Exercise therapy beneficial for some ME/CFS patients new Cochrane report says

[Keela Too]

I would like to coin a term, if it does not already exist.

BIBO

Babble In, Babble Out

I don't know who invented GIGO, but it needed an update.

LOL... Psychobabble in Psychobabble out!

 

[snowathlete]

I would like to coin a term, if it does not already exist.

BIBO

Babble In, Babble Out

I don't know who invented GIGO, but it needed an update.

The underlying flaws of the studies reviewed are ignored in the unjustified hope that they will go away. This might be OK for random bias, but the bias is systemic. Such bias is amplifed by meta-analyses.

This is an exemplar of what is wrong in "Evidence" Based Medicine. When the underlying studies are given a pass on scientific rigor, guess what happens to the meta-analysis?

I have found a different use of babble in, babble out, by Joanne Sales http://www.joannesales.com/articles/vacation_freedomfrom.html

I like that. This paper is not science, it is just more of the same propaganda to talk up out of date views with the aim of maintaing those out of date views. And conveinently released at a time to counter the IOM report. This review looks at CFS as defined like this:
Oxford, Oxford, Oxford, Oxford, Oxford, Fukuda, Fukuda, Fukuda.
The P2P and IOM reports make clear that this sort of research being reviewed here, is junk, it is inadequate and it fails patients. The P2P go so far as to say that Oxford should be retired entirely.

I really can't say it better than you did @alex3619: Babble In, Babble Out.

 

[alex3619]

Evidence based medicine is mostly managerial techniques used to process science. Its not about getting at the reality of the situation but about dealing with it. Its no coincidence a lot of this is from government agencies that have tight budgets.

Evidence based practice, though related, is actually a fair bit different and more easily justified.

 

[Esther12]

Looks like responses can be sent and should be replied to:

http://editorial-unit.cochrane.org/sites/editorial-unit.cochrane.org/files/uploads/14532_Final Print Ready.pdf

Edit. Not exactly clear where they should be sent. Anxiety, Neurosis and Depression Group?

Looks like this is it:

Cochrane Depression, Anxiety and Neurosis Group
Contact us



CCDAN Editorial Base Office
+44 (0)117 331 0172
contact@ccdan.org

Centre for Academic Mental Health, University of Bristol
Oakfield House, Oakfield Grove
Bristol, BS8 2BN
United Kingdom


Co-ordinating Editor: Dr Rachel Churchill

Managing Editor: Jessica Sharp

Trials Search Co-ordinator: Sarah Dawson

 

[Esther12]

I'm not sure this is correct. Anyone have evidence she is right?

From memory, I thought that was wrong.

This is from the Lancet paper:

the London criteria13 for myalgic
encephalomyelitis (version 2), requiring postexertional
fatigue, poor memory and concentration, symptoms that
fl uctuate, and no primary depressive or anxiety disorder
(interpreted as an absence of any such disorder).

I wonder if she misunderstood table 1 which gives % who fulfil London, and then goes on to give % with depression/anxiety for Oxford?

Couldn't see where % of with anxiety/depression who fulfilled London was given. I had a memory of it being given as 0, but may have imagined it. The above quote makes it sound like they excluded those with anxiety and depressive disorder.

 

[Esther12]

This has been included in most studies conducted in the USA and the Netherlands. The results from actigraphy indicate that, except for 7 individuals, there were no significant increases in activity after GET and similar therapies.

Anyone know the GET actigraphy results referred to here?

 

[Dolphin]

The trial manual indicates that the researchers adapted the lay version and I could tell from the results that the London criteria were not used as they exclude individuals with psychological disorders so the percentage for that variable should have been nil. It wasn’t.

That's not correct. See this extract of a letter that clarifies it (see underlined bit) - the letter was written by PD White, KA Goldsmith, AL Johnson, R Walwyn, HL Baber, T Chalder, M Sharpe, on behalf of all the co-authors (of the PACE Trial)

The selection of patients was for CFS operationalised using the broadest criteria (the Oxford criteria). No sensible neurologist would apply the diagnosis of CFS (or indeed ME) to patients who had "proven organic brain disease", such as Parkinson's disease. For the purposes of this trial ME was not regarded as a "proven organic brain disease". In order to ensure balance between the trial arms in those participants who met alternative criteria for CFS and ME, randomisation was stratified by the International (Centers for Disease Control) criteria (which require additional symptoms) and by the London ME criteria (based on Melvin Ramsay's original description, and which excludes co-existing "primary" psychiatric disorders which we interpreted as any psychiatric disorder and emphasises post-exertional fatigue). We were provided with the second revised version of the London ME criteria; we did not invent our own. We considered use of the Canadian criteria for ME but we found it impossible to operationalise them adequately for research purposes; to our knowledge they have not been used in a major research trial. We studied the results for differently defined subgroups and they were similar to those in the entire group.

