Difference between revisions of "Cifu"

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==<span style="font-size: 14pt;">Hyperbaric oxygen therapy no better than sham for the treatment of postconcussion syndrome</span>==  
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==<span style="font-size: 12pt;">Clinical Bottom Line:</span>==  
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== <span style="font-size: 14pt;">Hyperbaric oxygen therapy no better than sham for the treatment of postconcussion syndrome</span> ==
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{|  
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| '''<span style'''"font-size: 10pt;">1. No effect on postconcussion syndrome of either HBOT regimen compared to a sham treatment.</span>'''<br><br>**<span style'''"font-size: 10pt;"> 2. Some minor improvements in all groups compared to baseline but did not reach pre-defined clinical significance.</span>'''<br><br>**<span style="font-size: 10pt;">3, No improvement in eye tracking abnormailities with HBOT</span>'''
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== <span style="font-size: 12pt;">Clinical Bottom Line:</span> ==
 +
 
 +
{|
 
|-
 
|-
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|
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'''<span>1. No effect on postconcussion syndrome of either HBOT regimen compared to a sham treatment.</span><br/> <br/> 2. Some minor improvements in all groups compared to baseline but did not reach pre-defined clinical significance''''''.'''<br/> <br/> ''<span style="font-size: 10pt;">3.</span>''''''<span style="font-size: 10pt;">No improvement in eye tracking abnormailities with HBOT</span>'''
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'''<span style="font-size: 10pt;">4. No improvements in multiple cognitive and psychomotor assessments</span>'''
 +
 
|}
 
|}
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**<span style="font-size: 10pt;">Citation/s:</span>'''
 
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<span style="font-size: 10pt;"> 1. Cifu DX, Hart BB, West SL, Walker W, Carne W. The effect of hyperbaric oxygen on persistent postconcussion symptoms. Journal of Head Trauma and Rehabilitation 2014;29(1):11-20.</span>
 
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<span style="font-size: 10pt;"> 2. Cifu DX, Walker WC, West SL, Hart BB, Franke LM, Sima A, Graham CW, Carne W. Hyperbaric oxygen for blast-related postconcussion syndrome: three-month outcomes. Annals of Neurology 2014;75:277-286.</span>
 
  
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3. Cifu DX, Hole KW, Wetzel PA, Wares JR, Gitchel G, Carne W. Effects of hyperbaric oxygen on eye tracking abnormalities in males after mild traumatic brain injury. Journal of Rehabilitation Research and Development 2014;51(7):1047-1056
+
'''<span style="font-size: 10pt;">Citation/s:</span>'''
 +
 
 +
<span style="font-size: 10pt;">1. Cifu DX, Hart BB, West SL, Walker W, Carne W. The effect of hyperbaric oxygen on persistent postconcussion symptoms. Journal of Head Trauma and Rehabilitation 2014;29(1):11-20.</span>
 +
 
 +
<span style="font-size: 10pt;">2. Cifu DX, Walker WC, West SL, Hart BB, Franke LM, Sima A, Graham CW, Carne W. Hyperbaric oxygen for blast-related postconcussion syndrome: three-month outcomes. Annals of Neurology 2014;75:277-286.</span>
  
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<span style="font-size: 10pt;">'''Lead author's name and fax:''' William Carne William.Carne@va.gov </span>
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3. Wares D, Cifu DX, Hole KW, Wetzel PA, Wares JR, Gitchel G, Carne W. Effects of hyperbaric oxygen on eye tracking abnormalities in males after mild traumatic brain injury. Journal of Rehabilitation Research and Development 2014;51(7):1047-1056
−
**<span style="font-size: 10pt;">Three-part Clinical Question:</span>'''<span style="font-size: 10pt;"> For patients with postconcussion syndrome following blast injury, does HBOT compared to a sham therapy result in any improvement in symptoms?</span>
 
  
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<span style="font-size: 10pt;"> '''Search Terms:''' postconcussion syndrome; blast injury; post-truamatic stress disorder</span>
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4.&nbsp;Walker WC, Franke LM, Cifu DX, Hart BB. Randomized, Sham-controlled, feasibility trial of hyperbaric oxygen for service members with postconcussion syndrome: cognitive and psychomotor outcomes 1 week postintervention. Neurorehabilitation and neural repair. 2014 Jun;28(5):420-32.
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**<span style="font-size: 10pt;">The Study: </span>'''<span style="font-size: 10pt;">Double-blinded concealed randomised controlled trial with intention-to-treat.</span>
 
