Cochrane Review protocol: Exercise therapy for chronic fatigue syndrome (individual patient data)

[Dolphin]

The full text is available for free at:
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011040/full

Source: Cochrane Database of Systematic Reviews

2014, Issue 4. Art. No.: CD011040

Date: April 1, 2014

URL: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011040/abstract

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011040/full



Exercise therapy for chronic fatigue syndrome (individual patient data)

-----------------------------------------------------------------------

Lillebeth Larun(1,*), Jan Odgaard-Jensen(2), Kjetil G Brurberg(1), Trudie Chalder(3), Marianne Dybwad(4), Rona E Moss-Morris(5), Michael Sharpe(6), Karen Wallman(7), Alison Wearden(8), Peter D White(9), Paul P Glasziou(10)

1 Norwegian Knowledge Centre for the Health Services, Primary Care Unit, Oslo, Norway
2 Norwegian Knowledge Centre for the Health Services, Global Health Unit, Oslo, Norway
3 Institute of Psychiatry, King's College London, Department of Psychological Medicine, London, UK
4 Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway
5 Institute of Psychiatry, King's College London, Section of Health Psychology, London, UK
6 University of Oxford, Department of Psychiatry, Oxford, UK
7 The University of Western Australia, School of Sport Science, Exercise and Health, Crawley, Australia
8 University of Manchester, School of Psychological Sciences, Manchester, UK
9 Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Centre for Psychiatry, London, UK
10 Bond University, Centre for Research in Evidence-Based Practice (CREBP), Gold Coast, Queensland, Australia

* Corresponding author. Lillebeth Larun, Primary Care Unit, Norwegian Knowledge Centre for the Health Services, PO Box 7004, St Olav's plass, Oslo, N-0130, Norway. Lillebeth.Larun@kunnskapssenteret.no.

Editorial Group: Cochrane Depression, Anxiety and Neurosis Group

Abstract

This is the protocol for a review and there is no abstract.

The objectives are as follows:

To assess the effects of exercise therapy, alone and in combination, for people with chronic fatigue syndrome

(CFS) compared with treatment as usual control conditions and other interventions (psychological therapies, pharmacological treatment).

 

[Dolphin]

It seems unsatisfactory to me that investigators who represent a large chunk of the trials that have been done e.g. four out of the five GET studies in the last Cochrane Review of GET (not individual data), are the reviewers.

 

[medfeb]

Thanks for this, Dolphin

Just to clarify - is this saying that the people identified above will be the ones reviewing the evidence for efficacy of GET in CFS?

 

[Dolphin]

Thanks for this, Dolphin

Just to clarify - is this saying that the people identified above will be the ones reviewing the evidence for efficacy of GET in CFS?

Yes

 

[Tom Kindlon]

Some people on Facebook couldn't get the full text for some reason, so I've uploaded it here.

 

[Kati]

For crying out loud.

The Cochrane Library is one of the most respected tool for all diseases around the world.that is except for ME.
When I wrote to the Canadian Institutes for Health Research asking for funding and research for ME, the CEO pointed out to me that the Cochrane Library was very clear about CBT and GEt as the only treatments for ME.

This is what we are facing, day after day, after day.

How can we fight this, in your opinion, @Tom Kindlon ? Everyone?
Can the Workwell foundation ans IACFSME fight this, do they want to, can they?

 

[biophile]

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011040/full

People with CFS should have the opportunity to make decisions about their treatment informed by robust research evidence. This review will examine the effectiveness of exercise therapy, either as a stand-alone intervention or as one part of a treatment plan. Cochrane reviews address many aspects of treatments for CFS.

There is no mention of actigraphy, the objective measure which in previous trials has debunked claims made about GET increasing exercise and activity levels. This data will be ignored in their attempts at accounting for outcomes reporting bias, and is inconvenient when trying to make the following unsupported claims which they have been making for years:

The etiology and pathophysiology of CFS are controversial. Models of understanding can be broadly divided into biomedical and biopsychosocial models. The biomedical model explains the illness as caused by abnormalities of the immune, central nervous (Nijs 2011) or endocrine systems and/or a persistent infectious agent. The multifactorial biopsychosocial model (Moss-Morris 2012) distinguishes between precipitating and maintaining factors. Precipitating factors may include acute infective illness and/or excessive stress, while the illness is maintained by the interaction of behavior, thoughts, emotions and physiology. For example, after a severe infection or other illness, attempts to get back to normal life may result in bursts of activity punctuated by the need to rest up to recover, known as all-or-nothing behaviour (Moss-Morris 2010; Spence 2005). These periodic bursts of activity may exacerbate symptoms and result in failure, which further reinforces sufferers' belief that they have a serious, ongoing illness. As time goes by, efforts to meet previous standards of achievement are abandoned and patients become increasingly inactive and distressed by their ongoing symptoms. Inactivity in turn leads to physiological changes such as cardiovascular and muscular deconditioning, dysregulation of the hypothalamic-pituitary-adrenal axis and disrupted circadian rhythms. In this deconditioned state, any activity is liable to produce symptoms, the experience of which reinforces the fearful beliefs and hence reinforces the avoidance of activity (fear avoidance).

