The Jerusalem Post

Wrong on chronic fatigue

- • By JULIE REHMEYER and DAVID TULLER

What are some of the treatment regimens that sufferers of chronic fatigue syndrome should follow? Many major medical organizati­ons cite two: psychother­apy and a steady increase in exercise. There’s just one problem. The main study that has been cited as proof that patients can recover with those treatments overstated some of its results. In reality, the claim that patients can recover from these treatments is not justified by the data.

That’s the finding of a peer-reviewed preliminar­y re-analysis of previously unpublishe­d data from the clinical trial, the largest ever for chronic fatigue syndrome. Nicknamed the PACE trial, the core findings of the British study appeared in The Lancet in 2011 and Psychologi­cal Medicine in 2013. Patients battled for years to obtain the underlying data, and in spring 2016, a legal tribunal in Britain, the General Regulatory Chamber, directed the release of some of the study’s informatio­n.

The impact of the trial on treatment options for the estimated 1 million chronic fatigue patients in the United States has been profound. The Mayo Clinic, Kaiser Permanente, WebMD, the American Academy of Family Physicians and others recommend psychother­apy and a steady increase in exercise.

But this approach can be harmful. According to a 2015 report from the Institute of Medicine, now the National Academy of Medicine, even minimal activity can cause patients prolonged exhaustion, muscle pain, cognitive problems and more. In severe cases, a short conversati­on or a trip to the bathroom can deplete patients for hours, days or more. In surveys, patients routinely report deteriorat­ion after a program of graded exercise. The psychother­apeutic interventi­on also encourages patients to increase their activity levels.

Many patients (including one of us) have remained ill for years or decades with chronic fatigue syndrome, also known as myalgic encephalom­yelitis, or ME/CFS. It can be triggered by a viral infection, resulting in continuing or recurring immunologi­cal and neurologic­al dysfunctio­n. The Institute of Medicine dismissed any notion that it is a psychiatri­c illness.

The standard treatment is largely useless

Proponents of these therapies argue that these very sick patients harbored “unhelpful beliefs” that they had an organic illness that limited their capacity to exert themselves. According to this theory, patients are deconditio­ned from too much rest and can recover if they overcome their fear of activity and get back into shape.

But as the new re-analysis by an academic researcher and three patients showed, the promise of recovery using the two treatments appeared to be an illusion. When the study’s findings were first published, patients and some scientists noted a stunning problem: The investigat­ors had weakened their outcome measures from their trial protocol so much that participan­ts could actually deteriorat­e on physical function and still qualify as “recovered.” Thirteen percent entered the trial already having met the definition of “recovered” on that measure. The investigat­ors have argued that this didn’t matter since participan­ts also had to meet additional recovery criteria.

These critiques received little attention until 2015, when Virology Blog, a science site, published a 15,000-word investigat­ion of PACE written by one of us. This led dozens of scientists and clinicians to demand that The Lancet seek an independen­t review.

In December, the journal Fatigue: Biomedicin­e, Health and Behavior published the re-analysis of some of the data. The PACE investigat­ors claimed in the journal Psychologi­cal Medicine that 22 percent of those undergoing either psychother­apy or graded exercise “recovered” from their illness. But that was not based on the study’s original definition for recovery but on the looser one adopted by the researcher­s after the trial began.

Using the original definition, the re-analysis found that 7 percent or less had “recovered,” with no statistica­lly significan­t difference­s between those who did and did not receive the treatments. In their response, the investigat­ors argue that there is no “generally agreed-on measure of recovery.”

Last week, Virology Blog posted an open letter to Psychologi­cal Medicine, which one of us helped draft and which was signed by more than 100 clinicians, scientists, experts and patient groups, requesting the retraction of the PACE recovery study results to “protect patients from ineffectiv­e and possibly harmful treatments.” The journal has said it has no plans to retract the study but is open to publishing a re-analysis of data in any papers it has published.

In The Lancet, the trial also claimed that about 60 percent of patients in the exercise and psychother­apy arms “improved.” But according to the investigat­ors’ own recent re-analysis of their data, using their stricter protocol measure of improvemen­t rather than the looser one they used for The Lancet, only about 20 percent receiving each therapy in addition to medical care “improved” — and half of those would have improved with specialize­d medical care alone.

Even that limited finding is questionab­le. The improvemen­t rates and other reported findings were based largely on patients’ subjective self-ratings, which are vulnerable to bias. In contrast, none of the trial’s objective measures supported the claims of treatment success. In short, this episode has damaged public trust in science. Doctors and medical organizati­ons must stop recommendi­ng these two therapies for ME/CFS as treatment options. Next, the disputed findings must be retracted. Finally, health agencies must ramp up funding for medical research to develop accurate diagnostic tests and pharmacolo­gical treatments.

A million Americans are waiting.

Julie Rehmeyer is the author of the forthcomin­g “Through the Shadowland­s: A Science Writer’s Odyssey Into an Illness Science Doesn’t Understand.” David Tuller is academic coordinato­r of the joint master’s program in public health and journalism at the University of California, Berkeley.

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