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BACME's new clinical guide to practical management of M.E. for healthcare professionals

Sidereal

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Pharmacological approaches for which there is no evidence of benefit

None of these interventions are recommended but practitioners should be aware of them so that they can address patients’ concerns and questions. If patients are taking dietary supplements and they are feeling benefit and if the intervention is not toxic or too expensive then it seems reasonable to acquiesce in their use but these interventions cannot be recommended nor made available on the NHS. Practitioners should note that there is no evidence that dietary supplements are effective.

Rituximab: Rituximab primarily destroys B cells and is therefore used to treat diseases which are characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells, including auto-immune conditions.
A recent publication from Norway stated that in a study they had conducted there were beneficial effects of Rituximab on CFS/ME patients. If these effects are real and can be reproduced, the findings may guide us to understanding what causes CFS/ME.

Criticisms of the Norwegian study, some alluded to by the authors themselves, included the small number of patients participating in the study, and the high incidence of auto-immune illness already existing in the CFS/ME patients, or in their families. In addition, some of the tests and parameters used to measure the effects of treatment with Rituximab have not been used widely in previous trials, some of the methods used could have introduced bias, and statistical findings have been called into question. Finally, one of the major findings, the delayed response to reduction in fatigue by participants in this study, in comparison to the immediate response in all other auto-immune conditions in which depletion of B cells by Rituximab is used, has not been explained adequately.
Bullshit.
 

Bob

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There is the expected emphasis on CBT/GET, but the document isn't as appalling as I expected it to be, but I've only skimmed it, and i haven't read the last section for therapists. I think there's actually some helpful info for clinicians in there, esp in relation to prescribing pharmaceuticals for symptomatic relief. And they've not labelled the illness as a functional disorder, as far as I've noticed; If I didn't know much about the subject, I think i would be left with the impression that ME/CFS is a legitimate physical illness with a biomedical basis. (But perhaps my expectations were so low, that i've simply been pleasantly surprised? I may be less impressed on my second reading.)
 
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user9876

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Finally, one of the major findings, the delayed response to reduction in fatigue by participants in this study, in comparison to the immediate response in all other auto-immune conditions in which depletion of B cells by Rituximab is used, has not been explained adequately.
@Jonathan Edwards
Is there any grain of accuracy in this quote in the BAMCE report? I thought there was a delay generally in auto immune conditons?
 

A.B.

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Regarding "CFS/ME is not a mental health issue". Judging from the treatment recommendations one would get the impression that this is mainly a mental disorder.

I also question the recommendation for SSRIs as fluoxetine was shown to be worse than placebo in a double blinded trial. It didn't even have an effect on depressive symptoms.
 
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Bob

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BACME said:
Rituximab: Rituximab primarily destroys B cells and is therefore used to treat diseases which are characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells, including auto-immune conditions.
A recent publication from Norway stated that in a study they had conducted there were beneficial effects of Rituximab on CFS/ME patients. If these effects are real and can be reproduced, the findings may guide us to understanding what causes CFS/ME.
I welcome the apparent open-mindedness.

BACME said:
Criticisms of the Norwegian study, some alluded to by the authors themselves, included the small number of patients participating in the study, and the high incidence of auto-immune illness already existing in the CFS/ME patients, or in their families. In addition, some of the tests and parameters used to measure the effects of treatment with Rituximab have not been used widely in previous trials, some of the methods used could have introduced bias, and statistical findings have been called into question.
Oh, the delightful irony of questioning potential bias and statistical findings in relation to the phase II Rituximab trials while referring to CBT/GET as simply: "evidence based treatments".

BACME said:
Finally, one of the major findings, the delayed response to reduction in fatigue by participants in this study, in comparison to the immediate response in all other auto-immune conditions in which depletion of B cells by Rituximab is used, has not been explained adequately.
That's news to me. Does anyone have any insight into this? (Edit: i crossed posts with user, above.)
 
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worldbackwards

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Regarding "CFS/ME is not a mental health issue". Judging from the treatment recommendations one would get the impression that this is mainly a mental disorder.
Yeah, not looked that closely yet but what I've seen (unsurprisingly) has a distinct resemblance to NICE: throw a few bones to the patient groups (AfME have signed off on this, no really) but ultimately let the psychiatrists get on with whatever they deem to be "evidence based". And whatever else they want to do as well.
I welcome the apparent open-mindedness.
Doesn't this resemble Wessely's apparent open mindedness on the subject? Are we beginning to see a new "line to take" on this, possibly as a holding pattern until they can make it go away?
 
