NICE guidelines

The NICE guidelines are the UK's National Health Service (NHS) treatment guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and are currently being reviewed and updated by the NICE guidelines review committee.

NICE, the National Institute for Health and Care Excellence, is a UK government body that approves and recommends treatments for use within the NHS with the mission to improve health and social care through evidence-based guidance. In 2018, NICE began appointing a committee of professionals and lay members to the ME/CFS NICE Guidelines Review Committee.

NICE Guidelines Review for CFS/ME (2017-2020)
NICE initially announced that the 2007 guidelines would not be updated as a result of the review, but then changed this decision in September 20, 2017; the ME/CFS guideline review is currently in progress. The NICE guidelines update process began in 2017. The guidelines are expected to be finalized and published in 2020. The new guidelines refer to the illness as ME/CFS rather than CFS/ME.
 * NICE ME/CFS review panel members List of the Guideline Development Group (GDG) review panel members:
 * Peter Barry - Chair, pediatrician
 * Ilora Finlay - Vice chair, Baroness Finlay of Llandaff
 * Theo Anbu - secondary care pediatrician - clinical lead for Alder Hey pediatric CFS/ME clinic, Liverpool
 * Joanne Bond-Kendall - physiotherapist
 * Mike Beadsworth - physician with a special interest in CFS/ME, on the BACME executive
 * Susan Watson - occupational therapist, Leeds and West Yorkshire CFS/ME clinic
 * Jo Daniels - psychologist for CFS/ME clinic
 * Luis Nacul, Chris Burton - GPs
 * Tony Crouch - social worker
 * Alan Stanton - community pediatrician
 * Gabrielle Murphy - physician with a special interest in ME/CFS, also BACME Chair, see PACE trial
 * Charles Shepherd - doctor, co-opted member (no voting rights), ME Association medical advisor
 * William Weir - doctor (not confirmed by NICE yet)
 * Caroline Kingdon - nurse with special interest in ME/CFS
 * Dietician - role not filled


 * Children's community nurse - role not filled (removed from final list)
 * Lay members - Saran Bonser, Sally Burch, Nicola Kidby, Adam Lowe, and Dorinda Jack
 * Expert witnesses - Greg Crowhurst and Jonathan Edwards - invited to give evidence on particular topics

NICE stakeholders
A large number of organizations have registered as stakeholders, and a stakeholder meeting has already taken place, with a summary available online.

NICE Guideline Revision Progress in 2018
The public pressure from ME patients, including a petition by the ME Association, led to the decision to fully revise the guideline and which would not be concluded until around October 2020.

NICE held a Stakeholders Engagement Workshop on 16 January 2018 and a summary of the day has been produced by the ME Association.

Invest in ME wrote to Professor Mark Baker, Centre for Guidelines Director, on 15 January 2018 asking NICE to urgently remove or add an addendum or correction for the recommendation of CBT and GET now to avoid harm to patients. Prof Baker responded that they could not remove such recommendations for CBT and GET and had to wait for the full review of the guidelines which would be due in 2020. Invest in ME wrote back on 16 January repeating that they should at least add an addendum about CBT/GET. Patient advocates have commented that the right to refuse CBT/GET treatment as stated by Prof Baker is an offer you can't refuse.

An unprecedented proactive open letter to Sir Andrew Dillon was sent on 12 January by ME sufferers regarding the composition of the new GDG committee due to the history of the  CFS/ME NICE guideline and committee and a 'Appeal to NICE concerning the Guideline Committee for ME/CFS' petition was also  launched to support this. ME sufferers from ME Analysis produced a video to accompany the letter and petition.

An unprecedented third petition was launched to NICE 'Stop harming ME/CFS patients - take CBT/GET out of NICE guidelines NOW' which asked that NICE immediately remove CBT/GET from the guidelines in the face of evidence of harm amounts to medical abuse and violation of human rights.

In a BBC Newsround article it was again stated by patient groups that the guideline for CBT/GET should be withdrawn immediately but this was refuted by a statement by the "country's leading ME researchers" that they should not. It was later clarified that many of the proponents were involved in the PACE trial. The article stated that in 2018 "NICE admits there is "controversy" around existing treatments".

