Following the use of a modified version of the original London Criteria for ME in the PACE Trial, there have been questions about what the London Criteria is and how it is defined.
Below is the version that appeared in the 1994 Task Force Report on ME, CFS and PVFS, followed by some notes.
Dr Charles Shepherd
Hon Medical Adviser, ME Association
21 February 2011
___________________________________________________________
LONDON CRITERIA FOR M.E.
Authors: Dowsett EG, Goudsmit E, Macintyre A, Shepherd CB.
In: Report from The National Task Force on Chronic Fatigue Syndrome (CFS), Post Viral Fatigue Syndrome (PVFS), Myalgic Encephalomyelitis (ME). Westcare, 1994. pp. 96-98.
All three criteria must be present for a diagnosis of ME/PVFS to be made:
1. Exercise-induced fatigue precipitated by trivially small exertion (physical or mental) relative to the patient's previous exercise tolerance.
2. Impairment of short-term memory and loss of powers of concentration, usually coupled with other neurological and psychological disturbances such as emotional lability (= being upset by things that would not normally cause distress), nominal dysphasia (= difficulty finding the right word), disturbed sleep patterns, dysequilibrium (= imbalance or unsteadiness rather than vertigo/spinning round) or tinnitus (= noises in the ear).
3. Fluctuation of symptoms, usually precipitated by either physical or mental exercise.
These symptoms should have been present for at least 6 months and should be ongoing.
Although ME/PVFS typically follows an infection, usually a viral illness (which may be subclinical) in a previously fit and active person, it has also been observed to be triggered by other factors such as immunisations, life traumas and exposure to chemicals. Furthermore, in a minority of patients, ME/PVFS has a gradual onset with no apparent triggering factor. For these reasons proof of a preceding viral illness is not a prerequisite for diagnosis.
Many symptoms are experienced by people suffering from ME/PVFS and in the right symptomatic context they contribute to the validity of the diagnosis.
Nevertheless, not all people suffering from ME/PVFS experience all these symptoms and their absence does not exclude the condition.
These symptoms can be subdivided into the following two categories:
Autonomic:
> bouts of inappropriate night or day-time sweating
> Raynaud's phenomenon (= cold extremities)
> postural hypotension (= lowered blood pressure on standing)
> disturbance of bowel motility manifesting as recurrent diarrhoea or occasionally constipation (these symptoms are frequently indistinguishable from those of irritable bowel syndrome)
> photophobia (= sensitivity to bright light); blurred vision due to disturbed accommodation
> hyperacusis (= sensitivity to loud noise)
> frequency of micturition (= passing urine more often than normal); nocturia (= passing urine at night)
Immunological (symptoms suggesting persistent viral infection):
> episodes of low-grade fever (not exceeding an oral temperature of 38.6C) combined with feeling feverish, (i.e. a down-regulated ‘thermostat')
> sore throat which may be persistent or recurrent (i.e. present for at least one week per month)
> arthralgia (pain but not swelling in the joints) – fixed or migratory
This list is by no means exhaustive.
Headaches, nausea and bloating, for instance are common symptoms in many patients but are not sufficiently discriminative because of their widespread occurrence in many other disorders. The curious intolerance to alcohol and hypersensitivity to drugs are highly specific in this context. It should also be emphasised that the symptoms of ME tend to vary capriciously from hour to hour and day to day. Nevertheless it is absolutely characteristic that they tend to be exacerbated by physical or mental exertion and the association should always be sought whilst taking the history.
_________________________________________________________________________________________________
Additional Information
• The London Criteria was produced at a time when clinicians, researchers and scientific journals were becoming increasingly reluctant to use the term ME in a research context – preferring the term CFS instead. Consequently, there was very little research into ME taking place. The London Criteria, which were designed for research purposes, are based on Dr Melvin Ramsay's clinical description of ME as can be found on pages 30 – 31 of the second edition of his book Postviral fatigue syndrome – The saga of Royal Free disease (re-published by and available from The ME Association). Dr Ramsay was not involved in the process to develop the London Criteria because he died in 1990.
• The London Criteria was published in 1994 in the Task Force Report and was subsequently made use of in a small number of research studies – the most important one being the research carried out by Costa et al which demonstrated brain stem hypoperfusion. (ref: Costa D et al. Brainstem perfusion is impaired in patients with myalgic encephalomyelitis/chronic fatigue syndrome. Quarterly Journal of Medicine, 1995, 88, 767 – 773. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/8542261
• The London Criteria do not require the presence of pain – because pain is not always present in ME and, while Dr Melvin Ramsay includes the possible presence of muscle twitching and tenderness, his clinical description of ME it does not require pain to be present to make the diagnosis. The emphasis is on exercise-induced muscle fatigue.
• The London Criteria now requires updating to take account of developments in our understanding of the illness since 1993 (when it was prepared) and current requirements for research criteria. Some proposals were recently put forward in a paper: Goudsmit E; Shepherd C; Dancey P, Howes S. ME; Chronic fatigue syndrome or distinct clinical entity. Health Psychology Update, 2009, 18, 26 – 33. Relevant investigations and conditions that should be excluded, as in the various research criteria for CFS, also need to be added.
• The MEA was not involved in the decision to use a modified version of the London Criteria in the PACE trial.
• MEA statement on the PACE trial: https://meassociation.org.uk/?p=4607
How was the criteria modified for use in the PACE trial?
I understand that this is version 2 as used in the PACE trial – please note that I did not prepare version 2.
CS
Criteria 1 to 4 must be present for a diagnosis of ME to be made.
1. Exercise-induced fatigue precipitated by trivially small exertion (physical
or mental) relative to the patient’s/participant’s previous exercise tolerance.
2. Impairment of short-term memory *and* loss of powers of concentration,usually coupled with other [neurological and psychological} disturbances such
as:
[NB These should be asked for as symptoms, not tests, and do not have to be
total or persistent for the whole period. These symptoms (in a-e) should be
recorded but are not necessary, in order to make the diagnosis.]
a) emotional lability [feeling easily upset by things that would not
normally upset the participant, but the upset is brief and has usually gone
within a few hours, and certainly by the next day]
b) nominal dysphasia [difficulty finding the right word]
c) disturbed sleep patterns [of any sort]
d) disequilibrium [a feeling of imbalance]
e) tinnitus [ringing in the ears]
3. Fluctuation of symptoms
[The usual precipitation by ‘”physical or mental exercise”, should be recorded,
but is not necessary to meet the criteria.]
usually precipitated by either physical or mental exercise.
4. These symptoms should have been present for at least 6 months and should be
ongoing.
5. There is no primary depressive illness present and no anxiety/neurosis.
[N.B. This means that if any depressive or anxiety disorder are present, the
London criteria are not met.]
Version 2, 26.11.2004
Thanks for posting this Dr. Shepherd – very useful. Would it be possible to provide the links to where these criteria have been published for re-posting please?
I am not a scientist and am new to the various criteria for PVFS/ME/CFS but easily agree with you that they need updating.
I note criterion 1. “Exercise-induced fatigue precipitated by trivially small exertion (physical or mental) relative to the patient’s previous exercise tolerance.”
This is not the same as post-exertional malaise is it, which, as you know, is distinctly different from fatigue.