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Scarecrow

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Yeah, not looked that closely yet but what I've seen (unsurprisingly) has a distinct resemblance to NICE: throw a few bones to the patient groups (AfME have signed of on this, no really) but ultimately let the psychiatrists get on with whatever they deem to be "evidence based". And whatever else they want to do as well.
I think it was AYME rather than AfME
 

Bob

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Scarecrow

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It's all much of a muchness, isn't it? It was a genuine question.
Rather than trying to tease the information out of me (I may not be in the mood to play ;)), it might be better to put your own cards on the table and then ask me to comment.

So at the risk of guessing incorrectly, I assume you're alluding to their involvement with the PACE trial and the stance they've taken in response to the conclusions, which contrasts pretty sharply with that of MEA. In that respect, if that is what you mean, I can't disagree with you.

However, it doesn't alter the fact that they are two different organisations.
 

Purple

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Finally, one of the major findings, the delayed response to reduction in fatigue by participants in this study, in comparison to the immediate response in all other auto-immune conditions in which depletion of B cells by Rituximab is used, has not been explained adequately.
This is so amusing. Or rather it would be amusing - if some irrelevant lay person with no training in medicine would be saying this to their friend. It is a lot less amusing when people saying this are recommending healthcare policy concerning hundreds of thousands people with a crippling disease in the UK. Ah well, yet another one of their glaring errors...

ETA: I especially 'like' that they say 'all other auto-immune conditions'. Absolute statements like this - 'all' - have no place in science or medicine.
 
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Sidereal

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Psychoquacks said:
Finally, one of the major findings, the delayed response to reduction in fatigue by participants in this study,in comparison to the immediate response in all other auto-immune conditions in which depletion of B cells by Rituximab is used, has not been explained adequately.
@Jonathan Edwards
Is there any grain of accuracy in this quote in the BAMCE report? I thought there was a delay generally in auto immune conditons?
CBT crowd floated this claim in the comments section to the Fluge/Mella 2011 PLoS paper. Dr Edwards smacked it down:

RE: Rituximab in CFS; more research needed
Jonathan_Edwards replied to jvandermeer on 28 Oct 2011 at 17:10 GMT

The criticism made here contains several errors. There is nothing peculiar about the late response. It is to be expected. I was responsible for both the phase I and the proof of concept phase II (NEJM 2004) studies in rheumatoid disease, which formally established the validity of B cell depletion in autoimmune disorders. From the very outset in 2000 we reported that responses could take many months to develop, in line with autoantibody decline. An partial early response element was usually seen as well but was consistent with adjuvant use of corticosteroid or other agents.
http://www.plosone.org/annotation/listThread.action?root=6147
 

Sidereal

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Yeah, not looked that closely yet but what I've seen (unsurprisingly) has a distinct resemblance to NICE: throw a few bones to the patient groups (AfME have signed off on this, no really) but ultimately let the psychiatrists get on with whatever they deem to be "evidence based". And whatever else they want to do as well.
That's what it looks like to me. That sentence about CFS not being a mental health condition is a total red herring when you consider the rest of the document which seems to be concerned mostly with discouraging clinicians from prescribing anything (including vitamins) except antidepressants.
 

Scarecrow

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CBT crowd floated this claim in the comments section to the Fluge/Mella 2011 PLoS paper. Dr Edwards smacked it down:
http://www.plosone.org/annotation/listThread.action?root=6147
Nice find. The comments have been interesting reading. Here's a further extract, this time from Fluge, answering the same point, in which he discusses the range of response times in named autoimmune conditions:

We do not support their statement that a response within the first days to weeks necessarily is the usual pattern in other diseases where Rituximab intervention is used. Autoimmune cytopenias and some autoimmune diseases such as acute demyelinating polyneuropathy [2] may respond early, while in other diseases the responses usually start to occur after months. In accordance, the endpoints for clinical studies, or clinical benefit demonstrated in observational studies, are often defined at 6 - 12 months after treatment, with the clinical effects subsiding over the following months or year, such as in rheumatoid arthritis [3], lupus nephritis [4], and primary antiphospholipid antibody syndrome [5]. As an example, in a case study of pulmonary alveolar proteinosis, in which autoantibodies to GM-CSF have been demonstrated, the levels of autoantibodies declined the first three months after Rituximab treatment, while effect on alveolar-arterial gradient was seen at six months, and improvements in pulmonary function tests and CT scans were evident at nine months [6].

The full consequences of the action of Rituximab in other autoimmune diseases are only partly known, and also which of the known modes of action that are of greatest relative importance in individual patients [7]. CFS/ME is not a disease with evident widespread inflammatory lesions as in some established autoimmune conditions and the mode of action could thus be different from that seen in for example rheumatoid arthritis or lupus. Reduction of autoantibody levels (wash-out by reduced production following B-cell depletion) to a critical level before clinical responses become evident could therefore be one plausible mechanism explaining what we observed.