Technical ReportPDF Available

NICE Submission (Dr KN Hng, lead author) Group feedback submission to the National Institute of Clinical Excellence and Health consultation draft guidelines on Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management

Authors:
  • Doctors with M.E.

Abstract

Group feedback submission to the National Institute of Clinical Excellence and Health consultation draft guidelines on Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Please read the checklist for submitting comments at the end of this form. We cannot accept forms that are not
filled in correctly.
We would like to hear your views on the draft recommendations presented in the guideline, and any comments you
may have on the rationale and impact sections in the guideline and the evidence presented in the evidence reviews
documents. We would also welcome views on the Equality Impact Assessment.
In addition to your comments below on our guideline documents, we would like to hear your views on these
questions:
1. Which areas will have the biggest impact on practice and be challenging to implement? Please say for whom
and why.
2. Would implementation of any of the draft recommendations have significant cost implications?
3. What would help users overcome any challenges? (For example, existing practical resources or national
initiatives, or examples of good practice.)
See Developing NICE guidance: how to get involved for suggestions of general points to think about when
commenting.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Organisation name
Stakeholder or
respondent (if you are
responding as an
individual rather than a
registered stakeholder
please leave blank):
This is a joint submission by:
Dr. K.N. Hng Doctor, ME patient and author of “M.E. and Me: A Doctor’s Struggle with Chronic Fatigue Syndrome”.
Dr. Nigel Speight Consultant Paediatrician and ME Specialist, Co-author of “International Consensus Primer” and “ME/CFS
Diagnosis and Management in Young People: A Primer”, Medical Advisor of several ME/CFS charities.
Dr. Jonathan Kerr Consultant Microbiologist & ME Researcher, Norfolk & Norwich University Hospitals.
Prof. Malcolm Hooper Professor Emeritus of Medicine Chemistry, University of Sunderland.
Author of “MAGICAL MEDICINE: HOW TO MAKE A DISEASE DISAPPEAR.
Dr. Sarah Myhill GP, ME/CFS specialist and co-author of "Chronic fatigue syndrome and mitochondrial dysfunction" and
"Mitochondrial dysfunction and the pathophysiology of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)".
Dr. Nina Muirhead Dermatology Surgeon and ME patient, Chair of CMRC Medical Education Working Group.
Karl Morten, PhD Principal Investigator in Mitochondrial Diseases, Morten Group, Department of Women’s and Reproductive
Health, University of Oxford.
James WL Strong ME patient, data science collaborator & MSc candidate (Medical Statistics), Morten Group, University of
Oxford.
Dr. Rohen Kapur Psychiatrist (ret.) and ME patient
Dr. Tamar Morton Jones GP and ME patient
Natalie Boulton Wellcome public engagement fund award holder for "Dialogues for a neglected illness”(ME/CFS), long-term
carer for daughter with ME.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Susan Taylor-Brown, PhD ME patient and Clinical Professor of Paediatrics (ret.), University of Rochester Medical School.
Dr. Janet Campbell Psychoanalyst and ME patient, Ex-Reader in Psychoanalysis and Literature, University of Birmingham.
Ian Campbell ME/CFS patient and former:
City of Edinburgh SNP Councillor, SNP Spokesperson for Health and Social Care for the City of Edinburgh, Member of Lothian
NHS Health Board, Member of Edinburgh Integrated Joint Board for Health and Social Care, Member of COSLA Wellbeing
Board.
Sławomir Kujawski, PhD – Cognitive scientist, Department of Hygiene, Epidemiology, Ergonomy and Postgraduate Education,
Ludwik Rydygier Collegium Medicum in Bydgoszcz Nicolaus Copernicus University in Torun, Poland.
Millions Missing France a patient group
Heather Hill ME patient, Psychotherapist and former Mental Health Nurse.
Michelle Oswald ME patient, Occupational Therapist and Founder of OTs for ME.
Nicolas Else ME patient and Millions Missing advocate
Dr. Richard Ramyar Visiting Scholar with a special interest in the industry and macroeconomic implications of public policy
versus post-viral diseases.
Jane Samuel Severe ME sufferer
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Disclosure
Please disclose any past
or current, direct or indirect
links to, or funding from,
the tobacco industry.
None
Name of commentator
person completing form:
Dr. K.N. Hng, MBChB, MRCP, PG Cert in WBME, FHEA.
Type
[office use only]
Co
mm
ent
nu
mbe
r
Document
[guideline, evidence
review A, B, C etc.,
methods or other (please
specify which)]
Page
number
Or
‘general’
for
comments
on whole
document
Line
numbe
r
Or
‘general’
for
comments
on whole
document
Comments
Insert each comment in a new row.
Do not paste other tables into this table, because your comments could get lost type directly into this table.
1
Guideline front page
1
in box
Change:
This guideline will replace NICE guideline CG53 (published August 2007).
2
Spelling
general
general
“fatigability” should be spelt “fatiguability” throughout the document.
3
Guideline
general
general
We are concerned about the emphasis on specialist teams. This is because:
Current specialist teams are not fit for purpose.
Many are led by Psychiatrists or Psychologists instead of Physicians, Paediatricians or General
Practitioners. Since ME/CFS is a complex, multi-system, chronic medical condition, this is inappropriate.
Current specialist clinics work on the theory of deconditioning and promote outdated and harmful treatments
(GET and CBT).
They do not provide adequate ongoing care, and none at all to the very severely affected ME/CFS patients
who need them the most. Patients struggle physically, financially and cognitively to get to appointments and
need a lot of their care and assessment at home. Such patients are discharged without any alternative
provision.
They cannot handle the volume of ME/CFS patients.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Their existence disempowers General Practitioners and local Physicians/Paediatricians, many of whom have
disengaged from their ME/CFS patients.
Therefore we propose that:
Instead of specialist teams, ME/CFS should be managed locally by General Practitioners, Physicians and
Paediatricians, who are best placed to provide ongoing care.
All Physicians, Paediatricians and General Practitioners should be educated in and made competent in
diagnosing and managing ME/CFS. We already have the knowledge, expertise and educational materials to
be able to roll out basic information very quickly, with the right institutional support.
Existing specialist teams should be abolished and General Practitioners and local Physicians/ Paediatricians
should take ownership of their ME/CFS patients.
Local General Practitioners, Physicians and Paediatricians are responsible for co-ordinating care, providing
regular reviews, home visits, responding to patients’ concerns, and advising other agencies as necessary
such as social welfare, employment and education.
Only a few select specialist centres should remain. These should be led by Physicians, Paediatricians or
General Practitioners and serve an advisory, training and educational role only, or be developed to provide
specialised inpatient services for ME/CFS patients.
The performance of local ME/CFS services be regularly audited.
4
The role of infection
general
general
We are concerned that no effort at all is made in this guideline to address the fact that ME is often triggered by a viral
or other infection, and the importance of identifying and treating these infections quickly. For best effect, treatment
needs to be started within the first 6 weeks, yet the NHS currently neither tests for nor treats infections in suspected
ME/CFS. Comprehensive testing to identify viral and other infections should not wait until the diagnosis of ME is
confirmed after 3 months of symptoms, but should be done immediately. With effective treatment, long term
sequelae might be greatly reduced, or avoided altogether.
