Preprint Management of Nutritional Failure in People with Severe ME/CFS: Review of the Case for Supplementing NICE Guideline NG206, 2024, Edwards (Qeios)

Management of Nutritional Failure in People with Severe ME/CFS: Review of the Case for Supplementing NICE Guideline NG206 (preprint)
@Jonathan Edwards

Abstract:
In the United Kingdom, a small but steady stream of people diagnosed with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome) have run into serious problems with nutrition because of difficulties with eating and drinking, and some have not survived. The clinical problem is extremely difficult, with little or no formal evidence on which to base diagnosis-specific recommendations for care, or information about prognosis. In several cases, however, the problem has apparently been compounded by a lack of provision of adequate services, misunderstandings, and conflict between health care professionals over diagnosis and approach to management. The following is a review of the clinical problem, including some suggestions for protocol content that might supplement NICE Guideline NG206. The main conclusion is that there is an urgent need for a consensus amongst professionals that focuses on practice based on reliable evidence rather than theory-laden diagnosis. The author is a physician with no direct involvement in ME/CFS care but with an interest in the clinical and scientific problems the condition poses.

Link: https://www.qeios.com/read/T9SXEU
PDF: https://www.qeios.com/read/T9SXEU/pdf
DOI: https://doi.org/10.32388/T9SXEU

Updated version 26th August 2024
See post #174
Link: https://www.qeios.com/read/T9SXEU.3
PDF: https://www.qeios.com/read/T9SXEU.3/pdf
DOI: https://doi.org/10.32388/T9SXEU.3

 

I loved how scrupulously accurate you are, @Jonathan Edwards , in what you say, whilst also highlighting the absolute need for urgent action with individuals who may need alternative feeding methods.

No one should be indulging their pet theories whilst the patient starves to death.

 

I haven't read it all yet, but like what I've managed so far.

Yup.

 

And this is the most generous interpretation. There has been so much bad faith in forcing them into practice despite a complete lack of evidence, while it's precisely the act of putting it into standard practice, regardless of outcomes, that has become the main evidence for it, based on flawed reasoning that if it's been put into practice, it must be good. I see this all the time, MDs insisting that it works based on nothing but biased reports, exactly the same flawed reasoning that all alternative medicine practitioners use.

Medicine has so much work to do on itself addressing the excessive biases that go into everything they do. It is not a reliable witness to its own experience. Which is peak irony, considering that this is the model of chronic illness that has been pushed into standard practice, with zero credible evidence to support it.

The whole thing has been a sort of perverse Field of dreams thinking: if you build it, they will come. One that is perverted by the fact that the patients don't have a choice, this is all there is, medicine is a natural self-regulated monopoly. And as most things go, no one can self-regulate, everyone needs oversight and accountability to avoid falling into pitfalls dug out of hubris and biases.

 

An excellent paper, which clearly sets out the current very serious difficulties experienced by ME/CFS patients in this area of clinical concern.

It signposts for HCP’s and patients the validity around the existing ME/CFS diagnosis and the indicated resultant clinical care pathway of likely most relevance and help in a situation where an understanding of causation of the patient’s symptoms within a diagnosis of ME/CFS is not currently known to medical science.

The provided legal and ethical references in support of the sign posted way forward set out in the paper are also spot on and as such are compelling.

I very much hope that this signpost to the need for a new consensus Protocol around ‘Management of Nutrition Failure in ME/CFS’ will be taken forward by other HCP’s working in this area.

Thank you very much Jonathan.

 

yes, and makes the document all the more credible for it

 

Looks very useful, thanks.

 

Hear hear. I've read it all now, and it's a very important contribution.

 

Trial By Error: Professor Edwards’ Take on Nutrition and Severe ME Cases
https://virology.ws/2024/07/01/tria...dwards-take-on-nutrition-and-severe-me-cases/

 

I posted the comment below to the Virology Blog re David’s article on Jonathan’s paper and thought it also relevant and perhaps useful here. I would only add that the Montgomery Judgement has retrospective force applying to any treatments administered since at least 1998 and possibly earlier:

Comment posted on Virology Blog.

