NICE guidelines - Evidence of harm from Graded Exercise therapy

Trish

Trish

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This thread is intended for collecting evidence of harms from GET and other therapies that involve increasing activity and/or exercise.

Particularly useful would be any research demonstrating either that GET has directly caused harm, or that research on GET that claims no harm has not properly assessed harms.

Also any other materials that might be useful in informing the NICE committee and others that GET is not only useless, but is also harmful.
 
VanNess JM, Davenport TE, Snell CR et al. Letter to British Journal of Sports Medicine. Reproduced in Trial by Error: Letter to British Journal of Sports Medicine from CPET Experts. 2018.

http://www.virology.ws/2018/02/05/t...journal-of-sports-medicine-from-cpet-experts/

Workwell Foundation Letter for Healtcare Providers: ‘’Opposition to GET for ME/CFS.

http://www.workwellfoundation.org/w...T-Letter-to-Health-Care-Providers-v4-30-2.pdf

Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bulletin of the IACFS/ME. 2011;19:59–111.

Kindlon T. Do graded activity therapies cause harm in chronic fatigue syndrome? Journal of Health Psychology. 2017;22:1146–1154

ME Association. ME/CFS illness management survey results: No decisions about me without me. 2015. http://www.meassociation.org.uk/wpcontent/uploads/NO-DECISIONS-WITHOUTME-report.docx.
 
David T has collated the adverse effects and harm of the NICE GET and CBT approach - and requirement placed on "clients" involved with Insurance Company PHI and other OH claims with employers such as ill health retirement.(Optimum GET and CBT at that). ( SWiss Re PW et al)

Some of this was due to the NHS PLus 2006 Guidance and report, which NICE referenced both in 2007 and in the 2017 NICE Surveillance document and, and again 2018 at the Engagement Scoping events ...... It's now NHS Health & Work, not NHS Plus by the way....
NICE should address this in their background evidence work but they haven't to date!
 
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Paper: How does cognitive behavioral therapy reduce fatigue in patients with chronic fatigue syndrome?

(Spoiler: it doesn’t. Physical activity didn’t change with the use of CBT, though subjective reports made patients say they were not fatigued. https://www.ncbi.nlm.nih.gov/pubmed/20047707

Stordeur et al., (2008) analysed the effectiveness of CBT and GET in the Belgian CFS knowledge centres. They found no objective improvements after CBT and GET (VO2max) and fewer people were able to work and more people were receiving illness benefits.

Stordeur S, Thiry N and Eyssen M (2008) Chronisch Vermoeidheidssyndroom: Diagnose, behandeling en zorgorganisatie [Fatigue Syndrome: Diagnosis, treatment and organisation of care]. Technical report 88A (in Dutch).

Brussels: Belgian Healthcare Knowledge Center (KCE). Available at: https://kce.fgov.be/sites/default/files/page_documents/d20081027358.pdf (accessed 4 August 2018).

Employment status decreased at the end of the therapy, from an average of 18.3% of a 38h-working week, to 14.9%.

***You can see more here:
https://www.s4me.info/threads/who-s...-work-or-drop-in-benefits-after-get-cbt.6822/

BTW, I've started tagging posts where I'm asking for info "who said" so it's easy to find them again.
 
Nunez et al. reported worse physical function and more pain 12 months after a multidisciplinary intervention that combined GET and CBT.


Black & McCulley reported an “inability to sustain target activity levels, associated with pronounced worsening of symptomology” after a graded exercise program for ME/CFS patients.


Two studies by the Belgian research team of Nijs/Meeus showed that even a gentle and cautious exercise prescription increased symptoms in ME/CFS patients.


There’s also this quote from the AHQR report: "Harms were not well reported, although in one trial patients receiving GET reported more adverse events compared with those receiving cognitive behavior therapy (CBT), adaptive pacing, or usual care; one trial reported more withdrawals of patients receiving GET, one trial had a high percentage of patients refusing repeat exercise testing, and several other trials reported more withdrawals of patients receiving GET, all compared with controls."
 
