Today, on 29 October 2021, the National Institute for Health and Care Excellence (NICE) has finally published its new guideline on the diagnosis and management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The development of the guideline has been a long process mired with controversy, criticism, and unexpected delays. Its final publication, however, represents a historic change for the ME/CFS community. This blog post tries to clarify why.
The psychosomatic model
For those who could use some background info going into this story: ME/CFS is a chronic illness that causes debilitating fatigue, concentration problems, and many other dreadful symptoms. It often starts after infection but its cause and pathology remain largely unknown. Patients can become terribly ill (some are bedbound) but lab tests usually come back normal. Although the prognosis for ME/CFS varies, it’s usually unfavorable. Many patients remain incapacitated for decades.
The syndrome received increased attention after the Centers for Disease Control and Prevention (CDC) published a case definition in 1988. For most of the years that followed, the standard medical approach to ME/CFS was based on a psychosomatic model. It assumed that ME/CFS symptoms are the result of unhelpful thoughts and avoidance of activity. According to the theory, patients might have rested too much after infection and misinterpreted lingering fatigue after resuming activities as a sign that they were still sick and therefore needed to rest more.
A vicious cycle was envisioned which started with the patient’s belief in an organic disease as the cause of her (most ME/CFS patients are women) problems. This resulted in avoidance of activity, deconditioning, sleep disruption, anxiety, depression, and eventually more fatigue. The more symptoms the patient got, the more she rested, and then the cycle started all over again.
The group of mostly British psychiatrists who had formulated this fear-avoidance theory claimed to have a solution. Rehabilitative interventions were seen as a way out of the vicious cycle. The goal was to change patients’ beliefs about the cause of their illness and show that they could safely resume activities as long as they did so in a gradual and supervised way. Cognitive behavioral therapy (CBT) was offered to change patients’ “unhelpful” cognitions while graded exercise therapy (GET) was the tool to get patients back in shape.
This storyline was immensely popular among healthcare professionals. Until recently, it was the dominant narrative in prestigious medical journals such as The Lancet and the BMJ. It was dressed up in fancy terms such as kinesiophobia, somatic attributions, fear-avoidance, catastrophizing, and so forth. Because standard medical tests failed to show any abnormalities, it was easily assumed that there must be something wrong with the patients’ thoughts or behavior. Not the doctor’s ignorance but the patients were to blame. And GET and CBT offered easy solutions. Patients were told they could get better if they wanted to and tried hard enough. The previous NICE guidance on ME/CFS, published in 2007, recommended both GET and CBT.
Since the beginning of this theory, patients and some scientists performing biomedical research have voiced their objections. ME/CFS patients desperately want to be more active but can’t. Each time they try to do more and push through, their symptoms get worse. In the scientific literature, this phenomenon is referred to as “post-exertional malaise (PEM)”. Nowadays, it is generally viewed as one of the most characteristic features of ME/CFS. It looks like this: the patient overextends herself – for example for a doctor visit or family meeting – seems to be doing relatively fine but then suffers a severe setback afterward. This setback is often delayed and happens each time patients exceed their energy limit. It takes them a long time to recover and get back to the level they had before. Some say it feels like being trapped in a prison of energy limitation that gets smaller each time you try to escape.
GET and CBT assume that this prison is a dangerous illusion, that patients can safely increase their activity levels, and that they can fully recover by doing more. As one infamous paper stated, these treatments “assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity.” As soon as these treatments became the medical standard to treat ME/CFS, however, patients started reporting harm. In surveys that span multiple decades and various countries, ME/CFS patients have said that they became worse following GET and CBT or that they had to quit these treatments prematurely because their health deteriorated.
In part because of these reports of harm, patients and researchers started looking more closely at the scientific evidence for these interventions. ME/CFS is a heterogeneous condition with vague diagnostic criteria. One could assume that some patients responded favorably to these treatments while they have just the opposite effect in a different subgroup. This was a common assumption at the time. The more people looked at the evidence base, however, the more it became clear that it was seriously flawed. There was no reliable indication that these treatments worked for anyone. At long-term follow-up, the control group did just as well (or as bad, depending on how you look at it).
Ever since, patients and their families have been trying to get the attention of scientists to take a closer look at these problems. They wrote letters to scientific journals and pointed out that there is no method in place for monitoring adverse outcomes of GET and CBT. A collaboration of patients and scientists showed that the largest trial of these treatments had misleadingly claimed they were effective. After a tribunal ordered the release of the raw data, it was shown that improvement rates were inflated threefold. The more experts looked at the science behind the psychosomatic model of ME/CFS and its preferred treatments, the greater skepticism grew. Then, in September 2017, NICE decided it was time to review its guideline on ME/CFS.
The NICE review
By this time pretty much all ME/CFS organizations were advocating against GET, CBT, and the psychosomatic model. The feedback they got from patients suggested something was going wrong. They requested a thorough review of the evidence and NICE was the appropriate institute for this, producing evidence-based guidelines that are well-respected and influential even outside England and Wales.
NICE gathered a panel of 21 experts with different perspectives on ME/CFS. Although most were physicians, the guideline development group also included a psychologist, social worker, nurse, dietician, and several patients. They assessed the evidence for a long period of approximately 3 years. NICE also conducted a thorough review of the scientific evidence using a standardized approach. It published hundreds of pages full of assessment tables. On top of that, it performed its own qualitative research, for example, on the experiences of children with ME/CFS and patients with severe ME/CFS.
The NICE committee concluded that the evidence for GET and CBT was of “low to very low quality”. The guideline says that GET should no longer be recommended while CBT should only be offered to help patients cope with their chronic illness. It should not be offered as a cure for ME/CFS. Although the final guideline is a compromise where many issues remain (more about that in later blog posts) the overall message is clear. The psychosomatic theory of ME/CFS is viewed as misguided while many of the concerns patients have raised are vindicated.
NICE isn’t the only medical institution that came to that conclusion. The Healthcare Councils of Belgium and the Netherlands recently made a similar U-turn regarding the use of GET. In the United States, the website of the CDC no longer recommends GET and CBT for ME/CFS. Cochrane, another influential player in the medical field, is currently in the process of revising its systematic review on GET for ME/CFS.
The UK however, has always been the stronghold of the psychosomatic view of ME/CFS. It’s where most of the trials of GET and CBT were conducted. A relatively small group of British ‘experts’ has been able to present its psychosomatic approach to ME/CFS as evidence-based without much opposition. With the publications of the new NICE guideline, it seems that those days are over. For the ME/CFS community 29 October may turn out to be a historical turning point. Hopefully, this will open the way to more fruitful scientific research on the illness and eventually, a cure.