]. Fatigue surveys were repeated at 2 weeks and 6 weeks for each group. Any adverse events were recorded. Fatigue survey scores were then analyzed for statistical significance. As this was a “Proof of Concept” study, sample groups approximated 23 participants.
Fatigue Scores were summarized as means and standard deviations, standard error and confidence intervals were calculated. Changes were summarized as effect sizes, normalized to a 0–100% scale, wherein 100% is the highest amount of fatigue that can be measured with the survey instrument. Significance was calculated from student’s T Test scores in Excel by comparison to baseline.
The clinical trial is an open label, dose escalating “Proof of Concept” study for the use of anhydrous enol-oxaloacetate in the treatment of fatigue. It was initially set up with ME/CFS patients then extended to include arms of Long-COVID patients due to the similarities of the two conditions.
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