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On the other hand, I think that the evidence we have of harms of GET does not reflect the actual danger/risk of this therapy.

Most of the RCT’s of GET were seriously flawed and did not assess adverse reactions adequately. Only the PACE trial did an attempt, but we don’t know if those participants actually tried to increase their activity level in a time-contingent manner as the treatment prescribes. And these were patients selected using the oxford criteria.

The Belgian data (it wasn’t actually a study) concerns patients selected by the Fukuda-criteria but some professors have admitted that they didn’t know how to use the criteria adequately at the time and that they now exclude much more patients with sleep- or mood disorders from the CFS diagnosis. The Belgian data showed a tiny improvement in subjective outcomes (results were very similar to the PACE trial), so I do not think this reflects the actual danger of GET for ME/CFS patients.

So I hope that NICE will simply say that GET is not effective in ME/CFS contrary to what previously had been claimed and that patients consistently report to be harmed by the treatment. A different section in the guideline could provide more background on the adverse effects exercise (in general) can have on ME/CFS patients. That would enable us to go into more depth and add studies/data to back up our claims of how dangerous exercise can be for ME/CFS patients.

This could be in a section that explains PEM and the characteristics of the disease. Here one could write, as the CDC did: “While vigorous aerobic exercise can be beneficial for many chronic illnesses, patients with ME/CFS do not tolerate such exercise routines. Standard exercise recommendations for healthy people can be harmful for patients with ME/CFS.” As such, we could make the point without explicitly claiming that research has shown that GET is harmful for ME/CFS patients.
 
Trish said:
Particularly useful would be any research demonstrating either that GET has directly caused harm, or that research on GET that claims no harm has not properly assessed harms.
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I think this needs to include cases where "harms" have been inadequately defined, though I appreciate things can get a bit nebulous. But it's no good excluding harmful effects unless the person actually drops dead, or close to. One of the major problems is that PwME can be harmed by GET, but those harmful effects may fly under the radar of what is defined as "harms".
 
JaimeS said:
Paper: How does cognitive behavioral therapy reduce fatigue in patients with chronic fatigue syndrome?

(Spoiler: it doesn’t. Physical activity didn’t change with the use of CBT, though subjective reports made patients say they were not fatigued. https://www.ncbi.nlm.nih.gov/pubmed/20047707

Stordeur et al., (2008) analysed the effectiveness of CBT and GET in the Belgian CFS knowledge centres. They found no objective improvements after CBT and GET (VO2max) and fewer people were able to work and more people were receiving illness benefits.

Stordeur S, Thiry N and Eyssen M (2008) Chronisch Vermoeidheidssyndroom: Diagnose, behandeling en zorgorganisatie [Fatigue Syndrome: Diagnosis, treatment and organisation of care]. Technical report 88A (in Dutch).

Brussels: Belgian Healthcare Knowledge Center (KCE). Available at: https://kce.fgov.be/sites/default/files/page_documents/d20081027358.pdf (accessed 4 August 2018).

Employment status decreased at the end of the therapy, from an average of 18.3% of a 38h-working week, to 14.9%.

***You can see more here:
https://www.s4me.info/threads/who-s...-work-or-drop-in-benefits-after-get-cbt.6822/

BTW, I've started tagging posts where I'm asking for info "who said" so it's easy to find them again.
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Grouping up all the studies that did publish results from objective outcomes is probably a good starting point to make the evidence that it has no measurable positive effect. Going forward, evidence of GET being useless is just as good as being harmful since the psychs don't even believe harm is possible at all and don't accept the actual harm from the disease itself. We can't counter an argument that is devoid of reason by facts alone, they control the process and framing and we kind of have to play around the shifting rules they allow themselves to play in.

I think there are a few more than this but those studies make a solid case showing that whatever the subjective studies conclude, it failed every time it's been tried with objective outcomes. There are enough of those by this point. Deprecating all subjective research as being misleading given discrepancies between objective and subjective outcomes could be a key turning point, one that is decades overdue.

