On 10 February 2015, The Lancet published an editorial covering the Institute of Medicine report into ME/CFS, their proposal to introduce a new name for both CFS and ME: systemic exertion intolerance disease/SEID and new clinical diagnostic criteria, and the PACE trial.
The Lancet editorial can be read HERE
The MEA responded to The Lancet as follows in an ‘intended for publication' letter:
What's in a name? Systemic exertion intolerance disease
We agree with much of The Lancet editorial on the Institute of Medicine (IoM) report into ME/CFS(1). The report is a brave attempt to inform the public and policy makers about a serious, complex multisystem disease.
And having published the results of the PACE trial(2), that attracted criticism from The ME Association(3), and even politicians(4), we understand why The Lancet should want to defend their decision to do so – but not in this editorial.
The prime reason for our criticism of the PACE trial relates to patient evidence in the form of large scale surveys(5). These surveys have repeatedly confirmed that the majority of people with ME/CFS do not find cognitive behaviour therapy (CBT) helpful and around 50% report that graded exercise therapy (GET) makes their condition worse. By contrast, around 90% of people report that pacing is a safe and effective form of management.
Our second reason for criticising the PACE trial is that it is based on a flawed model of causation. This assumes that ME/CFS is largely maintained by abnormal illness beliefs and behaviours along with inactivity/deconditioning. This is a model that takes no real account of evidence to support a biomedical basis for both the central/brain fatigue (6) and the peripheral/muscle fatigue(7) found in ME/CFS.
However, to then claim in the editorial that the results of this PACE trial paved the way for the IoM report was somewhat disingenuous when the remit of the report was to investigate nomenclature, definition and symptomatology. There was no remit to cover management and the IoM did not comment on the validity of the PACE trial. In fact, the IoM report(8) noted on page 264 that: there is little evidence on the efficacy of interventions in ME/CFS patients with respect to function and disability.
The MEA welcomes the removal of the term CFS, as does the ME/CFS patient community, but we are not yet convinced that systemic exertion intolerance disease (SEID) is an appropriate replacement. We would prefer further consultation involving practitioners, researchers and patients, and suggest that the term myalgic encephalopathy is given further consideration.
We also welcome the IoM recommendation regarding a revised clinical definition – in particular the inclusion of orthostatic intolerance (OI) and post-exertional malaise as key diagnostic features. The MEA has long argued that this is the case and, unlike the NICE guideline on ME/CFS, provides information on both assessment and management of these key components.
We were therefore surprised to find that when we opposed the decision by NICE to place the 2007 ME/CFS guideline on their static list (10), partly on the basis that NICE do not include OI, or postural orthostatic tachycardia syndrome (POTS) in the sections on clinical assessment or management, our objections were dismissed.
Hopefully, the IoM report will result in an improvement in the understanding and recognition of ME/CFS, along with revision of the NICE guideline on ME/CFS into one that accepts the heterogeneity of both clinical presentation and disease pathways involved, as was acknowledged by Professor Mark Baker when he spoke to the Forward ME Group of charities at the House of Lords (11).
Dr Charles Shepherd
Hon Medical Adviser
The ME Association
7 Apollo Office Court
BUCKS MK18 4DF
1) What’s in a name? Systemic exertion intolerance disease. The Lancet. 2015; 385: 663
2) White, P D et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. The Lancet. 2011; 377: 823-836.
3) Shepherd C. Comments on ‘Recovery from chronic fatigue syndrome after treatments given in PACE trial’. Psychological Medicine. 2013: 43; 1790 – 1791.
4) House of Lords debates the PACE trial. ME Association 6 February 2013.
5) Managing my M.E. What people with ME/CFS and their carers want from the UK’s health and social services. ME Association May 2010. www.meassociation.org.uk/wp-content/uploads/2010/09/2010-survey-report-lo-res10.pdf
6) Nakatomi Y, et al. Neuroinflammation in patients with chronic fatigue syndrome/myalgic encephalomyelitis: An 11C-®-PK11195 PET study. Journal of Nuclear Medicine. 2014; 55: 945 – 950.
7) Jones DE, et al. Loss of capacity to recover from acidosis on repeat exercise in Chronic Fatigue Syndrome: a case-control study. European Journal of Clinical Investigation. 2012 ;42:186–194.
8) Beyond myalgic encephalomyelitis/chronic fatigue syndrome: Redefining an illness. Institute of Medicine – The National Academic Press. 19 February 2015.
9) Name change committee report. Comments by Dr Charles Shepherd, Medical Adviser, ME Association. 11 February 2015.
10) MEA oppose NICE decision not to review their guideline on ME/CFS. 11 April 2014.
11) Minutes of the Forward ME Group. 25 June 2014.
As medical journals do not like material that may be published appearing in the public domain prior to publication we did not publish this letter on the MEA website at the time of sending it.
However, we have now been told by The Lancet that after discussion by the editorial team they will not be publishing our letter – which means it can now be placed in the public domain.
This is the reply we received from a senior editor at The Lancet on March 25:
Dear Dr Shepherd,
Thank you for submitting your Letter to The Lancet. Having discussed your Letter with the Editor, and weighing it up against other submissions we have under consideration, I am sorry to say that we are unable to accept it at this time. Please be reassured that your Letter has been carefully read and discussed by the Editors. Thank you for your interest in The Lancet, I hope this decision does not deter you from considering us again in the future.