Article compares ME/MS and has a section on Rituximab

[Sasha]

From the CFSAC meeting thread:

also $3.2MM to Jared Younger (sp?) over 5 years to study biologic markers (tracking fatigue and cytokines day-to-day to understand correlation between the two)

I wonder how many patients he'll be tracking? I wonder if it would be enough to provide some general baseline data for time course that would help with trial design.

 

[Jonathan Edwards]

Do we need better data about the natural course of ME? Should a thousand of us be wearing Fitbits for a year? Serious question! I'd wear a Fitbit for a year in the interests of research.

That might be an inspired idea Sasha. A hundred would probably do. Maybe we should write a grant application - if we could get 100 Spanish PCEM (personas con encefalitis miálgica) and 100 Norwegian MMME (mennesker med myalgisk encefalitt) we could get an EU grant. I was never that good at that but I might know a man that is.

Does anybody know if these Fitbits have actually been used in trials on PWME yet, or is everyone just talking about it?

 

[Dr Speedy]

All forms of Guillain–Barré syndrome are autoimmune diseases yet there have been "lots" of (small) outbreaks.

 

[Jonathan Edwards]

I cannot find anything on Fitbits or actimeters in CFS on Medline - just stuff on old people and mice (some with head injuries!). Some sort of calibration study must surely be worth doing.

 

[Jonathan Edwards]

All forms of Guillain–Barré syndrome are autoimmune diseases yet there have been "lots" of (small) outbreaks.

The difficulty with Gullain Barré is that it is not actually clear that it is autoimmune rather than post-infective. Autoimmunity is by definition a situation where there is apecifi B or T cell reactivity to self antigens. Hugh Willison has made a very good case for some Gullian Barré syndrome involving autoantibodies although part of the story is developed in mice and that only provides circumstantial evidence. If some Guillain Barré is a damaging immune response to foreign protein, as in allergy and maybe post-streptococcal syndromes then it would be expected to show outbreaks but would not be autoimmune. Guillain Barré is an anomaly in that it is the one situation in man where molecular mimicry looks to be reasonably likely.

 

[Sasha]

Does anybody know if these Fitbits have actually been used in trials on PWME yet, or is everyone just talking about it?

I don't know about Fitbits specifically but actimeters were used in a European trial of CBT &/or GET that preceded PACE and demonstrated a lack of effect (hence the scandal over them being planned for PACE but dropped).

I think Fluge & Mella are using actimeters in their current Rtx trial (which you'll know all about).

I think that if they have been used up til now it will most likely have been in the context of CBT/GET trials and possibly sensible studies of activity in relation to the CPET/VO2 max PEM work.

@Tom Kindlon? Do you know about this?

...actually I just searched within the forum and here's Dr Enlander in NY using Fitbits in his research:

http://forums.phoenixrising.me/index.php?threads/is-cdc-out-to-bury-pem.31292/page-5#post-481650

 

[A.B.]

Although I have not kept a journal on this, sleep requirements seem to track symptoms very well.

 

[Jonathan Edwards]

I don't know about Fitbits specifically but actimeters were used in a European trial of CBT &/or GET that preceded PACE and demonstrated a lack of effect (hence the scandal over them being planned for PACE but dropped).

I think Fluge & Mella are using actimeters in their current Rtx trial (which you'll know all about).

I think that if they have been used up til now it will most likely have been in the context of CBT/GET trials and possibly sensible studies of activity in relation to the CPET/VO2 max PEM work.

@Tom Kindlon? Do you know about this?

...actually I just searched within the forum and here's Dr Enlander in NY using Fitbits in his research:

http://forums.phoenixrising.me/index.php?threads/is-cdc-out-to-bury-pem.31292/page-5#post-481650

Thanks Sasha, that shows that the Pubmed search engine is feeble - no surprise. Oystein Fluge will have looked at this in detail when looking for measures. I know he was considering actimeters but was not sure if it made the final protocol. There might still be a good case for a calibration study separate from the hurly burly of a drug trial.

 

[Sasha]

I've started a new thread on the actimeter issue so as not to mess this one up:

http://forums.phoenixrising.me/index.php?threads/what-me-research-has-used-actimeters-fitbits.34182/

 

[Valentijn]

The usual term is "actometers", though "actimeters" is sometimes used as well. Might help with the searching. I know at least three Dutch studies used them (reported in English), but they don't even mention the actometers in those studies, much less describe them. And I'm not sure if the study which compiled the actometer data later described much about them. The ones which were supposed to be used in PACE were tracked down at some point.

 

[Sasha]

The usual term is "actometers", though "actimeters" is sometimes used as well. Might help with the searching. I know at least three Dutch studies used them (reported in English), but they don't even mention the actometers in those studies, much less describe them. And I'm not sure if the study which compiled the actometer data later described much about them. The ones which were supposed to be used in PACE were tracked down at some point.

We crossed - yes, I've just found that out about the confusing spelling! Shall we take this over to the other thread? Would you like to repost there? That's interesting info!

 

[Marco]

That might be an inspired idea Sasha. A hundred would probably do. Maybe we should write a grant application - if we could get 100 Spanish PCEM (personas con encefalitis miálgica) and 100 Norwegian MMME (mennesker med myalgisk encefalitt) we could get an EU grant. I was never that good at that but I might know a man that is.

I don't know about EU science/medical research programmes but I know in other funding areas that there are often secondary selection criteria (gender inequality, social exclusion, use of ICT) that are all boxes that would be ticked by such a study.

Plus it would be good to establish the feasibility (and hopefully utility) of acti(o)meters as a objective measure.

 

[Woolie]

I think actometer measurements would need to be done monthly, maybe being worn for five days or something.

There is, however, another problem that has just surfaced in my mind. ME fluctuates much more than a lot of autoimmune disease symptoms I suspect. It may be a bit like lupus that has 'flares' and plateaus, or MS with 'episodes' and recoveries. These conditions are difficult to make sense of in time curve terms after treatment whether the measure is objective or subjective.

The basic problem is that ME is about the most difficult thing one could need to assess in a trial situation. Which is why other notable trials have come up with a lemon. I have a feeling that we need completely different sorts of trial designs for this condition, but I am not quite sure how best to approach it.

@Jonathan Edwards, thanks for all the feedback and comments on my autoimmune/rituximab questions. I certainly don't blame Fluge and Mella from using a self-report end point. Just figured it might have very different time course properties, that was the key point here.

Also, another good point you raised is this fluctuating quality of the illness which is key for many of us here. I know this sometimes from direct comments people make, but mostly because of all the posts on what to do/how you feel when you have a "crash". I am an extreme case, frequently very healthy, with only the mildest limits on my physical activity, but these periods are punctuated with "crashes" when I am bedridden and feel like I have a severe flu, every bit as bad as the initial glandular fever-type illness that kicked off the whole thing. My point was really, I've never understood the sense in things like the EIPS scale, where you are asked about your overall activity levels. My score would be 9 on good days and a 1 on bad, so which do I choose?