Improvement
in objective functional measurements in chronic multiple sclerosis with the
addition of hyperbaric oxygen therapy.
Clinical Bottom Line:
1.
Significant improvement in objective measures of ability in multiple sclerosis
with the application of hyperbaric oxygenation.
2.
Treatment effect persisted at 1 year follow-up, although some patients
experienced transient benefit only.
Appraised
by: Mike Bennett, Dept. of Diving and
Hyperbaric Medicine, Prince of Wales Hospital
Sydney; Monday, 15 March 1999
Clinical
Scenario: A patient with multiple
sclerosis presented for consideration of hyperbaric oxygen therapy. We wondered
whether HBO was efficacious in chronic multiple sclerosis.
Three-part
Question: For patients with advanced
chronic multiple sclerosis, does the addition of hyperbaric oxygen therapy to
the standard regime of treatments result in any functional improvement?
Search
Terms: Multiple sclerosis
The
Study:
Double-blinded concealed
randomised controlled trial without intention-to-treat.
Established multiple sclerosis
for 5 years with a neurological deficit for at least 2 years. Each patient
continued on the care established at entry to the trial. No patients having
acute exacerbations were admitted.
Control group (N = 20; 20
analysed): 10% oxygen at 2ATA for 90 minutes daily, 5 times each week to a total
of 20 sham treatments.
Experimental group (N = 20; 20
analysed): 100% oxygen at 2ATA on the same schedule as control.
The
Evidence:
|
Outcome |
Time
to Outcome |
Sham
group |
HBO
group |
Relative
benefit increase |
Absolute
benefit increase |
NNT |
|
Improvement
in at least one objective measure |
4
weeks |
0.05 |
0.600 |
1100% |
0.55 |
2 |
|
95%
CI: |
|
|
|
100%
to 630% |
0.79
to 0.32 |
1
to 3 |
|
Sustained
improvement |
1
year |
0.05 |
0.25 |
400% |
0.2 |
5 |
|
95%
CI: |
|
|
|
100%
to 25% |
-0.01
to 0.41 |
NNT=2
to INF NNH=80
to INF |
|
Deterioration |
1
year |
0.55 |
0.150 |
82% |
0.45 |
2 |
|
95%
CI: |
|
|
|
36%
to 100% |
0.20
to 0.71 |
1
to 5 |
Non-Event Outcomes Time to outcome
Placebo group
HBO group
P-value
Change
from initial
disability
score 1
year
+0.35
-0.59 <0.006
Comments:
1. Suggestion of more benefit
for patients who were both more recent in onset and had less functional
disability.
2. Three patients in the oxygen
group did not tolerate treatment beyond 5 sessions. They have been included
here, but excluded in the paper.
3. Well-conducted study with
good randomisation and blinding.
Expiry date: January 2005
References:
1. Fischer BH, Marks M, Reich T.
Hyperbaric-oxygen treatment of multiple sclerosis. A randomized,
placebo-controlled, double-blind study. New England Journal of Medicine 1983;
308:181-186.