Clearly the conclusion reached by Professor Edwards that:

“The simplest, and I think robust, analysis is that management of patients with stimulus challenge, often in the context of unsubstantiated diagnoses and outside established guidelines, has caused a huge amount of avoidable distress and needs to be abandoned. It has become clear that the challenge approach was never validated before use, and subsequent studies have shown no evidence of efficacy. Theories about psychosocial factors have failed to stand up; methods used to corroborate them have been poor, but good enough to show that the theories are flawed.’


reflects the situation described at paragraph 84 in the Montgomery Judgement referenced by Professor Edwards as setting out the legal situation around the need for Doctors to gain the patients ‘informed consent’ to medical treatment:

84. Furthermore, because the extent to which a doctor may be inclined to discuss

risks with a patient is not determined by medical learning or experience, the

application of the Bolam test to this question is liable to result in the

sanctioning of differences in practice which are attributable not to divergent

schools of thought in medical science, but merely to divergent attitudes

among doctors as to the degree of respect owed to their patients.

The Montgomery judgement sets aside the Bolam Test and reaffirms the long standing legal and ethical position that Doctors and other Health Care Professionals owe their patients/clients a ‘Duty of Care’ as described in paragraphs 82 and 83:

82. In the law of negligence, this approach entails a duty on the part of doctors

to take reasonable care to ensure that a patient is aware of material risks of

injury that are inherent in treatment. This can be understood, within the

traditional framework of negligence, as a duty of care to avoid exposing a

person to a risk of injury which she would otherwise have avoided, but it is

also the counterpart of the patient’s entitlement to decide whether or not to

incur that risk. The existence of that entitlement, and the fact that its exercise

does not depend exclusively on medical considerations, are important. They

point to a fundamental distinction between, on the one hand, the doctor’s role

when considering possible investigatory or treatment options and, on the

other, her role in discussing with the patient any recommended treatment and

possible alternatives, and the risks of injury which may be involved.


83. The former role is an exercise of professional skill and judgment: what risks

of injury are involved in an operation, for example, is a matter falling within

the expertise of members of the medical profession. But it is a non sequitur

to conclude that the question whether a risk of injury, or the availability of an

alternative form of treatment, ought to be discussed with the patient is also a

matter of purely professional judgment. The doctor’s advisory role cannot be

regarded as solely an exercise of medical skill without leaving out of account

the patient’s entitlement to decide on the risks to her health which she is

willing to run (a decision which may be influenced by non-medical

considerations). Responsibility for determining the nature and extent of a

person’s rights rests with the courts, not with the medical professions.


Professor Edward’s intervention in this paper is a much-needed reminder of the primary importance of the Medical Ethics principle of:

‘First do no harm’ which rests on the need to respect the patients right to the giving or withholding of the patient’s ‘fully informed’ consent to any recommended medical treatment.

That patient ‘right’ has the force of law behind it and not to respect that ‘right’ is to be ‘negligent’ towards the patient as defined by that law.

Clearly those patients to whom the ‘challenge approach’ has been widely recommended and applied as a valid treatment should have been informed by the prescribers it had not in fact been and has never been ‘validated’ at any stage. Patients are routinely not so informed and in fact often told the opposite. If they had been advised as Professor Edward’s now suggests, then the ‘huge amount of avoidable distress’ referred to by Professor Edward’s would not have occurred in the first place.

It is a fact that countless numbers of ME/CFS patients have over the last 30 plus years been granted State financial support after challenging at law a refusal of such support on medical advice that ME/CFS was not a physical illness but a psychological/behavioural illness. Those diagnosing ME/CFS as not physical could not and cannot provide the Courts with any evidence to substantiate their diagnosis or their treatment approach of denying access to that financial support. They have not so far abandoned this behavioural/psychological approach to ME/CFS despite their prolonged failure both scientifically and legally to substantiate their diagnosis or treatments.

That such a paper needed to be written, and questions remain for this writer as to whether it will succeed in meeting its objective of the abandonment of the invalidated and failed theory of stimulus challenge with regard to ME/CFS, poses serious questions around the regulation of Medical Practice.

This Paper is not simply about a medical or scientific argument between health care professionals but a fundamental examination about whether Doctors are demonstrating, the required by law, respect for the rights of individual patients within the delivery of medicine/health care to them.

This Paper clearly demonstrates that in the medicine and science around ME/CFS Doctors are not showing the required respect. It clearly describes the reasons why they are failing and what needs to be done to correct this failure.

Professor Edward’s is to be thanked not only for the clear common sense in this paper, but also for the respect he clearly demonstrates towards the ‘human rights’ of patients.

 

MEA Comment
(Dr Charles Shepherd)
Having helped to prepare recommendations on all aspects of hospital management for people with severe and very severe ME/CFS in the 2021 NICE guideline on ME/CFS, it is disappointing to find that there are people with severe ME who are still being very badly managed in hospital, especially in relation to nutritional assessment and nutritional support in the form of tube feeding.

