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

Just that they seemed to deserve priority. `The idea would be equally applicable to moderate or ,mild I guess.

 

If there is I am not aware of anything formalised. It is just that professionals recognise the problems that occur if mobility is not maintained and various actions are standardly put in place.

 

It is weird that NICE is supposed to be so evidence-driven, yet then recommend treatments they openly acknowledge are unsupported by evidence, but on the basis it is widely supported by expert opinion! I appreciate that expert opinion is not necessarily to be dismissed lightly in a lot of cases. But I strongly suspect that medical experts' opinions will often be influenced by NICE guidelines ... which it seems can then contribute to NICE guidelines content. The risk of self-reinforcing but nebulous 'expert' opinions seems pretty high.

 

Who selects the experts?

 

Experts are, probably selected by experts.

As who else would you trust but an expert, to make such an important decision?

Of course the potential problem with this system is....

 

An interesting guideline.

It reinforces my impression that NICE is producing to sorts of guidelines. One lot is for things often treated with drugs which is strict on evidence - to reduce cost. The other is for things where there are no drugs so it makes sense to use therapist-delivered treatments or advice - to reduce cost. Nobody who is familiar with the first lot will tend to notice the second lot so it does not matter too much if it is a bit soft on evidence. It is also a great place to advertise IAPT.

 

For context, I have severe ME (housebound, not bedbound) and am/was a Speech & Language Therapist.

I like the idea of trying to see what, if anything, works, out of all of the management advice that is currently given. And what might do harm.

I would vote for doing these trials with people with moderate ME. If something looks like it might help those with moderate ME, to a disability-reducing extent, then we could think about a trial with severe/very severe patients.

I appreciate the desire to prioritise those with severe ME, but I’m just not sure the extent of the impact of any exertion/stimulation on those with severe ME is being taken into account here.

It seems to me that it is very, very easy to make someone with severe or very severe ME worse. I think that health professionals often look at someone with severe or very severe ME and think, the only way is up, and that is just not the case.

There was mention above of doing sleep studies at the beginning and end of a, maybe, 6 month trial. That is far too much exertion to expect from people with severe/very severe ME. Of the subset who would be able to travel to hospital and do the sleep study for a night, I suspect that many would be wiped out for weeks/months. Some would have a long-term deterioration. You could alter the outcome of the trial just by PEM-ing the patients with a baseline sleep study.

If I was going to get severe or very severe patients to do anything, even fill out a brief form twice in 6 months, I’d really want to have a very good reason for thinking that it was going to benefit them. I don’t think we’re even close to that point.

If we clarified what was helpful for people with moderate ME, we’d have somewhere to start. It would be less risky; they’re a more robust group, but far from healthy.

The MEA’s 2010 survey is interesting regarding sleep (see p.17-18 https://www.meassociation.org.uk/wp-content/uploads/MEA-Management-Survey-2010.pdf. Results are probably more representative of the moderate-mild groups than of the ME population as a whole. 15% of respondents rated their “current state of health” as “severely” affected by their illness, 57% moderately and 28% mildly.

Respondents rated 5 therapies for sleep – 3 drugs, relaxation techniques and sleep hygiene advice.

Sleep hygiene advice came last in terms of those reporting a good or moderate effect: 36%. This compares poorly with the 58.1% who reported a good or moderate effect with short-acting sleeping tablets and the 57.8% who reported a good or moderate effect with relaxation techniques.

Most – 47.6% - reported no change with sleep hygiene advice.

Based on this survey (MEA 2010), the thing most worth looking at would be relaxation techniques or drugs.

Sleep was a priority for patients, the top priority, actually, of the 6 symptom areas that were asked about in the survey. 77.4% wanted help with sleep problems from the NHS, compared to, say, 47.6% for bowel symptoms.

So it seems like a trial around sleep management could be a good idea.

 

Seems like a lot of it is just relying on things that are universally good advice, hence the whole "exercise is good for everyone therefore quality specific evidence is not required to recommend it". Same with good diet, sleep and exercise. They seem to make assumptions that since a cognitive-behavioral approach "works", then we must clearly make bad choices about these things (even though it's been checked and debunked).

Especially bad considering how much of medicine is about exceptions. Like they're shutting their brains down because they believe they're only dealing with a behavioral problem so exceptions don't apply.

 

Turtles?

 

Well I don’t know if it is common practice but it’s certainly not the correct practice according NICE’s own principles as set out in the document “SOCIAL VALUE JUDGEMENTS: Principles for the development of NICE guidance”. This from page 16:

My bold

https://www.nice.org.uk/Media/Defau...ples-for-the-development-of-NICE-guidance.pdf

 

How would measuring the trend in heart rate variability (HRV) work as an objective outcome?

