2025: The 2019/24 Cochrane Larun review Exercise Therapy for CFS - including IAG, campaign, petition, comments and articles

Sasha said:
The problem is not that it's outdated, though - this is the obscurantist reason that the editor-in-chief gave to not pull the review in the first place. It allowed her to avoid saying it was rubbish. Something that is merely 'outdated' is fine. My sofa is outdated but I'm still sitting on it.

An honest editor's note would give the real reason why the review is so bad that it needed to be withdrawn (open label, subjective measures) but that would involve admitting that they were wrong to publish it in the first place and that the rest of the BPS literature is a house of cards.
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I agree. I was talking about least worst options not ideal options.

The ideal, as far as I'm concerned, would have been to do a proper update with correct methodology which would have found exercise useless and potentially harmful for anyone with chronic fatigue, including ME/CFS.

And Cochrane recognising the stuff about unblinded trials and subective outcomes publicly and withdrawing a whole swathe of other reviews.
 
Jonathan Edwards said:
It is taught in clinical pharmacology courses, if I remember rightly at the preclinical stage of basic sciences. When I was taught it we used Desmond Laurence's textbook (Desmond was at UCL). It is part of the basic explanation of why we do double-blind trials. Every medical student has heard of double blind trials and ought to have an understanding of why they are done. The let out is that if you have truly objective endpoints you may not need to double blind, but that is the exception.
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While we are taught about double blind, the cop-out when not being able to blind the participant is the same as the BPS are using: "It's difficult" and left at that. Nothing about how using objective outcomes could reduce the issue, or that subjective outcomes would be an additional issue. And since everyone is doing it then it must be fine.
 
Midnattsol said:
But when is this taught? I've taken methodology classes with medical students, and I've only ever really heard about this problem in the ME patient community. The go-to professor on stats at my medical faculty is a co-author on a study with just this problem (on ME patients to boot).
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I was taught as a psychology undergraduate forty five years ago that unblinded trials with subjective measures were inherently unreliable. Our lecturers did not go as far as to say this design should never be used, but that you could not rely on evidence from such trials alone.

In some clinical situations it may be very difficult to achieve the ideal design but then you need to seek convergent evidence from studies using different methodologies, in the hope you can counter balance the unavoidable bias in your initial study.

However, the ME/CFS exercise studies don’t all lack objective evidence. Many including PACE did include objective outcomes. However these studies either abandoned or sought to obscure these objective outcomes. The original protocol for Larun et al deliberately excluded consideration of the objective outcomes. Is it because as some researchers have tried to argue that ME/CFS is an inherently subjective experience so it can only be measured by patient self report or that the objective outcomes fail to provide the desired result. Also strangely the researchers are reluctant to even acknowledge the existence of patient reported harms.

[edited to add final paragraph]
 
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Peter Trewhitt said:
I was taught as a psychology undergraduate forty five years ago that unblinded trials with subjective measures were inherently unreliable. Our teachers did not go as far as to say this design should never be used, but that you could not rely on evidence from such trials alone.

In some clinical situations it may be very difficult to achieve the ideal design but then you need to seek convergent evidence from studies using different methodologies, in the hope you can counter balance the unavoidable bias in your initial study.
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When collecting diet intake data in large studies, we are supposed to validate using a method with different bias. In practice food frequency intake questionnaires are used and then "validated" by performing a diet intake interview with a selection of the participants (both have similar biases like recall and reporting bias). If they are validated at all. A few use double-labelled water and that can validate energy intake but it's difficult to do at scale.

I seem to recall a table with "rules" in Norwegian, but I can't find it again but as I recall it was like this for when something is seen as reliable:
Two large cohort studies that point in the same direction
One cohort study can be exchanged by five case-control studies

These studies can have the same biases so the rules don't work, but here we are.
 
Jonathan Edwards said:
No, it should never have been proposed. We know all we need to know from the NICE analysis. It was only ever playing Cochrane's own brand of football where if they are losing they are allowed a free kick with the goalie blindfolded.

If the old review was bad enough to justify a rewrite it should have been pulled and that would have been fine. The whole exercise was barmy.
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I said this over and over to Hilda and she was determined it would go ahead. I paraphrase, but her response to me was "we're doing it whether you like it or not, and that's that"
 
MEAction are continue to address the Cochrane exercise review debacle, they sent this email to their supporters list today:

We have an infuriating update to share about Cochrane’s 2019 review of exercise therapy for ME/CFS, which currently concludes that “exercise therapy probably has a positive effect on fatigue.”

Researchers, clinicians and advocates raised concerns about the review, and Cochrane agreed to a reanalysis and commissioned an Independent Advisory Group (IAG) to provide feedback. But at the end of last year, Cochrane reversed its decision and abandoned the project without warning. Healthcare providers and policymakers around the world rely on Cochrane's systematic reviews as evidence-based treatments for patients.

Cochrane didn’t just stop work on the reanalysis: its staff altered the date of publication of the review from 2019 to 2024. Altering the date of publication means that the review can now be cited as if the analysis were new instead of based on studies from 2014 or earlier.

The Independent Advisory Group responded by issuing an open letter to the chair of the Cochrane Governing Board last week, expressing grave concerns over Cochrane’s abrupt decision to cancel the analysis without prior consultation or transparency, and without properly addressing criticisms of the review.