Whether or not the trigger can be identified as viral, disruption of the immune system seems to be a common denominator so should be included as essential for diagnosis, i would have thought, as should neurological signs or symptoms.
That said, I am in favour of universal adoption of the Canadian Consensus Criteria. As I understand it, they are available for both clinical and research purposes and I think that, moving with the times, we should embrace internationally-agreed criteria, certainly for research purposes. I know they are not yet universally accepted but it would be good for UK to do so, in addition to other countries around the world – that would be a good step towards being clear about what it is and isn’t.
Personally, I’d prefer the CFS to be dropped altogether, as it merely serves to confuse. CFS is either the same or it is different. If it is different, then let’s stop using a hyphenated term, and use “ME and CFS” instead of “ME – aka CFS”. If it is the same, then why does one disease need 2 names? It’s just confusing and a hindrance to research and wider understanding of the disease in the medical profession and society as a whole, rather than a help.
To me as a lay-person, it seems unacceptable at this stage (the disease having been well-defined decades ago by Ramsay) for researchers to be allowed to use different criteria for the same disease. I realise that patient selection for studies may depend on the emphasis of the particular piece of research but researchers should be confident from the outset that they are actually studying patients with Myalgic Encephalomyelitis.
The London criteria was mentioned in the 1994 Task Force Report on ME, CFS and PVFS. It has not been published, validated or operationalised.
The London criteria could not have been used in the PACE trial for this reason, and also because the Oxford criteria was applied first, thereby excluding those with ME/CFS. So no ME/CFS patients were in the PACE trial.
http://www.meactionuk.org.uk/Ellen_and_the_London_criteria.htm
This is simply inaccurate
No it is not
I am only trying to be helpful here because I have been asked about how ME is defined in the (1993) London Criteria, as published on pages 96 – 98 in the 1994 Task Force Report, and the way this was later modified for use in the PACE trial – where 329 people met with the modified criteria.
Researchers are free to use whatever diagnostic criteria they want but have to take various factors into account – including the fact that funders and scientific journals may not want to be co-operative if the trial involves a research definition that has not been properly validated. The same problem applies to the Canadian Clinical Definition.
The Oxford criteria for CFS, along with the post-infectious sub-type, is a very wide brush – so it can include people with both Fukuda defined CFS and London Criteria defined ME, or Ramsay described ME. Incidentally, as a doctor who has ME, which was diagnosed by Dr Melvin Ramsay, I also meet with Oxford defined CFS (post-infectious sub-type) – as do many of the ME patients that I have seen over the past 30 years.
I am only trying to be helpful too.
The PACE Trial could not have contained people with ME/CFS, as the Oxford criteria was applied first.
The Canadian Criteria are in use, have been published, and have been operationalised by Jason. The London criteria have not.
Funders and journals are trying to help in hiding the neurological disease ME/CFS.
The Oxford criteria is a wide brush for fatigue, but it excludes those with neurological signs. ME/CFS is a neurological disease.
“British investigators have put forward an alternative, less strict, operational definition which is essentially chronic fatigue in the absence of neurological signs (but) with psychiatric symptoms as common associated features” Anthony David, Postviral syndrome and psychiatry, 1991 (colleague of Simon Wessely and co‐author of the Oxford criteria)
Dr Shepherd are you claiming that you have no neurological signs?
Thank you Charles, I appreciate your taking the time to answer.
The PACE trial participant selection was as follows:
First, they were volunteers from the NHS CFS clinics.
Then they were filtered by the Oxford Criteria. Not the London.
Here are some excerpts from the Oxford Criteria:
“There are no clinical signs characteristic of the condition, but patients should be fully examined, and the presence or absence of signs reported.”
“Patients with a current diagnosis of schizophrenia, manic depressive illness, substance abuse, eating disorder or proven organic brain disease. Other psychiatric disorders (including depressive illness, anxiety disorders, and hyper-ventilation syndrome) are not necessarily reasons for exclusion.”
I believe, having read this account by a participant, http://www.guardian.co.uk/discussion/comment-permalink/9627125 that they were subjected to blood tests for inflammation, and if positive for the inflammation test or if they did not pass the Oxford they were rejected.
The Oxford Criteria excludes neurological disease.
Then, and only then, did they use the London Criteria above. However, the London Criteria was not used to reject patients, but rather to stream them into groups. How any passed the London, after the previous entry criteria were passed, is beyond me and ME.
I’ve seen numerous references to the fact that Oxford excludes neurological disease, but I don’t see that in the Oxford criteria themselves…at least nothing I was able to find. Can you provide a link, please?
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1293107/pdf/jrsocmed00127-0072.pdf
“British investigators have put forward an alternative, less strict, operational definition which is essentially chronic fatigue in the absence of neurological signs (but) with psychiatric symptoms as common associated features” Anthony David, Postviral syndrome and psychiatry, 1991 (colleague of Simon Wessely and co‐author of the Oxford criteria)
Thanks for the link, though I still don’t see where, in the criteria themselves, neurological disorders are excluded. The only thing I see is in the beginning, where neuromuscular disorders are suggested as a comparison group. It may well be that the Oxford criteria are often applied non-literally, especially by those with a psychological bias who are looking at Mr. David’s intent, but I just don’t see a neurological symptom exclusion in the actual text of the criteria.
This is not to say the Oxford criteria aren’t horribly flawed – they are. I think something based on the Canadian criteria, which specifically excludes psychiatric cases, is a far preferable approach until we know more. It’s beyond me why it’s so hard to convince UK doctors to actually just *try* applying these criteria and doing at least a few studies based on them. I mean, is it really all that devastating to think that there might be both a psychological variant of CFS *and* a biological variant? (Or even several such variants?)
I know I pass all the psychiatric tests with flying colours, and I’d really like to see doctors, and UK doctors in particular, begin to move away from this outdated conception of CFS.
The Oxford criteria exclude neurological diseases. It is in there. You cannot state that they might be applied non-literally. The authors of the PACE would have to state what the difference was, they haven’t. They have however clearly said that they excluded neurological signs.
Oxford:
“(f)Certain patients should be excluded from the definition. They include:
(i)Patients with a current diagnosis of schizo-phrenia, manic depressive illness, substance abuse, eating disorder or proven organic brain disease.”
It’s not that the doctors need convincing, it’s because it will reveal the truth if they use the CCC. That’s why the MRC won’t say which criteria is acceptable. They want the truth hidden too.
It’s nothing to do with prejudices about mental health problems, they are biomedical anyway. This is about the correct diagnosis and treatment. ME/CFS is a neurological disease. That’s an excuse they love to throw around. Depression and anxiety occur in ME/CFS at rates similar to other serious diseases, so it would never explain the actually physiological process underlying the symptoms.
Replying to myself, as I can’t seem to reply to the latest post.
I’m sorry, but I’m still not seeing where you see a neurological exclusion in the Oxford criteria. The closest I see in what you quoted is “organic brain disease”. It’s debatable if that would on its own rule out ME/CFS. I would certainly say it does, as I see it as a physical disorder that causes impaired mental function (see http://en.wikipedia.org/wiki/Organic_brain_syndrome), however someone who believes ME/CFS to be psychiatric in origin would forcibly NOT rule out impaired mental function, since they would see it as having a psychiatric cause instead of a physical.