Particular attention should be paid to infection aspects in the history, and these should be recorded in the patients
case notes. For example, fevers, night sweats, rashes, lymphadenopathy, joint pain and swelling. The progression of
disease in relation to these symptoms should be recorded and their relationship with laboratory diagnosed infections,
vaccinations, and known exposures to other persons with known infections.
We would recommend that the ME Infection Screen be performed immediately upon suspicion of ME/CFS, or any
presentation with significant fatigue. This should be done by the local ME/CFS service if referral to an Infectious
Diseases specialist would introduce unacceptable delay. The ME Infection Screen should look for:
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Enteroviruses, especially Coxsackie B by PCR on faeces specimen.
Herpes viruses, including Epstein Barr virus (EBV), Cytomegalovirus (CMV), Human Herpes Virus 6 (HHV-6)
by serology and quantitative PCR on blood.
Polioviruses by PCR on relevant body fluid.
Parvovirus B19 by serology and PCR on blood.
Adenoviruses by serology and PCR on blood.
intra-cellular organisms such as Borrelia (Lyme), Chlamydia, Mycoplasma and Rickettsia (see below).
The International Consensus Primer provides guidance on infection and immunological testing on page 11. These
tests should be made routinely available on the NHS. http://bit.ly/IntConsPrimerME2012
Other tests to include are:
VP1 for enterovirus
antibodies to EBV dUTPase and DNApol
EBV induced gene 2 (EBI2), which is upregulated in peripheral blood mononuclear cells (PMBC).
Treatments such as valacyclovir and valganciclovir should be made available to treat EBV and other herpes viruses.
Pooled human immunoglobulin can be used to treat enteroviruses, and should be investigated further in clinical trials.
Lyme Disease and other pathogens require their own drug protocols.
5
Pharmacological
options
general
general
We are concerned that no guidance at all is given on pharmacological options that may be helpful. There is sufficient
experience, if not research evidence, to suggest that human immunoglobulin, vitamin B12, antivirals, pyridostigmine,
melatonin, cannabinoids, low dose naltrexone, etc. could help with different aspects of the illness.
6
Guideline Principles
of care
pg. 4
lines 5-6
Change to:
“…is a complex, chronic medical condition affecting multiple body systems, including neurological, autonomic,
metabolic, endocrine, and immune systems. There is mitochondrial dysfunction affecting cellular energy production.
Exact pathophysiology is still being elucidated. ME/CFS is classified by the World Health Organisation and by
SNOMED-CT as Neurological.
Rationale: This helps underline the biological nature of the illness.
References:
“Cellular bioenergetics is impaired in patients with chronic fatigue syndrome”
https://doi.org/10.1371/journal.pone.0186802
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
A SWATH-MS analysis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome peripheral blood mononuclear
cell proteomes reveals mitochondrial dysfunctionhttps://doi.org/10.1186/s12967-020-02533-3
“Chronic fatigue syndrome and mitochondrial dysfunction” http://www.ijcem.com/files/IJCEM812001.pdf
“Mitochondrial dysfunction and the pathophysiology of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
(ME/CFS)” http://www.ijcem.com/files/IJCEM1204005.pdf
Substrate utilisation of cultured skeletal muscle cells in patients with CFS
https://www.nature.com/articles/s41598-020-75406-w
An Isolated Complex V Inefficiency and Dysregulated Mitochondrial Function in Immortalized Lymphocytes from
ME/CFS Patientshttps://pubmed.ncbi.nlm.nih.gov/32041178/
Human Herpesvirus-6 Reactivation, Mitochondrial Fragmentation, and the Coordination of Antiviral and
Metabolic Phenotypes in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
https://www.immunohorizons.org/content/4/4/201
7
Guideline Principles
of care
pg. 4
lines
10-11
Add:
in its most severe form it can lead to substantial incapacity and even death…”
8
Guideline Principles
of care
pg. 4
line 15
Add to paragraph:
“Symptoms are exacerbated by exertion.”
9
Guideline Principles
of care
pg. 4
line 21
Insert new point:
1.1.3 The Biopsychosocial (BPS) Theory: The BPS theory has proved extremely damaging in ME/CFS and should
be discarded. It has played a central role in perpetuating disbelief in ME/CFS as an organic entity, and is
responsible for much of the neglect, disbelief and mismanagement to which the ME/CFS patient community has
been subjected over the years. Its basic tenet is that ME/CFS does not really exist, but instead is a non-disease
caused by a combination of faulty illness beliefs on the part of the patient, combined with deconditioning. It totally
fails to explain the existence of multiple other symptoms in addition to fatigue, the existence of epidemics, nor the
existence of the severe end of the spectrum of illness. Neither does it explain why Graded Exercise Therapy and
Cognitive Behavioural Therapy have failed so spectacularly to cure ME/CFS.
Rationale: In 2002 the Report of the Working Party to the Chief Medical Officer made a statement that ME/CFS was
a genuine medical illness. Yet eighteen years later there is still a need to repeat this. Therefore something more
emphatic and explicit is needed this time round. Many doctors still fail to accept the reality of ME/CFS as an organic
entity. A survey of trainee physicians in England found that 82% still see ME/CFS as partly or wholly psychosomatic.
The likely reason for this is the persistence of the Biopsychosocial Theory, and the failings of medical education to
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
discredit it. https://bit.ly/2yFAtY8
10
Guideline Principles
of care
pg. 5
line 23
Change to:
health and social care professionals, teachers and schools
11
Guideline Principles
of care
pg. 6
line 16
Complete the sentence:
extreme weakness, with severely reduced movement, even paralysis or near paralysis.”
12
Guideline Principles
of care
pg. 6
line 22
Add a symptom:
gastrointestinal difficulties such as abdominal pain, nausea…”
13
Guideline Principles
of care
pg. 6
lines
24-25
Complete the symptom list:
neurological symptoms such as “brain fog”, headaches, photophobia, dizziness, ataxia, incoordination, double vision
and other visual disorders, fasciculation.”
14
Guideline Principles
of care
pg. 7
line 7
Complete the sentence:
taking into account possible sensitivity to touch, the need to speak softly and/or work in dimmed light, and the need
to avoid perfumes or other strong smells.”
15
Guideline Principles
of care
pg. 7
line 8
Elaborate:
“need aids such as manual or electric wheelchairs, mobility scooters, hoists, stair lifts, hospital beds and/or pressure-
relieving mattresses.”
16
Guideline
Suspecting ME/CFS
pg. 8
line 9
Add to the sentence:
“baseline investigations to exclude other diagnoses such as those listed in the Chronic Fatigue Syndrome Myalgic
Encephalomyelitis Primer for Clinical Practitioners 2014 Edition” at: http://bit.ly/IACFS-ME-primer-2014
Rationale: Current understanding is so poor, doctors need more guidance. The IACFS Primer does this very well.
