Occupy M.E. blog post by Jennie Spotila, August 16 2016: AHRQ evidence review changes its conclusions
Mary Dimmock has led the way on this issue, and is co-author of this post.
In response to requests by U.S. patient organizations and advocates, the U.S. Agency for Healthcare Research and Quality (AHRQ) has issued an Addendum to its 2014 ME/CFS evidence review.
This Addendum downgrades the conclusions on the effectiveness of cognitive behavioral therapy (CBT) and graded exercise therapy (GET), and this has tremendous implications for medical education and treatment recommendations.
At Long Last, AHRQ Undertakes Reanalysis
The 2014 AHRQ evidence review had originally reported that treatment with CBT and GET improved fatigue, function, global improvements, and employment in ME/CFS patients.
This conclusion was based on an analysis that combined studies using any of seven CFS and ME definitions as though they represented the same disease.
We highlighted this fatal flaw in our comments on the draft evidence review.
The review itself acknowledged that CFS definitions did not require hallmark symptoms of the disease, that no treatment studies used ME/CFS or ME definitions, and that the Oxford definition was so broad that it would include patients with other diseases and should be retired.
And yet, the 2014 AHRQ evidence review maintained its conclusion that CBT and GET could benefit some “ME/CFS” patients, based in substantial part on studies that used the
Following the publication of David Tuller’s PACE analysis in October 2015, ME organizations and advocates called on AHRQ to reanalyze the PACE trial, to analyze the results of Oxford studies separate from studies using other definitions, and to analyze CBT studies separately from other forms of counseling.
They declined to reanalyze the PACE trial, which they had ranked a good trial with “undetected” reporting bias.
This new analysis was published in late July as an Addendum to the original report (see pages 1-16 of the linked report).
This updated review reanalyzed the effectiveness of GET, CBT, and other forms of counseling, first with Oxford studies included and then after Oxford studies were excluded.
As we predicted, breaking out the Oxford studies forced a significant downgrade in the review’s conclusions.
GET is Ineffective for ME Patients
The 2014 evidence review had combined four GET studies and two other exercise studies (qigong and orthostatic training) in its analysis and concluded, “GET improved measures of fatigue, function, and clinical global impression of change compared with controls.”
The Addendum reanalyzed just the four GET studies, three of which used the Oxford definition.
When all four GET studies were analyzed together, the Addendum reported a moderate strength of evidence of improved function and global improvement and low strength of evidence of improved fatigue and employment.
But when Oxford studies were excluded from the analysis, the Addendum reported that there was insufficient evidence of effectiveness of GET on any outcome.
Study Results with Oxford Results Excluding
Outcome Studies Oxford Studies
Function Moderate strength of Insufficient evidence
Fatigue Low strength of evidence Insufficient evidence
Quality of Life Insufficient evidence Insufficient evidence
that CBT does not impact quality of life
Employment Low strength of evidence Insufficient evidence
Global Improvement Moderate strength Insufficient evidence
Implications and What Next
The Addendum reaches a damning conclusion, cloaked in dry language:
This addendum has delineated differences in treatment effectiveness and harms according to case definitions, highlighting studies that used the Oxford case definition and how these studies impacted our conclusions.
Additionally, results of studies evaluating CBT have been considered independently from other counseling and behavioral therapies.
Our sensitivity analysis would result in a downgrading of our strength of evidence on several outcomes which can be attributed to the decrease in power, dominance of one large trial, or lack of trials using criteria other than the Oxford case definition for inclusion.
Blatantly missing from this body of literature are trials evaluating effectiveness of interventions in the treatment of individuals meeting case definitions for ME or ME/CFS.
In other words, there is no evidence that supports the conclusion that CBT and GET are effective treatments for ME or ME/CFS patients. And THAT is a ground breaking conclusion.
CBT and GET still remain the most common treatment recommendations across mainstream “evidence-based” medical education today.
Recommendations for CBT and GET have been based directly on Oxford studies like PACE, or indirectly through evidence reviews such as AHRQ and Cochrane that have relied heavily on Oxford studies.
At the same time, these treatment recommendations have ignored numerous patient surveys that have reported harms from CBT and GET.
The resultant medical education, including that from CDC and key medical education providers such as UpToDate, confuses medical providers on the nature of the disease and puts patients at significant risk of harm from inappropriate treatment.
Recommendations for CBT and GET have become so pervasive that they are also found in the educational plans of medical societies.
The American Academy of Family Physicians issued a 2016 needs assessment for education of members that specified that CBT and GET “improved fatigue, work and social adjustment, anxiety, and postexertional malaise” and called out the need for more training of doctors in the use of exercise therapies.
The problem, as this reanalysis found, is that when you remove the Oxford studies, the positive effect of CBT and GET disappears.
The Addendum notes that “using the Oxford case definition results in a high risk of including patients who may have an alternate fatiguing illness or whose illness resolves spontaneously with time.”
CBT and GET appears to help these patients to a limited extent. However, the recommendation of either of these therapies for ME and ME/CFS patients is inappropriate.
This Addendum highlights a key issue that has perverted medical education and evidence reviews in this field for a long time. It is medically inappropriate to make recommendations for disease treatment based on studies in patients who do not have the
CDC , UpToDate, AAFP, and other medical education sources must change their recommendations for ME/CFS treatments.
Furthermore, NIH must address the gap in treatment trials for ME and ME/CFS patients by funding intervention studies on these patients. There is no evidence that CBT and GET are effective treatments for us, and therefore, these treatments can no longer be recommended.
If CDC and others persist in recommending treatments for which there is no evidence of effectiveness in ME/CFS patients, it will not only perpetuate confusion but also put patients at risk.
Such an unscientific recommendation goes against the principles of evidence-based medicine and is not accepted in other diseases.
It will not be tolerated here.
PEM, NOT Chronic Fatigue, is why patients are bedridden, homebound, unemployed, and unable to walk a block.