Delay of British chronic fatigue syndrome guidelines is a setback for people with long Covid

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

The new guidelines would have represented NICE’s official retraction of a highly flawed version published in 2007. Back then, NICE endorsed two interventions that were supposedly able to cure ME/CFS — cognitive behavior therapy and a program of steady increases in exercise, called graded exercise therapy. These recommendations, however, were based on misguided hypotheses and research of questionable quality, and people with the disease often found these therapies to be ineffective, and even harmful.

Many in the ME/CFS community were eagerly awaiting the long-overdue update, which was developed by a carefully selected committee that included clinicians and patients. Instead, after protests from leading physicians organizations that prefer the status quo, NICE announced on Tuesday it was postponing publication of the new guidelines, which had been scheduled for Wednesday.

This move, which leaves in place the 2007 recommendations, represents a serious setback not only for people with ME/CFS but also for those experiencing what has been dubbed long Covid — the profound exhaustion, brain fog, dizziness and other symptoms that can continue for many months following a case of Covid-19.

NICE’s guidelines can influence medical practice not only in the U.K. but around the world, including in the United States. The revision of the ME/CFS guidelines have been in the works since 2017, long before the Covid-19 pandemic, but it has taken on added significance because of the potential impact of the guidelines on clinical attitudes and approaches to the surge of people with long Covid, given the similarities of the two conditions. Many people with long Covid, like generations of those before them with ME/CFS, have reported that doctors, employers, insurers and others have wrongly dismissed their symptoms as psychosomatic.

The U.S. Centers for Disease Control and Prevention estimates that as many as 2.5 million Americans live with ME/CFS, although most of them have not been diagnosed with it. No cause has been identified for the disease; people with it exhibit a range of immunological, neurological, and metabolic dysfunctions. Many, if not most, date the start of their condition to a viral illness like mononucleosis or a bad case of flu, although some report bacterial infections, mold, or environmental toxins as the triggering factor.

Experts agree that “post-exertional malaise,” a disproportionate and prolonged worsening of symptoms after minimal exertion, is a defining trait that helps distinguish ME/CFS from typical “fatigue.” Under such circumstances, treatment approaches that push people with ME/CFS to increase their activity, like those highlighted in the 2007 NICE guidelines, should be considered potentially harmful. In surveys of ME/CFS patients, significantly more report that graded exercise makes them worse rather than better.

To clinicians who believe ME/CFS is psychosomatic, its disabling symptoms stem from patients’ dysfunctional belief that they have an organic disease, which leads them to avoid exercise and become severely deconditioned. Within this framework, a graded exercise regimen is expected to help patients get back into shape, and cognitive behavior therapy is designed to relieve them of their purportedly unfounded anxieties about increasing their activity.

In November 2020, NICE published a draft of the new guidelines, along with a thorough review of the relevant studies. In assessing the data from this research, the NICE committee determined that the evidence from clinical trials of graded exercise and cognitive behavioral therapy for ME/CFS was of either “low” or “very low” quality. The draft advised against exercise and physical activity regimens “based on deconditioning as the cause of ME/CFS.” The draft also noted that cognitive behavior therapy “is not a cure for ME/CFS” and rejected the notion that “‘abnormal’ illness beliefs and behaviours” are “an underlying cause” of the illness.

The draft guidance allowed for psychological and behavioral approaches designed as supportive care for managing symptoms rather than as a path to recovery.

After NICE invited public comment, the guidelines committee revised some of the draft language for the final version while retaining the recommendations. During the same period, psychiatrists and other ardent defenders of the psychosomatic approach engaged in an energetic campaign to cast doubt on the NICE draft and promote their preferred therapies, with commentaries in medical journals and mainstream news outlets.

Viral diseases such as mononucleosis, West Nile, Ebola, and those caused by other recently identified coronaviruses are known to leave a minority of people who recover from the acute infection with chronic disabilities. With Covid-19, the aftermath is varied. (Long Covid has been given 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 kinds of symptoms, including post-exertional malaise, that overlap with criteria used to identify ME/CFS. In fact, some people with long Covid are now being diagnosed with ME/CFS.

That’s why experts believe that ongoing research into the causes of long Covid could yield significant insights into ME/CFS as well — and vice versa. In an article published this past week in the journal PNAS, experts from Johns Hopkins, Harvard, and the Solve ME/CFS Initiative reviewed commonalities in the pathophysiological processes associated with ME/CFS and long Covid, noting that “understanding the molecular underpinnings of both PASC and ME/CFS may lead to the development of novel therapeutics.”

Proponents of the psychosomatic approach to ME/CFS largely blame the symptoms associated with long Covid on anxiety, depression, post-traumatic stress disorder, and other mental health ailments arising from the pandemic’s psychological burden. They have suggested that people with long Covid should receive the traditional ME/CFS treatments — exercise and psychotherapy — once basic medical tests have found no abnormalities.

The revised ME/CFS guidelines, whether or not NICE ultimately publishes and adopts them, represent a decisive rejection of the psychosomatic approach. But they also acknowledge an unfortunate reality: No treatments for ME/CFS have been shown to be effective in well-conducted trials, and the optimal approach to care involves strategies for the management and relief of symptoms. So far, the same is true for long Covid. No one knows how best to address it even as investigators and clinicians urgently explore the underlying biology and potential treatments.

In the statement announcing what it referred to as a “pause” in publication, NICE defended the “rigorous methodology” of the process it pursued in developing the new guidelines, emphasizing that ME/CFS is a “complex, multi-system, chronic medical condition.” The agency attributed the delay in publication to concerns that the professionals charged with delivering care to patients would 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 explore if this support can be achieved,” the agency noted.

The statement did not indicate how long the pause to seek this support would last, whether the agency would eventually publish the new evidence-based guidelines without it, or whether the 2007 guidance — which continues to influence clinical practice — should still be considered operative in light of the “very low” and “low” quality of the evidence supporting the interventions.

Medicine, like all science, can be self-correcting only when it is willing to reevaluate previously accepted practices in light of better information. With people all over the world now reporting pandemic-related symptoms similar to ME/CFS, it is time for these ineffective interventions to be discarded as first-line treatments for non-specific post-viral symptoms following 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 foster appropriate care for people with long Covid, the emerging wave of biomedical research into that condition may provide answers as well for the long-neglected community of people with ME/CFS.

In the meantime, it is essential that NICE publish its revised guideline with all deliberate speed.

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