Collet
Hyperbaric oxygen administration for cerebral palsy had no advantage over an air sham treatment and was associated with a high rate of ear barotrauma
Clinical Bottom Line:
1. No advantage of hyperbaric oxygen over sham.
2. Both groups showed an improvement over the course of the trial in motor and neuropsychological outcomes.
3. The rate of middle ear barotrauma was greater in the hyperbaric oxygen arm.
Appraised by: Dan Connor and Mike Bennett, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney ; Tuesday, 28 August 2001
Clinical Scenario: A child aged 5 years with cerebral palsy of neonatal origin with stable symptoms and signs.
Three-part Question: For children with cerebral palsy, does the application of hyperbaric oxygen, compared to a sham treatment regimen result in any improvement in functional ability or memory? Search Terms: Hyperbaric oxygenation, cerebral palsy
The Study: Double-blinded concealed randomised controlled trial with intention-to-treat. Children aged 3-12 years with cerebral palsy of neonatal origin where symptoms are stable. Motor age 6 months to 4 years, psychological age more than 2 years.
Control group (N = 54; 53 analysed): Physical therapy and antispastic medication ceased 6 weeks prior to trial. 40 treatments over two months at 1.3ATA on air for 60 minutes.
Experimental group (N = 57; 54 analysed): As above but 100% oxygen at 1.75ATA for 60 minutes.
The Evidence:
Outcome |
Time to Outcome |
Sham group |
HBO group |
Relative risk reduction |
Absolute risk reduction |
NNT |
MEBT |
40 treatments |
0.11 |
0.53 |
374% |
0.41 |
2 |
95% CIs: |
235 to 513% |
0.26 to 0.57 |
2 to 4 | |||
Non-event outcomes |
Time to outcome |
Air group |
HBO group |
P-value |
|
Gross motor function score improvement (%) |
3 months |
3.1 (95%CI 2.2 to 4.1)
|
3.4 (95%CI 2.2 to 4.5) |
0.97 |
|
Visual span |
3 months |
+1.03 (95%CI 0.3 to 1.8) |
+1.1 (95%CI 0.4 1.8) |
0.91 |
Comments:
1. Controversial and fascinating trial as both sham and hyperbaric arms showed significant improvement after treatment in gross motor score, self-control, visual working memory and auditory attention. No significant differences between groups was demonstrated.
2. Only a subset of patients was available for neuropsychological assessment (N=75).
3. Cause of improvements seen is contentious. Authors feel they are most likely due to a participation effect in a group with highly motivated parents.
4. Relatively low pressure hyperbaric regimen. Sham treatment represents a PO2 achievable with 27% oxygen by mask at 1ATA.
5. The rate of barotrauma was importantly higher in HBOT arm. Other adverse events were rare and evenkly distributed. There were no oxygen toxic events.
6. Parents of sham group children subjectively perceived more improvements than HBO group parents.
Expiry date: August 2023
References:
1. Collet J-P, Vannasse M, Marois P et al. Hyperbaric oxygen for children with cerebral palsy: a randomised multicentre trial. Lancet 2001; 357:582-586.
2. Tremblay S, Vanasse M, Amar M, Marois P, Goldberg J, Dugas M, Cote M, Montgomery D, Lambert J, Lassonde M, Fortin J, Robinson A Lacriox V, Lacroix J, Rosenblat B, Sylvain M, Collet J-P.A double blind, randomized, placebo controlled trial, multicentric, clinical trial assessing the effects of hyperbaric oxygen therapy on cerebral palsy. Undersea and Hyperbaric Medicine 2000; 27(Suppl):64.
3. Hardy P, Collet JP, Goldberg J, Ducruet T, Vanasse M, Lambert J, Marois P et al. Neuropsychological effects of hyperbaric oxygen therapy in cerebral palsy. Developmental Medicine and Child Neurology 2002; 44:436-446.
4.Muller-Bolla M, Collet JP, Ducruet T, Robinson A. Side effects of hyperbaric oxygen therapy in children with cerebral palsy.Undersea Hyperb Med. 2006 Jul-Aug;33(4):237-44.
