A 4-day mindfulness-based cognitive behavioural intervention program for CFS/ME. An open study, with one-year follow-up, 2018, Stubhaug et al

A Norwegian blogger has written a post about the study where even more critical points are made.
I'm too brainfogged to get a hang of all the details, but here is the google translation in case someone are able to have a closer look.

(Is the translation readable? Feel free to tag me if some parts are unclear and I'll be happy to try to translate)

ToTo Neuroimmunologisk Kurativ Behandling: På ME-fronten: Bjarte Stubhaug med grovt forskningsetisk overtramp
google translation: At the ME-frontline: Bjarte Stubhaug with severe research ethical oversteps

Not in my wildest imagination, had I thought that researchers would misuse the PACE study's unregulated, as in unapproved protocol change, and then call it a new consensus for measurement efficacy in treatment studies for patients with Myalgic Encephalopathy (ME) disease. This has actually happened in publication with psychiatrist Bjarte Stubhaug with the health trust Helse Fonna 's best blessing. This is not only grossly unethical in terms of research, but it is immoral and grossly fraudulent, as in not good research practice.

 

Accepting PACE as solid evidence has the implication of declaring that anyone of any age functioning at the level of an average 80 year-old is perfectly healthy and fit. It's the premise of the trial, that this is the threshold at which someone, of any age, is "within normal range". This entirely redefines what it means to be fit and healthy to a degree that is basically close to death.

Researchers can't cherry-pick parts of a paper while ignoring the parts they don't like. They come in a single unified package. If they point to PACE as good evidence, they agree to that redefinition and all that it implies. And since The Lancet and Cochrane agree to that redefinition, then I guess we almost solved disease because 95% of the world's population is now fit, healthy and free of illness based on this new definition.

There's a good reason subjective research is generally not taken as evidence, it's just not credible. Carving arbitrary exceptions does not solve that problem and anyone building a kingdom on it will inevitably be revealed to be incompetent, a fool, or more like an incompetent fool.

 

History shows that this is not always good advice.

 

Big article in the regional newspaper where Stubhaug works.
It's paywalled, so here's a summary.

Four days on seminar made eight out of ten better

A new study shows very good results for patients with chronic fatigue. - I was sick when I got there and healthy when I returned home, says previous ME patient May Elin Game.

The article tells May's story who had been sick for 17 years when she went to Stubhaug. There was a big change on the last day of the seminar where she told the psychiatrist things she had never shared with others. Afterwards she listened to the Mindfullness app Stubhaug has made and she felt something happened with the body. The symptoms started to let go and she went for a walk that evening. The day after, when she returned home, she felt healthy.

The article continues with a few sentences about the petition against the national competence service and that the initiator is critical to Stubhaug's stress relief seminar and says it leads to deterioration for many ME patients.

But now Stubhaug has published a study together with four other researchers indicating that his treatment works. 80% of CFS/ME patients become significantly better. The improvement can be measured also a year after the seminar.

- These results are sensational. Most treatments studies on CFS/ME show little to moderate effect, according to Stubhaug.

The study includes 305 CFS/ME-patients. The participants fulfilled the least strict criteria for the diagnosis, but there were some very ill patients included as well.
- The most ill had actually larger improvement measured compared to the average patients, says Stubhaug.

The seminar contains classes, physical activity, mindfulness, writing exercises and group therapy. The seminar is build on elements as cognitive therapy, mindfulness and acceptance and commitment therapy (ACT).

- I know many previous patients are back to work and studies, but this isn't what we have measured, says Stubhaug.
50% of the participants have still quite a lot of fatigue, but compared with baseline they're better.

Stubhaug says ME/CFS is a physiological illness, not psychological.
- Knowledge makes people safer. They learn that CFS/ME is a physiological disturbance, but that the symptoms are not dangerous. They get a feeling of mastering and are less controlled by the symptoms, Stubhaug says.

Trude Schei from the Norwegian ME Association says that the study doesn't prove anything. Without a control group we don't know if the improvement is a normal variation. This is part of a long series of weak studies with too wide compound of patient groups. It's incomprehensible to me that these studies receive funding. We are in the middle of a paradigm shift when it comes to ME, and it's about time to focus on biomedical research instead.

- Our article is reviewed by professionals. They thought the results were worth to publish, Stubhaug says.

https://www.bt.no/nyheter/lokalt/i/RxMzRW/Fire-dager-pa-kurs-gjorde-atte-av-ti-friskere

 

Reaction from journalist Pål S. Schaatun. He followed the RituxME trial to Fluge & Mella and made a documentary interviewing the researchers and several of the participants. It's been shown on national TV several times.

