“A positive outcome would provide a new therapeutic avenue for treating ill gulf War veterans, for whom there are currently few treatment options.”
Presentations at the Military Health Research Forum, convened to share information on treating Gulf War Illness (GWI), Aug 31-Sep 3 in Kansas City, MO, include a paper on this ongoing trial at Mount Sinai Medical School in New York:
A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Mifepristone in Gulf War Veterans with Chronic Multisymptom Illness (CMI)
The trial is funded and managed by the DOD's Gulf War Illnesses Research Program and Congressionally Directed Medical Research Programs, respectively.
In summary, according to a related news release:
• A large percentage of Gulf War veterans – estimates range from 34% to 65% – continue to suffer from chronic multi-symptom illness, also known as GWI.
• Symptoms can include fatigue, joint pain, headache, rash and cognitive problems, which may reflect altered regulation of the hypothalamic-pituitary-adrenal (HPA) axis.
• The HPA axis is responsible for regulating many things in the body, from the immune system and energy usage, to controlling reactions to stress and trauma.
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• Abnormal functioning of the HPA leads to negative effects on many systems in the body, including the immune system and the nervous system.
• Studies have shown that veterans of the 1991 Gulf War have an enhanced [exacerbated] neuroendocrine response to a specific type of hormone called glucocorticoids.
• The increased physical response is associated with chronic fatigue syndrome, fibromyalgia, and post-traumatic stress disorder, all of which can occur with chronic multisymptom illness.
• This study aims to determine if the prescription drug mifepristone, a glucocorticoid receptor antagonist could decrease the enhanced response and therefore improve the physical and mental health and cognitive functioning of Gulf War veterans. [Commonly known as 'the morning after pill,' mifepristone has been studied as therapy for a variety of ills, from uterine fibroids to major depression.]
• Researchers from the Mount Sinai School of Medicine in New York and the James J. Peters VA Medical Center in the Bronx are evaluating veterans of the 1991 Gulf War with chronic multisymptom illness but without any exclusionary psychiatric or medical conditions.
• All subjects will be treated for a six-week time period with the mifepristone compound and then, a month later, treated with an alternative compound (placebo) in a crossover design. [To see the ClinicalTrials.gov listing of the trial – NCT00691067 – click here.]
• Researchers will then evaluate physical health, cognitive functioning and mental health in subjects and determine if there is improvement in these areas in relation to mifepristone administration.
"A positive outcome would provide a new therapeutic avenue for treating ill Gulf War veterans, for whom there are currently few treatment options," says principal investigator Julia Golier, MD. "The trial will also provide an important proof of concept of whether this type of drug will improve physical health and cognitive outcomes in symptomatic Gulf War veterans, thus improving their overall health."
Source: US Department of Defense Congressionally Directed Medical Research Programs, news release Sep 1, 2009