Abstract
BackgroundMild traumatic brain injury (mTBI) secondary to blast exposure is the most common battlefield injury in Southwest Asia. There has been little prospective work in the combat setting to test the efficacy of new countermeasures. The goal of this study was to compare the efficacy of N-acetyl cysteine (NAC) versus placebo on the symptoms associated with blast exposure mTBI in a combat setting.MethodsThis study was a randomized double blind, placebo-controlled study that was conducted on active duty service members at a forward deployed field hospital in Iraq. All symptomatic U.S. service members who were exposed to significant ordnance blast and who met the criteria for mTBI were offered participation in the study and 81 individuals agreed to participate. Individuals underwent a baseline evaluation and then were randomly assigned to receive either N-acetyl cysteine (NAC) or placebo for seven days. Each subject was re-evaluated at 3 and 7 days. Outcome measures were the presence of the following sequelae of mTBI: dizziness, hearing loss, headache, memory loss, sleep disturbances, and neurocognitive dysfunction. The resolution of these symptoms seven days after the blast exposure was the main outcome measure in this study. Logistic regression on the outcome of ‘no day 7 symptoms’ indicated that NAC treatment was significantly better than placebo (OR = 3.6, p = 0.006). Secondary analysis revealed subjects receiving NAC within 24 hours of blast had an 86% chance of symptom resolution with no reported side effects versus 42% for those seen early who received placebo.ConclusionThis study, conducted in an active theatre of war, demonstrates that NAC, a safe pharmaceutical countermeasure, has beneficial effects on the severity and resolution of sequelae of blast induced mTBI. This is the first demonstration of an effective short term countermeasure for mTBI. Further work on long term outcomes and the potential use of NAC in civilian mTBI is warranted.Trial RegistrationClinicalTrials.gov NCT00822263
Highlights
Mild traumatic brain injury is the most common injury seen in the current conflicts in Iraq and Afghanistan and an increasingly common injury in modern society
US Military Service members exposed to a significant blast in the Al Anbar province of Iraq were evaluated at TQ as rapidly as feasible
The subject demographic data (Table 1) did not differ between the N-acetyl cysteine (NAC) and the placebo groups, between subjects treated early (#24 hours) or late (26–72 hours) after injury, or between any of the four treatment groups defined by combinations of these factors
Summary
Mild traumatic brain injury (mTBI) is the most common injury seen in the current conflicts in Iraq and Afghanistan and an increasingly common injury in modern society. Over the last three decades the mechanisms, characteristics, diagnostic schemes, and treatment strategies for blunt head trauma have been studied extensively. Disentangling the neurological features of mTBI from PTSD is important for improving diagnosis and treatment of low-level blast injuries [3]. Diagnosis of mTBI requires a documented traumatic event, with a transient loss or alteration of consciousness, accompanied by at least one of a list of neurologic, neurotologic, or cognitive symptoms [5]. Mild traumatic brain injury (mTBI) secondary to blast exposure is the most common battlefield injury in Southwest Asia. The goal of this study was to compare the efficacy of N-acetyl cysteine (NAC) versus placebo on the symptoms associated with blast exposure mTBI in a combat setting
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