Delay of new guidelines is a setback for chronic fatigue patients (ME / CFS)

The National Institute for Health and Excellence in Care (NICE), a UK agency tasked with developing clinical guidelines for medical conditions, was due to publish new recommendations on August 18 for the treatment of people with chronic fatigue syndrome, also known as myalgic encephalomyelitis, or ME / CFS. Instead, he abruptly delayed the movement under pressure from powerful medical interests.

The new guidelines would have represented NICE’s official withdrawal of a very flawed version published in 2007. At the time, NICE approved two interventions believed to be able to cure ME / CFS – cognitive behavioral therapy and a program of constant increase in exercise, called graduated exercise therapy. These recommendations, however, were based on flawed assumptions and research of questionable quality, and people with the disease often found these therapies ineffective or even harmful.

Many members of the ME / CFS community were eagerly awaiting the long-awaited update, which was developed by a carefully selected committee that included clinicians and patients. Instead, after protests from major physician organizations who prefer the status quo, NICE announced Tuesday he postponed the publication of the new guidelines, which was scheduled for Wednesday.

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This decision, which leaves the 2007 recommendations in place, represents a serious setback not only for people with ME / CFS but also for those suffering from what has been dubbed the long Covid – deep exhaustion, fog. cerebral dizziness, dizziness and other symptoms that may persist for several months after a case of Covid-19.

NICE guidelines can influence medical practice not only in the UK but around the world, including the US. The review of the ME / CFS guidelines has been underway since 2017, long before the Covid-19 pandemic, but has gained increased importance due to the potential impact of the guidelines on attitudes and clinical approaches to the influx. of people with long-term Covid, given the similarities of the two conditions. Many people with long-term Covid, like generations of those who have had ME / CFS before them, have reported that doctors, employers, insurers and others have wrongly dismissed their symptoms as psychosomatic.

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United States Centers for Disease Control and Prevention estimates that up to 2.5 million Americans are living with ME / CFS, although most of them have not been diagnosed with it. No cause has been identified for the disease; affected individuals exhibit a range of immunological, neurological and metabolic dysfunctions. Many, if not most, date the onset of their illness to a viral illness like mononucleosis or a bad case of the flu, although some report bacterial infections, mold, or environmental toxins as a trigger.

Experts agree that “Post-effort discomfort”, A disproportionate and prolonged worsening of symptoms after minimal exertion is a defining trait that helps distinguish ME / CFS from typical “fatigue”. In such circumstances, treatment approaches that cause people with ME / CFS to increase their activity, such as those highlighted in the 2007 NICE guidelines, should be considered potentially dangerous. In surveys of ME / CFS patients, significantly more people report that gradual exercise makes them worse rather than better.

For clinicians who believe ME / CFS to be psychosomatic, its debilitating symptoms stem from patients’ dysfunctional belief that they have organic disease, which leads them to avoid exercise and become severely deconditioned. As part of this, a graduated exercise regimen is expected to help patients get back into shape, and cognitive behavioral therapy is designed to relieve them of their supposedly unfounded worries about increasing their activity. .

In November 2020, NICE published a draft of the new guidelines, as well as an in-depth review of relevant studies. In evaluating the data from this research, the NICE committee determined that the evidence from clinical trials of graduated exercise and cognitive behavioral therapy for ME / CFS was of “low” or “very low” quality. The project advised against exercise and physical activity regimens “based on deconditioning as the cause of ME / CFS”. The project also noted that cognitive behavioral therapy “is not a cure for ME / CFS” and rejected the idea that “” abnormal “beliefs and behaviors about disease” are “an underlying cause. Of the disease.

The draft guidelines enabled psychological and behavioral approaches designed as supportive care for symptom management rather than a path to recovery.

After NICE invited the public to comment, the guidelines committee revised some of the draft language for the final version while retaining the recommendations. At the same time, psychiatrists and other strong advocates of the psychosomatic approach embarked on a vigorous campaign to challenge the NICE project and promote their favorite therapies, with reviews in medical journals and mainstream media.

Viral diseases such as mononucleosis, West Nile, Ebola and those caused by other recently identified coronaviruses are known to leave a minority of people recovering from acute infection with chronic disabilities. With the Covid-19, the consequences are varied. (Long Covid received the more formal name of “Post-acute sequelae of Covid-19”.) Some people with Covid-19 experience identifiable damage to the lungs, heart, or other organs, which can lead to specific, long-term complications. Others report the types of symptoms, including post-exercise discomfort, that overlap with the criteria used to identify ME / CFS. In fact, some people with long Covid are now being diagnosed with ME / CFS.

That is why experts believe that ongoing research into the causes of long Covid could also yield important information about ME / CFS – and vice versa. In an article published last week in the journal PNAS, experts from Johns Hopkins, Harvard and the Solve ME / CFS initiative examined commonalities in the pathophysiological processes associated with ME / CFS and long-term Covid, noting that “understanding the molecular foundations of PASC and EM / CFS may lead to the development of new therapies.

Supporters of the ME / CFS psychosomatic approach largely attribute symptoms associated with long Covid to anxiety, depression, post-traumatic stress disorder and other mental health disorders resulting from psychological burden of the pandemic. They suggested that people with long-term Covid should receive traditional ME / CFS treatments – exercise and psychotherapy – once basic medical tests find no abnormalities.

The revised ME / CFS guidelines, whether or not NICE publishes and adopts them, represent a decisive rejection of the psychosomatic approach. But they also recognize a sad reality: No treatment for ME / CFS has been shown to be effective in well-conducted trials, and the optimal approach to care involves strategies for managing and relieving symptoms. So far, the same is true for the long Covid. No one knows how to fix it, even as researchers and clinicians urgently explore the underlying biology and potential treatments.

In the statement Announcing what he called a “pause” in the publication, NICE defended the “rigorous methodology” of the process it followed to develop the new guidelines, stressing that ME / CFS is a “complex chronic disease , multisystem “. The agency attributed the publication delay to fears that professionals responsible for providing patient care will refuse to accept the recommendations. “In order to have the desired impact, the recommendations must be supported by those who will implement them and NICE will now consider whether this support can be obtained,” the agency noted.

The statement did not say how long the hiatus would last to seek that support, whether the agency would eventually release the new evidence-based guidelines without it, or whether the 2007 guidelines – which continue to influence clinical practice. – should always be considered operational in light of the “very low” and “low” quality of the evidence supporting the interventions.

Medicine, like any science, can only self-correct when it is willing to reassess previously accepted practices in the light of better information. With people around the world now reporting pandemic-related symptoms similar to ME / CFS, it is time that these ineffective interventions were ruled out as first-line treatments for post-viral symptoms not specific to the disease. as a result of Covid-19 or other infections.

As the suspended revised guidelines make clear, the psychosomatic school is on the losing side of the scientific argument. Just as the new ME / CFS guidelines could help promote appropriate care for people with long-term Covid, the emerging wave of biomedical research on this condition may also provide answers to the long-neglected community of people with Covid. of EM / SFC.

In the meantime, it is essential that NICE publishes its revised directive with deliberate speed.

David Tuller is a senior public health and journalism researcher at the Center for Global Public Health at the University of California at Berkeley. Members of the ME / CFS patient community and advocates have donated to crowdfunding campaigns in support of Tuller’s position in Berkeley. Steven Lubet is Professor of Law at the Pritzker School of Law at Northwestern University. He has been living with chronic fatigue syndrome since 2006.