On 10 November 2020, the National Institute for Health and Care Excellence (NICE) published a long-awaited draft for its new guideline on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The document reveals how NICE is about to make a drastic change in recommending how the condition should be managed by healthcare professionals. While its previous guideline advised graded exercise therapy, the current draft explicitly discourages this approach because of low-quality evidence and multiple reports of harm.

Background: info on NICE and the previous guideline

NICE is an agency of the British National Health Service (NHS) that publishes guidelines and recommendations on the effectiveness of treatments and medical procedures. It assembles a diverse panel of experts (including patient representatives) to discuss and evaluate current evidence following a systematic review of the scientific literature. The methodology it uses is quite thorough, making NICE guidelines a respected source in the United Kingdom and abroad.

The 2007 NICE guideline on ME/CFS, however, has been quite controversial. One patient representative resigned from the guideline development group because of disagreement with the final recommendations. After its publication, two persons with ME/CFS initiated a Judicial Review of the guideline but without success. When the 2007 guideline was reviewed more than 10 years after its publication, practically all patient organizations insisted on a change.

The 2007 guideline was so controversial because it recommended two interventions – graded exercise therapy (GET) and cognitive behaviour therapy (CBT) –  after which patients frequently reported harms. Both treatments assume that ME/CFS is perpetuated by reversible physiological changes of deconditioning and avoidance of activity. GET and CBT, therefore, aim to increase the level of (physical) activity and address unhelpful thoughts about resting, sleep, and avoidance of exercise. The main idea is to expand the patients’ perceived limits and gradually extend their physical capacity under the guidance of a healthcare professional.

A quote from the minutes of the GDP meetings characterizes this line of thinking. One person said that it “would be wrong if we adopted a philosophy of merely supporting patients in their disability. We must change this feeling of hopelessness.” Accordingly, the guideline instructed healthcare professionals to “encourage cautious optimism”. It stated (without sound evidence) that “most people with CFS/ME will improve over time and some people will recover and be able to resume work and normal activities.” GET and CBT were the ideal tools to help patients improve and recover. To goal was to increase activities to 30 minutes of low-intensity exercise for 5 days out of 7, a level that even many healthy persons fail to maintain.  

Graded exercise therapy no longer recommended

The draft for the new NICE guideline on ME/CFS makes a turn of 180 degrees. It explicitly recommends not to offer “any programme based on fixed incremental increases in physical activity or exercise, for example graded exercise therapy” or “structured activity or exercise programmes that are based on deconditioning as the cause of ME/CFS.”

There are two main reasons for this drastic change of course. First is the consistent reporting of harm. In preparation for the new NICE guideline development, a survey was conducted by researchers from Oxford Brookes University where 80% of patients who started GET said it worsened their symptoms.  Although the survey might have been affected by selection bias (patients who deteriorated after GET might have been more likely to participate) the results are in agreement with multiple other surveys that were conducted in the United Kingdom and abroad.

These reports on harm were well-known in 2007. At the time, one member of the guideline development group remarked that “the guideline must acknowledge that some people will be made worse following a GET programme.” Another member, however, responded assertively that “if the guideline gives a message that it has significant risk, patients won’t be offered GET”. Little caution about the use of GET appeared in the NICE guideline. Deterioration was mainly ascribed to inappropriate delivery of GET, rather than the treatment itself, an explanation that became increasingly unlikely as more surveys on harm were published.

A second reason for the change of course is the low-quality evidence supporting GET. In 2007 only a handful of small trials suggested improvements following GET. These suffered from multiple shortcomings and were published by proponents of the intervention. Since then there have been two large trials – the FINE and PACE trial – that tried to replicate these findings. In both studies, there was not a significant improvement in the GET compared to the control group.

Although the draft cautions against GET, it does highlight the importance of ‘physical maintenance’, which is defined as “incorporating into daily activity a level of movement that does not exacerbate symptoms and ensures that joint and muscle flexibility does not deteriorate further than that caused by the condition so far.” This is to prevent possible complications of long-term immobility in patients with moderate to severe ME/CFS such as contractures, pressure ulcers, deep vein thrombosis, and osteoporosis.

