The
use of hyperbaric oxygen therapy does not decrease disability following
ischaemic stroke.
Clinical
Bottom Line:
1.
Hyperbaric oxygen therapy does not decrease disability after acute
ischemic stroke
2.
There is a trend for worse outcome following hyperbaric oxygen therapy.
Citation/s:
Rusyniak DE, Kirk MA, May JD et
al. Hyperbaric oxygen therapy in acute ischemic stroke. Results of the
hyperbaric oxygen in acute ischaemic stroke trial pilot study. Stroke
2003;34:571-574.
Lead author's name and fax: Daniel
E. Rusyniak, MD
Three-part
Clinical Question: In patients
with acute ischaemic stroke, does the application of hyperbaric oxygen compared
to standard measures result in any reduction in disability or death?
Search Terms: Cerebrovascular
accident, brain infarction
The
Study:
Double-blinded concealed
randomised controlled trial with intention-to-treat.
The Study Patients:
Adults greater than 18 years of age with clinical characteristics of
acute ischaemic stroke less than 24 hrs in duration. No haemorrhage on C/T.
Control group (N = 16; 13
analysed): Single 'sham' treatment with 100% oxygen for 60 minutes at 1.14 ATA
in a monoplace hyperbaric chamber
Experimental group (N = 17; 17
analysed): Single treatment with 100% oxygen for 60 minutes at 2.5 ATA in a
monoplace hyperbaric chamber
The
Evidence:
|
Outcome |
Time
to Outcome |
Sham
rate |
HBO
rate |
Relative
risk reduction |
Absolute
risk reduction |
NNT |
|
Favourable NIHSS score |
24 hrs |
0.313 |
0.176 |
44% |
0.14 |
7 |
|
95% CI |
|
|
|
-49% to 100% |
-0.15 to 0.43 |
NNT=2
to INF NNH=7 to INF |
|
Favourable NIHSS score |
90 days |
0.500 |
0.294 |
41% |
0.21 |
5 |
|
95% CI |
|
|
|
-24% to 100% |
-0.12 to 0.53 |
NNT=2 to INF NNH=8 to INF |
|
Death |
90 days |
0.188 |
0.118 |
37% |
0.07 |
14 |
|
95% CI |
|
|
|
-93% to 100% |
-0.18 to 0.32 |
NNT=3 to INF NNH=6 to INF |
Comments:
1. NIHSS is a widely used
disability scale specifically designed for stroke assessment. Favourable outcome
was improvement >4 points or score of 0 at 24hrs, and score <=1 at 90
days.
2. Missing and dead patients
allocated to unfavourable outcome in the 90 day analysis above. Analysis
excluding these subjects difficult to interpret.
3. Single 60 min hyperbaric oxygen
treatment is an unusual intervention.
4. Co-morbidities not described as
potential confounders.
5. The control group was younger
and predominantly white. Effect on result unknown.
6. Authors used results to abandon
further investigation.
7. Three additional stroke scales
used for 90 day analysis with no major differences.
Appraised
by: Benjamin Kliot MD and Mike Bennett, Prince of Wales
Hospital, Sydney;
Monday, 10 March 2003. Email: bkliot@mac.com.
Kill or Update By: March 2005