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

PETITION UPDATE
Cochrane: Withdraw the harmful 2019/2024 Exercise therapy for CFS review
Cochrane responds to our 2023 complaints

23 Feb 2025

In this update, we tell you about a video from one of the leading YouTube science channels about exercise and ME/CFS, and about researchers and clinicians calling for the withdrawal of the Larun et al review. And we share Cochrane's response to our 2023 complaints and request to withdraw the review, received this month.

Leading YouTube science channel says 'Exercise actually makes chronic fatigue syndrome worse'
On 21 February 2025, the SciShow, a science content maker on YouTube with over 8 million followers, launched an 8 minute video 'Exercise actually makes chronic fatigue syndrome worse'. In the first day, the video had 124,000 views and generated 1400 comments, almost all of them supportive and including comments from people with ME/CFS reporting they have been harmed by exercise.

The video notes:
"And while there’s still a lot scientists don’t know about the condition, they’ve learned quite a bit in the last few years about how different it is from other kinds of fatigue. Including the fact that exercise actually makes it worse."

It's hard to produce 8 minutes of engaging content about ME/CFS and have it all rock solid. While not every detail in this video is completely right, the producers have done very well. They criticise the PACE trial which is the very poor quality large trial of exercise therapy that the Larun et al review relies on.

"One early management idea was to make patients slowly increase the amount of exercise that they did, until they could tolerate a healthy amount of exercise. If that sounds like a bad plan to you, given what we know about ME/CFS, you’d be absolutely correct. While this type of increased exercise can be helpful for physical therapy after an injury, this only makes ME/CFS symptoms worse. ...

Unfortunately, this idea was spread throughout the scientific community due to a controversial study called the PACE trial. The trial reported that patients with ME/CFS showed normal physical function after increasing their exercise. But the researchers defined “normal” functioning as lower than the measurement that patients needed to be included in the study... So they could get worse and still be counted as normal by the end of the study. And even though patients and professionals alike have denounced the results of this study, that paper has still not been retracted."

It seems that the understanding that exercise does not help ME/CFS has gone mainstream, while Cochrane continues to promote outdated views and to support poor trial methodologies.



45 clinicians and researchers call for the review to be withdrawn
On 20 February 2025, David Tuller sent a letter to Cochrane calling for the withdrawal of the exercise therapy review, signed by 45 clinicians and researchers from around the world. It concludes:
"The amended exercise therapy review continues to pose a risk to people with ME/CFS, including those with Long COVID who meet diagnostic criteria. [6] It should be withdrawn. Failing that, the review should be prominently tagged with an editorial note making clear that it is out-of-date and should not be used for clinical decision-making."

If you are a health professional or a ME/CFS researcher and want to add your name to David's letter, please contact him at davetuller@berkeley.edu.



Cochrane's response to our 2023 complaints
On 15 February 2025, we received the following email from Cochrane:

"...
We acknowledge that our previous approach to managing complaints in Cochrane led to delays and, in the case of your complaints, frustration on your part. We apologise for this and recognise that our previous process could be difficult to navigate, which is why we overhauled our complaints process last year.

In 2024 Cochrane undertook an assessment of all the previous requests to withdraw the review published in 2019, including those submitted by S4ME. This was done to consider whether any request met the threshold for Cochrane’s policy for withdrawal. Cochrane’s assessments took account of the current guidance on harms from the Cochrane Handbook for Systematic Reviews of Interventions, Cochrane’s policy on withdrawal from the Cochrane Database of Systematic Reviews, and external quantitative and qualitative evidence syntheses on the topic. This included those used in the UK National Institute for Health and Care Excellence (NICE)guidelines, the German Institute for Quality and Efficiency in Health Care (IQWiG) evidence review, and an updated systematic review prepared by the Center for Disease Control (CDC) in the USA.

The outcome of this assessment was that no grounds for withdrawal could be established by any of the requests for withdrawal. This process took several months to conclude, and we apologise for the delay in updating you on the status of your complaint.

Yours sincerely
Cochrane Complaints"

We assume that the lack of detail is to hide the poor basis for their decision. They appear to believe that simply saying 'we looked at all the complaints about the Larun et al review, including yours, and we decided that the review is fine' is an appropriate response to detailed complaints alleging that the review is causing serious harm to thousands of people. We note that no one at Cochrane is willing to put their name to the outcome. We are appealing the decision.

The response, as inadequate, unspecific and disrespectful as it is, now leaves us free to take our complaints to the authorities that monitor charities and academic publishers and to Cochrane's funders.