A scoping workshop was undertaken on 25 May 2018. It was announced that the new Chair of the GDG would be Dr Peter Barry and the Vice Chair Ilora Finlay. A draft scope consultation was also produced. The terminology was changed from CFS/ME to ME/CFS and the new guideline was 'Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management' GID-NG10091. Some stakeholders were not notified until the night before of the workshop. Others raised some concerns with the stakeholder workshop.

Positive Health magazine reported on 'What Can We Expect from the Current Review of NICE Guideline CG53' and concluded that the BPS psychiatric proponents would still try to influence the guidelines to retain the status quo.

NICE Guidelines for CFS/ME - CG53 (2007)
The NICE guidelines for CFS/ME CG53 for the diagnosis and management of chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) were published in August 2007. They are used by the NHS and other medical professionals in the UK for diagnosing and treating CFS/ME.

Authors
The CFS/ME guideline development group consisted of the following members: Richard Baker, Jessica Bavinton, Esther Crawley, Tony Downes, Richard Eddleston, Ute Elliot, Richard Grünewald, William Hamilton, Judith Harding, Frederick Nye, Amanda O'Donovan, Alastair Santhouse, Julia Smedley, David Vickers, Gillian Walsh, Carol Wilson, Philip Wood, Gary Britton, Stefanie Kuntze, Elizabeth Shaw, Nancy Turnbull, and Tanya Harrison.

Definition
Healthcare professionals should consider the possibility of CFS/ME if a person has:


 * fatigue with all of the following features:
 * new or had a specific onset (that is, it is not lifelong)
 * persistent and/or recurrent
 * unexplained by other conditions
 * has resulted in a substantial reduction in activity level
 * characterised by post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)

and


 * one or more of the following symptoms:
 * difficulty with sleeping, such as insomnia, hypersomnia, unrefreshing sleep, a disturbed sleep–wake cycle
 * muscle and/or joint pain that is multi-site and without evidence of inflammation
 * headaches
 * painful lymph nodes without pathological enlargement
 * sore throat
 * cognitive dysfunction, such as difficulty thinking, inability to concentrate, impairment of short-term memory, and difficulties with word-finding, planning/organising thoughts and information processing
 * physical or mental exertion makes symptoms worse
 * general malaise or ‘flu-like’ symptoms
 * dizziness and/or nausea
 * palpitations in the absence of identified cardiac pathology

Healthcare professionals should be aware that the symptoms of CFS/ME fluctuate in severity and may change in nature over time.

Signs and symptoms that can be caused by other serious conditions (‘red flags’) should not be attributed to CFS/ME without consideration of alternative diagnoses or comorbidities. In particular, the following features should be investigated:
 * localising/focal neurological signs
 * signs and symptoms of inflammatory arthritis or connective tissue disease
 * signs and symptoms of cardiorespiratory disease
 * significant weight loss
 * sleep apnea
 * clinically significant lymphadenopathy

A diagnosis should be made after other possible diagnoses have been excluded and the symptoms have persisted for:
 * 4 months in an adult
 * 3 months in a child or young person; the diagnosis should be made or confirmed by a paediatrician

The diagnosis of CFS/ME should be reconsidered if none of the following key features are present:
 * post-exertional fatigue or malaise
 * cognitive difficulties
 * sleep disturbance
 * chronic pain

Criticism and controversy
Charities and patient groups condemned the guidelines as "unfit for purpose".

The submissions were from:

Invest in ME Submission

 * IIME Response to draft guidelines November 2006
 * IIME Stakeholder Submission Response to full Guidelines
 * IIME Respone to Final August 2007 NICE Guidelines CG53

ME Association Submission

 * MEA Submission on draft NICE guidelines
 * MEA August 2007 Comments

25 Percent ME Group Submission

 * 25% Group Response to NICE

Tymes Trust Submission
Tymes Trust November 2006 Submission

Agreed statement from all ME Charities
An agreed statement was also put out by all ME Charities.

MEActionUK Submission and Reports
MEActionUK published their Concerns and Submission over the draft NICE guidelines in October 2006 MEActionUK also published comment on the final draft of the August 2007 guidelines. The failure by NICE to fulfil its remit and the biomedical evidence that NICE ignored in its production is also investigated and reported on. MEActionUK have published a number of other reports into the criticism of the NICE guidelines on their website.

