Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial.
OBJECTIVE
Improvement has been anecdotally observed in patients with persistent postconcussion symptoms (PCS) after mild traumatic brain injury following treatment with hyperbaric oxygen (HBO). The effectiveness of HBO as an adjunctive treatment for PCS is unknown to date.


OBJECTIVE
To compare the safety of and to estimate the efficacy for symptomatic outcomes from standard PCS care alone, care supplemented with HBO, or a sham procedure.


METHODS
Multicenter, double-blind, sham-controlled clinical trial of 72 military service members with ongoing symptoms at least 4 months after mild traumatic brain injury enrolled at military hospitals in Colorado, North Carolina, California, and Georgia between April 26, 2011, and August 24, 2012. Assessments occurred before randomization, at the midpoint, and within 1 month after completing the interventions.


METHODS
Routine PCS care was provided in specialized clinics. In addition, participants were randomized 1:1:1 to 40 HBO sessions administered at 1.5 atmospheres absolute (ATA), 40 sham sessions consisting of room air at 1.2 ATA, or no supplemental chamber procedures.


METHODS
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) served as the primary outcome measure. A change score of at least 2 points on the RPQ-3 subscale (range, 0-12) was defined as clinically significant. Change scores from baseline were calculated for the RPQ-3 and for the total RPQ. Secondary measures included additional patient-reported outcomes and automated neuropsychometric testing.


RESULTS
On average, participants had sustained 3 lifetime mild traumatic brain injuries; the most recent occurred 23 months before enrollment. No differences were observed between groups for improvement of at least 2 points on the RPQ-3 subscale (25% in the no intervention group, 52% in the HBO group, and 33% in the sham group; P = .24). Compared with the no intervention group (mean change score, 0.5; 95% CI, -4.8 to 5.8; P = .91), both groups undergoing supplemental chamber procedures showed improvement in symptoms on the RPQ (mean change score, 5.4; 95% CI, -0.5 to 11.3; P = .008 in the HBO group and 7.0; 95% CI, 1.0-12.9; P = .02 in the sham group). No difference between the HBO group and the sham group was observed (P = .70). Chamber sessions were well tolerated.


CONCLUSIONS
Among service members with persistent PCS, HBO showed no benefits over sham compressions. Both intervention groups demonstrated improved outcomes compared with PCS care alone. This finding suggests that the observed improvements were not oxygen mediated but may reflect nonspecific improvements related to placebo effects.


BACKGROUND
clinicaltrials.gov Identifier: NCT01306968.
US Army Medical Materiel Development Activity, Fort Detrick, Maryland2currently with the Uniformed Services University of the Health Sciences, Bethesda, Maryland.
R Scott
RS
Miller
Department of Medicine, University of Utah School of Medicine, Salt Lake City4Department of Hyperbaric Medicine, LDS Hospital, Salt Lake City, Utah.
Lindell K
LK
Weaver
University of Colorado Anschutz Medical Campus, Aurora6Veterans Integrated Service Network 19, Mental Illness Research Education and Clinical Center, Denver, Colorado.
Nazanin
N
Bahraini
Department of Hyperbaric Medicine, LDS Hospital, Salt Lake City, Utah.
Susan
S
Churchill
Evans Army Community Hospital, Fort Carson, Colorado.
Robert C
RC
Price
Naval Hospital Camp Lejeune, Camp Lejeune, North Carolina.
Virginia
V
Skiba
Naval Hospital Camp Pendleton, Camp Pendleton, California.
James
J
Caviness
Eisenhower Army Medical Center, Fort Gordon, Georgia.
Scott
S
Mooney
Pharmaceutical Product Development, LLC, Wilmington, North Carolina.
Brian
B
Hetzell
Pharmaceutical Product Development, LLC, Wilmington, North Carolina.
Jun
J
Liu
Department of Hyperbaric Medicine, LDS Hospital, Salt Lake City, Utah.
Kayla
K
Deru
Defense Center of Excellence for Psychological Health and Traumatic Brain Injury, Silver Spring, Maryland.
Richard
R
Ricciardi
US Army Medical Materiel Development Activity, Fort Detrick, Maryland.
Susan
S
Fracisco
EmpiriStat Inc, Mt Airy, Maryland.
Nicole C
NC
Close
Evans Army Community Hospital, Fort Carson, Colorado.
Gerald W
GW
Surrett
Naval Hospital Camp Lejeune, Camp Lejeune, North Carolina.
Corinna
C
Bartos
Naval Hospital Camp Pendleton, Camp Pendleton, California.
Margaret
M
Ryan
University of Colorado Anschutz Medical Campus, Aurora6Veterans Integrated Service Network 19, Mental Illness Research Education and Clinical Center, Denver, Colorado.
Lisa A
LA
Brenner
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006931:Hyperbaric Oxygenation; D008297:Male; D008889:Military Personnel; D038223:Post-Concussion Syndrome / Q000628:therapy*; D011788:Quality of Life; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult