Review: Unity of opposites? CFS and the challenge of divergent perspectives in guideline development

[biophile]

If we were to believe the results of the PACE trial the correct statement would be that it shows that there exists a safe way of delivering GET. Smith and Wessely then makes a big jump and assumption to say that the issue of GET is resolved beyond all reasonable doubt. That generalisation suggests they are claiming that all implementations of GET are safe.

Indeed. GET is "safe" when patients do not increase overall activity levels. GET studies have not demonstrated otherwise, despite presumptions of such made in the underlying rationale of therapy.

 

[Enid]

My comments still stand I'm afraid Firestormm @ 19. Just had enough of hearing about "CFS" with it's ghastly history and misrepresentation here in the UK. To suggest the consultancy of SW here (though given up ME) is hardly giving up.

I entirely agree with gracenote's posting @ 10 of Margaret Williams' comments.

Peter has posted on another thread HERE

 

[biophile]

Of course she did reveal the finance behind the PACE trial but didn't explain why and (as has been commented upon above I think) she didn't point out the 'failings' of the Trial.

That is because there were no failings! </sarcasm> ;-)

Any challenge to PACE - incidentally - has to include the simple 'fact' that if 30-40% of patients did indeed improve (yeah I know) then that still left up to 70% who didn't.

It is worse than that. The response rate of SMC should be subtracted from the response rate of adjunctive therapy. This makes the response rate of CBT and GET about 11-16% for >=2/33 points in self-reported fatigue and >=8/100 points in self-reported physical function. The "30-40%" sounds like the "normal range" (28-30% for CBT/GET but which was not necessarily an improvement because it overlapped with trial entry criteria) and the clinical global impression (41% reported a "positive change" for either CBT or GET, but for SMC it was still 25%, so a net of 16%).

But the main factor is that the intense 'treatment' applied during PACE is not ANYWHERE applied in practice. No specialist centre or doctor's surgery or PCT or GP commissioner can AFFORD to apply sufficient resources in this manner.

PACE was a best case scenario and still underperformed expectations even if we assume that the modest changes in questionnaire-taking behaviour are accurate. Kindlon's harms paper shows that adverse effects are commonly reported in real world applications of CBT/GET. Even if these were eliminated by better monitoring (ironically by not pushing patients beyond their limits), Wessely was involved in a CBT study which suggests to me that there is an efficacy-effectiveness gap; CBT outside the confines of a RCT was substantially less effective.

http://simonwessely.com/Downloads/Publications/CFS/183.pdf

And even if they did - to get 40% [11-16% maximum] of people feeling a bit better but not to return to work or come off of benefits - is a ruddy financial disaster.

I wonder how they are going to explain away that particular failure!

 

[user9876]

Indeed. GET is "safe" when patients do not increase overall activity levels. GET studies have not demonstrated otherwise, despite presumptions of such made in the underlying rationale of therapy.

Yes good point, the PACE trial did not demonstrate that patients were complient to their GET protocols and it is unclear how much if any their activity increased. The results of the final 6 minuite walking test suggests that activity increases were miminal.

 

[Merry]

Interesting. Thanks, Firestorm, for posting extensive excerpts. Get some rest.

Simon Wessely feels threatened even by a Scottish Public Health Network report (one unduly influenced by pesky patient activists).

 

[In Vitro Infidelium]

Simon Wessely feels threatened even by a Scottish Public Health Network report ..............

This kind of unsubstantiated (and unsubstantianable) personalisation (a resort to ad hominem fallacy) only detracts from the very real (and substantianable) criticisms of the research that most readers here would consider has driven medical assessment of M.E/CFS in the wrong direction. It is entirely reasonable that Wessely (a clinician and academic who now holds a key professional position - Dean of Psychiatry at a world centre of Psychiatric teaching) would be a co-author of a document that is critical of the Scottish document. The two documents have to stand or fall on their own - irrespective of who wrote them, nullius in verba applies equally but so also does the fallaciousness of ad hominem argumentum.

