Contribute Evidence for NICE consultation

[Undisclosed]

Please Note -- we have removed a number of off-topic posts from this thread that were unrelated to contributing evidence for the NICE consultations.

I would suggest not to use threads on Phoenix Rising to air personal grievances against any ME organization without first being prepared to provide actual evidence and to do so in a manner that doesn't take existing threads off-topic. It's not that we can't discuss ME organizations/charities but it should be part of an on-topic, hopefully, constructive conversation (not always possible) as many members that take part on Phoenix Rising often volunteer for these organizations/charities.

Per our policies, any further off-topic comments on this thread will be removed.

Thank you.

 

[Jenny TipsforME]

We're currently drafting sections of our response and we are using some input from PR. In the current draft for example we're using an angle asking for consideration from the angle of stigma and discrimination as suggested by @Esther12 for the equalities section

A point of debate at the moment is the guidelines in relation to Severe ME. Is it really true that there is no evidence to support the recommendation for Graded Activity? Evidencing an absence is hard to do convincingly.

We can include the FINE trial to back this up

The FINE trial authors concluded after a 70-week follow-up that the 18-week program was not an effective treatment for CFS/ME because the small improvement in fatigue, sleep and depression that were initially observed were not maintained in a long-term follow-up: "Pragmatic rehabilitation delivered at home by trained general nurses over a period of 18 weeks improved fatigue, sleep, and depression among patients with CFS/ME, but these effects were not maintained in the long term once treatment was completed. Supportive listening delivered by trained general nurses was not an effective treatment for CFS/ME in primary care. More studies are needed to determine the optimal conditions under which pragmatic rehabilitation can be delivered to patients in the community with CFS/ME and whether the limited benefits seen in this trial can be sustained."[3]

What other evidence would you mention which shows graded activity (not exactly the same as GET) isn't appropriate as treatment for Severe ME? Or at least that this requires reconsideration in a full review...

 

[MEMum]

I would ref the papers on the physiological response to exercise, ie switch to anaerobic respiration with production of lactic acid and minimal production of ATP. This can only be tested in people with mild to moderate, but explains why anyone with ME should not be pushed to incrementally increase their exercise and push thro/keep going at increased exercise levels, despite feeling worse.
I guess that best evidence of this switch comes best from the Norwegian paper from ?Jan 2017, talking about the changes in levels of different types af amino acids depending on where they feed into glycolysis/TCA cycle and talks about inhibition of pyruvate dehydrogenase.

 

[Invisible Woman]

What other evidence would you mention which shows graded activity (not exactly the same as GET) isn't appropriate as treatment for Severe ME? Or at least that this requires reconsideration in a full review...

I wonder if it is worth taking the approach of showing that even where there has been research (mainly for GET rather than GAT I'm afraid) that the reporting of harms has been inadequate. I'm thinking primarily of @Tom Kindlon 's paper:

http://www.ncf-net.org/library/Reporting of Harms.pdf

 

[Jenny TipsforME]

@Invisible Woman
We are mentioning some of the many problems with GET research including querying reporting of harm.

Our specific query is whether we are right in our judgement that there is no evidence at all in favour of Graded Activity as effective treatment/management for Severe ME? I.e. This is a recommendation without foundation. We don't want to claim that and then get egg on our face because there are 5 trials with slightly different wording that we missed! So just checking with the Phoenix Rising knowledge base.

Personally I get the ncbi research abstracts in my inbox everyday and yet I feel like I know nothing about the background that justifies GAT for Severe ME. I know about the unsuccessful FINE trial and that's it.

Also is there evidence which is stronger than anecdotal about the nature of the stigma/discrimination for pwme?

Or evidence about people losing benefits/insurance due to non-compliance with NICE recommended treatments?

There is so much collective knowledge here, I expect some of you will just know this stuff.

 

[slysaint]

I remember from one of Nigel Speights talks that he said that before CBT/GET was 'adopted' there had been encouraging results with immunoglobulin which were ignored. He cites the papers in this:
http://www.sjmms.net/article.asp?is...me=1;issue=1;spage=11;epage=13;aulast=Speight

then there was this done by none other than White himself before the PACE trial.
http://www.tandfonline.com/doi/abs/10.1300/J092v12n02_06

"Conclusions: These results suggest that the relationship between physical activity and both pro-inflammatory and anti-inflammatory cytokines merits further investigation in patients with CFS. The results also emphasize the importance of defining a truly resting baseline condition in such studies."

