Sampanthavivat

Hyperbaric oxygen therapy did not improve the assessment of behaviour in children compared to a sham therapy

Clinical bottom line:

1. Some improvements noted over the treatment period in both groups – probably due to a participation effect
2. No evidence of greater improvements in behaviour with HBOT versus sham

Citation/s: 1. Sampanthavivat M, Singkhwa W, Chaiyakul T, Karoonyawanich S, Ajpru H. Hyperbaric oxygen in the treatment of childhood autism: a randomised controlled trial. Diving Hyperb Med. 2012 Sep 1;42(3):128-33.

Lead author's name and fax: Mayuree Sampanthavivat thanasawat.c@navy.mi.th

• • Three-part Clinical Question: For children with autism, does the application of hyperbaric oxygen therapy compared to a sham control result in any improvement in behaviour?

• • Search Terms: Autism; autism spectrum disorder
  • The Study: Double-blinded concealed randomised controlled trial without intention-to-treat.

• • The Study Patients: Children aged 3 to 9 years diagnosed with autism.

• • Control group (N = 30; 29 analysed): Sham treatment breathing air at 1.15ATA for one hour daily, Monday to Friday, to a total of 20 treatment sessions

• • Experimental group (N = 30; 29 analysed): As above, but breathing 100% oxygen at 1.5ATA.

• • The Evidence:

		Measure				Sham Group		HBOT Group		Difference		95% CI
		^		Mean		SD	Mean	SD		^		^
		Total Clinician Autism Treatment Evaluation Checklist Score (ATEC) (Range 0 better to 180 worse)		52.93		18.93	52.38	19.11		0.550		-9.45 to 10.56
		Parental Clinical Global Impression of Illness Severity Score (CGIS) (Range 1 better to 7 worse)		3.66		0.86	3.69	0.93		-0.030		-0.50 to 0.44
		Clinician Clinical Global Impression of Illness Severity Score (CGIS) (Range 1 better to 7 worse)		3.76		0.83	3.48	0.78		0.280		-0.14 to 0.70

Outcome	Time to Outcome	Sham group	HBO group	Relative risk reduction	Absolute risk reduction	NNT
Minor ear barotrauma	End of treatment	0.10	0.37	-267%	-0.27	-4
^	^		95%CIs:	-470% to -64%	-0.47 to -0.06	-16 to -2

• • Comments:

1. One participant lost in each group but not analysed by intention to treat

2. Both groups improved on their entry scores at baseline for the ATEC - presumed to be a participation effect

3. Clinicians did not score an improvement for either group on CGIS and only in the sham group for CGIC

4. Test for blinding suggested the strategy was successful 5. No extra benefit comes at the cost of minor barotrauma

• • Appraised by: Mike Bennett POWH

• • Email: m.bennett@unsw.edu.au

• • Kill or Update By: June 2020

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