“There is no therapy based on physical activity or exercise that is effective as a treatment or cure for ME/CFS”. NICE
Who would have thought? We knew that National Institute for Health and Care Excellence (NICE) – the executive branch in the U. responsible for producing treatment guidelines – was reconsidering its guidelines for ME (ME/CFS, chronic fatigue syndrome). Still, it came as a surprise when its draft guidance made explicit what people with ME/CFS have known for so long: that neither CBT nor graded exercise therapy (GET) is “a treatment or cure for ME/CFS”. NICE went on to say GET “should not be presumed to be safe for those with this disabling and often neglected illness.” (It also did not recommend the Lightning Process.)
Plus it finally, finally, put CBT into the context in which it should have been offered all along – as a “supportive psychological therapy which aims to improve wellbeing and quality of life”. That, CBT, when properly done, is certainly able to provide. Just don’t pretend it’s a treatment. (CBT was originally used in mood disorders but is now being used to assist with quality of life in many physiological disorders including heart disease, rheumatoid arthritis, multiple sclerosis, and cancer. )
One had the feeling that NICE was attempting to make up for past errors that have sidelined patients and their concerns and blunted their trust in the medical establishment. More severely ill patients have been particularly affected. The ME Association reported that Paul Barry, the Chair of the NICE group, singled out the more severely ill:
“This guideline reinforces the legitimacy of this biomedical disease and aims to reduce the disbelief and stigma felt by people with ME/CFS … It acknowledges the profound needs of people with severe ME/CFS and their carers whose lives are hugely impacted by ME/CFS, and states that this unique patient group should be treated with respect, dignity, and empathy.”
It appears to be a repudiation of the wrong-sighted and even, at times, cruel practices that have been foisted on ME patients in the UK for years. Of course, it’s too late for the people pushed to the edge and beyond by a system in denial.
The unremitting focus the UK and the Netherlands have had on GET has, of course, affected more than the patients in those countries. It’s cast a pall over the entire ME/CFS community and the field itself. Even in the U.S., where research efforts have remained overwhelmingly biological, the taint remained in the form of popular medical websites espousing these practices.
- NICE provides treatment guidelines for the UK health system.
- In its recent draft guidance, NICE no longer recommends either graded exercise therapy (GET) nor cognitive behavioral therapy (CBT) as treatments for ME/CFS. NICE could not say that GET was safe for people with ME/CFS.
- Instead of being seen as a treatment, it recommended that CBT be seen as an option for those wishing to use it to improve their quality of life.
- NICE stated that neither exercise nor CBT are cures for ME/CFS – and noted there are no cures.
- NICE acknowledged the distress that many patients have experienced and called for better training and support from the medical profession.
- The draft document is long and covers diagnosis and other facets of ME/CFS. Expect more complete analyses in the days ahead from the ME Association, David Tuller, ME Action and others.
- With CBT and/or GET getting the thumbs down from the CDC, the Dutch Health Council, the Mayo Clinic and now NICE, the biopsychosocial approach to ME/CFS appears to be winding down.
Ironically, given that these programs were largely developed by psychologists – the psychological cost to the ME/CFS community has been huge. It’s not just the disbelief that patients encountered amongst doctors and friends or the worsened health outcomes or lost opportunities.
There’s also been the loss of faith in the medical community itself. How is it that it could put so much emphasis for so long on practices that were so at odds with patients’ experience? Who among us, after all, did not wreck ourselves physically trying to maintain our careers and lifestyles? Who among us did has not tried again and again and again to “exercise”?
To their credit, the NICE authors began to acknowledge some of the harm that’s been done:
“Health professionals should also recognize that people with ME/CFS may feel wary of trusting them if they have encountered doubt about their symptoms and condition.
ME/CFS can cause profound, long-term illness and disability, and much of the distress surrounding it is caused by difficulties in recognizing, acknowledging, and accepting the condition and its impact.
(The) controversy over the use of graded exercise therapy and CBT that has served only to alienate many people with ME/CFS and in some cases undermine the confidence of those caring for them.”
It’s a big change for NICE in particular. GET for ME/CFS, after all, was basically borne in the UK. A search of PubMed indicated that London researcher Peter White lead the first GET M.E. trial in 1997. That first trial set the stage for the controversies that were going to embroil GET and ME/CFS for over 2 decades – and which finally culminated in NICE not recommending it as a treatment for ME.
