Churchill
Rates of adverse events from both sham and hyperbaric oxygen exposures in two mild traumatic brain injury trials were low and not serious.
|
Clinical bottom line: 1. The rates of adverse events were low per individual patient sessionin both HBO and sham treatment arms |
Citation/s:1. Churchill S, Deru K, Weaver LK, Wilson SH, Hebert D, Miller RS, Lindblad AS. Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms. Undersea & hyperbaric medicine: journal of the Undersea and Hyperbaric Medical Society, Inc. 2019;46(3):331
Lead author's name and fax: Susan Churchill via Lindell Weaver lindell.weaver@imail.org
Three-part Clinical Question:For patients with mild traumatic brain injury being treated or receiving sham in a randomised clinical trial, do those receiving hyperbaric oxygen have more adverse events and can they distinguish treatment from sham control?
Search Terms: Adverse events; mild traumatic brain injury; sham
The Study:Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Patients enrolled in two trials of hyperbaric oxygen for the treatment of mild traumatic brain injury.
Control group (N = 60 ; 60 analysed): 40 sessions once daily for five days/week breathing air at 1.2 ATA
Experimental group (N = 60 ; 60 analysed): As above, but breathing 100% oxygen at 1.5 ATA
The Evidence:
Outcome |
Time to Outcome |
Sham group |
HBO group |
Relative risk reduction |
Absolute risk reduction |
NNT |
Any adverse event |
13 weeks |
0.38 |
0.50 |
31% |
0.12 |
9 |
95% CIs: |
-16% to 77% |
-0.06 to 0.29 |
NNT = 17 to INF; NNH = 3 to INF | |||
Ear barotrauma |
13 weeks |
0.10 |
0.23 |
133% |
-0.133 |
8 |
95% CIs: |
-2% to 264% |
-0.002 to -0.26 |
4 to 545 | |||
Headache |
13 weeks |
0.08 |
0.05 |
40% |
0.03 |
30 |
95% CIs: |
-67% to 100% |
-0.06 to 0.12 |
NNT = 8 to INF; NNH = 18 to INF | |||
Comments:
1. Note these are composite results from two separately conducted RCTs. See Miller 2015 and Weaver 2018.
2. The overall rate of AEs per participant session in Miller 2015 was 1.1% and in Weaver 2016 was 2.2%.
3. No serious adverse events related to chamber sessions were reported in either study. Ear barotrauma was more common in the HBOT group.
4. Blinding success difficult to interpret. The authors conclude blinding was protected. Overall 16/56 of those receiving HBO correctly picked allocation and 19/51 receiving sham similarly correctly identified their allocation. The questionnaires were administered differently in each study.
5. Participants largely identified their group allocation according to the improvement or otherwise of their symptoms.
Appraised by:Mike Bennett m.bennett@unsw.edu.au; Friday, 1 January 2021
Kill or Update By: January 2023
