Reflections on the CODES trial for adults with dissociative seizures: what we found and considerations for future studies 2024 Stone, Carson, Chalder+

Exactly. How is a person ever supposed to move from disability/unemployment toward employment if they are continuing to have the same number of seizures as before the treatment? CODES trial participants had a very low rate of employment at baseline (34%) so clearly the condition was disabling. Let's say you are having several episodes a week/month of falling down on the floor and convulsing, then being confused for ages afterwards. What workplace is going to accommodate this? Even working from home would be almost impossible. If you're in a public environment like an office or a shop floor, people around you will call an ambulance etc. Their statements about how much the seizures are "bothering" you are completely divorced from day-to-day reality. Would Stone's workplace allow him to keep working while convulsing on the floor every few days?

 

I'm going to give it a go putting something coherent together later in the week if I can. I'm a bit battered after too much last week.

See what I can do from my 2020 letter to the Lancet Psychiatry where the original paper and Perez's commentary was published.

I'm assuming that the CODES trial authors saw my comments even though it was not published

 

I noted it before, but I still can't get over the fact that they note longer periods free of seizure as a good thing, when by the freaking laws of basic math it has to mean shorter periods as well, since the # of seizures is the same. Imagine boasting the same thing from an addiction program, and not being yelled at for being an idiot for not understanding how math works, that it means that they must go on occasional binges for the numbers to add up.

How is any of this nonsense not completely disqualifying?! They make obviously absurd claims and it makes zero difference, they still get to call it a win and get more money to do it again and again.

They just add this BS commentary about being able to utilize "strategies" to deal with seizures, which somehow, I guess, only work when they happen at home before bed? How?! Based on what?!

And actual professionals basically nod and rubberstamp it. Medicine is basically the original post-truth community, they were there long before the rest of society, given how long this BS has been going on.

 

But the authors have been promoting and defending seizure reduction as the primary outcome for ten years. blaming the choice on funders seems suspect to me.

 

I really went into some of this post-hoc "best-primary-outcome"-switching in my posts on CODES. But seems time for an update given their latest attempt to spin seizure reduction, after the fact, as not the most important thing. And it's interesting when Robert Howard and this other guy, Mark Ruffalo (psychiatrist, not the actor) go full-scale conversion disorder on the FND folks--they argue that talking about "brain network disorder" and the like is brainwashing patients who really need psychiatric treatment.

 

I wrote to Perez at the time asking him about his commentary. He basically wrote, "Whatever CODES found, I know from my clinical practice that CBT works, and quality of life is more important to patients anyway than seizure reduction, and we should also try all these other psychotherapeutic modalities as well even though there is no evidence base for any of them."

https://virology.ws/2020/06/26/tria...-commentary-promotes-eminence-based-medicine/

Added: Actually, I just re-read the post and it turns out I quoted from @Joan Crawford's letter to The Lancet! I'd forgotten that.

 

"Overall, inspection of our data does not support others’ suggestions that our treatment did not sustainably reduce DS frequency."

What does this sentence in the new paper mean? Are they arguing that their treatment did in fact reduce DS frequency even though the non-intervention group had greater seizure reduction? Can someone explain the point they're trying to make here?

 

I think they really are so biased that they do believe that they reduced DS frequency in the absence of evidence to support. I haven't read their paper in detail but I suspect they cherry pick some other outcome timescale to show it made some difference to DS frequency.

It's what they wish not the result they expected to be able to demonstrate when they started.

I suspect they genuinely believe their fear avoidance hypothesis and it is utterly beyond their comprehension to acknowledge and approach (fear avoidance ) of the reality they have created. I.e. no objective evidence that their tentative hypothesis has any real world value to patients

It takes courage to approach and begin to accept that what they believe in doesn't hold up under scrutiny and critical views. The path of least resistance is to keep believing.

What is I think absent here (I need to check their other literature) is the voice of the patients.

How were they told about the cbt they received?

Were they overtly told that overcoming fear avoidance would help them recover?

What happened in the therapeutic relationship when the hoped for recover did not materialise?

Did they feel blamed like the severe ME patients in FINE?

If the researchers are having a hard time to reconcile the failure and trying to grasp at some sort of positive how does this leave the patients?

How on earth do they now understand their condition?

