Trial By Error: The Conversation Recycles Biopsychosocial Nonsense

By David Tuller, DrPH

A new piece in The Conversation shows just how problematic it is when poorly done biopsychosocial studies claim to have documented that cognitive and/or behavioral therapies are effective—and when these questionable findings are published in high-impact journals. The headline of the article: “Success in treating persistent pain now offers hope for those with Long COVID.”

My response to that: “No it doesn’t.”

The Conversation is a venue in which academics and experts present information designed to be consumed by a lay audience. The co-authors of this piece are a GP and an orthopedic surgeon, both at the University of Otago, in New Zealand. They see no reason why insights into the neuroscience of pain should not be applied wholesale to the realm of “fatigue”—by which they apparently mean Long Covid and, along with that, the illness they call “CFS/ME.” (What is the current standard nomenclature in New Zealand?)

One excellent reason to challenge their arguments is the low quality of the research cited.

As they write, “Research has shown how appropriately trained general practitioners can provide explanations that aid recovery for a wide variety of persistent symptoms, including fatigue and pain.” The link for this claim is a study recently published by The Lancet of an intervention for a heterogeneous grab-bag of people with persistent physical symptoms (PPS). The lead author, Chris Burton, is a professor of primary medical care at the University of Sheffield. A long-time biopsychosocialist, he served on the committee that developed the new ME/CFS guidelines for the National Institute for Health and Care Excellence (NICE).

The NICE guidelines, which were issued in 2021, rescinded the recommendation for graded exercise therapy and cognitive behavior therapy as curative treatments. Even though this study is about PPS and not specifically ME/CFS, its approach nonetheless appears to undermine at least the spirit of the guidelines.

As is so often the case with these studies, this one was unblinded and relied solely on subjective outcomes. Because such studies are likely to produce an unknown amount of bias, the findings are generally hard to interpret or to take seriously as meaning much of anything—beyond, that is, proving that unblinded studies relying on subjective outcomes tend to produce at least modestly positive results. As Professor Burton well knows, NICE downgraded all such studies in its ratings of quality. The same judgement should be applied to Professor Burton’s new trial.

The intervention involved up to four sessions with GPs, who provided patients with “rational explanations” for their symptoms. These explanations were not identified, but presumably they focused on psychological, behavioral and related factors rather than “organic” causes, since the investigators specifically excluded patients with “organic” conditions from their study cohort.

The primary outcome was an instrument measuring the severity of somatic symptoms, the PHQ-15. All participants reported symptoms of moderate severity at the start of the trial. But the benefits for the primary outcome, while statistically significant, fell below the threshold considered to be the minimal clinically important difference (MCID) for the measure. In other words, the improvement was so marginal that it would not have been expected to be noticed or experienced by patients—and this was in a study already designed to generate positive bias.

And yet the investigators—and the journal—treated this finding as a success. As for the fact that the results for the primary outcome were not clinically significant, the investigators relegated this highly salient point to the deep bowels of the text. They also made efforts to downplay this very embarrassing detail by suggesting it didn’t matter much because at least some people seemed to have been helped by the intervention.

And now The Conversation has further disseminated their claims without qualification. Did the co-authors of the piece read Professor Burton’s study, or did they just review the headline or abstract? Did they know that the reported benefits did not meet the MCID and therefore had no practical impact on patient health? And if they did know, would they have cared or thought it was a problem worth highlighting?

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Long Covid and ME/CFS are not the same as “persistent fatigue”

And here’s more: “Recent insights from the burgeoning field of neuroscience now guide clinical management of chronic pain and may offer hope for people living with persistent fatigue.”

The word “may” is doing a lot of work in that sentence. In fact, this perspective is fraught with problems that render it suspect from the get-go.

For one thing, Long Covid is not “fatigue,” and it is not “persistent fatigue.” Nor is ME/CFS. The U.S. Centers for Disease Control inflicted huge damage on the patient community in 1988 when it dubbed the illness investigated in Lake Tahoe “the chronic fatigue syndrome.” Profound and—yes—persistent fatigue is a common experience among patients. But placing that word front and center ends up turning a distinct clinical entity into a single symptom.

The core characteristic of the illness is post-exertional malaise—or what is called post-exertional neuroimmune exhaustion (PENE) in the International Consensus Criteria for ME. The biopsychosocial crowd doesn’t seem to quite know what to make of PEM. They prefer to overlook the many scientific findings indicating that it involves pathophysiological responses to activity. That helps them believe it is amenable to a strategy focused on “desensitization,” as if it were some sort of phobia.

After presenting their theory that advances in pain neuroscience could help people with Long Covid, the investigators suggest this is already proving to be so. Unfortunately, the Dutch study they cite as evidence, published by the journal Clinical Infectious Diseases, is yet another in which the investigators claimed success on questionable grounds. The trial investigated the use of cognitive behavior therapy to address prolonged fatigue after acute cases of Covid-19. Like Professor Burton’s study, it was unblinded and relied on subjective outcomes for its reports of success. As expected with this design, the subjective findings were modestly positive. However, the investigators failed to report that their one objective outcome—how far people moved, as measured objectively by actigraphy—had null results.

The failure of this one objective outcome to match the modestly positive subjective results, as well as the decision by the investigators to engage in apparent research misconduct by not reporting those results in the trial paper, mean it is hard to take the study at face value. As I wrote at the time, the investigators offered “dog-ate-my-data” excuses on social media and in correspondence for not reporting these objective data. (Other posts on this Dutch study are here and here.)

