Lightning Process study in Norway - Given Ethics Approval February 2022

Trial by Error by David Tuller
Deja Vu All Over Again with Proposed Lightning Process Study in Norway

Quote
The proposed LP trial led by LP investigator and Recovery Norway co-founder Landmark cannot be supported on scientific and ethical grounds, for multiple reasons. It is troubling that key players in Norway’s medical establishment believe otherwise. Hopefully, the NEM will once again draw the appropriate conclusions.

 

For info, I'm guessing that this is the studys entry on the Clinical Trials website, https://clinicaltrials.gov/ct2/show/NCT05236465

 

Not finally, no. That was set up months ago--I assume after it got the regional ethics approval but while the final approval was still pending. Perhaps they're allowed to recruit based on the initial approval until it gets rejected, if it does.

 

Merged thread

A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial : 2022 Norway

Not a recommendation!

the description of this trial as it appears on this website(medifind)

Department of Psychology, NTNU
Recruiting
Trondheim

Author: Leif Edward Ottesen Kennair
Backup: Live Landmark

https://www.medifind.com/articles/clinical-trial/334206297

sourced from clinicaltrials.gov where we find what it is actually.......... ie the Lightning Process

https://clinicaltrials.gov/ct2/show/NCT05236465

 

Lightning Process is an Obedience Training.

 

Oh no. Does this mean they got ethics approval!

 

no, it's not official yet what the National Committee for Medical and Health Research Ethics decided regarding the ethical approval. Hope we'll get some news soon.

 

Also: CBT & GET work, according to the people who think LP is great. Or "psychological-led rehabilitation", if they feel very generic. That's even how they know it's psychological, even though it's well-known that inferring cause from pragmatic trials is invalid.

It's the quantum treatments that both work and don't work depending on how convenient it is to say either. There's both lots of evidence, hundreds of trials along with a "definitive" trial that is "the definitive one" but also just one among many, but so much more research is needed, so much that they just keep doing the exact same studies hundreds of times over, identical to one another, a completely generic formula.

We've literally always been at war with East Asia and anyone who says otherwise is suffering from psychosis, or whatever. Also, and obviously it must be said, but there has never, ever, been a war in Ba-Sing-Se, only special, uh, conflict mobilization, or something.

In addition to that, though, I don't understand how there aren't issues with pretending this is some generic "intervention", rather than a commercial product. They don't name it on purpose where it counts, it should be in the title and summary, explicitly named, since this is what's being tested, knowing it's unethical to do something like that, just not caring about it because by using different words, they genuinely seem to think it makes it all OK.

So tobacco companies funding trials showing their product is safe and healthy and will make your skin glow? Just say they have "motivated sponsors" with the actual names in footnotes, I guess. Conflicts of interest are so easy to deal with, you simply have to avoid using any reference to the commercial interests and it's all good.

 

I'm shocked

 

Nina E. Steinkopf: Kontroversiell ME-studie får etisk godkjenning
google translation: Controversial ME study receives ethical approval

quote:
A long-planned study where 100 ME patients will be treated with the alternative method Lightning Process received ethical approval in 2020. Following complaints, the approval was withdrawn in 2021. After a minor adjustment in the study design, the project received new ethical approval. New complaints have not been taken into account.

 

The verdict:

Et 3-dagers kurs for kronisk utmattelsessyndrom/Myalgisk encefalopati (CFS/ME) hos voksne: en randomisert, kontrollert studie

google translation:
A 3-day course for chronic fatigue syndrome/Myalgic encephalopathy (CFS/ME) in adults: a randomised, controlled trial

quote:
Appeal against a decision from REK In the middle of 8 April 2022, where a previously rejected project received prior approval after certain adjustments. The decision was appealed by, among others, two interest groups that REK found to have the right to appeal.

NEM does not accept the complaints, but supports the terms from REK Midt. NEM also sets additional conditions for pre-approval.