Cort Johnson from the Health Rising blog explores how a controversial treatment approach with only modest benefits came to dominate ME/CFS for more than two decades.
The ME/CFS community breathed a sigh of relief this year with the release of the 2021 NICE guideline on ME/CFS. In a dramatic shift, NICE – whose former recommendations had instilled cognitive behavioural therapy (CBT) and graded exercise therapy (GET) as the treatment regimen for a generation of ME/CFS patients – now no longer recommend GET as a therapeutic option, and emphasise that CBT is not curative and should be used for symptom management only.
Decades of effort to establish CBT/GET as the most effective treatment for ME/CFS were over.
The fall of CBT/GET leaves behind an important question: how did one controversial approach come to monopolise treatment options for patients in the UK and elsewhere, and affect how ME/CFS is viewed by many people across the world?
CBT/GET and the biopsychosocial approach to ME/CFS may have seemed pervasive and even impenetrable at times, but they were always controversial.
The first GET trial in ME/CFS – led by Peter White MD in 1997 – provoked four published dissenting comments, including one by Dr Charles Shepherd of the ME Association that, twenty years later, GET researchers were still unable to answer. Shepherd asked why, if the programme was such a success, were there no increases in either peak oxygen consumption or muscle strength.
Despite its clear flaws, the CBT/GET presence in the small ME/CFS field grew over time to industrial-strength proportions. Since the first paper on CBT in ME/CFS published in 1989, there have been more than 120 other ME/CFS CBT studies and papers in the scientific literature.
The consequences of that largesse were immense. As others struggled to get their small biological treatment trials funded, UK and Dutch researchers in particular, supported by massive funding, effectively swamped the ME/CFS clinical trials field.
For instance, a three-year analysis of ME/CFS clinical trials found that six drug trials had been produced, only two of which had more than thirty participants (two had fewer than five). Over the same period, twenty-two CBT/GET trials were published, each averaging more than 200 participants.
The answer to the question of how one treatment approach came to dominate a field has an easy answer: institutional support.
With ME/CFS receiving little interest from drug companies, and with the major medical research funder in the USA (the National Institutes of Health) refusing to fund any clinical trials, the way opened for a well-funded treatment approach to achieve unwonted prominence. The result was that ME/CFS increasingly became seen in a behavioural context.
The biopsychosocial approach to ME/CFS reached its peak (and also its nadir) with the 2011 PACE CBT/GET trial. Still easily the biggest single treatment trial ever done in ME/CFS, the 641-participant, almost £5-million trial attempted to demonstrate that a relatively low-cost, effective treatment for ME/CFS existed.
In the end, however, the trial would cast a pall over the biopsychosocial approach.
PACE researchers lowered the bar to recovery so completely as to make it possible to enter the trial already recovered – a fact that didn’t stop the authors from reporting that 22% of participants recovered. In fact, the trial was so fraught with problems that the Journal of Health Psychology – in what was surely a first – devoted an entire issue to elucidating them.
Even with the notable assists they’d provided themselves, the best the PACE authors could conclude was that CBT/GET might be able to “moderately improve” outcomes. And the closer outside researchers looked at the data, the more problems were found. A re-analysis of the trial data using the original criteria suggested that it had completely failed.
A Cochrane Review of GET studies was published in 2019, and wasn’t able to conclude anything with any great certainty. The authors couldn’t say if exercise therapy reduced fatigue at all. The best they could conclude after the millions of dollars that had been poured into exercise therapy was that, compared with adaptive pacing (and with low-certainty evidence), it might “slightly improve” physical functioning, depression and sleep.
Even those mediocre results may have been an overstatement. When Mark Vink and Alexandra Vink-Niese re-analysed the GET studies used in the Cochrane review, they concluded that the studies actually suggested that GET was completely ineffective.
It was perhaps no wonder then that a 2020 review reported that “bias was prominently found” throughout the CBT/GET studies it reviewed.
(Cochrane have since committed to a full update of this Cochrane Review, including a review of the protocol, and the involvement of partners from patient-advocacy groups.)
It turned out that the return on investment from the millions of dollars and decades of work on CBT/GET was paltry at best – yielding one treatment that had, at best, moderate effects on fatigue, and one that has been discarded.
In recent years, the biopsychosocial approach to ME/CFS has taken hit after hit.
In 2016, following a report from an influential US federal analysis group, the Centers for Disease Control dropped its recommendation that CBT/GET be used to treat ME/CFS. In 2018, the Dutch Health Council – hailing from another major centre of CBT/GET studies – recommended against funding GET studies or using GET to treat ME/CFS. And last year, the Mayo Clinic in the USA removed its recommendations for CBT/GET from their website.
Large CBT/GET studies are still being published, but the updated NICE guideline has put the CBT/GET genie back into its bottle. CBT is now recognised to play the same role in ME/CFS that it does in many other diseases (such as heart failure and Parkinson’s disease): as a way to better manage an illness.
That opens the way for UK (and other) funders to focus on the real work – the work that ME Research UK and others are committed to – uncovering the biological roots of ME/CFS.