Update to the NICE Guideline for ME/CFS ‘Paused’

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UPDATE: 21st September 2021 – NICE has announced that the roundtable meeting to discuss the ME/CFS Guideline will take place on the 18th October 2021 in London and Professor Dame Carol Black has been appointed as the ‘independent’ chair.

(Author’s narration)

On Tuesday 17th August 2021 NICE (National Institute for Health and Care Excellence) announced its decision to ‘pause’ publication of the update to the 2007 guideline on the diagnosis and management of ME/CFS.  This announcement has caused shock, anger and bewilderment amongst the M.E. Community. The ‘pause’ is yet another affront to a patient group that has been marginalised and mistreated for years. NICE guidelines are produced to inform healthcare professionals on the diagnosis and treatment of patients in the UK and the role of the organisation is to improve outcomes for patients. Sadly, for those patients diagnosed with ME/CFS, faith in NICE is wearing very thin. The timeline below details the story of the NICE Guideline for ME/CFS so far:

August 2007
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Current Guideline for ME/CFS Published

The current guideline for ME/CFS recommends Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT) as the two main treatments. The evidence at the time the guideline was published was based on a few small trials.

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Results of PACE Trial Published

The results of the controversial PACE Trial (which took place between March 2005 and January 2010) were published in The Lancet – recommending Graded Exercise Therapy and Cognitive Behavioural Therapy for ME patients. However, ‘the claim has proved controversial because patient groups had showed that exercise made patients worse, and CBT didn’t help.’ (MEpedia) The PACE Trial was funded by the UK Medical Research Council, Department of Health and Social Care (UK) for England, Scottish Chief Scientist Office, and the Department for Work and Pensions.

March 2011
March 2011
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Guideline Not Updated

NICE made the decision not to update the guideline for ME/CFS, based on the evidence provided by the PACE Trial Study.

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Guideline Placed on Static List

NICE placed the guideline for ME/CFS on the static list, due to a lack of further ‘important studies’ into the illness, meaning the guideline would not be reviewed. This led to protests from patients, clinicians and researchers.

February 2014
September 2017
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NICE Begins a Review of the Guideline

After bowing to pressure from patients and other stakeholders, NICE began a review of the guideline and it was acknowledged that: ‘Patient surveys appear to contradict findings from randomised controlled trials and systematic reviews regarding the safety and efficacy of CBT, GET and pacing’. (Nice.org)

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Guideline Publication Date Delayed

The publication date for the updated ME/CFS guideline was put back from 14th October 2020 to 9th December 2020, after making a call for evidence at the end of August 2019.

December 2019
November 2020
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Draft Updated Guideline Issued

NICE issued a draft updated guideline for ME/CFS which removed Graded Exercise Therapy and made it clear that Cognitive Behavioural Therapy is not ‘a treatment or cure’. (Nice.org)

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Guideline Publication Delayed Again

The publication date for the guideline was delayed a second time, ‘because of the large number of comments received during the consultation’ and changed to 18th August 2021. (Nice.org)

March 2021
4th August 2021
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Final Version of the Guideline Circulated to Stakeholders

According to the NICE Stages of Guideline Development, once a draft guideline has been consulted on, it is then revised in response to stakeholder comments, signed off by the NICE Guidance Executive and then a confidential advance copy is released to the stakeholders who commented on the draft. This is purely for a final error check. The Guideline, NICE Pathway and information for the public is then published.

On the 4th of August 2021, in line with the usual procedure, an advance copy of the final version of the new guideline for ME/CFS was circulated to the stakeholders who had commented on the draft. (Although it is worth noting here that there were three resignations from the original guideline committee in the weeks leading up to the expected publication of the guideline, and one member was removed by NICE, which has added further intrigue and unease to the situation.) This should have been the last step in the process prior to publication of the updated guideline…

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Guideline Paused Less Than 24 Hours Ahead of Publication

Less than twenty four hours before publication, the updated guideline was ‘paused’ with no indication of the expected timeline going forwards.

17th August 2021
27th August 2021
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NICE Announces Next Steps for ME/CFS Guideline

NICE announced it will hold a roundtable meeting in September 2021 “to better understand the issues raised and determine how it can gain support for the guideline to ensure effective implementation.” The meeting will “include representatives from patient organisations and charities, relevant professional societies and from NHS England and NHS Improvement, NICE and the guideline committee” and the chairperson will be independent. Paul Chrisp, director for the Centre for Guidelines at NICE, said: “We remain optimistic that we can reach a way forward to publish a guideline that will have the support of people living with ME/CFS, the people who care for them and the professionals who treat them.”

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Date of Roundtable Meeting Delayed

The news article NICE announces next steps for ME/CFS was updated on the NICE website ‘to change the month of the (roundtable) meeting from September to October.’ The update did not provide a date in October, or give any additional information.

10th September 2021
21st September 2021
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Date Given for the NICE ME/CFS Guideline Roundtable Discussion

NICE confirmed that the roundtable meeting to discuss the ME/CFS Guideline will take place on 18th October 2021 in London and Professor Dame Carol Black has been appointed as the independent chair.

