charles shepherd
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Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of, and finding treatments for, complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia, long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.
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I thought White et al. always denied that PACE studied patients with ME. Wasn't the international criteria they used Empirical? Call me confused.Finally, the authors concluded that we need trials with analyses of patients meeting different case definitions; we agree and this has already happened. White and colleagues found no statistically significant differences in the efficacy of CBT and GET in sub-groups of those patients meeting Oxford criteria for CFS who also met either CDC defined CFS or myalgic encephalomyelitis (ME)(5).
No, they denied studying "CFS/ME" patients (in relation to a question on the Canadian criteria I think). Some activists jumped on this quote to say they were saying they never studied ME patients but if one looks at the Lancet 2011 paper, they have figures on the subgroup satisfying ME criteria so I never felt one should say they said they weren't studying ME patients.I thought White et al. always denied that PACE studied patients with ME.
No, not the empirical criteria (which uses odd thresholds for the SF-36 and MFI).Wasn't the international criteria they used Empirical? Call me confused.
while the Fukuda asks about symptoms over the last six months so not a perfect way of using the Fukuda criteria.Please score whether you have had any of the following symptoms in the last week:
Thank you for the clarification. I see that they used the London criteria for ME: 329 of the 641 participants met those criteria.No, they denied studying "CFS/ME" patients (in relation to a question on the Canadian criteria I think). Some activists jumped on this quote to say they were saying they never studied ME patients but if one looks at the Lancet 2011 paper, they have figures on the subgroup satisfying ME criteria so I never felt one should say they said they weren't studying ME patients.
Thank you for the clarification. I see that they used the London criteria for ME: 329 of the 641 participants met those criteria.
Title: PACE Trial - 97% of the participants who didn't have a psychiatric disorder satisfied the definition of M.E. used
[I and others have noted these percentages in discussions on the internet before; however, I thought the latest quote brings clarity to the wording in the Lancet paper. Tom]
In the Lancet paper on the PACE Trial (by White et al (2011)), it said:
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"Participants were also assessed by international criteria for chronic fatigue syndrome,12 requiring four or more accompanying symptoms, and the London criteria13 for myalgic encephalomyelitis (version 2), requiring postexertional
fatigue, poor memory and concentration, symptoms that fluctuate, and no primary depressive or anxiety disorder
(interpreted as an absence of any such disorder)."
-----------
I was not 100% sure what "no primary depressive or anxiety disorder
(interpreted as an absence of any such disorder)" meant in relation to the
percentage we were given for "any psychiatric disorder" i.e. could there be
an overlap.
The following is an extract of a letter that clarifies it (see asterisked
bit) - the letter was written by PD White, KA Goldsmith, AL Johnson, R
Walwyn, HL Baber, T Chalder, M Sharpe, on behalf of all the co-authors (of
the PACE Trial)
---------
The trial did not study ME/CFS (pages 12-18)
The selection of patients was for CFS operationalised using the broadest
criteria (the Oxford criteria). No sensible neurologist would apply the
diagnosis of CFS (or indeed ME) to patients who had "proven organic brain
disease", such as Parkinson's disease. For the purposes of this trial ME was
not regarded as a "proven organic brain disease". In order to ensure balance
between the trial arms in those participants who met alternative criteria
for CFS and ME, randomisation was stratified by the International (Centers
for Disease Control) criteria (which require additional symptoms) and by the
London ME criteria (based on Melvin Ramsay's original description, and which
excludes co-existing "primary" psychiatric disorders [****which we
interpreted as any psychiatric disorder****] and emphasises post-exertional
fatigue). We were provided with the second revised version of the London ME
criteria; we did not invent our own. We considered use of the Canadian
criteria for ME but we found it impossible to operationalise them adequately
for research purposes; to our knowledge they have not been used in a major
research trial. We studied the results for differently defined subgroups and
they were similar to those in the entire group.
(source: http://www.meactionuk.org.uk/whitereply.htm )
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The figures from the paper (Table 1) show that, of the 640 participants, 300
(46.9%) had "any psychiatric disorder" and 51.4% (329) satisfied the London
criteria*.
