This is a cross-post originally published in Jennie Spotila’s blog, Occupy ME.
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. The 2015 NIH Pathways to Prevention report concurred that Oxford should be retired, stating that it could “impair progress and cause harm.” 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 Oxford definition.
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. Following requests in November 2015 and again in February 2016, AHRQ agreed to ask the authors to reanalyze studies by definition and to separate out CBT from other counseling studies. 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 Outcome||Results with Oxford Studies||Results Excluding Oxford Studies|
|Function||Moderate strength of evidence||Insufficient evidence|
|Fatigue||Low strength of evidence||Insufficient evidence|
|Quality of Life||Insufficient evidence||Insufficient evidence|
|Employment||Low strength of evidence||Insufficient evidence|
|Global Improvement||Moderate strength of evidence||Insufficient evidence|
CBT Is Barely Effective
The 2014 evidence review combined CBT and other counseling therapies in its analysis and concluded that collectively, these therapies improved fatigue, function, quality of life, and global improvement. Acknowledging that “CBT is a unique approach with disputable underlying rationale regarding the fear avoidance theory contributing to the perpetuation of symptoms in ME/CFS,” the Addendum reanalyzed the seven CBT studies separately from the other counseling studies. The Addendum also analyzed the Oxford CBT studies separately from the Fukuda CBT studies, although one study (Deale 1997, 2001) appears to have been incorrectly classified.
When all seven CBT studies were reanalyzed, the Addendum reported low strength of evidence for improved function, fatigue, and global improvement; insufficient evidence of improvement in employment; and low strength of evidence that CBT did not improve quality of life. When Oxford studies were excluded from the reanalysis, the Addendum found insufficient evidence of effectiveness of CBT on function, employment and global improvement and a low strength of evidence of improved fatigue.
|Study Outcome||Results with Oxford Studies||Results Excluding Oxford Studies|
|Function||Low strength of evidence of improvement||Insufficient evidence|
|Fatigue||Low strength of evidence of improvement||Low strength of evidence of improvement|
|Quality of Life||Low strength of evidence that CBT does not impact quality of life||Low strength of evidence that CBT does not impact quality of life|
|Employment||Insufficient evidence||Insufficient evidence|
|Global Improvement||Low strength of evidence of improvement||Insufficient evidence|
What are the implications of this decision? What are our next steps?
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10 thoughts on “AHRQ Agrees: GET useless, CBT ineffective”
How about the part on pacing in this study. Has it also been downgraded?
Skimmed the article but is there initiatives taking place to have ME groups and advocates release press releases, send letter to all Universities, Send documents to physicians, have this info changed on the CDC and Mayo Clinic Website, etc?
All other publications saying these treatments effective need to be aware of all this preliminary reaults of the review in hopes of stopping these ineffective methods being communicated.
There is a meeting in about a month with the CDC in order to talk to them about getting the information on their site changed, and this decision by the AHRQ will help make the case for changing those recommendations. Each of these actions is its own, small push: at least as far as I see it, there will not be one action that swiftly shifts everything. Instead, it will be multiple people, working together and separately, at multiple actions and from multiple angles that produce the change we need in the way ME is diagnosed, treated, and understood by the public.
Congratulations to Mary for spearheading this — it’s an important step forward.
If a document is created around all this info. Its a copy and paste to peoples emails. Just rather see actions then articles then maybe and article that says….1 million people contacted and informed about flawed PACE data that the QMUL Spent over $10,000,000 USD to not release.
This is news about an effective action in which Mary and Jennie’s advocacy efforts paid off. It’s important to me, at least, to see examples of effective advocacy and how they’re changing the landscape of ME.
You are correct. This is just the first step to get AHRQ to acknowledge that recommendations for CBT and GET were based on Oxford studies. Additional actions, such as those you outlined, need to be taken to get these recommendations removed from medical education but have been put in place yet. Having this Addendum will make that easier.
I strongly agree that CBT is not a therapy that produces enough positive results to warrant the extra expenditure of effort necessary for the patient (me) to go through an hour-long session. For me this also means an hour’s drive each way, asking a friend to take me; and the inevitable result of at least two days of recovery time after the session. In other words, as much as I’ve enjoyed talking with my therapist over the past eight years — better than dumping on my friends — the sessions have got to make me feel significantly better, stronger and more capable of coping with my chronic illness on a daily basis for me to “spend” my energy on therapy at all. That said, what other psychological approach is better than CBT for all of us suffering with chronic and invisible illnesses??????
Nice replies iin return of this question with real arguments and explaining the
whole thing regarding that.
Great delivery. Outstanding arguments. Keep up tthe amaazing effort.
The rheumatologist I have to see four times a year for disability is finally not pushing exercise on me! I loved exercising and I made this clear to him decades ago, but recently, thanks to ME Action and researchers who get it, he’s now letting me know that while I’m encouraged to exercise, he understands I have to do so at my own pace and using my best judgment. Thank you!!!
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