In 2022, Cochrane's Editor-in -Chief Dr Karls Shares Weisser noted when presenting a plan for the future of the organisation that
"While Cochrane is still widely recognized as the "gold standard" producer of evidence syntheses, there is clearly scope for improvement. The potential for our reputation to be impacted by inconsistent quality, slow delivery and poor author experience is a real danger. "

Sadly, the danger of Cochrane's incompetence is not just to its reputation, but also to millions of health service consumers. The debacle over its advice on the use of masks to stop infection transmission and the issues with its review on the use of steroid injections in pregnancy in low resource environments show that people with ME/CFS are not the only ones put at risk of harm.

Thanks
As the petition numbers climb towards 16,000, please keep telling people and organisations who you think might be interested about it, especially people who have dealings with and fund Cochrane.
 
Cochrane's response to the 2023 complaint said the following:
Hutan said:
"...
Cochrane’s assessments took account of the current guidance on harms from the Cochrane Handbook for Systematic Reviews of Interventions, Cochrane’s policy on withdrawal from the Cochrane Database of Systematic Reviews, and external quantitative and qualitative evidence syntheses on the topic. This included those used in the UK National Institute for Health and Care Excellence (NICE)guidelines, the German Institute for Quality and Efficiency in Health Care (IQWiG) evidence review, and an updated systematic review prepared by the Center for Disease Control (CDC) in the USA.
Click to expand...

Has anybody looked at that document and what it says about harms? If so, would you mind sharing what you found?

On their point about the updated systematic review prepared for CDC... It's not clear which one they are talking about as there were three
  • The 2014 review done for CDC by the Pacific Northwest Evidence-based Practice Center and published.
  • The 2016 addendum to the 2014 review that addressed a narrow set of concerns raised by the community. Among its conclusions, it said trials using definitions that required PEM were "blatantly missing"
  • The 2022 review done for CDC by the same group. But the community raised so many issues during the comment period that CDC declined to publish it.
As far as I can tell, the only one online today is the 2014 review. The 2016 review is on an archived page and the 2022 review seems to have vanished
 
Cochrane's response to the 2023 complaint said the following:
Cochrane’s assessments took account of the current guidance on harms from the Cochrane Handbook for Systematic Reviews of Interventions, Cochrane’s policy on withdrawal from the Cochrane Database of Systematic Reviews, and external quantitative and qualitative evidence syntheses on the topic.
Click to expand...

Has anybody looked at that document and what it says about harms? If so, would you mind sharing what you found?
Click to expand...

I quoted from these in our letter to Cochrane about harms in March 2024:

https://www.s4me.info/threads/s4me-...rcise-therapy-review.34973/page-2#post-521800

Evidence in support of withdrawal

1. Withdrawal of the review is in line with Cochrane's editorial policy

Cochrane Reviews are withdrawn when serious issues with conduct or reporting are identified. The 2019 review meets the conditions for withdrawal of the review on the grounds, both that there are "factual errors in describing one or more included studies that risk misinforming implementation or investment decisions about an intervention" and that "Following the conclusions of the published review could result in harm to patients or populations of interest (other than known adverse effects)."
(Cochrane's editorial policy: Withdrawal of published articles)

2. Cochrane's guidance to reviewers has not been followed

The 2019 review places adverse events in a key position as one of two primary outcomes. However, the reviewers made the narrowest possible interpretation of this, including only data from one trial. This is contrary to the Cochrane handbook which specifies a more detailed analysis of adverse effects in cases such as this where the potential for harm has a major influence on treatment and policy decisions. In such cases it is expected that a bespoke search process will be undertaken that includes a wider selection of sources than that required to identify data on beneficial outcomes. (Cochrane Handbook for reviewers Chapter 19 - Adverse events)
Click to expand...