Lowered HRV has been linked to all sorts of conditions, not just cardiac problems (e.g. sepsis, cancer progression, and more), so seems to be a measure of general health in some way.

Wikipedia notes: "Factors that affect the input are the baroreflex, thermoregulation, hormones, sleep-wake cycle, meals, physical activity, and stress."

My personal experience is that HRV tracks my ME state very closely. Not sure if there've been any studies published looking at this in ME?

The most accurate HRV is measured by chest strap but that would probably be too hard on very severe patients. But maybe a wristband or a ring on the finger would be acceptable, and still accurate enough to pick up any trends? (Though I think any experimentation with changing routines would better be tried by the moderate-severe first, too risky for the very severe.)

 

It is possible to do sleep studies at home. I don't know how reliable or intrusive they are. But a pilot study would be needed to check that the measurement process was not influencing outcomes as you say.

 

I want to say one thing when it comes to comparing what the BPS bunch proposed as compared to what patients would propose when it comes to guidelines for this disease. The BPS ideas about ME or CFS originated in their minds with theories that are not based in reality. It is something they made up. It does not resonate with what patients know to be true. And the results of the 8 million dollar PACE trial (the trial that was supposed to be the definitive proof of their ideas) support this conclusion. They might want to promote the BPS ideas as evidence-based, but that doesn't make it so.

Patients, however, have had years, decades, of personal experience of living with this disease and know it from the inside out. They have had to learn how to best live with ME/CFS, for the most part, without the help and support of the medical profession. Although there is variability in how patients experience this disease, and this disease can vary over time, the underlying issues of this disease are present in the stories of all ME/CFS patients. Physicians need to learn how to recognize this pattern. I really don't believe it is that difficult.

It may not be "evidenced-based" as such, but there is much to learn from patient experiences. The medical profession has to learn to listen to patients, and to respect what they have to say. Right now, that's really all we have due to the lack of sufficient medical research. I think these patient experiences should guide the guidelines if the medical profession really wants to help patients..

 

Dear Willow,
You are correct: who more than patients and their caregivers can give insight to what this illness does, and how to best cope with it. That said, I don't think I'm wrong, however, in saying that I wish instead there was more "sufficient medical research" instead of anything else. I think that the desperation, the utter sheer urgency, the daily misery is somehow getting lost. Imagine if you stuck a knife into someone: yes, they might try to find a position where it might not hurt so much. But as the days and months and years would go by, the horror of the pain would start to really change the person and they would cry out for relief or an end. Sadly, I just find this is not understood at all. The horror of this illness is just not grasped: it is anti life in every way. For my part, I am desperate for the doctors and researchers to please find some help for all the young people soldered to their beds.

 

Thank you @Perrier for your eloquent reply. You are, of course, right. Your despair and cry for help for all those suffering from this horrible disease touches my heart. If only the powers that be would wake up to the totality of the suffering this disease causes to us and our loved ones, and finally resolve to do something about it. We have waited far too long for a proper response from them. In the meantime, I don't want them producing guidelines that repeat the mistakes of the prior guidelines because they hang on to mistaken ideas promulgated by those who truly do not grasp (or choose not to grasp) what this disease is. That would be a disaster to our whole ME/CFS Community.

 

Another thing that has caused us a great deal of harm and needs to change is the notion that ME or CFS is "unexplained fatigue with no medical cause." The emphasis on fatigue is problematic and misleading in itself, but setting that aside for the time being is the notion of unexplained fatigue. In my mind, the fatigue is explained. It's explained by the disease ME. Not knowing a lot about what causes ME, does not equate to not knowing anything about it, or that the disease itself doesn't exist. We see it every day in the lives of those around us who have had the misfortune to come down with it. And the entire phrase "unexplained fatigue with no medical cause" leads too quickly to the assumption that it must therefore be psychological. How we have developed and use these phrases matter. We must not be so arrogant as to think that just because we presently do not know something, it therefore must not exist.

A worry I have is that it seems to me the number of people affected by ME continues to increase. I don't have proof of that, but that is how it seems to me. If that is so, then I would think that would be a motivating factor to increase the efforts to find its cause so that we can learn how to prevent ever increasing numbers of people becoming disabled. I would think that this would catch the attention of governments and the medical community. But, so far, that hasn't seemed to happen.

 

How many moderate / severe patients take supplements? I suspect there are common combinations, but overall these may be idiosyncratic.
How to you modulate for these?
Do you take these into assessment?

Eg my aunt is bedbound. She had horrendous tachicardic episodes. Injected magnesium has made a difference - or was it the combination of this with the other supplements she takes- or would it have got better anyway?

The same goes for sleep/ activity