But putting that aside, the specific wording or even the implication of filtering out neurological symptoms just doesn’t seem to be in the Oxford criteria. If it is, kindly quote *precisely* what wording you think it is that does so.
As I said above, I’m not even remotely arguing for the Oxford criteria to be used, I’m simply debating your point that they inherently exclude patients with neurological symptoms.
It would RobinHood, as would White’s decision to admit no one with neurological signs. If it was applied correctly, there would be no ME/CFS patients in the PACE trial.
ME/CFS is a multi system disorder, one area being cognitive dysfunction. It is classified as neurological, which is an organic brain disease. What one group has decided to force upon those with the disease is unimportant, as they deny the existence of thousands of papers covering the known biology of the disease.
It is odd that you are choosing to disagree with what is stated in the paper. Obviously the authors of the Oxford criteria disagree with your belief, as do the PACE trial investigators.
Wikipedia is not a reliable source of information, anyone and everyone can edit it.
It doesn’t RobinHood.
‘Organic Brain Disease’ does not exclude sufferers of our illness.
It is semantics at this point in time.
Encephalomylitis has never been proven to apply to ME patients and even the MEA prefer the term Encephalopathy.
‘Pathologically, encephalomyelitis indicates inflammation within the brain and spinal cord – a description for which there is now very limited evidence (Schwartz et al 1994).’
Organic brain disease excludes other known conditions, not ME or CFS for that matter.
I have seen this ‘argument’ used by commentators across the internet and in newspaper comments, as a reason to dismiss the PACE trial.
It is in my opinion a misplaced belief at best. The trial results are in no way a confirmation that our illness is psychological in origin or a result of ‘deconditioning’.
The worry for me is that practitioners will take bits of the trial – like those journalists have – and exploit it to their own ends, to the detriment of us all.
Using the ‘argument’ that the trial excluded neurological disorders is not the way to gain any credible defence.
In my opinion…
If the MEA and others decide to create a new London criteria, that will of course need validating and operationalising, will they be accessible?
There are no immediate plans to officially revise the original (Task Force Report) London Criteria for ME and I do not want to simply replace this with the version used in the PACE trial.
However, Dr Ellen Goudsmit and I have put forward some ideas on revision in the paper I referred to in the main posting.
I am quite happy to help produce an updated version of the London Criteria now that it has been given some renewed professional credibility but it all depends on public and professional reaction.
Do people and researchers want a research definition that is based on Ramsay-described ME?
Or do they want a research version of the Canadian Clinical Criiteria for ME/CFS.
Or both?
If the London Criteria for Ramsay-described ME is going to be taken forward I can assure you that this would have to take note of public opinion as well.
CS
But it hasn’t been given any renewed professional credibility. The PACE trial contained no people with ME/CFS, and the London criteria has not been published, validated or operationalised.
I would like to see CCC as that has been used in research, validated and operationalised.
Dr. Shepherd, can you clarify what you mean by, “now that it has been given some renewed professional credibility” please, and by the London criteria possibly being taken forward? I am new to the discussion about criteria.
How about using this a topic for an MEA poll? Which criteria would people prefer? .. to guage public opinion on the subject?
“Do people and researchers want a research definition that is based on Ramsay-described ME?
Or do they want a research version of the Canadian Clinical Criiteria for ME/CFS.
Or both?”
To my mind, both. However, I am totally oblivious to costs involved.
I would also want researchers to use the appropriate ICDs and where they adapt the ICD, to state why.
Personally, I couldn’t give a rhesus.
Though ‘proven organic brain disease’ does not exclude CFS/ME sufferers.
I have never been ‘tested’ for having one, and I have consistently met all your preferred criteria, even in the USA, and France where I have also had my diagnosis confirmed.
If anyone does venture down a path of including a specific and provable symptom, without having first established any cause, then surely to goodness that will mean wholesale testing of patients, without there being any identifiable test!
This would mean no patient who currently has ME or CFS being proven to have it, and that would mean no damned patients!
I’ve placed a note about the LC on the main FB site.
In my view, the revised ME criteria are as good as one is going to get. I disapprove of version 2 of the LC and ergo, what was in the Westcare report. I have seen what was used in PACE and it wasn’t version 2 but an amended version of that. The Americans are now devising their own criteria for ME as they see the difference between ME/CFS (Canadian criteria ) and Ramsay’s concept of ME. You can lump ME-like disorders, or just focus on Ramsay’s concept. The latter might select the same people as the former but unless someone tests that, we don’t know.
Having read a lot of criticisms of the LC, my view is that those who go on about operationalisation almost certainly don’t know what the word means. Version 1 was operationalised a great deal more in e.g. in relation to ‘fatigue’ than all the CDC criteria and the Oxford criteria, and were close to the Canadian criteria, but focused on patterns, i.e. Ramsay’s diagnostic triad, not the presence of individual and common symptoms like pain and sleep disorders. They don’t separate sheep from goats. No one complained about the London criteria in the 90s because they were the only criteira for ME in existence. If you know Ramsay’s view of ME, you’ll realise how good version 1 was. We had the LC and the Oxford criteria. The latter do not select ME. PACE could not use the later version of the ME criteria as they had not been devised in 2003. However, they had a choice of version 1 and 2 and choose the one nearest to the Oxford criteria, i.e. version 2. That is why the citation refers to the Westcare report. I refused to have my name associated with their decision. (They had version 1; I sent it on request). I had not been involved in version 2 and considered it not good enough. My refusal caused a problem at PACE HQ. That’s where the Westcare ref comes from.
Sorry if I sound miffed but all this misinformation about the LC not being operationalised drives me nuts. And when were the Canadian criteria validated exactly? The LC were for use in studies funded by AFME and were therefore not published. We had no ambitions for its wider use at the time and wanted to see how they worked. We needed feedback. You don’t have to publish criteria in a journal, as some Nijmegen papers prove, all medicine requires is a source and AFME was the source. Hence people could obtain them and replicate and that’s the essential bit. As a result, several researchers asked for them, even without wanting funding. Some of those studies were published and without problems. We now have published the refined criteria so researchers can have easy access and cite them. And they have been cited.
If people want to study ME, there are now two sets to choose from. Published but not validated, as no other criteria have been, but nicely operationalised.
Having had to go over all the details a few months ago for a court case, I know the events re the LC rather well.
The London criteria has not been published. It was only mentioned in 1994 Task Force Report.
Furthermore it appears that in the PACE trial after they rid themselves of pesky ME/CFS patients. The CDC criteria they used was the Empiric (Reeves, 2005) not Fukuda, and that the altered London criteria (which doesn’t exist anyway) require no neurological disturbances or PEM.
So who is right? White of the PACE trial, or White of the PACE trial protocol?
Additional information on the London Criteria:
ASSESSMENT, INVESTIGATION AND DIAGNOSlS
When diagnosing M.E. for research purposes, particular attention must be paid to two factors:
– many of the symptoms and signs evident in people suffering from M.E./PVFS could be due to a large number of other important diseases/conditions.
– M.E. may run in parallel with other diseases having similar symptoms and signs.
Because it is vital that the M.E. study groups we use in research are as ‘pure’ as possible, the existence of a parallel disease would be grounds for disqualification. The most common alternative diagnoses/parallel. diseases to be borne in mind before referring a research subject volunteer to an M.E. study group can be considered under the following headings:
Chronic infections:
toxoplasmosis, Lyme disease, HIV infection, chronic active hepatitis, schistosomiasis, brucellosis, occult sepsis, tuberculosis, giardia.
