B-Lymphocyte Depletion in Patients With ME/cfs: A Randomized, Double-Blind, Placebo-Controlled Trial (2019) Fluge et al

Does the 18.9% serious adverse events in the placebo group suggest that adverse events in PACE were not properly recorded?

 

Good question. In the PACE-trial only 8% of participants in the GET group and only 4% in the CBT group had serious adverse events. Can't access the Fluge et al. paper yet, but it will be interesting to compare this outcome with what was reported in the PACE-trial.

 

So good to Rituxme finally published. Nice to see such a well conducted study, and what a contrast to Wyller, the people who talks about LP and all that pseudo.

The result is as we all have known for a long time negative, but this is still what it is all about. A hypothesis that can be tested and the method in place. That is exactly what patients want, but the BPS-brigade misses out on this obvious point when talking about patients steering science in a direction. That is just utter rubbish. Patients wants science and that’s all.

Thanks to the team at Haukeland for gaining knowledge and plugging on.

 

A reasonable questipn but I think defonition of seripus adverse event is alwaysgoing to vary from trial to trial. I thinl this result may indicate the vigilant approach in Norway. As to PACE I am not sure anything changes!

 

But. I was told by eminent professors that we threw tantrums about research when we don't like the results and should be expected to go on a rampage any minute now. Lock the gates. Hide the kids and pets, you never know what our bloodthirsty hordes will do!

How. How could that be? Surely they did not... *gasp*... lie?! That would be very, very unethical and unbecoming.

Reality shattered

 

Normal fluctuations of the disease definitely could explain that. Incredibly frustrating to have to take account of this much unpredictability. And it works both ways. No doubt some of the "improvements" in psychosocial studies are explained by some of this randomness, which likely disappeared and fluctuated wildly between the time the self-reported questionnaire was completed and when it was analyzed.

 

Absolutely.

Clearly a controversial opinion, sadly, but real objective science > subjective, ideologically-motivated outcome-seeking. Any day of the week. Hell, every planck time unit of the whole of existence.

Guess we riot now? According to Sharpe and Wessely this should be expected any minute.

Any minute...

 

Speak for yourself. I'm so mad with rage I want to destroy erlenmeyer flasks and do controlled chemical burns on periodic tables. That's how anti-science militants rage, with spit by the mole-full while we curse Newton and whack away at Darwin pinatas.

Oh, wait, April fool's was yesterday. Nevermind.

 

I most definitely expect that they were not.

Anyone doubt that?

After all it's in the premise that it is harmless. Can't continue arguing that it's harmless (despite no evidence of that) when you report harm. Bit of a contradiction.

 

Might also have been more mild cases in PACE considering the criteria they use? Also didn`t a lot of patients drop out of PACE for undisclosed reasons? I dont remember exactly

 

I agree, but also worth noting that the placebo wasn’t a dummy pill in this study: it was 500ml IV saline, this could conceivably provide some temporary symptom relief in volume depleted patients, a condition that has been shown to occur frequently in pwME. I wonder if, on observing this, some patients suspected they were on active treatment and this biased their self-report?

 

I haven`t gone through the individual data yet, but that effect should disappear anyway in the long term follow up?

 

It ought to have the same effect as taking four hours to drink a bowl of rather salty soup, unlikely to last more than afurther hour.
I doubt it could be relevant.

 

Does anyone know if patients in the placebo group got active premedication before their main course of ‘Rituximab’, or were all their meds fakes? Isn’t Ritux usually served following a starter of glucocorticoids, and possibly some other stuff? These might be a possible cause of adverse reaction, in some cases.

 

I suspect that is the case, but also patients in Fluge et al were likely more severely affected with limited mobility.

 

Article in Medscape by Miriam Tucker. Log-in is required.
Rituximab Fails to Improve Symptoms in ME/CFS

 

Typically placebo controlled are getting the same premedication as if you were receiving the drug. Nurses do not know what is in the Iv bag when it comes time to infusion.

 

Based on a very brief glance, this article seems to suggest that Dr Naith believes autoimmune antibodies play a role in ME (http://simmaronresearch.com/2019/04/nath-chronic-fatigue-syndrome-east-african-disease-model/). The used "a kind of protein chip technology that allowed them to screen for thousands of antibodies at once" i.e. to try to identify the sequence the auto-antibodies are targeting. @Jonathan Edwards what do you make of this technology; are you aware of a disease where it has helped identify the auto-antibodies/there target?

I agree with your statement above i.e. that the results of the rituximab trial mean that it is unlikely that a significant proportion of people with ME have an autoimmune disease.

 

Rituximab is not a treatment of “all” autoimmune diseases...

 

Mostly unrelated to the study. This is one of the key reasons why control groups are used...

Politely, I'd say the difference in reported adverse effects is certainly in part due to methodological differences.