This is the strongest case against GET. It literally fails objectively every time it's tried. It's absurd that there is even an argument over this by now but the psychosomatic ideologues mostly get away with it by pretending those studies don't exist or aren't quite as reliable as the subjective ones.
 
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Not sure if this comment risks derailing this thread, or alternatively if it might be very relevant - mods decide please.

How much good evidence is there that the deconditioning hypothesis is itself unfounded and invalid? Because surely any treatment for any condition, whose use is premised and trialled under completely false assumptions, significantly risks harm once its clinical use is generalised to a wider population. And in such circumstances, would resulting harms necessarily become clearly evident, given the form of those harms might be obscured due to the flawed hypothesising.

Just wondering if, in conjunction with asking the question about evidence of harms, it might also be worth asking for evidence (good solid evidence) about the falsity of the deconditioning theory.

But like I say, not really sure if this derails or not. If so then please ignore :).
 
At the time the deconditioning theory was proposed there does not seem to have been anything resembling proof, nor much resembling evidence.

For instance in 1996 Sharpe wrote "Prolonged inactivity is likely to have produced profound physiological deconditioning and reduced tolerance of exercise."

The reference given is Riley MS, O'Brien CJ, McCluskey DR, Bell NP, and Nicholls DP (1990) Aerobic work capacity in patients with chronic fatigue syndrome. British Medical Journal, 301, 953-6

Chronic fatigue. Michael Sharpe in Science and practice of Cognitive Behaviour Therapy edited by David M Clark and Christopher G Fairburn @p391
 
Although many here will already be familiar with this, this is worth keeping in mind ...

Includes comments from PACE participants, including one I only just tracked down again, where it was suggested the heart rate readings not be recorded as they had to be wrong.
 
Barry said:
the deconditioning hypothesis is itself unfounded and invalid?
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Any study that compares pwME to deconditioned controls should apply, provided you are looking at minor or moderate patients and not 'severe'. Vermeulen et al. compared 'sedentary controls' and made those were people who were active for "one hour a day or less". This is from memory but I'm 95% certain.

The issue with 'sedentary' in general is that the definition is pretty active -- according to one study, 5-6K/day is considered 'sedentary' for adults!

On an average day, I walk 2500 - 5000 steps, so on most days I am 'below sedentary'. Americans on average are slightly more active than I am, at about 5K per day. This means the average person qualifies as a sedentary control!

So. Since 'sedentary' is actually 'average' you'd have to be pretty careful just saying sedentary controls had a comparable activity level to pwME, even minor-moderate ones. You'd do better to find a group with the same number of steps/day on average as your pwME group.

Finding the definition of deconditioning is harder -- it's mostly that they have symptoms like ours: lactic acidosis, trouble breathing, muscles giving out, autonomic issues -- so it looks more symptomatic, which I don't like. Makes it all rather vague.
 
JaimeS said:
Any study that compares pwME to deconditioned controls should apply, provided you are looking at minor or moderate patients and not 'severe'. Vermeulen et al. compared 'sedentary controls' and made those were people who were active for "one hour a day or less". This is from memory but I'm 95% certain.

The issue with 'sedentary' in general is that the definition is pretty active -- according to one study, 5-6K/day is considered 'sedentary' for adults!

On an average day, I walk 2500 - 5000 steps, so on most days I am 'below sedentary'. Americans on average are slightly more active than I am, at about 5K per day. This means the average person qualifies as a sedentary control!

So. Since 'sedentary' is actually 'average' you'd have to be pretty careful just saying sedentary controls had a comparable activity level to pwME, even minor-moderate ones. You'd do better to find a group with the same number of steps/day on average as your pwME group.