IVI

 

[Merry]

This kind of unsunstantiated (and unsubstantianable) personalisation (a resort to ad hominem fallacy) only detracts from the very real (and substantianable) criticisms of the research that most readers here would consider has driven medical assessment of M.E/CFS in the wrong direction. It is entirely reasonable that Wessely (a clinician and academic who now holds a key professional position - Dean of Psychiatry at a world centre of Psychiatric teaching) would be a co-author of a document that is critical of the Scottish document. The two documents have to stand or fall on their own - irrespective of who wrote them, nullius in verba applies equally but so also does the fallaciousness of ad hominem argumentum.

IVI

IVI, I am not qualified to judge the research in the way that you are. But I can see for myself what kind of person Simon Wessely is and the harm he has done. Your posts that criticize others for the way they choose to participate in activism (such as telling Kati, in the "Simon Wessely Wins Award for 'Standing Up for Science' " thread, not to tweet) are out of line.

 

[alex3619]

Yes good point, the PACE trial did not demonstrate that patients were complient to their GET protocols and it is unclear how much if any their activity increased. The results of the final 6 minuite walking test suggests that activity increases were miminal.

Yes, that is a very good point. Safety might be directly linked to non-compliance. Interesting possibility. Bye, Alex

 

[user9876]

Yes, that is a very good point. Safety might be directly linked to non-compliance. Interesting possibility. Bye, Alex

I was trying to make a different point in this and my previous post which is it is useful to identify exactly what the PACE trial tells us. Then we can look at what inferences are being separately drawn and the basis for them being made. In their reasoning they seem to be assuming compliance and they are also implying that patients activity increased. However, I don't remember them quoting any evidence on either bit - I've not read the protocol so I'm not sure what they would have recorded.

 

[barbc56]

IVI, I am not qualified to judge the research in the way that you are. But I can see for myself what kind of person Simon Wessely is and the harm he has done. Your posts that criticize others for the way they choose to participate in activism (such as telling Kati, in the "Simon Wessely Wins Award for 'Standing Up for Science' " thread, not to tweet) are out of line.

I don't think any opinion as long as it's appropriate and within the rules of this forum is "out of line". I don't remember what was said but I think there are a lot of sides to this issue and it's healthy to air these.

Take care.
Barb C.:>)

 

[Merry]

I don't think any opinion as long as it's appropriate and within the rules of this forum is "out of line". I don't remember what was said but I think there are a lot of sides to this issue and it's healthy to air these.

Take care.
Barb C.:>)

Barb C., please translate "out of line" as "I don't like this behavior." I wasn't suggesting IVI had broken forum rules.

 

[In Vitro Infidelium]

Your posts that criticize others for the way they choose to participate in activism (such as telling Kati, in the "Simon Wessely Wins Award for 'Standing Up for Science' " thread, not to tweet) are out of line.

I doubt I have ever written anything on any M.E/CFS forum that tells anyone what they can or can not do. I do often present 'if - then' arguments, because that structure allows clear reasoning and demonstration of the potential effects of differing choices. Advocacy impacts upon us all - if it is carried out badly, the consequences affect future efforts; explaining to someone what the consequences of their actions are, or are likely to be, isn't some interference with a religious freedom, it's a basic democratic process. In the real world such 'explanations are frequent and usually delivered in far more robust terms than the very restrained way I responded on the other thread.

IVI

 

[Firestormm]

Came across this earlier. Seems relevant to part of the discussion raised in the Review concerning the Canadian Criteria, but also in relation to more recent criteria also perhaps:

Use of the Canadian criteria to diagnose CFS, British Medical Journal, 18 July 2011: http://www.meassociation.org.uk/?p=7156

Fiona Godlee suggests that adoption of the Canadian criteria to diagnose chronic fatigue syndrome (CFS) is a reasonable request (1). It may be reasonable, but is probably not practicable.

These criteria require the assessment of some 65 discrete symptoms and 14 comorbid conditions, before even considering exclusionary conditions (2); a significant burden on both patients and doctors. More worrying is that “symptoms”, such as ataxia, “palpitations with cardiac arrhythmias”, and “loss of thermostatic stability” count towards the diagnosis, rather than suggesting alternative diagnoses.

All criteria used to diagnose CFS/ME require disabling fatigue lasting between 4 and 6 months; a varying number of symptoms and the exclusion of other illnesses that cause fatigue. There is no evidence that different diagnostic criteria diagnose a different condition (3).