He says:
I'm shocked over the angle in BT (newspaper Bergens Tidende) who simplifies the serious disease ME to a fast and cheap headline: "Eight out of ten improved after seminar".
Great for those who got help. But a disdain for patients who for many years have tried all treatments with not effect. Very few ME patients improve physiologically after such seminars, if you read other research and the ME Association's surveys. That doesn't mean the seminars are bad. Everyone can benefit from mental training, but it seldom cures serious diseases. BT is giving ME journalism a 10 year set back.

 

Succeeding in putting patients into an optimistic state of mind doesn't mean having succeeded in treating their illness.

 

The initiator behind the petition against the Norwegian competence service for ME/CFS and their psychosomatic views (discussed in this thread) says on Facebook:
On the same day as the petition is about to reach incredible 6 500 signatures, the newspaper Bergens Tidende publishes an article about psychiatrist Bjarte Stubhaug 's recent study. The study, which concludes that ME patients have good effect from his classes in stress relief, is by other professors described as a pathetic mess.

There is a widespread impression that ME and "fatigue" is the same thing. That's a bit like believing that everyone who coughs have the same illness. There were both ME patients and patients with other illnesses in the study. The Canadian criteria, which is recommended by the Norwegian Directorate of Health, require that among others psychological illnesses are ruled out before an ME diagnosis is given. The result of the study can thus not be transferred to ME patients.

We know that many ME patients have deteriorated after Stubhaug's treatment and it is important that this is covered in media. I assume Bergens Tidende wants to give a nuanced account of this and that negative experiences will be given place as well. I urge those of you who have deteriorated to get in touch with the journalist and tell your story: kari.pedersen@bt.no

Once again we see how important it is to have a Competence Service being clear on the usage of strict diagnostic criteria both in assessment and research.

 

Looks like Recovery Norge were promoting more junk-science. Norwegian journalists seem to love being provided with inspiring anecdotes!

 

Another sensationalist article about this study. This time in one of Norway's biggest newspapers. It includes a comment from Olav Mella.
The article is paywalled, so here's a summary:

There's an introduction of the treatment:
Education: 2 lessons for two hours, on day one and day three
Physical activity: Walk each day for 60-90 minutes with low/moderate intensity. Breaks with mindfulness sessions.
Sense practice: Mindfulness two times each day
Writing practice: write about a positive experience for 15 minutes every day
Group Therapy: 1-2 times a day for 30-60 minutes. The participants understanding of their illness, interpretations of symptoms and behaviour were challenged. Apart from this, the participants were encouraged to not talk about the illness, but about something they were happy about or changes they wanted to do

Then there is a case story about Benedicte. She got sick after a flu in 2014. In 2015 she got the treatment and now she's studying to become a nurse. There's a picture of her jogging.

The article says 8 out of ten improves after the treatment.
Stubhaug says the results are sensational. There is a debate whether ME is physiological or psychological. Stubhaug believes ME is a physiological illness with psychological elements.
- ME is an illness with physiological disturbances, but the illness can also lead to health issues as pain, anxiety and depression. The patients interpretation of the symptoms and the behavioural reactions are possible to treat. We help the patient to understand what is happening in the body, for instance fever and flu sensation in connection with exertion, and to interpret the symptoms as less dangerous, Stubhaug says.
We have seen many examples of those who recover after four days, but usually they get a programme they can use, and the improvement takes time. Not everyone become symptom free, but most can live better and master their lives differently.

Olav Mella believes ME is a physiological illness. That doesn't exclude there can be psychological elements.
- I don't want to polarise the debate more than necessary and believe patients can benefit from focusing on positive experiences, Mella says. He doesn't believe the new study will cause much attention internationally, there are too many weaknesses.
- We must be aware that this is not a pure ME-population. The patients are diagnosed with Oxford criteria, which is a much wider definition than what we use for our studies.
The measurements for quality of life at the start of the study shows twice as high score as in our study. These are patients with different forms of tiredness, and not just ME patients.
He says the biggest objection is lack of control group and it's therefore difficult to say if the treatment led to a real effect, or just reflects natural variations in the illness.
These patients were a lot better than what you'll find in a pure ME population, and the expectation in itself of improvement, can have effect.

Stubhaug says the patients who participated were motivated for this type of treatment. You have to be motivated and willing to challenge the anxiety for exertion. Those who increase their activity, often get more symptoms in the beginning. If you're not motivated or interpret the affliction in the wrong way, you will believe that more nuisance means you've become worse. But it's not true that more symptoms means you have deteriorated.

Mella says that nobody knows what causes ME.
- Most believe there's a deficiency in the immune system, but it has lasted for a long time and it might not be the same thing that maintains the illness as what initiated it.There might be something cognitive in some patients that maintains the illness, Mella says.

