The SMC gives voice to the usual suspects> White, Wessley,Chaulder, Sharpe and Miller who perpetuate that 'thing of beauty, The PACE trial.
NOVEMBER 10, 2020
expert reaction to NICE draft guideline on diagnosis and management of ME/CFS
NICE have released an updated draft guideline for the diagnosis and management of myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome (ME/CFS).
Prof Michael Sharpe, Professor of Psychological Medicine, University of Oxford, said:
“As the NICE report says, it is paramount that patients are listened to and their symptoms and concerns taken seriously. It is also essential that evidence-based rehabilitative treatments (graded activity/exercise and cognitive behaviour therapy) are given only to those patients who want them and then given in a personalized expert fashion in partnership with them. It is to hoped that these new guidelines improve the quality of delivery of these treatments. It is also to be hoped that the strongly stated concerns about the effect of badly delivered treatments, do not make it even harder for patients to access the well delivered, evidence-based treatments.”
Prof Trudie Chalder, Professor of Cognitive Behavioural Psychotherapy, Institute of Psychiatry Psychology & Neuroscience (IoPPN), King’s College London, said:
“Cognitive behaviour therapy (CBT) and graded exercise therapy (GET ) are evidence-based treatments for chronic fatigue syndrome (CFS) in that they facilitate reductions in fatigue and improve people’s quality of life if delivered by a qualified therapist. Previous reviews of the science provide the evidence. Our clinics are full of patients who are very keen to receive these evidence-based treatments and our patient reported outcomes support their use. My concerns are a) that patients should be offered these treatments to avoid a situation in which their condition stays the same or worsens b) that health professionals will stop offering evidence-based treatments.”
Dr Alastair Miller, Deputy Medical Director at the Joint Royal Colleges of Physicians Training Board (JRCPTB), said:
“As a consultant physician in general medicine and infectious diseases who has been caring for patients with CFS since the early 90s I found the previous NICE guidelines extremely useful in confirming the role of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) as evidence based useful therapies. We had previously followed their general principles in all the clinical settings where I had worked and it was very helpful to have the NICE guidelines available to support our approach. Not everyone improved with the advised approach but most did seem to have some benefit and in the absence of any other reasonable approach and no pharmacologic intervention, many of my patients seem to have benefitted over the years from CBT and GET. I am aware that there has been controversy over these approaches but there has never been any evidence of harm and they remain the only evidence based treatment approach in CFS. It is therefore extremely disappointing that NICE has chosen to exclude them from the updated guidelines and I certainly have concerns that this omission is based more on political pressure than good science. It will certainly deny many of our patients access to the therapies that offer their best chance of recovery.”
Prof Sir Simon Wessely, Regius Chair of Psychiatry, King’s College London, said:
“As someone who has been treating patients with ME/CFS for over 30 years, I am in no doubt of the importance of continuing to treat CFS patients with empathy and respect, and offering individualised patient centred care. This was in the previous NICE guidelines in 2007, and it is depressing that this still needs to be said today. If even one patient feels that they are not been taking seriously, there is more work to be done. 13 years ago there were only two treatments with clinical trial support, namely graded exercise therapy (GET) or cogniti behavioural therapy (CBT), and that has not changed over the years. In the new guidelines NICE has again emphasised that these approaches should not be fixed or set in stone, which is already the case for those few centres with proper supervision and expert leadership that do provide such services at present. Such services will agree that “unstructured exercise that is not part of a supervised programme” should be avoided. There is alot of helpful detail as to how such programmes should be implemented, but still some odd inconsistencies. Finally, sufferers should rightly beware any claims of miracle cures from any quarter, but be reassured that existing programmes that take a cautious, collaborative, clinically supervised approach, backed by evidence from randomised controlled trials, the gold standard of assessing effectiveness, offer some hope of meaningful improvement in what remains a complex, little understood and still sometimes misunderstood condition.”
Prof Peter White, Emeritus Professorof Psychological Medicine, Queen Mary University of London, said:
“NICE is usually commended by being led by the science. It is therefore a great surprise that this guideline proscribes or qualifies treatments for CFS/ME for which there is the best evidence of efficacy, namely graded exercise therapy (GET) and cognitive behaviour therapy.