This is the key points from the chapter in adverse events linked in the above quote

Key Points:
  • To achieve a balanced perspective, all reviews should try to consider adverse aspects of interventions.
  • A detailed analysis of adverse effects is particularly relevant when evidence on the potential for harm has a major influence on treatment or policy decisions.
  • There are major challenges in specifying relevant outcomes and study designs for systematic reviews evaluating adverse effects. This is due to high diversity in the number and type of possible adverse effects, as well as variation in their definition, methods of ascertainment, incidence and time-course.
  • Review authors should pre-specify their approach to reviewing studies of adverse effects within the review protocol. The approach may be confirmatory (focused on particular adverse effects of interest), exploratory (opportunistic capture of any adverse effects that happen to be reported), or a hybrid (combination of both).
  • Depending on the approach used and outcomes of interest to the review, identification of relevant adverse effects data may require a bespoke search process that includes a wider selection of sources than that required to identify data on beneficial outcomes.
  • Because adverse effects data are often handled with less rigour than the primary beneficial outcomes of a study, review authors must recognize the possibility of poor case definition, inadequate monitoring and incomplete reporting when synthesizing data.
Click to expand...
my bolding
 
Last edited:
Hutan said:
Cochrane’s assessments took account of the current guidance on harms from the Cochrane Handbook for Systematic Reviews of Interventions, Cochrane’s policy on withdrawal from the Cochrane Database of Systematic Reviews, and external quantitative and qualitative evidence syntheses on the topic. This included those used in the UK National Institute for Health and Care Excellence (NICE)guidelines, the German Institute for Quality and Efficiency in Health Care (IQWiG) evidence review, and an updated systematic review prepared by the Center for Disease Control (CDC) in the USA.

The outcome of this assessment was that no grounds for withdrawal could be established by any of the requests for withdrawal. This process took several months to conclude, and we apologise for the delay in updating you on the status of your complaint.
Click to expand...

As well as not actually responding to any of our complaints, not even indicating any understanding of them, they do not actually give any actual reasons for rejecting withdrawal of Larun et al. They do give a list of documents that supposedly informed their decision making but provide no evidence that they actually looked at any of them.

Unfortunately their lack of any concrete detail means we have to look at all these documents in detail to counter their un argued assertion.
 
Peter Trewhitt said:
As well as not actually responding to any of our complaints, not even indicating any understanding of them, they do not actually give any actual reasons for rejecting withdrawal of Larun et al. They do give a list of documents that supposedly informed their decision making but provide no evidence that they actually looked at any of them.

Unfortunately their lack of any concrete detail means we have to look at all these documents in detail to counter their un argued assertion.
Click to expand...
We're currently preparing an appeal against this decision and the lack of information in the letter telling us the outcome.
 
Trish said:
We're currently preparing an appeal against this decision and the lack of information in the letter telling us the outcome.
Click to expand...

Thank you to all putting the work into this.

Having reread this response several times I could not but comment that their response was basically ‘we don’t don’t actually have to give any reasons, so yarboosucks to you, though because we are so clever here is a list of impressive sounding documents’.

This reminds me of an incompetent undergrad essay, where the student had not actually done any of the reading but bunged in some arbitrary references from the reading list anyway.

It is theoretically possible that they reached an informed reasoned conclusion based on actual evidence, but they have singularly failed to communicate that. Further previous experience, since Tovey backed tracked on withdrawing Larun et al in 2018, would suggest that Cochrane’s decision making is based on internal politicking and intrigue rather than reasoned debate and scientific evidence.
 
Peter Trewhitt said:
It is theoretically possible that they reached an informed reasoned conclusion based on actual evidence, but they have singularly failed to communicate that.
Click to expand...
In my limited experience, if you actually work this way (informed reasoning), it’s pretty difficult to write such a lackluster response. Mostly because you’d have to make up new reasons instead of just writing down the ones you’ve already used.

And they are not stupid, they should be able to predict that we would deem their response insufficient. There’s nothing to indicate that we would not be willing to pursue this to the very end. The only reason they don’t give in, is because they care more about pleasing themselves and/or other stakeholders for as long as possible.

As you said, it’s not a conflict of reasoning, it’s a conflict of interests.
 
Utsikt said:
In my limited experience, if you actually work this way (informed reasoning), it’s pretty difficult to write such a lackluster response. Mostly because you’d have to make up new reasons instead of just writing down the ones you’ve already used.
Click to expand...

Given Cochrane’s current policy of sending out such communications without any named signatory, it is possible that a junior person writing response this had no direct involvement in the decision making or complaints processes and simply tried to write something placatory without knowing what they were talking about.

However as you say, @Utsikt, the chances are the author knew this was totally unsatisfactory and deliberately wrote this as a box ticking exercise to kick the can on down the road.

(Note, in the long run I don’t see how this deliberate policy of dealing with such issues without any named signatory or contact person will serve to diffuse tensions. It may make life easier for individuals at Cochrane but it certainly won’t help placate complainants.)
 
I have now submitted an appeal to Cochrane to the decision we received on 14th February 2024.
The decision refers to our complaint submitted on 26th January 2025 which was about the lack of response to our letters and complaints dating back to October 2023 and March 2024.

