Building an evidence base for management of severe ME (including sleep management)

My last point on this for now:

To not harm severely affected with experiments, do we have any evidence with regard to sleep regulation and other symptoms management from homecare/ palliative care in other illnesses such as MS that could be applied to ME?

 

The discussion seems to be stuck with the idea of studying sleep, which, to be fair, was suggested in @Jonathan Edwards 's OP. What I sense from this discussion, and certainly my own experience bears this out, is that sleep may be too complicated to study. Perhaps seeing if sleep hygiene is something patients could even comply with may well have value. But after nearly 20 years I have not been able to get my sleep into a routine much to my utter utter frustration. Some days I can't sleep until 1-3am but wake at 5-6am and can't get back to sleep. A few days later I'm falling asleep at 11pm and waking at 2am and not falling asleep again until 4-5 am. Or sleeping straight through until 11am the next day. Some of the variation is due to my monthly cycle, but not all of it (I dunno, maybe it is -- could we get better measures of that?). (ETA: I don't--usually can't--sleep during the day.)

Mostly without treatments, if we could just get a handle on not making us worse, that would be a big step. One big one for me was home visits. In my case, because I was on Coumadin, years of office visits to check INR took a HUGE toll on my functional capacity. Once I switched to a doctor who made housecalls, my functional capacity very clearly improved over the next several months. Now that I'm on Xaralto, I only see the doctor 1-3x/year so the effect would not be as large. I suspect for most ME/CFS patients, they are probably only needing to see a clinician a few times a year. But for severe patients, I would imagine the effect would be easy to measure in terms of PEM.

Didn't Fred Frieberg do some research like this several years ago using heart rate and actigraphs?

 

Yes, I've been pondering this. But I think a study would get more complicated even than that. My wife's symptoms vary significantly over quite short timescales, depending on what is going on in her life. When life is fairly routine, my wife can pace herself fairly well. But when we have grandchildren staying, no matter how well their Mum takes the load, my wife's pacing gets blown apart. So for many pwME their symptoms and illness management can vary, maybe over quite short and aperiodic timescales.

So any questionnaire would have to account for this, else risk gathering very unrepresentative data. For any one pwME, there answers would potentially vary, and risk looking like different sub-types. Although a statistician might think it would be fine, because with a large enough cohort the stats would balance out (catching different pwME at different points in their fluctuations), that would miss a vital point! It could look like different sub-types in the data analysis, when in fact may be the same sub-type but simply at different points in their fluctuating pattern. (I avoid using the word 'cycle' here, because it is often not cyclic ... event driven not time based).

 

Yes, @Jonathan Edwards only really noted it as an example, but because it is an easy one to discuss, we have got a bit hung up on it.

 

Precisely. However for those of us with monthly cycles, there is, or strongly appears to be, a distinct cycle to it. ;-)

 

Is this it?
https://www.sciencedaily.com/releases/2016/06/160623184238.htm

https://me-pedia.org/wiki/Fred_Friedberg

 

In small portions. Breaking frozen food is difficult, taking two portions is not.

 

I agree.

 

Thanks @Trish for bringing this thread back into focus, re NICE and evidence based (or lack of) recommendations.

Many of the bits in your NICE quote are scary:

"Management of severe CFS/ME is difficult and complex and healthcare professionals should recognise that specialist expertise is needed when planning and providing care for people with severe CFS/ME."
"Diagnosis, investigations, management and follow-up care for people with severe CFS/ME should be supervised or supported by a specialist in CFS/ME."

Depends on the specialists!


"Most people with CFS/ME will not need hospital admission. However, there may be circumstances when a planned admission should be considered. The decision to admit should be made with the person with CFS/ME and their family, and be based on an informed consideration of the benefits and disadvantages. For example, a planned admission may be useful if assessment of a management plan and investigations would require frequent visits to the hospital."

All manner of red flags here, especially for children with ME and their parents.


"When making decisions about prolonged bed rest, healthcare professionals should seek advice from a specialist experienced in the care of people with severe CFS/ME. The significant physical and psychological risks associated with prolonged bed rest should be taken into account."

ME/CFS specialists' experience is so often desperately misguided.