Professor Hooper also submitted written evidence to the House of Commons Select Committee on NICE and the CFS/ME guidelines.

NICE Judicial Review Court Case (2009)
Add the court case background and links here.

Anglie ME Action have reported on the judicial review

Move to static list (2013)
On September 2013 NICE placed the CFS/ME guidelines CG53 on a static list and confirmed they won't be reviewing them, this then led to protests from patients, researchers and clinicians; and a guideline review was announced in September 2017. There were considerable concerns raised on 2013.

The Countess of Mar and Forward-ME said "We express our extreme concern over this proposal and strongly feel that the guideline must remain on the active list for the following reasons. Medical and scientific advances in relation to ME and CFS are taking place very rapidly. ". This was a joint letter was signed by a number of ME Charities.

The ME Association opposed the plan to place it on static list and wrote a submission with four reasons including that "Along with most other ME/CFS charities, and people with ME/CFS, we have been unable to endorse the current NICE guideline." .

Patients and patient advocacy groups are not in favor of the NICE guidelines and on June 25th 2014 the Forward-ME Group met with Prof Mark Baker, Director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence (NICE)]. Professor Baker that the ME/CFS Guideline did not meet patient needs nor those of NICE. He said the Guideline did not promote innovation and only a "passive" intervention such as CBT and Graded Exercise. "There was not much of an evidence base to go on, and in NICE it was evidence that drove guidance."

Doctor Speedy weighs in with Is it NICE guidelines or NONSENSE guidelines? and the ME Association's Dr. Charles Shepherd pointed out during a meeting with Dr. Martin McShane of NHS England "that graded exercise therapy was causing harm to patients and that if a drug was causing harm, guidelines would be reviewed immediately."

A FOI request to NICE about the US developments was submitted to NICE in 2016 and they responded to it in 2016 in which they dismissed foreign work on ME/CFS.

NICE 10 year surveillance (2017)
In June 2017 stakeholders were advised that NICE would consider reviewing the guidelines. In July NICE stated they decided not to review the guidelines.

A petition to NICE 'The NICE guideline for CFS/ME is not fit for purpose and needs a complete revision' gathered over 15,000 signatures

All patient stakeholders requested that guidelines be reviewed.


 * The MEAction Network's response to NICE stated the NICE guidelines be reviewed and "Given the context of this discrimination, we ask that the updated NICE guidelines be made clearer to account for the limitations of the evidence, patient reports of long term relapse following graded exercise, and the importance of genuine patient choice without reprisal".


 * Invest in ME's response to NICE stated the NICE guidelines be reviewed.


 * Forward-ME's response to NICE stated the NICE guidelines be reviewedand included "Because the current guideline directs patients squarely towards behavioural management, it clearly does obstruct patients’ access to biological testing, treatment and support. To avoid this ethical violation, we request that the guideline be revised to present a truthful, neutral picture of the current debate about the nature and management of CFS/ME. ".


 * Hope for ME Fibro response to NICE stated the NICE guidelines be reviewed.


 * ME Association's response to NICE stated the NICE guidelines be reviewed..


 * Action for ME response to NICE stated the NICE guidelines be reviewed and "strongly disagrees with the proposal not to update the guideline for the following reasons...There is not, at the present time, a conclusive evidence base for treatments for CFS/M.E., including those recommended in the guideline, such as CBT and/or GET.".


 * Tymes Trust response to NICE stated the NICE guidelines be reviewed.

The ME Association petition represents biggest expression of no confidence in a NICE guideline ever recorded.

A letter was also sent to the Chief Executive of NICE Sir Andrew Dillon

Dr David Tuller in his investigation stated NICE did not disclose the names of the topic experts to the Countess of Mar and the ME Association and himself were also awaiting for a response to the names

A letter to the Chief Medical Officer was sent by the MEA.

Dr Charles Shepherd of the MEA wrote to NICE in July 2017 to ask for further information on the team that decided to not review the guidelines but NICE refused. He followed up with another email in August but this also did not respond to the request asked and stated " remain very disappointed that NICE is unwilling to release the names of members of a group who have been involved in producing what is a very unpopular conclusion regarding the possible updating of the NICE guideline on ME/CFS" and correspondence continued.

Dr Diane O’Leary, Kennedy Institute of Ethics of Georgetown University, Washington DC, said to the Forward ME Parliamentary meetingthat "Guideline as it stands is unethical".