However, Professor Dame Carol Black has links to the Department of Work and Pensions (which funded the PACE Trial) and is also an advocate of Cognitive Behavioural Therapy. In the light of the damage done to the ME/CFS Community by the PACE Trial (recommending Graded Exercise Therapy and Cognitive Behavioural Therapy for ME patients, and part funded by the Department of Work and Pensions), this choice of ‘independent’ chair feels ominous.

Why The ‘Pause’?

The current guideline is fourteen years old, which suggests it is well overdue an update. The update process was started in September 2017, almost four years ago, and now it has been suddenly and mysteriously paused. The statement from NICE regarding the ‘pause’ is not very illuminating and is, in fact, somewhat unnerving: ‘NICE has used its usual rigorous methodology and process in developing this guideline but despite the best efforts of the committee, that followed these to the letter to bring together the available evidence and the real, lived experience and testimony of people with ME/CFS, we have not been able to produce a guideline that is supported by all.’ (NICE.org)

So, it’s not been made clear precisely which members of the committee aren’t in support of publishing the updated guideline, or exactly what isn’t supported. This leaves the situation open to speculation (and deep concern, while Graded Exercise Therapy and Cognitive Behavioural Therapy continue to be recommended as the treatment options under the current guideline) but surely ‘rigorous methodology and process’ and ‘evidence and real lived experience and testimony’ should be the guiding force here?

Why The Update Is Urgently Needed

As an organisation, the purpose of NICE is ‘to improve outcomes for people using the NHS and other public health and social care services’ (NICE.org) but the current recommendation is: ‘Cognitive behavioural therapy (CBT) and/or graded exercise therapy (GET) should be offered to people with mild or moderate CFS/ME and provided to those who choose these approaches, because currently these are the interventions for which there is the clearest research evidence of benefit.’ (NICE.org). This is despite Graded Exercise Therapy causing known harm to significant numbers of patients and Cognitive Behavioural Therapy not treating the defining symptoms of the illness.

The Draft NICE Guideline of November 2020 counters:

Do not offer people with ME/CFS any therapy based on physical activity or exercise as a treatment or cure for ME/CFS


Furthermore, the rationale behind the committee making this recommendation within the draft update is that: ‘In developing more specific recommendations on the content, approach and delivery of physical activity management, the committee considered the benefits and harms associated with graded exercise therapy that had been identified in the qualitative evidence and their own experiences of these types of interventions. They recommended not to offer any programme based on fixed incremental physical activity or exercise, for example graded exercise therapy or structured activity or exercise programmes that are based on deconditioning as the cause of ME/CFS.’ (NICE.org)

NICE itself states that ‘NICE clinical guidelines are updated as needed so that recommendations take into account important new information. We check for new evidence 2 and 4 years after publication, to decide whether all or part of the guideline should be updated. If important new evidence is published at other times, we may decide to do a more rapid update of some recommendations.’ (NICE.org) Surely the evidence that Graded Exercise Therapy harms patients is ‘important new information’ and worthy of a ‘rapid update’?

Cognitive Behavioural Therapy may be a useful tool for some people, in terms of mentally adjusting to life with a chronic health condition; but it is certainly not a cure, and it isn’t going to rid people of their physical symptoms. Furthermore, the draft guideline states:

Do not offer CBT as a treatment or cure for ME/CFS


What Next?

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Based on the November draft, it looked like the Guideline for ME/CFS was finally going to be changed for the better but the ‘pause’ in publication has caused uncertainty as we are now moving into unchartered territory. The copy of the Guideline for ME/CFS that was circulated on the 4th of August should have been the final version. The ‘pause’ and the upcoming roundtable meeting, to be held on the 18th of October 2021, have gone beyond the usual process and into the unknown. NICE is no longer following its own procedure for guideline publication.

NICE states that the roundtable meeting ‘will be an opportunity for all parties to discuss key issues raised prior to publication’ (NICE.org) yet there has still not been any official word on exactly what these ‘key issues’ are. Hopefully the agenda, which is due to be released before the meeting, will provide an explanation but it is not clear whether the agenda will be made public, or when it will be finalised.

We have also been advised that Professor Dame Carol Black will act as an ‘independent’ chair of the roundtable discussion but she has previously been an advisor to the government, producing the report Working for a healthier tomorrow: work and health in Britain (Department for Work and Pensions), in which she advocates the use of Cognitive Behavioural Therapy and ‘exercise and physical training and activity’. In the light of the contention surrounding Cognitive Behavioural Therapy and Graded Exercise Therapy in relation to ME/CFS, this connection seems inappropriate and brings into question the neutrality of the discussion which will be facilitated by Professor Dame Carol Black.

Dr Paul Chrisp, Director of the Centre for Guidelines at NICE, comments: “We acknowledge that patients will be concerned about these further developments in what has been a long and difficult guideline process. We hope that by holding a roundtable discussion we can understand the issues raised by the professional bodies to inform NICE’s thinking on the next steps for publication of the guideline” (NICE.org). So it sounds like there will be further delays following the roundtable meeting, depending on the ‘next steps for the publication of the guideline.’ In the meantime, patients have every right to be concerned; as the 2007 Guideline for ME/CFS still stands. How many more patients will be harmed by Graded Exercise Therapy and have their physical symptoms undermined by Cognitive Behavioural Therapy before the guideline is updated?

Sign the petition to get the Draft Guideline published here.

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