Sorry, there are a lot of replies and I don't really have time or motivation to go through them all. I'm aware of the issues. The point is that they can be mitigated to a certain extent (e.g. having an attention control as a comparitor, as in this trial). There will always be bias when there are subjective measures. As I pointed out in an earlier reply today, pain is subjective, so there is no other option than having a subjective outcome. That doesn't mean that we shouldn't bother doing any research. As I said in the previous comment to hutan: how do you believe studies like this could be better?
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Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain an RCT, 2021, Asher, Gordon et al
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Sorry, there are a lot of replies and I don't really have time or motivation to go through them all. I'm aware of the issues. The point is that they can be mitigated to a certain extent (e.g. having an attention control as a comparitor, as in this trial). There will always be bias when there are subjective measures. As I pointed out in an earlier reply today, pain is subjective, so there is no other option than having a subjective outcome. That doesn't mean that we shouldn't bother doing any research. As I said in the previous comment to hutan: how do you believe studies like this could be better?
Have you looked at the neuroscience?
Yes, I agree the placebo is terrible in this case. I agree with another poster that it should be a different psychological treatment, perhaps relaxation therapy.
Jonathan Edwards
Senior Member (Voting Rights)
Yes, I spend much of my time working on perception. I spent much of today checking through the neuroscience quoted in the Brain Retraining/ Pain Reprocessing literature. It is just handwaving importation of buzzwords. Neuroscience is not sufficiently advanced to make any real difference to theories of pain causation in disease that might be relevant to these treatment programmes. This is not real science. Sorry, but having spent my life in translational medicine and trial design I do have some practical knowledge of this.
rvallee
Senior Member (Voting Rights)
I think we can even extend that and say that most actions have no rational basis. What they do usually have is a consistent action-and-outcome sequence. That is, doing X results in Y, and Y is desirable, so then is doing X. It's possible, even likely, that it does for completely different reasons than any person would decide is why they do X in the expectation of Y, when the simple explanation is simply that Y occurs, and humans simply don't have the capacity to do much more.
This is why figuring things out is so hard. In fact it's so hard that history is mainly made of two things: wars (and generally breaking stuff), and figuring out how things work, and the impacts it has.
Because it usually doesn't matter if the reasons we do things are rational, all that matters in most cases is that by doing X, we get Y, and when we want Y, then it can be deemed somewhat rational, but the internal rationalizations people have about how X lead to Y are almost always wrong. Because most people are wrong about most things. This is why almost all of us have to go to school for 12 or so years. And it's not a bad thing, it's just that figuring things out from scratch is usually impossible, and almost never happens.
Sasha
Senior Member (Voting Rights)
Fair enough but this is the fundamental issue and the reason why you're finding no agreement with your position here.
But 'mitigated to a certain extent' isn't good enough if you're trying to draw conclusions about whether a therapy works. You can never know to what extent you've failed to mitigate and therefore you can't interpret any results.
It means exactly that, if that research is an open-label trial with subjective measures.
I can't think of a solution to the problem. Maybe @Jonathan Edwards knows of a solution. But if there isn't one, that doesn't mean that open-label/subjective-measures studies should continue just because there's no better way of doing them. Such studies have no value and should be stopped. It's not ethical to waste patients' time and effort by putting them through worthless research.
Utsikt
Senior Member (Voting Rights)
Does this mean that you support doing studies that can’t possibly (edit: or reasonably) provide any useful information?
Do you think that’s an acceptable use of resources, on an economic, societal and ethical level?
It seems to me like you fail to consider that ‘their best’ might not be ‘good enough’ at all. We can’t just lower the scientific standards to accommodate pseudoscience.
rvallee
Senior Member (Voting Rights)
Plus, I don't see how this is much different than Deepak Chopra-esque invocation of quantum this and that. Quantum field theory is the most tested scientific theory we have. It is valid, useful, correct, predictive. It doesn't mean that it can be invoked to explain consciousness, and other things that we don't understand.
But the current level of neuroscience is many orders of magnitude below that. Hence why it's almost always invoked in the same vaguely generic: look at the neuroscience. The. Neuroscience. It's just an invocation, neuroscience is very far from being advanced enough to explain those things.
It has certainly shown that pain is experience bidirectionally with the brain, but not how. As textbook example of how a little knowledge can be dangerous. So damn dangerous it has destroyed millions of lives. Including mine, which I very much resent, but would just as much by itself if it didn't happen to me. It's just wrong.
The article gives references to the current state of pain neuroscience in the first four paragraphs. How exactly is the study not consistent with that evidence?
No, it's not true that they can't provide "any useful information". As I said, with appropriate methodology, bias can be minimized, and you can provide useful information.
Actually, this is not true (and I've given detailed and logical reasons why) and is not the opinion of the wider scientific community. It's a little odd that it is the overwhelming opinion of s4me, which is why I only spend a limited amount of time responding here. Perhaps you should invite more scientists to contribute here who work in this area.
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Utsikt
Senior Member (Voting Rights)
If you are going to state that as a fact, I suggest that you prove your assertion by providing a description of study design you believe is suited to provide valuable information about any psychosomatic aspects of ME/CFS.
If you can’t do that, you can’t claim that it’s true. That would be fine, but then you would have to be clear that it’s your guess and not a fact.
Utsikt
Senior Member (Voting Rights)
As per my post above - please provide a concrete example that is applicable for the specific situation of ME/CFS.
Nobody here care about opinions - they are often wrong. We care about facts and proofs.
