done:
What needs researching (what treatment, test or other intervention)?
Rituximab (monoclonal antibody targetting B cells) as a treatment for CFS/ME.
What outcome should we measure?
1. Physical activity (using motion sensor) 2. Post-exertional Malaise (core symptom, self-report) 3. Fatigue (self-report) 4. Cognitive functioning (test)
Why would this research be important for the public, patients or the NHS?
There are currently no good treatments available for CFS/ME The current 'best', CBT/GET showed only moderate gains in self-reported function and fatigue vs unblinded group with no placebo, & didn't work for me. Two studies in Norway have shown promising results; a large multicentre trial (N=150) is underway but I gather this won't be enough to convince NICE. I want a large robust UK trial to test this treatment so I won't have to wait forever for an approved treatment. Inital 2011 study
http://bit.ly/1EIxsTt Second 2015 study (to help design large trial)
http://bit.ly/1JYiKmU About 1/4 of patients showed really dramatic gains - way more than any other published study - and the gains were sustained in the second study, using maintenance doses