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The new NICE Guideline for ME/CFS: Ten Questions Answered

1. What’s going on?

2. How is the new guideline different to the old one?

3. Why is the new guideline being welcomed?

4. Why was the old guideline problematic?

5. How did NICE arrive at the new guideline?

6. Was NICE overly harsh in using the ‘GRADE’ system to dismiss past research?

7. Was the NICE review process distorted by patient advocacy at the expense of scientific rigour?

8. Is it accurate to refer to CBT and GET as “evidence-based” treatments for ME/CFS?

9. Why do some clinicians persist in defending the old treatments based on CBT/GET?

10. How does this fit in with Long COVID?

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1. What’s going on?

This week*, in the United Kingdom, the National Institute for Health and Care Excellence (NICE) is publishing a new guideline for the diagnosis and management of a set of conditions referred to as “myalgic encephalomyelitis (or encephalopathy)” or “chronic fatigue syndrome” (ME/CFS). “ME/CFS” is a broad acronym that is often used to refer to many conditions. It has been estimated that between 0.5% and 1% of the population may be diagnosable with ME/CFS, equating to more than 300,000 people in the UK. The new guideline is to be published on 18 August. [*UPDATE: Now paused].

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2. How is the new guideline different to the old one?

The most significant differences relate to treatment recommendations. The old guideline, published back in 2007, had suggested that ME/CFS could be treated using a combination of cognitive behavioural therapy (CBT) and graded exercise therapy (GET). Essentially, the old UK guideline approached ME/CFS as if it were a psychological illness. By contrast, the World Health Organization defines ME/CFS as a neurological disease, listing it within the neurological disorders section of ICD-10, its illness classification system.

Based on the contents of the draft published last November, we now know that the new guideline moves firmly away from the old UK view. The new guideline states that neither GET nor CBT should be used as treatments for ME/CFS, and that clinicians should only consider CBT as a psychotherapy for patients who are in distress and who seek psychological support. In the new guideline, NICE has thoroughly revised the formal treatment standards for ME/CFS. It has done so based on a review of the relevant research, most of which was conducted after 2007.

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3. Why is the new guideline being welcomed?

The new guideline is being welcomed by clinical experts, research scientists, and patient advocacy groups around the world.

The UK has been an outlier in treatment standards for ME/CFS. ME was first classified as a neurological disease by the World Health Organization back in 1969. In the United States, the relevant National Academy defines ME/CFS as a physiological condition requiring physiological (not behavioural) treatment. The health council in Belgium has concluded that CBT and GET are no longer supported by evidence, while that in the Netherlands has questioned whether many patients could benefit from CBT.

The scientific community has long come to view ME/CFS as a physical disease and not a psychiatric one, for which CBT and GET are likely to be ineffective treatments. While the exact physiology of ME/CFS remains unclear, it is the target of intensive medical research around the world.

Many patient groups have drawn attention to the ineffectiveness of CBT and GET as treatments. In particular, GET has been widely reported by patients as causing further damage to their health. However, because NICE had previously listed CBT and GET as approved treatments, ME/CFS patients in Britain were often unable to challenge clinicians who insisted these treatments be used. Patient advocacy groups have been vocal for decades on this issue, but have often found their views dismissed. Based on their objection to the old NICE guideline, ME/CFS patients have frequently been depicted in the wider media as contrarians, malingerers, or irrational malcontents.

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4. Why was the old guideline problematic?

The old guideline promoted therapies that were widely seen by patients, clinicians, and scientists as being ineffective.

As mentioned, many patients reported that GET caused their health to deteriorate rather than improve. More broadly, by prioritising psychological and behavioural treatments, the old NICE guideline framed ME/CFS as a psychiatric condition, and not a physiological one. In practical terms, this meant that patients were directed to psychiatric services rather than to other medical specialisms where they might have received more effective treatment.

In cultural terms, the framing of ME/CFS as a psychiatric condition often had the effect of stigmatising patients, by implying they had a mental illness and so were incapable of understanding their own symptoms.

The old guideline was also problematic because it implied that CBT and GET were supported by strong research evidence. In fact, the specific research evidence cited by the 2007 NICE guideline was narrow, spanning just a handful of studies, and very tentative.

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5. How did NICE arrive at the new guideline?

