Cognitive behavioural therapy for adults with dissociative seizures (CODES): a ... multicentre, randomised controlled trial (2020) Goldstein, Chalder

Joan Crawford said:
It is rather poor that a journal like Lancet Psychiatry have allowed this through peer review.
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Well, in the protocol they only said to interpret with caution. It would seem like maybe one of the peer reviewers said, "Hey, what about correcting for multiple comparisons?" So they mention it in the abstract and add a paragraph because they have to, but otherwise ignore it. However, it doesn't seem like they obeyed their own idea to interpret secondary outcomes with caution.
 
This was my response on the 2nd of June to Dr Marsh regarding rejecting my letter re Dr Perez's commentary:

Dear Dr Marsh,

Thank you for your swift response to my letter.

I am heartened that The Lancet Psychiatry is normally open to debate such as that raised in my correspondence. I was rather startled by your reasoning for not engaging in such a debate now.

Whilst we are in difficult and new medical territory with potential uncharted times ahead of us, it makes it more relevant than ever to ensure that the possible neurological and psychiatric consequences of COVID-19 are debated openly. There is, for example, the possibility that post-COVID-19 may well develop into poorly understood post-viral, ME/CFS type conditions in some people. Much debate and criticism has been levelled at similar type of research to the CODES trial in recent years, including the PACE trial. This highlighted the importance of the need for objective, measurable outcome measures, otherwise non-blinded trials may well produce misleading results. Moreover, it is not beyond reason to suggest that other poorly understood conditions such as dissociative seizures may also increase post COVID-19. Now is a good and effective time to be debating and discussing how the medical, neurology and psychiatry professions cope with medical uncertainty, ambiguity and chronicity in patients that they currently struggle to help.

I have reviewed the contents of the June 2020 edition and note that COVID-19 is covered in detail in the Editorial and Position Paper sections; COVID-19 is completely absent from the Insight, Articles and Review sections and forms 25% of Comment and just over a third of Correspondence sections. It appears to be being covered thoroughly with ample room for other debates and discussions. For example, under a third of Online First section is dedicated to COVID-19 with plenty of other material covering a wide range of psychiatry topics including: schizophrenia, the built environment, spirituality, treatment for depression, medical notes, leadership in Africa and Aboriginal/Australian issues.

As debate is a cornerstone of good science and how patients are managed emotionally and psychologically during times of uncertainty, engaging in a debate including with leaders in the field such as Dr Perez, could not be more timely.

I would ask you to review your decision regarding my correspondence. I make sound and clear points that are of interest to your readers and will generate debate which can clearly be included in future editions of the journal as other non-specific COVID-19 related topics have been covered well in 2020.

I look forward to a positive response from you soon.

Regards,


Joan Crawford
Chartered Counselling Psychologist
===

Her reply to me on the 4th of June (just found it in my junk folder):

Dear Dr Crawford,

We have discussed your appeal and our decision stands.

Regards,
Joan

==

So, that's that? or is it?

I can see so a lot wrong with the CODES trial that needs challenging. So many similar mistakes to the PACE et al trials.

I'm listing the issues I think need challenging and I'm going to ponder, seek feedback form colleagues and submit a further letter about the trial itself. This kinda poor quality RCT takes up a lot of resources and needs to be challenged firmly at design/conception level and through the peer review process. The lack of critical review is staggering. And the belief that all that the (medical profession) doesn't understand must somehow then be a 'problem' that resides within the patient - i.e. dissociation due to previous psychological trauma or symptoms develop and are maintained via autopoetic process (i.e derived from within oneself - as per MUS) is all speculation. Makes no sense to patients - no face validity. But it is believed wholeheartedly by proponents.
 
Joan Crawford said:
We have discussed your appeal and our decision stands.
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But you literally provided them evidence that their decision was bogus, providing receipts.

And our BPS overlords scream "WE ARE BEING SILENCED" and are actually taken seriously while this is what actual silencing looks like. What a sick joke. This is politicized science.

Maybe CBT watch would be interested? The exchange, or its details anyway, deserves to be discussed openly, this is not the proper process of scientific debate. Lancet is not behaving as a neutral arbiter here.
 
rvallee said:
But you literally provided them evidence that their decision was bogus, providing receipts.

