Trial By Error: Journal Publishes Confusing Section on “Enduring Symptoms”

By David Tuller, DrPH

As part of its December issue, Future Healthcare Journal, sponsored by the UK’s Royal College of Physicians, has published a special section called “Challenging Myths: Debunking Functional Disorders.” The special section title itself creates confusion. In what way are functional disorders being “debunked”? I assume the idea is to debunk the purported “myths” about functional disorders, whatever they are—but that’s not what the words mean in this combination.

Moreover, the journal can’t seem to decide on the right label for the phenomenon it is exploring. While the special section title refers to “functional disorders,” the headline of the editorial introducing the project refers to “enduring symptoms”—a phrase I hadn’t seen used before in this context. (Has anyone else?) Mixing it up further, the editorial’s first sentence refers to “symptom-based disorders.” Are we all supposed to know whether these term are completely interchangeable?

Until like last week in the UK, the most popular collective tag for this category of conditions of unknown etiology seemed to be “medically unexplained symptoms,” shorthanded to MUS. That name has now apparently fallen out of favor, like the earlier terms “psychosomatic” and “psychogenic”–which is actually what the recent and more neutral names still mean to a lot of medical professionals. 

The lack of clarity in the terminology indicates how much the medical field still struggles to grapple with these complicated and difficult-to-treat syndromes and illnesses. Whatever the name, the category has generally been defined as including fibromyalgia, irritable bowel syndrome, functional neurological disorder, chronic fatigue and chronic fatigue syndrome, chronic pain, and any prolonged and disabling physical symptoms unexplained by known pathological mechanisms. Long COVID has now been lumped together with this group. 

The editorial of the special section promotes some of the standard unhelpful narrative, with definitive assertions that these conditions “involve an interplay of biopsychosocial mechanisms” and “represent dysregulation rather than damage or degeneration.” The editorial also notes that these conditions have “a significant impact on resource utilisation within health services.”

Given the latter, a major goal of UK healthcare policy seems to be to limit this “resource utilization” in a purported effort to protect patients from themselves. According to the editorial, “We must empower clinicians in all fields to positively identify the features of symptom-based disorders, to prevent multiple referrals, investigations and even unnecessary interventions…Over-medicalisation and over-diagnosis are detrimental to patients.”

Instead, per the editorial, patients should be “supported by a multidisciplinary team including peer support, social prescribing, social and employment support, and in-reach from specialist services including psychology.” That can mean, more or less: “No more co$tly doctor$ and medical te$t$ for you. Instead, take art classes and discuss stuff with other patients or a counselor.”

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A debate that misses the point

The special section includes a he-said/he-said exchange called “The FHJ debate: The NHS [National Health Service] is failing to provide services for patients with symptom-based disorders.” Debating in favor of the proposition—i.e., that NHS is failing in this goal—is Chris Burton, a professor of primary medical care at the University of Sheffield; his opponent is Benjamin Ellis, a consultant rheumatologist at Imperial College Healthcare NHS Trust. 

The debate misses the point. Like the editorial, it presumes that multidisciplinary interventions are of undisputed value. But here’s the problem. The research shows that trials of these kinds of rehabilitative treatments for people with this group of illnesses only seem to produce marginally positive findings. Let’s take the following passage from Professor Burton’s argument:

“Hope – the possibility that things can be different – is important. Our recent trial of extended medical consultations for people with multiple physical symptoms found statistically significant differences in symptoms sustained for at least 9 months after the end of treatment.”

As Professor Burton indicates, he is the lead investigator of the trial mentioned. Called “Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial,” it was published in The Lancet last year. (“Persistent physical symptoms” is another name for the same category.)

Like so many trials in this field, Professor Burton’s offers less than meets the eye. It was unblinded and relied for its claims of success on subjective measures—a study design that generates an unknown amount of bias. Despite the claims of “statistically significant differences,” the article does not mention that the results for the primary outcome, a quality-of-life questionnaire, fell below the outcome’s threshold for “minimal clinically important difference” (MCID), as my colleague Joan Crawford and I pointed out in a recently published letter to the journal. 

In other words, the difference between the intervention and comparison groups was so small as to be clinically meaningless, despite being “statistically significant.” In their vacuous response to our letter, Professor Burton and his colleagues fail to address that critical point.

Marginally positive results that fall below a metric’s MCID are what you might anticipate from bias alone in a trial of this design. While patients need “hope,” they need realism as well. To offer them “hope” based on meager results that do not represent real-world clinical benefits is deceptive. That sort of approach doesn’t help patients; it does them a disservice.

In arguing that the NHS is already capable of providing needed interventions, Dr Ellis also references Professor Burton’s trial as an example of what is currently possible. So both participants in this exchange are grounding their positions in research that does not document what it claims to document—that these interventions can produce substantive changes, not just “statistically significant” ones. They’re debating the wrong thing.

An interesting sidenote is that Professor Burton does not include the 2021 ME/CFS guidelines from the National Institute for Health and Care Excellence (NICE) among the references. According to NICE, the quality of evidence in favor of graded exercise therapy (GET) and a putatively curative form of cognitive behavior therapy (CBT) was of “low” or “very low” quality. The 2021 document rescinded NICE’s previous recommendations for these treatments. 

The various multidisciplinary interventions for “symptom-based disorders” generally include variations of these approaches. Since Professor Burton himself was a member of the NICE committee that approved these guidelines, it is curious he has chosen not to cite them here—despite their obvious relevance to the question of whether such interventions are helpful with this category of illness.

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A corrective to the narrative

The same special section includes some important counter-programming to the biopsychosocial narrative–a piece called “A patient perspective on enduring symptoms – the unmet need.” The author, Katharine Cheston, a post-doctoral fellow in medical humanities at the University of Durham, provides a sharp and welcome dose of reality for readers unaware of the hell patients can go through.

Here’s an excerpt: “Drawing on qualitative interviews, the paper highlights the profound suffering, isolation, and lack of medical support experienced by this underserved population. It examines the systemic barriers to care, including stigma, the absence of follow-up services, and the traumatising nature of some healthcare encounters, which can lead to healthcare avoidance even in the face of potentially life-threatening symptoms…The sheer magnitude of the unmet needs is devastating: this population live with disabling and life-limiting symptoms, yet they feel alone and abandoned, receiving little to no institutional support, care or recognition of their suffering.” 

Importantly, Dr Cheston recognizes that biomedical research is a core priority in order to really address patients’ unmet needs. She specifically mentions DecodeME, the groundbreaking genome wide association study spearheaded by a team from the University of Edinburgh; the investigators identified several regions of the genome associated with ME/CFS and published their findings earlier this year as a pre-print. As she notes, “The impressive initial results of the DecodeME study, which revealed a potential genetic predisposition to developing ME/CFS, indicate the huge potential for discovery in this field; providing dedicated, ring-fenced funding for biomedical research could produce the answers that this patient group desperately need and deserve.”

Dr Cheston’s piece serves as something of a corrective to other content in the special section. Perhaps her fellow authors will read it and learn something.