Exercise is physical activity that requires effort (OED 2012). Exercise therapy uses physical exercise to improve health and well-being in people who are unwell, and can include modalities such as strength training or endurance exercise given as a part of a goal-oriented, multidisciplinary approach (Rietberg 2004; Takken 2008). There are a number of different approaches to exercise therapy for CFS. These include aerobic exercise such as walking, jogging, swimming or cycling, as well as anaerobic exercise such as strength or stabilising exercises. It is important to look at all kinds of therapeutic exercise, not only aerobic exercise. Behavioral approaches which use carefully graded exercise as a form of systematic desensitisation focus on breaking the fear avoidance cycle and the tendency to interpret symptoms as signs of illness. These approaches usually set a low initial exercise level, which gives patients the opportunity to experience exercise which does not produce a large increase in symptoms. Exercise is then built up gradually in a programme agreed in advance with the patient. If patients experience an increase in symptoms, then planned increases in exercise frequency, duration or intensity are temporarily deferred until symptoms are less intense. Exercise therapy based on improving fitness typically involves setting targets based on physiological indicators of baseline fitness (such as VO2 max) and prescribing increases in exercise based on ongoing monitoring of measures of fitness. Whereas both of the above types of exercise therapy include gradual increases in activity over time, a third approach allows patients to reduce activity in response to symptom exacerbations.

 

[Dolphin]

There is no mention of actigraphy, the objective measure which in previous trials has debunked claims made about GET increasing exercise and activity levels. This data will be ignored in their attempts at accounting for outcomes reporting bias, and is inconvenient when trying to make the following unsupported claims which they have been making for years:

I agree such data would be very useful. However was it collected for many exercise therapy trials as an outcome measure? The only one that comes to mind is Jason et al (2007). It would of course be good if any such data was reported. Previous Cochrane reviews have reported data on particular measures from only one trial.

 

[Dolphin]

The etiology and pathophysiology of CFS are controversial. Models of understanding can be broadly divided into biomedical and biopsychosocial models. The biomedical model explains the illness as caused by abnormalities of the immune, central nervous (Nijs 2011) or endocrine systems and/or a persistent infectious agent. The multifactorial biopsychosocial model (Moss-Morris 2012) distinguishes between precipitating and maintaining factors. Precipitating factors may include acute infective illness and/or excessive stress, while the illness is maintained by the interaction of behavior, thoughts, emotions and physiology. For example, after a severe infection or other illness, attempts to get back to normal life may result in bursts of activity punctuated by the need to rest up to recover, known as all-or-nothing behaviour (Moss-Morris 2010; Spence 2005). These periodic bursts of activity may exacerbate symptoms and result in failure, which further reinforces sufferers' belief that they have a serious, ongoing illness. As time goes by, efforts to meet previous standards of achievement are abandoned and patients become increasingly inactive and distressed by their ongoing symptoms. Inactivity in turn leads to physiological changes such as cardiovascular and muscular deconditioning, dysregulation of the hypothalamic-pituitary-adrenal axis and disrupted circadian rhythms. In this deconditioned state, any activity is liable to produce symptoms, the experience of which reinforces the fearful beliefs and hence reinforces the avoidance of activity (fear avoidance).

I recall one or two studies which found that activity didn't vary any more in ME/CFS patients compared to healthy people when looking at day-to-day fluctuations.

Plenty of studies with deconditioned controls suggest the abnormalities can't be explained by deconditioning.

 

[biophile]

I agree such data would be very useful. However was it collected for many exercise therapy trials as an outcome measure? The only one that comes to mind is Jason et al (2007). It would of course be good if any such data was reported. Previous Cochrane reviews have reported data from one trial.

Good point. The answer is probably no. However, the several CBT trials which did use actigraphy also incorporated GET into the program. It just seems that every year the tools to measure presumed treatment effects get more complicated and the house of cards grows ever higher without these people ever considering that they are mostly measuring the methodological artifacts of placebo response and patient reporting bias while objective outcomes do not improve yet presumed to.

 

[Dolphin]

Whereas both of the above types of exercise therapy include gradual increases in activity over time, a third approach allows patients to reduce activity in response to symptom exacerbations.

I haven't looked at it (the protocol) yet. It would be good if different types of exercise weren't all collapsed into one group. The third approach, which involves pacing, was used in Wallman et al.

 

[kaffiend]

Inexpensive GPS activity monitors are widely available for dogs. Unfortunately they'll keep rooting through the existing pile of dung (completed GET/CBT studies) for the time being, but I can't see the lack of objective data being acceptable much longer.

 

[Dolphin]

Saw somebody highlight the following:


Here's some info on conflict of interest in Cochrane reviews. (Note that they state the policy is being revised.)

Some of the bits that may be relevant to this review:

"General Principle: Cochrane Reviews must be free of any real or perceived bias introduced by any financial relationships or other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing the Cochrane Protocol or Review."

