NICE Revisions backed by evidence

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The NICE Revisions Explained

The  National Institute for Health and Care Excellence (NICE) guidelines are the principle clinical guidance for the UK, and are utilised by many other countries, including Aotearoa/New Zealand. In October 2021, the NICE released revised guidelines for the diagnosis, treatment, and management of Myalgic Encephalomyelitis (ME) / Chronic Fatigue Syndrome (CFS).1

The publication of these guidelines represents a significant opportunity to correct historic misinformation about ME/CFS, and to ensure educators and clinicians have current, methodologically-sound evidence to guide their understanding of pathophysiology, assessment, and management.  

Revision of the ME/CFS NICE guidelines occurred over several years (2017-2021) and followed the standard robust NICE review processes. This included evaluation of the research evidence using the GRADE framework, a widely adopted system for formulating clinical practice recommendations.  Analysis of the evaluation was then conducted by a panel of clinicians and lay persons, followed by review by the NICE guideline committee. The Committee was chaired by Clinical advisor and paediatrician Dr. Peter Barry and Vice Chair Baroness Finlay, Consultant in Palliative Medicine, Clinical Lead for Palliative Care for Wales.

The major changes in the NICE guidelines for ME/CFS are: 

  • Acknowledgement of the cardinal diagnostic symptom of Post Exertional Malaise (PEM), a worsening of symptoms after activity. 
  • The removal of Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET)  as recommended treatment 
  • The recommendation that Lightning Process should NOT be used to treat ME/CFS 
  • Treatment focus is on symptom management.
summary of recommendation available on NICE website

The historical use of Cognitive Behavioural therapy (CBT) and graded exercise therapy (GET) as a treatment for ME/CFS stemmed from an inaccurate formulation that psychological factors are key in the causation and/or maintenance of symptoms. The risk to people with ME/CFS was that cognitive behavioural techniques urged people to view their symptoms as exaggerated illness behaviours and to counter this by engaging in increasing levels of activity/exercise. Exceeding the energy envelope risks Post Exertional Malaise (PEM) and can result in a prolonged or permanent worsening of the condition.

As evidence of the pathophysiology underlying ME/CFS has mounted, and the potential for harm of CBT and GET has become clear, CBT/GET has been abandoned as a treatment strategy in the USA and many other countries. Major guidance publications have either dropped all reference to these and related therapies, or cautioned against the use of them (e.g. CDC, IoM/NAM).
The 2021 publication of the NICE guidelines likewise clarified that there is insufficient evidence for the use of CBT and GET and removed the recommendation.
The NICE review process also discredited the validity of research included in the 2007 NICE guidelines that claimed these strategies were safe and effective. Evaluations of the quality of evidence used in 2007 to develop these claims, determined that across 172 individual CBT outcomes, as examined across multiple studies, all evidence cited for CBT was found to be of “low” or “very low” methodological quality. Similarly across 64 individual GET outcomes, all evidence for GET was of “low” or “very low” quality. 

The NICE committee took the scrutiny of evidence for psychological therapies a step further by singling out the Lightning Process for additional evaluation. This is a programme, developed by a UK osteopath, that promotes a rudimentary neurolinguistic programming technique as curative of a range of conditions, primarily ME/CFS, and more recently long Covid. The concerns around this programme stem from the formulation that ME/CFS symptoms are a learned response to stress and that alternate responses need to be rewired.  This can result in people engaging in actions that precipitate Post Exertional Malaise thus worsening their condition. The NICE Committee found available evidence for the Lightning Process to be of “very low” quality upon review and now recommends that the Lightning Process not be offered to people with ME/CFS. Furthermore, the British Standard Advertising Authority took legal action against the Lightning Process owners, citing false advertising due to unsubstantiated claims. This action was upheld.

In spite of a lack of evidence for CBT/GET and other therapies such as Lightning Process, there are influential academic and clinical groups in the UK and some European countries, who continue to promote and research psychological interpretations of ME/CFS. In New Zealand, in the face of a proliferation of evidence showing a pathophysiological basis for symptoms, and growing numbers of people being diagnosed with ME/CFS following PASC (long covid), some clinicians in New Zealand remain unaware of this evidence and potential harm, and continue to promote psychological therapies as curative. This is in spite of The Ministry of Health’s recognition of  ME/CFS as biomedical in 2002, and removal of CBT/GET in the clinical advice in the regional Health Pathways in New Zealand from 2019.

In December 2022, the Ministry of Health supported the conclusions of the guidance for ME/CFS published by NICE (2021) saying ‘that ME/CFS is a serious and complex medical condition/disease with varying severity rather than a mental health condition and that there is not a primary psychological basis underlying its development and/or maintenance.’

The NICE Guidelines (2021) now include best practice recommendations for treatment focussing on symptom management and emphasise the importance of energy management techniques, such as pacing, that are proven to be effective in preventing or minimising Post Exertional Malaise (PEM) – the diagnostic characteristic of ME.

“The keys to pacing are knowing when to stop and rest by listening to and understanding one’s own body, taking a flexible approach and staying within one’s limits; different people use different techniques to do this.” – NICE Guidelines 

Final words

ME/CFS is a complex, debilitating condition and best practice care involves a person-centred approach where symptom management is the key to controlling the fluctuating relapse and remittance that occurs. Evidence-based strategies that are shown to be effective are pacing and energy management, and symptom management strategies including a care and support plan, good nutrition, specialist physiotherapy, rest, sleep and pain management.

ANZMES considers the 2021 NICE guidelines to be comprehensive, evidence-based, and backed by a rigorous review process.  We encourage all healthcare professionals, medical bodies, medical schools, and ministry staff (in particular MoH, MSD) in New Zealand to update their understanding of ME/CFS and to become acquainted with the 2021 NICE guidelines.  

It’s one of the biggest challenges in clinical practice in medicine or psychology to try to work with somebody for whom you have no answers, you have no magic bullets. So it is disappointing but one of the reasons we have maybe a shortage of evidence-based treatments for this condition is because of the emphasis on cognitive behavioural therapy and GET … the research is very behind on where it would be if there was actually a level playing field to begin with.
The unfair emphasis on these treatments has created this deficit of knowledge. You have to manage the symptoms of this condition … but to use that as some kind of rationale for retaining therapies that we know are ineffective, doesn’t follow logically.

Professor Brian Hughes, BA, EdM, PhD, Psychology Professor NUI Galway.2

If you are a medical professional or member of a medical body or ministry staff member who would like to know more about ME/CFS, including the up-to-date scientific research, and evidence-based treatment options, please contact ANZMES.

World ME Alliance responds to opinion piece

In July 2023 an article titled “Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis” was published in the Journal of Neurology and Neurosurgery and Psychiatry (JNNP).

The World ME Alliance provided a rapid response to the article which the JNNP chose not to publish.

The World ME Alliance, of which ANZMES is a founding member, is a global collective of national organisations with 27 member organisations (24 at the time of the rapid response).

The full response can be read on the World ME Alliance website.

JNNP publishes detailed NICE response article

On March 1st, 2024, the Journal of Neurology and Neurosurgery and Psychiatry (JNNP) published a full article from authors of the NICE guideline on #MECFS, clearly laying out how this guideline is a rigorous and accurate assessment of current knowledge. Through this, the authors demonstrate the reliability and importance of the recommendations on care for people with ME.

Read the full article here:

2Professor Brian Hughes interview minute 19.09:

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