17
Guideline
Suspecting ME/CFS
pg. 8
line 15
Add clarification to this bullet point:
“Compare to the patient’s own baseline. For example, being able to run only one mile a day may not seem like a
problem to ordinary folk, but for a marathon runner used to running ten miles a day this represents a significant
reduction.”
Rationale: This clarification helps ensure patients are not missed.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
18
Guideline
Suspecting ME/CFS
pg. 8
line 16
Remove bullet point: “symptoms are new and had a specific onset”
Rationale: Not all ME/CFS patients have a sudden onset of symptoms, many have a gradual onset. Yet others
have struggled for many years before diagnosis, and may not be able to pinpoint when their symptoms started.
Furthermore, a gradual onset can be mistaken for a sudden onset when patients erroneously perceive their illness to
originate from an event that was in actual fact just the proverbial last straw, in a person who was already ill but still
managing to cope.
19
Guideline
Suspecting ME/CFS
pg. 8-9
Box 1
The heading “unrefreshing sleep” should be replaced with “sleep disturbance”.
Rationale: “Unrefreshing sleep” is too specific and may cause some people to discount or not report the presence
of sleep disturbance.
20
Guideline
Suspecting ME/CFS
pg. 8-9
Box 1
These diagnostic criteria do not fit with the IOM criteria.
Box 1 requires four symptoms (fatigue, PEM, sleep disturbance, cognitive impairment) while IOM only requires three
(fatigue, PEM, sleep disturbance) plus one of two optional symptoms (cognitive difficulties, orthostatic intolerance).
Cognitive difficulty should NOT be an essential criteria for diagnosis.
Rationale: From my own experience, at the beginning I would not have classed myself as having cognitive
difficulties, because despite struggling desperately at work, likely partly because of cognitive difficulties, I was still
performing complex cognitive tasks. I completed a leadership training course and co-authored an online e-learning
module for Manchester Medical School.” (quote, Dr. Hng)
Thus, cognitive difficulty may not be obvious in the early phases of illness in people who have high baseline cognitive
function. Making it an essential requirement will wrongly exclude patients with high baseline cognitive function, or
others whose cognitive abilities are under challenged e.g. patients who are homemakers, unemployed, incarcerated,
neglected children, neurodiverse, etc.
The last bullet point in Box 1 should therefore read,
At least one of:
Cognitive difficulties (often described as “brain fog”) including problems finding words, temporary dyslexia
or dyscalculia, slurred speech, slowed responsiveness, short-term memory problems, confusion,
disorientation and difficulty concentrating or multitasking.
Orthostatic Intolerance (OI) with symptoms such as dizziness, fatigue, brain fog, palpitations, pallor,
nausea and fainting on standing or sitting upright from a reclining position.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
21
Guideline
Suspecting ME/CFS
pg. 9
lines 4-6
Remove. This symptom has been moved into Box 1.
22
Guideline
Suspecting ME/CFS
pg. 9
lines 17-
20
Change to:
“Do not delay making a provisional diagnosis of ME/CFS if a person meets the criteria set out above. ME/CFS
should be regarded as a positive clinical diagnosis based on the taking of a careful and thorough history. It is not a
"diagnosis of exclusion", although other conditions need to be excluded. Post-exertional worsening is a cardinal
symptom. As soon as ME/CFS is suspected, give the patient advice to avoid over-exertion.”
23
Guideline Advice for
people with
suspected ME/CFS
pg. 10
line 20
Elaborate:
to listen to their bodies and rest as they need to. It is important to get enough rest and sleep, to give their bodies the
best chance of healing and achieving the best function possible in the long term.”
24
Guideline Making a
diagnosis
pg. 11
lines 5-6
Add to the sentence:
“Diagnose ME/CFS in a child, young person or adult who has the symptoms in recommendation 1.2.3 that have
persisted for 3 months, after excluding other possible causes for their symptoms, as in the Chronic Fatigue
Syndrome Myalgic Encephalomyelitis Primer for Clinical Practitioners 2014 Edition at: http://bit.ly/IACFS-ME-primer-
2014 Note finding no abnormalities on routine investigations is usual for ME/CFS, and ME/CFS is NOT Functional
Neurological Disorder (FND). A diagnosis of ME/CFS explicitly excludes the diagnosis of FND for symptoms that
relate to the ME/CFS.
Rationale: It is very important to rule out other pathologies, and also to prevent misdiagnosis as FND.
25
Guideline Making a
diagnosis
pg. 11
line 7
Insert additional points after 1.4.1, before 1.4.2:
1.4.2 Important exclusionary conditions (alternative diagnoses important not to miss):
Anaemias
Autoimmune diseases such as rheumatoid arthritis, lupus
Cardiac disease
Endocrine disorders such as diabetes, Addison’s disease, thyroid disease, menopause
Infectious diseases such as tuberculosis, HIV/AIDS, chronic hepatitis, Lyme disease
Intestinal diseases such as Coeliac or Crohn’s disease
Malignancies
Mitochondrial Diseases
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Neurological disorders such as multiple sclerosis, Parkinson's disease, myasthenia gravis
Primary psychiatric disorders and substance abuse (but not clinical depression)
Significant pulmonary disease
Primary sleep disorders such as sleep apnoea
1.4.3 Non-exclusionary conditions:
Entities that commonly occur in association with ME/CFS such as allergies, fibromyalgia, irritable bowel
syndrome, multiple chemical sensitivities, hypermobility and Ehlers Danlos Syndrome.
Any medical condition that has been adequately treated and is under control.
Any isolated physical abnormality or laboratory test that is insufficient to diagnose an exclusionary condition.
1.4.4 For more information on the pathophysiology and diagnosis of ME/CFS, see:
http://bit.ly/IntConsPrimerME2012
Rationale: Current understanding is so poor, doctors need more detailed guidance. The Chronic Fatigue Syndrome
Myalgic Encephalomyelitis Primer for Clinical Practitioners does this very well. http://bit.ly/IACFS-ME-primer-2014
26
Guideline Making a
diagnosis
pg. 11
lines 7-8
Change sentence to:
After diagnosis, refer adults to a Physician or General Practitioner trained in managing ME/CFS to develop a
management plan. Referral to a Psychiatrist is not appropriate in ME/CFS unless there is a psychiatric comorbidity,
as ME/CFS is not a mental health issue.
27
Guideline Making a
diagnosis
pg. 11
line 9
Change to:
“After diagnosis, refer children or young people to a Paediatrician.”
Rationale: We are recommending that the current centralised model of care be replaced with a community based
model, and medical education to ensure that every Paediatrician is able to diagnose and manage ME/CFS
competently.
28
Guideline Making a
Diagnosis
pg. 11
line 12
Insert additional point before grey box:
“Be aware that many ME/CFS symptoms and resulting behavioural adjustments (e.g. avoiding social contact,
spending large amounts of time in bed, palpitations) can be confused with depression or anxiety. Standard
screening questionnaires for depression and anxiety are inappropriate in ME/CFS as they will result in false
positives. Care must be taken not to confuse ME/CFS with depression or anxiety, as the treatments for these are
vastly different from the management of ME/CFS, and can result in great harm. The following table shows some
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
differences between ME/CFS and depression.”
