Dr Charles Shepherd, Honorary Medical Adviser to the ME Association sends a rapid response (published 13th July 2023) to the British Medical Journal (BMJ) in reference to the online article ‘ME/CFS: Researchers question credibility of NICE guidance' which followed recent media coverage on this subject.
Read the ME Association's full statement in response to the news articles from the 11th July 2023 here
Guidance from the National Institute for Health and Care Excellence (NICE) on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) “deviated from usual scientific standards” and could cause harm, a group of researchers have claimed.
More than 50 international specialists analysed NICE’s 2021 guidance and questioned the evidence underlying the decision to stop recommending graded exercise therapy (GET) and recommending only cognitive behavioural therapy (CBT) for symptom management and distress. “The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability,” they wrote in the Journal of Neurology, Neurosurgery and Psychiatry.
NICE has vehemently rejected the study’s conclusions, telling The BMJ that it stands by the recommendations outlined in the guidelines.
The institute produced its first CFS/ME guidance in 2007, which recommended two forms of rehabilitation—GET and CBT. It then reviewed the guidelines in 2021 and said that some people with ME/CFS reported “worsening of symptoms with GET and no benefit from CBT.” It said that, while research on pacing (energy management) was “sparse,” this method was “preferred by many people with ME/CFS.” As such, NICE recommended pacing instead, which involves patients managing their activities to stay within their energy limit.
In their paper the researchers said that NICE had “prioritised evidence from qualitative studies and patient organised surveys” in its 2021 review and that it had included “remarkably little aggregation and meta-analysis, making it hard to conclude what treatments worked.” They added that the committee had “created a new definition of CFS/ME, which ‘downgraded’ the certainty of trial evidence.”
The researchers highlighted a number of meta-analyses published since 2007, which they argued showed that the evidence for GET and CBT had strengthened, not weakened, since the initial NICE guidance. They pointed to NICE guidance on other relevant conditions, including chronic unexplained pain, that still recommended GET and CBT. Their paper asked, “Since such pain is common in CFS/ME, how can a clinician choose which guideline to follow?”
On the pacing recommendation, the researchers added that the “only substantial trial” on this showed that it was “no more effective” than specialist medical care alone and “less effective than either CBT or GET.” As such, they warned that the guidance could result in patients missing out on helpful treatments.
National Institute for Health and Care Excellence
In response, a spokesperson for NICE said, “We reject entirely the conclusions drawn by the authors of this analysis, and in particular their conclusion that NICE has not followed international standards for guideline development which has led to guidance that could harm rather than help patients.
“In developing our guideline, as well as bringing together the best available scientific evidence, we also listened to the real, lived experience and testimony of people with ME/CFS to produce a balanced guideline which has their wellbeing at its heart.”
NICE has said that it will provide a “detailed response to this analysis” soon, but it was “confident that system partners and the ME/CFS community will continue to work together to make sure the important recommendations in our guideline are implemented.”NICE Spokesperson
People with ME/CFS welcome the recommendations in the NICE guideline
The NICE guideline committee (of which I was a member) spent an enormous amount of time over three years reviewing all the evidence on CBT and GET from both clinical trials and from people with ME/CFS.
They concluded that the clinical trial evidence for the use of CBT and GET was of very poor quality and acknowledged that people with ME/CFS have consistently reported that CBT was ineffective and that GET made their condition worse – some ending up in wheelchairs as a result of receiving harmful advice on activity management.
The ME Association is therefore pleased to see that NICE is robustly defending the new recommendations regarding the use of CBT and the removal of GET and the way in which these recommendations were reached.
These recommendations have been widely welcomed by the ME/CFS patient community here and abroad, and by the vast majority of health professionals who are actively involved in managing people with ME/CFS in both primary and secondary care.
Dr Charles Shepherd,
Trustee and Hon. Medical Adviser to the ME Association.