Endocrine disorders:
hypothyroidism, thyrotoxicosis, Addison’s disease, Cushing’s syndrome, diabetes mellitus, hyperparathyroidism.
Neuromuscular disorders:
myasthenia gravis, multiple sclerosis, mitochondrial myopathy, Parkinson’s disease.
Cardiovascular disorders:
cardiac ischaemia.
Metabolic disorders:
sleep apnoea syndrome, chronic renal failure.
Malignant disease:
occult tumours such as undiagnosed lymphomas, retroperitoneal sarcomas; renal and liver tumours; frontal lobe tumours.
Auto-immune disease:
rheumatoid arthritis, systemic lupus erythematosus, thyroiditis, Sjogrens syndrome. Haematological disorders: leukaemias and anaemias of varying origin.
Miscellaneous:
heavy metal poisoning, chronic intoxications due to prolonged exposure to chemicals such as petrol, benzene, organo-phosphorous compounds and methylene chloride; drug side effects such as those due to beta-blockers, and long-term benzodiazepine usage; chronic alcoholism; coeliac disease.
Psychiatric:
primary depressive illness, anxiety neurosis.
OTHER REASONS FOR EXCLUSION FROM RESEARCH INTO M.E.
Of particular importance is to eliminate chronic fatigue primarily associated with psychological factors. If there are signs of persistent anhedonia, apathy, low self-esteem, feelings of worthlessness and guilt, the possibility: of primary depressive illness should be actively considered and, if there is any doubt whatsoever, the subject eliminated from the research study.
If the subject has had any other diseases or conditions in the last three months they should be excluded from, research into M.E.
If the subject has taken any treatments – orthodox, complementary or nutritional – in the last three months they may have to be excluded from certain research projects.
PHYSICAL SIGNS sometimes evident in people suffering from M.E. / PVFS
Characteristic physical signs are seen in M.E./PVFS and in the right symptomatic context they contribute to the validity of the diagnosis. Nevertheless their absence does not exclude the condition, and they are as follows:
(a) Pharyngitis which is either persistent or recurrent (present for at least one week every month) with or without tonsillar enlargement. This is nearly always non-exudative and when present may be accompanied by the low-grade fever mentioned under immunological symptoms.
(b) Tender and possible enlargement of lymph nodes, particularly of the cervical groups; these also may accompany the fever and they may decrease in size during the afebrile periods.
(c) Muscle tenderness with a particular predilection for the neck and shoulder girdle and the major muscles of locomotion. Points of exquisite tenderness are occasionally found by palpating the affected muscles with the tip of a finger.
(d). A positive Romberg test (for balance)
CS
As the London criteria has not been published, is it not better to use the CCC. After all it was used in Lombardi et al. Of the original 101 patients in that paper, 99 have now been found to be postive for MRV retroviruses
I have never pretended to understand any of these debates that seem to consume forums across the internet.
On the whole I find them devisive and unhelpful.
When encephalomyelitis was preferred it could not be proven and so it was changed to encephalopathy.
With MS for example inflammation in the central nervous system (brain and spinal cord) was presumably proven in clinical trials, and then became the central part of any disease process.
A new patient would come along and be subjected to an analysis of his or her history, symptoms and ability to function. Tests would be run to exclude other possible causes.
Whether or not it would be possible to test for the central condition of MS for each and every patient I do not know, but I assume not.
Drugs and a treatment protocol would be put in place along with care and support that including psychological processes, attempting to improve a persons quality of life, understanding of their disability, and acheiving a greater degree of acceptance.
‘We’ have no prove of what is causing ‘our’ illness. And yet here we are – again – dallying around with a criteria that will effect diagnostic procedure – without any proof.
This is being driven by patients – and not all patients at that. It is not coming as the result of any definitive biomedical research.
Prove something. Establish a disease process – if their is one. Get some consensus and acceptance. And then form another more relevant criteria if it is necessary to do so.
In the meantime, I need all the care and support I can get, as do many other of the hundred’s of thousands of sufferers in this country.
I am fed-up with having to justify my genuine suffering. And that is not helped in any way by people pushing for changes to be made to something that is already unproven, without further proof.
Stop ostacising me and my illness any more than you have done. This is not helping me or other sufferers. Work with what we have and establish some greater credibility, before narrowing the ‘pot’.
Fourteen years, numerous re-confirmed diagnosis either of ME or CFS, in several countries. This will not improve things for me or anyone else without proof.
You risk alienating people even more. The MS Society claim to be the biggest charity in the UK representing an estimated 85,000 sufferers.
85,0000! That is all! From the feedback I have had, many are not even aware that CFS or ME is classified as a chronic neurological disease, the same as is their own. The support and care and understanding of MS is way superior to CFS or ME.
And you again run the risk of diluting what little credibility has been established thus far. If ‘we’ cannot come together and offer a united front, then the department of health – the Government – will continue to avoid issues and claim we are divided amongst ourselves.
250,000 estimated sufferers! Work with it. Use it. Within the system.
As I keep saying, researchers are free to choose whatever diagostic criteria – Australian (Lloyd et al), Canadian, Fukuda, Holmes, London, Oxford – for CFS, ME and PVFS (Behan and Bakheit) – they wish.
Lombardi et al used Fukuda plus Canadian.
White et all used Oxford plus a modified version of London to sub-group.
The bottom line is that we need some international agreement.
But if people and researchers want to look at Ramsay ME under the ME/CFs umbrella (which is my preference) then we do need a research definition based on Melvin’s clinical description – which is what we did in relation to the London Criteria back in 1993.
At the time I think it was a helpful contribution to the debate.
Thanks are due to Charles Shepherd and Ellen Goudsmit for taking the time to give their respective explanations, sadly I think any hope for a productive debate in open internet forum is unlikely to be realised.
Although the language of science is being used, a large number of M.E affected people (carers and sufferers) are adopting a discourse which is both combative and unreasoned, being based far more on belief than upon scientific principles. Those who disagree with this ‘militant’ approach are now being described as ‘the enemy’ and subject to consistent insult.
EG’s comment that “all this misinformation about the LC not being operationalised drives me nuts.” identifies how scientific terminology is being used to support semantic and politicised arguments that support a single view of what M.E/CFS is. The constant repetition across blogs, websites and forums of misinformation is creating a factionalism amongst M.E affected people where “who’s side you’re on” defines what judgement one will make about the condition that we suffer in common.
I agree with EG’s assessment: ” the revised ME criteria are as good as one is going to get.” not because I see no hope of a re-appraisal from the scientific community, but because there are unbridgeable gulfs within the “M.E Community”. I doubt it would even be possible to get agreement on what the ‘divides’ consist of , though some of the factional rallying points seem to be around notions such as ‘psychiatry is evil’ and ‘M.E is caused by XMRV – if you don’t have XMRV you don’t have M.E’. In any event the listing of criteria is irreparably linked with which banner is being chosen to fight under, and there is therefore no chance of reasoned agreement.
As far as the MEA, and MEA members are concerned I think it would be very valuable for the discussion that Dr Shepherd has initiated here to continue, but IMO I think that it can only productively go forward in a strictly moderated venue (no criticism implied here) where real world identities can safely be required.