Depression
Diagnosis
Requires mood change
Timing
Worst in mornings and improves later
Sleep pattern
Patients go to bed early and wake in the
early hours
Effect of exercise
Symptoms improve
Type of
Increased negative affect (apathy,
emotional change
hopelessness, suicidal ideation,
self reproach)
If you recover
Long list of things they would like to
Cannot imagine wanting to do anything
completely tomorrow,
do and achieve
what will you do?
Rationale: The misdiagnosis rate is extremely high (up to 40% in some studies), so this information is necessary.
29
Guideline -
Assessment and care
planning by a
specialist ME/CFS
team
pg. 11
line 13
Change heading to:
“Assessment and care planning by the local ME/CFS service
Rationale: We are recommending that the current centralised model of care be replaced with a community based
model.
30
Guideline -
Assessment and care
planning by a
specialist ME/CFS
team
pg. 11
line 15
Insert additional points before 1.5.1:
1.5.1 It is recommended that the current system of specialist clinics be replaced with a community based model of
care, so that overall responsibility for and ownership of ME/CFS patients now lies with General Practitioners, local
Physicians and local Paediatricians. The majority of existing ME/CFS clinics should be abolished, leaving only a
select few with advisory, training and educational roles. These should be led by Physicians, Paediatricians or
General Practitioners with training and experience in ME/CFS, not Psychiatrists. Some or all of these could be
developed to provide specialised inpatient services for ME/CFS patients.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Rationale:
Current specialist teams are not fit for purpose.
Many are led by Psychiatrists or Psychologists instead of Physicians, Paediatricians or General
Practitioners. Since ME/CFS is a complex, multi-system, chronic medical condition, this is inappropriate,
and in many cases has proven very harmful.
Current specialist clinics work on the theory of deconditioning and promote outdated and harmful treatments
(GET and CBT).
They do not provide adequate ongoing care, and none at all to the very severely affected ME/CFS patients
who need them the most. Patients struggle physically, financially and cognitively to get to appointments and
need a lot of their care and assessment at home. Such patients are discharged without any alternative
provision.
They cannot handle the volume of ME/CFS patients.
General Practitioners and local Physicians and Paediatricians are best placed to provide ongoing care for
ME/CFS patients, not remote specialist centres.
1.5.2 Local ME/CFS services should be led by Physicians, Paediatricians or General Practitioners with appropriate
training in ME/CFS, not Psychiatrists. Services should be community based, and at a minimum include Doctor(s),
Occupational Therapists and Social Workers. Early Occupational Therapy assessment and support is essential,
within a month of diagnosis, and patients often also need:
district or community nurse input to enable procedures to be carried out at home,
social care,
physiotherapy,
dietetic support,
psychological support and
home visits by their doctor.
All of these should be available at home should the patient require it. Every patient should have a designated case
worker from the local ME/CFS service responsible for co-ordinating all their health and social care needs. The case
worker is their first point of contact. Shared care arrangements between Physician/Paediatrician and Primary Care
can be useful.
Rationale: ME/CFS is a complex, multi-system, chronic medical condition, not a mental illness. General
Practitioners and local Physicians/Paediatricians are best placed to provide ongoing care for ME/CFS patients, not
remote specialist centres. Many ME/CFS patients need much of their care and support at home, not providing it this
way means care is simply denied. As ME/CFS is a chronic, debilitating and currently incurable condition,
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Occupational Therapy support is essential, and social care needs must be assessed and provided for.
1.5.3 As ME/CFS is a chronic, debilitating and currently incurable condition, Occupational Therapy is a key part of
management. Occupational therapists are trained in both physical and mental health care, in the social and medical
model. They are trained to assess and implement support for those whose health impact their ability to participate in
activities of daily living, including sleep, cognitive, sensory and physical tasks. The word “occupational” here refers
to any activity that one engages time in. This includes personal care, productivity (for example education, parenting,
employment, home making duties), leisure and social activities. Occupational therapists have core skills in:
Activity analysis.
Activity management.
Adaptive strategies including rest, energy conservation and pacing.
Environmental assessment and home modification.
Equipment prescription, including seating, beds, hoists and wheelchairs.
Ability to advise and signpost on for care support.
Ability to write reports for benefit applications.
Work place assessment and guidance, including the allied health professional (AHP) fitness for work report
to support people to remain in employment, and employers with advice on phased return to work.
Rationale: It is important to provide this information so that service providers and medical leaders involved in
designing ME/CFS services understand the central role of Occupational Therapy.
31
Guideline
Information about
ME/CFS
pg. 15
line 8
Add to the sentence:
advice about financial support, including applying for benefits, and provide medical evidence as required.”
32
Guideline
Safeguarding
pg. 16
lines 6-8
Change to:
“If Safeguarding assessments are required for people with confirmed or suspected ME/CFS, they should be carried
out or overseen by health and social care professionals who have training and experience in ME/CFS.”
Rationale: The current wording can be misconstrued to mean ALL confirmed or suspected cases of ME/CFS must
undergo Safeguarding assessment.
33
Guideline - Access to
care
pg. 18
line 24
Change to sentence:
“…supporting their applications for aids, appliances and financial support.”
34
Guideline - Hospital
pg. 19
line 29
Elaborate by adding:
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
care
“Staff should not use perfumes, deodorants or air fresheners.”
35
Guideline
Maintaining
independence
pg. 20
line 12
Add:
access to technology, including online access, voice to text software and text to voice (audio readout) software.”
36
Guideline
Maintaining
independence
pg. 20
line 16
Add to the paragraph:
“Provide medical evidence where necessary.”
37
Guideline
Maintaining
independence
pg. 20
line 8
Insert third bullet point to 1.8.7 after “mobility”:
“How they manage tasks that require going out of their home, such as shopping or taking children to school, and
whether they need help with these.”
Rationale: There is a huge unmet need for support, especially for single parents with ME.
38
Guideline
Maintaining
independence
pg. 20
lines
26-30
Change to:
For people with moderate, severe or very severe ME/CFS, consider providing or recommending aids and
adaptations such as:
For mobility a manual or electric wheelchair, mobility scooter, automatic or adapted car, blue badge,
sunflower lanyard, stair lift, walking aids, grab rails.
Daily living reclining chair, hoist, hospital bed, pressure relieving mattress, shower or kitchen stool,
blender, feeding cup or straw, speech to text software.
Environmental adaptations blackout blinds, extra dark sunglasses, sound proofed windows, special light
bulbs (daylight white), dimmable switches, blue light blocking glasses for screens, ear plugs, ear defenders,
noise cancelling headphones.
Remember that aids and adaptations do not just maintain independence and improve quality of life, they help people
with ME/CFS conserve energy and stay within their energy envelope, thus maintaining their level of health and
function.
