Coenzyme Q10 for Gulf War Illness: A Replication Study

All outcomes are assessed as change from baseline.

All outcomes are assessed as change from baseline.

All outcomes are assessed as change from baseline. 5 point scale, higher is good.

7 validated single-item symptom self-ratings: headache; energy; fatigue with exertion, muscle pain; irritability; impatience; trouble recalling words/names. Each benefited with coQ10, p<0.05 (two-sided), in the prior coQ10 trial.

Benefit to timed chair rises will relate to blood coQ10 change. This outcome assesses the relation between change in time to complete five chair rises (in seconds) to change in blood level of CoQ10 (in ug/mL). The prediction of change in time to perform five chair rises by change in coQ10 blood level (regression with robust standard errors).

Change in symptoms on coQ10 versus placebo will be assessed in men (male subset of sample).

Change in timed chair rises on coQ10 versus placebo will be assessed in men (male subset of sample).

Change in GSRH on coQ10 versus placebo will be assessed in men (male subset of sample).

Compare the effect of coQ10 300mg/day to placebo, and to coQ10 100mg/d on symptoms.

Compare the effect of coQ10 300mg/day to placebo, and to coQ10 100mg/d on timed chair rises.

Compare the effect of coQ10 300mg/day to placebo, and to coQ10 100mg/d on GSRH.

Following seven months of study participation, participants will have been on coQ10 for either 3.5 months or 7 months. These two groups will be compared to assess the impact of longer vs. shorter duration treatment (those initially randomized to placebo will crossover to active coQ10 for the final 3.5 months, while those originally randomized to coQ10 will have been on coQ10 for 7 months).

Following seven months of study participation, participants will have been on coQ10 for either 3.5 months or 7 months. These two groups will be compared to assess the impact of longer vs. shorter duration treatment (those initially randomized to placebo will crossover to active coQ10 for the final 3.5 months, while those originally randomized to coQ10 will have been on coQ10 for 7 months).

Following seven months of study participation, participants will have been on coQ10 for either 3.5 months or 7 months. These two groups will be compared to assess the impact of longer vs. shorter duration treatment (those initially randomized to placebo will crossover to active coQ10 for the final 3.5 months, while those originally randomized to coQ10 will have been on coQ10 for 7 months).

Specifically, change in blood pressure on coq10 versus placebo will be assessed considering those with low blood pressure at baseline separately from those with borderline or high blood pressure at baseline.

For instance, participants who transition from coQ10 to placebo might drop because of lost of needed benefits of coQ10 -- because the participant felt worse. Alternatively, participants who transition from placebo run-in to coQ10 might drop out due to problems like activation insomnia on active treatment. The number of dropouts will be compared on active treatment vs placebo, and the causes of dropout will be compared also. (Participants who drop because their physicians ask them to do so for some unrelated reason, not because the patient has had a problem or perceive a problem, will count as dropouts, but not as dropouts for "cause" -- cause here refers to a symptom change and/or medical event.) In addition to overall assessment, assessment of dropouts for cause will be evaluated stratified by whether the participant is transitioning from coQ10.

This outcome assesses the relation between change in symptoms to change in blood level of CoQ10 (in ug/mL).

This outcome assesses the relation between change in single-item General Self-Rated Health (GSRH) to change in blood level of CoQ10 (in ug/mL). The GSRH is a 5 point scale, higher is good.

For inclusion in sleep apnea stratum during analysis, the following will be qualifying: Diagnosed sleep apnea, nocturia, awaking from sleep gasping or choking (or observed by others gasping or choking during sleep), daytime hypersomnolence, night sweats, or awaking with headache or anxiety. This is exploratory, but each outcome will be stratified by sleep apnea-compatible problems.