ME Action blog post, 5 February 2018, by Mary Dimmock: The failure of clinical guidance for people with ME

ME advocate Mary Dimmock has written a comprehensive report about the flawed science that led to the recommendation of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) for people with Myalgic Encephalomyelitis.

The patient community has long reported these treatments to be ineffective and harmful, and, yet, health societies and governments across the world continue to recommend them as treatment, including the Mayo Clinic and UK government.

Below is a two-page excerpt from Dimmock’s report. Read her full paper: Clinical Guidance for ME: “Evidence-Based” Guidance Gone Awry

This article is intended as a high-level summary of key issues in the conduct of ME “evidence- based” reviews and clinical guidance that have resulted in flawed guidance. This has misled medical providers on the nature of ME and its appropriate treatment and put people with ME at risk of harm.

Comments can be sent to medimmock@gmail.com

Summary

For many years, ME evidence-based reviews and clinical guidance globally, such as those from Cochrane, UpToDate, Mayo, NICE, and various medical journals and societies around the world have recommended cognitive behavioral therapy (CBT) and graded exercise therapy (GET) as effective and safe treatments for ME. Further, these sources have sometimes claimed that disease risk and poor prognosis is the result of behavioral and psychological factors such as maladaptive coping, a history of abuse, perfectionism, and the patient’s belief that the disease is organic. In spite of patient surveys and ancedotal
reports that these treatments were not only ineffective but harmful, these recommendations and statements have remained.

Since 2015, a growing chorus of international journalists and scientists, along with reports by the U.S. Health and Human Services have documented serious deficiencies in the supporting studies that call into question the validity of these recommendations. In parallel, the U.S. Institute of Medicine (IOM, now called the National Academy of Medicine) published a report that directly contradicts the disease theory underpinning these studies. These deficiencies and contradictions include the following (Further details in Appendix II):

1. Lack of external validity:
   According to the US Agency for Healthcare Research and Quality (AHRQ), the use of an overly broad definition (the Oxford definition) in many of these studies resulted in the inclusion of “patients who may have an alternate fatiguing illness.” The 2016 AHRQ report also noted that studies using more specific definitions requiring hallmark symptoms of ME such as an abnormal response to exertion were “blatantly missing.”  After excluding Oxford studies from its analysis, AHRQ found no evidence of effectiveness for GET and barely any for CBT. This raises
   serious questions about the validity of applying CBT and GET recommendations to people with ME.
2. Study design and conduct issues:
   The CBT and GET evidence base is biased by unblinded studies that relied on subjective outcome measures, ignored or dismissed objective findings that contradicted subjective reports, switched outcomes, inflated claims of improvement and recovery, and contained other significant problems in the design and conduct of studies. The issues in these studies, including the UK’s flagship £5 million PACE trial, call into question the quality and reliability of claims of CBT and GET effectiveness.
3. Inadequate reporting of harms:
   Conclusions that these therapies are safe are based on studies that inadequately reported adverse effects and did not monitor treatment compliance. Further, neither the evidence reviews such as Cochrane nor the individual studies adequately account for patient survey reports of harm from these therapies. Nor do they account for the published biomedical evidence and the IOM report demonstrating the disease’s abnormal physiological response to exertion, a response that supports concerns with the risk of harm from exertion. Claims of CBT and GET safety are not supported by the evidence.
4. Flawed disease theory:
   The disease theory underlying the use of CBT and GET in this disease is that the symptoms and the debility are not the result of an organic disease but rather the result of deconditioning which in turn is the result of false cognitions and a fear of activity. This disease theory also links a predisposition to the disease and poor prognosis with behavioral and psychological factors such as those described above. This theory is unproven and the studies cited to support it have most
   often used the overly broad Oxford definition which could include patients with a primary mental illness. But more importantly, this psychogenic theory cannot be reconciled with the 2015 Institute of Medicine report which found that ME is not psychological or a problem of deconditioning. Instead, the IOM found substantial evidence of neurological, immunological, autonomic, and energy metabolism
   impairment. In no other disease would such impairment be treated by talk therapy intended to convince the patients they are not really sick. The ethicality of doing do in this disease must be questioned.

In July 2017, the US Centers for Disease Control and Prevention (CDC) removed long-standing recommendations for CBT and GET from its website. Yet, today, the vast majority of providers for clinical guidance for ME globally still continue to use these flawed studies as the basis of CBT and GET recommendations and conclusions about poor
prognosis.

In Japan, recommendations for CBT and GET are scheduled to be published in a widely read medical journal in March. In the UK, NICE has agreed to review its guidelines but the current CBT and GET recommendations remain. In the US, even clinical guidance that has
adopted the IOM criteria with its hallmark abnormal response to exertion still recommends CBT and GET. For instance, one medical education provider has adopted the IOM criteria and IOM-derived statements about neurological, immunological, and metabolism impairment but then goes on to recommend PACE-style CBT and GET and
link poor prognosis to a patient’s belief that the disease is physical.

It is stunning that such highly regarded organizations continue to produce “evidence-based” guidance for ME using such poor-quality, contested, and inappropriate evidence. Doing so not only misleads medical providers on the nature of ME and its appropriate treatment but puts people with ME at direct risk of significant harm by their medical providers.

To best protect patients from further harm, it is essential that evidence review publishers such as Cochrane and providers of evidence-based clinical guidance such as Uptodate, Healthwise, Mayo, and various medical societies reevaluate the quality and validity of the evidence that they are using to support their conclusions and recommendations for ME. It is essential that these organizations update their reviews and guidance to remove the erroneous conclusions and recommendations based on poorly conducted, invalid studies and to incorporate what is known today about the biopathology of ME and its proper treatment.

Read the full report