|
1. No indication of benefit from hyperbaric
oxygen, a trend to better outcome with sham. |
Citation/s:
1. Annane D, Depondt J, Aubert P, Villart M, Gehanno P, Gajdos P, Chevret S.
Hyperbaric oxygen therapy for radionecrosis of the jaw: a randomised,
placebo-controlled, double-blind trial from the ORN96 study group. Journal of
Clinical Oncology 2004; 22(24):1-8.
Lead author's name and fax: Djillal Annane djillal.annane@rpc.ap-hop-paris.fr
Three-part Clinical Question: For patients with established
osteoradionecrosis of the mandible, does the hyperbaric oxygenation without
surgery result in any improvement in satisfactory outcomes?
Search Terms: Hyperbaric oxygenation, osteoradionecrosis, radiation
tissue injury
The Study:
Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Adults with established osteoradionecrosis but
excluded if pathological fracture, bone loss to inferior border or active
cancer. Stratified randomisation: Group A - exposed bone <20mm diameter, no
fistula and no clear need for surgery, Group B – exposed bone >20mm,
fistula or clear need for surgery.
Control group (N = 31; 31 analysed): Conservative treatment involving
analgesia, antibiotics, debridement/curettage/irrigation plus daily sessions for
90 minutes breathing 9% oxygen at 2.4ATA to a total of 30. 10 further sessions
post-operatively if surgery required.
Experimental group (N = 37; 37 analysed): As above, but sessions involved
breathing 100% oxygen at 2.4ATA.
The Evidence:
|
Outcome |
Time to
Outcome |
Control
event rate |
HBOT Event
rate |
Relative
risk reduction |
Absolute
risk reduction |
NNT |
|
Recovered
|
1
year |
0.32 |
0.19 |
-67% |
-0.13 |
-8 |
|
95% Confidence Intervals: |
-173% to 39% |
-0.34 to 0.08 |
NNT = 13 to INF NNH = 3 to INF |
|||
|
Recovered
as above or cured following surgery |
1
year |
0.87 |
0.74 |
-17% |
-0.12 |
-8 |
|
95% Confidence Intervals: |
-42% to 9% |
-0.31 to 0.07 |
NNT = 15 to INF NNH = 3 to INF |
|||
|
Persistent
ulceration |
1
year |
0.41 |
0.42 |
3% |
0.01 |
71 |
|
95% Confidence Intervals: |
-53% to 59% |
-0.22 to 0.25 |
NNT = 4 to INF NNH = 5 to INF |
|||
Comments:
1. Trend to poor outcomes with HBO lead to termination of the trial (blinded and
predetermined).
2. Unusual definition of 'recovered' as opposed to ‘failure of therapy’ did
not allow good outcome if an individual moved from A to B, but was later cured.
It is not clear how many ‘recovered’ are from each of strata A and B
3. Some outcomes are data collected after the one year follow-up, but it is not
clear which. Two individuals were operated on in the control group after one
year (personal communication).
Appraised by: Mike Bennett +61 2 9382 3882 ; Tuesday, 21 December 2004
Email: m.bennett@unsw.edu.au
Kill or Update By: July 2005