Racic
Bell's palsy recovered more completely and more rapidly with hyperbaric oxygen therapy than with prednisone.
Clinical Bottom Line: 1. Complete recovery was obtained with hyperbaric oxygen therapy in 95% of cases, significantly better than the rate with prednisone treatment. 2. Time to recovery was significantly shorter with HBO. 3. The degree of deficit in those not fully recovered was less with hyperbaric.
Appraised by: Mike Bennett, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital Sydney; Wednesday, 18 November, 1998
Clinical Scenario: A patient with facial palsy of unknown origin. Three-part Question: In patients with facial palsy of unknown origin, does the application of hyperbaric oxygenation as compared to the administration of steroids, result in earlier or more complete resolution of the palsy? Search Terms: hyperbaric oxygenation, Bell's palsy
The Study: Single (?double)-blinded concealed randomised controlled trial with intention-to-treat. Adult patients with established diagnosis of moderate or severe Bell's palsy with less than 1 week of facial weakness. Control group (N = 37; 37 analysed): 8 days Prednisone (total 450mg) in a tailing dose plus sham hyperbaric exposure on schedule below. Experimental group (N = 42; 42 analysed): Placebo dosing regime as above plus hyperbaric oxygen therapy at 2.8ATA for 60 minutes, twice daily for five days.
The Evidence:
Outcome | Time to Outcome | Prednisone | Hyperbaric | Relative risk reduction | Absolute risk reduction | Number needed to treat |
Complete resolution | 9 months | 0.757 | 0.952 | 26% | 0.195 | 5 |
95% CI | 6% to 46% | 0.04 to 0.35 | 3 to 24 | |||
Nerve excitability test improved | 9 months | 0 | 0.071 | INF | 0.071 | 14 |
95% CI | 0.15 to -0.01 | 7 to INF | ||||
Complete recovery and mild palsy | 9 months | 0.865 | 1.0 | 16% | 0.14 | 7 |
95% CI | 3% to 28% | 0.25 to 0.03 | 4 to 40 |
Time to outcome | Prednisone | Hyperbaric | P-value | |
Average time **to recovery |
9 months | 34.4 days | 22 days | <0.001 |
- Comments:
1 Information lacking on randomisation method and observer blinding. 2. Reliable placebo/sham was employed for blinding but the sham HBOT regimen is potentially unsafe (decompression illness risk) and is equivalent to breathing 56% oxygen at the surface 3. Clinical importance of the nerve excitability test is unclear. 4. If steroids are the standard of care, it may be useful to test both treatments together versus steroids alone.
Expiry date: June 2020 References: 1. Racic G, Denoble PJ, Sprem N, Bojic L, Bota B. Hyperbaric oxygen as a therapy of Bell's palsy. Undersea and Hyperbaric Medicine 1997; 24:35-38.