Evidence Based Medicine For ME (and CFS)

[alex3619]

The entire evidence based medicine issue for ME (and CFS) is a nightmare. People have begun discussing it here:

http://forums.phoenixrising.me/showthread.php?16366-Advocacy-Brainstorming-The-Thread-on-Threads

This needs a new thread as it is off topic for that thread, so here it is.

Evidence Based Medicine (EBM) has been called Zombie Science. The argument that it is the only way forward is probably right, but how it is being done is by distortion, half-truths and political or funding priority. The concept is good, the execution is likely to be a brake on medical progress and a detriment to the public.

This thread is for discussing advocacy toward either EBM or the need for evidence to back theories and treatments, as well as the problems that arise. Discussions of EBM and the need for evidence are OK, but it might need another thread in another section.

I will post more on this later.

PS On Zombie Science you might like to start with: http://www.mecfswa.org.au/News_and_Media/News_Details/Zombie_Science_in_ME-CFS/Default.aspx

For a thread on Zombie Science and EBM specifically, see: http://forums.phoenixrising.me/show...ncl-one-calling-it-a-quot-Zombie-Science-quot

That thread is a better place to discuss the science (or otherwise) of EBM, whereas this thread is to discuss what advocacy can do about it.

 

[Dolphin]

One obvious thing people do is send in e-letters, or letters for publication.

I think this paper provides an opportunity:

Chronic fatigue syndrome in the media: a content analysis of newspaper articles
http://shortreports.rsmjournals.com/content/2/5/42.full

The full text is an easy read.
No biology.
Main statistics are bar charts and percentages.
Short.

Max 400 words, 5 refs. Best to have one or two references (one can be the initial study if you're stuck!) to make it look like more professional. But e-letters don't have to be word perfect.

 

[Guido den Broeder]

Evidence-based medicine is hopelessly ineffective. The correct way, similar to all other sciences, is model-based medicine.

 

[alex3619]

Hi Guido den Broeder, I tend to agree with you, although I hestitate to use the word "correct". Would you like to explain further?

I don't think that evidence based medicine is intrinsically opposed to model-based science or good scientific practice, the failure is in its implementation. It is a problem of oversight and direction, not one of principle I suspect. The main issue as I see it is that evidence based medicine grew out of bureaucracy not science. In addition, there is now a trend toward evidence based medical managment. This is not science, its management. They rely far too heavily on the numbers without understanding what the numbers mean. I will be writing more on EBM later, its not my current focus for investigation. A big part of what I am aiming to do is debunk the evidence based approach with respect to ME and CFS.

Bye, Alex

 

[justinreilly]

One obvious thing people do is send in e-letters, or letters for publication.

I think this paper provides an opportunity:

The full text is an easy read.
No biology.
Main statistics are bar charts and percentages.
Short.

Max 400 words, 5 refs. Best to have one or two references (one can be the initial study if you're stuck!) to make it look like more professional. But e-letters don't have to be word perfect.

Pls join me in emailing:
Arnstein.Mykletun@uib.no and
http://shortreports.rsmjournals.com/feedback (webpage email form)

Just a short email saying you agree with Justin Reilly's comments on the article would be great. Thanks everyone!

re: Chronic fatigue syndrome in the media: a content analysis of newspaper articles
J R Soc Med Sh Rep, May 2011 vol. 2 no. 5 42

Dear Journal of the Royal Society of Medicine, Dr. Mykletun and the other authors of the above referenced paper:

Your paper claims that it is harmful for the media to present 'pseudo-facts' such as the efficacy of non- "evidence-based" treatments for ME ("CFS"). In fact, there are treatments such as Ampligen, Kutapressin, GcMAF and Rituxin which have efficacy in treating ME, at least in a substantial percentage of patients. The so-called 'evidence-based' treatments of ME, namely Graded Exercise and CBT have been shown to be ineffective. GET has been shown to be the most harmful of all 'treatments' for ME since it provokes Post-Exertional Relapse, the hallmark of the disease. I implore you to read the following excellent papers on the subject:

A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Twisk FN, Maes M. Neuro Endocrinol Lett. 2009;30(3):284-99.
http://www.ncbi.nlm.nih.gov/pubmed/19855350


Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Tom Kindlon. Bulletin of the IACFS/ME. 2011;19(2):59-111.
http://www.iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/tabid/501/Default.aspx

Thank you for your consideration.