I could not agree more IVI.
You make total sense and summarise the situation on certain forums and among those who shout loudest, perfectly.
I am a member of the MEA – again. It is the MEA and the MEA alone, in my opinion, who have consistently provided the most objective and reasoned information about my illness – whatever it’s preferred label.
I echo your praise of Dr Shepherd and Ellen Goudsmit, and agree that if matters such as this really are in the best interests of sufferers, they are best debated when those who debate them are in full disclosure of identities and interests.
There is absolutely nothing combative or unreasoned in stating that the London criteria do not exist. That have never been published. How is it scientific to state that they have?
ME/CFS is a discreet neuological disease, Chronic fatigue the symptom is a broad homologous group of diseases with fatigue as the main symptom.
If you have been following the MRV research closely, and are able to understand the science behind it, you would know that the evidence for it being associated with ME/CFS is very strong.
Any research conducted should use the sickest patients who meet the CCC. It is illogical to use a broad definition like Fukuda, as all you will do is muddy the results. Once you can pull out what defines that group, you can then have a better chance at working out the disease for everyone else.
Why would knowing the identity of people make a difference to what they think?
Re ‘…the London Criteria do not exist’
Have you considered joining the flat earth society?
Seriously though, they are referenced in The Lancet paper and have appeared in print, and on the internet, on numerous occasions over the past 20 years.
Dr Shepherd, the London criteria has never been published in a journal. Trying to dismiss this point by claiming I am a flat earther is no argument.
Here is a quote from Professor Hooper, that recently appeared in a letter to Mr Jameson regarding the PACE Trial, to make this a bit clearer:
“The “London Criteria” have no known authors; they have never been published; there is no methods paper which specifically describes them as a “case definition”; they have never been approved nor have they even been finally defined (there are various versions); they have never been validated and they are not on PubMed thus are not available for scrutiny so they cannot be accessed for comparison. This means that Professor White was essentially able to create his own version of the “London Criteria” as evidenced on page 188 of the Full Protocol. Your assertion that the London Criteria required postexertional malaise is thus incorrect despite the PIs having said in their Lancet paper that it was required, and this is an issue for Professor White to address ie. he needs to clarify whether or not he adhered to his own Protocol.”
How the PACE Trial could reference that is a mystery.
JT: I’m spending quite a lot of time dealing with one person’s criticisms of what we are doing and providing corrections. I’m happy to deal with constructive criticism and answer questions but I don’t have time to argue with inflexible beliefs about the London Criteria.
What I do find difficult to understand is why anyone should be getting cross about a proposed piece of research criteria for Ramsay described ME that a group of us put together about 20 years ago in order to try and persuade researchers to carry out research into Ramsay described ME. This was obviously at a time when the medical profession had decided to rename and redefine ME as CFS and (if possible) put a very thick red line through the term ME.
People with ME were pleased by this initiative to try and maintain a research interest in ME. But we failed to persuade the researchers – with a few exceptions – to make use of the London Criteria. The combined pressure from their colleagues and scientific publications won the day.
Dr Betty Dowsett worked with Dr Melivin Ramsay for many years and so did I after becoming friends with him when he diagnosed my own ME. I remain friends with the Ramsay family and Louie Ramsay is a Patron of the MEA. The London Criteria is not intended to be critical of Melvin’s work in any way – but the clinical description did need clarification and additional information (eg you need a list of exclusions in modern research criteria) to make it suitable as a research definition. So the London Criteria includes all the key clinical features (and examination findings) of Ramsay ME in a format that would be acceptable to researchers who are willing to question the dominance of CFS research criteria.
The authorship is well known – just type London Criteria into google and you will find several references to the four authors (Dowsett, Goudsmit, Macintyre, Shepherd) listed in the main MEA posting. We have no reason to be anonymous and I am very happy to have my name associated with this work.
Publication can be defined in various ways but as I keep saying the London Criteria were printed over three pages in the report from the National Task Force on ME in 1994 – the year after they were written.
Nobody is claiming that the London Criteria has been through a rigorous validation process, or that they appear on PubMed. They were proposed criteria which have been modified over the course of time (as many other scientific criteria are) and I have to say I was quite surprised when it turned out the they were going to be used in the PACE trial.
The MEA does not include the London Criteria in it’s guidance for doctors or include it in our literature list. We do mention the Canadian Clinical Criteria in both and offer a nice printed booklet of the CC in our literature list. But as people are aware, the scientific research community has not been willing to endorse or use the CCC as stand alone criteria for research purposes and I suspect that this situation will remain.
With renewed interest into the use of an up-todate research criteria for ME, Dr Ellen Goudsmit and I (and others) did some further work in 2009 on revision. Our conclusions and recommendations were published in the journal referred to in the main posting.
The bottom line is that we want to see research carried out which identifies sub-groups of people that come under the CFS umbrella of published research and we have been doing something very practical on one level to take this forward.
We are not trying to force the London Criteria onto the research agenda – it is there as an option for sub-grouping of clinical phenotypes if a research group wants to use it.
But if it is clear that people want a research definition of Ramsay ME transferred to the history books we will obviously take note.
NB: The London Criteria that we produced states that Exercise-induced fatigue precipitatied by relatively small exertion (relative to the person’s previous exercise tolerance) must be present if a diagnosis of ME is going to be made.
CS
Ever considered the possibility that Prof H might be wrong on this? He is. His assistant knows exactly who the authors are and still talks to one or two of them.
Professor Hooper is not wrong.
Comments that appear to seek to promote the fallacy that there is a huge and deep divide in the ME community are unhelpful, and appear to be an attempt to quieten down the masses by divide and rule.
If something is inaccurate in a comment by all means correct it – if someone’s viewpoint does not accord with your own then by all means articulate your own point of view.
Comments that are merely dismissive and contemptuous of others do nothing to contribute to a debate that people who have ME are fully entitled to engage in.
No disrespect, and I know that the MEA does its best, but the experts have singularly failed – for decades now – to get us anywhere near proper recognition, serious public funding for research or even adequte public awareness-raising of ME, so perhaps it is about time “lay” patients had their say and asked some serious and challenging questions of the organisations that attract funding for our disease.
The facility to make comments on the MEA website is a welcome development and I hope that no-one will be put off from asking questions or expressing their viewpoint by patronising and frankly insulting comments, whether or not they are made by people using their true identity.
‘I doubt it would even be possible to get agreement on what the ‘divides’ consist of , though some of the factional rallying points seem to be around notions such as ‘psychiatry is evil’ and ‘M.E is caused by XMRV – if you don’t have XMRV you don’t have M.E’. ‘
@in vitro infidelium
This London criteria debate I find hard to follow, it hurts my head, and I have no idea if I have XMRV but I know I have virally-induced (Coxsackie B4) Ramsay-defined ME. I was diagnosed in 1984 by Prof Behan, a consultant neurologist with a special interest in Coxsackie virus. (He could have called it ABC, I had never heard of ME, it wouldn’t have mattered to me, he was at least explaining why I felt so hellish.) But the name given was ME and that is the illness I have. I also know that psychiatrists’ involvement in my illness has been wholly inappropriate and unhelpful. This is why we may appear combative, we want truth, that is all. And deliberate conflation by psychiatrists of neuroimmune illness and psychiatric illness is NEVER going to get us anywhere. So, yes, in the context of ME, psychiatry is evil. Certain psychiatrists have made their careers out of denying that ME is neurological. It is reprehensible and incomprehensible.
