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

[Jonathan Edwards]

I have been thinking a lot about the evidence base for ME/CFS management. There are some good negative studies but a positive evidence base is hard to find, as we know.

At the NICE scoping meetings there was a consensus that what could be justified in the current situation was more ongoing supportive care and diagnostic review, rather than short term efforts at rehabilitation.

So I started looking around for the evidence base for specific recommendations for supportive care - in particular for severe bed bound cases. So far I have not even really found any specific recommendations, just an acknowledgement that support is needed.

Which makes me think that we really ought to know what in practice helps to keep people functioning, and maybe even aid improvement or protect against worsening. We should have trials looking at a series of slightly different ways of providing support to see which if any is the most helpful. Of course the problems of unblinded comparisons would be present but if the comparisons are not theory laden and merely differ in practical procedures that are theory neutral and the endpoints are underpinned with objective measures then the prospect of a meaningful answer would not be too distant.

So I am floating the idea that there ought to be some theory neutral trials of long term support for severe cases.

I am also interested in what people have found to work. In particular I would be interested to know what the supportive care was during a period when someone was fortunate enough to rise up out of a severe phase and function at a moderate level. I guess that the responses to this might be endless but I am particularly interested in plans for daily routines that can fairly easily be defined as potential alternative ingredients. An obvious one would be regulating sleep and wake times and so on.

 

[Andy]

Personally I'd question the value of routine, including regulation of sleep. I would argue that what would be of more value would be the ability to adapt expectations to the available energy of the patient on any given day.

I feel what helped me the most when I was at my worst was to sleep as long as I needed, and to do what I was able to, when I had the energy for it. But, from a pure research point of view, perhaps that is something that needs to be tested against vs a system where routine is of prime importance.

But I do have unease with the idea of requiring severe patients to stick to a routine, as that is too much like the idea of GET to me.

 

[Milo]

I think what has helped a few that i know of has been pharmacological support, such as addressing POTS and NMH, and while some will grumble due to the lack of scientific evidence, others have improved greatly by anti-virals.

Lifestyle changes such as sleep ‘hygiene’, pacing and activity management is not going to move anyone from very severe to severe. Dietary changes will not change disease severities either but that is just an opinion.

This said, thank you @Jonathan Edwards for initiating this very important discussion.

 

[Trish]

I agree this is an important discussion.

For me, as someone who is borderline moderate/severe, and caring for someone who is severe, the greatest need is home visits from doctors when needed and someone (eg a nurse practitioner) who visits regularly to check on us (I wish), and sufficient practical support for personal care, meals etc. And no set routine, but help with regulating activity in the sense of not doing too much.

Also for the bedbound, nursing care that would be provided for anyone else who is bedbound.

One of the most difficult things I find is balancing the need for practical help, and the downside of this is the inevitable interaction, instructing helpers etc which is itself exhausting.

And for the very severe, especially those without a full time family carers available and willing, as well as a visiting medical nursing team when needed, there is also need for decent quiet and supportive hospital care. I found Jessica Taylor Bearman's book enlightening on the good, the bad and the diabolically awful hospital care she encountered.

 

[Jonathan Edwards]

I sense theory creeping in already! But still interesting thoughts.

I think I am looking for recommendations that can be described succinctly and do not require any interpretation - such as what constitutes available energy. And I am not suggesting that we should be thinking that routine for routine's sake should be good or bad.

So I think a plan that standardises wake and sleep times could be compared with a plan that does not - with no hang ups about why. And the outcome measure would simply be how active the person was over a period.

 

[Jonathan Edwards]

I found Jessica Taylor Bearman's book enlightening on the good, the bad and the diabolically awful hospital care she encountered.

Yes, I too thought J TB might be a very useful source for starters here.

I also suspect that health care workers in ME teams may have a lot of very useful suggestions to make. The reason these suggestions do not appear in literature may be that the literature always has to be politically correct about 'why' rather than just based on documented experience.

 

[Milo]

So I think a plan that standardises wake and sleep times could be compared with a plan that does not - with no hang ups about why. And the outcome measure would simply be how active the person was over a period.

