Trial design for drug trials for ME/CFS - discussion thread

I seem to remember we were unimpressed by the quality of the cryotherapy trials.
I read over 30 years ago about someone who claimed he had cured his ME by sitting in cold baths. I decided to try it. My ME was mild at the time and I was still working part time. I immersed myself in a cold bath daily for a few weeks. I imagined I had more energy, though my other symptoms didn't change as far as I remember. The inevitable happened. I started using that imagined extra energy and crashed badly. End of experiment.
 
Jonathan Edwards said:
I have yet to see anything that suggests that this is serious science. There is no coherent background hypothesis as far as I know and no meaningful trials to date. That leaves us with something of the status of some arbitrary nineteenth century magical cure. If I remember rightly cryotherapy - once claimed to help psoriasis - has been around for at least forty years and maybe even a century or more but never proven to be of any use.
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Back in the 90s (?), after years in bed and having to have my food cut up for me, I had a spectacular improvement after several weeks of a cold-water therapy that consisted of immersing yourself in an increasingly cold bath for longer and longer. I'd read about it in the Daily Mail :sick: - a Professor Kakkar (this guy, I think) had published a protocol for readers with ME to follow and IIRC was claiming to have got results and was promising a clinical trial (which never appeared, AFAIK).

I went from bedbound to walking four miles a day, pretty quickly, without slowly grading up. Then seemed to catch another bug and the improvement disappeared and never came back, even though I persisted with the horrible baths for ages.

I think this situation - weird treatment, no obvious mechanism, spectacular N=1 anecdote that might have been coincidence - raises some interesting questions about the value (or otherwise) of anecdotes, such as:

  • I think you're now positing that ME/CFS might be caused by something that medical science doesn't yet know about. If that's the case, should the lack of a meaningful background hypothesis based on current knowledge matter (or even be a good thing)?

  • We know that whatever preceded one PwME's spectacular remission rarely (though maybe sometimes) helps other PwME but could this be an interesting indication of subgroups? If we could identify PwME for whom a particular intervention seems to have worked, could we identify what else distinguishes them from other PwME (genetics, microbiome, etc.) and move our knowledge forward that way? Could this be a follow-up project with DecodeME's data?

  • Anecdotes on their own are dodgy but surely they're often also sometimes massive signposts to research-worthy interventions, like the serendipitous observations with rituximab that led to the Fluge and Mella trial. Is there a more powerful and systematic way of taking advantage of anecdotal improvements in PwME following some sort of intervention?
 
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