M.bennett at 05:48, 1 January 2021

2021-01-01T05:48:05Z

M.bennett: Created page with " '''Rates of adverse even..."

2021-01-01T05:42:21Z

Created page with " '''Rates of adverse even..."

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'''Rates of adverse events from both sham and hyperbaric oxygen exposures in two mild traumatic brain injury trials were low and not serious.'''

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'''Clinical bottom line:'''

'''1. The rates of adverse events were low per individual patient sessionin both HBO and sham treatment arms  2. Blinding was effective.'''

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'''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:'''

{| class="Table" style="border:solid windowtext 1.0pt"
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| style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | '''Outcome'''
| style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | '''Time to Outcome'''
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | '''Sham group'''
| style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | '''HBO group'''
| style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | '''Relative risk reduction'''
| style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | '''Absolute risk reduction'''
| style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | '''NNT'''
|-
| rowspan="2" style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | '''Any adverse event'''
| style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | 13 weeks
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | 0.38
| style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | 0.50
| style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | 31%
| style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | 0.12
| style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | 9
|-
| colspan="3" style="width:126.1pt; border:solid windowtext 1.0pt" width="168" | 95% CIs:
| style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | -16% to 77%
| style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | -0.06 to 0.29
| style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | NNT = 17 to INF; NNH = 3 to INF
|-
| rowspan="2" style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | '''Ear barotrauma'''
| style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | 13 weeks
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | 0.10
| style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | 0.23
| style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | 133%
| style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | -0.133
| style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | 8
|-
| colspan="3" style="width:126.1pt; border:solid windowtext 1.0pt" width="168" | 95% CIs:
| style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | -2% to 264%
| style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | -0.002 to -0.26
| style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | 4 to 545
|-
| rowspan="2" style="width:61.3pt; border:solid windowtext 1.0pt" width="82" | '''Headache'''
| style="width:48.1pt; border:solid windowtext 1.0pt" width="64" | 13 weeks
| style="width:33.95pt; border:solid windowtext 1.0pt" width="45" | 0.08
| style="width:41.05pt; border:solid windowtext 1.0pt" width="55" | 0.05
| style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | 40%
| style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | 0.03
| style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | 30
|-
| colspan="3" style="width:126.1pt; border:solid windowtext 1.0pt" width="168" | 95% CIs:
| style="width:69.35pt; border:solid windowtext 1.0pt" width="92" | -67% to 100%
| style="width:76.45pt; border:solid windowtext 1.0pt" width="102" | -0.06 to 0.12
| style="width:108.6pt; border:solid windowtext 1.0pt" width="145" | 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

Churchill - Revision history

M.bennett at 05:48, 1 January 2021

M.bennett: Created page with " '''Rates of adverse even..."