(source: http://www.meactionuk.org.uk/whitereply.htm )

 

[Dolphin]

Good find by @Maxwhd on Twitter (here's link if anyone wants to RT it: https://twitter.com/maxwhd/status/567862160887549952 )

Jonathan R Price led the new Cochrane Review on GET (he has also been involved in the Cochrane Review on CFS)

http://www.twitlonger.com/show/n_1sko23e


#mecfs #seid Cochrane GET Review *Jonathan R. Price* Larun, Bruberg, Odgaard-Jensen


https://twitter.com/TomKindlon/status/565539080445112320


http://www.ncbi.nlm.nih.gov/myncbi/ellen m.goudsmit.1/comments/


https://books.google.co.uk/books?id=cud8PW92ulQC&pg=PA311&lpg=PA311&dq=%22Chronic+Fatigue+Syndrome:+A+Real+Disease,+A+Real+Problem%22&source=bl&ots=-s8f4lJwyJ&sig=_UQJt3-nk2JBp8gemGGpHTbbogk&hl=en&sa=X&ei=8OnjVNuWLIXJPZ7zgJAF&ved=0CCoQ6AEwAQ#v=onepage&q=%22Chronic%20Fatigue%20Syndrome%3A%20A%20Real%20Disease%2C%20A%20Real%20Problem%22&f=false



Chronic Fatigue Syndrome: A Real Disease, A Real Problem


Jonathan R. Price


http://www.psych.ox.ac.uk/team/senior-researchers/jonathan-price


Chronic fatigue syndrome (CFS) is one of the most challenging medical problems for doctors to manage and for patients to experience.


Sharpe and Wessely are to be commended for their thorough and balanced approach in their review of current evidence.


CFS sits within a vexatious group of disorders, known variably as “functional”, “psychosomatic”, and “somatoform”.


These disorders present major problems, not least because of the apparent complexity of their aetiology, and associated difficulties in engaging many patients.


Sharpe and Wessely do not shirk from wholeheartedly embracing the biopsychosocial perspective, in which a person’s social and psychological context, in addition to relevant biological factors, is a key factor in their illness and recovery [1].


The adoption of this perspective triggers, for some, the question of whether CFS is a “medical” or a “psychiatric” condition.


This question is unnecessarily polarizing.


Psychiatrists are excited by the burgeoning evidence for the relevance of psychological interventions in the management of a wide range of disorders, many of which are “physical”, and all of which are legitimate illnesses like CFS that cause real disability and distress.


CFS is obviously a disease, with unmistakable associated distress and disability.


As a psychiatrist, I do not doubt this.


I regard depression as an important disease of the nervous system, just as I regard diabetes mellitus as an important disease of the endocrine system.


Depression may be “all in the mind”, but it is a true disease.


Why, therefore, does the suggestion that the aetiology of CFS involves potent psychological factors arouse such passions, among many patients and some doctors?


Isn’t it good news that, according to the cognitive-behavioural model, biological factors are only partly responsible for the illness, or largely reversible [2] ?


For many CFS patients, this is not the case.


The suggestion that psychological factors are relevant or, indeed, pivotal, is seen as questioning the legitimacy of the illness, not taking their problems seriously, or dismissing their experience and expertise [3].


Doctor and patient are potentially placed at odds, in a situation that has been likened to a political arena, where facts and beliefs are opposed and confused [4].


Similar responses are seen in other common problems with which biomedicine struggles to provide clear aetiological or therapeutic answers, such as low back pain [5].


The common reluctance of patients to accept an integrated, biopsychosocial model of aetiology and, thereby, of treatment is a problem for both patients and doctors.


Sharpe and Wessely try hard to embrace concerns about the biopsychosocial approach.


And so they should.


Meaningful and effective engagement with CFS sufferers, their carers, and their support and advocacy organizations is pivotal to successful treatment.


Fifty, or even twenty, years ago, the doctor’s “expert” view would inevitably have triumphed over that of the patient’s.


By 2005, the balance of power has shifted as governments have endorsed the validity and centrality of the patient’s view, and embedded patient power within the delivery and management of health care.


Simultaneously, the Internet has given ready access to medical evidence of all kinds.


The patient is also an expert now, and a powerful one.


How should the doctor respond?


Help the patient make his own decision, rather than dominate or coerce.


Assist the patient to understand the evidence.


Be frank about uncertainty—most patients will appreciate candour.


Encourage the patient to have an open mind, rather than close down therapeutic possibilities.


Encourage an experimental approach—discuss and facilitate therapeutic ‘n of 1’ trials.


Finally, be positive about the prospects for improvement.


As Sharpe and Wessely state, presenting a positive diagnosis, with an aetiological formulation that addresses biological, psychological and social factors, and a management plan that clearly relates to that formulation, is “an essential starting point for effective management”.


