CDC Treatment Evidence Review - consultation period

They did include the following study:

Stubhaug B, Lie SA, Ursin H, et al. Cognitive-behavioural therapy v. mirtazapine for chronic fatigue and neurasthenia: randomised placebo-controlled trial. Br J Psychiatry. 2008;192(3):217-23. doi: 10.1192/bjp.bp.106.031815. PMID: 18310583
​

This is weird because the trial selected patients using the ICD–10 research criteria for neurasthenia (code F48.0). The previous report excluded it because of code 5 'wrong population'. I think the inclusion is questionable. Here's the info the trial report gives:

Illness definition was operationalised by examining ICD–10 criteria. These diagnostic criteria are the presence of persistent and distressing feelings of exhaustion after minor mental effort or of fatigue after minor physical effort, accompanied by one or more of the following symptoms: muscular aches or pains; dizziness; tension headache; sleep disturbance; inability to relax; and irritability. There should be an inability to recover through rest, relaxation or enjoyment; the duration should exceed 3 months, and there should be no organic mental disorder, affective disorder, or panic or generalised anxiety disorder. The included patients satisfied these ICD–10 criteria, allowing for mild depressive or anxiety symptoms clinically evaluated to be independent of or secondary to fatigue symptoms. The criteria for chronic fatigue syndrome, specified by the Centers for Disease Control (CDC),4 and the Oxford group3 were also examined in this population: 65 of the 72 patients fulfilled case definition by the Oxford (British) criteria and 29 patients fulfilled the CDC (US) criteria.​

 

I've always found it very weird that they claimed it was Fukuda except for the four required additional symptom. WTF? I mean, it's mind-boggling. Take those away and it's Oxford, period. It was very bizarre.

 

Of course, PACE was randomized and this is what it showed.

 

Convenient way to claim they used the important, authoritative CDC criteria, which stands out to casual readers & medics/researchers whose views were/are already fixed (most of them, let's be honest) and wouldn't read further. And wouldn't care if they did, because it's all the same to them. When cited I would think it'd be classified as defined by CDC Fukuda, which it seems to me would be more important to reviewers and editors than any modifications they made in selecting patients.

We're talking about an area where Crawley comes up with a prevalence based on a sample where a diagnosis wasn't mandatory; where the Cochrane review for CBT in CFS included unpublished data as well as studies where a formal diagnosis wasn't required, where peer reviewers don't read past the abstract & papers are published anyway. These wouldn't happen in any other illness, & nobody cared & most still don't. Try using the hashtag "MedTwitter" & see if anyone responds to a tweet about ME/CFS, ever. I've never seen one. They did it because they could, they knew they could, and it was a way of ensuring they'd get the results they wanted.

It was starting to look like things had changed; but now this. They do what they want no matter the reasons not to & they don't care. For the first time I am hopeful they won't get away with this sort of thing, especially with something as big as this, as more people are paying attention, but I don't know what would stop them choosing to publish.

 

It seems that this trial by Cleare and Wessely on hydrocortisone reported in the Lancet was excluded (I suppose because the treatment duration of 1 month was too short)

Cleare AJ, Heap E, Malhi GS, et al. Low-dose hydrocortisone in chronic fatigue syndrome: a randomised crossover trial. Lancet. 1999;353(9151):455-8. PMID: 9989716. Excluded: inadequate duration​

 

Seems that they have also excluded this Belgian RCT on methylphenidate because of "inadequate duration". Given the many flaws the studies that were included, have I think it would be best if they included studies with inadequate duration and simply highlight their limitation and shortcoming (rather than exclude them which might be confusing).

