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Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War Illness (Abstract)
Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War Illness
Fatigue: Biomedicine, Health & Behavior
09 June 2018
Background: 30% of Gulf War veterans developed Gulf War Illness (GWI) with chronic fatigue, pain, and neuropsychological disabilities.
Purpose: To assess the efficacy of low-dose naltrexone to treat GWI.
Methods: A double-blinded, placebo-controlled crossover trial of naltrexone 4.5 mg/day was conducted. The Clinical global impression scale (CGIS), visual analogue scales (VAS), SF-36 Health Survey, and the Connors Continuous Performance Test assessed treatment response. ClinicalTrials.gov registry Identifier is NCT02206490.
Results: Thirty-seven participants completed the protocol. 100% had upper airway inflammation on examination. 88% were overweight or obese. The CGIS detected improvement in 38% of patients (n = 14) (responders), with 6 of these patients reporting much improvement. Non-responders were rated as showing no change from baseline (n = 18; 49%), or were rated minimally worse (n = 5; 13%). On the SF-36 Health Survey, responders showed significantly less disability than non-responders with respect to emotional limitations (p = 0.01) as well as greater improvement on VAS scales for confusion (p < 0.01), vertigo (p = 0.03) and depression (p = 0.05). All enrolled participants had detectable levels of naltrexone in their serum at the end of the treatment period, with values ranging from 1.5to 18 ng/ml. Anecdotally, some subjects and their spouses felt that naltrexone should be continued after the study ended.
Conclusion: This pilot trial suggests low-dose naltrexone may be effective for some with GWI. Further study and consideration of other doses is needed.
Keywords: Gulf War illness, naltrexone, chronic fatigue, chronic pain, neuropsychological disabilities