Lightning Process study in Norway - Given Ethics Approval February 2022

Midnattsol said:
The problem with this would be the difference between different scientific fields, and a difference of opinion about what is important to research. For example, blinding will be hard/impossible in some fields due to the nature of the interventions used. And how the control group should be treated (or not ;) ) would depend on the goal of the study. I don't think dismissing "stepped wedge" as a bad design is useful for us, but explaining why it's not a good design for ME/CFS (the fluctuating symptoms like @Invisible Woman brought up) might work.
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I agree, in this case, unless ive missed something, I think the problem is that the nature of the intervention is to hype patients up to believe they are healthy. Obviously this will then affect their subjective outcomes, especially early on, making it important to have a long follow up where u can also exclude placebo somewhat. And also to check via objective measures how the subjective and objective endpoints correlate. I dont mind stepped wedge in some scenarios either, but here it just seems to me to make the study far worse
 
Could be worth mentioning the claims of Parker's super-natural healing abilities:

eg: "He discovered that their bodies would suddenly tell him important bits of information about them and their past, which to his surprise turned out to be factually correct! He further developed this ability to step into other people’s bodies over the years to assist them in their healing with amazing results. After working as a healer for 20 years, Phil Parker has developed a powerful and magical program to help you unlock your natural healing abilities."

https://www.virology.ws/2017/12/13/trial-by-error-the-smile-trials-undisclosed-outcomes/

The sort of people who believe that Phil Parker's techniques are a priority for research funding may not be the most rigorous minded.
 
A norwegian blog (I read with google translate) made the point that we don't know much about rates of spontaneous recovery in the first years of ME/CFS. This point together with the fact that Landmark wants to treat newly ill patients and that there is no long-term control group, not even an unblinded one, is very problematic.
https://lillemeglede.wordpress.com/2020/05/01/hvordan-designe-en-darlig-studie/
 
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A comment not directed at including for a journalist but a point I think that may be an issue.

Even if there is a truly independent statistical analysis this cannot be construed as validating the results until and unless the data is available for others to analyse.

I believe we've seen that not all statisticians understand statistical analysis despite the expectation that they should know what they're doing. It's unclear, at least to me at this point that using statistical analysis is straight forward and obvious as to how it should be done.

In fact I think that it might benefit scientific research if there was more discussion around how what manner of statistic analysis would yield an interpretation of data that best matches what we can truly be confident of.(Awkwardly worded)*

*I am way out of my depth talking about this so I'd be happy for correction to my thinking and hearing more on the subject.

Also (out of my depth) but my prior point also means that the data needs to transparently available in a format that is amenable to confirming that not only that the analysis is valid but that the data itself is valid since I imagine one can do a really good analysis of the data but if the data is corrupt then the analysis is moot.

My above thinking puts me in mind of the loud defence of (apologies can't remember which paper) where because the researchers had all the right boxes ticked off regarding ethics (ah, maybe a EC paper?) that the paper was seen as valid simply because the ethics people failed in their duty.

Also, I very much agree regarding Trish's point being crucial.
 
My brain is struggling at the minute so please forgive if this is repetition-

Do we know if harms are identified as part of the design?

When a patient tells their LP practitioner that their condition has become worse, the protocol is to encourage the patient to work harder at practicing the therapy.

There doesn't seem to be any mechanism with LP for the patient to report harm & receive any other response than some version of keep doing it and try harder regardless of the reason & level of deterioration.

This is unethical. Patients may deteriorate to the extent they lose their current level of function, perhaps left no longer able to work part time, study or live independently. LP therapy does not allow patients to be informed of possible harms & so patients cannot give informed consent.
 
It is a given that LP will harm many ME-patients. Especially thinking of longstanding patients, that for a number of reasons, more than anything motivation and exceptional endurance, in many ways have done exactly what LP says you’re supposed to do, just carry on. Well, we know quite a lot of how a long push-crash cycle turns ut. This approach have had a profound and deteriorating consequence for many patients. Thats without LP, managing as best as you can, trying to keep things going. And it should be of no surprise that if you add LP to this approach (which many patients have experienced), it might just add substantially more harm.

The gigantic problem for a majority of patients, is that the model for LP is completely rotten, whether you call it avoidance of doing, cause of fear of consequences, or whatever. It is just bizarre. Patients mentioned, that being the majority of patients, that have done exactly the opposite of what the LP-model is based upon, have absolutely no value of LP, quite the contrary. But how can you include such patients? I find it hard to believe that these type of patients, that haven’t taken LP before, would try it, knowing the model which is nothing else than insane? And what about the same type of patients, that already also have done LP? Should they, if they have any capacity left at all, do LP again? Who’s willing to do that? There are numerous ethical and methodical challenges.
 