Rationale: Patients’ needs must be explicitly stated as they are currently largely neglected and left to struggle on
their own. For example, wheelchairs are only provided if patients are completely unable to mobilise within their
homes. Difficulties mobilising outside of the home is not taken into account, nor is the need to conserve energy in
order to preserve function. Hospital beds are only provided in hospice situations which is grossly inadequate, given
that people with ME/CFS can be mostly or completely bedbound for many years or decades. No support at all is
given for sensory hypersensitivities.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
39
Guideline
Supporting people
with ME/CFS in work,
education and training
pg. 21
line 15
Insert additional point between 1.9.2 and 1.9.3:
Adjustments at work or education could include home schooling, working from home, flexible or reduced hours,
providing transport, designated parking space, a quieter work area with lower light settings, speech to text software,
text to speech software, audiobooks, ergonomic assessment, or a place to rest when needed.
Rationale: Useful, achievable suggestions are needed.
40
Guideline
Supporting people
with ME/CFS in work,
education and training
pg. 22
lines
8-12
Replace with:
Advise children and young people with ME/CFS (and their parents and carers) that the pursuit of training or
education should not be at the cost of everything else. The child or young person’s need for family and social time or
other interests must be carefully balanced against the need for education, so that all activity fits within the child or
young person’s energy envelope and does not make his/her illness worse.
Rationale: The wording as it stands may place undue pressure on people with ME/CFS to take on more than they
can safely manage.
41
Guideline -
Multidisciplinary care
pg. 23
lines 5-6
Change to:
“Care for people whose ME/CFS is managed in primary care should be supported by a Physician, Paediatrician or
GP led local ME/CFS service.”
Rationale: We are recommending that the current centralised model of care be replaced with a community based
model.
42
Guideline
Multidisciplinary care
pg. 23
lines
7-10
Change to:
“Inform people with ME/CFS (and their family members and carers, as appropriate) of their designated case worker
from their local ME/CFS service, who will coordinate their management plan, help them access services and support
them during periods of relapse.
Rationale: Every patient should be assigned a case worker as their needs are very complex. Joined up service like
this is sorely lacking, with the result that ME/CFS patients are simply neglected. We are recommending that the
current centralised model of care be replaced with a community based model.
43
Guideline
Multidisciplinary care
pg. 23
lines
12-15
Change to sentence:
Provide parents and carers of children and young people with ME/CFS with details of a named professional in their
local ME/CFS service who they can contact with any concerns about their child’s health, education or social life.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
44
Guideline Energy
management
pg. 24
line 9
Remove and risks
45
Guideline Energy
management
pg. 24
line 23
Insert:
“improved and have been stable for some time, and allows for…”
46
Guideline Physical
activity
pg. 27
line 23
Change to:
Do not advise people with ME/CFS to undertake unstructured exercise that is not part of a supervised programme,
such as telling them to go to the gym or exercise more. Physical exercise can cause serious damage in ME,
resulting in severe relapse.”
47
Guideline Physical
activity
pg. 28
line 22
Add to the paragraph:
“A physical activity programme will not cure their ME/CFS. At best it may achieve a very gradual increase in
function. If not approached with great caution, it can easily provoke a relapse.
Rationale: Clarifies the role of a physical activity programme, and what the risks and benefits are.
48
Guideline Physical
activity
pg. 29
line 11
Insert third bullet point:
“incorporating extra periods of rest and sleep, listening to their bodies and resting or sleeping as much as they need
to.”
49
Guideline Rest and
sleep
pg. 29-30
pg. 29
pg. 29
line 18
line 22
The section on Rest and Sleep needs considerably more useful information:
Rationale: The advice on rest needs more substance, and the issue of sleep hasn’t been addressed in this draft.
Currently ill-informed advice including draconian “sleep hygiene” practices are severely harming patients, especially
children. (“Banned from sleeping”, Tymes Trust: http://bit.ly/TTBannedFromSleeping)
Change heading to:
“Rest periods – advise people with ME/CFS:”
Insert fourth bullet point:
“on how to rest. Patients may consider a sedentary activity such as reading to be rest, unaware that they are still
undertaking mental exertion. Proper rest includes lying down with their eyes shut, meditation, or sleeping.”
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
pg. 30
pg. 30
line 2
line 2
Add last bullet point:
“that it is important to listen to their bodies. They should resist the temptation to complete an activity but stop to rest
as soon as they feel a little tired. Pushing through will result in needing much more rest later and is counter-
productive.”
Insert additional point: 1.11.24 Sleep:
Sleep patterns are often disordered in ME/CFS. Patients should try to go with the flow if possible, and learn to
live with their natural rhythm, even if their sleep times are very abnormal or variable.
Getting sleep is more important than when they sleep.
In the early stages of the illness, hypersomnia is common. It is important that people with ME/CFS listen to their
bodies and sleep as much as they need to. This gives the best chance of recovery and functional improvement
in the long term.
Hypersomnia can also happen during flares and relapses. As always, patients should listen to their bodies in
order to get out of the flares or relapses.
Standard sleep hygiene practices may not be appropriate in ME/CFS, such as strictly limiting daytime sleep.
Education should be provided flexibly to enable children and young people with ME/CFS to get the sleep they
need.
Where it is necessary to adjust a patient’s sleep pattern, e.g. to fit around work hours, melatonin or other
sedatives can be tried. Changes should be made gradually in small increments.
Insomnia is a common problem. Melatonin, low dose amitriptyline or other sedatives can be tried. Start low and
go slow ME/CFS patients are very sensitive to medication and prone to side effects. Formal sleep studies may
be required in some patients to diagnose concomitant sleep disorders.
On waking, patients often experience a period of profound weakness or paralysis, subjectively experienced as
“heaviness” or “dead weight”, in which they are unable to move. This takes a variable amount of time (hours) to
wear off completely, and may be felt to some degree even after patients manage to get out of bed.
50
Guideline Managing
orthostatic intolerance
pg. 30
lines
3-12
Remove and replace with:
Managing Orthostatic Intolerance (OI)
1.11.24 Orthostatic Intolerance is extremely common in people with ME/CFS. Symptoms include dizziness, fatigue,
brain fog, palpitations, pallor, nausea and fainting. In severe cases, symptoms can be triggered just by sitting up.
Orthostatic stress can trigger Post Exertional Symptom Exacerbation (PESE) in people with ME/CFS. The most
common forms of OI are Postural Orthostatic Tachycardia Syndrome (POTS), Neurally Mediated Hypotension
(NMH), and orthostatic hypotension (OH). These syndromes are not mutually exclusive. Patients with ME/CFS can
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
also have orthostatic intolerance with significant reduction in cerebral blood flow without any associated changes in
blood pressure or heart rate.
POTS is characterized by an increase in heart rate between the supine position and 10 minutes of standing.
It is defined as an increase of more than 30 bpm for adults or 40 bpm for adolescents, or a heart rate that
reaches 120 bpm or higher during the first 10 minutes of upright posture in the absence of orthostatic
hypotension. This change in heart rate must also be accompanied by characteristic orthostatic symptoms.
Neurally mediated hypotension is a drop in systolic blood pressure of at least 25 mm Hg during standing
or upright tilt testing compared with supine systolic pressure. Typically, it is preceded by orthostatic
symptoms of lightheadedness, nausea, pallor, and warmth, and it is accompanied by slowing of the heart
rate.