There has been a recent attempt to improve the “vaguely worded” Canadian criteria (4), incorporating elements of more orthodox research criteria (5). But these revised criteria still require assessment of too many symptoms of dubious validity.

The one advantage of the Canadian criteria over alternative diagnostic criteria is that they require what many would regard as the characteristic feature of CFS, post-exertional malaise (6). This is something that may need incorporating in future definitions to help differentiate CFS from more general fatigue.

BMJ Rapid response - link will take you to original Godlee article: "Ending the Stalemate": http://www.bmj.com/content/342/bmj.d3956/reply#bmj_el_266989

 

[Marco]

Mmm.

More worrying is that “symptoms”, such as ataxia, “palpitations with cardiac arrhythmias”, and “loss of thermostatic stability” count towards the diagnosis, rather than suggesting alternative diagnoses

Check for all three. Should we have a straw poll as to how many here count ataxia amongst their symptoms?

In my case I have periodic ataxia. Should I therefore go back to my GP and remind him of this symptom and demand an alternative diagnosis?
I'm not aware of any family history of ataxia and it hasn't been a lifelong problem; ergo it is an acquired ataxia :

Ataxia is caused by damage to a part of the brain known as the cerebellum and sometimes part of the spinal cord.
The spinal cord is a cable of nerves that runs from the brain to the rest of the body.
The cerebellum sits at the base of the brain and is responsible for controlling:

• walking and sitting balance
• limb co-ordination
• eye movements

Damage can occur as a result of injury or illness (as is the case with acquired ataxia) or because the cerebellum or spinal cord degenerates (as is the case with hereditary ataxia).
In a minority of cases there is no clear cause why the cerebellum and spinal cord become damaged as is the case with idiopathic late onset cerebellar ataxia (ILOA).
Acquired ataxia

Acquired ataxia can have a wide range of potential causes, such as:

• severe head injury, such as the type of injury that can occur during a car crash or a fall
• bacterial infection that affects the brain, such as meningitis or encephalitis (an infection of the brain itself)
• viral infection – some types of viral infection such as chickenpox or measles can spread to the brain, although this is very uncommon
• conditions that disrupt the supply of blood to the brain, such as a stroke,haemorrhage (bleeding in or around the brain) or a transient ischaemic attack (a so-called mini-stroke)
• cerebral palsy – a series of conditions that can disrupt a child’s normal growth and development
• multiple sclerosis – a long-term condition that causes damage to the nerve fibres of the central nervous system
• prolonged long-term alcohol misuse
• underactive thyroid gland
• cancer
• certain toxic chemicals, such as mercury, lead, solvents and some types of pesticides, can trigger ataxia if a person is exposed to enough of them
• certain medications, such as benzodiazepines (a medication used to relax people who are anxious or have problems sleeping), can occasionally trigger ataxia as a side effect
• health conditions where the immune system attacks healthy tissue (autoimmune conditions), such as lupus
• in children, epilepsy – a condition that can cause a person to experience repeated seizures (fits)

http://www.nhs.uk/Conditions/Ataxia/Pages/Causes.aspx

That's quite a list of possible causes that would need to be excluded (via extensive testing) before arriving at a safe diagnosis and assuming they were excluded, would a diagnosis of idiopathic late onset cerebellar ataxia (ILOA) be any more satisfactory of lead to better treatment?

Would excluding other possible causes of ataxia, “palpitations with cardiac arrhythmias”, and “loss of thermostatic stability” rather than considering the possibility that they are frequent symptoms of the 'syndrome' not represent

a significant burden on both patients and doctors

Have they really thought through the implications of their opposition to the CCC and later criteria?

PS Apologies for the variable fonts - too much copy and pasting.

 

[Firestormm]

Morning Marco,

I think that the point is Ataxia and other specific conditions cannot be consider part of 'ME'. They are differential diagnoses. At least that's the argument being advanced. 'ME' is 'ME' i.e. a distinct condition all of it's own. The larger argument of course is not addressed in this Review.

So as I referred to previously, examinations that result in a confirmed diagnosis following e.g. 'fitting' of e.g. 'epilepsy' cannot be considered a symptom of 'ME'.

I would expect that very few people with 'ME' also have a confirmed diagnosis of e.g. Ataxia. This could be simply because they haven't been appropriately assessed.