Formal appeal to decision regarding complaint #COMP00192844
____________________

Appeal part 1: Complaints submitted 30th October 2023.

We submitted a set of 5 complaints to Cochrane on 30th October 2023, listed and linked in #COMP00192844.

As we outlined in #COMP00192844, there followed over a year of attempts on our part to find out whether any of the complaints were considered, if so which ones, and the outcomes.

We received a brief outcome letter on 14th February 2025.

We assume the first part of this letter refers to these five 2023 complaints:

"We acknowledge that our previous approach to managing complaints in Cochrane led to delays and, in the case of your complaints, frustration on your part. We apologise for this and recognise that our previous process could be difficult to navigate, which is why we overhauled our complaints process last year."

In this appeal we are asking you to provide us with answers to questions we have been asking for over a year and which the outcome letter fails to address.

Appeal 1a.
We appeal the decision not to inform us which of the complaints submitted in October 2023 were investigated, why were some not investigated, and what were the outcomes of each complaint.
To be clear, we ask that you provide a specific response for each complaint with enough detail for us to understand why no action is being taken.

Appeal 1b.
We appeal the decision, unstated, but from recent actions clearly made, to renege on editors' promises to address critical comments about the review in the Cochrane Library, including that by Michiel Tack in 2020 that we highlighted in October 2023 (Complaint B).
____________________

Appeal part 2: Appeal of decision not to withdraw the review on the grounds of harm.

As we outlined in #COMP00192844 submitted on 26th January 2025, we provided Cochrane with detailed evidence on harms from exercise therapy for ME/CFS in March 2024. We explained why we consider that there is sufficient evidence that Larun et al had not fulfilled Cochrane's guidance on searching for wider sources of harms evidence. We explained why we consider that the level of evidence meets Cochrane's policy on withdrawal of reviews on the grounds of harms.

Combining the harms evidence with the critiques that show any beneficial effects to be minimal and such findings to be uncertain and unsound, and evidence evaluations such as that of NICE, we cannot understand why the investigation reached the outcome stated in your letter of 14th February 2025.

"The outcome of this assessment was that no grounds for withdrawal could be established by any of the requests for withdrawal."

We find this evident lack of understanding of the degree and scale of harms experienced by people with ME/CFS shocking.
__________

Appeal 2a Lack of explanation

We appeal the decision to provide no explanation of the decision not to withdraw the review. We do not consider it appropriate for a body that regards itself as the gold standard in reviews to simply dismiss without explanation serious criticisms of a review that continues to be used to promote ineffective and harmful treatments. We ask you to provide us with more detail of what led to the decision. Specifically we ask for a copy of any report produced by those who carried out the investigation, and minutes of any meetings at which the decision was made.

Appeal 2b Lack of ownership of decisions

As a professional body employing experts to review scientific materials, we would expect those involved to put their names to their work, just as authors of Cochrane reviews and those whose comments on reviews you publish are expected to sign their work. We do not consider it acceptable for a professional body making decisions affecting people's health to do so anonymously.
An unsigned letter is not an appropriate way to deliver the outcome of investigation of a complaint, especially in circumstances where we have alerted you to the conflicts of interests of advisors to the review.
Please provide us with the names and roles in the organisation of the individuals who contributed to, influenced and signed off on this decision.

Appeals 2c Lack of impartiality

Since we have not been provided with the names or views of those who made this decision, we are left assuming bias. We have already highlighted the inappropriate involvement of two people credited as advisors to the review who have professional and financial conflicts of interest. We are not reassured that others in the Cochrane organisation are able to approach this subject impartially. We therefore appeal the decision on the grounds of lack of impartiality.
We ask that impartial reviewers acceptable to S4ME be appointed to review the decision on withdrawal.
__________________

We note that we have been told that the time scale for appeals is the same or longer than that for complaints. Since we are still waiting for answers on some complaints over a year old, we do not consider it appropriate to wait for the response to this appeal before escalating our complaints to other bodies.

Signed, Trish Davis on behalf of the committee of the Science for ME international forum.
________________________

https://www.s4me.info/threads/s4me-...rcise-therapy-review.34973/page-3#post-582680
 
Trish said:
I have now submitted an appeal to Cochrane to the decision we received on 14th February 2024.
The decision refers to our complaint submitted on 26th January 2025 which was about the lack of response to our letters and complaints dating back to October 2023 and March 2024.