Orthostatic hypotension involves an immediate and sustained drop of at least 20 mm Hg in systolic
pressure or 10 mm Hg in diastolic pressure in the first 3 minutes of standing or upright tilt. Although this is
uncommon in ME/CFS, a delayed form has been reported in which blood pressure changes occur after 3
minutes upright.
1.11.25 ME/CFS patients are often unable to tolerate a full tilt table test, which can trigger a relapse in their illness.
Instead, diagnosis may be made using the NASA 10 Minute Lean Test. The following testing strategy is suggested:
Perform the NASA 10 Minute Lean Test for any patient with ME/CFS who is able to tolerate sitting with their
feet on the ground for longer than a few minutes without triggering post-exertional symptom exacerbation
(PESE) lasting longer than a few days: http://bit.ly/BHC-10minLeanTest
If a NASA 10 Minute Lean Test is negative, perform a full tilt table test to exclude Orthostatic Intolerance.
Consider if the patient is likely to tolerate this ask him/her how long he/she can usually sit or stand for
without triggering PESE and whether he/she can attend outpatient appointments without triggering PESE.
For patients with severe OI, who are unable to sit with their feet on the ground for longer than a few minutes
without triggering PESE, a supine to seated version of the NASA 10 minute Lean Test is suggested to
screen for orthostatic intolerance.
1.11.26 Patients with Orthostatic Intolerance should be referred to a specialist with an interest in Orthostatic
Intolerance, such as those listed on https://www.potsuk.org/specialists. Consider providing compression hosiery (at
least thigh high and at least 20-30mmHg compression) and increasing salt and fluid intake whilst awaiting specialist
input, and avoiding triggers such as overheating, alcohol and medications that could be contributing. POTS UK is a
useful source of information. https://www.potsuk.org/gp_guide
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
1.11.27 Pharmacological treatments for Orthostatic Intolerance should be prescribed by specialists with experience
in managing Orthostatic Intolerance. If significant delay in accessing specialist input is anticipated, medications such
as fludrocortisone, pyridostigmine and midodrine may be cautiously tried with advice from a clinician experienced in
managing Orthostatic Intolerance. Ensure there are no contraindications, start low (e.g. half the normal dose or less)
and go slow ME/CFS patients are often very sensitive to medications and prone to adverse effects. Monitor
progress and be alert for side effects. The NASA 10 Minute Lean Test may be repeated to monitor progress.
1.11.28 All doctors involved in the care of ME/CFS patients must endeavour to educate themselves in the
management of Orthostatic Intolerance. POTS UK provides a comprehensive lecture series and several guidelines.
When implementing management strategies, be mindful of the limitations of people with ME/CFS.
https://www.potsuk.org/lectures
https://www.potsuk.org/guidelines
https://batemanhornecenter.org/education/me-cfs/
1.11.29 If there are concerns that another condition may be the cause of orthostatic symptoms, refer to secondary
care as appropriate.
Rationale: The guideline here is totally inadequate and effectively leaves patients without any help at all. It is
unrealistic and unhelpful to recommend that only specialists be allowed to prescribe drug treatments for OI, as these
specialists are few and far between. Most Cardiologists have no interest in OI, and will simply discharge the patient
if they are unable to tolerate a tilt table test. Most GPs do not know where or how to find a specialist in Orthostatic
Intolerance. If a specialist is found, the distance is likely to be prohibitive for people with ME/CFS, nor can the small
number of specialists realistically provide enough care for ME/CFS patients as a whole. The POTS UK website lists
only 34 specialists, and some of these do not accept new referrals or referrals out of region.
Therefore it is much better to:
1. Provide some basic management advice.
2. Recommend that all doctors involved in the care of ME/CFS patients educate themselves on how to manage
this debilitating symptom.
3. Provide resources with which this education can start.
4. Allow doctors involved in the care of ME/CFS patients to prescribe medications for Orthostatic Intolerance.
5. Allow generalists to gain experience and expertise in managing Orthostatic Intolerance. Only with this
approach will the needs of ME/CFS patients be met in the long term.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
51
Guideline Managing
nausea
pg. 31
lines 1-4
Change to:
“Managing abdominal pain and nausea
1.11.28 Encourage people with ME/CFS who have abdominal pain or nausea to keep up adequate fluid intake and
advise them to try to eat regularly, taking small amounts often.”
52
Guideline Managing
nausea
pg. 32
line 5
Add:
“…complications caused by abdominal pain or nausea…”
53
Guideline Dietary
management
pg. 33
line 2
Insert additional point after line 2:
1.11.40 Consider Mast Cell Activation Syndrome and Coeliac Disease in patients with multiple food intolerances.
54
Guideline Dietary
management
pg. 33
line 11
Insert:
abdominal pain, nausea or difficulty swallowing and chewing.”
55
Guideline
psychological support
pg. 34
line 1
Change title to:
“Psychological support for living with a chronic disabling illness
Rationale: CBT should be removed from the title as psychological support does not need to be in the form of CBT.
Adding the clarification of ‘for living with a chronic disabling illness’ to the title helps prevent any misunderstanding
that psychological support is still being recommended as a treatment for ME/CFS.
56
Guideline
Psychological support
pg. 34
lines 2-5
Change to:
Psychological therapy, including CBT, is not a treatment or cure for ME/CFS. Only offer formal psychological
support to people with ME/CFS who would like to use it to support them in managing their symptoms of ME/CFS
living with chronic illness and to reduce the psychological distress associated with this. Apart from CBT,
psychological support can include various modalities of psychotherapy and supportive counselling.“
Rationale: CBT isn’t appropriate for everyone and psychological support does not have to be in the form of CBT.
Psychological therapy does not manage symptoms of ME/CFS. It manages the associated psychological distress.
57
Guideline
Psychological support
pg. 34
lines
17-18
Remove the portion after comma:
“…does not assume people have ‘abnormal’ illness beliefs and behaviours as an underlying cause of their ME/CFS,
but recognises that thoughts, feelings, behaviours and physiology interact with each other.
Rationale: To use this as part of the CBT guideline for ME/CFS places too much emphasis on the notion that the
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
patient has control over the subtype, severity, nature (progressive vs. relapsing and remitting), duration and
prognosis of their ME/CFS. Some practitioners may infer from this that recovery is possible with appropriate
thoughts, feelings and behaviours and/or that inappropriate thoughts, feelings and behaviours are causing or
perpetuating the disease. To attempt to treat a patient based on this premise could cause harm.
58
Guideline Managing
coexisting conditions
pg. 36
line 7
Insert additional points between 1.12.2 and 1.12.3:
1.12.3 Where indicated, refer people with ME/CFS to other specialists who are able to help manage associated
conditions, such as Postural Orthostatic Tachycardia Syndrome (POTS), Fibromyalgia, Mast Cell Activation
Syndrome, etc.
1.12.4 Where people with ME/CFS need to access secondary care or other specialties, considerations in section 1.8
should be provided for as needed, and funded (e.g. doctor to visit patient at home). The number of trips to clinic or
hospital should be minimised, for example by co-ordinating investigations to be done at the same visit.
Rationale: Patients’ needs must be made explicit due to the poor current level of understanding.