 

[Esther12]

I think that FINE was the closest they've got to testing exercise therapy for the severely affected.

 

[slysaint]

There is plenty on the adverse affect of GET from presentations at the Bristol Watershed:
http://voicesfromtheshadowsfilm.co.uk/exercise-mecfs-event/

"Prof Mark VanNess from the Workwell Foundation explains how damaging aerobic exercise can be for patients with ME/CFS. The Workwell 2 day testing protocol demonstrates the astonishing post exertional amplification of symptoms in ME patients; a hallmark symptom of ME. This damage to the aerobic energy system means that it is utterly counter productive to try to use aerobic exercise, such as graded exercise therapy, to improve health in these patients."

"Clearly CFS to Mark VanNess is not the same as the conditions loosely called CFS here in the UK! The Cure ME Team is working with quite precise research criteria in comparison with the general NHS and NICE definition."

Comment from Nathalie Boulton on the Voice from the shadows film:
"The story of how physically ill children and young people, had been encouraged, persuaded, coerced, and even physically forced as a last resort, to conform to a view of this illness which is now proved to be utterly misguided and false – even though it is still being widely promoted."

I wonder if anyone on the NICE committee have seen the film or any of these presentations? (unlikely.........as they only read the abstracts of 'peer-reviewed' research).

 

[Jenny TipsforME]

@slysaint thanks copied to our notes

 

[Jo Best]

Wondering if everyone on this thread has had an opportunity to read or at least skim the surveillance review proposal.
Here's the link just in case (hope that's ok Jenny): https://www.nice.org.uk/guidance/cg53/documents/surveillance-review-proposal

 

[Jo Best]

Hope it's also ok to say, for anyone new to this, that NICE has been presented with evidence from all the UK ME orgs. as well as from international sources, since the guideline was originally in development, so that while it is very important to keep that increasing evidence base flowing in NICE's direction, and for as many ME orgs. as possible to register as stakeholders (thank you @Jenny TipsforME and colleagues) to add perspectives and to the weight of evidence, this review process is about the NICE selectively reviewing evidence to support government policy (e.g. reminder that £5m+ PACE trial was co-funded by Dept. for Work and Pensions) and will, in my opinion, take positive and proactive political action to resolve, so please don't make yourselves ill by over-exertion within this very short window of opportunity provided by NICE for consulation. The history page: https://www.nice.org.uk/guidance/cg53/history

 

[trishrhymes]

I haven't read all this thread, but there is evidence of detrimental effects of exercise listed in this document by Frank Twisk
https://oatext.com/pdf/PMRR-2-134.pdf

 

[Jenny TipsforME]

Our current rough draft includes @Tom Kindlon harm paper.

I've got a feeling that there's a really recent paper that discusses this too. Is it one of the Journal of Health Psychology ones?

 

[Jenny TipsforME]

take positive and proactive political action to resolve

I agree that in and of itself our consultation document is unlikely to result in a road to Damascus revelation for NICE! We are also in tandem combining this with two campaigns (though personally I've been focused on the consultation).

To see the campaigns:
http://www.meaction.net/2017/07/12/troubled-by-nice-guidelines-three-easy-ways-you-can-help/

http://www.meaction.net/2017/07/12/write-to-your-mp-in-5-minutes-about-the-mecfs-nice-guidelines/

Please share these around the internet. I don't know if anyone has started a separate thread yet.

 

[Tom Kindlon]

Our current rough draft includes @Tom Kindlon harm paper.

I've got a feeling that there's a really recent paper that discusses this too. Is it one of the Journal of Health Psychology ones?

http://journals.sagepub.com/doi/full/10.1177/1359105317697323

 

[Jenny TipsforME]

@Tom Kindlon thanks you're great!

 

[Tom Kindlon]

@Tom Kindlon thanks you're great!

Despite the title, my 2017 paper was written in response to PACE trial commentary so a lot of it concentrates on the PACE trial study

 

[Jenny TipsforME]

These are likely in the reference list of another paper somewhere:

Does anyone know an existing list of all CBT/GET trials which are unblinded and also only use subjective self report measures?

Similarly trials where PEM isn't mandatory (which I think is all of them )

All the null long term follow ups...

Just trying to save energy on referencing.

 

[Jenny TipsforME]

What about a study into all the conditions involving long term fatigue as a symptom?

 

[Jenny TipsforME]

What about forthcoming biomedical trials such as Rituximab (in terms of being off the static list)?
Doesn't OMF have something in the pipeline?