Evidence map›Paper›PMID 23372680›Full record

Trial reportPloS one2013

Amelioration of acute sequelae of blast induced mild traumatic brain injury by N-acetyl cysteine: a double-blind, placebo controlled study.

Michael E Hoffer, Carey Balaban, Martin D Slade, Jack W Tsao, Barry Hoffer

3 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 100 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 3 pooled it
13.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00822263 nacompletednot on this map

The Use of Anti-oxidants to Reduce Sequela of Mild TBI (mTBI) After Blast Exposure

TypeinterventionalSponsorBrooke Army Medical CenterRan2008 to 2009Enrolled150ConditionsMild Traumatic Brain InjuryArmsN-acetyl-cysteine (NAC), Placebo
NCT04918719 phase2completednot on this mapstarted 2023, after this paper: background citation

Randomized Placebo Controlled Trial of Intravenous N-Acetylcysteine for the Treatment of Acute Ischemic Stroke

TypeinterventionalSponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterRan2023 to 2024Enrolled4ConditionsAcute Ischemic StrokeArmsAcetylcysteine, Dextrose in Water
NCT06729632 narecruitingnot on this mapstarted 2024, after this paper: background citation

Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

TypeinterventionalSponsorRestorear Devices LLCRan2024 to 2027Enrolled116ConditionsNoise Exposure, Noise-induced Hearing Loss, Noise, Adverse EffectArmsCold pack-delivered mild therapeutic hypothermia
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 3 syntheses or guidelines pooled it, 205 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Mitochondrial-targeted therapies in traumatic brain injury: From bench to bedside.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
  15. Review
  16. Review
  17. Review
  18. Role of Oxidative Stress in Sensorineural Hearing Loss.International journal of molecular sciences · 2024
    Review
  19. Review
  20. Review

40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 5 institutions in 1 country.

Michael E HofferDepartment of Otolaryngology, Naval Medical Center San Diego, San Diego, California, United States of America. Michael.hoffer@med.navy.mil
Carey Balaban
Martin D Slade
Jack W Tsao
Barry Hoffer
Bureau of Medicine and SurgeryNaval Medical Center San Diego · USUniversity of Pittsburgh · USWestern University of Health Sciences · USYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Iraq War, 2003-2011Military PersonnelAcetylcysteineAdolescentAdultBlast InjuriesBrain InjuriesCognition DisordersDouble-Blind MethodFemaleFree Radical ScavengersHumansMaleMemory DisordersNeuropsychological TestsPlacebosAcetylcysteineFree Radical ScavengersPlacebos

Identifiers

PMID23372680
PMCPMC3553161
OpenAlexW2119701105

What OpenQuestion holds

Textmetadata
LicenceCC0
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.