So you basically are looking for behavioral modification for people who sleep too much or sleep at the wrong time? I am uneasy with that. Please do not design a study or trial to find out whether standardization of sleep helps anything.

 

[Jonathan Edwards]

So you basically are looking for behavioral modification for people who sleep too much or sleep at the wrong time? I am uneasy with that. Please do not design a study or trial to find out whether standardization of sleep helps anything.

I am not looking for behaviour modification. I am looking for evidence for one or other sort of advice being sound. Why would you be uneasy with such a trial? Don't we need to know what the answer is? We cannot assume standardisation is bad without evidence, any more than assuming it is good. At present 'sleep hygiene' advice is recommended. If the suspicion is that this is misguided then we want the evidence for that.

 

[Trish]

How about a long term study using actometers that simply collects data on activity levels and sleep patterns in severe and very severe patients, alongside an app that has easy to fill in symptoms each day. In other words, no intervention, simply measuring and looking for patterns.

My concern about imposing a pattern of activity/rest/sleep etc. of any sort on someone who is already very severely affected could be in danger of making their health much worse long term, and therefore as unethical as imposing an exercise program on them.

 

[Hoopoe]

Help with cooking and cleaning could be helpful in cases where merely doing all of these every day is already overexertion or places a high burden on carers who may have other responsibilities like a job.

This might prevent deterioration, or perhaps increase chances of improving in a year or two. I'm not speaking from personal experienc here.

 

[Milo]

I am not looking for behaviour modification. I am looking for evidence for one or other sort of advice being sound. Why would you be uneasy with such a trial? Don't we need to know what the answer is? We cannot assume standardisation is bad without evidence, any more than assuming it is good. At present 'sleep hygiene' advice is recommended. If the suspicion is that this is misguided then we want the evidence for that.

Because looking into sleep and sleep hygiene has not led us anywhere, and implies that we have a sleep problem and therefore no other pathology.

Re standardization of sleep, such as ‘only sleep from 9 PM and set the alarm at 7 AM and get up then islikely to cause more harm because too many of us cannot do that. And if we are forced into doing that it means less sleep, and worsened functional status, and worsened quality of life. You can try it for yourself, stay awake for a full 24 hours and see what happens.

All the while, energy is not spent into researching biomarkers and underlying pathology.

And sleep hygiene is all about behavioral modification.

 

[Sam Carter]

My two pennies worth.

If tolerated, medication to improve sleep and medication to improve pain. This can involve a lot of experimentation with different drugs, often given at much lower doses than normal.

W.r.t regulating sleep and wake times, I think it's more important to emphasise quality of sleep rather than trying to guide it into a regular schedule.

Proactive support and advice should be offered to help patients apply for and keep social security benefits. This is the one area where doctors can genuinely make a difference but are usually reluctant to get involved.

Encourage a culture where patients are given “permission” to rest and not to feel guilty when they can't do things.

The belief that ill-health can be overcome by exercise, diet, and positive thinking is so strongly embedded in Western culture that an explicit instruction (“doctor’s orders”) needs to be issued which makes clear that "fighting" the condition causes relapse and that the relapse may be permanent. It’s important that the person’s family, the DWP, and the person’s GP are made aware of this to prevent the psychological harm that follows from suggesting that someone is not trying hard enough.

I also think that it’s important that ME specialists should review patients every year or two so that they build up an awareness of how the illness changes / progresses over time. The current UK system, where specialist interest ends after diagnosis, is entirely inadequate and leaves patients at the mercy of ill-informed GPs.

 

[Trish]

A study of different sleep medications for ME might be useful, including melatonin.

Crossposted with Sam Carter. Good suggestions, Sam.

 

[wigglethemouse]

Two areas I don't hear talked about enough are SIBO and MCAS. Both have recognised tests available. Some of the US doctors are starting to find MCAS prevalent in ME patients. IBS is known to be prevalent. Unfortunately very few gastroenterologists are testing SIBO, and MCAS knowledgeable doctors are rare.

