The Problem: Gulf War illness (GWI) greatly reduces the quality of life for many Gulf War veterans. Sinus problems and fatigue are two of the most common symptoms; treatment for both is challenging and impact on quality of life is especially high. The cause of these symptoms in patients with GWI is not known; however, sinusitis and fatigue share common biological components known as cytokines. This biological relationship is not well understood in GWI. Effective treatment of sinus symptoms and fatigue, and a better understanding of the underlying biological relationships of GWI, sinusitis, and fatigue would improve (1) the quality of life of patients with GWI and (2) our understanding of the biological nature of GWI.
The Treatment to Be Tested: Nasal irrigation is a therapy for sinusitis that bathes the nasal cavity. It has been reported to be effective for sinusitis and fatigue. There are two promising nasal irrigation solutions. Saline solution improves sinus symptoms by thinning, cleaning, and clearing mucus, and it is also thought to improve the protective function of the nasal cavity. Xylitol solution changes the salinity of the nasal surface, resulting in improved antimicrobial properties. Both solutions are helpful for patients with sinusitis and fatigue in the general population, but neither form of nasal irrigation has been tested in a group of Gulf War veterans and neither has been assessed for its potential to change the underlying biological environment of sinus symptoms and fatigue
The Study: We will conduct a 26-week randomized controlled trial with 75 study subjects divided into 3 groups of 25. Subjects in all groups will use routine medical care for their sinus symptoms and fatigue. In addition, Group 1 will use Saline Nasal Irrigation twice a day and Group 2 will use Xylitol Nasal Irrigation twice a day. Group 3 will continue to use routine medical care with no other additions.
We will test three questions in our study. (1) Do subjects in Groups 1 and 2 show improved sinus symptoms and quality of life compared to subjects who use routine medical care for sinusitis and fatigue? (2) Does either form of nasal irrigation result in reduced costs compared to routine medical care? (3) What are the biological relationships among the important cytokines before and after treatment?
The Potential Clinical Applications to Be Derived from This Study: If either type of nasal irrigation is found to be significantly better and more cost-effective than routine care alone for sinus problems and fatigue, the study would show that these treatments can improve the quality of life for affected patients and potentially help society through reduced need for medical care and improved work attendance.
Significant relationships among the cytokines before and after treatment would suggest that there is a deep biological mechanism of action that happens when patients use nasal irrigation. This would contribute to the understanding of the biological nature of sinusitis and fatigue among patients with GWI. These findings would be important to further research on additional therapies for patients with GWI and would improve understanding of the way that nasal irrigation works.
The Time Required to Improve Care for Patients with GWI, Sinusitis, and Fatigue if the Study Results Are Positive: Positive results from this study could be immediately translated to outpatient treatment. Both Saline Nasal Irrigation and Xylitol Nasal Irrigation therapies are simple to perform by the patient and can be done at home after minimal instruction. Physicians can recommend nasal irrigation of either form in the office setting, and inexpensive materials can be purchased over the counter at most pharmacies.
|Effective start/end date
|7/1/11 → 6/30/15
- Congressionally Directed Medical Research Programs: $668,072.00