Internet based self-help randomized trial for motor Functional Neurological Disorder (SHIFT), 2020, Stone et al

Andy

Andy

Retired committee member
Objective: To determine if self-rated health of patients with motor Functional Neurological Disorder can be improved by unguided internet-based self-help and education.

Methods: In this non-blinded randomised controlled trial, patients were 1:1 allocated unbiased to an unguided education and self-help website in addition to usual care, or usual care only. Patients over 17 years of age with a functional motor symptom which caused distress or disability were included. The primary outcome was self-rated health on the Clinical Global Improvement (CGI) scale, at three and six months. Secondary outcomes were severity of motor symptoms, other physical and psychiatric symptoms, physical functioning, quality of life, work and social adjustment, illness beliefs and satisfaction with care.

Results: 186 patients were randomised, with a follow-up rate of 87% at 6 months. There was no difference in improvement of self-rated health at three months (44% vs 40%, p=0.899) or six months (42% vs 43%, p=0.435). Secondary outcomes did not differ between groups with a threshold of p<0.01. Satisfaction was high, with 86% of patients recommending the website to other patients.

Conclusion: We found no significant effect of the intervention added to usual care on self-rated health or secondary outcome measures, despite high patient satisfaction with the intervention. These results suggest online education and non-guided self-help could be valuable additions to stepped care for motor FND, but are not effective treatments as interventions in their own right.

Classification of Evidence: This study provides Class III evidence that for patients with motor Functional Neurological Disorder, an online education and self-help intervention does not significantly improve self-rated health.
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Paywall, https://n.neurology.org/content/early/2020/07/20/WNL.0000000000010381
Not available via Sci hub at time of posting
 
These results suggest online education and non-guided self-help could be valuable additions to stepped care for motor FND, but are not effective treatments as interventions in their own right.
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So how does the doctor advise the patient?
'I'm presribing this online self help guide for you. It doesn't work, but you might enjoy it anyway.'
 
dave30th said:
would NHS pay for that as a "valuable addition" to your care even if it's not "an effective treatment in its own right"?
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God knows. They pay for IAPT, and slimming classes so why not, if it gets the patient out of the doctor's office for a while. And yet the NHS is desperately short of funds for real treatments. Though perhaps it might fall at the hurdle of NICE.
 
dave30th said:
Exactly. They might also enjoy watching The Wizard of Oz, but it won't help their condition.
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I see what you did there!




Also note, from: https://clinicaltrials.gov/ct2/show/NCT02589886

Exclusion Criteria:

  • Incapacitated (Not able to provide informed consent)
  • Accidental finding of a motor symptom in a patient with other (functional) complaints.
  • Known existing visitor of the (previously available, but currently offline) translated version of a website by Dr. Jon Stone
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I therefore suspect the "self-help" website in the intervention is at least partially based on Jon Stone's neurosymptoms dot org (no direct link please).
 
Placebos work because they change people’s brains.
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Eww...

Yes, they "work" in the sense that they change the psychological state of patients in the way that would be expected by being given some treatment, and they change brains in the same sense as well.

Disease that can be measured objectively don't meaningfully change because of a placebo. And ordinary things like watching TV also changes your brain.

So do placebos affect diseases that can't be measured objectively? We don't know. It seems very unlikely due to all the other diseases where this can be verified and shown not to be the case.
 
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Silly people doing silly things. But at what point do authorities stop funding things that are clearly worthless? It never, ever works. I don't fault quacks for continuing to abuse the system and fund their pet theories but at some point authorities are expected to stop enabling silliness and waste of resources.
There was no difference in improvement of self-rated health at three months (44% vs 40%, p=0.899) or six months (42% vs 43%, p=0.435). Secondary outcomes did not differ between groups with a threshold of p<0.01. Satisfaction was high
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This has been an issue for a while and if this were a serious field there would be demands to disambiguate. In all trials that produce no useful results there is some level of "satisfaction". That's a meaningless term, it has no clinical value. People can be satisfied with a quick shoulder massage or free beer or a bunch of other silly things.

What it shows is that "satisfaction" in this context has nothing whatsoever to do with usefulness. So clearly the very concept of satisfaction should be reevaluated, because otherwise it leads exactly to this kind of abuse where they admit failure in producing any benefits beyond "satisfaction" and still argue it is useful because satisfaction.

Silly, silly people. Why are silly people enabled like this, given millions in endless funding for doing the exact same things over and over again for decades on end?
 
Sean said:
Satisfaction was high.

Patients were relieved they didn't deteriorate?
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Someone was nice to them.
Someone assured them their experience was real.

There are a surprising amount of FND pstients who are not aware they are being gaslit precisely due to the above .
These may also be the basis for the " satisfaction " rating.

Also explains why there are usually no proper control arms.
 
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