It provoked 4 published dissenting comments, including one by Charles Shepherd, which began by stating that:
“We remain firmly opposed to exercise programmes that encourage patients with the chronic fatigue syndrome to increase their levels of physical activity progressively without making allowance for fluctuating levels of disablement”. Shepherd went on to comment why, if the program was such a success, no increases in either peak oxygen consumption or muscle strength were seen.”
So it went for the next couple of decades. Biopsychosocial researchers presented sometimes garbled and misleading results, while patients, researchers and academics pushed back.
There’s always been a corrective to the graded exercise therapy (GET) mania that gripped institutional funders in the UK and the Netherlands for so long. It was called research. It’s not that GET research has been particularly good. David Tuller, a thorn in the side of the CBT/GET crowd, has repeatedly exposed problems in the biopsychosocial (BPS) research done in Europe.
Plus, there were the shenanigans that took place in the huge PACE CBT/GET trial. It was notable that even when the researchers lowered the bar to recovery so completely as to make it possible to enter the trial “already recovered” – even then – the best the PACE trial could conclude was that CBT/GET could “moderately improve” outcomes.
That was actually quite a overstatement. The trial was so poorly done that the Journal of Health Psychology – in what was surely a first for it – devoted an entire issue to problems found in the trial. A re-analysis of the trial data using the original criteria suggested that it completely failed. Later, the best the authors of the large 2017 GETSET trial could muster up was “it might reduce fatigue”.
The vaunted Cochrane reports didn’t have that much good to say about GET either. The 2019 review of GET studies (containing over 1,500 participants) concluded that exercise therapy “may slightly improve” physical functioning, depression and sleep compared to adaptive pacing (low-certainty evidence). The authors were also “uncertain if exercise therapy….reduces fatigue”. An earlier Cochrane report stated that “little or no difference in physical functioning, depression, anxiety and sleep” was seen.
Even that may have been an overstatement. Mark Vink and Alexandra Vink-Niese re-analyzed the GET studies used in the Cochrane review, and concluded that the Cochrane conclusions were wrong and that studies actually suggested that GET was completely “ineffective”.
Dr. Alastair Miller’s take on the NICE’s GET turnabout was that NICE had succumbed to political pressure – but maybe NICE was just following the science. Perhaps NICE thought one could reasonably expect that two decades of work and millions of dollars spent should result in something better than “may slightly improve” physical functioning and “little or no difference in physical functioning”.
In the end, it’s no wonder NICE is turning its back on GET – GET’s return on investment has been atrocious. The wonder is what took it so long.
In truth, NICE is a bit late to the game. NICE’s new recommendation is just the latest blow to the biopsychosocial approach to ME/CFS. The U.S. dropped the first bomb on CBT/GET when a re-analysis by the U.S. Agency for Healthcare Research and Quality (AHRQ) of CBT/GET studies left it unable to recommend them for ME/CFS. That prompted the Centers for Disease Control to remove its recommendations for CBT/GET from its website.
Then, the Dutch Health Council – hailing from one of the centers of the biopsychosocial movement – recommended that GET not be used to treat ME/CFS. Then, just this year after receiving a call from Vicki Whittemore of the NIH, and Elizabeth Unger of the CDC (and work from many advocates – read more here from MEAction), the Mayo Clinic removed recommendations for CBT/GET from their website.
CBT and GET’s time has been coming for years.
As GET’s allure has been fading, research findings elsewhere have been steadily undermining its premise – that deconditioning was keeping people with chronic fatigue syndrome (ME/CFS) down. It’s not that deconditioning is not present in some people with ME/CFS – of course it is. Deconditioning will occur in anyone who is bedridden for a period of time.
GET practitioners, though, proposed that deconditioning was behind ME/CFS patients’ inability to exercise. If that was true, then a slow ramp-up of exercise (i.e. a graded exercise protocol) was just the ticket.
In 2018, though, a Visser/Van Campen/Rowe study definitively demonstrated that not only was deconditioning not causing the energy production problems in ME/CFS – it didn’t even appear to be impacting them.
The study found everyone in ME/CFS – whether they were deconditioned or not – had the same impaired stroke volume. Since it was reduced stroke volume that was supposedly signaling that deconditioning was present, that finding blew apart the deconditioning hypothesis. The Visser study indicated that the core energy production problems in ME/CFS had to come from somewhere else.
Meanwhile, more and more studies have continued to establish that energy production is indeed impaired in ME/CFS. From Workwell’s two-day cardiopulmonary exercise test (CPET) studies to Systrom’s invasive exercise studies, every year more and more evidence of an energetic breakdown in ME/CFS has accumulated. A recently published study was even able to predict – using biological factors – which patients dropped out of a GET study. (Half the patients dropped out.) Just last month, a small Cara Tomas study found that ME/CFS patients’ muscle cells were less able to use their main energy source – glucose.
