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Nothing is concerning. I never claimed anything about the role of SFN in SjD nor did I ever claim it should not be included in SjD. It is hard to have a discussion when the opposite person prefers to invent statements about what other people are supposed to have said instead of actually having a...

I would strongly recommend to actually read what others write, before laughing and making accusations. You indicated a connection between ME/CFS and Sjörgens based on SFN prevalence. There is however no good research to indicate that SFN is more prevalent in ME/CFS than in the general...

Hey @Pibee some points have been raised that I think are worth discussing, much has already been layed out in @Evergreen's post: Sjögrens is associated with Ro and La antibodies. Several studies have looked at antibodies in ME/CFS comparing them to levels in HCs including Ro and La antibodies...

I'm not entirely sure on that. You also have the additional problem of unblinding the PI, which I see no reason for introducing. Some of this will also depend on how much information was fed back to the participants. I agree they probably had justified resonse for a dose titration protocol. I...

Ivabradine measurably affects heart rate when lying down in this trial and placebo does not. Heart rate when lying down was measured multiple times as part of this trial. People had their dosage changed respectively chosen according to those results. I find the section on dosage and titration...

I'm guessing since they uploaded some data they are probably not breaking any laws.

Looking at the data that has been released on the 22 people in the drug group and 15 people in the placebo-group these are the changes: - Both groups got better on COMPASS but the positive changes were slighlty more pronounced in the placebo group - Both groups got better on the MALMÖ but the...

I'm a bit confused, from what I can tell quite a lot of the data has actually been uploaded half a year ago (but not all data for all patients): https://clinicaltrials.gov/study/NCT05633407?term=Efgartigimod&page=2&rank=19&tab=history&a=14#version-content-panel. Why does the article not discuss...

I think you raise some very valuable points. The other side of the coin is that the picture painted in the article is somewhat different: The people are saying it is not hard to remember and compare the level of suffering before and after treatment but rather that they've seen drastic changes. I...

Purely out of curiosity I filed an FDA complaint and swiftly received the response that such complaints can't be dealt with since certain federal government activities have ceased due to lack of appropriated funding. I know that Dysautonomia International already did a lot of lobbying to have...

Wasn't the trial terminated in the middle of the open label phase? I'm no expert but you tend to only do that when you are convinced of there not being an efficacy precisely because most costs have already occured. I can understand people talking about problematic trial design and that is...

Maybe, but I don't see why. Why would they care? I could obviously be wrong but my guess is the following: The trial didn't only show that the placebo and treatment were equal off, but that placebo even did better than treatment. As Hutan has mentioned companies tend to torture data even when it...

From what I know the drug company cannot refuse to release the data. I think there's even a fairly short limit on the time duration for how long data can be withheld. They are forced to relase it by US laws, the problem is getting timely compliance. I'm sure there are probably many gray zones...

Indeed, I just re-noticed the one third vs one-half split. From what I've heard nobody was unblinded. Sure or they all got the drug previously already, the chances of that are higher, one day we'll know.

AFAIK there was no unblinding. Since it seems that just as many people in the placebo group got better you currently probably have to assume that one third of the people that are reporting their improvements not based on the open label part actually didn't receive the drug and the ones reporting...

AFAIK it has to be made available, but the company can wait as much as they want. There's no point for them to spend resources quickly on something that didn't work out, especially when they are currently busy conducting trials with much higher success chances.

Comparing Table 1 and Table 2 to me suggests that the reported HR values in Table 2 are not the ones taken at the first visit but rather the ones taken before ivabradine was given, which for the placebo first group happened after the first round of placebo (if we assume Table 1 also refers to...

Yes, it seems were only discussing semantics once in the context of blinded trials and once in the context of when blinding becomes compromised and I can see there being a need for a differentiation and nuance. I think we're in agreement on the "actual stuff".

This is the following example I hand in mind: A placebo-controlled study is conducted on a population suffering from low levels of an antibody. The placebo perfectly matches the treatment in terms of side-effects and treatment groups are randomly assigned without anybody knowing the labels. The...

I'm a bit lost to what is being argued here. You seem to be concluding that blinding for the subjective outcome measures is broken on the basis of tachychardia observations. That very much fits the definition of what I proposed as blinding and why it's reasonable to think that the trial doesn't...