Below is my correspondence with Cochrane which started with an email to The Cochrane Editor-in-Chief in November 2020. I notified her that following the conclusions of the two reviews Exercise therapy for chronic fatigue syndrome and Cognitive behaviour therapy for chronic fatigue syndrome in adults could lead to patient harm. Therefore, according to Cochrane’s own criteria, they should be withdrawn.
From: Caroline Struthers
Date: Thursday, 19 November 2020 at 22:08
To: Karla Soares-Weiser
Subject: Request for withdrawal of reviews Exercise therapy for chronic fatigue syndrome and CBT for chronic fatigue syndrome
Dear Karla
Yesterday I had a BMJ rapid response posted “Re: NICE backtracks on graded exercise therapy and CBT in draft revision to CFS guidance: time for Cochrane to withdraw the reviews”
In November 2018 I made a formal complaint [1] about the Exercise therapy for chronic fatigue syndrome [2] and requested it be withdrawn. I met you in July 2019, along with two people with ME,
and again we tried to persuade you not to proceed with publishing an amended version of the review but to withdraw it. Despite watering down its previous overly positive conclusions, the amended review still concludes that “Exercise therapy probably has a positive effect on fatigue in adults with CFS…evidence regarding adverse effects is uncertain.”. I have more recently called for the withdrawal of the review Cognitive behaviour therapy for chronic fatigue syndrome in adults [3]. This review is twelve years out of date yet is still used in four clinical guidelines. It concludes that “CBT is effective in reducing the symptoms of fatigue at post-treatment compared with usual care and may be more effective in reducing fatigue symptoms compared with other psychological therapies”.Both Cochrane reviews were excluded from the NICE review for the nonpharmacological management of ME/CFS [4] because they didn’t include critical outcomes and included study participants where not all participants had ME/CFS [page 8]. The NICE review also concluded that evidence from the randomised trials for both exercise therapy and CBT ranged from low to very low quality [pages 317, 319]
Shortly after we met, in August 2019, the withdrawal policy changed to make withdrawal possible only in exceptional circumstances. According to the new policy [5], a review should be withdrawn if there is a serious error, such as “…following the conclusions of the published review could result in harm to patients…”.
The findings of the NICE guideline committee have led to a reversal of the recommendations for GET and CBT to treat ME/CFS because of lack of good quality evidence of benefit and considerable evidence of harm [6,7]. Therefore, following the conclusions of the Cochrane reviews which both state that exercise therapy and CBT may be helpful for ME/CFS could result in harm to patients. According to the Cochrane policy [8] I am notifying you of these serious errors
Please withdraw both of these reviews as soon as possible.
With best wishes
Caroline
- My complaint to the Cochrane Governing Board about the Cochrane review of Exercise for chronic fatigue syndrome (November 2018) https://healthycontrolblog.wordpres…iew-of-exercise-for-chronic-fatigue-syndrome/
- Larun L, Brurberg KG, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome.
Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No.: CD003200. DOI:
10.1002/14651858.CD003200.pub8. - Price JR, Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for chronic fatigue syndrome in
adults. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD001027. DOI:
10.1002/14651858.CD001027.pub2. - Myalgic encephalomyelitis (or encephalopathy) /chronic fatigue syndrome: diagnosis and
management [G] Evidence reviews for the nonpharmacological management of ME/CFS:
https://www.nice.org.uk/guidance/gid-ng10091/documents/evidence-review-7 - Withdrawing published Cochrane Reviews July 2019:
https://documentation.cochrane.org/display/EPPR/Withdrawing+published+Cochrane+Reviews - Geraghty K, Hann M, Kurtev S. 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. 2019;24(10):1318-1333. doi:10.1177/1359105317726152
- ME Association. Consolidated report: Evaluation of a survey exploring the experiences of adults and children with ME/CFS who have participated in CBT and GET interventional programmes, April 2019: https://meassociation.org.uk/wp-con…nd-GET-Final-Consolidated-Report-03.04.19.pdf
- Serious errors in published Cochrane Reviews:
https://documentation.cochrane.org/display/EPPR/Serious+errors+in+published+Cochrane+Reviews
Caroline Struthers
Senior EQUATOR Research Fellow
From: Karla Soares-Weiser
Sent: 20 November 2020 08:19
To: Caroline Struthers; Rachel Marshall
Dear Caroline,
Thank you for your email. As you know, Rachel is coordinating the activities of the proposed update of this review and she will respond to your email within the next two weeks.