CBT to help patients cope, not to treat or cure their illness

The draft also makes an important change regarding CBT. To explain it clearly, it is useful to distinguish between two types of CBT.

The first type of CBT is the one traditionally used for ME/CFS and the one recommended in the previous guideline as an evidence-based treatment. It assumes that ME/CFS patients have unhelpful thoughts and behaviors such as perfectionism, fear-avoidance, catastrophizing, and somatization that perpetuate their symptoms. By changing these ineffective thoughts and behaviors, CBT was believed to treat ME/CFS and help patients get better. The previous NICE guideline explained that CBT focuses on “addressing any over-vigilance to symptoms” or “challenging thoughts and expectations that may affect symptom improvement and outcomes.”

The draft for the new NICE guideline makes a second drastic change by stating that CBT should not be offered as a treatment or cure for ME/CFS. Instead, it mentions a different type of CBT, one that “does not assume people have ‘abnormal’ illness beliefs and behaviours as an underlying cause of their ME/CFS.” This type of CBT focuses on supporting patients in managing their symptoms or coping with disability. The draft states that this type of CBT can be offered to patients if they would like support; for example, with reducing the psychological distress associated with having a chronic illness. According to the NICE committee, “the qualitative evidence showed that people with ME/CFS have found CBT useful when delivered by a therapist who understands ME/CFS.”

Be aware there is no current treatment or cure

Unfortunately, no treatment is able to replace GET or CBT in the draft for the new NICE guideline. Little progress has been made in the treatment of ME/CFS in the past 13 years. According to the draft, “the evidence for non-pharmacological and pharmacological interventions for ME/CFS was heterogenous and inconclusive, with limited evidence for any one intervention, and this supported the committee’s experience.” Therefore, the draft states firmly: “Be aware there is no current treatment or cure (non-pharmacological or pharmacological) for ME/CFS.”

The intent behind this statement is quite likely to prevent quackery and remedies that are marketed as a cure for ME/CFS. The draft even advises healthcare providers explicitly not to offer the ‘Lightning Process’,  a pseudoscientific approach based on osteopathy, life coaching, and neurolinguistic programming that is popular in the ME/CFS community, in part because some academics gave credibility to it.

The text also explains that “there is currently no diagnostic test for ME/CFS” and the illness “is recognised on clinical grounds alone”. This gives a clear message to patients, that if their doctors claim to use diagnostic tests or treatments for ME/CFS, that these are not supported by reliable evidence. 

The energy envelope theory

The draft focuses strongly on an activity management strategy that is traditionally called ‘pacing’ within the ME/CFS patient community, but which the text labels and defines in somewhat different terms.

The keyword here is ‘energy envelope’: the amount of energy a person has, to do all activities, without triggering an increase in their symptoms. The draft explains that ME/CFS is characterized by symptom exacerbations following exertion, which typically has a delayed onset and prolonged recovery period.  In the scientific literature, this is referred to as post-exertional malaise.

The draft recommends a self-management strategy that helps patients to avoid these symptom exacerbations and stay within their energy envelope. The text states, for example, that patients should be advised: “not to use more energy than they perceive they have − they should plan their daily activity to stay within their energy envelope and not push through activity.” The document also stresses to “reduce activity as the first step, plan periods of rest and activity, and incorporate the need for pre-emptive rest.”             

Early diagnosis and management

One area where the draft agrees with the previous guideline is the need for early diagnosis and management. It recommends considering the diagnosis of ME/CFS when patients present with symptoms of disabling fatiguability, post-exertional malaise, unrefreshing sleep, and cognitive difficulties, all for a minimum of 6 weeks (4 weeks in children and young people). The committee argues that it would be unusual for an acute illness, including a viral illness, to persist longer than 6 weeks.