“It is also remarkable that the committee use the symptom of post-exertional fatigue as a reason for not providing GET, when the largest ever trial of GET showed that it significantly reduced this symptom more than staying within one’s energy envelope. Should this guideline be adopted as suggested, I fear that it will discourage healthcare professionals from offering the two treatments that give patients the best chance to safely improve their health.”
There are shortcomings, but it says to do not offer CBT as at treatment.
DRAFT FOR CONSULTATION Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: NICE guideline DRAFT (November 2020) 34 of 72 1 Psychological support: cognitive behavioural therapy 2 1.11.43 Only offer cognitive behavioural therapy (CBT) to people with ME/CFS 3 who would like to use it to support them in managing their symptoms of 4 ME/CFS and to reduce the psychological distress associated with having 5 a chronic illness. Do not offer CBT as a treatment or cure for ME/CFS.
We are reviewing the guideline in detail, as a priority. We are hugely encouraged to note the following, so far:
"Do not offer people with ME/CFS any therapy based on physical activity or exercise as a treatment or cure for ME/CFS [or] any programme based on fixed incremental increases in physical 6 activity or exercise, for example graded exercise therapy.”
"Only offer cognitive behavioural therapy (CBT) to people with ME/CFS who would like to use it to support them in managing their symptoms of ME/CFS and to reduce the psychological distress associated with having a chronic illness. Do not offer CBT as a treatment or cure for ME/CFS."
"Recognise that people with ME/CFS may have experienced prejudice and disbelief and feel stigmatised by people who do not understand their illness."
It was the opinion of the committee that a physical activity or exercise programme can be 45 beneficial for people who have chronic fatigue (not ME/CFS) and in a subset of people with 46 ME/CFS who have already begun to improve and feel they want to do more. Due to the 47 reported harms identified in the qualitative review, as well as the committee’s experience of 48 the effects of exceeding individual limitations in exercise capacity the committee agreed that 49 it would be misleading and harmful to advise people with ME/CFS that a physical activity 50 programme will be appropriate for them except in certain circumstances. They described this DRAFT FOR CONSULTATION
The committee’s discussion and interpretation of the evidence 1 as people who are able and ready to progress their physical activity beyond their current 2 activities of daily living and as such would like to focus on their ME/CFS energy management 3 around physical activity. The committee agreed the expertise of the person delivering the 4 intervention is of high importance to prevent harm, they agreed that any physical activity 5 programme should only be implemented under the supervision of specialist ME/CFS 6 physiotherapy and/or occupational therapy service.
The committee made a recommendation 7 to reflect this. 8 The committee discussed that people with ME/CFS react significantly differently to physical 9 activity compared to healthy people and people with other medical conditions. The concept of 10 an ‘anaerobic threshold’ was found to be useful by some committee members to describe the 11 limitations in energy capacity experienced by many people with ME/CFS, however other 12 committee members thought it was not easily understood and refers to something that 13 cannot be readily measured in clinical practice.
The committee thought it was important to 14 note that this ‘threshold’ is different for different people, is not fixed (i.e. it can fluctuate/move 15 up or down), and is usually identified through trial and error, therefore people with ME/CFS 16 may not be able to assess risk of harm. ‘Energy limits’ and ‘energy envelope’ were preferred 17 terms as they were considered to be more practical and more widely understood. 18
The committee noted the positive experiences of people who had participated in an aquatic 19 exercise intervention. Session duration gradually increased over time, although the 20 intervention was based on a model of adapted pacing therapy where patients are active only 21 within their symptom limits and energy envelope.
The committee considered the low quality 22 of the evidence, which was based on one small study and the lack of any clinical outcome 23 data from randomised controlled trials and decided that there was not enough evidence to 24 recommend this type of exercise intervention.
25 The committee agreed their recommendations should emphasise that activity and/or physical 26 activity programmes should not assume that increasing activity is standard requirement but 27 rather that activity should be graded down, towards stabilisation, or up, taking into account 28 individual symptoms and stage of illness. Therefore, the committee decided make a ‘do not ‘ 29 recommendation to offer advice to undertake unsupervised, or unstructured, exercise, 30 generalised physical activity or exercise programmes, structured activity or exercise 31 programmes that are based on deconditioning as the cause of ME/CFS and any programme 32 based on fixed incremental in physical activity or exercise ( for example graded exercise 33 therapy). 34 In developing more specific recommendations regarding the content, approach and delivery
of physical activity management, the committee considered the experiences of the benefits
36 and harms associated with GET interventions identified in the qualitative review, as well as 37 evidence from other qualitative reviews and reports and their own experiences of these types 38 of interventions. The committee noted that some people with ME/CFS have found physical 39 activity programmes can make their symptoms worsen, for some people it makes no 40 difference and others find them helpful.