"Healthcare professionals working with people with severe CFS/ME who are in bed most (or all) of the time, should explain the associated risks (such as postural hypotension, deep venous thrombosis, osteoporosis, pressure sores and deconditioning) and monitor these."

Yes of course, but so long as this is sensibly balanced against the other risks, which are so poorly understood.


"Management approaches

People with severe CFS/ME should be offered an individually tailored activity management programme (see recommendation 1.6.2.22) as the core therapeutic strategy, which may:
- be delivered at home, or using telephone or email if appropriate
- incorporate the elements of recommendation 1.6.2.22 and draw on the principles of CBT and GET (see recommendations 1.6.2.1–21).

An activity management programme should be reviewed regularly and frequently."

This of course varies from worrying to totally dire!


However, I find this next bit eminently sensible (for any severity level not just severe) and is invariably overlooked. Is why I sometimes go in with my wife, depending on what she wishes:

"People with severe CFS/ME should be offered a summary record of every consultation because of their cognitive difficulties."

But of course it depends on the summary record and whether bias has crept in between the consultation and the recording of it.

 

"Mostly without treatments, if we could just get a handle on not making us worse, that would be a big step. One big one for me was home visits. In my case, because I was on Coumadin, years of office visits to check INR took a HUGE toll on my functional capacity. Once I switched to a doctor who made housecalls, my functional capacity very clearly improved over the next several months. Now that I'm on Xaralto, I only see the doctor 1-3x/year so the effect would not be as large. I suspect for most ME/CFS patients, they are probably only needing to see a clinician a few times a year. But for severe patients, I would imagine the effect would be easy to measure in terms of PEM."


House calls domiciliary services are vital. 30% of all referrals were treated as domiciliary patients way back in 2006 here. There were 460 patients annually accommodated this way across the Eastern Region. And there was follow up and ongoing care.

At the time, P W and Barts did 5 "experimental' visits!
Thet were charging £4500 ish for a patient referrals under 'choose and book'!

Last year Peterborough and Cambs struggled to do 2 domicilaries!

That's how far things have deteriorated..... see the evidence from 2006-2008 presented to the Strategic Health Authority at the time.

 

might it not be worth someone contacting the 25%group for input on this?
https://25megroup.org/
https://25megroup.org/contact-us

 

I’d like to comment but, although in bad PEM I have been simply surviving in bed dark and silent going mad with frustration at the waiting, I am not severe and have not been severe (in the sense of it being my ‘normal’).

I guess the reason you focused on severe (as opposed to moderate) pwME is the clarity of diagnosis/impairment? Or some idea that severe pwME show a more consistent pattern than moderates and certainly those classified as ‘mild’?

I think your idea of testing empirically what tends to lead to the preferred outcomes longer term is great.

If only to have a ‘right’ to contribute, I’d ask that you consider your thought process in defining your interest as specific to ‘severe’ pwME. ...and possibly refer to a scale you had in mind for that?

Just a thought.

 

You want an evidence base to help manage severe ME patients, and you think you're going to capture inferential data without any questions from this population where labs and imaging are pretty much a bust, and when they're not, the testing is often controversial or unproven?

You certainly can try.

My guess is you will need to ask questions.

 

re the discussion about sleep (but not directly related to v.severe);
in a lot of the NHS literature, and info from the BPS proponents, they often say that X,Y,Z are 'normal' responses to exercise/activity, and that it will help you sleep.

It would be useful, if only to prove this presumption wrong, to have info/data on whether or not sleep/ability to fall asleep is improved (I think Crawley often says it is) or (as is my experience and I think others experience) if 'over-exertion'/doing too much actually makes it worse (ie harder to get to sleep).

 

I guess you measure not getting worse just by getting the same numbers on your activity measures. It is an interesting point that most clinical trials do not even consider worsening and staying the same is considered failure. But the situation is not unique. There are now a lot of trials of drugs for MS where not getting worse is the sign of success.

Heterogeneity obviously needs to be addressed and I am not at all sure how. But amongst the popular ways of giving advice on activity management it might turn out that some recipes are better than others. Maybe heart rate monitoring helps, maybe it is actually misleading. And so on.

 

To be honest what is there at present just looks like blather. OK, having someone with experience of looking after severe ME is likely to be sensible - but only if they know what they are doing and without any objective evidence on this it is difficult to see how they can know. With luck they will have learnt from what the patients say but that may be optimistic.