Could be wrong, but I think that's what they are getting at with things like Ataxia.

 

[Marco]

Morning Marco,

I think that the point is Ataxia and other specific conditions cannot be consider part of 'ME'. They are differential diagnoses. At least that's the argument being advanced. 'ME' is 'ME' i.e. a distinct condition all of it's own. The larger argument of course is not addressed in this Review.

So as I referred to previously, examinations that result in a confirmed diagnosis following e.g. 'fitting' of e.g. 'epilepsy' cannot be considered a symptom of 'ME'.

I would expect that very few people with 'ME' also have a confirmed diagnosis of e.g. Ataxia. This could be simply because they haven't been appropriately assessed.

Could be wrong, but I think that's what they are getting at with things like Ataxia.

Perhaps not for this thread but to me this is a fundamental problem of 'differential diagnosis'. It assumes that an individual's illness must fall into a little box that is discrete and different from all other little boxes and diagnosis, research and treatment follows in this vein.

Ataxia and 'fitting' are symptoms that may have many causes. In some cases the cause may be clearly identified, in others a cause may be suspected but not confirmed or the presentation of symptoms may be 'untypical' or indeed all likely causes are excluded and it is designated as idiopathic.

None of this logically excludes the possibility that these symptoms are part of a distinct ME/CFS syndrome, that ME/CFS and say diabetes (which can cause ataxia) can't occur co-morbidly or that none of these labels are in fact discrete illnesses but individual manifestations of a common underlying pathology.

I lean to the latter view and 'differential diagnosis' that excludes less common symptoms as likely reflecting missed or misdiagnosis only serves divert attention from what may be important clues to the underlying pathology.

In my humble opinion.

 

[Firestormm]

Of course the flip side to the argument of differential diagnoses and/or co-morbidities is this: if you associate everything with the largely untreatable 'ME' then you run the risk of condemning a person to little effective intervention. Whereas if you are examined and assessed as having e.g. Ataxia or epilepsy or even depression - alongside 'ME' - then these might be treatable. Hope that makes some sense

 

[Marco]

Of course the flip side to the argument of differential diagnoses and/or co-morbidities is this: if you associate everything with the largely untreatable 'ME' then you run the risk of condemning a person to little effective intervention. Whereas if you are examined and assessed as having e.g. Ataxia or epilepsy or even depression - alongside 'ME' - then these might be treatable. Hope that makes some sense

Makes perfect sense and a fair point although I'm not convinced White and Crawley were as much concerned with missed diagnoses or untreated co-morbidities as they were with the inclusion of ataxia etc in a ME/CFS case description. I don't recall any objections to mood disorders etc being considered part of the ME/CFS syndrome rather than merely treatable co-morbidities.

Anecdotally I have been diagnosed (in chronological order) with OCD, depression, IBS, fibromyalgia, ME and then CFS. Onset of all was contemporaneous but all were treated by the various 'specialists' as discrete conditions.

No treatment to date has been in the least effective for any of these 'co-morbidities' and once you strip them out of the symptom constellation you're pretty much left with fatigue that remains unexplained and untreatable.

 

[Holmsey]

Barb C., please translate "out of line" as "I don't like this behavior." I wasn't suggesting IVI had broken forum rules.

Hi Merry, I don't think IVI has either, but my understanding of the personal attack rule is that you cannot post personal opinion of other users, and that your comment must be pertinent to the thread under discussion. I think suggesting IVI is 'out of line' breaches both, this is unarguably personal, directed and was based on postings in a different thread!

IVI's post to my mind calmly and rationally outlines the reality within which Simon Wessely operates, within the establishment he is highly qualified, highly respected and seen as an authoritative innovator with respect to our illness. Large parts of that same establishment probably subscribe to the view that Simon Wessely holds of us, that we are irrational, counter productive and bordering on the criminal.

IVI gets this and I believe was simply pointing out that among the pointless spleen venting and name calling the rational voice of verifiable science is lost.

I see great advantage in getting that message through to the same establishment that SW has so impressed, I see no advantage in personal attack which only serves to close those same ears while loading the gun of the next tabloid attack on our illness.

IVI asks you to understand that every posting is an act of advocacy and that all advocacy, good or bad, effects us all equally. Again I feel this is an unarguable standpoint.