cassava7
Senior Member (Voting Rights)
One of the study authors said otherwise.
So they would have changed their placebo since the older 2014 study for allergic rhinitis... strange?
One of the study authors said otherwise.
The INMEST device consists of a thin plastic probe placed in the nose that vibrates at a set frequency to mimic turbulent airflow within the nasal cavity and induces a nerve reflex transmitted to the vagus nerve nuclei in the brainstem and other higher centers (24) (Fig. 1B). It is important to note that the effect of INMEST on the vagus nerve is different from that of classic vagus nerve stimulation. INMEST shifts the balance of sympathetic and parasympathetic tone resulting in a reduction of heart rate variability (23).
It is important to note that many patients struggled with biweekly visits to the clinic and some patients suffered episodes of deterioration as a consequence of post-exertional malaise.
It is important to note that the effect of INMEST on the vagus nerve is different from that of classic vagus nerve stimulation. INMEST shifts the balance of sympathetic and parasympathetic tone resulting in a reduction of heart rate variability(23).
The primary outcome measure in this study was fatigue as defined by thefatigue severity scale (FSS) (27), but no significant effect of INMEST treatment was seen with respect to this outcome variable.
The primary outcome measure in this study was fatigue as defined by the fatigue severity scale (FSS) (27), but no significant effect of INMEST treatment was seen with respect to this outcome variable
Quite frustrating how the results are reported here.
That last suggestion would be interesting. If every patient were asked whether they received a placebo or active treatment, the results could be very telling. Maybe something other researchers could consider?Note, they state their trial failed to have an effect on their initially specified primary outcome measure.
I was about to say the same thing. None of the PROM data is directly reported, no objective outcomes were used. They don't even explain where the "relative symptom" score comes from. Data on other aspects such as the Seahorse testing is not provided either (probably because their sample sizes of n=3 was too small to be statistically meaningful).
But most of all, it still surprises me that researchers conduct "placebo controlled" trials, without asking participants whether they have guessed which arm they are in...
As such, it is hard to interpret the rest of the immunological findings (that are claimed to be associated with treatment) that may well just be the result of natural variation.
Amy Proal
@microbeminded2
7/ In order to help my thinking on those points: were you able to test if patients sustained symptom improvement from INMEST after the 8 week treatment course? Or does the ME/CFS symptom improvement you noted require ongoing use of INMEST in order to be maintained?
4:28 PM · Feb 22, 2020·Twitter Web App
and the response persisted after cessation of treatment in both groups and even improved further in the most actively treated group, suggesting that further improvements could be possible with a prolonged treatment protocol
the paper said:It is important to note that the effect of INMEST on the vagus nerve is different from that of classic vagus nerve stimulation. INMEST shifts the balance of sympathetic and parasympathetic tone resulting in a reduction of heart rate variability(23).
https://sass.uottawa.ca/sites/sass.uottawa.ca/files/how_to_stimulate_your_vagus_nerve_for_better_mental_health_1.pdf said:The vagus nerve is connected to your vocal cords and the muscles at the back of your throat. Singing, humming, chanting and gargling can activate these muscles and stimulate your vagus nerve. And this has been shown to increase heart-rate variability and vagal tone (12).
(maybe a stress like having a vibrating balloon in your nasal cavities? or making the journey into the clinic while suffering PEM from the last journey into the clinic?)HRVcourse said:Generally, a low HRV (or less variability in the heart beats) indicates that the body is under stress from exercise, psychological events, or other internal or external stressors.
What is confusing however is that fatigue did not improve. Is it not very likely that fatigue is closely related to metabolism? At least I think of it that way.
I'm confused (although I haven't read the paper). I thought our problem was that we already had low HRV?
We've got Dr Vallings telling people with ME to gargle and sing in the shower - and that supposedly is increasing HRV and vagal tone.?
I thought low HRV was a bad thing?
(maybe a stress like having a vibrating balloon in your nasal cavities? or making the journey into the clinic while suffering PEM from the last journey into the clinic?)
But in this study, a reduction in HRV is a good thing? If low HRV is a good thing after all, then should we be avoiding the mindfulness courses and instead seeking out 'psychological events or other internal or external stressors' if we can't get a vibrating balloon to do the job?
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Finally, multiple gene sets regulated by INMEST involved cellular energy metabolism, which is curious given that fatigue is the cardinal symptom of ME and linked to alterations in cellular metabolism (38). The GO:
Negative regulation of cellular carbohydrate metabolism is affected by INMEST with genes like GCK encoding the glucose sensor Glucokinase, which shifts cellular metabolism based on the availability of glucose
(39) and was found in this cohort to be repressed in ME-patients after INMESTtreatment (Fig. 5E).
Before continuing, the reader is reminded that the Network Analysis referenced in the posts has been generated on April 2017. For a number of posts we will be referring to this version of Network Analysis. However, the latest Network analysis and algorithmic runs (not shown at present) have been suggesting the potential importance of Glucokinase.
From the Wikipedia entry about Glucokinase, we read :
"Most of the glucokinase in a mammal is found in the liver, and glucokinase provides approximately 95% of the hexokinase activity in hepatocytes. Phosphorylation of glucose to glucose-6-phosphate (G6P) by glucokinase is the first step of both glycogen synthesis and glycolysis in the liver."