Formal appeal to decision regarding complaint #COMP00192844
____________________

Appeal part 1: Complaints submitted 30th October 2023.

We submitted a set of 5 complaints to Cochrane on 30th October 2023, listed and linked in #COMP00192844.

As we outlined in #COMP00192844, there followed over a year of attempts on our part to find out whether any of the complaints were considered, if so which ones, and the outcomes.

We received a brief outcome letter on 14th February 2025.

We assume the first part of this letter refers to these five 2023 complaints:

"We acknowledge that our previous approach to managing complaints in Cochrane led to delays and, in the case of your complaints, frustration on your part. We apologise for this and recognise that our previous process could be difficult to navigate, which is why we overhauled our complaints process last year."

In this appeal we are asking you to provide us with answers to questions we have been asking for over a year and which the outcome letter fails to address.

Appeal 1a.
We appeal the decision not to inform us which of the complaints submitted in October 2023 were investigated, why were some not investigated, and what were the outcomes of each complaint.
To be clear, we ask that you provide a specific response for each complaint with enough detail for us to understand why no action is being taken.

Appeal 1b.
We appeal the decision, unstated, but from recent actions clearly made, to renege on editors' promises to address critical comments about the review in the Cochrane Library, including that by Michiel Tack in 2020 that we highlighted in October 2023 (Complaint B).
____________________

Appeal part 2: Appeal of decision not to withdraw the review on the grounds of harm.

As we outlined in #COMP00192844 submitted on 26th January 2025, we provided Cochrane with detailed evidence on harms from exercise therapy for ME/CFS in March 2024. We explained why we consider that there is sufficient evidence that Larun et al had not fulfilled Cochrane's guidance on searching for wider sources of harms evidence. We explained why we consider that the level of evidence meets Cochrane's policy on withdrawal of reviews on the grounds of harms.

Combining the harms evidence with the critiques that show any beneficial effects to be minimal and such findings to be uncertain and unsound, and evidence evaluations such as that of NICE, we cannot understand why the investigation reached the outcome stated in your letter of 14th February 2025.

"The outcome of this assessment was that no grounds for withdrawal could be established by any of the requests for withdrawal."

We find this evident lack of understanding of the degree and scale of harms experienced by people with ME/CFS shocking.
__________

Appeal 2a Lack of explanation

We appeal the decision to provide no explanation of the decision not to withdraw the review. We do not consider it appropriate for a body that regards itself as the gold standard in reviews to simply dismiss without explanation serious criticisms of a review that continues to be used to promote ineffective and harmful treatments. We ask you to provide us with more detail of what led to the decision. Specifically we ask for a copy of any report produced by those who carried out the investigation, and minutes of any meetings at which the decision was made.

Appeal 2b Lack of ownership of decisions

As a professional body employing experts to review scientific materials, we would expect those involved to put their names to their work, just as authors of Cochrane reviews and those whose comments on reviews you publish are expected to sign their work. We do not consider it acceptable for a professional body making decisions affecting people's health to do so anonymously.
An unsigned letter is not an appropriate way to deliver the outcome of investigation of a complaint, especially in circumstances where we have alerted you to the conflicts of interests of advisors to the review.
Please provide us with the names and roles in the organisation of the individuals who contributed to, influenced and signed off on this decision.

Appeals 2c Lack of impartiality

Since we have not been provided with the names or views of those who made this decision, we are left assuming bias. We have already highlighted the inappropriate involvement of two people credited as advisors to the review who have professional and financial conflicts of interest. We are not reassured that others in the Cochrane organisation are able to approach this subject impartially. We therefore appeal the decision on the grounds of lack of impartiality.
We ask that impartial reviewers acceptable to S4ME be appointed to review the decision on withdrawal.
__________________

We note that we have been told that the time scale for appeals is the same or longer than that for complaints. Since we are still waiting for answers on some complaints over a year old, we do not consider it appropriate to wait for the response to this appeal before escalating our complaints to other bodies.

Signed, Trish Davis on behalf of the committee of the Science for ME international forum.
________________________

https://www.s4me.info/threads/s4me-...rcise-therapy-review.34973/page-3#post-582680
Click to expand...
This is all just brilliant
 
Thanks for all the work you and others are putting into this @Trish ! Whilst Oonagh Cousins can claim the title of anti-recovery-activist, after all the work you have to put into this tedious process, I'm sure the title of anti-effort-preference champion would be well deserved for everyone working on this.
 
You must log in or register to reply here.
Back
Top Bottom