If these two can be addressed then the severe patient can improve a bit allowing more variety of food intake which will help overall functioning. Probably will still be severe, but it could help stabilise the patient from further decline. And treatment would be based on medical tests. I don't believe I've seen any papers on prevalence that would help a NICE panel.

Dr Emma Reinhold has a fair bit of MCAS knowledge in the EDS sphere and wrote the EDS toolkit for the RCGPs - this has an "Emerging Major Associations" section that includes POTS and MCAS. Perhaps you can touch base with her to get her thoughts. Here is the toolkit
https://www.rcgp.org.uk/eds

 

[Hoopoe]

There urgently need to be some sort of specialists that can treat rapidly deteriorating patients, those in need of hospital care for whatever reason. Contact with healthcare systems at the moment is so bad that it can really harm patients. If there existed such specialists we would also learn more about severe ME.

PS: something that can prevent Robert Courtney scenarios, and cases like the one where a man with ME starved to death because the GP thought he could care for himself.

 

[Milo]

I would prefer full on sleep studies, with and without sleep aid. QEEG. Cortisol and other markers (inflammation? Norepinephrine? Thyroid? Aldosterone? Leptin? Others? ) differences between very severe and moderate /severe patients

 

[Jonathan Edwards]

How about a long term study using actometers that simply collects data on activity levels and sleep patterns in severe and very severe patients, alongside an app that has easy to fill in symptoms each day. In other words, no intervention, simply measuring and looking for patterns.

My concern about imposing a pattern of activity/rest/sleep etc. of any sort on someone who is already very severely affected could be in danger of making their health much worse long term, and therefore as unethical as imposing an exercise program on them.

Yes, we have already thought about long term actometry and I am all for it. But it will not provide any information about what advice to give.

I am not suggesting imposing anything here - it is interesting that everyone seems to be reacting to this. I am just suggesting that various types of plan are compared. Nobody would be told 'this is the thing to do'. I know that is what has gone before but the idea here is quite different. It is just the suggestion of a plan with no implication that it it has a theoretical base or is known to be good for you. One lot of people would try out a sleep standardisation plan and others would not. Plans could have several components and be cross stratified to tease out the elements that were associated with better outcome.

I clearly remember someone recently saying that sleep standardisation was a huge help - so it seems to help some people. But if course a controlled experiment is needed to see if that is borne out.

 

[Jonathan Edwards]

Help with cooking and cleaning could be helpful in cases where merely doing all of these every day is already overexertion or places a high burden on carers who may have other responsibilities like a job.

This might prevent deterioration, or perhaps increase chances of improving in a year or two. I'm not speaking from personal experienc here.

This might be true but it needs testing before any advice is given. Help with cooking is pretty much bound to be helpful at the time but the question is whether it makes a difference to long term progress. If not then there is no point putting it in the advice literature or NICE guidelines.

 

[Jonathan Edwards]

Because looking into sleep and sleep hygiene has not led us anywhere, and implies that we have a sleep problem and therefore no other pathology.

So at present one of the few things in the advice in the guidelines is sleep regulation. If that is no use we need to establish that. How do we know it has not led us anywhere. Nobody has found out whether or not it affects long term progress. And there is no implication that there is a sleep problem. Athletes are advised sleep regulation as part of their training so that they can win gold medals. Nobody suggests they have a sleep problem. This is just about what helps keep people well. Nothing to do with theory.

 

[Sasha]

So I think a plan that standardises wake and sleep times could be compared with a plan that does not

In practice, I think that standardising wake and sleep times for a PWME is extremely difficult. I can set my alarm to wake up but might feel so ill that I can't actually get out of bed. It might take three hours to get up, by which time I'll probably have drowsed off. If I'm able to force myself out of bed in response to an alarm but haven't had enough sleep, then when I'm inevitably forced to lie down (because of my OI), I can't help drifting off.

Someone in good health who is sleep-deprived can keep themselves going, but if your ME forces you to rest in the day, you'll fall asleep. My attempts to get to sleep earlier by following the usual method of getting up earlier actually resulted in my sleep cycle shifting further and further forward because of over-napping during the day.