The committee considered it important to discuss this 41 with people with ME/CFS and made a recommendation to reflect the risks and benefits. The 42 committee also outlined what a personalised physical activity programme should look like 43 based on their experience, the programme included establishing the person’s physical 44 activity baseline at a level that does not worsen their symptoms, starts by reducing the 45 person’s activity to within their energy envelope, can be maintained successfully before 46 attempting to increase physical ability , uses flexible increments for people who want to focus 47 on improving their physical abilities while remaining within their energy envelope, recognises 48 flares and relapses early and outlines how to manage them and incorporates reviews 49 regularly as well as whenever the person requests one.
The committee stated the 50 importance of flexible increments that were sensitive to the person’s energy envelope and 51 emphasised that fixed increments were not part of a programme. The committee DRAFT FOR CONSULTATION The committee’s discussion and interpretation of the evidence 1 recommended the plan should only be delivered or overseen by a physiotherapist or 2 occupational therapist who has training and expertise in ME/CFS. 3 Physical maintenance
4 The committee discussed that it is important to acknowledge that people with ME/CFS can 5 have reduced and limited mobility and in their experience this can lead to health problems. 6 They noted it is important that where appropriate people with ME/CFS have management 7 plans for physical maintenance, symptom control or restoration of physical ability.
The plans 8 should consider the following components: joint mobility, muscle flexibility, postural and 9 positional support, muscle strength and endurance, bone health and cardiovascular health. 10 The committee included a definition of physical maintenance in the terms used in the 11 guideline to clarify that physical Maintenance is the process of incorporating in daily activity,
12 a level of movement which does not exacerbate symptoms, and which ensures that joint and 13 muscle flexibility does not deteriorate further than that caused by the condition so far. 14 The committee recommended that people with ME/CFS who are immobile should be given 15 information about the recognition and prevention of the possible complications of long-term 16 immobility such as bone health and skin problems.
Some of the committee members with 17 personal experience of caring for people with limited mobility commented on the lack of 18 support or information they had received in these areas of care (for example, how to transfer 19 someone from a bed to a chair) and how it would have helped them.
The committee 20 supported this and made a recommended that families and carers are given advice on 21 support on how to help a person with ME/CFS follow their agreed physical maintenance 22 plans. 23 Children and young people 24 The committee did not consider that there were any specific considerations for children and
Be aware that people with severe or very severe ME/CFS may experience some of the following symptoms that significantly affect their emotional wellbeing, communication, mobility and ability to interact with others and care for themselves:
• severe and constant pain, which can have muscular, arthralgic or neuropathic features
• hypersensitivity to light, noise, touch, movement, temperature extremes and smells
• extreme weakness, with severely reduced movement
• reduced ability or inability to speak or swallow
• cognitive difficulties, causing a limited ability to communicate and take
in written or verbal communication
• sleep disturbance such as unrefreshing sleep, hypersomnia, altered
• gastrointestinal difficulties such as nausea, incontinence, constipation
• neurological symptoms such as double vision and other visual
• postural orthostatic tachycardia syndrome (POTS) and postural
Recognise that symptoms of severe or very severe ME/CFS may mean that people:
DRAFT FOR CONSULTATION
1 • 2
4 • 5
discussing and regularly reviewing with the child or young person how they want to be involved in decisions about their care (taking into account that their parents or carers may act as advocate)
taking into account that children and young people may find it difficult to describe their symptoms and may need their parents or carers to help them.
7 Awareness of severe or very severe ME/CFS
need a low-stimulus environment, for example a dark quiet room with interaction at a level of their choice (this may be little or no social interaction)
are housebound or bed-bound and may need support with all activities of daily living
need careful physical contact when supported with activities of daily living, taking into account possible sensitivity to touch
need aids such as wheelchairs
cannot communicate without support and may need someone else they have chosen to be their advocate and communicate for them
are unable to eat and digest food easily and may need support with hydration and nutrition (see the section on dietary management and strategies)
have problems accessing information, for example because of difficulty with screens, noise and light sensitivity, headaches affecting their ability to read, or brain fog affecting their concentration.