Thanks, JBME, for making some very important points. I agree that the ME community is united in their wish for understanding and treatment of this devastating disease, and regret that all the many years of work put in by so many well intentioned people has got us, to date, no nearer to those goals.
One problem we face is the one discussed on this page, the issue of definitions. It is true that there are a bewildering number out there, Holmes, Fukuda, Oxford, London, Ramsay, CDC 2005, CCC 2003, CCC/Jason 2010, and more I haven’t mentioned. Of all these the CCC is the most reliable in picking up those with HGRV’s, and IMHO for that reason, and for the reason that it reliably excludes Major Depressive Disorders, is the one that we all should be advocating for as correct at this point in time.
It may be that in the near future there will be an accessible diagnostic test, in which case the need for complex definitions will diminish. I therefore feel it is a waste of resources just now to spend time and money on another updated definition. If all ME associations were calling for the use of the CCC, would that be possible to ignore?
@ JBME I’ll take it as read that it was my post which you found so objectionable. The offending post was a response to CS and EG, in which I expressed some disagreement with CS and some agreement with EG, and explained my reasoning behind my conclusions. There was no call on anyone to stop expressing themselves
Comments that appear to seek to promote the fallacy that there is a huge and deep divide in the ME community are unhelpful, and appear to be an attempt to quieten down the masses by divide and rule.
If something is inaccurate in a comment by all means correct it – if someone’s viewpoint does not accord with your own then by all means articulate your own point of view.
So if a viewpoint is articulated that you do not agree with, then it is seeking to promote a fallacy and is unhelpful and therefore should not have been articulated ? Isn’t that the very process of quietening the masses that you complain of ?
Anyone who is in doubt about the existence of divides in opinion amongst those affected by M.E need only look through the various internet forums and blogs (simply type M.E CFS forum into a web browser and follow the links). The invective found on some of the forums is now infecting the web pages of at least one M.E organisation. If people want to start thinking about rolling back from their entrenched positions, that’s very welcome, but let’s not pretend that the entrenchment does not exist.
No disrespect, and I know that the MEA does its best, but the experts have singularly failed – for decades now – to get us anywhere near proper recognition, serious public funding for research or even adequate public awareness-raising of ME, so perhaps it is about time “lay” patients had their say and asked some serious and challenging questions of the organisations that attract funding for our disease.
I don’t know about disrespect but Charles Shepherd’s invocation of flatearthism seems equally apposite in response to your assertion of singularly failed – for decades now. The MEA has a long history (albeit with one salutary though thankfully short lived interlude) of giving all its members a voice. The achievements of those experts who have advised the MEA, in co-operation with the MEA’s members are a matter for the MEA membership, of which in my opinion, only a small fraction would see failure as having been involved.
The facility to make comments on the MEA website is a welcome development and I hope that no-one will be put off from asking questions or expressing their viewpoint by patronising and frankly insulting comments, whether or not they are made by people using their true identity.
Pseudonymous posting on news items is fine, it’s a facility I’m more than happy to use but Dr Shepherd is asking for an informed discussion on a very difficult issue. I believe the MEA membership can participate in such a discussion, however I don’t believe that either the membership or the discussion is well served by having it take place on a public forum where users can hide behind pseudonyms, no matter how valid the use of pseudonyms may be in a public forum.
*….The London Criteria was published in 1994 in the Task Force Report and was subsequently made use of in a small number of research studies – the most important one being the research carried out by Costa et al which demonstrated brain stem hypoperfusion. (ref: Costa D et al. Brainstem perfusion is impaired in patients with myalgic encephalomyelitis/chronic fatigue syndrome. Quarterly Journal of Medicine, 1995, 88, 767 – 773. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/8542261….*
“““
That the *London criteria* were used in the study Costa D et al. *Brainstem perfusion is impaired in patients with myalgic encephalomyelitis/chronic fatigue syndrome* is a fairy tale.
“““
From the Costa D et al. Brainstem perfusion is impaired in patients with myalgic encephalomyelitis/chronic fatigue syndrome:
All ME/CFS patients were clinically assessed diagnosed according to standard criteria (Oxford.12*, CDC.13* and ME Action.14*). The following exclusion criteria were applied:
(i) clinical conditions known to produce chronic fatigue, e.g. anaemia, acute or chronic infections of known aetiology, thyroid dysfunction, diabetes mellitus and chronically debilitating diseases (oncological or others); (ii) neuropsychiatric diseases, particularly schizophrenia, manic-depressive illness, drug abuse, eating disorders and proven organic CMS disease.
Oxford.12*, CDC.13* and ME Action.14*
*12. Sharpe MC, Archard LC, Banatvala JE, et al. A report
chronic fatigue syndrome: guidelines for research. J Roy Soc
Med 1991;84:118-21.
*13. Holmes GP, Kaplan JE, Grantz NM, et al. Chronic fatigue
syndrome: a working case definition. Ann Intern Med 1988;
108:378-9.
*14. Criteria for a diagnosis of ME for use in the ME Action
funded research. Based on the criteria suggested by W.R.C.
Weir in Post Viral Fatigue Syndromes by Jenkins & Mowbray,
pp 248-9.
“““““
Note:
Dr Weir in his chapter in the 1991 Jenkins/ Mowbray book refers to the 1988 Holmes et al criteria.
The Jenkins & Mowbray textbook at pp 248-249 sets out Dr Weir’s own modification of the Holmes et al 1988 criteria and makes no mention of any “London” criteria, nor of the authors of the criteria being Goudsmit, Macintyre and Shepherd.
It is apparent that the “ME Action” criteria used by Costa, Tannock and Brostoff were based on criteria suggested by Dr Weir.
~jan van roijen
~~~~
This was a neuroimaging study that was partially funded by Action for ME (p772, QJM), who were involved in the development of the London Criiteria just before the study was funded and started.
I am obviously aware of the information in the reference but after speaking to those involved at the time, including Durval Costa at the Middx (whom I knew quite well), my understanding is that the criteria used by the funder to select ME patients was the one that they had been involved in preparing for research purposes (ie London Criteria) – which obviously makes sense because the Holmes criteria is a long way from defining Ramsay described ME.
I will speak to Dr William Weir and AfME about this again – if people are concerned.
CS
Of course was this a neuroimage study; by whom it was funded, does not matter in this context.
When Costa claims in his references nr 14: Based on the criteria suggested by W.R.C. Weir in Post Viral Fatigue Syndromes by Jenkins & Mowbray, pp 248-9 – while he used in fact the London Criteria (without even saying, which of the many versions of the LC), then the whole study is fraudulent.
~jvr
Jan, you have been misinformed by one individual and the errors have been repeated over and over again, as though repetition will somehow turn the mistake into an accurate fact. While I admire your loyalty and perseverance, it’s helpful to try and clarify so people here have a more accurate view of what, who and why.
