|
1. More patients had a favourable outcome, judged
by a neurologic outcome scale, when treated with a combination of
edaravone and HBOT. |
Citation/s:
1. Imai K, Mori T, Izumoto H, Takabatake N, Kuneida T, Watanabe M. Hyperbaric
oxygen combined with intravenous edaravone for treatment of acute embolic
stroke: a pilot clinical trial. Neurological Medicine and Surgery (
Three-part Clinical Question: For patients with acute embolic stroke,
does the administration of hyperbaric oxygen in addition to standard therapy,
result in any decrease in morbidity or mortality?
Search Terms: stroke, free radical scavengers, cerebral embolus
The Study:
Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Adults with a clinical diagnosis of embolic stroke in
the anterior cerebral circulation with an NIHSS of more than 4, and who
presented within 48 hours of onset.
Control group (N = 19; 19 analysed): Usual supportive treatment including
heparin 10,000 units intravenously daily for 7 days.
Experimental group (N = 19; 19 analysed): As above plus 100% oxygen at
2.0 ATA for one hour daily for seven days and edaravone 30mg IV before and after
each session.
The Evidence:
|
Outcome |
Time
to Outcome |
Control
group |
HBOT
group |
Relative
risk reduction |
Absolute
risk reduction |
Number
needed to treat |
|
Favourable
outcome (Rankin 0
or 1) |
90
days |
0.053 |
0.32 |
496% |
0.26 |
-4 |
|
95% Confidence Intervals: |
934% to 58% |
0.50 to 0.03 |
-32 to -2 |
|||
|
Death |
90
days |
0.053 |
0.16 |
-198% |
-0.11 |
-10 |
|
95% Confidence Intervals: |
-561% to 100% |
-0.30 to 0.09 |
NNT = 11 to INF NNH = 3 to INF |
|||
|
Non-Event
Outcomes |
Time to
outcome/s |
Control
group |
HBOT
group |
P-value |
|
Median NIHSS |
7 days |
8 [2 - 30] |
13 [1 - 21] |
> 0.05 |
Comments:
1. It is not clear which of the two agents (or the combination) is responsible
for the observed improvement in outcome.
2. Significantly improved modified Rankin Scale at 90 days, but not NIHSS at 7
days. The Rankin Scale is a simple 6 point descriptive scale from well to death
- favourable outcome here is no significant functional disability or better),
The NIHSS is a quantified measure of neurologic status (lower is better).
3. No attempt at blinding this study.
4. Edaravone is a free radical scavenger that has been suggested as a
neuroprotective agent in acute ischaemic stroke. It was combined with HBOT in
this trial in an attempt to ameliorate any adverse effects from the oxygen
administration.
5. There were no serious adverse effects of therapy noted, but more subjects
died in the HBOT group.
6. Only about 50% of embolic stroke patients satisfied the inclusion criteria.
Appraised by: Mike Bennett, POWH Sydney ; Tuesday, 5 June 2007
Email: m.bennett@unsw.edu.au
Kill or Update By: June 2009