Blockmans D, Persoons P, Van Houdenhove B, et al. Does methylphenidate reduce the symptoms of chronic fatigue syndrome? Am J Med. 2006;119(2):167.e23-30. PMID: 16443425. Excluded: inadequate duration​

 

https://twitter.com/user/status/1405187151055183873


Summary of the CDC evidence review
The Centers for Disease Control and Prevention (CDC) have commissioned a systematic review on the management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The review is conducted by the Pacific Northwest Evidence-Based Practice Center (EPC) at Oregon Health and Science University. A draft report was released on 17 May 2021 and interested individuals or organizations are invited to submit comments and feedback.

Much like the draft report by the National Institute for Health and Care Excellence (NICE) in the United Kingdom, the CDC review rated the strength of evidence for graded exercise therapy (GET) and cognitive-behavioral therapy (CBT) as ‘low’. The evidence for drug therapies fared no better. This blog post summarizes the main findings of the 419-pages-long document.

Full text: https://mecfsskeptic.com/summary-of-the-cdc-evidence-review/

 

I don't understand why in Appendix F. Risk of Bias for Randomized Controlled Trials (starting on page 228) all trials received the label "Yes" for the question "Outcomes Pre-specified"

Does anyone understand what they mean?

 

I understand it as: before beginning, all RCTs were registered in a clinical trials database or had published their respective protocols, but I do not think that would be the case.

 

https://twitter.com/user/status/1406203707893690372


Comments on the CDC evidence review on ME/CFS
In a previous blog post, we summarized the draft report of a systematic review on the management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The review was commissioned by the Centers for Disease Control and Prevention (CDC) in the United States.

Unfortunately, the draft report suffers from multiple flaws such as failure to include objective measurements and reports of harms from observational studies. The report also underestimates the risk of bias in non-blinded trials where subjective questionnaires are used, where the intervention influences how patients view their symptoms and where the control group receives no intervention at all. Such trials are at high risk of bias but this is not reflected in the draft report.

In this blog post, we present our comments and feedback to the report. We identified major shortcomings and included recommendations on how the review could be improved. Our comments are also available in pdf format below.

Full text at: https://mecfsskeptic.com/comments-on-the-cdc-evidence-review-on-me-cfs/

 

CDC's original plan had been to use this review as the first step in developing treatment guidelines. But in
MEAction's initial communication about this draft review, posted by @Hutan above, they shared an email from CDC's Dr. Unger saying CDC will not be using this review to develop treatment guidelines.

"...the systematic review provided little new data and the process for guideline development would not be likely to provide an advance over what is currently available from the ME/CFS Clinician Coalition and IACFSME. We will be completing the Systematic Review and will not be proceeding with guideline development until clinical trial data becomes available."​

 

Well then it's a cursed blessing that Covid came along or that would have taken us all the way to the 2050's and beyond.

What do clinical trials have anything to do with this anyway? A trial means trying something. There is nothing to try. So why would a trial be of any use in telling us anything?

This all sounds like running out the clock. Hey, it's just millions of lives no big deal take all the time you want it doesn't even affect you.

 

MEAction has written a draft response to the CDC Evidence Review. Please see https://www.meaction.net/wp-content...tion-Draft-Response-CDC-Systematic-Review.pdf. Please feel free to submit suggestions and/or add your signature. Relevant information is at the beginning of the aforementioned link. Thank you.

 

I realize that there's information in this thread saying that this CDC evidence review will not be used to develop a treatment guideline.

Good news, but there's a part of me that's cynical (gee, I wonder why?) and worries that decisions like these could be reversed.

So although it may be a bit paranoid I still think it's a good idea to get details on the record, from as many ME patients and ME advocacy groups as possible, about why this CDC evidence review is flawed.

 

The S4ME Management Committee has decided, with regret, that we will not be making an S4ME submission to the CDC Evidence Review consultation. There has not been a lot of discussion about the content of the evidence review here, and we do not have the capacity to undertake the work by the closing date, 17th August.

If individuals wish to submit a comment, the details of how to do so are here: https://www.regulations.gov/docket/CDC-2021-0053/document

 

You can’t do everything! This work is definitely a community effort, with the baton often being shared around.