This is often due to the fact that people with severe ME/CFS who are admitted to hospital are then being cared for by health professionals who have no experience in managing ME/CFS, are not aware of the NICE guideline recommendations, and conclude that feeding problems are caused by a psychological eating disorder.

I have been closely involved with several of these distressing cases. So, I was very pleased when Jonathan Edwards decided that further expert guidance was required and asked for input on the production of a protocol for hospital management of severe ME/CFS that would build on what is already in the NICE guideline and enlarge on nutritional assessment and support.

I hope that doctors and other health professionals will now follow both the NICE guideline recommendations and this very comprehensive protocol when they have a patient with severe ME/CFS who requires nutritional support – as they may be at risk from life threatening malnutrition if this is not forthcoming

https://meassociation.org.uk/2024/0...dwards-take-on-nutrition-and-severe-me-cases/

 

Charles seems to have slightly missed the point of my article. I decided that further guidance was not required - the current guidance is enough to keep people alive. Although, I did suggest that setting up research to gain more evidence was a good idea.

 

Interesting post.
Your discussion in the middle about how those patients recently had clearly not been informed that the challenge approach had not been validated is interesting

it struck me that the selling of the idea there is such a thing as a placebo effect that is in the patient mind rather than ‘of the whole trial’ (eg people pleasing eager staff) is almost at odds or undermining the concept of consent and certainly informed consent. Because it seems in the sales pitch from some to be going as far as suggesting that effect is so good it could be used as a treatment, and that treatment is in effect ‘lying’ that it’s giving someone something that IS validated?

When it suggests’x will only work if they believe y’ then it’s almost undermining validation too.


Edit: or indeed nocebo (when doctor believes someone is only ill because they expect x stimulus to make them feel ill) as it’s all the selling of the nonsense belief in the expectation effect, for others

 

Jonathan, I think, covers these points in the paper when he states that:

‘Concern in this area highlights the fact that health professionals may not appreciate that giving advice on care, when reliable evidence for that advice does not exist, is a form of misrepresentation or deceit.’

He further comments:

‘ME/CFS is not an understood ’biopsychosocial’ process, but nor is it a clearly defined disease of which we understand the physiological mechanism. It is hard not to conclude events in both immune and nervous systems are involved in many cases, but that is about as much as can be said.’

When Jonathan states that the ‘challenge approach was never validated before use’ he is I think, in effect, commenting that to tell patients that this approach is either supported by ‘reliable evidence’ when no such evidence exists or to not tell patients that no such ‘reliable evidence’ exists are both a form of ‘deceit or misrepresentation’.

The BPS approach to ME/CFS has always been based on this form of misrepresentation/deceit as it has never been able to reference ‘reliable evidence’ either before or after use and as such has been unable to substantiate itself when challenged at law or subjected to competent medical/scientific analysis.

Jonathan’s call for medics to abandon ‘the challenge approach’ has the force not only of medical ethics and medical science behind it, but also the law as set out in the Montgomery and other earlier legal Judgements.

The bottom line in Jonathans paper is that the ‘Challenge Approach’ is very likely harmful to patients with the ‘risk’ of avoidable or earlier Death occurring in some cases of ME/CFS. Medics who do not explain to the patient the lack of ‘validity’ in either their diagnosis or care suggestions to ME/CFS patients and all the risks associated with their diagnosis and medical care prescriptions to patients, consequently, leave themselves open to possible legal sanction and/or possible claims for ‘Damages’ as set out in the Montgomery Judgement.

The very many successful challenges over the last 35 plus years at law by ME/CFS patients or parents of children with ME/CFS to denial of ‘validated’ biological medical care/ social care/financial support have long spoken very loudly in support with regard to the message Jonathan seeks to convey in this paper, that the ‘challenge approach’ is an unacceptable unvalidated system of Medical Care and should be abandoned by Doctors.

The Montgomery Judgement clearly places the decision as to what ‘risks’ are acceptable to the patient, lies wholly with the patient and states that prescribers ‘have a duty of care’ to inform patients of all risks in their diagnosis and treatment suggestions, and to explain other alternative proportionate medical care and the risks in that other proportionate care. Other earlier legal judgements also require Doctors to explain the reliable evidence on why they make a different diagnosis to a previous Doctors diagnosis of ME/CFS.

We can all judge for ourselves how well the BPS or other Doctors ‘challenge approach’ to ME/CFS patients met or currently meets those ethical, reliable medical evidence and legal requirements in order to gain the patients properly ‘informed consent’.

 

Just reminded me that I think Peter Pan the book has a scene where you can only fly if you believe hard enough

oh quick Google and maybe it’s even more near the knuckle than that: “a combination of fairies dust and happy thoughts”