And our BPS overlords scream "WE ARE BEING SILENCED" and are actually taken seriously while this is what actual silencing looks like. What a sick joke. This is politicized science.

Maybe CBT watch would be interested? The exchange, or its details anyway, deserves to be discussed openly, this is not the proper process of scientific debate. Lancet is not behaving as a neutral arbiter here.
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I'm speaking to Mike Scott on Thursday. I'll discuss with him then
 
Andy said:
And you did.

Trial By Error: A King’s College London Press Release Hides the Bad News
https://www.virology.ws/2020/06/11/...lege-london-press-release-hides-the-bad-news/
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In CODES, the primary outcome was the average number of seizures per month at 12 months post-randomization. That number fell in both arms of the study–great!–but CBT provided no benefit, with no statistically significant differences between the two trial groups. Let’s say that again—the outcome that the investigators had spent at least a decade promoting as the critical measure of treatment success had null results. The therapy did not work as billed, leading to questions about the therapy’s theoretical underpinnings.
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From David Tuller's blog:

The study was the largest of its kind, with 368 participants randomized to receive either standardized medical care, or standardized medical care combined with a form of CBT designed specifically for the disorder. The results were published by Lancet Psychiatry, a high-impact journal. The press release included comments from the investigators about the significance of the work, a common feature of such releases.
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Call me crazy, but I think there might be a pattern emerging here.

“Our CBT approach is predicated on the assumption that PNES represent dissociative responses to arousal, occurring when the person is faced with fearful or intolerable circumstances."
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Does intolerable circumstances include patients enduring decades of increasingly unscientific and unethical behaviour by medical authorities?

The statistical analysis plan included no details about how the secondary outcomes would be analyzed—presumably because the investigators considered these outcomes to be of only secondary importance.
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And they have learned from experience to not commit themselves to too much detail before seeing the results. Post-hoc analysis being all the rage now.
 
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Andy said:
And you did.

Trial By Error: A King’s College London Press Release Hides the Bad News
https://www.virology.ws/2020/06/11/...lege-london-press-release-hides-the-bad-news/
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CBT provided no benefit, with no statistically significant differences between the two trial groups. Let’s say that again—the outcome that the investigators had spent at least a decade promoting as the critical measure of treatment success had null results. The therapy did not work as billed, leading to questions about the therapy’s theoretical underpinnings.
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longer periods of seizure freedom
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This is mathematically impossible. Unless they mean both arms, if there was an actual reduction, since there was no difference in the arms. So that invalidates the alleged effect of the CBT. And frankly there is way too much hand-waving over "standardized medical care". There is no such thing. Medicine is not generic, not everyone receives the same care, even with the same condition, this is beyond absurd. I don't know how this is supposed to make any credible sense.

Let's be honest here, had there been a demonstrated effect, it would be hailed as proving the hypothesis of psychogenic origin. But failure does not mean evidence against the hypothesis, in fact it's literally presented as a success despite past insistence that only the primary outcome was significant. This is a level of dishonesty that is off the charts. They are destroying the credibility of science and it will have serious repercussions, a gift to quacks and charlatans, especially anti-vaccine zealots.

Hailing failure as a success, amplifying the effectiveness of what is effectively useless are hallmarks of pseudoscience. Coming from authoritative sources this is disastrous with huge implications on the credibility of all medical evidence.

This is a PR exercise, not proper reporting on a scientific study. The SMC is a complete failure in its stated role.
 
Neurologists’ experiences of participating in the CODES study—A multicentre randomised controlled trial comparing cognitive behavioural therapy vs standardised medical care for dissociative seizures

