Wiles

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 NNT6 to INF NNH5 to INF
Walking 1 month 0.333 0.286 14% 0.047 21
95% CI: -45% to 73% -0.150 to 0.244 NNT4 to INF NNH7 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 2015 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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