Marky said:
I agree, in this case, unless ive missed something, I think the problem is that the nature of the intervention is to hype patients up to believe they are healthy. Obviously this will then affect their subjective outcomes, especially early on, making it important to have a long follow up where u can also exclude placebo somewhat. And also to check via objective measures how the subjective and objective endpoints correlate. I dont mind stepped wedge in some scenarios either, but here it just seems to me to make the study far worse
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It does, but explaining why is crucial, else we'll just hear about how it is a validated study design yada yada yada...


Snowdrop said:
A comment not directed at including for a journalist but a point I think that may be an issue.

Even if there is a truly independent statistical analysis this cannot be construed as validating the results until and unless the data is available for others to analyse.

I believe we've seen that not all statisticians understand statistical analysis despite the expectation that they should know what they're doing. It's unclear, at least to me at this point that using statistical analysis is straight forward and obvious as to how it should be done.

In fact I think that it might benefit scientific research if there was more discussion around how what manner of statistic analysis would yield an interpretation of data that best matches what we can truly be confident of.(Awkwardly worded)*

*I am way out of my depth talking about this so I'd be happy for correction to my thinking and hearing more on the subject.

Also (out of my depth) but my prior point also means that the data needs to transparently available in a format that is amenable to confirming that not only that the analysis is valid but that the data itself is valid since I imagine one can do a really good analysis of the data but if the data is corrupt then the analysis is moot.

My above thinking puts me in mind of the loud defence of (apologies can't remember which paper) where because the researchers had all the right boxes ticked off regarding ethics (ah, maybe a EC paper?) that the paper was seen as valid simply because the ethics people failed in their duty.

Also, I very much agree regarding Trish's point being crucial.
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Regarding your last point, I don't think the problem with people claiming PACE is ok due to HRA saying so is because they're bad at statistics, they just don't understand the HRA report.. :p

Regarding the first one: I doubt most studies have their own statistician doing analysis. So people do what they've been taught, and the level of understanding will vary. There's been som studies about the many statistical shortcomings found in published research.

The wrong tests may be used, they might be interpreted wrong etc. It's a huge problem, but if you just have a statistician you might end up losing clinically relevant findings because the statistician doesn't know what they are, or you'll get some "statistical significant" finding that means zero in a clinical sense. Collaboration would be nice, but I don't think it's feasible to get a statistician to overlook everything that is done in every research group, and yes the statisticians themselves might not be good at what they do.

(No I am not banging my head against the wall trying to find the best way to analyse metabolomics and being frustrated by the lack of proper guidelines for newbies like me :whistle:)
 
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Only able to skim and not able to write anything coherent at the moment, so just dropping some lines here I drafted for another purpose a while ago -- in case there is something useful in it for you, @Marky -- and thanks for your work on this!

Kalliope said:
Article about the study in the newspaper Dagsavisen Fremtiden.
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"Previously, Parker advertised that LP could treat everything from rashes, stage fright and hay fever - to ME and Multiple Sclerosis (MS), but this has now been removed from the website."

I'm sure Phil Parker has a skilled legal adviser.

Parker still has links to 'research', also on MS on his website, just doesn't spell out himself that his trademarked 'Lightning Process' should explicitly work for MS:

https://web.archive.org/web/20200514060942/https://lightningprocess.com/research/

Instead he says LP is "suitable" for anyone who...

"know(s) how it feels to

"…be stuck with re-occurring pain, health symptoms and issues?

"…want a better life and health but just can’t find anything that works?"

etc.

https://lightningprocess.com/is-it-suitable-for-me/

This includes any chronic illness, also MS.

For people who can relate to those questions he words the "the kind of changes you can expect", where the strongest claim about an effect of one's illness is:

"After the seminar
You will learn to balance your recovery with sensible levels of activity, whilst using your new skills to assist your physiology to improve so you can comfortably do more. "

It's on the basis of learning, and the premise of this learning "is that they are pathways that don’t help your health to flourish" that it is possible to "switch on pathways that will directly change how your physiology works".

And any potential "unpleasant" effects are resolvable "by seeking the support of your coach and using the tailored tools of the LP in a compassionate way."

"Are there any unpleasant side-effects or downsides?
In our 21 years of experience, and supported by recent research with the University of Bristol, applying these compassionate and gentle brain and body retraining techniques in alignment with the training and with the help of a supportive coach will not produce downsides or unpleasant side-effects.

