Gulf War Illness Inflammation Reduction Trial
Abstract
Gulf War illness (GWI) is a deployment-related chronic multi-symptom illness impacting the health-related quality of life (HRQOL) of many U.S. Military Veterans of the 1990-91 Gulf War. A proinflammatory blood biomarker fingerprint was discovered in our initial study of GWI. This led to the hypothesis that chronic inflammation is a component of GWI pathophysiology. Objectives: The GWI inflammation hypothesis was tested in this Phase 2 randomized controlled trial by measuring the effects of prednisone, an anti-inflammatory drug, on the HRQOL of Veterans with GWI. ClinicalTrials.gov, Identifier: NCT02506192. Trial design and methods: Gulf War Veterans meeting the Kansas case definition for GWI were randomized to receive either prednisone or placebo. The Veterans RAND 36-Item Health Survey was used to assess HRQOL. The primary outcome was a change from baseline in the physical component summary score (PCS). PCS is a measure of HRQOL with respect to physical functioning and symptoms. Results: The 8 week prednisone treatment produced a statistically significant PCS increase from baseline. Conclusions: The improvement in physical HRQOL following prednisone-treatment supports the hypothesis that chronic inflammation of is a component of GWI pathophysiology. A Phase 3 RCT is required to determine the efficacy of prednisone as a treatment for GWI.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1190967
Entities
People
- Ronald R Bach
Organizations
- Minneapolis VA Medical Center