The key message is that CFS is not a fixed, unalterable disease, lying outside the patient’s control.


Rather, CFS is a real disease that is reversible by the patient’s own efforts, alongside those of professionals.


Self-care, appropriately informed and supported, is the focus here.


Relatively simple interventions may be effective, if they have a clear rationale that is well communicated to patients [6].


Recent decades have seen an increased public interest in “stress” and its consequences.


Simultaneously, medicine has been criticized for being too biomedical and neglecting “the whole person”.


It therefore seems surprising that many CFS patients are reluctant to embrace a more holistic, biopsychosocial, approach to their management.


We need the help of sociologists and anthropologists to try to understand this paradox, which is at the core of many problems that biomedicine struggles to understand.


But biomedicine itself may come to our rescue.


Functional neuroimaging promises to visualize the currently invisible and, thereby, to explain the inexplicable.


As psychiatry becomes more biological, we will be able to demonstrate the “organic” basis of what has hitherto been “functional”.


Apparent abnormalities in brain function in CFS patients are already being reported [7], and we look forward to the endorsement of the role of the brain in this problematic disorder.


[ see http://www.wolfson.qmul.ac.uk/current-projects/brain-in-pain-ii

http://www.wolfson.qmul.ac.uk/current-projects/brain-in-pain-iii

http://twitdoc.com/upload/maxwhd/bourke-pain.pdf

http://www.ncbi.nlm.nih.gov/pubmed/25598410

http://www.ncbi.nlm.nih.gov/pubmed/23967878

http://www.wolfson.qmul.ac.uk/centres/cfp/liaison etc]


REFERENCES


1. White P. (Ed) (2005) Biopsychosocial Medicine. Oxford University Press: Oxford.

2. Surawy C., Hackmann A., Hawton K.E., Sharpe M. (1995) Chronic fatigue syndrome: a cognitive approach. Behav. Res. Ther. 33: 535—544.

3. Asbring P., Närvanen AL. (2002) Women’s experiences of stigma in relation to chronic fatigue syndrome and fibromyalgia. Qual. Health Res. 12: 148—160.

4. Banks J., Prior L. (2001) Doing things with illness. The micro politics of the CFS clinic. Soc. Sci. Med. 52: 11—23.

5. Johansson E.E., Hamberg K., Lindgren G., Westman G. (1996) “I’ve been crying my way” —qualitative analysis of a group of female patients’ consultation experiences. Fam. Pract. 13: 498—503.

6. Powell P., Bentall R.P., Nye F.J., Edwards R.H.T. (2001) Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syn drome. Br. Med. J. 322: 387—390.

7. DeLange F.P., Kalkman J.S., Bleijenberg C., Hagoort P., van der Werf S.P., van der Meer J.W., Toni I. (2004) Neural correlates of the chronic fatigue syndrome—an fMRI study. Brain 127: 1948—1957.5.11

@Maxwhd finds and posts lots of interesting stuff about CBT/GET school psychiatrists, psychologists.

 

[Valentijn]

So another Cochrane reviewer endorses the research which reinforces his own pre-formed views Cochrane is turning into a bad joke.

 

[Snow Leopard]

This Cochrane review is a classic example of cherry picking evidence. Sadly, this is something that people assume doesn't happen in Cochrane reviews...

Not to mention the allegiance effect...

 

[Sean]

Yeah, that is a little disappointing that Cochrane are allowing such partisan players to be major reviewers.

Isn’t it good news that, according to the cognitive-behavioural model, biological factors are only partly responsible for the illness, or largely reversible [2] ?

Only if it is true and it works, you effing muppet.

 

[Scarecrow]

Rather, CFS is a real disease that is reversible by the patient’s own efforts, alongside those of professionals.

Must try harder. Must try harder. Must try harder.

Oh bugger! That seems to have backfired. Didn't see that one coming.

 

[A.B.]

The psychobabblers have dug themselves into a hole by pretending to treat a disease characterized by intolerance to exertion with exercise.

This is not surprising, as the unspoken rule in behaviorist "science" is to always do the opposite of what the patients believe should be done.

 

[anciendaze]

I'm going to propose a simple thought experiment to make the logical structure of arguments about questionable therapeutic approaches to diseases of unknown etiology clearer. Where you see the proposed therapy mentioned, substitute "painting patients blue". (This is particularly appropriate for studies done in the British Isles, where there is a real historical background for the practice. See Caesar's Commentarii de Bello Gallico.) Where you read "without adverse effects" substitute "without killing them" or "nobody died". Where you find a purely subjective evaluation of results, substitute "we thought this looked quite attractive."

This reduces the PACE trial to "We investigated the approach of painting patients blue, and found this could be done without killing them. After detailed analysis we concluded that we all thought this looked quite attractive."

