Coenzyme Q10 Phase III Trial in Gulf War Illness, completed 2020, Klimas et al

[Hutan]

ClinicalTrials.gov

clinicaltrials.gov

A trial registered on Clinical Trials

Brief Summary
The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms. Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity level, and cognitive and mental functioning.

This is a randomized, two group, double blind, placebo controlled, Phase III clinical trial. The treatment group will receive a (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The placebo group will receive matching placebo (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The primary outcome measure for this clinical trial is a change from baseline of SF-36, with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of biomarkers, and of GWI-associated symptoms of chronic pain, fatigue, sleep issues, and cognitive impairment.


The trial started in 2017.
51 Gulf War Veterans were allocated to the CoQ10 treatment; 49 Gulf War Veterans were allocated to the placebo
Measurements were made for 6 months.
Recruitment halted due to the Covid-19 pandemic
Results for the many measures are presented on the Clinical Trials entry, as means with SD, no p values.

There is no record of this study being published yet.

 

[Hutan]

Thanks to @forestglip for finding this study.

Here are the results, bearing in mind there are no p values. I've classified a minor improvement as something less than 10% of the total scale. An improvement is greater than 10% of the total scale.




In summary, there were trivial changes in both the treatment and placebo group, with neither group looking better or worse overall.



For the primary outcome, the Veterans Short Form 36, the CoQ10 group had a score improvement by 0.7 on a scale of 0 to 100. The placebo group's mean score improved by 0.3/100. These differences are tiny.

On the Gulf War Illness Health Symptom Checklist, there was substantial improvement for both groups, with the placebo group doing marginally better (-9.4/42 compared to -8.7/42).

For the Hit Reaction time, there was no scale. I'm not completely sure if the authors had the signs of the values right, but it looks as though the reaction time worsened (increased) by 24 in the CoQ10 group and by only 12.8 in the placebo group. I don't know how consequential those changes are.

There were also measurements of some features of blood, of thyroid hormones and of other hormones, all of which were within normal bounds. there were measures of sleep as recorded by the Fitbit, but there is no normative data given and it's hard to make much of it. There doesn't look to be much difference in sleep hours or sleep type.



It seems clear that the CoQ10 was not having an effect on anything that was measured.