Research Reports - Effects of Hyperbaric Oxygen on Symptoms and Quality of Life Among Service Members With Persistent Postconcussion Symptoms
JAMA Intern Med. 2014 Nov 17
Miller RS(1), Weaver LK(2), Bahraini N(3), Churchill S(4), Price RC(5), Skiba V(6), Caviness J(7), Mooney S(8), Hetzell B(9), Liu J(9), Deru K(4), Ricciardi R(10), Fracisco S(11), Close NC(12), Surrett GW(5), Bartos C(6), Ryan M(7), Brenner LA(3)
Importance: 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.
Objectives: 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
Design, Setting, and Participants: 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.
Interventions: 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.
Main Outcomes and Measures: 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
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 and Relevance: 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.