Lightning Process study in Norway - Given Ethics Approval February 2022

Thanks for sharing. It is interesting. I used to meditate and thought it would be a way to control the illness but eventually gave up because it made things worse. I know from this practice that one can learn to reach blissful and other pleasant and powerful emotional states through meditation. LP might be a way for some to do something similar. But the idea that this is a treatment for illness is an illusion.

 

I've posted this in the main thread on the Crawley trial but thought it worth posting this here due to

https://edzardernst.com/2020/06/the-lightning-process-implausible-unproven-hyped-and-expensive/

ETA: His tweet
https://twitter.com/user/status/1267366911727337472

 

Thanks Andy. I think it could be useful to leave comments to show that this is an important topic. Maybe it will help attract some attention from readers that otherwise have no contact with the topics ME/CFS or LP.

 

One has to wonder whether this has now become some sort of design feature for these trials?

- Set up some apparently strong objective outcomes that would make the trial look fantastic if the outcome measure produced positive results.

- When setting these objective outcomes, make sure in advance that there is a readily available “reasonable flaw” that can be “discovered” in the process of the trial.

- Set up easily manipulated subjective outcome measures as secondary outcomes.

- Implement the “reasonable flaw” if the primary (objective) outcome measure fails to produce the desired result.

- Substitute a secondary (subjective) outcome as the primary outcome so that the desired result may still be reported??

 

Edzard Ernst asks:

Could anyone from Norway give the latest info on this?

 

NTNU (The Norwegian University of Science and Technology) is involved with the study and Live Landmark is doing a PHD on this project. Some of it has been funded by involved communes, and the rest i believe is from the research council of Norway.

Maybe @Midnattsol knows more specifics

Edit: Never mind shes already answered

 

Thanks for the info Trish. Yes that`s what i originally wanted to say, that this would have been easy for the researchers to investigate prior to starting the study. I guess if they were to do a similar study again, they should use actometers (and actually publish the results mind u)

 

Exactly.
If cognitive and/or behavioural therapies actually led to remission, we'd all be in remission by now!

It boggles the mind that anyone could think that LP could be any more effective than generalised CBT.

Stoic, is that a nice way of saying laid-back and lazy?

 

This all really sounds like things they easily should have planned for. If the plan is "paint myself in the corner" you can't really use the fact that you are stuck in a corner as an excuse for being stuck there. This is typical for BPS but totally inexcusable of journals and various oversight and funding bodies to be OK with this being a systemic pattern.

 

Pretty much

Although I think of it more as "energy efficient". I have to say it comes in handy when having to deal with the ME monster, I was energy efficient before I had to be.

 

Jørn Tore Haugen has written a letter to Dagbladet criticising their article. It's also available as a guest blog at Sissel Sunde's blog "Life With ME By Sissel".
The letter is available in both Norwegian and English.

Simplifying, one can say that Wyller, Flottorp, etc. builds their line of arguments, and for which Dagbladet makes speeches, on 2.3% (35/1499) of the total research, and neglects everything else.

It all becomes even more absurd when none of these 2.3% studies are done on CFS/ME-patients defined as recommended by the Norwegian Directorate of Health, NAM/IOM, the CFS/ME Center at Aker Hospital, the Norwegian ME-Association and most others who have worked with the disease for a long time.

Norwegian newspaper Dagbladet's biased reporting on CFS/ME
Dagbladet's skjeve reportasjeserier om CFS/ME

 

Carl Sagans ECREE may have been stated with outer space in mind, but it surely points out the important principles of all scientific disciplines. Under all circumstances, one could also say that LP have some outer space touch to it.

ECREE = Extraordinary claims require extraordinary evidence.

When dealing with LP we have the nerves and slippery tongue and words of snake oil salesmen. They claim that a study from UK proves that LP works. Among other obscure things, a minor qualitative study from Norway some years ago supports that claim. There are claims, speculation, faith, whatever, but there are absolutely no evidence whatsoever.

Then they promote LP as some sort of cure to everybody again and again. They’ve done it long before any study at all on LP. Last few years they can point to a couple of studies that have no evidence to it.

When confronted with unsubstantiated propaganda, they will at some point, it takes a lot to get there, finally back down and say something like, “it works for someone”. The response is, why must you be vexatious activists? All we have done is that we first say that LP works for everybody, which is not true, which you vexatious patients points out, so then we say that LP at least works for somebody. And they don’t understand why patients react? Obviously they do. It is cynicism to perfection, always adjusting wording just as it pleases them.

They also have this final ace to sort of stop any discussion. If confronted with what is meant as constructive opinions, like what we actually do know of harm, concerns regarding methodology and other concerns. If such things are brought to attention and they don’t have any arguments left, they do this magical switch from we have studies showing this and that, to suddenly:

We just don’t know. We need to check this out. We cannot continue to discuss the efficiency of LP, meaning that almost any study imaginable on LP are legitimate! That’s how we get rid of vexatious patients, all ethical concerns, everything! It is almost just as magical as LP itself.

At the moment I think it is fair to say that these people claim that LP helps everybody. As above, there are inconsistent arguments. If challenged, they will at last back down and say “works for someone”, but the impression they give and want to get across in public, is that LP is some kind of cure for ME patients in general. So what they make is this extraordinary claim. If so, and if the study sees light of day, what should one demand when it comes to extraordinary evidence? I can think of a couple of things.

- that long term severe patients that have been trying but deteriorated over years, bounce back to full work. Measured and followed up for at least 3-5 years.

- that long term severe patients that have little physical capacity and experience serious PEM suddenly bounce back to do whatever activities without experiencing any PEM.

- that long term severe patients bounce back to do whatever it takes that is considered normal for that age group.

And so on.

 

Signe Flottorp, research director at the Norwegian Institute of Public Health (FHI) sent a letter to the Norway's National Research Center in Complementary and Alternative Medicine (NAFKAM) in April this year, before the Dagbladet article. In the letter she asked them to retract and apologise for their, in Flottorp's view, erroneous risk assessment of Lightning Process.

She received an answer from Miek Jong, Head of Nafkam (who writes in English).

The Norwegian Directorate of Health were put on copy and the correspondence was thus available by a FOI request.

Attached are the letter from Flottorp with answer from Miek Jong and a google translated version of Flottorp's letter.

 

Edzard Ernst replies to one of his LP blog article's commenter:

https://edzardernst.com/2020/06/the...-unproven-hyped-and-expensive/#comment-123663

Just spotted the abstract of the Cochrane exercise review among those links --- which, when retrieved on the PubMed website doesn't even show the link to the editor-in-chief's comment or any other hint that Cochrane decided an update and a new approach ist needed.(*)
https://pubmed.ncbi.nlm.nih.gov/31577366/?from_term=cfs,+me.+therapy.+review&from_sort=pubdate&from_pos=3

Anyone feels up to provide Ernst with some discouraging facts about the review and that most (all?) of the trials the Cochrane reviews included are having methodological issues similar to the SMILE and planned LP trial etc?

And that actually the majority of ME research is bad science, not only if it's asspciated with too obvious pseudoscience like the magical LP?

Perhaps the links to the Cochrane IAG spreadsheets will help?

(Apologies for just popping in -- have not been able to catch up with the thread yet.)

Edit 1 -- for clarity.

Edit 2 to add: Not able to check now, but I bet all the other papers have references to the Cochrane review.

Edit 3 to add links to the Cochrane IAG and the editor-in-chief's comment.