Wolf

Hyperbaric oxygen therapy no better than sham in improving post-concussion symptoms following mild traumatic brain injury

Clinical bottom line:

1. No clear advantage of HBOT over the sham group 2. Improved symptoms over the treatment course in both sham and HBOT groups

Citation/s: 1. Wolf G, Cifu D, Baugh L, Carne W, Profenna L. The effect of hyperbric oxygen on symptoms after mild traumatic brain injury. Journal of Neurotrauma 2012;29:2606-2612.

2. Weaver LK, Cifu D, Hart B, Wolf G, Miller S. Hyperbaric oxygen for post-concussion syndrome: design of Department of Defense clinical trials. Undersea Hyperb Med. 2012 Jul-Aug;39(4):807-14.

3. Wolf EG, Baugh LM, Kabban CM, Richards MF, Prye J. Cognitive function in a traumatic brain injury hyperbaric oxygen randomized trial. SCHOOL OF AEROSPACE MEDICINE WRIGHT PATTERSON AFB AEROSPACE MEDICINE DEPT; 2015 Aug 7

4. Shandley S, Wolf EG, Schubert-Kappan CM, Baugh LM, Richards MF, Prye J, Arizpe HM, Kalns J. Increased circulating stem cells and better cognitive performance in traumatic brain injury subjects following hyperbaric oxygen therapy. Undersea & hyperbaric medicine: journal of the Undersea and Hyperbaric Medical Society, Inc. 2017;44(3):257-69.

5. Wolf G, Prye J, Michaelson R, Brower G, Profenna L, Boneta O. Hyperbaric side-effects in a traumatic brain injury randomised controlled trial. Undersea Hyperb Med 2012;39(6):1075-1082.

Lead author's name and fax: David Cifu dcifu@mcvh-vcu.edu

Three-part Clinical Question:For patients with post-concussion symptoms after mild traumatic brain injury, does a course of hyperbaric oxygen therapy combined with standard treatment approaches result in any improvement in symptoms?

Search Terms: Mild traumatic brain injury; post-concussion syndrome

The Study: Double-blinded concealed randomised controlled trial with intention-to-treat.

The Study Patients: Serving US military personnel with stable chronic post concussion symptoms (2 to 71 months) following one or more episodes of mild traumatic brain injury suffered during their service.

Control group (N = 25; 24 analysed): Usual ongoing care plus a sham exposure breathing air at 1.3 ATA drifting down to 1.2 ATA for 90 minutes daily five days per week to a total of 30 sessions over eight weeks.

Experimental group (N = 25; 24 analysed): Usual ongoing care plus hyperbaric sessions at 2.4 ATA breathing 100% oxygen on the same schedule as controls.

The Evidence:

Outcome	Sham Group		HBO Group		Difference	95% CI
	Mean	SD	Mean	SD
ImPACT*	26.0	9.8	32.8	0.51	-6.8	-10.8 to -2.8
PCL-M*	40.6	4.9	41.6	4.9	-1.0	-3.8 to 1.8

  *ImmediatePost-concussion Assessment and Cognitive Testing (scale unknown, lower better) and Post-Traumatic Disorder Check List –Military Version (17 fields with 1 to 5 Likert scale each (17 -85), higher score worse. Mean and SE have been read off the figures, then SE converted to SD.

Comments:

1. Well conducted trial. Blinding tested in participants and was successful.

2. Participants had experienced between 1 and 50 concussive episodes

3. Both groups showed improvement over the course of the study in both outcomes. This seems most likely due to a participation effect.

4. The ImPACT total scores at final follow up were better in the control group. Authors report significant downward trend in scores over the trial in both groups. but no significant differences between groups when testing against each other over all time periods. Our result only takes into account a single time point (6 weeks follow-up).

5. Actual statistical method is not reported.

6. Post-hoc subgroup analyses suggest there may be a subgroup that benefit from HBO - the group with multipless concussive events, treated within two years or within one year of a single event.

7. A 'pilot group' analysis of 28 patients (13 sham and 15 HBO) was used to examine circulating stem cells after treatment. There was a trend to increasing numbers of stem cells with increasing HBO exposure, but not with the sham exposure. Increases in circulating stem cells were associated with improved neurocognitive performance in general.

​​​​​​​8. Citation 5 above demonstrated no major adverse events and concluded the treatment was safe. (Ear block 1.1% sham versus 5.9% HBOT, for example).

Appraised by: Mike Bennett; Thursday, 4 July 2013

Email: m.bennett@unsw.edu.au

Kill or Update By: November 2021

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