|
1. Significantly greater chance of a good outcome from radiation proctitis with the application of HBOT, with an NNT of 3. |
Citation/s:
1. Clarke D, Tenorio C, Dominguez L, Toklu A, Hussey J. Treatment of radiation
necrosis with hyperbaric oxygen: a randomized, double-blind, placebo controlled
trial. Proceedings of the Undersea and Hyperbaric Medical Society Annual
Scientific Meeting 2004; abstract F202.
Three-part Clinical Question: For patients with soft tissue radiation
injury, does the application of hyperbaric oxygen therapy, compared to any other
measures or a sham treatment, result in any improvement in mortality, symptoms
or function?
Search Terms: Radiation injury, proctitis, cystitis
The Study:
Double-blinded concealed randomised controlled trial without intention-to-treat.
The Study Patients: Patients with a history of tumour requiring
irradiation and with later onset of radiation injury to the anus or rectum.
Control group (N = 34; 27 analysed): Sham treatment breathing air at
1ATA, with a brief excursion to trivial pressure, once daily for 2 hours to a
total of 30 to 40 treatments over 6 to 8 weeks.
Experimental group (N = 34; 30 analysed): As above, but breathing 100%
oxygen at 2ATA.
The Evidence:
|
Outcome |
Time to
Outcome |
Sham
group |
Hyperbaric
group |
Relative
risk reduction |
Absolute
risk reduction |
NNT |
|
Significant
improvement or healed |
8 weeks |
0.18 |
0.47 |
168% |
0.30 |
3 |
|
95% Confidence Intervals: |
48% to 288% |
0.08 to 0.51 |
2 to 12 |
|||
|
Measure |
Sham
Group |
HBOT
Group |
Difference |
P value |
||
|
Mean |
SD |
Mean |
SD |
|||
| Change in LENT scale |
0.65 |
|
4.6 |
|
3.95 |
0.002 |
Comments:
1. Abstract only and presents interim data for 1 arm of an 8 armed study.
2. Numbers presented here are by intention to treat, the abstract quotes figures
excluding patients who did not complete the protocol (11 of 68 enrolled - 16% -
did not reach analysis). None of the sham patients healed completely (figure for
active arm not given).
3. Logistic regression supports significant effect of HBOT (P=0.15, OR 4.0,
95%CI 1.3 to 12.7).
Appraised by: Mike Bennett POWH, Sydney ; Sunday, 1 August 2004
Email: m.bennett@unsw.edu.au
Kill or Update By: August 2005