Oh, and did I mention that The Conversation piece also highlights the self-serving screed from the so-called “Oslo Chronic Fatigue Consortium,” which includes key proponents of the Lightning Process, the woo-woo program developed by self-proclaimed faith healer Phil Parker?

In other words, the two New Zealand “experts” who wrote this piece for The Conversation either don’t understand the limitations of the literature, or they don’t care. Whichever it is, nothing they say here is worth paying attention to.

8 thoughts on “Trial By Error: The Conversation Recycles Biopsychosocial Nonsense”

  1. Alicia Butcher Ehrhardt, PhD

    Taking care of and helping sick disabled individuals – especially when there are so many new ones from Long Covid – is an expensive proposition for health systems and governments.

    Much easier to blame it on the victims – and save all that money by supporting, with a small portion of those funds, these nonsense studies and their promulgation.

    Where are the investigative journalists to follow the money trail? Dr. David Tuller is one of them – there need to be more.

  2. Lady Shambles

    Thanks for highlighting ‘PENE’ / ICC which is far more representative of what happens to pwme when they have have moved beyond what is doable for them.

    As for pain, I genuinely (and I mean ‘genuinely’)’ wish that those who write drivel about pain and how psychological interventions can help it, can become afflicted with severe pain .. real ‘humdinger severe pain’.. maybe SFPN like me… and find out the hard way that they are talking utter bo**ox! Because, in reality, unless they have a good serving of the symptoms they fraudulently claim to treat in this way, they will continue with this horror-fest of gaslighting, whilst presumably patting themselves on the back for being so darn clever (not!). What a waste of dna these people are!

  3. Thanks for your comment on the article in the conversation. I totally agree. The authors have also ignored the recent research identifying multiple pathophysiological features in LC. It seems both wilful and woeful. It is disinformation and misinformation.

  4. As a New Zealander I am embarrassed we have two Professors, Hamish Wilson and John Douglas Dunbar both from the University of Otago, not interested enough to understand ‘Post Exertional Malaise’. PEM, which occurs in both ME/CFS and half of all Long Covid patients.

    There’s already biological evidence to prove PEM exists via the ‘Invasive Cardiopulmonary Exercise Test’ (ICEPT) studied by Dr David Systrom in collaboration with Harvard, showing patients with PEM have blood returning to the heart still highly oxygenated, because it was only being partially utilised by the muscles even when the patient in the test was being exercise stressed.

    The “Two Day ICEPT’ shows both ME/CFS and LC patients worsen after exercise. The testing also shows up a unique heart issue called ‘Preload failure.’

    It’s also utterly appalling that Wilson and Dunbar had the audacity to arrogantly write that patients “nervous system and its role in creating, and at times inadvertently perpetuating, the debilitating sensation of fatigue”
    Because using the phrase ‘sensation of fatigue’ is suggesting it’s not actually real fatigue, but just the mind creating a sensation of it.

    Yet ME/CFS researchers and we as ME/CFS patients know full well that if we ignore this so-called ‘fatigue sensation’ we end up worse off because PEM attacks us within 24 to 48 hours of even small amounts of physical exertion. And that sickness can last days to weeks. Often we don’t even get the signal of fatigue while exerting ourselves, yet it still triggers a PEM crash.
    How can these two ‘professors’ not know this!?

    It’s even been shown that PEM is actually causing muscle damage to patients.
    Source
    ‘Nature Communications’
    ‘Muscle abnormalities worsen after post-exertional malaise in long COVID’
    https://www.nature.com/articles/s41467-023-44432-3

    Wilson and Dunbar I know you’ll be reading this, you need to start looking at the biological ME/CFS literature on PEM, instead of ignorantly insulting an entire patient group as if you know better. Because you have proven you don’t.

    There’s a big difference between fatigue that’s long lasting, and the disease ME/CFS which also includes Long Covid patients who also have PEM. Learn to spot the difference.

  5. So it appears to me to go something like this:

    Doctors meet a patient who’s in severe pain, but rather than investigating to find out where that pain is coming from or how it is arising, as they might have done in the past, there’s now a trendy new term called “central sensitization” that they can throw around to make their work so much simpler. Hospital managers buy into this idea because it could save their services lots of money – they won’t have to investigate the origin of patients’ pain anymore nor fund the interventions to resolve that pain that might have been indicated by those investigations. All their hospital needs to provide is a bit of cheap psychotherapy and physio for those who agree to engage with it. And it doesn’t matter if a patient declines bio-, psycho-, or socially. If their life falls apart and they become one of their nation’s increasing number of economically inactive dropouts then that can be blamed on their lack of engagement with the “central sensitization” explanation and with the recommended therapies. Science and investigations are out, it seems, and suffering (due to medics’ faulty beliefs) is most definitely in. Of course, if the patient can’t deal with that suffering then that’s their own fault too for not accepting their fate and committing well enough to their healthcare provider’s dirt-cheap management plan. It looks to me like medicine has now fully embraced neoliberalism and that, far from being good biopsychosocialists, in taking the central sensitization theory as fact doctors have allowed themselves to become neoliberal, ultra-capitalist oppressors.

    That, I think, is the conversation we should all be having.

  6. We researchers should develop well validated PEM endpoints for studies. Because such an instrument is lacking, many studies are going to be published that give false hope to patients with PAIS and other diseases that trigger PEM.

  7. Anne Kennedy

    Hi David,

    Have you heard of Dr Gillian deakin in Australia. She’s written a book called what the hell is wrong with me.

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