  
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<span style="font-size: 10pt;"> '''The Study Patients:''' Patients diagnosed with mild traumatic brain injury 3 months to 3 years in the past and with postconcussion symptoms.</span>
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<span style="font-size: 10pt;">'''Lead author's name and fax:''' William Carne William.Carne@va.gov</span>
  
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<span style="font-size: 10pt;"> '''Control group''' (N = 21; 21 analysed): Sham treatment using compression to 2 ATA breathing 10.5% oxygen for 40 daily exposures for 60 minutes</span>
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'''<span style="font-size: 10pt;">Three-part Clinical Question:&nbsp;</span>'''<span style="font-size: 10pt;">For patients with postconcussion syndrome following blast injury, does HBOT compared to a sham therapy result in any improvement in symptoms?</span>
  
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<span style="font-size: 10pt;"> '''Experimental group''' (N = 40; 39 analysed): 1. 100% oxygen breathing at 1.5 ATA on the same schedule as control. 2. 100% oxygen breathing at 2 ATA on the same schedule as control.</span>
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<span style="font-size: 10pt;">'''Search Terms:''' postconcussion syndrome; blast injury; post-truamatic stress disorder</span>
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**<span style="font-size: 10pt;">The Evidence:</span>'''
 
  
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{|
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<span style="font-size: 10pt;">'''The Study:''' Double-blinded concealed randomised controlled trial with intention-to-treat.</span>
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">Measure</span>'''</span></span> |||| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">Control Group</span>'''</span></span> |||| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">HBOT Groups</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">Difference</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style="font-size: 10pt;">P-value</span>'''</span></span>
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 +
<span style="font-size: 10pt;">'''The Study Patients:''' Patients diagnosed with mild traumatic brain injury 3 months to 3 years in the past and with postconcussion symptoms.</span>
 +
 
 +
<span style="font-size: 10pt;">'''Control group''' (N = 21; 21 analysed): Sham treatment using compression to 2 ATA breathing 10.5% oxygen for 40 daily exposures for 60 minutes</span>
 +
 
 +
<span style="font-size: 10pt;">'''Experimental group''' (N = 40; 39 analysed): 1. 100% oxygen breathing at 1.5 ATA on the same schedule as control. 2. 100% oxygen breathing at 2 ATA on the same schedule as control.</span>
 +
 
 +
'''​​​​​​​<span style="font-size: 10pt;">The Evidence:</span>'''
 +
 
 +
{| class="Table" style="border:solid windowtext 1.0pt"
 
|-
 
|-
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|^  || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">Mean</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">SD</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">Mean</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 10pt;">SD</span>'''</span></span> ||^  ||^ 
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| style="border:solid windowtext 1.0pt" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''Measure'''</p>
 +
| style="width:36.85pt; border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" width="51" | &nbsp;
 +
| style="width:59.8pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''Control Group'''</p>
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| style="width:43.55pt; border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" width="60" | &nbsp;
 +
| style="width:49.5pt; border:solid windowtext 1.0pt" width="68" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''HBOT Groups'''</p>
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| style="border:solid windowtext 1.0pt" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''Difference'''</p>  
 +
| style="border:solid windowtext 1.0pt" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''P-value'''</p>  
 
|-
 
|-
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| '''<span style'''"font-size: 10pt;">RPQ-16 at end of treatment</span>''' || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-size: 10pt; text-align: center;">32.86</span></span> ||  || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-size: 10pt; text-align: center;">28.62</span></span> ||  || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-size: 10pt; text-align: center;">4.24</span></span> || <span style'''"display: block; text-align: center;"><span style="display: block; font-size: 10pt; text-align: center;">NS</span></span>
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| style="border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" | &nbsp;
 +
| style="width:36.85pt; border:solid windowtext 1.0pt" width="51" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''Mean'''</p>
 +
| style="width:59.8pt; border:solid windowtext 1.0pt" width="82" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''SD'''</p>  
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| style="width:43.55pt; border:solid windowtext 1.0pt" width="60" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''Mean'''</p>  
 +
| style="width:49.5pt; border:solid windowtext 1.0pt" width="68" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''SD'''</p>  
 +
| style="border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" | &nbsp;
 +
| style="border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" | &nbsp;
 