This means that of the 340 patients in the trial (i.e. who satisfied the
Oxford criteria**, with a principal symptom of fatigue, who did not have a
psychiatric disorder), 329 (96.8%) satisfied the London criteria for M.E.,
the definition of M.E. used in the trial!
This is an amazingly high figure for a definition of M.E. given the
"looseness" of the Oxford criteria e.g. unlike the Fukuda CFS criteria or
Carruthers ME/CFS criteria, it doesn't require other symptoms apart from
fatigue.
It seems to me the definition for M.E., at least as it was used in this
trial, is very suspect. And hence it is questionable what can read from
into how people with M.E. responded in the trial.
Strangely enough, I've been pondering something similar, based on the figures here:The figures from the paper (Table 1) show that, of the 640 participants, 300
(46.9%) had "any psychiatric disorder" and 51.4% (329) satisfied the London
criteria*.
This means that of the 340 patients in the trial (i.e. who satisfied the
Oxford criteria**, with a principal symptom of fatigue, who did not have a
psychiatric disorder), 329 (96.8%) satisfied the London criteria for M.E.,
the definition of M.E. used in the trial!
This is an amazingly high figure for a definition of M.E. given the
"looseness" of the Oxford criteria e.g. unlike the Fukuda CFS criteria or
Carruthers ME/CFS criteria, it doesn't require other symptoms apart from
fatigue.
It seems to me the definition for M.E., at least as it was used in this
trial, is very suspect. And hence it is questionable what can read from
into how people with M.E. responded in the trial.
Which part of the comment by Charles Shepherd and me is incorrect?I'm afraid the comments by White et al. and by Shepherd et al. are both incorrect.
There are only two sorts of ME patients who can do graded exercise therapy. First group of patients are patients where the disease is in remission, which is a very small group, and the second group of people who can do graded exercise therapy are "ME" patients were the diagnosis is wrong. For all other ME patients graded exercise therapy constitutes torture and BREACHES the do no harm principle.
@Dr Speedy - Published comments have to be quite short and with only a few references. This means that it's impossible to address more than one or two simple points. But you can submit a comment as well if you like. Just keep in mind that it has to be 100% factual/unemotional and every statement must have a reference backing it up.
Seriously?!Why is there no mention of the survey by the ME Association recently calling 4 the abandonment of GET ? Why no mention that graded exercise therapy is very harmful for real ME patients ?
"we should not rush to accept any claims that GET has been found to be safe for ME/CFS." GET is harmful and you should say so.
The ME Association survey However would have been the most important thing in the comment. And in my opinion it is incorrect not to mention how harmful graded exercise therapy is.
The way your comment is written, it is very unclear what you actually say / mean.
Thanks Mark.Seriously?!
You're saying that this particular comment, which Charles Shepherd and Tom Kindlon managed to get published in the Annals of Internal Medicine, is "incorrect", not because there's anything wrong with what they said, but because they didn't happen to mention the MEA's own survey report on GET and because they didn't "mention how harmful graded exercise therapy is" - even though they did in fact reference Tom's paper on the evidence of harms associated with GET, and noted that "Fifty-one percent of survey respondents...reported that GET worsened their health".
That's a creative use of the word "incorrect", especially since you say that in reference to a comment by the two people who have produced probably the best two papers in existence regarding the evidence of harms of GET. If you went to a lecture on black holes by Stephen Hawking, would you stand up to tell him he was wrong because he failed to cite his own paper on black hole radiation in his presentation?
I agree that it would be a good exercise for you to try to get a post accepted by Annals on this subject. Perhaps it would be worth checking the guidelines for comments first though, to see whether the MEA's GET report actually qualifies as a paper that can be referenced in a comment, or whether one can only reference papers that were published in a recognised journal - conceivably that's the reason they referenced Tom's paper on the harms of GET and not the MEA survey.