The draft advises to “not delay in making a provisional diagnosis of ME/CFS” and that at this point doctors can continue performing tests to exclude alternative explanations for the patient’s symptoms. They should explain that this does not affect the patient’s provisional diagnosis of ME/CFS. The text recommends making an ME/CFS diagnosis after a period of 3 months, which is sooner than the 6 months specified in the Fukuda-criteria, the most commonly used case definition in research, and the 4 months recommended by the previous NICE guideline.  Although there is little evidence on this topic, the committee’s experience suggested that managing symptoms early may prevent them from getting worse and the person’s health from deteriorating.

Adapting to the patient’s need: home visits and a low-stimuli environment

The sections on treatment and diagnosis are arguably the most important ones in the draft for the new NICE guideline. There are however several other paragraphs with important advice and recommendations indicating the thoroughness with which the committee fulfilled its assignment. Several notable sections focus on the rights of ME/CFS patients, which could reflect the fact that 5 patient representatives were included in the guideline development group, instead of the usual 2 or 3.

The text advises healthcare provides to “explain to people with ME/CFS and their family or carers that they have the right to decline or withdraw from any part of their management plan” and that patients are in charge of deciding what treatments or advice they will follow. It says to give patients and their carers information about self-help groups and advice about financial support, including applying for benefits.

In an important paragraph the draft states that “Service providers should ensure people with ME/CFS can access health and social care services by adapting the timing, length and frequency of all appointments to the person’s need taking into account sensitivities to light, noise, touch, pain, temperature extremes or smells providing care flexibly, such as by phone or video conferencing or making home visits.”

ME/CFS patients are unlikely to be seen at their worst

Another section explains to healthcare professionals that ME/CFS patients are unlikely to be seen at their worst because debilitating symptoms and post-exertional symptom exacerbation may prevent people from leaving their homes. It also mentions that because of cognitive difficulties, patients may wait until they feel they can speak and explain themselves clearly before contacting help or services.

There is also a section on patients with severe ME/CFS. It is explained that these patients need a low-stimulus environment, for example, a dark quiet room with interaction at a level of their choice. Some may need wheelchairs, while others cannot communicate without support and may need someone else, they have chosen to be their advocate and communicate for them. The most severe cases can be unable to eat or digest food easily and may need support with hydration and nutrition.

ME/CFS patients may have lost trust in health and social services

Importantly, the draft encourages healthcare providers to “recognize that people with ME/CFS may have experienced prejudice and disbelief and feel stigmatized” and “that they may have lost trust in health and social services and be hesitant about involving them.”

One British patient organization, Tymes Trust, has, for example, had to focus much of its activity on countering false allegations of child abuse in cases of ME/CFS In children. The draft states that “people with ME/CFS, particularly those with severe or very severe ME/CFS, are at risk of their symptoms being confused with signs of abuse or neglect.” It clarifies that reduced school attendance, having physical symptoms that do not fit a commonly recognized illness pattern, having more than one child or family member with ME/CFS, declining therapy, or parents acting as an advocate on behalf of the child, are all not necessarily a sign of abuse or neglect in young people with ME/CFS.

Treatment recommendations

Finally, the draft also makes several research recommendations. These are areas where the committee thinks more scientific research is most urgently needed. The text advises to focus research on tests and criteria for the diagnosis of ME/CFS, outcome measures to be used in treatment trials, and studies on the cost-effectiveness of sleep management, dietary strategies, and self-monitoring techniques in guiding energy management.

Submit your feedback

The document that NICE has released on 10 November is a draft, a provisional text that may undergo several changes before publication. All stakeholders are now invited to provide feedback so that the text can be further improved. Several patient organizations have provided guidance on how persons with ME/CFS can contribute to this process. A ‘Comments form’ is available on the NICE website and helps to specify the document, page number and line number of the section that is being commented on.

While the draft was welcomed by ME/CFS experts and ME/CFS patient organizations, proponents of GET and CBT criticized the document and accused NICE of letting activism and political considerations overpower scientific evidence.