|-
 
|-
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| '''<span style'''"font-size: 10pt;">PCL-M at end treatment</span>''' || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-size: 10pt; text-align: center;">43.9</span></span> ||  || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-size: 10pt; text-align: center;">42.93</span></span> ||   || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-size: 10pt; text-align: center;">0.970</span></span> || <span style'''"display: block; text-align: center;"><span style="display: block; font-size: 10pt; text-align: center;">NS</span></span>  
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| style="border:solid windowtext 1.0pt" |
 +
'''RPQ-16 at end of treatment'''
 +
 
 +
| style="width:36.85pt; border:solid windowtext 1.0pt" width="51" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">32.86</p>  
 +
| style="width:59.8pt; border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" width="82" | &nbsp;
 +
| style="width:43.55pt; border:solid windowtext 1.0pt" width="60" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">28.62</p>  
 +
| style="width:49.5pt; border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" width="68" | &nbsp;
 +
| style="border:solid windowtext 1.0pt" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">4.24</p>  
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| style="border:solid windowtext 1.0pt" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">NS</p>  
 
|-
 
|-
 +
| style="border:solid windowtext 1.0pt" |
 +
'''PCL-M at end treatment'''
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 +
| style="width:36.85pt; border:solid windowtext 1.0pt" width="51" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">43.9</p>
 +
| style="width:59.8pt; border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" width="82" | &nbsp;
 +
| style="width:43.55pt; border:solid windowtext 1.0pt" width="60" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">42.93</p>
 +
| style="width:49.5pt; border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" width="68" | &nbsp;
 +
| style="border:solid windowtext 1.0pt" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">0.970</p>
 +
| style="border:solid windowtext 1.0pt" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">NS</p>
 
|}
 
|}
 +
 
<span style="font-size: 10pt;">RPQ-16: Rivermead Postconcussion Questionnaire-16. PCL-M: Posttraumatic Disorder Checklist – Military Version.</span>
 
<span style="font-size: 10pt;">RPQ-16: Rivermead Postconcussion Questionnaire-16. PCL-M: Posttraumatic Disorder Checklist – Military Version.</span>
  
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Mixed model ANOVA for tracking variables - Interaction of oxygen level and time:
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&nbsp;
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**Vertical''' Mean of non-normalized primary position error: P = 0.44
 
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**Horizontal''' Mean of normalized primary position error: P = 0.68
 
  
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**<span style="font-size: 10pt;">Comments:</span>'''
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'''<span style="font-size: 10pt;">Comments:</span>'''
  
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<span style="font-size: 10pt;"> 1. Well conducted study with rigorous design including blinding, allocation concealment and two regimens for HBOT. </span>
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<span style="font-size: 10pt;">1. Well conducted study with rigorous design including blinding, allocation concealment and two regimens for HBOT.</span>
  
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<span style="font-size: 10pt;"> 2. Sham here unusual in that there was pressure exposure at a PIO2 identical with air at 1 ATA.</span>
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<span style="font-size: 10pt;">2. Sham here unusual in that there was pressure exposure at a PIO2 identical with air at 1 ATA.</span>
  
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<span style="font-size: 10pt;"> 3. Improvements noted were ascribed most likely due to placebo or Hawthorne effects.</span>
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<span style="font-size: 10pt;">3. Improvements noted were ascribed most likely due to placebo or Hawthorne effects.</span>
  
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<span style="font-size: 10pt;"> 4. Three month outcomes were analysed by repeated measure mixed effects modelling - no difference was found due to the group allocation.</span>
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<span style="font-size: 10pt;">4. Three month outcomes were analysed by repeated measure mixed effects modelling - no difference was found due to the group allocation.</span>
  
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<span style="font-size: 10pt;"> 5. Males only studied and all were military personnel.May affect generalizability</span>
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<span style="font-size: 10pt;">5. Males only studied and all were military personnel.May affect generalizability</span>
  
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**<span style="font-size: 10pt;">Appraised by:</span>'''<span style="font-size: 10pt;"> Mike Bennett, University of NSW ; Thursday, 30 October 2014 Email: m.bennett@unsw.edu.au</span>
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'''​​​​​​​<span style="font-size: 10pt;">Appraised by:&nbsp;</span>'''<span style="font-size: 10pt;">Mike Bennett, University of NSW&nbsp;; Thursday, 30 October 2014 Email: m.bennett@unsw.edu.au</span>
  