Yours,
Justin Reilly, esq.
M.E. Law & Policy Center

 

[alex3619]

Hi justinreilly, rather than reiterate the same point as you I wrote my own reply:


In Reply to: Chronic fatigue syndrome in the media: a content analysis of newspaper articles

There are both factual errors and misleading implications in this article.

First, the most successful treatment for ME and CFS to date is antiviral therapy. Year by year this approach is getting better results as protocols are refined. The results are an order of magnitude better than that of CBT/GET. It is correct to say this has not been supported as evidence based by institutions that make such judgements, but this only shows the failure of evidence based medicine.

In addition the recent finding that Rituximab can produce full cures has made it the most important therapy being researched to date. Phase 3 clinical trials are about to commence.

As for CBT/GET there is not even ONE study showing an improvement in functional capacity following treatment for ME or CFS, despite two decades of trying to show this. To my knowledge every study that has used objective (not subjective) measures has found either no improvement or a worsening of functional capacity. This matches patient experience and patient surveys on the high rates of illness decline after graded exercise in particular. THIS is why patients reject CBT/GET as therapies.

Furthermore the question of exactly who is being studied in most CBT/GET studies is still open. Most do not have myalgic encephalomyelitis, a neurological disorder recognized by the WHO. Many of these studies actually rule out those who have neurological signs. In addition, none of these studies examine patients with more than moderate levels of ME disability. Those with severe or very severe symptoms are incapable of participating in treatment. It is not even clear how someone who cannot follow prolonged speech or get out of bed could even be considered to participate. Yet this accounts for maybe 10% of patients, and maybe another 15% cannot travel for therapy. Such patients are therefore routinely excluded from studies, which means the CBT/GET research on ME and CFS is not representative of patients in real life.

Furthermore most researchers in ME and CFS do not regard CBT/GET as successful. This is only accurate with regard to a small minority of researchers in Europe, most of whom are psychiatrists.

As a result the media has failed to address the important issues involved in ME and CFS. This is an almost universal failure.

Bye, Alex Young, aka alex3619

 

[Dolphin]

Pls join me in emailing:
Arnstein.Mykletun@uib.no and
http://shortreports.rsmjournals.com/feedback (webpage email form)

Just a short email saying you agree with Justin Reilly's comments on the article would be great. Thanks everyone!

It's great you're writing.
However, what I was suggesting was go to:
http://shortreports.rsmjournals.com/content/2/5/42.full
and click
"Send a Quick Comment"
That is for this specific article.

Also best to reference it like a medical paper. I've adjusted your letter slightly to try to get it fit the usual style used in journals.

The paper claims that it is harmful for the media to present 'pseudo-facts' such as the efficacy of non- "evidence-based" treatments for ME ("CFS"). In fact, there are treatments such as Ampligen, Kutapressin, GcMAF and Rituxin which have efficacy in treating ME, at least in a substantial percentage of patients. The so-called 'evidence-based' treatments of ME, namely Graded Exercise and CBT have been shown to be ineffective. GET has been shown to be the most harmful of all 'treatments' for ME since it provokes Post-Exertional Relapse, the hallmark of the disease. There are two excellent papers on the subject (1,2).

References:

1. Twisk FN, Maes M. A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009;30(3):284-99. http://www.ncbi.nlm.nih.gov/pubmed/19855350

2. Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Bulletin of the IACFS/ME. 2011;19(2):59-111.
http://www.iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/tabid/501/Default.aspx

Thank you for your consideration.

Yours,
Justin Reilly, esq.
M.E. Law & Policy Center

 

[Dolphin]

Hi justinreilly, rather than reiterate the same point as you I wrote my own reply:


In Reply to: Chronic fatigue syndrome in the media: a content analysis of newspaper articles

There are both factual errors and misleading implications in this article.

