may alter or change with negative charge.

    Cure CFS may easy and simple. Remove the negative charge source and body electric tune up.

    Thank you so much for publicising this important work. The patient community has long needed established scientists to point out the flaws in the current treatments offered to people with ME. As a former referee for science journals it amazes me that this paper was even accepted in the first place.

    I hope this finds its way into the mainstream media that was sold a lie by the Science Media Centre.

    surprise surprise, “Insanity is doing the same thing over and over again, but expecting different results.”

    If there were more people like you we (M.E.-patiënts) where not bed-bounded during 20 years!!THANK YOU VERY,VERY MUCH♥♥♥♥♥?????????? BELGUIM THANKS YOU

    Thank you, Tuller and everybody who has done such a good job, fighting for the truth.
    Thank you for bringing the truth to daylight!
    Let us talk about the facts and the reality in this illness.
    Lest do true and clean research to end this awful desease.
    We want to come back to life again.
    This is one big and important step in right direction.
    Thank you!

    Greetings from Norway.

    THANK YOU, THANK YOU, THANK YOU, David Tuller and Undark, for all your efforts to expose this junk science. I’m into my 34th year of this illness. Some of us can’t even think, and the profound fatigue is immobilizing. I held a full time position as an Electron Microscopist and TWO part time jobs when this thing invaded my body in 1983. We are not lazy people. Most people know very well what it feels like to be sick to their stomach, but how do you describe what it feels like to be sick to your brain? The cognitive problems make it impossible for me to fight for myself. My gratitude is boundless for doing this for us!

    I was one of the authors on the recent reanalysis you describe here, and I wanted to extend by thanks for this excellent article. My co-authors and I think this article is rather special, as it represents a collaboration between researchers and patients. I am lucky to have worked with such brilliant and dedicated group of patients, who have worked so selflessly to improve the lot of those suffering from this devastating and misunderstood illness – often at the expense of their own health.

    Listening to patients’ perspectives is always important, but never more so than when they suffer from an illness that is so poorly understood as MECFS. Here it is all too easy for researchers and practitioners to resort to psychological explanations and theories (you might say that medicine abhors a vacuum!). This kind of psychologisation is rarely evidence-based and can do real harm to patients. Not only can it negatively affect how patients are treated by their doctors, but in the long-term, it can significantly hinder research into better, more effective treatments.

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