"Unsurprisingly, not putting the skills into to practice is unlikely to improve your health from its pre-course state. In this case, depending on your issues, the effort of travelling and attending the course, or the emotional upset of not getting what you hoped for, may have the usual kinds of effects on your wellbeing. These however can be resolved by seeking the support of your coach and using the tailored tools of the LP in a compassionate way."
 
Midnattsol said:
It does, but explaining why is crucial, else we'll just hear about how it is a validated study design yada yada yada...



Regarding your last point, I don't think the problem with people claiming PACE is ok due to HRA saying so is because they're bad at statistics, they just don't understand the HRA report.. :p

Regarding the first one: I doubt most studies have their own statistician doing analysis. So people do what they've been taught, and the level of understanding will vary. There's been som studies about the many statistical shortcomings found in published research.

The wrong tests may be used, they might be interpreted wrong etc. It's a huge problem, but if you just have a statistician you might end up losing clinically relevant findings because the statistician doesn't know what they are. Collaboration would be nice, but I don't think it's feasible to get a statistician to overlook everything that is done in every research group, and yes the statisticians themselves might not be good at what they do.

(No I am not banging my head against the wall trying to find the best way to analyse metabolomics and being frustrated by the lack of proper guidelines for newbies like me :whistle:)
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I see the confusion. Although I was comparing the result the two issues are different. One was an issue of ethics. The other is an issue of 'well the stat analysis says . . .' as a different way of validating a piece of work that is fraught with problems. Different boxes being ticked but same problem in terms of thinking a piece of research is valid as a result.

Hope that clarifies.
 
Which pathways, is their any biomedical evidence that these pathways exist, and if there is, is there any that suggest that these pathways are indeed activated by positive thoughts and shouting at circles. and.....is there any evidence, that if they do exist in a biomedical sense, that if activated, they will do squat useful for pwME?

Where is all the research to back up these claims, the claims of a , person with a leaning towards very aggressive promotion of 'treatment', in the manner of a cult?
 
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It is quite a dilemma. It would be terrific if we could settle the total lack of effect, the harmful effect of LP for the vast majority of ME-patients once and for all. If done properly, this study would bury LP as a sound intervention for approx 9/10 of correctly diagnosed ME-patients. But the done properly-bit is tricky and close to impossible.

It is a shame that a study like this have the blessing of institutions, most of all cause they don’t have proper knowledge of the situation. But a blessing seems easy, and the institutions could point to giving the cause interest and actually doing something. Thats just lazy and sad. The dilemma is that there are so many things that should have been done prior to a study on LP. If the ones responsible actually did that, did the job and looked in to the chaotic situation and sorted out a thing or three, I doubt that the same people would give they’re blessing to a study like this.

Authorities should do things that are in favor of the majority of patients, not produces a study on a bizarre alternative method that may work for a minority of patients for many different and problematic reasons. I find the narrative we- just- don’t- know- anything-, so-we- can- do- almost- anything, untrue and unethical. Unfortunately valuable resources are thrown in the bin. On the positive side, the study will, if done in a proper way, if at all possible? dig LPs grave once and for all. Maybe naive, but trying to see something positive here.
 
Peter said:
It is quite a dilemma. It would be terrific if we could settle the total lack of effect, the harmful effect of LP for the vast majority of ME-patients once and for all. If done properly, this study would bury LP as a sound intervention for approx 9/10 of correctly diagnosed ME-patients. But the done properly-bit is tricky and close to impossible.

It is a shame that a study like this have the blessing of institutions, most of all cause they don’t have proper knowledge of the situation. But a blessing seems easy, and the institutions could point to giving the cause interest and actually doing something. Thats just lazy and sad. The dilemma is that there are so many things that should have been done prior to a study on LP. If the ones responsible actually did that, did the job and looked in to the chaotic situation and sorted out a thing or three, I doubt that the same people would give they’re blessing to a study like this.

Authorities should do things that are in favor of the majority of patients, not produces a study on a bizarre alternative method that may work for a minority of patients for many different and problematic reasons. I find the narrative we- just- don’t- know- anything-, so-we- can- do- almost- anything, untrue and unethical. Unfortunately valuable resources are thrown in the bin. On the positive side, the study will, if done in a proper way, if at all possible? dig LPs grave once and for all. Maybe naive, but trying to see something positive here.
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Good points.

I am 95 perc sure that if the study goes ahead in its present form it they will get statistically significant results from the questionnaires even though the majority of the responders are still physically disabled and on benefits
 
Marky said:
Good points.

I am 95 perc sure that if the study goes ahead in its present form it they will get statistically significant results from the questionnaires even though the majority of the responders are still physically disabled and on benefits
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Or it could be that the people chosen are those most likely to improve naturally anyway. With young people, new PVFS, etc there can be high rates of natural recovery.

