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

[Jonathan Edwards]

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.

I was not intending to get involved with drugs, which would require controlled trials of their own.

And, hang on, I am not asking people to give advice here - because the whole point is that we do not know what advice to give, any more than Dr Chalder does. We need to test options. One of the things that I pointed out in my evidence to NICE was that Dr Wessely and Dr Chalder wrote a paper with fifteen instances of the word should in it before they had even done any trials.

I am wanting to get evidence. Peopl's experience is valuable but as a starting point for gathering evidence, otherwise we are just tiptoeing in the BPS footsteps.

 

[Jonathan Edwards]

Two areas I don't hear talked about enough are SIBO and MCAS. Both have recognised tests available.

But this is all theory based stuff. I am just interested in finding evidence that practical eadvice actually helps. That should be theory neutral. If it isn't you are back in the expectation bias carousel.

 

[Diluted-biscuit]

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.

Better guidelines with regards to assessing ME/CFS sufferers for PIP would help with this side of things. The current ones are mixed at best and of course the system is bad on top. This is outside of what jonathan is talking about here of course and better NICE guidelines would hopefully lead on to them improving the ME/CFS PIP advice.

 

[Jonathan Edwards]

In practice, I think that standardising wake and sleep times for a PWME is extremely difficult.

It may well be, but that doesn't matter. We still want to ask the question as to whether advice on trying to standardise sleep is helpful, harmful or neutral. At the moment the advice is there. I had assumed it was fairly uncontroversial because nobody had complained about it at NICE scoping. But if people think it is wrong then it should be tested. We need evidence.

 

[Jonathan Edwards]

Better guidelines with regards to assessing ME/CFS sufferers for PIP would help with this side of things.

Yes but that is not an issue of planning support. It is a political issue relating to the PIP system.

I am not asking for suggestions for advice per se. I am asking for suggestions for plans that might be tested to see if they improve, or worsen, long term progress.

Edit: sorry, I see you realised that.

 

[Peter T]

From my personal experience when I was bedbound, before any issues of managing my ME, practical support for getting food, personal hygiene, housework, etc need to come first.

Being in the same clothes unchanged for several weeks, eating cold food directly from a tin can, etc. At this stage it was a nightmare getting any domiciliary support, doctors' or nurses' home visits did not happen and it was only when I had CAB support to get PIP, a short term voluntary agency support worker and then ongoing personal assistant support that the daily living activities I was attempting were reduced to within my energy envelope allowing some spontaneous improvement to occur.

We need some basic evidence on the value of practical support that allows people to function within their current energy envelope.

Also, I resisted family pressure to find inpatient or respite care, because of the issues of noise, presence of other people continuously and the risk of pressure to do more, to follow an external programme. I felt the option of long periods in quiet without mistaken pressure to 'rehabilitate' me in my own home was more important than the practical support in that setting.

So again we need basic evidence on what are the environmental requirements of people with severe ME.

I believe appropriate support allowed a degree of spontaneous recovery, which can be objectively measured by amount of time spent not lying down, by practical activities done. Obviously this anecdotal, and I have a relapsing and remitting form, so my experience may not be relevant to other patterns of ME.

 

[Diluted-biscuit]

Yes but that is not an issue of planning support. It is a political issue relating to the PIP system.

I am not asking for suggestions for advice per se. I am asking for suggestions for plans that might be tested to see if they improve, or worsen, long term progress.

Yes, that was what I was trying to say really. That help with home care could be taken care of with the separate system of PIP.

 

[chrisb]

There is one thing that strikes me in particular from the other thread which has presumably precipitated this debate. There may possibly be a compression of time due either to the circumstances or to the illness, but if the comments are taken at face value, it sounds as though enforced behavioural modification was started before any period had elapsed to allow for observation and assessment. Without proper observation there seems to be no way that the medical team could form their own professional judgment as to the appropriateness of any action.

The person who wrote the instruction manual did not have that patient in front of them.

Nothing should be done without proper observation and evaluation- all duly recorded in the notes for the benefit of any tribunal or court overseeing proceedings.

 

[Jonathan Edwards]

Thanks, I edited to indicate I realised you were making a lateral point.

 

[MSEsperanza]

In practice, I think that standardising wake and sleep times for a PWME is extremely difficult.

It may well be, but that doesn't matter. We still want to ask the question as to whether advice on trying to standardise sleep is helpful, harmful or neutral. At the moment the advice is there. I had assumed it was fairly uncontroversial because nobody had complained about it at NICE scoping. But if people think it is wrong then it should be tested. We need evidence.

But over how many days would you think one would have to follow a sleep routine to have sufficient evidence whether it helps or does harm?

edited to add: for me I think it helps, but I'm not bedbound. And sometimes I have to lie down again shortly after I got out of bed. I also have several regular naps over the day, but if I go to bed early, usually am able to sleep neverthelss.

 

[wigglethemouse]

Maybe take a look at this book. Seems like some clinics are sharing it.

 

[Jonathan Edwards]

Without proper observation there seems to be no way that the medical team could form their own professional judgment as to the appropriateness of any action.

That makes sense to a degree. But without controlled studies how do the staff know what is the appropriate way to deal with any particular set of problems? 'Professional judgment' may be good common sense but historically it has mostly been bullshit. The teams at present constantly talk about individualising treatment. But how do they know how to do that if they don't even know if any treatment works?