I have copies of the contract that ME Action required researchers to complete and accept. I was Chair of the Research Working Party at the time and I was thus lucky person who sorted out the admin. I kept it because of the signature (Dr Costa was a world authority). We spent about £80000 on the research. Because they used the LC, we know that this study is therefore on patients with ME. Dr Macintyre helped to select patients, not only using the criteria, but also her additional questionnaire to help improve diagnosis. If you compare version 1 with the CDC criteria, you’ll see that we operationalised ‘fatigue’ to select people with the muscle fatiguability that Ramsay described. This wasn’t just fatigue, this was muscle fatiguability after minimal exertion. Prof. White has a copy of the questionnaire that went with the LC but did not use it. ME Action did not just require use of their criteria, but also the involvement of one of their approved doctors. Dr. Dowsett was also on that list. That was the system in place at the time. After the Oxford criteria, we were very keen to spend our funds on studies on ME. Not CFS. Not chronic fatigue. So there’s paperwork and at least three people who can verify that the info on the LC that Charles and I have provided is accurate, i.e. we helped write it, it was used in various studies including Costa et al, and Costa made a mistake. The evidence was sent to a journal and they permitted me a right-of-reply when I responded to queries about ‘never been used’ etc. there was also an independent review and the response of that was published on one or two websites, again, noting that my information was correct. Costa did refer to the ME Action criteria and the early copies actually refer to this. One can imagine showing old copies with the ME Action bits and then the copies headed the London criteria, so the jury can see that they refer to the same thing. Whatever, the LC were generally considered a good thing when the study was published in 1995. It became an issue only when the LC were included in the protocol for the PACE Trial. This introduced a political element, i.e. some argued that if one could show that the LC were no good, what was it doing in an expensive, government funded trial and the only proper action was to stop that trial. We all got that. Activists therefore began questioning everything they could about the LC. They did not check , e.g. with Dr Costa, because the truth would have undermined their efforts, or with Dr Weir.
The problem in 2004 was that the authors did not hold the copyright and AFME handed the criteria over without our knowledge or consent. When Prof. White refused to use the version I had been invovled in, I requested that my name not be included in the references, which was very inconvenient for the researchers. However, it was wrong to be cited as an author of something one had had nothing to do with, i.e. version 2. We have no idea who thought that the London criteria were based on Weir’s description and if you actually read his chapter, you’ll see the clear differences. However, I did not proofread the paper so had no chance to correct this error. Weir was not involved with the London criteria. I knew him at the time. Version 2 was almost certainly written by Nick Anderson. The version used in the PACE trial was not written by any of those who were invovled with the London criteria. I’ve seen the manual and don’t recognise it. Moreover, I have an email from Prof. White that his sample bears little resemblance to ME as I have described it over the years and as described in the article published in 2009? (available online and very cheap). And if that wasn’t enough, White’s colleague very helpfully pointed out in a podcast that any patient with neurological symptoms and signs, like a weak left leg, would not be diagnosed as having CFS and be referred to neurology. Thus we have good evidence that many patients with ME who would have met the version 1 criteria were excluded from the trial by the Oxford criteria. Margaret Williams speculated that this might happen and it appears that she was right. Thus I have grave reservations about the ME group in the PACE trial having ME as Ramsay described it. Given the major criterion (muscle fatiguability…), there is no way that patients could complete GET and feel better.
We now have to deal with the future and that will probably depend on what they find in the US and Australia.
To readers, Charles and I have not lied to you about the criteria. We gained nothing from the LC. Ramsay, sadly, did not want to devise esearch criteria and the ones he used himself are very strict (i.e. his cohort were all well before they became ill, so that would exclude all of those with allergies and a host of other, normal problems). His inclusion criteria were not assessed and there was little operationalisation. As for validation.. Only the CDC criteria have been validated (recently) and they’re not very valid.
I like the revised CC myself but to test the assumption of equivalence (is ME the same as CFS), you need criteria for ME and they exist too. I used the LC myself and the study was published but don’t think I used the snappy title. Just described them, as Ramsay had done. I’ve tested the assumpton of equivalence and sofar, found no differences. If they exist, they lie in the neurology where I haven’t looked. Or the immune system (idem ditto).
Hope this helps and please, don’t be so aggressive some of you. We don’t deserve that.
The study “Brainstem perfusion is impaired in patients with myalgic encephalomyelitis/chronic fatigue syndrome” does not report the use of the London criteria.
Frankly I’m not interested in the unpublished London criteria, others obviously may feel differently, which it is that right to do so.
It would be a better use of time to use the CCC.
If you are ‘not interested in the unpublished London Criteria’ why are you spending so much of your time and energy in this discussion about the London Criteria?
You have now made 13 contributions to this debate – far more than anyone else I suspect!
Does it matter how many times I post. I am responding to your points, as you are mine.
This is a discussion about the London criteria. If researchers are going to claim to use them, I think it is perfectly reasonable to therefore discuss them. It would be remiss of anyone to ignore an issue merely because they have an opinion on it. My opinion on the use of the London criteria, is of course, not the same as saying I am not interested in discussing London criteria.
Reply to Dr Shepherd’s post earlier.
Dr Shepherd, I have not criticised or agued with anyone in any of my previous posts. I have merely passed along factual information regarding what is called the “London criteria”. I am also in no way angry about anything.
As you have now stated, the “London criteria” is a proposal, and was only mentioned in the report from the National Task Force on ME in 1994. This is of course not the same as publishing in a peer review journal. You also confirm that the criteria is not validated, and does not appear on PubMed. Therefore, it is not relevant that the criteria has been modified several times, as it still remains unpublished.
If researchers wish to use such a criteria for ME, why not use the CCC, or even published the “London criteria” first and have it validated and operationalised. It is more than strange that the PACE Trial authors have claimed to have used what was proposed in the Task force report.
Dr Shepherd could you tell me who all the authors of the proposed “London criteria” are? As there are several versions knocking about the web.
As for the Canadian criteria. It has been published, validated and operationalised. It was used in Lombardi et al, and it is well known that Lipkin is to use this in his multi lab MRV study. I also believe that Ilia Singh is to also use the CCC in her soon to be published MRV study. There is also the UK MRV study from the WPI and NCI, that will no doubt be published in the near future.
Do I take this statement, “…we want to see research carried out which identifies sub-groups of people that come under the CFS umbrella”, to mean that the MEA is not only interested in ME/CFS, but also non-neuoloigical fatigue?
Re para 4: As I keep saying, researchers can use whatever criteria they want, modify existing criteria, or even make up their own new criteria. But this will obviously depend on the views of the funder of the study, the likely reaction to peer review to suitability to the study, and the view of scientific journals where they hope to publish the results. Researchers may also need the co-operation of clinicians who are willing to diagnose patients using ME or Canadian criteria – which is not normally the case in the NHS here in the UK.
Re para 5: As stated previously, the authors of the London Criteria are myself, Betty Dowsett (now retired), Ellen Goudsmit, Anne Macintyre (now retired).
Re para 6: I don’t have any problem with the CC being used for research. I’m just pointing out that the research community are very reluctant to do so – partly because they do not feel it has been validated and operationalised for research purposes. So when it is occasionally used (eg Lombardi et al) it is used in conjunction with one for CFS (Fukuda in the case of Lombardi et al) that meets with widespread peer approval. Incidentally, the actual Science paper does not mention the CCC – you have to look in the background information for details of what the ‘CFS patients’ are..
Re final para: The MEA wants to see people who currently come under the ME/CFS research umbrella dissected out into clinical and pathological sub-groups. This will inevitably mean identifying those with what you term ‘non neurological fatigue’ and then removing them into a more suitable place for the research community to investigate.
