*October is crowdfunding month at Berkeley. I conduct this project as a senior fellow in public health and journalism and the university’s Center for Global Public Health. If you would like to support the project, here’s the place: https://crowdfund.berkeley.edu/project/22602
By David Tuller, DrPH
Proponents of cognitive behavior therapy and graded exercise therapy as treatments for CFS, ME, or their variants keep trotting out their favored interventions for patients suffering from persistent fatigue and other symptoms after acute Covid-19. Last week, the Royal Society of Medicine conducted an online webinar called “Long COVID: Understanding the shadow of the virus.” Three physicians participated: Alastair Miller, an infectious disease expert from Liverpool who used to run a local CFS/ME clinic; Carolyn Chew-Graham, a professor of general practice research at Keele University in Staffordshire; and Nisreen Alwan, an associate professor of public health at the University of Southampton.
The first two have been longtime members of the CBT/GET brigades. Chew-Graham is the main author of the Royal College of General Practitioners’ unfortunate online training program on CFS/ME, which I critiqued here. Chew-Graham is also a prominent player in the push to ensure that GPs learn to identify patients suffering from so-called “medically unexplained symptoms” and shunt them off to psycho-behavioral interventions rather than referring them to specialists. (More on her webinar comments in a subsequent post.)
Alwan was one of dozens of physicians who signed a recent open letter, published on BMJ’s site, urging caution on exercise as a treatment, among other messages. As she explained in the webinar, she got sick in March and has since experienced remitting periods of illness and exhaustion. When she realized through online forums that many others were having similar post-Covid complaints, she found the dearth of information troubling.
“I was really astounded that nobody was quantifying morbidity,” she said, urging viewers to lobby for basic epidemiology and research on the condition.
Whatever Alwen’s previous experience or thoughts about ME and CFS, she pressed strongly near the start of the webinar against applying the prevailing graded exercise approach to patients with persistent symptoms after acute Covid-19. As she said:
“As far as I know, there’s no evidence to support graded exercise in long-covid patients. We shouldn’t really be premature and label long-covid as any other previous condition. It could be similar to CFS in many aspects, but also there are some different aspects, and we need to characterize the condition. It would be unusual if we start recommending all these treatments when we haven’t even got a case definition.”
Alastair Miller’s Take
That was clearly a point well taken—but it didn’t appear to make much of an impression on Miller. During his presentation, he made appropriate noises about the need to exclude identifiable biomedical causes for persistent symptoms after Covid-19, especially those related to organ damage. Yet the majority of these patients appear to have non-specific symptoms, he said, identifying their condition as a post-viral syndrome identical to chronic fatigue syndrome.
Here’s what he said:
“All the experience and historical context and symptomology would suggest this is a post-viral fatigue syndrome for probably a majority of people, and in that situation the two evidence-based NICE-approved [the UK National Institute of Health and Care Excellence creates clinical guidelines for medical conditions] approved approaches to treatment are cognitive behavioural therapy and graded exercise therapy or graded activity therapy. They’re based on a number of studies, some of which are very controversial.
“The PACE trial…has had a lot of bad press…That study along with a number of other meta-analyses have shown benefits of CBT and graded exercise, and that’s the approach that we used in Liverpool. And from our results, which are pretty much in line with PACE and all the other centers that are using these therapies, we reckoned that about one third of our patients made a complete recovery and go back to a pre-morbid existence, about a third made an improvement but still had some symptoms, and about a third did not recover.”
Miller stressed that “compromise” was key to progress with post-viral fatigue syndrome and chronic fatigue syndrome—and, presumably, most cases of post-Covid syndrome. The compromise, he said, was between someone thinking they can “just blast this out of your system” with exercise and “someone saying, Oh, God, I’m so fatigued I’m just going to sit in the wheelchair.”
He suggested that the country’s network of specialized CFS clinics were well-placed to assessing whether patients were suffering from symptoms linked to specific organ damage or from a standard post-viral syndrome. “Unfortunately, they’re not getting the support that they needed and certain commissioning groups have actually tried to withdraw support for them, but I think this is an opportunity to beef those up,” he said.
What did that mean?
Ok, let’s unpack this a bit. I’m not going to go through the entire argument against the CBT/GET paradigm. The notion that PACE suffers mainly from “bad press” rather than poor methodological choices and disqualifying breaches of scientific standards is silly. The rest of the CBT/GET literature in this domain also suffers from readily identifiable weaknesses.
More than 100 experts from Harvard, University College London, Columbia Berkeley, and elsewhere do not sign letters to Lancet editor Richard Horton citing “unacceptable methodological lapses” and demanding an independent investigation, as happened with PACE, based on “bad press.” Surely Miller himself should recognize that a study in which 13% of participants met outcome thresholds at baseline does not qualify as good science.
The flaws in this body of research is what prompted NICE to order a revision of the guidelines highlighted by Miller. In addition to not mentioning the upcoming revamped version of the guidelines, Miller failed to mention that NICE issued a statement about this matter early in the pandemic. The statement specifically warned against the assumption that the CFS/ME guidelines’ endorsement of GET meant that it was appropriate for treating post-Covid symptoms. Apparently it was not considered important to alert webinar viewers to that salient detail.
Miller said that a third of patients at his clinic made a “complete recovery” and returned fully to their pre-morbid lives–and that these findings parallel those of the PACE trial and other research. This is not an accurate statement. The PACE authors themselves reported that 22 % “recovered”—which they later acknowledged only meant “remission,” so it certainly was not “complete recovery.” And that number fell to single-digits, with no statistically significant benefits over the comparison groups, when the data were reanalyzed by the original methods the investigators themselves outlined in their trial protocol.
A recent snapshot from these specialized clinics comes from a study published last month in the Royal Society of Medicine’s own publication–the Journal of the Royal Society of Medicine. This study presented data so deceptively that it smacked of desperation on the part of CBT proponents. Perhaps they were trying to shore up support of CBT as NICE prepares its new ME/CFS guidance. It is hard to understand how this eyesore passed peer review. (It might have helped that one of the authors was Professor Sir Simon Wessely, the most recent past president of the society. The senior author was Sir Simon’s King’s College London colleague, Professor Trudie Chalder.)
In any event, the study–“Cognitive behavioural therapy for chronic fatigue and chronic fatigue syndrome: outcomes from a specialist clinic in the UK— seemed to conflate idiopathic chronic fatigue and chronic fatigue syndrome, as the title suggests. In this case, less than half the full sample provided data for the physical function questionnaire at the 12-month endpoint and the 3-month follow-up assessment. The mean score for those who did respond, while somewhat improved from the mean score at baseline, remained below the threshold that represented serious enough disability to enter the PACE trial. These unimpressive results from less than half the sample do not seem capable of supporting a claim that a third of the patients in these clinics achieve “complete recovery.”
Perhaps Miller has not yet seen this study or analyzed how the investigators have presented their data. It would be interesting to review comparable findings from the CFS/ME clinical service in Liverpool and see how they stack up. Certainly the available results from these clinical services do not justify using the coronavirus pandemic as a chance, in Miller’s words, “to beef them up.”