 

At least the journalist got a comment from Mella. That’s worth something.

The description of the course is quite extensive.I really do wonder what kind of ME-patients that are able to follow such course? Says a whole lot of the many mixes of the meaningless fatigue and the extremely heterogeneous patient population.

Most of all, this horrendous attitude that patients do not know what’s good for them, what’s dangerous and not, that they don’t try hard enough, the don’t know they’re own best and so on, it just so wrong and disgusting.

 

Agree. Articles like this promoting that view causes set backs for ME patients and leads to more suspicion, patient blaming and more suffering. I keep thinking we're beyond discussing whether ME is physiological or psychological, but the psychosomatics don't let go easily, do they?

 

I kind of wish there was some commonly used mechanism for disinterested and skeptical researchers to actually observe a study directly as it unfolds.

With the PACE study I recall reading here that some patients had to come forward to shine a light on certain questionable practices that could not be apparent from reading the published paper or any planning document...

This 'study' is claiming much greater success than PACE - truly miraculous results. Given the absurdity of the reported results, I have to imagine that a reasonable and reasonably-informed person sitting in on this four-day thing would read the claims in the paper, find them totally at odds with any sane interpretation of reality, and be able to give an account to that effect.

Maybe this would be impractical or counterproductive. But... while it's well and good to point out weaknesses or flaws in the reported methods, as things stand it's up to patients to testify if researchers are proffering systemically un-credible interpretations of reality.

 

One has got to be a little crazy to believe that patients are being cured in four days.

Ona more serious note, I think it's just strong wishful thinking and a "high" induced by motivational speaking. The same thing that happens during lightning process courses, or religious ceremonies and the like.

 

Indeed.

It’s good to know that the quiet slow science is working beyond the nonsense that recovery/getting better from ME, is up to motivation and “the way of thinking. The other side of it, that media probably have no clue of, is that patients meet this bollo... up front or behind they’re backs from so many angles. Media contribute to give patients a hard(er) time, and its a shame they 9/10 times focus on the simple sensational stuff. They should focus more on the boring stuff.

What one could categorize as boring in the context of recovery or not, is the fact that many patients, despite trying many things, being positive aargh#!?*, having the right focus, just dosent get better over time, many get worse. Why is that? Could there be an idea, if you don’t label them as “wrong-thinkers”, to gain some knowledge of why? What about looking into the knowledge situation in primary care. How are patients met early on? All these familiar things. Could there be an idea to look into the ratio of actual recovery and non-recovery? Boring questions for media and journalists, but would be way more important.

Let go of the many misdiagnosed. Then, - what is the similar main reason for not recovering? Without being categoric, it’s fair to say that the main cause is not only not doing things right early on, but often doing the opposite of what one should for to long. As we know, the level of knowledge is not acceptable where it should be, causing all sorts of problem, and at the end of the day, making prognosis of recovery extremely hard. Many patients have had their long-run prognosis wrecked early on. That’s were focus should be. On the unacceptable knowledge situation first-line. It can’t be stressed enough how important this is, when we know how vital it is for recovery/better to actually meet knowledge early on. If we can’t fix it, at least do no harm. But we’re not there today.

It’s a little ironic that the ones that was not completely bedbound around the clock early on, but pushed on because of no or wrong advice and trying to maintain bits of life, well they often don’t get better/recover. They did just what the sensational anecdotes tell you to do.. But non-recoverers been there and they failed. Should be an important lesson to learn. Opposite, many of the sensational stories focus on the “bedbound” early on for long time before getting better. Well, maybe they did the right things sort of by chance early on, maybe they met good advice and really did what they’ve were supposed to do to have a proper chance of recovery/getting better. In regard of prognosis and chance to recover, it is vital to do the right things early on!

So; media should focus on the boring situation of way to little knowledge where it’s supposed to be and the principle of do no harm. The knowledge of not pushing trough early on would save many patients life and make way for a far better prognosis. But guess it’s to radical when dealing with the truth of just push trough/carry on and “get out of my office”. Statistics just don’t support that anachronism when it comes to ME.

 

It's telling, about both the poor quality, but also the potential impact it's having in Norway - that this study even got Mella to make a comment.

They never do that, unless it's about their own research. Fluge/Mella have said that they chose to not participate in the very heathed 'ME-debate' over here, and focus on their own work, quite understandably. Thank you, for making an exception on this <3

 

Typical for this kind of studies and mostly because any truly random group would have some controls question the rationality of what the hell is this cult and how is anyone claiming this is serious scientific research?

 

I hear the Defense position is open.

 

stories like this are endlessly astounding. How does this just pop out of anyone's mouth. Both intellectually and emotionally blinkered thing to say