 

[Sean]

Rather, CFS is a real disease that is reversible by the patient’s own efforts, alongside those of professionals.

That is a reckless and disgraceful claim. Well outside what the science says.

Actually very angry about that one. Together with the rest of the article, he is just another propagandist, using all the usual rhetorical tricks.

 

[Sean]

As psychiatry becomes more biological

It becomes less psychiatry.

 

[anciendaze]

Following up on my post above, I would like to reference a high-impact publication, The Onion, concerning different criteria for evaluating effectiveness.

 

[MeSci]

Following up on my post above, I would like to reference a high-impact publication, The Onion, concerning different criteria for evaluating effectiveness.

'Like' isn't enough for that - I love it!

 

[Dolphin]

Joan Crawford has today posted a comment on this on PubMed Commons http://www.ncbi.nlm.nih.gov/pubmed/25674924#cm25674924_9193

This review states: “Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory.”

This is important because the above description of CFS and the addition of trials in the review only requiring chronic fatigue as an inclusionary requirement (Sharpe et al, 1991) makes generalisation of the findings problematic as many patients with major depressive disorder (MDD) would also meet the above description of CFS and Sharpe et al.'s (1991) criteria if their condition was fatiguing – a common feature - along with muscular aches and pains, sleep disturbance, cognitive difficulties and so on. The high percentage of patients included in these trials suffering from depression (Table 1. Study demographics) indicates this may be their primary condition – confounding the results. Exercise, through behavioural activation programs, has a moderately positive impact on patients with depression (Cooney et al., 2013). It is unclear whether the modest improvement seen in some of these trials can be accounted for by an improvement in low mood caused by depression. Moreover, where there is data there is a high usage of antidepressants in patients included in the reviewed trials (Table 1. Study demographics).

Of the eight exercise trials included in this review, five used broad inclusion criteria (Sharpe et al, 1991) (N=1287) – 85% of all participants. Two of these studies also used a version of the London criteria, which did not exclude patients with depression and other psychiatric conditions as originally specified by the authors making it hard to assess how these criteria were operationalised. Three further trials used the CDC Fukuda (1994) CFS criteria (N=231). While these purport to be more selective, they do not necessary include patients whose primary difficulties include post exertional weakness and debility and flu-like symptoms and so on beyond broadly defined fatigue and other general symptoms which could be attributed to CFS or MDD.

There is also an issue with lack of evidence of patients’ fidelity to exercise programs using objective measures. We do not know if patients increased their activity as suggested to them by their clinicians. Without using devises such as actimeters or pedometers to track daily activity levels we have no accurate way of assessing whether an increase in activity occurred and whether this helps. Black & McCully’s (2005) study demonstrates objectively the difficulties patients face when trying to increase activity and concluded that they were exercise intolerant, unable to sustain activity targets.

The report is bold in stating “no evidence suggests that exercise therapy may worsen outcomes“. Many patient surveys from across the world report numerous instances of harm and worsening of symptoms from taking part in exercise programs. For a summary of the difficulties and limitations of the reporting of harms, in and outside of clinical trials, and why these might be underestimated please see Kindlon (2011).

References

Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE (2013). Exercise for depression. The Cochrane Library. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004366.pub6/abstract

Fukuda, K., Straus, S.E., Hickie, I., Sharpe, M.C., Dobbins, J.G., & Komaroff, A. (1994). The chronic fatigue syndrome: A comprehensive approach to its definition and study. International chronic fatigue syndrome study group. Annals of Internal Medicine, 121(12), 953-959.

Kindlon T. (2011). Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in Myalgic Encephalomyelitis/chronic fatigue syndrome. Bulletin of the IACFS/ME. 19(2): 59-111.

M, Archard L, Banatvala J, Borysiewicz LK, Clare AW, David A, et al. (1991). Chronic fatigue syndrome: guidelines for research. Journal of the Royal Society of Medicine, 84(2):118–21.

 

[user9876]

I'm slowly working my way through the text of the review and this statement worried me

Two studies (Wearden 2010; White 2011) referenced published protocols, and when we checked these against the published results, we found that reporting was adequate. In one study (Wearden 1998), trial investigators reported numerical data for only one subscale (health perception) of the Medical Outcomes Survey (MOS) scale (Ware 1992), for which data favour the intervention group; no numerical data were given for the five other subscales, nor for another scale (anxiety), as data were "similar in trial completers." It was not possible to check the other studies for selective reporting bias; therefore their risk of bias is considered unclear.

I know many of us have read toe protocol and compared what is published to the original protocol and with PACE it is largely different (maybe just things like the scoring process for the CFQ but different). So it surprises me that they say they have checked it and reporting is adequate.

I suspect they are only referring to the measures used in their meta analysis but this still seems like a very sloppy piece of work. Maybe Cochrane accept that a clinical protocol can be rewritten for a non-blinded trial?