Cognitive behavioural therapy for ME/chronic fatigue syndrome is not effective. Re-analysis of a Cochrane review, 2019, Vink & Vink-Niese

Andy

Andy

Retired committee member
Abstract
Analysis of the 2008 Cochrane review of cognitive behavioural therapy for chronic fatigue syndrome shows that seven patients with mild chronic fatigue syndrome need to be treated for one to report a small, short-lived subjective improvement of fatigue. This is not matched by an objective improvement of physical fitness or employment and illness benefit status. Most studies in the Cochrane review failed to report on safety or adverse reactions. Patient evidence suggests adverse outcomes in 20 per cent of cases. If a trial of a drug or surgical procedure uncovered a similar high rate, it would be unlikely to be accepted as safe. It is time to downgrade cognitive behavioural therapy to an adjunct support-level therapy, rather than a treatment for chronic fatigue syndrome.
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Open access at https://journals.sagepub.com/doi/full/10.1177/2055102919840614
 
How Cochrane ever got a solid reputation when it publishes reviews of such dismal quality is beyond me. This is shockingly incompetent. Medical research needs serious adult supervision ASAP.

Software development has a (justified) reputation for low quality work. I have seen shockingly low quality programming and this is right up there with the worst of it, the kind that leaves someone permanently in unimportant roles that no one competent wants to assume. The people involved in this seem barely capable of exercising enough judgment to not use paint with their morning cereal.

How anyone can find it OK to use unpublished studies in a systematic review is a problem that needs a serious investigation, not just to fix the immediate issue but to make sure that it can't happen again.
 
Jonathan Edwards said:
Excellent detail here.

I had not realised that both Cochrane reviews were written by Jonathan Price who is a junior member of Michael Sharpe's department.
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Some people are stretching the intent of peer review a bit too far. Peer as in professional equal, not like-minded colleague with aligned interests.

Playing the refs is for amateurs. Professional cheaters just become the ref.
 
It's a very dense and detailed paper. I might have to read it again to really grasp everything and check out some of the arguments made. But overall I think this is a good overview of the problems with these CBT-trials and a good critique of the Cochrane review by Price et al.

All of the major issues and problems are explained in it, except perhaps for how CBT actively tries to change how patients interpret their symptoms as this is probably a major reason for the short-term subjective improvements seen. But the paper is already 23 pages long and is restricted in scope because it focuses on a critique of the Cochrane review, so this is not a flaw.

I've tried to summarize the content of the paper on twitter:

1) Mark Vink (@Huisarts_Vink), a doctor and severely ill ME-patient, has just co-authored a detailed critique of the Cochrane review for cognitive behavioral therapy (CBT) in chronic fatigue syndrome. The paper is open-access at :
https://journals.sagepub.com/doi/full/10.1177/2055102919840614

2) Most of the controversy around Cochrane involved the review of graded exercise therapy (GET) (Larun et al. 2017). But there’s also, an older Cochrane review of cognitive behavioral therapy (CBT) in CFS (Price et al., 2008). It has many similar flaws.

3) Vink & Vink-Niese list them all: trials were conducted by those who already favored CBT. Some trials selected patients with the overly broad Oxford criteria or they used the Chalder Fatigue Scale on which some patients could not get worse due to ceiling effects…

4) In many CBT-trials the control group received no active treatment as an alternative but only usual care. Some trials had large drop-out rates where more than a quarter of patients in the CBT-group stepped out of the trial. And so on…

5) A major flaw of the Cochrane review was that it relied on subjective outcomes in open-label trials. Patients knew which treatment they were receiving and that might have influenced how they filled in their questionnaires.

6) Vink & Vink-Niese looked at the objective outcomes because these are less prone to such biases. These include walking tests, actigraphy, exercise tests, employment data, disability payments, neurocognitive tests etc. Taken together these overwhelmingly showed no improvement.

7) The authors address policymakers and illness benefit assessors when they write: “This reanalysis shows that CBT does not lead to an improvement of fitness, a reduction of the number of patients on sickness and disability benefits or an improvement of employment status.”

