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The researchers aim to include 152 patients from Norway.
In the study, half of the patients have rituximab and the other half salty water.
Everyone will get a total of six infusions...
Two infusions two weeks apart initially, then infusions after 3 , 6, 9 and 12 months .
The study will be double blinded until the last patient has been included in the 24 -month follow-up.
Thank you for the update. Forgive me if this seems obvious but I am assuming that study design takes into account that the placebo - saline, depending upon how much - can be a short-lived treatment for OI symptoms in ME/CFS patients. I suspect that even if the placebo controls are given enough saline to have a short term effect, the improvement for those responding to Rituximab will still be clearly superior, perhaps the difference being slightly smaller than it otherwise would have been. All that said, I'm not sure that I have a better idea for an appropriate control.
I remember having this discussion in another thread a while ago and we concluded that while saline may have transient helpful effects they would not be very pronounced and most importantly would not be long lasting. For those in the medical profession to take such a study seriously it needs to be double-blinded with a control and it'd likely raise more concern if they used a different placebo than the research standard.
I think the point to remember here is that the saline is being given as placebo simply because the rituximab comes in that amount of saline. This is not a standard placebo - it just an 'empty rituximab bag'. All trials like this can only detect differences - in this case the difference in improvement between the two. So everything except the rituximab has to be the same if possible. It does not matter if there are any improvements due to the saline - they get cancelled out of the result. Another point is that a litre of saline once off is no big deal, except psychologically. This litre is given over a period of about five hours usually. So the impact on the circulation will actually be less noticeable than drinking a large bowl of salty soup for lunch - or eating a packet of crisps washed down with coke. We all take in this sort of amount of water quicker than that in a day and eat more salt than that in a big salty meal. All the salt and water gets into the circulation from the gut - and probably quicker than by very slow drip. The psychological impact can be significant though - which is the key reason for making the placebo as similar to the rituximab bag as possible.