Hyperbaric oxygenation alone did not improve recovery rate with osteoradionecrosis of the mandible.


Clinical Bottom Line:
1. No indication of benefit from hyperbaric oxygen, a trend to better outcome with sham.
2. Success rate probably high in both arms (?74% versus ?86%).
3. Did not test the combination of HBOT and surgery, but rather of HBT alone

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 INFNNH = 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 INFNNH = 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 INFNNH = 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 2014


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