#MEAction is working on sending a letter to Cochrane in which we will support and echo the IAG’s demands: for an editorial note to be added stating that the review is out of date and should not be used for clinical decision-making, as Cochrane has done for other reviews; and a meeting with Dr Susan Phillips, Chair of the Cochrane Governing Board.

#MEAction is also sounding the alarm on social media and in the press about Cochrane’s unconscionable, unethical, and illogical decision. #MEAction’s Scientific Director was one of the members of the Independent Advisory Group.

Read more about Cochrane’s review of exercise therapy for ME/CFS.

We are continuing to monitor this situation, and will keep you updated about any new developments.

In solidarity,

All of us at #MEAction
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Jonathan Edwards said:
The potato is too hot.
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I wonder how much if this is coming from government.

A lot of financial, political and ideological capital has been invested in the exercise-is-medicine and CBT-cures-everything approach.

With millions affected by chronic ill health and the possibility that social factors are responsible for nearly as much of it as disease, they haven't got much else to offer.
 
Hutan said:
Still no comments showing on the MEAction blog
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Interesting that MEAction are focusing solely on the editorial note rather than withdrawal, stressing their link to the IAG and avoiding any mention of our ‘withdraw of Larun et al’ campaign.

It maybe that they regard the editorial note as the most realistic goal, though it seems to me something of a cop out, in it gives Cochrane a way of putting the issue to bed if the outcry gets too embarrassing, without addressing the central problem of the inherent bias in the use of subjective outcomes in unblinded trials. Both @Hutan and I reference these wider issues in our comments on the MEAction blog. I wonder, given our comments are still lurking in moderation (echoes of Hilda’s moderating strategy), if our demand for withdrawal of the old review is a hot potatoe for them too.
 
Utsikt said:
If the narrow population (NP) is such that the entire population fits inside the wider population (WP), then it’s still possible that a study on the WP doesn’t include any patients from the NP.
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I don't want you thinking we are dismissing this risk. It is a true risk. It is possible that a Fukuda cohort has no people with PEM in it. But, look at the Fukuda criteria. You aren't just picking up people with chronic tiredness, they have to have other things going on too, and they may have PEM lasting 24 hours as one of the required four extra symptoms. I think the risk of a Fukuda cohort not having people with PEM in it is quite low; requiring results to be replicated from multiple studies can help to cover that risk.

CDC Fukuda definition of CFS
Primary symptoms

Clinically evaluated, unexplained, persistent or relapsing chronic fatigue that is:

Additional symptoms
The concurrent occurrence of four or more of the following symptoms:
These symptoms must have persisted or reoccurred during 6 or more consecutive months of illness and must not have stated before the fatigue.[1]


Final requirement
All other known causes of chronic fatigue must have been ruled out, specifically clinical depression, side effects of medication, eating disorders and substance abuse.
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Yes, making a selection criteria for a trial as precise as possible is important. I don't think anyone here is saying that using the Fukuda criteria is a good thing, and the problems get even worse when researchers use less restrictive versions of Fukuda. We do want to see studies trying to ensure that people labelled as having ME/CFS all do report PEM.

But. As Jonathan said, the BPS studies on GET, even using the Fukuda criteria, even with their subjective outcomes and lack of blinding, even with all the other various flaws, have pretty much failed to find any clinically relevant benefit. For anyone. Reported benefits slosh around in the range that is entirely compatible with a placebo treatment.

Focusing on the issue of the diagnostic criteria distracts from this main message of studies with a very high risk of bias and small to very small reported benefits that cannot be differentiated from placebo responses.
 
@Hutan I agree that methodology is the core issues.

But it should also be noted that when you don’t differentiate based on PEM, all of the responders could have been the non-PEM patients.

In itself, that makes the studies non-generalizable to ME/CFS with PEM.

If they fix their methodology, but don’t fix the inclusion criteria, we might end up with robust studies that are still wrong. They need to require both to include a study in the review.

Which unfortunately means that most of the current research is useless due to older criteria being used.
 
SNT Gatchaman said:
TG re-upping on Bluesky —
"BMJ has picked up on the Cochrane scandal"
https://bsky.app/profile/trishgreenhalgh.bsky.social/post/3lgud5ckclc2f
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I so do not understand where Trisha Greenhalgh is on this. I haven't been following closely but she seemed to be prejudiced against people with ME/CFS, blocking reasonable people on Twitter. But argues against people with Long Covid being subject to BPS ideas? And now she is retweeting Jacqui Wise's good article in the BMJ that is supportive of people with ME/CFS?

Perhaps it doesn't really matter what she thinks, although she seems to pop up in various influential places. But, does anyone understand what is going on there?
 
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Utsikt said:
If they fix their methodology, but don’t fix the inclusion criteria, we might end up with robust studies that are still wrong. They need to require both to include a study in the review.
Which unfortunately means that most of the current research is useless due to older criteria being used.
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I think those horribly flawed studies can still tell us something though. If you can bias your study so badly in favour of finding a positive result, and, at the end of it you still can't show that exercise therapy provides a benefit for people with chronic fatigue above a level easily achieved with a placebo, that is useful information.
 
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