Weaver2018
Some evidence to inform the choice of useful outcome measures for the use of HBOT versus sham therapy for post-concussion syndromes.
| 1. This study generated some evidence-based rationale for the best choice of outcome measures in the use of HBOT to treat post-concussion syndromes. 2. In general, HBOT produced some benefits compared to sham at 13 weeks which tended to disappear at six and 12 months follow-up |
Citation/s: 1.Weaver LK, Wilson SH, Lindblad AS, Churchill S, Deru K, Price RC, Williams CS, Orrison WW, Walker JM, Meehan A, Mirow S. Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial. Undersea & hyperbaric medicine: journal of the Undersea and Hyperbaric Medical Society, Inc. 2018;45(2):129-56.
2. Wetzel PA, Lindblad AS, Mulatya C, Kannan MA, Villmar Z, Gitchel GT, Weaver LK. Eye tracker outcomes in a randomized trial of 40 sessions of hyperbaric oxygen or sham in participants with persistent post concussive symptoms. Undersea & hyperbaric medicine: journal of the Undersea and Hyperbaric Medical Society, Inc. 2019;46(3):299.
3. Weaver LK, Chhoeu A, Lindblad AS, Churchill S, Wilson SH. Hyperbaric oxygen for mild traumatic brain injury: Design and baseline summary. Undersea & Hyperbaric Medicine: Journal of the Undersea and Hyperbaric Medical Society, Inc. 2016 Aug 1;43(5):491-509.
Lead author's name and fax: LindellWeaver lindell.weaver@imail.org
Three-part Clinical Question: For patients with persistent symptoms after mild traumatic brain injury, does a course of HBOT, compared to a sham course, result in any measured benefits across a wide range of potentially useful outcomes?
Search Terms: Traumatic brain injury; post-concussion; PTSD
The Study: Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Military personnel with persistent symptoms following mild traumatic brain injury.
Control group (N = 35; 33 analysed): Breathing room air at 1.2 ATA for sixty minutes daily over 12 weeks.
Experimental group (N = 36; 36 analysed): As above but breathing 100% oxygen at 1.5 ATA.
The Evidence:
Outcome |
Time to Outcome |
Sham Group |
HBOT Group |
Relative Risk Reduction |
Absolute Risk Reduction |
NNT |
|
Patient Global Impression of Change Score >4 |
13 weeks |
0.29 |
0.53 |
85% |
0.24 |
4 |
95% CIs: |
7% to 167% |
0.02 to 0.46 |
2 to 48 | |||
Measure |
Sham Group |
HBOT Group |
Difference |
95% CI | ||
Mean |
SD |
Mean |
SD | |||
|
Change in Rivermead Post-Concussion Symptom Questionnaire |
-0.7 |
14.6 |
5.8 |
12.4 |
6.5 |
0.02 to 13.0 |
|
Change in Rivermead Post-Concussion Symptom Questionnaire |
-4.3 |
14.0 |
2.6 |
11.6 |
6.9 |
0.75 to 13.1 |
|
PTSD checklist (17 - 85) at 6 months |
-1.4 |
14.0 |
1.6 |
9,2 |
3.0 |
-2.6 to 8.6 |
|
Neurobehavioral Symptom Inventory (0 to 88) at 13 weeks |
-3.6 |
16.1 |
3.9 |
11.9 |
7.5 |
0.7 to 14.3 |
|
Neurobehavioral Symptom Inventory at 6 months |
-1.6 |
13.1 |
-0.1 |
13.2 |
1.5 |
-4.8 to 7.8 |
Comments
1. This study was described by the authors as 'exploratory' (71 patients and > 600 outcomes evaluated). The study is designed to identify those outcomes of most interest and not powered to make definitive statements about the efficacy of HBOT in this setting.
2. Hypothesis testing was not adjusted for multiple comparisons (by design given the above).
3. Patients had an average of 3.6 episodes of mild TBI and the most recent was 26 months prior to the study.
4. The improvement with HBOT appears stronger in patients with PTSD
5. The improvements seen at 13 weeks in general diminished progressively at six months and 12 months. This may represent under-dosing or the need for ongoing treatment to maintain any benefit.
6. This trial reports that in contrast to some prior RCTs in similar patients, there was no evidence of improvement following the sham sessions.
7. Wetzel et al reported no important differences between HBO and sham in measures of eye movement
Appraised by: Mike Bennett m.bennett@unsw.edu.au; Friday, 23 November 2018
Kill or Update By: November 2021
