Preparing Comments for: The Systemic Report for diagnosis and Treatment of ME/CFS

Posted: 22 May 2021
Updated: 29 November 2021

Image of puzzle pieces

On May 16, 2021 the CDC posted a call for comments on the report titled “Management of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): An Updated Systematic Evidence Review” in the Federal Register.

Comments must be submitted before 16 August 2021. To see ME International’s response to the Systemic Review Report for Diagnosis and Treatment of ME/CFS, see our follow-up blog HERE.

In this blog we will share some of the important aspects found in this 419 page report.

Link to the Federal register announcement found HERE
Link to the website to download the 419 page report found HERE

Who Did The Report?

Company: Pacific Northwest Evidence-based Practice Center
Investigators: Roger Chou, MD, FACP Marian McDonagh, Pharm.D. Jessica C. Griffin, MS Sara Grusing, BA

NOTE: This is the same organization that did the 2014 Pathways to Prevention (P2P) report.

A 2014 blog by Jeannette Burmeister highlights the issues raised on those doing the work on the 2014 report having no experience with ME/CFS.

“In response to a question from an IOM committee member, Susan Maier described the workshop as based on the “jury model” that requires the exclusion of any clinician or researcher who has any experience with ME/CFS.”

Introduction

“This report was commissioned by the Centers for Disease Control and Prevention (CDC) to inform the development of a guideline on evaluation and management of myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS).

It builds upon and updates a 2014 Agency for Healthcare Research and Quality (AHRQ) review that was conducted to support a National Institutes of Health Pathways to Prevention conference.”

Conclusion

“Evidence on effective treatments for ME/CFS remains limited.

Although graded exercise and CBT were more effective than inactive control therapies (usual care, usual specialist care, or an attention control) in improving fatigue, function, and other outcomes, the magnitude of effects was small to moderate and methodological and other limitations (imprecision, inconsistency, uncertain generalizability) precluded strong conclusions.

Other therapies were not shown to be effective or require additional evidence to verify effectiveness.

Non-ME/CFS conditions were common in patients presenting with fatigue.”

Who Does This Report Apply To?

From page 1: “ME/CFS is a condition characterized by a constellation of symptoms; hallmarks of ME/CFS are post-exertional malaise and/or persistent and disabling fatigue, as well as various additional manifestations, including pain, sleep disturbance, orthostatic intolerance, motor impairment, neurological and cognitive manifestations (i.e., impaired concentration, mental processing, and memory), and altered immune and autonomic responses.”

NOTE: This description uses the Fukuda definition that does not require post-exertional malaise (PEM). This is not in compliance with the expert information in more recent criteria that has made clear PEM is a requirement for diagnosis. The International Consensus Criteria clarified that the required symptom for diagnosis of ME is post exertional neuroimmune exhaustion (PENE).

The following statement from the report seems to recognize that this report using the Fukuda definition for chronic fatigue syndrome may not apply to those with myalgic encephalomyelitis.

“Although the terms ME and CFS are often used together or interchangeably, ME may be considered a subset of CFS or its own distinct disease.”

Concerning Statement

From Page 12 – “Key Question 1. In patients undergoing evaluation for possible ME/CFS, what is the frequency of non-ME/CFS conditions?”

“A systematic review of studies of patients presenting with tiredness/fatigue found a pooled prevalence of anemia of 2.8% (95% CI 1.6% to 4.8%; 3 studies, N=1091), malignancy 0.6% (0.3% to 1.3%; 3 studies, N=1091), depression 18.5% (16.2% to 21.0%; 6 studies, N=1000), and serious somatic diseases 4.3% (2.7% to 6.7%; 3 studies, N=436).”

Information in that statement raises the question of how the reviewers view the disease ME/CFS. “Serious somatic diseases 4.3%”. Somatic is defined as relating to the body, especially as distinct from the mind.

This seems to indicate the reviewers do not think ME/CFS is a somatic disease or that it isn’t a “serious” somatic disease.

Background on the Report

Pacific Northwest Evidence-based Practice Center was hired to do a follow up report from the AHRQ Pathways to Prevention (P2P) report done in 2014.

This 2014 report was reviewed by MEadvocacy.org in their blog entitled: “Sold Down the River in a Canoe with no Paddles.”

“This is a carefully crafted political document. If your alarm bells didn’t ring at the five mentions of “self-management” in the Draft Executive Summary, then the myriad ways the authors stated the psychological: major depressive disorder, biopsychosocial parameters, multimodal therapy, mind-body connection, anxiety, and fear surely should have gotten your attention.”

This statement from that blog applies to this new report as well. “We deserve better than this P2P report. Myalgic Encephalomyelitis (ME) deserves to be recognized as its own distinct disease (separate from chronic fatigue syndrome (CFS)), with a true ME definition that includes post exertional relapse as the hallmark symptom.”

See the P2P and IOM – Born Under A Bad Sign blog from MEadvocacy.org for more background on the 2014 report.

Comments & Responses from 2014

Preparing Comments for: The Systematic Review Report for Diagnosis and Treatment of ME/CFS

See the Disposition of Comments for Diagnosis and Treatment for ME/CFS from 2015 which gives the comments and responses from that P2P report. Comments covered a wide variety of issues that need to be reviewed within the current report.

It is interesting to note that the responses from the 2015 comments addressing errors regarding the ICC include:

We have reviewed the ICC again and have edited the report to reflect their preference of the term ME. We have continued to use the label ME/C[F]S throughout the report in accordance with the P2P workshop.

Also

We have reviewed the consensus panel statement and have edited the report text accordingly:
“The most recent international consensus report advocates moving away from the term CFS in favor of the term ME to better reflect an underlying pathophysiology involving widespread inflammation and neuropathology, and to embrace the two terms as synonymous. This panel of experts suggests that ME is a distinct illness inaccurately represented by the broader criteria of CFS.
And:
They recommend that patients meeting the International consensus criteria be given the name ME, and that those only meeting the criteria for CFS remain classified as CFS.“”

Going Forward

At 419 pages there is a lot of information to review. Initial impressions raise serious doubts about the usefulness of this report for patients with myalgic encephalomyelitis. ME International will be submitting comments. We welcome your input. We can be reached at Admin@ME-International.org, our page on Facebook or in our Facebook group.

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