Format

Send to

Choose Destination
JAMA Intern Med. 2015 Jan;175(1):43-52. doi: 10.1001/jamainternmed.2014.5479.

Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial.

Author information

1
US Army Medical Materiel Development Activity, Fort Detrick, Maryland2currently with the Uniformed Services University of the Health Sciences, Bethesda, Maryland.
2
Department of Medicine, University of Utah School of Medicine, Salt Lake City4Department of Hyperbaric Medicine, LDS Hospital, Salt Lake City, Utah.
3
University of Colorado Anschutz Medical Campus, Aurora6Veterans Integrated Service Network 19, Mental Illness Research Education and Clinical Center, Denver, Colorado.
4
Department of Hyperbaric Medicine, LDS Hospital, Salt Lake City, Utah.
5
Evans Army Community Hospital, Fort Carson, Colorado.
6
Naval Hospital Camp Lejeune, Camp Lejeune, North Carolina.
7
Naval Hospital Camp Pendleton, Camp Pendleton, California.
8
Eisenhower Army Medical Center, Fort Gordon, Georgia.
9
Pharmaceutical Product Development, LLC, Wilmington, North Carolina.
10
Defense Center of Excellence for Psychological Health and Traumatic Brain Injury, Silver Spring, Maryland.
11
US Army Medical Materiel Development Activity, Fort Detrick, Maryland.
12
EmpiriStat Inc, Mt Airy, Maryland.

Abstract

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 procedure.

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 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 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.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01306968.

PMID:
25401463
DOI:
10.1001/jamainternmed.2014.5479
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center