8) According to Vink & Vink-Niese, “The time has come to downgrade CBT to adjunct support level status and only use it if patients need help coping with a debilitating disease or with a comorbid depression or anxiety disorder.”​
 
Vink & Vink-Niese really hammer on the fact that subjective outcomes can be unreliable. I found this passage on page 4 particularly interesting:
The unreliability of subjective outcomes in non-blinded trials is illustrated by the following examples. In Jason et al. (2007), there was a large difference in SF-36 physical functioning scores at baseline between the relaxation group (RELAX) and the anaerobic activity group (ACT), 53.77 to 39.17. However, the objective physical functioning scores (6MWT) at baseline were almost identical: 1335 (ACT) versus 1317 (RELAX). In the PACE trial (White et al., 2011), there was a subjective improvement of physical functioning after CBT of 18.2 per cent (7.1/39.0; SF-36 physical functioning) compared to Specialist Medical Care (SMC), yet the step test (fitness) and 6MWT showed that objectively there was no difference. Moss-Morris et al. (2005) reported that subjective physical functioning scores after GET improved by 30 per cent (15.95/53.1), yet objectively they deteriorated by 15 per cent (4.78/31.99; VO2 peak).
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And elsewhere they write with a bit of irony:
it is unclear why the trials relied on subjective primary outcomes when the basis of CBT for CFS is that patients suffer from false illness beliefs and they do not know how to interpret their symptoms correctly.
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A strange thing is that the Price et al Cochrane review included all sorts of studies that should not have been in there (for example a trial on chronic fatigue instead of CFS, or a trial on mindfulness rather than CBT). There were also quite a lot of unpublished studies as well, which we can't check wether they are reliable or not.
 
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Michiel Tack said:
And elsewhere they write with a bit of irony:

it is unclear why the trials relied on subjective primary outcomes when the basis of CBT for CFS is that patients suffer from false illness beliefs and they do not know how to interpret their symptoms correctly.
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Based on their model, literally comparable to a trial of CBT on compulsive liars that relies on the participants stating that they have stopped lying and taking it at face value, but only if positive, and doing no validation whatsoever after the fact.

I am really disappointed at how so few medical professionals find fault with that obvious contradiction at the very heart of the model (or more likely they just don't care because it validates their prejudice anyway, which is even worse and a massive ethical and professional failure). It's really depressing just how much mediocrity still runs our world, even in situations of life and death. Just shows how critical thinking is rare.
 
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I read somewhere, I forget where, that CBT and GET were introduced to overcome the "therapeutic nihilism" of the time. I think it was Wessely. It seemed a neat turn of phrase, if a poor justification for inflicting the treatment on an ungrateful patient population.

I mention this because I came across this:

Michael Gelder encouraged both of us, in different ways, to challenge therapeutic nihilism in the area of OCD.

Obsessive-compulsive disorder. Paul M Salkovskis and Joan Kirk in Science and Practice of Cognitive Behaviour Therapy David M Clark and Christopher G Fairburn (1997) @p179

The book is an encomium by the Geldings to Michael Gelder. It includes a chapter on "Chronic Fatigue" by Sharpe. The chances of two separate groups using that unusual term independently of each other are vanishingly small. It seems unlikely that Salkoskis and Kirk would have borrowed the term from a paper on CFS. We are left with the probable conclusion that both authors derived the term from Gelder. This would not be surprising were it Sharpe who had used it, but I don't think it was.

One also sees interesting parallels in the chapter on Panic disorder and social phobia by David M Clark @p121:

Both disorders were considered to be the result of conditioning. In phobias it was hypothesised that one of the maintaining factors was avoidance of the feared stimulus. This led to exposure therapy...…..In (OCD) it was hypothesised that the compulsive behaviour...prevented the fear associated with the obsessional thought from extinguishing. This led to the development of the exposure and response prevention treatment approach....

Just add exercise and GET, and CBT, and it rather looks like the Henry Ford (You can have any colour as long as it's black) model of health provision. You can have any treatment as long as it's CBT.

In the circumstances it is hardly surprising that CBT would be ineffective.
 
chrisb said:
I read somewhere, I forget where, that CBT and GET were introduced to overcome the "therapeutic nihilism" of the time. I think it was Wessely.
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Perhaps a little off topic, but I happened to be reading the paper where he used it. It's in Butler et al. (1991). Cognitive behaviour therapy in chronic fatigue syndrome. It wasn't actually Wessely who introduced the term because he refers to another paper:
Others are told to accept disability as "living within their limits". This state of affairs has been succinctly described as "therapeutic nihilism"
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The reference he uses to is: "Bayliss R, op cit Dawson J. Brainstorming the postviral fatigue syndrome. Br Med J 1988;297:1151." But I can't track it. There's a BMJ article with that name, but other authors listed. Perhaps it was a response to this article?
 
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