Finding the definition of deconditioning is harder -- it's mostly that they have symptoms like ours: lactic acidosis, trouble breathing, muscles giving out, autonomic issues -- so it looks more symptomatic, which I don't like. Makes it all rather vague.
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America must be fitter than us. Maybe it's all that extra space to walk around in?

According to the NHS and Durham University, we walk 3-4K per day on average in the UK. That counts as sedentary.

https://www.nhs.uk/live-well/exercise/walking-for-health/

https://www.dur.ac.uk/hr/tenkstepchallenge/walkingforhealth/
 
chrisb said:
The reference given is Riley MS, O'Brien CJ, McCluskey DR, Bell NP, and Nicholls DP (1990) Aerobic work capacity in patients with chronic fatigue syndrome. British Medical Journal, 301, 953-6
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I am just quoting my own post to link back.

This is the paper
/www.researchgate.net/publication/20907096_Aerobic_work_capacity_in_patients_with_chronic_fatigue_syndrome
Aerobic work capacity in patients with chronic fatigue syndrome
Article in BMJ Clinical Research 301(6758):953-6 · November 1990 with 16 Reads
DOI: 10.1136/bmj.301.6758.953 ·

To determine the aerobic work capacity of patients with the chronic fatigue syndrome and compare it with that of two control groups, and to assess the patients' perception of their level of activity before and during illness. A symptom limited exercise treadmill test with on line gas analysis and blood sampling was used. Subjects were assessed by one investigator, who was blind to the group which they were in. Department of medicine, Royal Victoria Hospital, Belfast. 13 Patients (10 women, three men) who fulfilled the diagnostic criteria for chronic fatigue syndrome. Two control groups of similar age, sex, and body weight: 13 normal subjects (10 women, three men) and seven patients (five women, two men) with the irritable bowel syndrome. Aerobic work capacity as assessed by several variables such as length of time on treadmill, heart rate, and biochemical measurements; Borg score; and visual analogue scores of perceived level of physical activity. The patients with the chronic fatigue syndrome had a reduced exercise capacity compared with that of the other subjects, spending a significantly shorter time on the treadmill. They had a significantly higher heart rate at submaximal levels of exertion and at stage III exertion had significantly higher blood lactate concentrations. Using a Borg score, they showed a significantly altered perception of their degree of physical exertion with a mean score of 8.2 compared with 6.6 and 5.3 for the normal subjects and patients with the irritable bowel syndrome respectively. Using a visual analogue scale they indicated that they had a greater capacity for activity before illness than had the patients with the irritable bowel syndrome, but the scores were not significantly different between the two groups. Both groups of patients indicated reduced activity at the time of testing. Normal controls and patients with the irritable bowel syndrome aspired to a greater level of activity than their current level, but the patients with the chronic fatigue syndrome aspired to a level similar to that which they had had before their illness. Patients with the chronic fatigue syndrome have reduced aerobic work capacity compared with normal subjects and patients with the irritable bowel syndrome. They also have an altered perception of their degree of exertion and their premorbid level of physical activity.

I understand that abstracts may be posted in full, if not I will edit this appropriately.

This raises interesting questions. I have yet to read the full paper, but it would appear that the only way that this can be considered to support the idea that perpetuation of symptoms is caused by deconditioning is if reduction in aerobic capacity is interpreted as deconditioning, no other conditions being needed. This is a possible use of language but not what I always thought of as deconditioning. The mere loss of "condition" is not evidence for the proposition that it may be regained by "conditioning".

One gets the feeling that differences of linguistic, conceptual use conceal the wish to view a tautology as something of substance.

On skimming through Clark's book I had a "lightbulb" moment when he was discussing behaviourist treatments, and "conditioning" as treatment for fear and anxiety conditions. It talks of overcoming maladaptive behavioural responses by these means. It rather looks as though illnesses had to be created to fit the treatments available. I will read further.
 
chrisb said:
it would appear that the only way that this can be considered to support the idea that perpetuation of symptoms is caused by deconditioning is if reduction in aerobic capacity is interpreted as deconditioning, no other conditions being needed. This is a possible use of language but not what I always thought of as deconditioning. The mere loss of "condition" is not evidence for the proposition that it may be regained by "conditioning".
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Yes, I noted this in other papers, too -- that they considered ANY loss of aerobic functioning to mean 'deconditioning'. It's suspect at best.
 