Consistent with its normal practice, NICE established a review group to consider the issues and to assess the available research evidence on treatments for ME/CFS. The process began in 2017.

The chair and vice-chair of the review group were medical consultants. The rest of the group group comprised thirteen clinicians (four medical consultants, a professor of medicine, two senior academics, a social worker, a physiotherapist, an occupational therapist, a dietician, a GP, and a clinical service lead) and five “lay” members representing patient groups.

As part of the review, the group oversaw an assessment of research on treatments for ME/CFS. The research evidence was evaluated using the GRADE framework, a widely adopted system for formulating clinical practice recommendations.

Based on this evaluation, the review group attached quality-determinations to each piece of research evidence relating to the use of CBT and GET as treatments for ME/CFS. Across 172 individual CBT outcomes, as examined across multiple studies, all evidence for CBT was found to be of either “Low” or “Very Low” quality. Similarly, across 64 individual GET outcomes, as examined across multiple studies, all evidence for GET was found to be of either “Low” or “Very Low” quality.

As a consequence, the review group determined that the use of either CBT or GET as ME/CFS treatment was not supported by research evidence.

As per standard practice, the full details of the GRADE evaluations were presented by the review group in a 356-page document made publicly available on the relevant NICE website. Contrary to some media reports, the NICE review group did not base their new guideline on “qualitative” feedback from patients regarding treatments.

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6. Was NICE overly harsh in using the ‘GRADE’ system to dismiss past research?

The GRADE system is widely endorsed by research organisations as a means to promote evidence-based medicine. It is rigorous, detailed, and codified. The GRADE system evaluates research by taking account of five factors: inherent study bias (e.g., a lack of “blinding” in a study); imprecision in measurement; inconsistency across studies; indirectness of findings (i.e., whether results are derived from core research designs or whether they emerge incidentally, and possibly randomly, as unexpected secondary findings); and publication bias (i.e., the degree to which medical journals are selective when choosing what study results to publish).

There is nothing inherent in behavioural or psychological therapy research that is not envisaged by the GRADE system. The main purpose of GRADE is to produce objective evaluations and to minimise the problems that arise when clinicians are asked to subjectivity evaluate their own preferred treatment approaches. Such biases are particularly common in behavioural research, so, if anything, the use of GRADE is especially appropriate when seeking to evaluate treatments such as CBT and GET.

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7. Was the NICE review process distorted by patient advocacy at the expense of scientific rigour?

As described above, only a small subset of the NICE review group were patient representatives. A large majority of its members were clinically trained professionals with specialist knowledge and holding senior positions in their fields. The detailed evaluation of research was conducted using the GRADE system and so the conclusions regarding evidence-based treatment options were guided by empirical results rather than by lobbying or negotiation.

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8. Is it accurate to refer to CBT and GET as “evidence-based” treatments for ME/CFS?

No.

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9. Why do some clinicians persist in defending the old treatments based on CBT/GET?

Processes such as NICE reviews are needed because clinical judgment on its own is insufficient for drawing consistent conclusions about treatment options. Clinicians are human beings, whether they be service leaders, senior academics, or eminent professors. They are subject to human fallibilities. These fallibilities include the problem of being naturally wary of anything that upsets the status quo, especially where one’s own professional reputation is threatened.

Understandably, many clinicians have based their practice on the previous NICE guideline. They have invested time and effort developing services around the provision of CBT and GET to ME/CFS patients. Overhauling these services in light of the new NICE guideline will be especially challenging for these clinicians, for both psychological and logistical reasons.

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10. How does this fit in with Long COVID?

Many symptoms of Long COVID resemble those of ME/CFS, and some medical authorities believe the two conditions may be linked by a common underlying pathology. Already, some clinicians have been attempting to establish a treatment standard whereby Long COVID patients are treated using GET and CBT. NICE have published a “rapid guideline” for the treatment of Long COVID, and has tentatively cautioned against the use of GET for Long COVID. The new ME/CFS guideline, by dispensing with CBT and GET as treatments, highlights the lack of research evidence that exists for using these therapies in fatigue-related conditions, including Long COVID.

As such, the relevance of the new NICE guideline for ME/CFS extends far beyond those patients and families affected by this debilitating condition.

@b_m_hughes