Trial Report Successful Subcutaneous Immunoglobulin Therapy in a Case Series of Patients With [ME/CFS], 2024, Sjogren, Bragée, Britton.

To me, this is about the minimum significance that is worth even looking at. Anything below that is just noise, typical minimum clinical significance is set way too low to be of any relevance, often as low as 5%. That's horseshit.

So that's 2/17 who have significant improvements, but without controls it's impossible to say much. But that's just a pilot study, those results actually do warrant more rigorous trials, but shouldn't be taken as significant yet. It's still at the noise floor level.

I don't think we should be looking at pooled results, there are too many variations between individuals so that no treatment should be expected to work for everyone, probably will never happen. What will likely matter the most from those trials is seeing what changes for subsets, providing clues for an underlying mechanism, even if only for some. For the most part pragmatic trials are useless on their own, they're only useful in terms of what can be learned about their effects.

 

I think that for many of us, immune activation from whatever cause, increases the severity of our symptoms. Blocking that activation could drop patients to their otherwise baseline. In probably rare cases, it might even switch ME off. So, if they're not overly inflating the results, it seems a reasonable to pursue a larger study (with proper controls and statistics critics). A treatment that helps even a few percent of PWME--without ridiculous expense or high risk of bad side effects--would be a good thing.

 

7/17 with some improvement, only looks like 2 that are significant enough. The bar is always set too low for significance.

 

These effects are likely due to placebo or people getting better by themselves, the dosage of IG these patients received was miniscule, 3-5g per patient per month, 99/100 MDs will tell you that's bullshit, of course, they will also tell you ME is bullshit. I am inclined to agree with the 99 who say that this dose is not likely to have any effect, though.

 

It is useful to see who attaches their name to papers so poor that they should be ashamed even to be acknowledged on them.

 

Just skimmed this very quickly. Initial thoughts:
The patients "with infection-associated ME/CFS with ongoing recurrent infections" - IMHO this needs to be elaborated on; were there objective signs of contemporaneous ongoing infection? Why were they having recurrent infections?

Small sample size (n=17). No blinding, no control group. Self-reported QoL & composite symptom scores. There's little detail on the questionnaire that was administered, other than it's a composite of 15 categories, no mention of validation. (How was "working ability" assessed, for example?) Also I don't see effect sizes where it would've been useful to see them & multiple outcomes were analysed without any apparent correction for multiple comparisons. Additionally: (1) before start of treatment (n = 17), (2) at the end of treatment (n = 12), and (3) at follow-up 5 weeks after the end of treatment (n = 13). N differs due to incomplete questionnaire responses. - I don't see any mention of how missing data was handled?

On the IVIG dose, looking at typical dose ranges for different conditions the dose given seems to be around 5-15% of what is typical.

Finally, statements like "we found pronounced beneficial effects of low-dose [IVIG] in a large proportion of patients with infection-related ME/CFS" - I don't find that appropriate. Obviously you can't make causal attributions with such a trial design.

I'm sorry to say I don't think this tells us very much at all.