"Authors with a direct financial interest in a particular intervention should not be involved in a Cochrane Review of that intervention."

"Being an author of a study or studies that may be eligible for a Cochrane Review does not exclude that person from authoring a Cochrane Review. However, this should be disclosed in The Cochrane Collaboration's disclosure of potential conflicts of interest form and therefore the Cochrane Review. Also, there should be an independent assessment of eligibility and risk of bias by a second author who was not involved in the study/studies. The co-author would not necessarily be the contact author for the review, but could act as a ‘guarantor’."

 

[SOC]

It seems unsatisfactory to me that investigators who represent a large chunk of the trials that have been done e.g. four out of the five GET studies in the last Cochrane Review of GET (not individual data), are the reviewers.

"Unsatisfactory" is hardly the word for it. I'd go with "unethical" or "incestuous".

 

[dancer]

I'm just boggling that the document says the group is called:

"Editorial Group: Cochrane Depression, Anxiety and Neurosis Group"

 

[Sean]

"Unsatisfactory" is hardly the word for it. I'd go with "unethical" or "incestuous".

And even that is being generous.

How much more blatant is this rigging going to get? White, Sharpe, and Chalder, three of the most partisan and vested interest soaked players in the game, get to review their own highly contentious and dodgy work? What next? They get to review their own funding grant applications? Salary levels? Suitability for sainthood?

Very, very disappointed in and angry with Cochrane. Massive fail from every angle. How can they possibly justify using those three as reviewers? They are the last three anybody should consider for this crucial task.

It seems – surprise, surprise, – quite clear that this review team are going to frame the whole thing as psychosomatic from the start, and ignore any evidence to the contrary. Like they have since forever.

Make no mistake: If, as is likely, this comes out in favour of GET, and for the usual bullshit reasons, then we are in deep shit. It will be used to beat us into submission.

Un-effing-believable.

 

[Bob]

Here's some info on conflict of interest in Cochrane reviews...

I think we need to list all the papers that each of these authors has been involved with that investigated exercise therapy for CFS, list the nature of their current employment, and list all their past and recently declared conflicts of interest, to create a database of COIs to submit to Cochrane.

 

[Valentijn]

I don't think the more obvious names are the only problem. For example, Paul Glasziou has not been directly involved in CFS research, but often cites it as an example where exercise, as a non-pharmaceutical intervention, is successful. He seems to see it as useful for pretty much any problem, but mentions it in the context of CFS several times in his research, with no trace of doubt regarding the claims of effectiveness:
Exercise guides needed (CFS): https://www.mja.com.au/system/files/issues/191_02_200709/gla10407_fm.pdf
Effect of disease names (ME v CFS): http://www.biomedcentral.com/1472-6920/12/19
Exercise reduces CFS fatigue: http://www.crebp.net.au/can-we-do-better-at-prescribing-exercise-in-primary-care/
Exercise is effective for CFS but underused: http://mdm.sagepub.com/content/32/1/E20.full

So while he's not really been a propagator of the GET-for-CFS party line, he's definitely an unquestioning believer in that dogma, and frequently uses it as an example.

 

[Cheshire]

Types of participants

We will include male and female participants over the age of 17, irrespective of culture and setting. As several sets of criteria are currently used to diagnose CFS (Sharpe 1991; Fukuda 1994; Carruthers 2011) we will include trials given that the patients fulfil the following diagnostic criteria for CFS:

• Fatigue or a synonym is a prominent symptom;

• Fatigue is medically unexplained (i.e. other diagnosis known to cause fatigue such as psychiatric disorders and cancer should be excluded);

• Fatigue is sufficiently severe to significantly disable or distress the patient; and

• Fatigue has persisted for at least six months.

So more or less Oxford criteria...

 

[Valentijn]

Alison Wearden is a fairly well-known member of the BPS school, and was the principal author of the FINE trial. Here's some other stuff directly involving and/or referencing her research and beliefs about exercise and CFS (mostly or all Oxford):
GET is effective, maximal exertion is harmless: http://bjsm.bmj.com/content/33/5/352.full.pdf+html
GET is effective: http://bjp.rcpsych.org/content/172/6/485.short
Pragmatic Rehabilitation (CBT/GET) reduces fatigue: http://www.bmj.com/content/340/bmj.c1777.long
FINE, a trial of CBT/GET: link.springer.com/content/pdf/10.1186%2F1741-7015-4-9.pdf
GET is proven effective in specialist settings: http://chi.sagepub.com/content/2/2/143.short
GET in CFS: http://bjp.rcpsych.org/content/201/3/227.full.pdf+html
Pragmatic Rehabilitation improves fatigue and beliefs but not exercise capacity: http://psycnet.apa.org/journals/ccp/81/5/831/

At least one of her papers seems to acknowledge that GET doesn't improve objective physical ability, but she doesn't have a problem with that. As long as people say they feel slightly less fatigued on questionnaires, that's good enough! Basically a hard-core proponent of psychological CFS theories, but seems less inclined to spin results than other members.