There
was no evidence of subjective or functional improvement associated with the
administration of hyperbaric oxygen to patients with chronic progressive
multiple sclerosis.
Clinical
Bottom Line:
1. No evidence of significant functional improvement with the addition
of hyperbaric oxygenation to the treatment of multiple sclerosis.
Appraised
by:
Mike Bennett
Dept of Diving and Hyperbaric Medicine
Prince of Wales Hospital
Sydney; Monday, 8 March 1999
Clinical
Scenario:
A patient with chronic progressive multiple sclerosis presented for
treatment. We wondered if the addition of hyperbaric oxygen would improve
function or prevent deterioration.
Three-part
Question:
In patients with chronic progressive multiple sclerosis, does the addition of
hyperbaric oxygen therapy to the usual on-going measures, result in any addition
benefit in terms of functional improvement or subjective awareness of
improvement?
Search
Terms:
Hyperbaric oxygenation, multiple sclerosis
The
Study:
Double-blinded concealed randomised controlled trial with
intention-to-treat.
Known chronic progressive multiple sclerosis with no acute relapse in
the past year and no steroids or immunosuppression in the past six months.
Control group (N = 44; 44 analysed): Twenty sham hyperbaric oxygen
sessions, 5 times per week for 5 weeks, by the administration of air at 1.1ATA.
Experimental group (N = 44; 44 analysed): Twenty hyperbaric oxygen
sessions at 2ATA on 100% oxygen by the same treatment schedule as above.
The
Evidence:
|
Outcome (Patient assessment of improvement) |
Time to Outcome |
Air group |
HBO group |
Relative risk reduction |
Absolute risk reduction |
NNT |
|
Bladder symptoms |
1
month |
0.286 |
0.310 |
-8% |
-0.024 |
-42 |
|
95% CI: |
|
|
|
-77%
to 60% |
-0.220
to 0.172 |
NNT=6
to INF NNH=5 to
INF |
|
Walking |
1
month |
0.333 |
0.286 |
14% |
0.047 |
21 |
|
95% CI: |
|
|
|
-45%
to 73% |
-0.150
to 0.244 |
NNT=4
to INF NNH=7 to
INF |
Non-Event
Outcomes
Time to outcome Air group
HBO group P-value
Patient assessment of
change compared to pre-trial
1 month
+0.7 +10.1
>0.05
(mm) on a scale 0-100mm
Neurologist assessment
1 month
-1.9
-0.2 >0.05
(similar to above)
Timed walk over 50m (sec)
1 month
2.9
-2.0 >0.05
Change in Kurtzke disability
score (0-10)
1
month
+0.01 +0.05
>0.05
Comments:
1. Good methodological study with 90% power to detect a difference in
improvement of disability score of 1.0 points.
2. The design planned for further assessment at 3 months, 6 months and 1
year but the results do not appear to have been published.
3. Data was analysed by multiple regression to account for any treatment
centre bias and 5 patients who did not tolerate treatment were analysed by
intention to do so.
Expiry date: January 2005
References:
1. Wiles CM, Clarke CR,
Irwin HP, Edgar EF, Swan AV. Hyperbaric oxygen in multiple sclerosis: a double
blind trial. British Medical Journal 1986; 292:367-371.
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