A Detoxification Intervention for Gulf War Illness: A Pilot Randomized Controlled Trial

Abstract

Approximately 30% of the 700,000 US veterans of the 1990–1991 Persian Gulf War developed multiple persistent symptoms called Gulf War illness. While the etiology is uncertain, several toxic exposures including pesticides and chemical warfare agents have shown associations. There is no effective medical treatment. An intervention to enhance detoxification developed by Hubbard has improved quality of life and/or reduced body burdens in other cohorts. We evaluated its feasibility and efficacy in ill Gulf War (GW) veterans in a randomized, waitlist-controlled, pilot study at a community-based rehabilitation facility in the United States. Eligible participants (n = 32) were randomly assigned to the intervention (n = 22) or a four-week waitlist control (n = 10). The daily 4–6 week intervention consisted of exercise, sauna-induced sweating, crystalline nicotinic acid and other supplements. Primary outcomes included recruitment, retention and safety; and efficacy was measured via Veteran’s Short Form-36 (SF-36) quality of life, McGill pain, multidimensional fatigue inventory questionnaires and neuropsychological batteries. Scoring of outcomes was blinded. All 32 completed the trial and 21 completed 3-month follow-up. Mean SF-36 physical component summary score after the intervention was 6.9 (95% CI; −0.3, 14.2) points higher compared to waitlist control and 11 of 16 quality of life, pain and fatigue measures improved, with no serious adverse events. Most improvements were retained after 3 months. The Hubbard regimen was feasible, safe and might offer relief for symptoms of GW illness.

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“…Improvements were also seen in the McGill total pain score and all subscales of the Multidimensional fatigue inventory (MFI). Thus, for the physical symptoms measured, the findings were improvements in the majority of the measures (16 of 19) at the seven-day follow-up that were maintained at the three-month follow-up (13 of 16) 16 . The improvement in the VR-36 vitality sub measure was consistent with improvements seen in other HDM studies 22 and the MFI improvements surpassed those found in other GWI research 23 .…”

“…Neuropsychological measures indicated that eight of ten of these measures improved from before intervention and the seven-day follow-up (logical memory 1, logical memory 2, family pictures 1, trail marking A, trail marking B, dominant hand grooved pegboard, Stroop words total, and Stroop colors total; while family pictures 2 and Stroop color-word remained stable), with sustained improvement in seven of those measures at the three-month followup (logical memory 1, family pictures 1, trail marking A, trail marking B, dominant hand grooved pegboard, Stroop words total, and Stroop colors total) 17 . Kerr and colleagues reported a clinically relevant improvement compared to controls in health-related quality of life, and levels of pain and fatigue 16 . The ShortForm36 (VR-36) for veterans includes 8 subscales of which 5 (role-physical, bodily pain, general health, vitality, and mental health) improved.…”

“…The 2014 RACGWI-updated report assumes that GWI is associated with continued effects of toxic exposure or from residual toxins taken in during the GW and noted that a clinical trial of a detoxification approach which could either reduce the burden of the toxins or reduce the toxic effects on psychological, neuro-psychological, and physical functioning was underway 13 . Researchers have taken on this question by applying a novel detoxification program, the Hubbard detoxification method (HDM) 14,15 , to those meeting the GWI criteria 16,17 . The goal of the detoxification process was to reduce the body's burden of toxins and enhance endogenous systems of biotransformation and elimination.…”

“…The detoxification method has been applied to varying toxicant exposed populations with chronic symptoms reminiscent of GWI veterans, with positive outcomes such as increases in cognitive 20 , neurocognitive function 21 , and quality of life measures 22 . The work of Kerr and colleagues 16 represents a significant application and test of the detoxification method.…”

“…The improvement in the VR-36 vitality sub measure was consistent with improvements seen in other HDM studies 22 and the MFI improvements surpassed those found in other GWI research 23 . In addition, 29% of the participants who completed the 3-month follow-up were no longer classified by the Kansas case criteria as having GWI 16 .…”