https://www.sciencedirect.com/science/article/pii/S1059131119301876
Highlights

• Over 80% of doctors asked found it easy to recruit patients to the trial.
• 90% wanted the treatment pathway developed for the trial to continue.
• Only 50% could routinely make direct referrals to psychotherapy before / after CODES.
• Over 85% of doctors reported the CBT package as ‘very’ or ‘extremely’ useful.
• 79% perceived patient satisfaction with the CBT package as ‘very good’.
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Purpose
We investigated neurologists’ experience of participating in the large CODES trial involving around 900 adults with dissociative seizures which subsequently evaluated the effectiveness of tailored cognitive behavioural therapy (CBT) plus standardised medical care versus standardised medical care alone in 368 patients with dissociative seizures.
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Results
Forty-three (51%) neurologists completed the questionnaire. Only about half of neurologists could make referrals to psychological intervention specific for dissociative seizures before and after the trial. One-third of doctors reported having changed their referral practice following their involvement. The majority (>69%) agreed that patient satisfaction with different aspects of the trial was very high, and 83.7% thought that it was easy to recruit patients for the study. Over 90% agreed they would like the treatment pathway to continue. Respondents found different elements of the trial useful, in particular, the patient factsheet booklet (98%), diagnosis communication advice (93%) and the CBT package (93%).
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Neurologists participating in CODES generally found it easy to recruit patients and perceived patient satisfaction as very high. However, 46.5% of neurologists could not offer psychotherapy once the trial had finished, suggesting that problems with lack of access to psychological treatment for dissociative seizures persist.
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High degree of satisfaction for clinicians in a trial that has null results is just peak BPS. Rating patients' satisfaction by asking the clinicians is just meta peak BPS.
 
Trial by Error by David Tuller:
More Questions About CODES Trial of CBT for Seizures

Post-CODES, it should no longer be possible to assert that CBT is a treatment for dissociative seizures. At best, it appears to be an intervention that can provide some patients with the kinds of psychosocial relief that would be expected from a course of CBT—and no more. The CODES protocol promised that care would be taken “when interpreting the numerous secondary outcomes.” Given the efforts to promote the trial as a success based on a handful of modest findings in some secondary outcomes, that promise seems to have been breached.
 
Kalliope said:
Trial by Error by David Tuller:
More Questions About CODES Trial of CBT for Seizures

Post-CODES, it should no longer be possible to assert that CBT is a treatment for dissociative seizures. At best, it appears to be an intervention that can provide some patients with the kinds of psychosocial relief that would be expected from a course of CBT—and no more. The CODES protocol promised that care would be taken “when interpreting the numerous secondary outcomes.” Given the efforts to promote the trial as a success based on a handful of modest findings in some secondary outcomes, that promise seems to have been breached.
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Wow. The more you look the worse it gets. Thank you David for being on top of this.
At the 12-month assessment, those in the SMC group had a median of 7 seizures per month—a reduction of 12 seizures. In comparison, the CBT group had a median of 4 seizures a month—a reduction of 8.5 seizures.
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The treatment arm actually did worse. Of course it's likely a statistical artifact that was further affected by a different interpretation of what qualifies as a seizure, it's hard to otherwise explain a comparable drop in both arms. But this is failure. They should acknowledge failure. Failure in research is normal and good. This treatment is useless. They should not have been making claims of effectiveness for a decade but that does not change that their definitive test shows this treatment is useless.

So this is fraud. I'm sorry but this is pure fraud. The results do not support the claims. The grandiose claims of massive benefits are absolutely fraudulent. As usual. Why is fraud tolerated in medicine and how the hell do we speak to the manager because this is bullshit?
 
My Letter to the Investigators of the CODES Trial

Subject: Invitation to respond to my posts about CODES

Dear Professors Goldstein, Stone and Chalder–

I have recently posted some blogs about the CODES trial on Virology Blog, a well-read science site hosted by Professor Vincent Racaniello, a microbiologist at Columbia University. These posts are here, here and here.
Given my critical assessment, I felt it was important to offer you a chance to respond directly to the concerns I have raised. If you send me your comments, at whatever length you choose, I will be happy to post them in full on Virology Blog, without editorial comment or interruption. If I decide to respond, I will do so in a separate post. (I have cc’d Professor Racaniello on this e-mail.)
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https://www.virology.ws/2020/06/25/...ics-project-my-letter-to-codes-investigators/
 
It's seriously disappointing how few people pick on this blatant fraud. So much for the "professional skeptics" and a self-corrective process. Then again, the self-corrective part is the scientific method and EBM has basically morphed into a blank check to sidesteps all scientific requirements, ethical and otherwise. A veritable platform for fraud and charlatanism.

But the point has been reached past which medicine has no place to criticize alternative medicine anymore. Not without cleaning house first. Medicine loves quackery just as much as anyone, it just loves the single one, though, but it loves it to death.
 
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