With best wishes, Karla
Karla Soares-Weiser (MD, MSc, PhD)
Editor in Chief, Cochrane Library
From: Caroline Struthers
Sent: 20 November 2020 08:40
To: Karla Soares-Weiser Cc: Rachel Marshall ; Rachel Churchill; Chris Eccleston
Dear Karla (cc Rachel Marshall, Rachel Churchill, Chris Eccleston)
My previous email was not about the update of the Exercise for CFS review. I was notifying you of a serious error in two published reviews which should, according to your policy,
https://documentation.cochrane.org/display/EPPR/Withdrawing+published+Cochrane+Reviews
lead to their withdrawal. The policy on serious errors https://documentation.cochrane.org/display/EPPR/Serious+errors+in+published+Cochrane+Reviews states that you should be notified which I did in my previous email.I have copied in the Coordinating Editor of the CRG and who I believe is the appropriate Network Senior Editor to assist the process
With best wishes
Caroline
Caroline Struthers
Senior EQUATOR Research Fellow
From: Rachel Marshall
Sent: 24 November 2020 16:11
To: Caroline Struthers Cc: Karla Soares-Weiser
Dear Caroline,
Thank you for your email and for raising concerns of a serious error in the current version of the review. As per our policy on serious errors “The Editor in Chief along with the Co-ordinating Editor of the Cochrane Review Group (CRG) that published the Cochrane Review and the Network Senior Editor will investigate and agree a course of action.” We aim to conclude the investigation by January 2021, and we will be back in touch with you in due course.
With best regards, Rachel
Rachel Marshall
Senior Editorial Officer
From: Rachel Marshall
Sent: 01 February 2021 17:35
To: Caroline Struthers Cc: Karla Soares-Weiser
Dear Caroline,
Thank you again for your email regarding the Cochrane reviews on exercise therapy and cognitive behavioural therapy (CBT) for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
A sub-group of the Cochrane Editorial Board and a Co-ordinating editor have reviewed and discussed the information from the updated NICE guideline under consultation on ME/CFS, and the associated NICE evidence review on non-pharmacological management [review G]. The editors have agreed that the information within does not meet Cochrane’s criteria for a serious error, and both reviews will remain on the Cochrane Library. The two Cochrane reviews each have an editorial note within the abstract, explaining the current status of the review. Cochrane will update the editorial note for the CBT review to further clarify that the strength of evidence has not been evaluated using GRADE methodology, and this change to the editorial note will be made within the next few days.
With best regards, Rachel
Rachel Marshall
Senior Editorial Officer
From: Caroline Struthers
Sent: 01 February 2021 21:38
To: Rachel Marshall Cc: Karla Soares-Weiser
Hi Rachel
“The editors have agreed that the information within [the draft NICE guideline] does not meet Cochrane’s criteria for a serious error”
This sentence doesn’t make sense.
I notified the Editor in Chief that following the conclusions of the reviews could lead to patient harm which is one of Cochrane’s definitions of a serious error.
Can you confirm that the message below means that the editors have concluded that following the conclusions of either of these reviews could not lead to patient harm.
This is despite the new draft NICE guideline recommending that neither intervention should be recommended due to extremely poor evidence of effectiveness, and with recent reliable evidence of harm.
