New guidance discouraging doctors from recommending exercise and cognitive behavioural therapy for people with chronic fatigue syndrome (CFS) patients is not evidence-based, according to researchers.
A study questions the National Institute for Health and Care Excellence (Nice) review process for this guideline for clinicians dealing with CFS, also called myalgic encephalomyelitis (ME), and its use of scientific standards in considering the evidence.
One of the study’s lead authors, Prof Trudie Chalder from the psychiatry department at King’s College London, said: “The decision to change the guideline has had a direct effect on doctors’ and therapists’ ability to treat patients. Services are no longer able to provide a full range of evidence-based therapeutic interventions.
“This could have a devastating impact on people’s lives in that they will no longer be able to access the treatment that could help them the most.”
ME/CFS is a long-term condition believed to affect about 250,000 people in the UK. It has a wide range of symptoms, including extreme tiredness, muscle pain, mental fogginess and insomnia.
In 2007 Nice produced its first guideline, which recommended two forms of rehabilitation: graded exercise therapy (GET), which starts patients on exercise very slowly and gradually increases over time, and CBT, a type of talking therapy.
In 2021 Nice reviewed the scientific evidence, concluding that the benefits from CBT and GET were low, that GET was unsafe, and CBT should only be used to manage symptoms and distress, not to aid recovery. Chalder said the research evidence base for both therapies had “strengthened, not weakened” since the 2007 guideline.
Instead, the new guideline recommend energy management, providing advice on how to live with the illness and make the best use of energy. However, the researchers said there was little evidence that this was effective.
The study, which was published in the Journal of Neurology, Neurosurgery and Psychiatry and draws on 50 international experts, identified eight methodological, scientific, statistical and epidemiological flaws in the process for establishing the new guideline.
The researchers concluded there had been “remarkably little” aggregation and meta-analysis of research, falling short of international standards and making it hard to establish what treatments worked.
Another weakness involved the use of a new definition of chronic fatigue, not used in most previous studies, meaning that most trials were excluded. Nice also downgraded all self-reported fatigue-related outcomes on grounds it was too subjective, even though there is no other means of establishing whether a treatment has worked.
Co-author on the review Paul Garner, a professor who has worked in evidence synthesis and guideline methodology for 25 years, said: “Nice has not followed international standards for guideline development, which has led to guidance that could harm rather than help patients.”
Garner said the backdrop to the guideline relates to how poorly understood chronic fatigue is, in part due to limited understanding of the relationship between the brain and the body. Some sufferers feel that in the past their condition has been dismissed by the medical establishment as “all in the head”, he said.
Many sufferers believe ME/CFS is purely biomedical, whereas some experts think it may be a brain-body disorder. Many patients are sensitive to the inference psychological factors such as stress may contribute to the condition and dismiss psychological treatments such as cognitive behavioural therapy, he added.
Such sensitivities have led to controversy over whether rest is an appropriate treatment. Although sufferers may feel exhausted after doing things, rest can “perpetuate the illness”, he said.
A Nice spokesperson 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.
“We will provide a detailed response to this analysis and in the meantime we are 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.”
• This article was amended on 11 July 2023. ME/CFS affects an estimated 250,000 people in the UK, not 25,000 as an earlier version said.