The the stuff about rest is really just saying how it might be a bad idea. There are risks, certainly, but it would be very easy for professionals to interpret this text as meaning rest is bad. And of course the idea that activity management is the mainstay of 'therapeutic' management is unfounded.

And where are the sensible practical suggestions? What about the best way to advise people about getting to the loo? What about advice on intolerance of stimuli that might help allow people to benefit best from the short periods that they can manage talking to others or listening to the news or whatever? There is actually nothing about supporting people here.

 

Actually this decsribes in a much better and clearer way what I thought when reading this thread.

I hope I understand the idea, and if I do, I think it makes sense. But one needs to remember that experiments can worsen a being's state. Since the example of sleep was brought up: It seems some people report benefits from "organized sleep", and some people report a substantial worsening. Doing a trial on finding this out would be like doing a GET trial - some reported it's ok, some detoriated. Because of those that WILL worsen, such a trial is unacceptable.

My very personal experience is that the body needs to get what it calls for. And this won't fit into a "plan", may it only be short or "flexible".

I had an overall worsening for months from one 24h-RR measurement, i.e. every hour I woke, shocked at what was happening (well, the measurement). This was just one "bad" night that led to a months worth of worsening.

 

Exactly. When reading this it struck me that it’s only general words of logic. But where are the things you mention? Where are the real advice that really can help patients?

I also agree very much with a previous comment here, that preventing harm early on, preventing new severe patients are more important than anything else. And I do think we have some hard evidence here of not what do do. It is great if “old damaged patients” can learn from each other and improve some, and I think we can gather lots of meaningful and helpful advice. May be hard to back them up by scientific evidence, but patients live the disease and experience it and should be listened to in important documents. We need advice for patients of all categories (and not forget that many patients travel between categories), but many end up severe. Labeling patients in strict categories is another problem, but not here and now..

There are so many things to work with here both for patients of today, and patients of tomorrow. Patients of today can contribute on both, but maybe the best way and backed by loads of hard and softer evidence Is what patients not should do initially. So much harm have been done due to old “truths”, just words like “carry on as best you can”. That is dangerous. General words and truths is not addressing the problem but much closer to some sort of convenient negligence.

 

For me the difficulty is identifying the very narrow range of the balance of activity (physical, cognitive, social, emotional, infection) and rest (including sleep) which doesn't

• Immediately excerbate symptoms
• Trigger PEM
• Trigger a relapse
• Contribute to the cumulative "activity" load which pushes me over the edge into the above

I find heart rate monitoring (using a wrist monitor) and taking morning heart rate variability readings helpful.

In the day my average heart rate and the amount of time my HR is over 77 and 84 BPM gives me an indicator of how well my body has coped with "activity" during the day. My wrist monitor has also been set up to beep when I go over 84 BPM, so I also have immediate feedback.

I wear a wrist monitor at night too, and the amount of time that my HR is under 59 BPM is an indicator of sleep quality. On a bad night I may be asleep but have no time under 59 BPM, on a super dooper night, over 400 minutes under 59 BPM.

I graph my data so I can see trends and the effect of various "activity"

I use the HRV4Training app to manage my HRV data. The app is aimed at athletes, but is still useful. Over time a "normal range" of HRV for the individual can be established. Taking a reading on waking can give an indication of how the individual has coped with the previous day's activity. Low HR can be an indicator of activity beyond personal limits, as can high HR.

Orthostatic problems have thrown rather a spanner in the works. BB have given me a measure of stability. The stability is still precarious, easily disrupted, and the cumulative effect of activity still seems to be a movable feast.

For some HRM can also be useful when it comes to food sensitivities.

Nonetheless, for me, HR data has helped me change my activity and change the way I do things. I do pace more effectively now. It is a long term strategy, months rather than weeks though and doesn't suit everyone.

At the recent emerge conference Dr Mark Donihoe talked about "pulling up anchors". How patients and clinicians try various strategies, but there can be a tendancy to attribute improvement to the most recent change rather than the cumulative effect of a number of changes. https://mecfsconference.org.au/videos/mark-donohoe/

Edited to correct error kindly pointed out by @Wonko