Best wishes
Caroline
Caroline Struthers
Senior EQUATOR Research Fellow
From: Caroline Struthers
Sent: 05 February 2021 10:14
To: Karla Soares-Weiser Cc: Rachel Marshall
Subject: Notification of a serious error in reviews Exercise therapy for chronic fatigue syndrome and CBT for chronic fatigue syndrome: resubmission
Dear Karla (cc Rachel Marshall)
According to Cochrane’s policy on withdrawing published reviews (1), and the procedure which states that The Editor in Chief must be notified of all suspected or confirmed serious errors (2) I am resubmitting my notification to you of a serious error in the Cochrane reviews Exercise therapy for chronic fatigue syndrome (3) and CBT for chronic fatigue syndrome (4) which should lead to them being withdrawn.
For the avoidance of doubt, the criteria met for withdrawal in this case is one of the examples of a serious error specified in Cochrane’s own policy documents (1, 2)
“Following the conclusions of the review could result in harm to patients”
As I informed you in my original notification on 19 November 2020, the NICE draft guidelines (5) have reversed the recommendations for Exercise therapy and CBT to treat ME/CFS because of lack of good quality evidence of benefit and recent evidence of harm (6, 7). Therefore, following the conclusions of the Cochrane reviews which state that Exercise therapy and CBT may be helpful for ME/CFS is continuing to put patients in harm’s way.
Please will you acknowledge receipt of this notification and let me know when you anticipate concluding your investigation and deciding a course of action.
With best wishes
Caroline
- Withdrawing published Cochrane Reviews last modified on Jul 30, 2019 [cited 5 Feb 2021] https://documentation.cochrane.org/display/EPPR/Withdrawing+published+Cochrane+Reviews
- Serious errors in published Cochrane Reviews last modified on Jul 05, 2019 [cited 5 Feb 2021 https://documentation.cochrane.org/display/EPPR/Serious+errors+in+published+Cochrane+Reviews
- Larun L, Brurberg KG, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No.: CD003200. DOI: 10.1002/14651858.CD003200.pub8.
- Price JR, Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for chronic fatigue syndrome in adults. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD001027. DOI: 10.1002/14651858.CD001027.pub2.
- Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management In development [GID-NG10091] Expected publication date: 21 April 2021 https://www.nice.org.uk/guidance/indevelopment/gid-ng10091/documents
- Geraghty K, Hann M, Kurtev S. 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. 2019;24(10):1318-1333. doi:10.1177/1359105317726152
- 7.ME Association. Consolidated report: Evaluation of a survey exploring the experiences of
- adults and children with ME/CFS who have participated in CBT and GET interventional programmes, April 2019: https://meassociation.org.uk/wp-con…nd-GET-Final-Consolidated-Report-03.04.19.pdf
Caroline Struthers
Senior EQUATOR Research Fellow
From: Rachel Marshall
Sent: 08 February 2021 17:50
To: Caroline Struthers Cc: Karla Soares-Weiser
Dear Caroline,
The Editors have reviewed the information within the NICE guideline and the associated evidence review, and they have agreed that the criteria for a serious error has not been met. Therefore, the reviews on exercise for ME/CFS and cognitive behavioural therapy for ME/CFS will remain on the Cochrane Library, along with editorial notes explaining the status of each review. The investigation has now been concluded.
With best regards, Rachel
Rachel Marshall
Senior Editorial Officer
From: Caroline Struthers
Sent: 08 February 2021 20:37
To: Rachel Marshall Cc: Karla Soares-Weiser
Dear Rachel
Please could you confirm the criteria the editors used to come to this conclusion?
I have been clear about why these reviews should be withdrawn, which is the continued risk of harm to patients. As a charity whose beneficiaries are patients and the public, I expect Cochrane to give me more detail on how the conclusion that keeping these reviews on the library could not cause harm to patients was reached.
With best wishes
Caroline
Caroline Struthers
Senior EQUATOR Research Fellow
Thank you Caroline 🙂