Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial
Autor: | Susan Churchill, Lindell K. Weaver, Robert C. Price, James M. Walker, Anna Meehan, Steffanie H Wilson, Christopher S Williams, William W Orrison, Susan Mirow, Anne S. Lindblad, Kayla Deru |
---|---|
Rok vydání: | 2018 |
Předmět: |
021110 strategic
defence & security studies medicine.medical_specialty medicine.diagnostic_test business.industry Traumatic brain injury Sham Intervention 0211 other engineering and technologies Neuropsychology Cognition 02 engineering and technology General Medicine Electroencephalography medicine.disease law.invention 03 medical and health sciences 0302 clinical medicine Quality of life Randomized controlled trial law Physical therapy Medicine business 030217 neurology & neurosurgery Balance (ability) |
Zdroj: | Undersea and Hyperbaric Medicine. 45:129-156 |
ISSN: | 1066-2936 |
DOI: | 10.22462/03.04.2018.1 |
Popis: | Background: In prior military randomized trials, participants with persistent symptoms after mild traumatic brain injury (TBI) reported improvement regardless of receiving hyperbaric oxygen (HBO2) or sham intervention. This study’s objectives were to identify outcomes for future efficacy trials and describe changes by intervention. Methods: This Phase II, randomized, double-blind, sham- controlled trial enrolled military personnel with mild TBI and persistent post-concussive symptoms. Participants were ran- domized to receive 40 HBO2 (1.5 atmospheres absolute (ATA), >99% oxygen, 60 minutes) or sham chamber sessions (1.2 ATA, room air, 60 minutes) over 12 weeks. Participants and evalua- tors were blinded to allocation. Outcomes assessed at baseline, 13 weeks and six months included symptoms, quality of life, neuropsychological, neurological, electroencephalography, sleep, auditory, vestibular, autonomic, visual, neuroimaging, and laboratory testing. Participants completed 12-month questionnaires. Intention-to-treat results are reported. Results: From 9/11/2012 to 5/19/2014, 71 randomized parti- cipants received HBO2 (n=36) or sham (n=35). At baseline, 35 participants (49%) met post-traumatic stress disorder (PTSD) criteria. By the Neurobehavioral Symptom Inventory, the HBO2 group had improved 13-week scores (mean change -3.6 points, P=0.03) compared to sham (+3.9 points). In participants with PTSD, change with HBO2 was more pronounced (-8.6 vs. +4.8 points with sham, P=0.02). PTSD symptoms also improved in the HBO2 group, and more so in the subgroup with PTSD. Improvements regressed at six and 12 months. Hyperbaric oxygen improved some cognitive processing speed and sleep measures. Participants with PTSD receiving HBO2 had improved functional balance and reduced vestibular complaints at 13 weeks. Conclusions: By 13 weeks, HBO2 improved post-concussive and PTSD symptoms, cognitive processing speed, sleep quality, and balance function, most dramatically in those with PTSD. Changes did not persist beyond six months. Several outcomes appeared sensitive to change; additional studies are warranted. |
Databáze: | OpenAIRE |
Externí odkaz: |