What is the purpose of this study? Gulf War Illness (GWI) is a potentially debilitating condition that affects over 250,000 veterans. There are currently no treatments available for GWI. This study is designed to test nine plant-based compounds that may reduce inflammation and help those with GWI.
What will we do? We will examine 40 individuals with GWI. Each individual will be randomly assigned to take 3 of the 9 treatments. They will not know which treatments they are receiving. They will record their symptoms every day on a handheld computer for 60 days for each treatment. We will then analyze the data to see which treatments show the most promise in treating GWI.
Why botanical treatments? Many of our most powerful medications are derived from plant sources. There are many botanicals that are currently available and have anti-inflammatory properties that may make them effective in treating GWI. Botanical treatments are generally much cheaper than pharmaceuticals, have fewer side-effects, and have a longer history of use in humans. However, they have not undergone proper scientific study, and there is a great amount of misinformation on the internet. These potentially helpful treatments therefore need to undergo clinical trials.
Why test nine treatments? When testing a treatment that has not been previously studied, there is a high chance it will not be successful in helping the disorder. In that case, all the time and money devoted to the study may be wasted. We have therefore chosen to test nine different treatments concurrently. Doing so increases our chances of finding at least one treatment that is effective in reducing GWI symptoms.
How did we choose the treatments? We believe that GWI is caused by inflammation in the brain. The inflammation results from overactive immune cells that are reacting to an unknown trigger. The chemicals released from the activated immune cells change the function of brain cells called neurons and cause pain, fatigue, cognitive problems, and other symptoms related to GWI. We believe that the best way to treat GWI is to administer anti-inflammatory agents. The idea is similar to how aspirin is used to reduce inflammation and swelling in the body, but common anti-inflammatory drugs do not cross into the brain easily. We are hoping to find plant-based compounds that can reach the brain and reduce inflammation.
What are the potential clinical applications? This study is designed to help individuals with GWI. It may treat the range of GWI symptoms. The treatments may also ultimately benefit other individuals, including people with fibromyalgia and chronic fatigue syndrome, who have similar symptoms.
What are the risks? Botanical treatments have risks. Some compounds can cause stomach upset in some individuals. The compounds should not be taken by individuals who have low blood pressure, take blood pressure medication, have diabetes, have a blood clotting disease, or take anti-clotting medications.
How will this study advance GWI science and treatment? If these compounds work in GWI, it will strongly support the role of inflammation in GWI. Such information will help guide the science of GWI by pointing researchers and clinicians in the right direction for future work.
What is the projected time it may take to achieve a patient-related outcome? One of the main advantages of this study is that it tests compounds that are already available for human use. New drugs may take over 20 years, and millions of dollars, to go through the required regulations to be used in humans. In many cases, a treatment that works very well in animals fails to work at all in humans. During the time taken for drug development, patients continue to suffer. Individuals with GWI have already suffered for over 20 years and it is therefore essential that we test treatments and make them available as quickly as possible. We focus on treatments that allow us to skip animal testing and lengthy drug development. Individuals could take the treatments after the three-year study is completed. However, complete information about the effectiveness of the treatments may take up to 8 years to produce.