Great response. Thankful.~New response from Lily Chu et al:
First, do no harm: graded exercise therapy and myalgic encephalomyelitis/ chronic fatigue syndrome
Posted on July 11, 2015
Lily Chu, MD, MSHS (1), Lucinda Bateman, MD (2), Todd Davenport, PT, DPT, OCS (3), Eleanor Stein, MD, FRCP(C) (4), Staci Stevens, MA (5)
(1) Independent Consultant, Burlingame, CA, USA; (2) Bateman Horne Center, Salt Lake City, UT, USA; (3) Department of Physical Therapy, Thomas J. Long School of Pharmacy and Health Sciences,
Conflict of Interest: All authors are involved in ME/CFS research. LB, ES, TD, and SS are involved in the clinical care of ME/CFS patients. LB, SS, and TD were members of the International Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis Primer Writing Committee. No funding was received in support of this work.
We concur with Smith et al. (1) that graded exercise therapy (GET) can cause harm in some patients with myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS). However, we believe the benefits from GET would have been reduced and the harms assessed as even greater if the following points had been considered.
(1) The authors recognized that the non-specific nature of the Oxford criteria might recruit subjects “with other fatiguing illnesses or illnesses that resolve spontaneously” (1) yet they analyzed studies using Oxford criteria with those using Fukuda criteria together. This is similar to lumping people who have congestive heart failure, chronic obstructive pulmonary disease, and pneumonia together because all three diagnoses share shortness of breath as a symptom. It would have been more informative had they assessed trials using Fukuda and Oxford separately and then compared those results to the combined results. Darbishire et al. found that the factor most predictive of a poor outcome when a GET or cognitive behavioral therapy (CBT) regimen was applied to a group of subjects suffering chronic fatigue was fitting Fukuda criteria (2).
(2) Nunez et. al. is classified in Appendix Table 1 as not reporting any harms (1). However, this study found not just that the combined GET/ CBT intervention had no benefit but that these treatments caused a significant decline in physical function and increase in bodily pain scores as measured by the SF-36 at 12 months.
(3) Smith et al. appropriately suggest that future research should strive to include the input of patients and advocates. Because their review was based on clinical trials, however, it did not include clinician and patient experiences outside of trials. On average, 50% of thousands of patients internationally have reported worsened health due to treatments involving exercise (3). Clinicians specializing in ME/CFS do not recommend GET and instead advise patients to balance their active periods with rest breaks (4). This cautious attitude is supported by studies (5) showing that patients with ME/CFS do not respond to or recover from physical activity in the same way as healthy people or people with other medical conditions.
As with any medical condition, clinicians need to tailor treatments to the individual patient. If patients describe exacerbation of symptoms and no improvement with exercise-related therapies, rather than attributing those reports to low motivation, distorted thinking, or exaggeration, clinicians should consider that there is a problem and stop the treatment.
(1) Smith MB, Haney E, McDonagh M, Pappas M, Daeges M, Wasson N, et al. Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015;162:841-850. doi:10.7326/M15-0114
(2) Darbishire L, Seed P, Risdale L. Predictors of outcome following treatment for chronic fatigue. Br J Psychiatry. 2005; 186 (4) 350-351.
(3) Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioral therapy in myalgic encephalomyelitis/ chronic fatigue syndrome [Internet]. Chicago, Illinois: International Association for Chronic Fatigue Syndrome/ Myalgic Encepahlomyelitis; 2011 October [cited 2015 July 8]. Available from: http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx
(4) International Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis Primer Writing Committee. ME/CFS: a primer for clinical practitioners [Internet]. Chicago, IL: International Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis; 2014 July [cited 2015 July 8]. Available from: http://iacfsme.org/portals/0/pdf/Primer_Post_2014_conference.pdf
(5) Institute of Medicine: Committee on the Diagnostic Criteria for myalgic encephalomyelitis/ chronic fatigue syndrome. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness [Internet]. Washington, DC: National Academies Press; 2015 Feb [cited 2015 July 8]. Available from: http://iom.nationalacademies.org/Reports/2015/ME-CFS.aspx
This is beyond excellent. Clear, calm, and absolutely damning. Even a major idiot reading this would have a hard time missing the point. That's not easy to achieve in less than 400 words.~New response from Lily Chu et al:
Amen, and so well said!I think it's now pretty clear that it's the psychobabblers who are part of the lunatic fringe.