The evidence that something with the energy metabolism has gone wrong – something which no GET protocol could fix – has been building and building and building.
The Evidence Base Issue
Proponents of GET will say that whatever its mediocre results, CBT/GET are still the only “evidence-based” treatment for ME/CFS. There’s a reason for that, though – a gross inequity in funding. The reason that CBT/GET has dominated treatment recommendations on medical websites is simply that they’ve been funded to an extraordinary degree. CBT/GET are two of the few treatment options that have been significantly investigated in ME/CFS.
A three year PubMed survey of treatment trials in ME/CFS dating from 2015 indicated that 69% of them, and two-thirds of them from the UK and the Netherlands, involved behavioral treatments.
The average size of the 11 CBT and/or GET trials produced by the two major CBT/GET researchers (Chalder, Bleijenberg) was 367 participants. Only two of the six ME/CFS drug trials done during that timespan had over 30 participants, and two had less than five (!).
That’s the kind of inequity which occurs when federal governments decide to put their resources behind one particular treatment option.
The fact is that the treatment options available for people with ME/CFS – particularly in the UK and Europe – are not a function of the treatment possibilities present. Rather, they’re more a function of the treatments that have been supported by federal institutions.
With its immense federal medical funding apparatus, the U.S. of course, could have been a corrective. It has, after all, been focused almost entirely on biological studies. The NIH’s high bar to treatment trial funding and its laissez-faire approach to medical funding overall has left it, though, on the sidelines as CBT/GET dominated the treatment picture in ME/CFS.
Is the Biopsychosocial Approach to ME/CFS Dead?
The NICE draft guidance document is large and covers diagnosis and other issues. It will take time to unpack. Plus, it’s a draft document and could be changed. David Tuller has noted that substantial pushback is already beginning to emerge. Look for future analyses from the ME Association, David Tuller and ME Action in the future.
With the CDC, the Dutch Health Council, and now the NICE draft document giving GET a thumbs down and relegating CBT to a supportive, elective aid, though, the biopsychosocial movement has been dealt some big body blows lately. Is it winding to a close? Time will tell, but it’s hard to imagine funders throwing much more money down the CBT/GET rabbit hole after this.
One hopes that the institutional funders in the U.K. have given up on there being an easy way out for ME/CFS, and are willing to knuckle down and get to work puzzling out the pathophysiology. Certainly the UK has a strong bench of excellent researchers that could be funded.
It’s notable that NICE is embracing an approach to exercise that has held sway in the U.S. for years. Instead of trying to push out of one’s energy envelope, it recommends staying in it. Exercise can be helpful for some, but it must be managed carefully. NICE recommends that physical or occupational therapists with expertise in ME/CFS guide exercise protocols.
The U.S. approach, ironically, is more “research-based” in that it often relies on using exercise test results to assess cardiovascular functioning and determine acceptable exercise levels. It bears noticing that the first GET trial in 1997 may have been the first and last GET trial to employ exercise testing and physiological measures like oxygen consumption. Contrast that with the numerous studies and presentations from exercise physiologists like the folks at Workwell, which embrace and use physiological measures to produce scientifically guided exercise programs for ME/CFS patients.
NICE would be smart to – if it hasn’t already, refer physical therapists to an award winning model of ME/CFS (“Conceptual Model for Physical Therapist Management of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis“), put together by Todd Davenport and the exercise physiologists at Workwell, which uses a heart rate-based approach to activity management.
Other helpful published reports include Workwell’s “A Realistic Approach to Exercise for CFS Patients” and numerous presentations on their website including Mark VanNess’s 2-hour 2016 presentation, “Expanding Physical Capacity in ME/CFS”.
No one has missed the fact that this turnaround comes at a most opportune time for the thousands of long haulers that are starting to hit the UK’s medical system. Long haulers and ME/CFS patients everywhere should know that cardiovascular exercise testing provides a gold standard – in fact the only gold standard – for those ill enough to need to get disability.
One big question is what’s next for ME/CFS patients in the UK given the close embrace its national health system has given GET over the years. It’s got some catching up to do. The ME Association reported that Paul Barry stated that NICE:
“recognizes the pressing need for training and education for health and social care practitioners in this neglected field.”
Given the stories that have come out of the UK, nothing could be more true.
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