First, the most successful treatment for ME and CFS to date is antiviral therapy. Year by year this approach is getting better results as protocols are refined. The results are an order of magnitude better than that of CBT/GET. It is correct to say this has not been supported as evidence based by institutions that make such judgements, but this only shows the failure of evidence based medicine.

In addition the recent finding that Rituximab can produce full cures has made it the most important therapy being researched to date. Phase 3 clinical trials are about to commence.

As for CBT/GET there is not even ONE study showing an improvement in functional capacity following treatment for ME or CFS, despite two decades of trying to show this. To my knowledge every study that has used objective (not subjective) measures has found either no improvement or a worsening of functional capacity. This matches patient experience and patient surveys on the high rates of illness decline after graded exercise in particular. THIS is why patients reject CBT/GET as therapies.

Furthermore the question of exactly who is being studied in most CBT/GET studies is still open. Most do not have myalgic encephalomyelitis, a neurological disorder recognized by the WHO. Many of these studies actually rule out those who have neurological signs. In addition, none of these studies examine patients with more than moderate levels of ME disability. Those with severe or very severe symptoms are incapable of participating in treatment. It is not even clear how someone who cannot follow prolonged speech or get out of bed could even be considered to participate. Yet this accounts for maybe 10% of patients, and maybe another 15% cannot travel for therapy. Such patients are therefore routinely excluded from studies, which means the CBT/GET research on ME and CFS is not representative of patients in real life.

Furthermore most researchers in ME and CFS do not regard CBT/GET as successful. This is only accurate with regard to a small minority of researchers in Europe, most of whom are psychiatrists.

As a result the media has failed to address the important issues involved in ME and CFS. This is an almost universal failure.

Bye, Alex Young, aka alex3619

Great you're writing.
But I think you should use the link I mentioned in other post.

Also, without one or ideally at least two references under it, you give them an excuse not to publish. The BMJ would probably put it up but ideally it's best to take no chances.

References can often be found by searching PubMed http://www.ncbi.nlm.nih.gov/pubmed/ .

So I remembered Mella and Fluge were involved in the recent study, stuck it in to Pubmed, and found the result.
Alternatively, searching for
rituximab "chronic fatigue syndrome"
also brings it up.

Fluge , Bruland O, Risa K, et al. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. Epub 2011 Oct 19.

So here's a version that is (partly) referenced:

There are both factual errors and misleading implications in this article.

First, the most successful treatment for ME and CFS to date is antiviral therapy. Year by year this approach is getting better results as protocols are refined. The results are an order of magnitude better than that of CBT/GET. It is correct to say this has not been supported as evidence based by institutions that make such judgements, but this only shows the failure of evidence based medicine.

In addition the recent finding that Rituximab can produce full cures has made it the most important therapy being researched to date (1). Phase 3 clinical trials are about to commence.

As for CBT/GET there is not even ONE study showing an improvement in functional capacity following treatment for ME or CFS, despite two decades of trying to show this. To my knowledge every study that has used objective (not subjective) measures has found either no improvement or a worsening of functional capacity. This matches patient experience and patient surveys on the high rates of illness decline after graded exercise in particular (2,3). THIS is why patients reject CBT/GET as therapies.

Furthermore the question of exactly who is being studied in most CBT/GET studies is still open. Most do not have myalgic encephalomyelitis, a neurological disorder recognized by the WHO. Many of these studies actually rule out those who have neurological signs. In addition, none of these studies examine patients with more than moderate levels of ME disability. Those with severe or very severe symptoms are incapable of participating in treatment. It is not even clear how someone who cannot follow prolonged speech or get out of bed could even be considered to participate. Yet this accounts for maybe 10% of patients, and maybe another 15% cannot travel for therapy. Such patients are therefore routinely excluded from studies, which means the CBT/GET research on ME and CFS is not representative of patients in real life.