In essence to use 'professional judgement' you have to have some sort of theoretical model with which to judge what to do. We don't have a validated theoretical model. So leaving things to professional judgment seems to me to be giving anyone with their own theories about what is wrong with you carte blanche. And that seems to be the problem we are in already.

 

[Peter T]

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.

My personal prejudice would be to react strongly against sleep standardisation, however in discussion forums a, for me surprising, number of people do report very structured standardised sleep patterns help them. Though off the top of my head it was mainly people with mild to moderate impairment still trying to work and/or look after their families.

 

[Jonathan Edwards]

But over how many days would you think one would have to follow a sleep routine to have sufficient evidence whether it helps or does harm?

I would guess at comparing plans in place over a period of say six months.

It is not that anyone has to follow the sleep routine, if it is problematic. It is simply suggesting that it is proposed as a plan to try - with no value judgment attached.

 

[Milo]

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

For me, being sleep deprived does not result in more sleepiness during the day, it means feeling sicker and sicker. And trying to fall asleep earlier results in me staring at the ceiling and turning from side to side. My sleep schedule works for me, using sleep aids.

Recommendations of sleep hygiene were revolting to me (don’t use the bed during the day, sleep regulation, etc) and i assume are quite impratical for ME patients that need to lay flat in a dark room away from noise and other people’s movement.

Lastly when a patient says that something helps them, they mean that they feel a fraction better using this modality, but it doesn’t mean they are cured. And the reason they are a fraction better may be due to the modality itself or it could be due to placebo or the sense of control they have over their symptoms. For instance some may feel better when they say their prayers. It does not mean they are cured, and we do not know whether their God was truly listening and applied Divinity.

 

[wigglethemouse]

Have you thought of contacting Dr. Lucinda Bateman? She is chairing a group writing a clinical consensus document which will be written and signed off on by the US ME/CFS clinicians coalition. While you probably cannot use something that has not yet been published, she might know of some existing literature that could be useful.

 

[chrisb]

In essence to use 'professional judgement' you have to have some sort of theoretical model with which to judge what to do. We don't have a validated theoretical model. So leaving things to professional judgment seems to me to be giving anyone with their own theories about what is wrong with you carte blanche. And that seems to be the problem we are in already.

Certainly, but the problem seems to me to be that there is unlikely to be a "one size fits all solution". My gut feeling is strongly against sleep modification. Abnormal sleep is a consequence, not a cause, of the illness. If it is found to be a cause the patient was suffering from sleep deprivation. There is always going to have to be some degree of judgment exercised. I am sure we can all think of those whose judgment we would trust, or not.

 

[lunarainbows]

Hi Jonathan Edwards, @Jonathan Edwards
I have severe M.E and live in south London, my mum has functional neurological disorder and is my carer and struggles greatly. I have had M.E for 4 years now and have had very little in the way of help (and the “help” I did have was disastrous - I was on the PRINCE secondary trial which pushed me from moderate to severe and have never recovered).

I would say, please, please, please raise the very important issue that severe M.E patients mostly become too unwell to travel (and going into hospital appointments can make them very unwell), so what that means is severe M.E patients are unable to access care for other conditions that may be greatly needed. My mum was speaking to a lovely doctor today at our local hospital who understands M.E and said the same thing - that this is something that needs to be recognised. For example, I think it is recognised that at least a proportion of M.E patients have PoTS, yet we mostly cannot do the tilt table test. In my case, a doctor I saw 2 years ago was happy to proceed with trying Ivabradine on a trial basis just based on the results of my echocardiogram and holter, and yes it has helped me. My heart rate was horrendous otherwise. But now I’m having tests for thyroid - but if anything is found, I can’t go in and outs of hospital because even one visit in a private ambulance 20 mins away is enough to make me so sick that I’m unable to eat solid food for a week.

I really think severe M.E patients all need a dedicated doctor and dedicated nurse who would liase with other medical professionals to do as much as they can (I understand limitations) to provide medical care in a persons home. So something like creating a small national network of M.E doctors (cardiologists, endocrinologists, at the very least well trained GPs who could liase with those specialists), and nurses specifically for severe M.E patients who would be willing to travel to our homes and do basic tests there. Because I cannot stress just how panic inducing it is, to be so unwell that you cannot even go into the hospital! At the moment I rely only on my nurse, and all she can do is an asthma check. I have lupus and yet I haven’t seen my lupus doctor in 3 years.

(Edit:another addition may be also M.E trained physios (note, not “normal” physios), to help with 1-2 small movements while in bed, that help us keep some strength in our bodies as we cannot move much, in the same way that physios help others with serious life limiting conditions. But they must be well trained in how serious severe M.E is and on PEM, pain and so on. Currently there’s very little help nationally on this).

I know this is a complex issue but really I think it’s essential.

 

[Milo]

In terms of building guidelines for very severe ME, one could take a look at what guidelines for similar diseases are, such as progressive MS or ALS, or Parkinson’s disease.

The commonalities would be that symptom management or palliative care would rank high when there is not much that can be done for their illness. What are the most disturbing symptoms and how to deal with them?

Then assistance with activities of daily living. Bathing, feeding, and bathroom related needs.

Socio-economic needs also rank high, so the patient is not constantly worried about whether they will get cut-off from benefits or forced back to work.

 

[Jonathan Edwards]

Maybe take a look at this book. Seems like some clinics are sharing it.

The comments on Amazon are not very encouraging. It sounds as if the author knows all the answers - for some reason that is not clear.