Difference between revisions of "Wolf"
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| − | ==<span style="font-size: 21px;">Hyperbaric oxygen therapy no better than sham in improving post-concussion symptoms following mild traumatic brain injury </span>== | + | == <span style="font-size: 21px;">Hyperbaric oxygen therapy no better than sham in improving post-concussion symptoms following mild traumatic brain injury</span> == |
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| − | + | <span style="font-size: 21px;"><span style="font-size:medium;">'''Clinical bottom line''':</span></span> | |
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| + | {| | ||
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| + | | <span style="font-size:larger;">'''1. No clear advantage of HBOT over the sham group'''<br/> '''2. Improved symptoms over the treatment course in both sham and HBOT groups'''</span> | ||
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| − | <span style="font-size: 15px;">'''Lead author's name and fax:''' David Cifu dcifu@mcvh-vcu.edu </span> | + | <span style="font-size:small;">'''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.</span> |
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| + | <span style="font-size:small;">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.</span> | ||
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| + | <span style="font-size:small;">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</span> | ||
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| + | <span style="font-size:small;">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.</span> | ||
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| + | <span style="font-size:small;">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.</span> | ||
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| + | <span style="font-size: 15px;">'''Lead author's name and fax:''' David Cifu dcifu@mcvh-vcu.edu</span> | ||
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| + | '''<span style="font-size: 15px;">Three-part Clinical Question:</span>'''<span style="font-size: 15px;">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?</span> | ||
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<span style="font-size: 15px;">'''Search Terms:''' Mild traumatic brain injury; post-concussion syndrome</span> | <span style="font-size: 15px;">'''Search Terms:''' Mild traumatic brain injury; post-concussion syndrome</span> | ||
| − | + | <span style="font-size: 15px;">'''The Study:''' Double-blinded concealed randomised controlled trial with intention-to-treat.</span> | |
| − | <span style="font-size: 15px;">'''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. </span> | + | |
| − | <span style="font-size: 15px;">'''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. </span> | + | <span style="font-size: 15px;">'''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.</span> |
| + | |||
| + | <span style="font-size: 15px;">'''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.</span> | ||
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<span style="font-size: 15px;">'''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.</span> | <span style="font-size: 15px;">'''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.</span> | ||
| − | + | '''<span style="font-size: 15px;">The Evidence:</span>''' | |
| − | {| | + | |
| − | + | {| class="Table" style="border: 1pt solid windowtext; width: 481px;" | |
|- | |- | ||
| − | | | + | | style="border: 1pt solid windowtext; width: 56px;" | <p style="padding: 0.75pt; text-align: center;">'''Outcome'''</p> |
| + | | colspan="2" style="border: 1pt solid windowtext; width: 110px;" | <p style="padding: 0.75pt; text-align: center;">'''Sham Group'''</p> | ||
| + | | colspan="2" style="border: 1pt solid windowtext; width: 91px;" | <p style="padding: 0.75pt; text-align: center;">'''HBO Group'''</p> | ||
| + | | style="border: 1pt solid windowtext; width: 87px;" | <p style="padding: 0.75pt; text-align: center;">'''Difference'''</p> | ||
| + | | style="border: 1pt solid windowtext; width: 98px;" | <p style="padding: 0.75pt; text-align: center;">'''95% CI'''</p> | ||
|- | |- | ||
| − | | ''' | + | | style="border: 1pt solid windowtext; width: 56px;" | |
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| + | | style="border: 1pt solid windowtext; width: 56px;" | <p style="padding: 0.75pt; text-align: center;">'''Mean'''</p> | ||
| + | | style="border: 1pt solid windowtext; width: 41px;" | <p style="padding: 0.75pt; text-align: center;">'''SD'''</p> | ||
| + | | style="border: 1pt solid windowtext; width: 45px;" | <p style="padding: 0.75pt; text-align: center;">'''Mean'''</p> | ||
| + | | style="border: 1pt solid windowtext; width: 54px;" | <p style="padding: 0.75pt; text-align: center;">'''SD'''</p> | ||
| + | | style="border: 1pt solid windowtext; width: 87px;" | | ||
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| + | | style="border: 1pt solid windowtext; width: 98px;" | | ||