Furthermore most researchers in ME and CFS do not regard CBT/GET as successful. This is only accurate with regard to a small minority of researchers in Europe, most of whom are psychiatrists.

As a result the media has failed to address the important issues involved in ME and CFS. This is an almost universal failure.

References:

1. Fluge , Bruland O, Risa K, et al. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. Epub 2011 Oct 19.

2. Twisk FN, Maes M. A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009;30(3):284-99. http://www.ncbi.nlm.nih.gov/pubmed/19855350

3. Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Bulletin of the IACFS/ME. 2011;19(2):59-111.
http://www.iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/tabid/501/Default.aspx

 

[alex3619]

Hi Dolphin, my email was not intended for publication, only to appraise the authors and the publishing house of some issues. If its intended for publication in the same journal as the paper, then there is considerable scope for a longer more thoroughly researched article. However, the email I sent is not directly on the topic of the paper - I focus more on ME background information that is erroneous, whereas the paper is on media reports.

So my questions are: what should be the proper focus/scope for a reply? What are we trying to achieve? What is required for them to publish - do we know anything about this publication?

If we want to get something published then we need to research the publication, have a look at its editorial requirements (there will be a page somewhere) and so on.

Bye, Alex

PS Given that this is a British journal I am not expecting anything to be published. This is not about getting published in my view, its about letting them know we are not buying their arguments. In addition, since we did it and posted it here, its now on the public record. They cannot say they were not informed, although they might say something like they do not take unsolicted emails from patients seriously.

 

[Dolphin]

Hi Dolphin, my email was not intended for publication, only to appraise the authors and the publishing house of some issues. If its intended for publication in the same journal as the paper, then there is considerable scope for a longer more thoroughly researched article. However, the email I sent is not directly on the topic of the paper - I focus more on ME background information that is erroneous, whereas the paper is on media reports.

So my questions are: what should be the proper focus/scope for a reply? What are we trying to achieve? What is required for them to publish - do we know anything about this publication?

If we want to get something published then we need to research the publication, have a look at its editorial requirements (there will be a page somewhere) and so on.

Bye, Alex

PS Given that this is a British journal I am not expecting anything to be published. This is not about getting published in my view, its about letting them know we are not buying their arguments. In addition, since we did it and posted it here, its now on the public record. They cannot say they were not informed, although they might say something like they do not take unsolicted emails from patients seriously.

Ok.
However, I don't consider e-letters/e-comments really published letters.
I have maybe 100 or more of them up around the place.
To get an e-letter/e-comment up, something doesn't have to be brilliant.

Some journals (as this one) choose from the e-letters/comments, what they will publish "officially" e.g. that will show up in PubMed.
However, particularly if it's an online journal, simply having an e-letter/comment with the article will mean lots of people will see it.

 

[Dolphin]

Hi Dolphin, my email was not intended for publication, only to appraise the authors and the publishing house of some issues. If its intended for publication in the same journal as the paper, then there is considerable scope for a longer more thoroughly researched article. However, the email I sent is not directly on the topic of the paper - I focus more on ME background information that is erroneous, whereas the paper is on media reports.

So my questions are: what should be the proper focus/scope for a reply? What are we trying to achieve? What is required for them to publish - do we know anything about this publication?

If we want to get something published then we need to research the publication, have a look at its editorial requirements (there will be a page somewhere) and so on.

Bye, Alex

PS Given that this is a British journal I am not expecting anything to be published. This is not about getting published in my view, its about letting them know we are not buying their arguments. In addition, since we did it and posted it here, its now on the public record. They cannot say they were not informed, although they might say something like they do not take unsolicted emails from patients seriously.

Ok.
However, I don't consider e-letters/e-comments really published letters.
I have maybe 100 or more of them up around the place.
To get an e-letter/e-comment up, something doesn't have to be brilliant.

Some journals (as this one) choose from the e-letters/comments, what they will publish "officially" e.g. that will show up in PubMed.
However, particularly if it's an online journal, simply having an e-letter/comment with the article will mean lots of people who read the initial paper will see it.