Trish said:
Particularly useful would be any research demonstrating either that GET has directly caused harm, or that research on GET that claims no harm has not properly assessed harms.
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If you examine the figures from the ME Association's large 2008 survey of 4,217 ME/CFS patients about the efficacy of various therapies, GET tops the table on page 10 as the therapy which made the most patients worse (56.5% were made worse by GET).

Their 2012 survey of 1,428 patients also showed that GET made patients worse: on page 26 they state their findings:
Effect of Courses on Illness Severity – GET

There was significant movement between categories of severity of ME/CFS in GET:

• Before GET courses, 62% of respondents were mild to moderate sufferers and 38% were severe to very severe sufferers

• After GET courses, 41% of respondents were mild to moderate sufferers and 59% were severe to very severe sufferers
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So as a result of receiving GET, lot of patients who were previously in the mild to moderate category were pushed into the severe to very severe category.
 
Links to papers on patient surveys and to the surveys themselves below.

In terms of patient-level evidence of possible harm from GET, there are published papers that review multiple patient surveys, which could be helpful:

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 192: 59–111
https://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx

Kirke, K. D. (2017). PACE investigators’ response is misleading regarding patient survey results. Journal of Health Psychology, 22(9), 1168–1176. https://doi.org/10.1177/1359105317703787 https://journals.sagepub.com/doi/full/10.1177/1359105317703787

Geraghty, K., Hann, M., & Kurtev, S. (2017). Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: Analysis of a primary survey compared with secondary surveys. Journal of Health Psychology. https://doi.org/10.1177/1359105317726152 https://journals.sagepub.com/eprint/hWSxVIBTzDtqisvafkhE/full


Kirke 2017 reviews UK patient surveys published from 2001-2015.

There are sections entitled “Patients find GET harmful” and “Further evidence of harm from exercise therapies” that go into some detail. The latter section discusses the implementation argument – i.e. the idea that it is not GET that is harmful, but poor implementation of GET – and argues against that idea with evidence from patient surveys.


Here’s figure 1:

upload_2018-12-18_12-47-40.png



Figure 1. Summary of patient survey evidence on safety and efficacy of GET, CBT and pacing


Both Kindlon 2011 & Geraghty et al 2017 look at surveys beyond the UK as well.

The main UK survey links are here:

The ME Association (2010) Managing my M.E.: What people with ME/CFS and their carers want from the UK’s health and social services: The results of the ME Association’s major survey of illness management requirements. Available at: http://www.meassociation.org.uk/wp-content/uploads/2010/09/2010-survey-report-lo-res10.pdf

The ME Association (2015) ME/CFS illness management survey results: ‘No decisions about me without me’. Part 1: Results and in-depth analysis of the 2012 ME association patient survey examining the acceptability, efficacy and safety of cognitive behavioural therapy, graded exercise therapy and pacing, as interventions used as management strategies for ME/CFS. Available at: http://www.meassociation.org.uk/wp-...No-decisions-about-me-without-me-30.05.15.pdf

Action for ME and Association of Young People with ME (2008) M.E. 2008: What progress? Initial findings of a national survey of over 2,760 people with M.E. focusing on their health and welfare. Available at: http://ssb4mesupport.weebly.com/uploads/8/0/5/0/8050248/action_for_me_survey_2008.pdf

NB Action for ME’s 2008 survey report also includes the results of its 2001 survey.

Action for ME (2014) M.E. Time to Deliver: Initial Findings of Action for ME’s 2014 Survey. Bristol: Action for ME. Available at: https://www.actionforme.org.uk/uploads/pdfs/me-time-to-deliver-survey-report.pdf
 
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