 

I was also taken aback by this sentence. I guess they’re saying that if you carry out 40+ statistical tests at 6 and 12 month follow-ups, as they did in the initial Lancet Psych paper + various follow-up papers, you get some significant results so it’s not all “negative”. Of course, trials don’t work like that. There’s usually a very good reason why something is designated the primary endpoint. In this case, it was seizure frequency at 12 months which is a good objective outcome measure. The CBT group did numerically better than SMC but it wasn’t statistically significant despite the huge sample size (median 4 seizures [IQR 0–20] in the CBT plus standardised medical care group vs 7 seizures [1–35] in the standardised medical care group; estimated incidence rate ratio [IRR] 0·78 [95% CI 0·56–1·09]; p=0·144). No amount of flailing can change that. I bet they’re still using CBT for FND in their clinics despite evidence that it doesn’t work.

 

sorry to be thick Sid, i am not good at all with numbers... am i understanding it right that those who had CBT went from 7 seizures a week to 4?

dont get me wrong i'm not supporting the trial, results, spin, authors etc, I'm just seeking to get my head around it. I thought the numbers/frequency of seizures didnt reduce?

TBH if i was having these seizures & saw my per week seizure numbers go from 7 to 4 i'd be pretty pleased, thats the number almost halved.

what am i getting wrong/missing? I'm just asking because someone else who doesnt really understand statistics etc either, might wonder too & not be bold enough/able to ask

 

The number reduced in both groups, but it reduced more in the non-intervention group. They can't claim their intervention was responsible for any reduction at all. They seem to be claiming that those in the non-intervention group had good results because they received the information about seizures that was part of the content of the intervention, even though they didn't receive the CBT itself. So they seem to be claiming somoe sort of credit for the reductions in both groups, as I understand it. But I could be misunderstanding. The issue is whether the intervention was beneficial, not whether groups had reductions. If they had reductions whether or not there was an intervention, the intervention can't be said to have added anything.

 

It does seem a good change but there is another factor to consider.
Seizures of various sorts often come in phases or batches with good periods and bad periods for novelly obvious reason. People will always tend to be recruited to trials during bad periods - they may need to have had a certain number of seizures in a certain time to qualify in fact. But a while later many may have shifted into a good phase. Unless you have some difference between treatment groups you cannot exclude a change due to the natural course of the problem - and that course is biased towards improvement in any fluctuating disease.

 

thank you @Jonathan Edwards & @dave30th that makes complete sense.

So the issue (when i'm talking about it in a lay manner, to other lay people) is that the treatment arm didnt do any better than the SMC arm, so cant be said to have had any meaningful effect - similar (in lay terms) as a drug doing no better than placebo. And while there were small improvements in both arms, that means nothing, because they'd likely have improved anyway due to fluctuating conditions are inherently biased towards improvement in these types of studies anyway... due to <reasons you explained>

Is that right?

 

Trial By Error: New Paper Seeks to Reframe Poor Findings in CODES Trial of CBT for Non-Epileptic Seizures

https://virology.ws/2024/07/05/tria...odes-trial-of-cbt-for-non-epileptic-seizures/

 

yup!

 

Good question. No, the way they analysed this is they simply counted the number of seizures in the past month in the CBT group vs SMC group at 12 month follow up. They asked people at 12 months how many seizures did you have in the past 4 weeks and calculated the median in each group. The median was lower in the CBT group (4 seizures) compared to the SMC group (7 seizures). So it's not looking at change over time but rather difference between two groups at a single (prespecified) timepoint. The difference as you can see is that the CBT group was doing a bit better but this difference wasn't statistically significant.

 

In Table 2 they report the median number of seizures in each group at each timepoint (baseline, 6 months, 12 months). As you can see, despite randomisation there was an imbalance between the two groups in terms of the median number of monthly seizures at baseline which is problematic because one group is sicker to begin with.

SMC group started with 19 seizures per month at baseline and ended up with 7 seizures per month at 12 month follow-up.

CBT group started off with "only" 12.5 seizures per month at baseline and ended up with 4 seizures per month at 12 month follow-up.

So in the SMC group seizures dropped more over time than in the CBT group but this would be expected (regression to the mean).

https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(20)30128-0/

 

yes, it was surprising that the difference at baseline was that large given the randomization. I don't know if having 13 vs 19 seizures a month represents a significant difference from the patient's perspective.

 

It really is nothing but what they believe it is. Opinions, with zero supporting evidence. An entire industry and professional discipline built entirely on feels, vibes and traditions.

They just want this to be true. And they've been allowed to pretend that it's the same thing as being true, having used this as standard practice for decades. It all fails simply because there is no process to account for failed models put into standard practice. They can fail indefinitely on the simple basis that admitting that it was a failure is too embarrassing, since they've been pretending that it must be true for too long.

Very similar to how wars often go on for far longer than necessary, simply because the people who started them depend on their continuation. Some have gone on for decades after the people who started them were dead. Better millions suffer horribly than they face shame, they are willing to make that tradeoff as long as they don't see the whole of it.