Utsikt
Senior Member (Voting Rights)
I think he said that the ‘evidence’ and the ‘current state of neuroscience’ is quite bad.
Jonathan Edwards
Senior Member (Voting Rights)
No but it does mean that we need to stop doing useless research and find better ways of assessing theories. I review ME/CFS research projects for major funding bodies internationally and would have no problem recommending a project on Brain Retraining or whatever if there was any science there and any attention to basic methodology. But what I have seen would not encourage me to do so..
The key message of PACE is that the treatments being tested really don't do very much at all even if they do something. And we know that exposure to such treatments has a lot of unwanted effects. Even if you think the problem is psychological amplification the treatments must be considered major failures just because so many people end up seriously aggrieved. It isn't actually that difficult to get a result even with serious methodological problems if you have a treatment that makes a big impact, as these biopsychosocial-type approaches are claimed to do. More objective surrogate outcomes are perfectly good enough if we think people are actually going to recover.
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Sasha
Senior Member (Voting Rights)
You've given reasons that you believe to be logical but you don't seem to be taking in the counter-arguments, such as the one I just made.
That's an appeal to authority rather than logic, but the people who do double-blind placebo-controlled drug trials would, I expect, share my opinion (and that of others here) about open-label, subjective-measure trials.
It's not odd at all, because most of the trials done in ME/CFS are of this poor type and so we're very familiar with the issues.
BPS scientists have always been free to join, but when pressed on this particular issue in other arenas, they dodge it. They're calling themselves scientists without actually being so.
It's not that hard to think of things that might make a better study. Perhaps the people that you should be asking, dundrum, are the researchers who are currently producing these low quality studies. First, they need to accept that they are currently producing studies that are a waste of everyone's time.
Here are some ideas, off the top of my head:
Researcher equipoise and bias management
Not all of the researchers on the team should be biased to getting a positive result for the treatment. Ideally, the trial would be run entirely by people whose careers/reputations/ financial income would not be affected by the result. Then, there should be bias management wherever possible. So, for example, the protocol should be written and posted/published in advance of the study, and it should be followed.
Data analysis could be undertaken by people with equipoise and blinded to the interventions associated with the groups. The data should be open access, so other researchers can examine it.
Participant selection
Participants should be selected as much as possible in a way that does not select for people with a strong belief that the intervention will work. This can be difficult, as there is typically bias in people who are referred to a particular clinic and even more in those willing to take time to participate in a study. Recruitment of volunteers by posters or online ads is very bad though. Going to GPs and asking for their help can be good, so long as the researchers have not cherry picked GPs who believe in the therapy. Whatever is done, it is important to quantify the entire population and show the selection ratios for the study.
People should be selected that have had the pain/problem for a sufficiently long time, to eliminate those who only have a temporary problem. People should be selected who have the pain/problem to a sufficiently severe degree that it is really clear that they have a problem. Ideally, there should be some functional impact as a result of the problem e.g. unable to walk, unable to walk at a normal speed or for more than a specific distance, a low level of daily activity, unable to work...
Participants could be asked about their beliefs that the treatments will work, before the intervention starts, so that relationships between that pre-existing belief and responses (and drop outs) can be assessed.
Study size and duration
The size needs to be large enough. What that means will vary, but there probably should be at least 30 people in each treatment. The study needs to last a sufficiently long time. That normally means more than 6 months after the last contact with the therapist.
Controls
There should normally be a control intervention that is plausible to the participants. There are ways to do that, especially with pain because there are actual treatments (painkillers).
You could chop the psychological intervention up into its component parts and see the effect of each one. So, if you are teaching pain distraction techniques, goal setting and meditation, with 'tea, biscuit and group chat', or whatever, you could have groups doing just one of the components, or two, or the whole lot. You could have separate therapists for each component, so they wouldn't know which participants were getting the supposed 'therapeutic package'. If all of the groups (with one or a combination of treatments) had similar results, then you could conclude that nothing did anything much.
Outcomes
Somehow, I've lost some of what I wrote for some of the headings and all of what I wrote for this one. So I'll just jot down some of the points I remember.
This idea that because pain is a subjective feeling, the outcomes can only be subjective is complete nonsense.
Objective outcomes are possible, because a condition typically has a functional impact.
I agree that the 6 minute walk test isn't useful for mild ME/CFS, or any condition where people can walk at normal speed for six minutes. But, it can be ok for some conditions. Activity levels, measured with monitors. If sleep is affected, then some measure of sleep fragmentation, measured with a monitor. Use of drugs for pain relief.
Subjective measures as adjuncts can be ok - e.g. a simple measure of change in quality of life. Subjective measures of pain or fatigue should be taken as close to real time as possible e.g. with an app 'what is your pain level right now?', rather than something like 'what level has your pain been over the last month?'
There should be time between the intervention and all the enthusiasm and hope that goes with it, and the primary outcome assessment.
@dundrum, Do you agree that the study that is the subject of this thread is not good enough to be useful evidence about pain reprocessing works, other than, at best, it's scarcely better than an open label placebo? What do you believe a good study would look like?
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Some posts about an Irish functional medicine clinic have been moved here:
Ireland: Drummartin Functional Medicine Clinic
Ireland: Drummartin Functional Medicine Clinic
I agree with all your points.
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Snow Leopard
Senior Member (Voting Rights)
The critical point is that those circuits regulate attentional and behavioural responses to pain (something that is very important to animal survival). Those circuits cannot cause pain on their own and while behavioural responses can potentially be modified, the attentional and emotional responses are much more hard-wired than some medical practitioners or psychologists suggest.
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