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|- | |- | ||
| − | | ''' | + | | style="border: 1pt solid windowtext; width: 56px;" | |
| + | '''ImPACT'''* | ||
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| + | | style="border: 1pt solid windowtext; width: 56px;" | <p style="padding: 0.75pt; text-align: center;">26.0</p> | ||
| + | | style="border: 1pt solid windowtext; width: 41px;" | <p style="padding: 0.75pt; text-align: center;">9.8</p> | ||
| + | | style="border: 1pt solid windowtext; width: 45px;" | <p style="padding: 0.75pt; text-align: center;">32.8</p> | ||
| + | | style="border: 1pt solid windowtext; width: 54px;" | <p style="padding: 0.75pt; text-align: center;">0.51</p> | ||
| + | | style="border: 1pt solid windowtext; width: 87px;" | <p style="padding: 0.75pt; text-align: center;">-6.8</p> | ||
| + | | style="border: 1pt solid windowtext; width: 98px;" | <p style="padding: 0.75pt; text-align: center;">-10.8 to -2.8</p> | ||
|- | |- | ||
| + | | style="border: 1pt solid windowtext; width: 56px;" | <p style="padding: 0.75pt; text-align: center;">'''PCL-M'''*</p> | ||
| + | | style="border: 1pt solid windowtext; width: 56px;" | <p style="padding: 0.75pt; text-align: center;">40.6</p> | ||
| + | | style="border: 1pt solid windowtext; width: 41px;" | <p style="padding: 0.75pt; text-align: center;">4.9</p> | ||
| + | | style="border: 1pt solid windowtext; width: 45px;" | <p style="padding: 0.75pt; text-align: center;">41.6</p> | ||
| + | | style="border: 1pt solid windowtext; width: 54px;" | <p style="padding: 0.75pt; text-align: center;">4.9</p> | ||
| + | | style="border: 1pt solid windowtext; width: 87px;" | <p style="padding: 0.75pt; text-align: center;">-1.0</p> | ||
| + | | style="border: 1pt solid windowtext; width: 98px;" | <p style="padding: 0.75pt; text-align: center;">-3.8 to 1.8</p> | ||
|} | |} | ||
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| − | + | <span style="font-size:smaller;"> <span style="font-family: Arial, Helvetica, sans-serif;">*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.</span></span> | |
| − | <span style="font-family: Arial,Helvetica,sans-serif | + | |
| − | <span style="font-family: Arial,Helvetica,sans-serif | + | '''<span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">Comments:</span></span>''' |
| − | <span style="font-family: Arial,Helvetica,sans-serif | + | |
| − | <span style="font-family: Arial,Helvetica,sans-serif | + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">1. Well conducted trial. Blinding tested in participants and was successful.</span></span> |
| − | <span style="font-family: Arial,Helvetica,sans-serif | + | |
| − | <span style="font-family: Arial,Helvetica,sans-serif | + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">2. Participants had experienced between 1 and 50 concussive episodes</span></span> |
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| + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">3. Both groups showed improvement over the course of the study in both outcomes. This seems most likely due to a participation effect.</span></span> | ||
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| + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">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).</span></span> | ||
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| + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">5. Actual statistical method is not reported.</span></span> | ||
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| + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">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.</span></span> | ||
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| + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">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.</span></span> | ||
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| + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">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).</span></span> | ||
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| + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">'''Appraised by''': Mike Bennett; Thursday, 4 July 2013</span></span> | ||
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| + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">'''Email:''' m.bennett@unsw.edu.au</span></span> | ||
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| + | <span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">'''Kill or Update By''': November 2021</span></span> | ||
| − | + | <span style="display: block; text-align: center;">[[File:Sumhorsa.gif|center|Sumhorsa.gif]]</span> | |
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| − | <span style="color: #7c00ff; display: block; font-size: 26px; text-align: center;">[[ | + | <span style="color: #7c00ff; display: block; font-size: 26px; text-align: center;">[[Head_Injury|BACK]]</span> |
Latest revision as of 04:41, 8 July 2019
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