Dr Tuller's own FOI request was rejected on 31 July 2017 for the names of the experts.

Dr David Tuller also wrote to the NICE Chief Executive, Sir Andrew Dillon, with 15 questions of which none were responded to.

Dr David Tuller submitted an additional FOI request for the NICE Topic Expert Reports which were provided to him. Tuller examined these and said " this set of comments is the best NICE could drum up in seeking external guidance for this critical review process is deeply worrying." .

Due to the shock that the NICE guidelines were not reviewed, MEAction supporters raised a parliamentary petition called an Early Day Motion (271) in September to put further pressure on NICE.

On 20 September 2017 due to the pressure on NICE it announced that instead a full review would take place effectively overturning the previous expert advice not to.

The Times on 24 September reported it as 'Mutiny by ME sufferers forces a climbdown on exercise treatment' and the article described the patient revolt over  the reassessment of  NICE Guidelines was over the validity of the PACE trial.

Dr David Tuller reported on it Trial By Error: NICE Rejects Current Guidance, Plans “Full Update”.

Jennifer Brea was interviewed in The Times for the Unrest film in which she criticised  the British approach on CBT/GET and the NICE guidelines in the UK  as “not an easy place to have ME”. . The Telegraph reported on the Unrest film with the article 'Could this documentary change the way we perceive chronic fatigue syndrome?' and   Brea  said of the NICE guidelines   “I hope the UK will look at the science and update the guidelines”.

Dr Tuller also wrote another letter to Sir Andrew Dillon questioning why CFS/ME was also stated under 'Improving Access to Psychological Therapies' (IAPT) and furthermore in another NICE guideline 'Suspected Neurological Conditions' where CFS/ME was wrongly categorised as Medically Unexplained Symptoms.

NICE CFS/ME Guideline Revision (2018)
The public pressure from ME patients, including a petition by the ME Association, led to the decision to fully revise the guideline and which would not be concluded until around October 2020.

NICE held a Stakeholders Engagement Workshop on 16 January 2018 and a summary of the day has been produced by the ME Association.

Invest in ME wrote to Professor Mark Baker, Centre for Guidelines Director, on 15 January 2018 asking NICE to urgently remove or add an addendum or correction for the recommendation of CBT and GET now to avoid harm to patients. Prof Baker responded that they could not remove such recommendations for CBT and GET and had to wait for the full review of the guidelines which would be due in 2020. Invest in ME wrote back on 16 January repeating that they should at least add an addendum about CBT/GET. Patient advocates have commented that the right to refuse CBT/GET treatment as stated by Prof Baker is an offer you can't refuse.

An unprecedented proactive open letter to Sir Andrew Dillon was sent on 12 January  by ME sufferers regarding the composition of the new GDG committee due to the history of the  CFS/ME NICE guideline and committee and a 'Appeal to NICE concerning the Guideline Committee for ME/CFS' petition was also  launched to support this. ME sufferers from ME Analysis produced a video to accompany the letter and petition.

An unprecedented third petition was launched to NICE 'Stop harming ME/CFS patients - take CBT/GET out of NICE guidelines NOW' which asked that NICE immediately remove CBT/GET from the guidelines in the face of evidence of harm amounts to medical abuse and violation of human rights.

In a BBC Newsround article it was again stated by patient groups that the guideline for CBT/GET should be withdrawn immediately but this was refuted by a statement by the "country's leading ME researchers" that they should not. It was later clarified that many of the proponents were involved in the PACE trial. The article stated that in 2018 "NICE admits there is "controversy" around existing treatments".

A scoping workshop was undertaken on 25 May 2018. It was announced that the new Chair of the GDG would be Dr Peter Barry and the Vice Chair Ilora Finlay. A draft scope consultation was also produced. The terminology was changed from CFS/ME to ME/CFS and the new guideline was 'Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management' GID-NG10091. Some stakeholders were not notified until the night before of the workshop. Others raised some concerns with the stakeholder workshop.

Positive Health magazine reported on 'What Can We Expect from the Current Review of NICE Guideline CG53' and concluded that the BPS psychiatric proponents would still try to influence the guidelines to retain the status quo.

Learn more

 * NICE guidelines CG53 stakeholder comments (PDF) - 2017