59
Guideline Managing
flares and relapse
pg. 37
line 9
Add to sentence:
temporarily reducing activity levels and increasing rest periods or sleep
60
Guideline Managing
flares and relapse
pg. 38
lines 8-9
Changes to sentence:
advise the person to contact their named contact in the primary care team or case worker from their local ME/CFS
service for review.
61
Guideline - Review
pg. 39
lines
8-10
Changes to sentence:
“When undertaking a review in primary care, ensure you have access to the person’s management plan and (if
relevant) letters from the local ME/CFS service.
62
Guideline - Review
pg. 39
lines
21-22
Changes to sentence:
Refer the person with ME/CFS to their case worker from their local ME/CFS service if there are any new or
deteriorating aspects of their condition.”
Rationale: We are recommending that the current centralised model of care be replaced with a community based
model.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
63
Guideline - Review
pg. 40
line 9
Add new subsection: People with severe or very severe ME/CFS
1.14.9 People with severe or very severe ME/CFS should be reviewed in their homes as getting to clinic will cause
a significant flare or relapse.
Rationale: There is poor understanding of the needs of severely and very severely ill ME/CFS patients which results
in inadequate care.
64
Guideline Training
for health and social
care professionals
pg. 40
line 12
Insert additional points before 1.15.1:
1.15.1 ME/CFS should be included in the undergraduate medical curriculum, and postgraduate Physician,
Paediatric and General Practice curriculums. All doctors should understand that ME/CFS is a complex, multi-
system, chronic medical illness, not a psychological or psychiatric condition. It is classified by the World Health
Organisation and by SNOMED-CT as Neurological. All Physicians, Paediatricians and General Practitioners must be
competent diagnosing and managing ME/CFS.
Rationale: For ME/CFS patients’ needs to be met, doctors must be properly educated. Current understanding is
extremely poor and most doctors believe ME/CFS is psychological. See: https://bit.ly/2yFAtY8
1.5.2 Medical education should begin immediately, given the current poor state of knowledge and attitudes.
Medical Schools must incorporate ME/CFS into the curriculum by the next intake in September 2021, and all doctors
graduating from July 2022 onwards must:
Understand that ME/CFS is a complex, multi-system, chronic medical illness, not a psychological or
psychiatric condition.
Know the most common symptoms of ME/CFS (debilitating fatigue, post-exertional symptom exacerbation,
sleep disturbance, cognitive difficulties, orthostatic intolerance, myalgia).
Know who to ask for help if they suspect ME/CFS (General Practitioner, Physician, Paediatrician).
Know that Graded Exercise Therapy and CBT based on the deconditioning theory is harmful in ME/CFS,
and that any exercise or physical activity programme requires great caution.
Rationale: The need for medical education is urgent. There is no reason for any delay as we already have the
knowledge, expertise and educational materials to be able to roll out basic information very quickly, with the right
institutional support.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
1.5.3 Health Education England, its equivalents in devolved nations and medical Royal Colleges must incorporate
ME/CFS into the postgraduate Physician, Paediatric and General Practice curriculums immediately, with the
following initial learning objectives (to be updated as scientific knowledge on ME/CFS grows):
Be able to take a thorough history and diagnose ME/CFS.
Be able to exclude other alternative diagnoses as appropriate.
Understand the biological nature of ME/CFS that it is not a psychological or psychiatric condition,
fabricated or fictitious.
Understand the long term nature of ME/CFS, the level of disability it can cause, and its impact on patients
and their families.
Know the common symptoms of ME/CFS and commonly associated conditions.
Know how ME/CFS can present to their own Specialty and common symptoms in relation to that.
Be willing to take a patient centred approach to management.
Know that Graded Exercise Therapy and CBT based on the deconditioning theory is harmful in ME/CFS
and reject their use as treatments for ME/CFS.
Know that any exercise or physical activity programme requires great caution in line with this guideline.
Understand ME/CFS patients hypersensitivity to medication and the need to start low and go slow.
Be able to provide medical evidence as needed to enable patients to obtain financial and social support, or
adjustments to work, education and training.
Be familiar with this guideline.
Competencies in these learning objectives must be demonstrated as a requirement for Certificate of Completion of
Training (CCT) from 1/1/2022.
Rationale: The need for medical education is urgent. There is no reason for any delay as we already have the
knowledge, expertise and educational materials to be able to roll out basic information very quickly, with the right
institutional support.
1.5.4 Physicians, Paediatricians and GPs who have achieved CCT before 1/1/2022 must undertake continuous
professional development in ME/CFS to bring themselves up-to-date. Their compliance with this must be reviewed
at their next appraisal and their next GMC revalidation.
65
Guideline Training
for health and social
care professionals
pg. 40
lines
17-18
Change to:
provide evidence-based content developed by and in collaboration with:
Practicing Physician and Paediatric ME/CFS experts who take a biomedical approach towards ME/CFS.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
Medical professionals who have ME/CFS, especially those who also have expertise in Medical Education.
Clinical and scientific experts including international experts.
People with ME/CFS.”
Rationale: Training programmes must be developed by the right people in order that the programmes reflect the
new, accurate and scientific narrative of illness.
66
Guideline
Recommendations
pg. 41
line 5
Insert new section: 1.16 Audit
The performance of ME/CFS services must be audited. Data such as these must be collected annually:
Time between initial presentation and diagnosis.
Length of symptoms before patients present.
Whether patients are managed by a formal community based ME/CFS service, existing generic local
services, a Psychiatrist or Psychologist led specialist clinic, or a Physician/Paediatrician/GP led specialist
clinic.
Whether patients have a designated case worker and who this is (OT, social worker, ME nurse, etc.)
Severity category mild, moderate, severe, very severe.
Severity category in the previous year and at initial presentation/diagnosis.
Time between diagnosis and first OT assessment. Whether this was done at home.
Whether patients received their regular review (annually for adults, 6 monthly for children). If not, why not.
Whether patients are in employment, education or training. Full time or part time.
Were patients or their families the subject of Safeguarding investigations. The outcome of the investigations.
The effect on the patients’ health.
Sample of patients’ views of the services.
Diagnostic process for ME/CFS including timeliness.
Are their health care needs being met, what needs to change.
Are their social care needs being met, what needs to change.
Are health services accessible, e.g. blood tests, patient transport, scans, appointments?
Are social services accessible, any barriers to access?
Do they feel supported and understood. If not, which part of the service is falling short.
Rationale: The care of people with ME/CFS has been grossly inadequate to date. It is imperative we make sure the
situation is improving, and learn from where it’s not working.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
67
Glossary section
pg. 44
lines
20-21
Changes to sentence:
Symptoms typically worsen 12 to 72 hours after activity and can last for days, weeks or even months.”
68
Glossary section
pg. 44
lines
27-28
Change to sentence:
“The person’s symptoms and level of disability may be similar to or worse than at illness onset.”
69
Glossary section
pg. 45
line 10
Add to paragraph:
“In extreme cases very severe ME/CFS can be fatal.”