CS
Yes, researchers can use whatever criteria they like. However, it is important to consider why they are using particular definitions and not others. It is very clear that the MRC wish to use anything but a criteria of inclusion, and instead prefer the broad definitions of Fukuda and Oxford. Which frankly are very unlikely to lead us anywhere. Many also don’t bother to separate out ICF and CFS, which the Fukuda criteria states they should do.
I’m not so sure that the research community is reluctant to use the CCC, and as I have said, many are using it. Really the issue is with funders refusing to allow a stricter criteria to be used. The reasons for this are obvious. The CCC has of course been validated, and Jason has recently operationalised them. The team behind the Science paper used the CCC because it “requires post-exertional malaise, which many clinicians feel is the sine qua non of ME/ CFS”, and because “the CCC further requires that patients exhibit post exertional fatigue, unrefreshing sleep, pain and neurological/cognitive manifesta- tions, rather than these being optional symptoms.” They used the Fukuda criteria because they “have the advantage of a longer period of usage and existence of many publications that have added modifications. Suffice it to say that the clinician author of the Science paper elected to use both criteria, thus bypassing the argument of which criteria were better.” Under the circumstances I would argue they were right to do so. As for widespread approval for the use of Fukuda, I guess we are only referring to those who would like to make ME/CFS disappear.
When you say that the Science paper does not mention the CCC in the main paper, this is true. But it is also true that the Fukuda criteria was also not mentioned in the main paper. Both appeared in the supporting materials, which were published along with the paper.
I’m afraid I don’t have the time at the moment to read the messages (inbox needs attention) but this “find” suggesting the London criteria may have been misused may be of interest:
http://bit.ly/dO3nnM i.e.
http://forums.aboutmecfs.org/showthread.php?4926-PACE-Trial-and-PACE-Trial-Protocol&p=159369&viewfull=1#post159369
Yes – there are some very interesting and detailed points here on both the LC and the serious defects in the PACE trial.
But some of the people who are contributing to the discussion on this (?American) list do not appear to be aware of the original fairly detailed description of ME, and exclusion clauses etc, in the original version of the London Criteria that we prepared.
I would not want to endorse the version used in the PACE trial.
Dr Shepherd could you explain the following.
You state that you were involved in the creation of the London criteria Version 1, along with Betty Dowsett, Ellen Goudsmit, and Anne Macintyre.
You state that Version 2 was used in the PACE Trial: “I understand that this is version 2 as used in the PACE trial – please note that I did not prepare version 2.”
However, Ellen Goudsmit states that there were 2 versions in circulation in 2004, here: http://www.me-cvs.nl/index.php?pageid=7056&printlink=true&highlight=myalgic
Therefore is the version used in the PACE trial number 3? And could you tell me who were the authors of Version 2?
Simple answer is that the Task Force Report published an original version of the London Criteria minus a few very important bits – eg the exclusion diagnoses and the physical examination findings – that I have now placed in a comment box in this thread.
More than one version appeared at the time – in 1993/1994.
Peter White et al modified the Task Force version (hence the reference to this in the PACE references) and called it version 2.
If people want me to pursue this further I am going to have to go to the attic and dig out all the old London Criteria paperwork. Remember: this work was all done almost 20 years ago and I cannot accurately remember everything that was done at the time.
I will also try and speak to Ellen Goudsmit sometime next week.
CS
How Wikepedia summarises ME and CFS diagnostic criteria:
http://en.wikipedia.org/wiki/Clinical_descriptions_of_chronic_fatigue_syndrome
Dr Shepherd, I wouldn’t in anyway rely on wikipedia as a reliable source of information.
I’m not that naive!
This was purely for information in relation to the discussion.
I’m now off to London for a couple of days – so won’t be able to return to the London Criteria discussion (if it’s still going) till later in the week.
Just a note to avoid confusion. I can see differences between version 1 of the LC and Weir’s criteria, but there are also similarities. Indeed, it is striking that a number of sentences are exactly the same. I suspect that both copied from the same source, which will either be Ramsay or Dowsett (some sentenes are almost the same as those in her guidelines that she had when a consultant microbiologist – a green? paper). I can’t find the exact passages at the moment (will take some searching after my Spring tidy-up and have higher priorities). If the sentences in question or some of the sentences were copied directly from Weir, then I didn’t know about it. to emphasize, there are differences, e.g. he has two major criteria, the LC has 4. Weir, when I knew him was also influenced by Ramsay, so it’s no surprise that there was much agreement.
The Oxford criteria were not published in a peer reviewed journal (it wasn’t then, it is now), and the CC have not been validated and were not published in a PubMed journal. I have just helped to write a paper where a study used the CC. It’s been submitted. One can use any criteria you want, e.g your own, as Behan and Ho-Yen used to do. Nijmegen had a period where they used the simple criterion of fatigue lasting a year.
If people criticise, can they please apply the same criteria to all equally? The main author of the CC 2003 confirmed that the CC were devised for clinical work only and that they require tweaking for research. I even posted it on a website for all to see. The CC 2003 are too broad for research. The revised version is better and deserves more attention. When you see them, you’ll notice their similarity to the LC. The LC simply were not that bad because they were focused on the illness ME as decribed by Ramsay. They were not as good as they could have been, and hence we had a rethink and came up with an improved set of criteria. The only people who wouldn’t like them are the individuals who believe that ME does not exist as a distinct entity, that it is a belief system and that Ramsay was a poor doctor. Criticising them because they were not validated makes little sense as at the time of the anti-PACE movement when all the anti arguments began (2004), none were.
Because CFS is such a dustbin diagnosis, it’s rare to find replication of findings. Everyone is studying different samples. Forget PACE for a minute. The LC found abnormalities in 100% of the samples selected, except in one study (on melatonin). In practice, they worked well, which is why researchers began to request them for studies not funded by AFME (e.g. Scholey, McCue, Perrin etc). Paul et al were funded by AFME and should have used the LC (it’s in their contract) but they didn’t. That didn’t come out till 2004. Had I still been at AFME, I’d have demanded my money back for breach of contract. They could have used them in addition to the CDC criteria; or the Oxford criteria, to make them more palatable to referees but that was not the reason they didn’t use them. The good news is that patients were selected by my boss, Dr Parish, and he knows his ME. So even though the study refers to CFS and the CDC criteria, I know that the sample had ME. And the abnormalities documented were found in all those tested. They support the criterion of muscle fatiguability and delayed recovery after exertion ends. It’s objective evidence for the view of ME as a neurological disease. Had McCue published her results on cognitive impairment (the findings ended up in her PhD), that would have supported criterion 2. Sometimes PhDs are downloadable from Ethos, so I’ll have a look for hers. It wasn’t there last time. Her findings are important because they undermine the concept of ‘mental fatigue’, as per Oxford criteria. I’m not promoting the further use of the LC as there are improved criteria now. But they were a lot better than the Oxford criteria when we devised them in 1993! You have to see this in context. As for PACE, it turned out they didn’t use the LC but made up their own version. All that anti-LC effort in 2004 proved irrelevant in the end. The criteria they did use haven’t been validated, published or used before, but that’s a relatively minor flaw that should not detract us from the much more significant ones. See discussion on PACE on Facebook.