Colette J-P

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.

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	Air group	HBO group	Relative risk increase	Absolute risk increase	Number needed to harm
Ear barotrauma	anytime	0.226	0.5	121%	0.27	4
95% C I:				44% to ?%	-0.10 to -0.45	2 to 10

Non-Event Outcomes Time to outcome Air group HBO group P-value

Gross motor function

score improvement (%) 3 months 3.1 3.4 0.97

95%CI 2.2 - 4.1 2.2 - 4.5

Visual span (Corsi Block) 3 months +1.03 +1.1 0.91

95%CI +0.3 - +1.8 +0.4 - +1.8

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.

3. Relatively low pressure hyperbaric regimen. Sham treatment represents a PO2 achievable with 27% oxygen by mask at 1ATA.

4. High rate of barotrauma in both arms.

5. Parents of sham group children subjectively perceived more improvements than HBO group parents.

Expiry date: August 2004

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.