70
Recommendations for
Research
pg. 45-47
From
line 23
til end of
section
Remove and replace with:
1. Research populations
Research populations must be well defined. They should only include people who suffer from ME/CFS, and
not other causes of fatigue such as depression, other mental health disorders, other major physical illnesses,
or idiopathic chronic fatigue.
Post Exertional Malaise (PEM) / Post Exertional Symptom Exacerbation (PESE) must be a minimum
inclusion criteria. Research subjects must also meet the diagnostic criteria set out in this guideline in section
1.2 and 1.4. Bear in mind that patients currently labelled as having ME/CFS may not have been diagnosed
using these criteria, and do not automatically qualify without further evaluation.
2. Research funding
Biomedical research into ME/CFS is urgently needed to:
Unravel the pathophysiology and causation of ME/CFS.
Find reliable biomarkers and identify accurate diagnostic tests that can be made easily accessible in the
clinical setting.
Find effective treatments.
Funding for biomedical research must be significantly increased commensurate with the disease burden of
ME/CFS (250,000 patients in the UK) compared to other diseases such as MS. This funding must be ring-
fenced for ME/CFS.
Funding for biomedical research into ME/CFS should be increased even further to catch up with 30 years of
gross underfunding and to move forward scientific understanding, diagnosis and treatments for people with
ME/CFS.
All research into exercise treatments, graded activity of any sort, and psychological treatments for ME/CFS
must no longer be funded. Any ongoing non-biological research in these areas must be discontinued, and
any upcoming research cancelled. Funding must be reallocated to biomedical research only, and any
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
current or future research applications for exercise treatments, graded activity of any sort, and psychological
treatments for ME/CFS must be rejected.
3. Research avenues
The following research avenues are encouraged and should be funded:
Drug treatments that have previously or anecdotally shown promise such as Human Immunoglobulin,
Ampligen, Pyridostigmine, LDN and CBD.
Objective diagnostics, including multi-modal identifiers, such as combined use of metabolomics and
biometrics.
Assessment of cognitive function, including after exertion.
Changes in physiology following exertion.
Development of new approaches to quantitatively assess PESE (e.g. blood biomarkers, stratification of
cognitive and physical PESE, autonomic assessments, intestinal permeability, and minimally injurious
induction of PESE necessary to ascertain a patient’s exertional response status).
Applications exploring the impact of transcriptional elements in cells such as Peripheral Blood Mononuclear
Cells (PMBCs) on mitochondrial function.
The translation of in vitro findings (e.g. impaired PMBC metabolism) into in vivo experiments using
techniques such as dynamic nuclear polarisation with 13C pyruvate/13C glutamine labelled substrates.
Management of the symptoms of ME/CFS, such as medications, activity management and dietary support.
Comparison with Long Covid subjects.
3. Research outcomes
Wherever possible, objective outcomes must be used rather than subjective outcomes. Examples of
objective outcomes are:
- objective measurements of activity such as actigraphy and 6 Minute Walking Distance.
- physiological measurements such as blood metabolite profile and Forced Expiratory Volume (FEV).
Subjective outcomes may supplement objective outcomes but cannot be the primary or only outcomes used.
Examples are:
- RAND Short Form 36v2 and DePaul PEM Questionnaire.
- data (not self-reported estimates) relating to school attendance, work or benefits.
- Fatigue indicators such as the Chalder Fatigue Scale and Fatigue Severity Scale should not be used in
isolation as they fail to account for PESE and in non-blinded scenarios are prone to confirmation bias.
Their low maximal ceilings do not allow for worsening of symptoms to be recorded.
Funders must seriously question any research proposal which plans to use only or mostly subjective
outcomes. We recommend that such studies are probably not needed for the advancement of the field of
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
ME/CFS.
4. Research governance and oversight
All individuals involved in the governance and oversight of research projects on ME/CFS must not have had stated
views which diverge from the primary findings of NICE’s research review on ME/CFS, as stated on this guideline.
This includes individuals involved in funding decisions, ethical reviews and approvals, peer reviews and systematic
reviews such as Cochrane reviews. The standards laid out in the UK policy framework for health and
social care research must be adhered to and public transparency and accountability throughout the process is
essential. This is to ensure methodological rigour and prevent repeat of the unscientific methods that have thus far
plagued this field, and also to ensure research effort into ME/CFS is focused on the right avenues.
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-
social-care-research/uk-policy-framework-health-and-social-care-research/
71
Guideline - context
pg. 71
lines 15-
19
Add to paragraph:
Recent data from the UK Biobank suggests that there are over 250,000 people in England and Wales with ME/CFS,
with about 2.4 times as many women affected as men. It is a complex, multi-system, chronic medical condition with
demonstrable abnormalities in immune, cardiovascular, autonomic, neurocognitive and mitochondrial function.
ME/CFS has considerable personal, social and economic consequences and a significant impact on a person’s
emotional wellbeing and quality of life.
Rationale: This helps underline the biological nature of the illness.
Insert extra rows as needed
Checklist for submitting comments
Use this comment form and submit it as a Word document (not a PDF).
Complete the disclosure about links with, or funding from, the tobacco industry.
Include page and line number (not section number) of the text each comment is about.
Combine all comments from your organisation into 1 response. We cannot accept more than 1 response from each
organisation.
Do not paste other tables into this table type directly into the table.
Ensure each comment stands alone; do not cross-refer within one comment to another comment.
Clearly mark any confidential information or other material that you do not wish to be made public. Also, ensure you state
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
in your email to NICE that your submission includes confidential comments.
Do not name or identify any person or include medical information about yourself or another person from which you or the
person could be identified as all such data will be deleted or redacted.
Spell out any abbreviations you use
For copyright reasons, do not include attachments such as research articles, letters or leaflets. We return comments forms that
have attachments without reading them. The stakeholder may resubmit the form without attachments, but it must be received by the
deadline.
We have not reviewed the evidence for the recommendations shaded in grey. Therefore, please do not submit comments
relating to these recommendations as we cannot accept comments on them.
We do not accept comments submitted after the deadline stated for close of consultation.
You can see any guidance that we have produced on topics related to this guideline by checking NICE Pathways.
Note: We reserve the right to summarise and edit comments received during consultations, or not to publish them at all, if we consider the
comments are too long, or publication would be unlawful or otherwise inappropriate.
Comments received during our consultations are published in the interests of openness and transparency, and to promote understanding of
how recommendations are developed. The comments are published as a record of the comments we received, and are not endorsed by NICE,
its officers or advisory Committees.
Data protection
The information you submit on this form will be retained and used by NICE and its advisers for the purpose of developing its guidance and
may be passed to other approved third parties. Please do not name or identify any individual patient or refer to their medical condition in your
comments as all such data will be deleted or redacted. The information may appear on the NICE website in due course in which case all
personal data will be removed in accordance with NICE policies.
By submitting your data via this form you are confirming that you have read and understood this statement.
For more information about how we process your data, please see our privacy notice.
Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management
Consultation on draft guideline deadline for comments 5pm on 22/12/20 email: cfs@nice.org.uk
Please return to: cfs@nice.org.uk
ResearchGate has not been able to resolve any citations for this publication.
ResearchGate has not been able to resolve any references for this publication.