Personal care and support for people with severe or very severe ME/CFS should be carried out by health and social care practitioners who are:
• known to the person and their family members or carers wherever possible
• aware of the person’s needs.
Risk assess each interaction with a person with severe or very severe ME/CFS in advance to ensure its benefits will outweigh the risks to the person (for example, worsening their symptoms). For people with very severe ME/CFS, think about discussing this with the person’s family or carer on their behalf.”
I am very disappointed by the new draft guidelines. At last NICE recognises that GET/CBT are not cures for ME and that GET is not an appropriate treatment. Plus it acknowledges that there is a dire need for education of health professionals and the distrust that many pwME feel towards the medical community. Is that it?!
The recommendations are weak and I do not believe will do much to significantly improve the life outcomes for pwME. The draft talks about specialist services working with pwME to draw up personalised care plans and support them. However, there is a dire shortage of these services across the UK. Do the draft recognize this? NO Does it recommend a big investment into providing specialist care for pwME? NO
I live in West Yorkshire (pop approx 1.9 million) there is one NHS specialist centre to my knowledge based in Leeds. I've been to it twice and I got alot worse under its tender mercies.
The recommendations for future research are again weak. Take the issue of pain. I recently interviewed Professor Jan Nijs, who has spent the many years researching chronic pain and ME. His latest research points to a link between neuro-inflammation and diet as contributing factors in causing pain in pwME. Will NICE recommend research into these biological causes of pain in pwME? NO
I could write a book about bad this draft is. I agree with a press release recently put out by Invest in ME that this is tepid stuff that won't make much of a difference to the life outcomes for pwME.
Am going to carry on fighting against the dire lack of resources put into supporting pwME - hell yes.
We can at least credit the SMC for including this expert reaction:
Prof Simon Carding, Group Leader in gut microbes in health and disease, Quadram Institute Bioscience, said:
“Patients will welcome the acknowledgement from NICE that deleterious therapies that may harm patients, such as GET, are the wrong path to take and that high quality biomedical research is required to overcome the lack of treatments for this devastating disease. At Quadram Institute we are pursuing a strategy of gaining scientific evidence/data and trialling possible treatment for a subgroup of ME patients. Working with European UK and collaborators and patients we hope we can provide more evidence for the next NICE review.”
I enjoyed reading this - even though I experienced symptom flare up while doing it.
An expert testimony that can put the Wessely MUS rationale for CBT and GET for PWME to rest. I'll try reading the rest over the next couple of days.
I'm also thinking about some of the human rights violations of institutionalizing people and not accommodating their sensitives in hospital. These draft guidelines make sensitivities a consideration for caretakers.
However, @Bronc is correct that there is a lot left to fill in the gaps with lack of services available and a dearth of treatment options. The human rights work continues...
I think it's a great start. Yes, there is so much more to be done, but at least maybe this will help prevent the torture of people like Eva in this thread. From what I understand, the doctors "treating" her justified everything they did (and didn't do) saying they were just following standard recommended treatment.
I’m too ill to read the guidelines Which sound mainly “good” by taking out the most bad that should never have been there, including I think the naf NICE CriTeria? I personally would prefer NICE not to go off on its own regarding PESE , there seems always an attempt to make the british way different and operating in its own bubble when we would do better to standardise terms and criteria now globally in my view.
i was concerned that even with Dr Charles Shepherd etc on the panel they managed to put out in my view a very problematic description of severe ME.
In the last the NICE guidelines they just had three categories and this time, even though there’s four, they’ve kept last times definition of severe as being able to only wash your face etc, which to me is just inaccurate. There’s a massive jump from how they describe moderate to then severe which is illogical and it doesn’t match The ME association own severity scale.
I have no problems with 4 rough categories, we all use these terms, but defining severe so extremely when it is suppose to cover the bottom 1/4 of function is to me unhelpful. I’m afraid the cynic in me has wondered if this is to minimise severe ME by making it a smaller minority than the 25% it is. I’m very severe btw and that category was fine.
People are saying the research recommendactions are a problem, are the recommendations supposed to be general ones or ones specific to what the NICE committee would find helpful in their remit of writing management guideline?