Or it could be that LP is a wonder cure.
 
So many problems even before the study gets started.

It really is incredibly hard to imagine that a person vested in the LP as their vocation would be involved in a study that might have the potential to yield negative results.

Just for consideration here is a copy of the amount of and cost of training to be a practitioner.

And just a random observation: the LP practitioners routinely offer 'refresher' courses. So not necessarily a one time and you're fixed situation. (IMO this makes sense since it's nothing more than brain-washing).
 
Peter said:
It is quite a dilemma. It would be terrific if we could settle the total lack of effect, the harmful effect of LP for the vast majority of ME-patients once and for all. If done properly, this study would bury LP as a sound intervention for approx 9/10 of correctly diagnosed ME-patients. But the done properly-bit is tricky and close to impossible.

It is a shame that a study like this have the blessing of institutions, most of all cause they don’t have proper knowledge of the situation. But a blessing seems easy, and the institutions could point to giving the cause interest and actually doing something. Thats just lazy and sad. The dilemma is that there are so many things that should have been done prior to a study on LP. If the ones responsible actually did that, did the job and looked in to the chaotic situation and sorted out a thing or three, I doubt that the same people would give they’re blessing to a study like this.

Authorities should do things that are in favor of the majority of patients, not produces a study on a bizarre alternative method that may work for a minority of patients for many different and problematic reasons. I find the narrative we- just- don’t- know- anything-, so-we- can- do- almost- anything, untrue and unethical. Unfortunately valuable resources are thrown in the bin. On the positive side, the study will, if done in a proper way, if at all possible? dig LPs grave once and for all. Maybe naive, but trying to see something positive here.
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Honestly as long as the CBT-GET paradigm remains, I have no issues with LP being up there with it. They are equally worthless and have identical "effectiveness" (0=0) so the more LP gets exposure, which will inevitably end up in shameful embarrassment, the more it splashes on the ideology.

I really don't find any significant difference between LP, CBT and GET. Or "the switch". Or The Secret. Or shoving pennies up the ass. Anyone who promotes any of those has forever voided any pretense of expertise or credibility. Putting them on equal grounds will only work to show just how blatantly absurd the entire thing is.

Really this is a jumping the shark thing. It's still worth pointing all the absurdity, putting it on record, it will only show that actually it's the patient community that values science while the charlatans who have choked this entire disease into death and suffering are nothing but quacks and snake oil peddlers.

Go hog wild on the LP. Do cow urine baths. Try homeopathic treatments stirred with a dildo. (Not your dildo, always a dildo.) Shred The Secret into confetti and turn that into a treatment party. Who gives a damn? Let them show they are nothing but quacks.
 
rvallee said:
Honestly as long as the CBT-GET paradigm remains, I have no issues with LP being up there with it. They are equally worthless and have identical "effectiveness" (0=0) so the more LP gets exposure, which will inevitably end up in shameful embarrassment, the more it splashes on the ideology.

I really don't find any significant difference between LP, CBT and GET. Or "the switch". Or The Secret. Or shoving pennies up the ass. Anyone who promotes any of those has forever voided any pretense of expertise or credibility. Putting them on equal grounds will only work to show just how blatantly absurd the entire thing is.

Really this is a jumping the shark thing. It's still worth pointing all the absurdity, putting it on record, it will only show that actually it's the patient community that values science while the charlatans who have choked this entire disease into death and suffering are nothing but quacks and snake oil peddlers.

Go hog wild on the LP. Do cow urine baths. Try homeopathic treatments stirred with a dildo. (Not your dildo, always a dildo.) Shred The Secret into confetti and turn that into a treatment party. Who gives a damn? Let them show they are nothing but quacks.
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Yes.

Both CBT and LP are equally fundamentally wrong, when intervening like taking care of root cause. That is just an horrible way to approach ME.

But I actually think LP is far more dangerous than CBT. In most cases CBT will give zero effect, may also harm. But LP will to a greater extent cause serious and irreversible harm to patients. I imagine that more cases of CBT actually will stop, if recognizing zero effect/harm, but that is often not the case with LP. The chance of being a good student, plugging on “brainwashed” for way to long, even when experiencing you’re heading in the wrong direction, are far greater if doing LP. . The mantra of “you are doing ME” has the potential of really turning everything upside down, and is exactly what cause a lot of harm for so many.
 
Esther12 said:
Or it could be that the people chosen are those most likely to improve naturally anyway. With young people, new PVFS, etc there can be high rates of natural recovery.

Or it could be that LP is a wonder cure.
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Yes but that will still be camouflaged by the fact that the study is rigged in the sense that its a part of the intervention to say ur healthy
 
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