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<span style="font-size: 10pt;"> '''Kill or Update By:''' November 2021</span>
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<span style="font-size: 10pt;">'''Kill or Update By:''' November 2021</span>
  
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[[File:sumhorsa.gif|center]]
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[[File:Sumhorsa.gif|center|Sumhorsa.gif]]
  
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<span style="display: block; text-align: center;"><span style="font-size: 26px;">[[Head Injury | BACK ]]</span></span><span style="display: block; text-align: center;">
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<span style="display: block; text-align: center;"><span style="font-size: 26px;">[[Head_Injury|BACK]]</span></span>
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</span><span style="display: block; text-align: center;">
 
  
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</span>
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&nbsp;

Latest revision as of 21:42, 12 November 2020

Hyperbaric oxygen therapy no better than sham for the treatment of postconcussion syndrome

Clinical Bottom Line:

'1. No effect on postconcussion syndrome of either HBOT regimen compared to a sham treatment.

2. Some minor improvements in all groups compared to baseline but did not reach pre-defined clinical significance'.

3.'No improvement in eye tracking abnormailities with HBOT

4. No improvements in multiple cognitive and psychomotor assessments

Citation/s:

1. Cifu DX, Hart BB, West SL, Walker W, Carne W. The effect of hyperbaric oxygen on persistent postconcussion symptoms. Journal of Head Trauma and Rehabilitation 2014;29(1):11-20.

2. Cifu DX, Walker WC, West SL, Hart BB, Franke LM, Sima A, Graham CW, Carne W. Hyperbaric oxygen for blast-related postconcussion syndrome: three-month outcomes. Annals of Neurology 2014;75:277-286.

3. Wares D, Cifu DX, Hole KW, Wetzel PA, Wares JR, Gitchel G, Carne W. Effects of hyperbaric oxygen on eye tracking abnormalities in males after mild traumatic brain injury. Journal of Rehabilitation Research and Development 2014;51(7):1047-1056

4. Walker WC, Franke LM, Cifu DX, Hart BB. Randomized, Sham-controlled, feasibility trial of hyperbaric oxygen for service members with postconcussion syndrome: cognitive and psychomotor outcomes 1 week postintervention. Neurorehabilitation and neural repair. 2014 Jun;28(5):420-32.

Lead author's name and fax: William Carne William.Carne@va.gov

Three-part Clinical Question: For patients with postconcussion syndrome following blast injury, does HBOT compared to a sham therapy result in any improvement in symptoms?

Search Terms: postconcussion syndrome; blast injury; post-truamatic stress disorder

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

The Study Patients: Patients diagnosed with mild traumatic brain injury 3 months to 3 years in the past and with postconcussion symptoms.

Control group (N = 21; 21 analysed): Sham treatment using compression to 2 ATA breathing 10.5% oxygen for 40 daily exposures for 60 minutes

Experimental group (N = 40; 39 analysed): 1. 100% oxygen breathing at 1.5 ATA on the same schedule as control. 2. 100% oxygen breathing at 2 ATA on the same schedule as control.

​​​​​​​The Evidence:

Measure

  

Control Group

  

HBOT Groups

Difference

P-value

 

Mean

SD

Mean

SD

    

RPQ-16 at end of treatment

32.86

  

28.62

  

4.24

NS

PCL-M at end treatment

43.9

  

42.93

  

0.970

NS

RPQ-16: Rivermead Postconcussion Questionnaire-16. PCL-M: Posttraumatic Disorder Checklist – Military Version.

 

Comments:

1. Well conducted study with rigorous design including blinding, allocation concealment and two regimens for HBOT.

2. Sham here unusual in that there was pressure exposure at a PIO2 identical with air at 1 ATA.

3. Improvements noted were ascribed most likely due to placebo or Hawthorne effects.

4. Three month outcomes were analysed by repeated measure mixed effects modelling - no difference was found due to the group allocation.

5. Males only studied and all were military personnel.May affect generalizability

​​​​​​​Appraised by: Mike Bennett, University of NSW ; Thursday, 30 October 2014 Email: m.bennett@unsw.edu.au

Kill or Update By: November 2021

Sumhorsa.gif

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