|
5 of 7 patients have suffered adverse events |
Citation/s:
Gesell LB, Warnick RE, Brenerman JC, Vogt CJ, Lindsell CJ. A randomized,
controlled trial of hyperbaric oxygen therapy for brain radionecrosis. Undersea
and Hyperbaric Medicine, 2005. 32(4): 235-236
Three-part Clinical Question: For patients with brain radionecrosis,
does hyperbaric oxygen therapy improve functional outcome?
Search Terms: Radiation injury, Brain tumour, Neuropsychiatric testing
The Study:
Non-blinded randomised controlled trial intention-to-treat unknown.
The Study Patients: PET-scan confirmed brain radionecrosis on steroids at
a dose that cannot be tapered down
Control group (N = ?): Steroid treatment, dose adjusted to oedema volume
and Karnofsky score, for 3 months
Experimental group (N = ?): As above, plus 60 treatments of 100% oxygen
breathing at an unspecified pressure on an ‘accelerated air break’ protocol
The Evidence:
|
Outcome |
Time
to Outcome |
Total |
|
|
Adverse
events |
unknown
|
5
of 7 patients enrolled |
|
|
|
|||
|
Non-Event
Outcomes |
Time to
outcome/s |
|
Quality of Life |
4 months |
|
Neuropsychologoical testing |
4 months |
|
Neuroimaging |
4 months |
Comments:
1. Abstract only
2. 7 patients enrolled, allocation unknown
3. No discussion of randomization procedure, blinding, or allocation concealment
4. Severe nature of disease and co-morbidities threaten to disrupt this trial
Appraised by: A/Prof Mike Bennett, Dr Sean Hopson
Department of Diving and Hyperbaric Medicine Prince of Wales Hospital Sydney
; Friday, 22 September 2006
Email: m.bennett@unsw.edu.au