Tack’s Take on 2020 Studies; Professor Edwards’ Statement to NICE

By David Tuller, DrPH

I have been laying low during the recent holiday and coup season. Today I’m watching the impeachment hearings. And I might find it challenging to get back up to full speed until after New Year’s–which for me will be January 20^th, or whichever day the White House is finally de-Trumped. For now, here are a couple of things worth reading on topics of direct interest to our main theme.

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ME/CFS Skeptic highlights notable 2020 research

Michiel Tack is a very smart young Belgian patient. I was pleased he invited me to collaborate on a paper called “Bias caused by reliance on patient-reported outcome measures in non-blinded randomized trials: an in-depth look at exercise therapy for chronic fatigue syndrome,” which was published last year in the journal Fatigue: Biomedicine, Health & Behavior. When BMJ Paediatrics Open published a specious paper about cognitive behvior therapy plus music therapy as a treatment for chronic fatigue in adolescents after mononucleosis (or glandular fever), his letter to the journal ultimately led to retraction. (I also pressured the journal publicly to address the issues.) Unfortunately, the journal replaced it with a revised version that was almost as bad.

Tack posts cogent comments about research at his blog, ME/CFS Skeptic: A Critical View into ME/CFS Research. I learn a lot from his writings. He recently posted a review of some of last year’s notable research developments. It begins with praise of a pediatrics study from the team led by Leonard Jason, a prolific ME/CFS investigator and a professor of psychology at DePaul University in Chicago:

“The most impressive study of the year was conducted by Leonard Jason and colleagues in Chicago. They ran approximately 150.000 phone numbers to get an estimate of how prevalent ME/CFS is in young people (aged 5-17). This was the first ME/CFS prevalence study in youth that used a comprehensive community-screening followed by a complete physical examination. The results showed a high prevalence of pediatric ME/CFS of 0.75%, notably higher than the 0.42% prevalence Jason and colleagues reported in adults in 1999. Only 5% of those identified as having ME/CFS were already diagnosed with the illness. The vast majority of patients did not have a diagnosis yet. One downside of this study is that a lot of people in Chicago didn’t answer their telephone. It is unclear if this led to an overestimation of the prevalence of pediatric ME/CFS.”

The rest is well worth reading, as are Tack’s other posts.

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Professor Edwards’ Statement to the NICE ME/CFS Committee

In November, the National Institute for Health and Care Excellence (NICE) published the draft of its new clinical guidelines for ME/CFS. At the same time, NICE released related material, including an extensive evidence review and statements from consulted experts. One of these statements was delivered to the NICE committee in September of 2019 by Professor Jonathan Edwards, emeritus professor of medicine at UCL.

I interviewed Professor Edwards more than five years ago when I was working on my initial investigation of PACE. He described the trial then as “a mass of un-interpretability”–a description that has stood the test of time. He has invested significant time and effort into challenging the science and research behind what has long been the prevailing approach of prescribing cognitive behavior therapy and/or graded exercise therapy (CBT/GET). Here’s the subject of his presentation to the committee: “The difficulties of conducting intervention trials for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome.”

Professor Edwards’ statement is thorough and convincing–a robust rebuttal to any possible arguments that advocates of CBT and GET could mount. Whether or not this document was frequently mentioned in the course of debate among committee members, it must have hovered in the ether as they made decisions regarding the CBT/GET framework.

Professor Edwards’ statement provides great insight into why the body of CBT/GET research does not meet minimal standards needed for drawing reliable or valid conclusions. The summary of his testimony offers a reasonable overview of the argument:

“Therapeutic trials for ME/CFS are particularly at risk from
expectation bias because of the subjective core features and
fluctuating nature of the illness. Therapist-delivered
treatments, with lack of blinding, and particularly those
involving cognitive intervention, are even more at risk
because of role-playing and deliberate influence on attitudes
to health status. Trials of drug treatments have tended to
navigate difficulties adequately but have yielded negative (or
equivocal) results. Trials of therapist-delivered treatments to
date have not met basic requirements for minimising bias and
are therefore unsuitable as an evidence base for treatment
recommendations. Inasmuch as they are interpretable, they
suggest that although attitudes to health status may be
influenced this does not lead to significant improvement in
objectively measures of disability. There are also specific
ethical concerns with trials of treatments that aim to persuade
patients of an unproven theoretical model for their illness and
for which there is prima facie evidence of significant harm (for
exercise therapy). The failure to meet basic requirements
indicates a problem with quality control through peer review
in this area, as illustrated with problems with Cochrane
reviews (see bibliography: Vink and Vink-Niese, 2018; Vink
and Vink-Niese, 2019). Trials to date have failed to make use
of methods that can significantly mitigate difficulties with bias
from subjective outcomes, but it may be that for unblindable
treatments new forms of trial methodology will be needed if
useful assessment is to be achieved. In my view, the
uninterpretability of evidence from trials that fail to overcome
basic difficulties, combined with ethical concerns, means that
it is inappropriate to recommend either cognitive behavioural
therapy or exercise therapies for ME/CFS.”