Clarke
Hyperbaric oxygen therapy resulted in improved outcomes for radiation proctitis patients
| Clinical Bottom Line: 1. Significantly greater chance of a good outcome from radiation proctitis with the application of HBOT, with an NNT of 5. |
Citation/s:1. Clarke R, 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.
2. Clarke RE, Tenorio C, Hussey JR, Toklu AS, Cone L, Hinojosa JG, Desai SP, Parra LD, Rodrigues SD, Long RJ, Walker MB. Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow up. Int. J. Radiation Oncology Biol. Phys 2008; Sep 1;72(1):134-43.
Three-part Clinical Question: For patients with soft tissue radiation injury, does the application of hyperbaric oxygen therapy, compared to 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 = 75; 59 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 = 75; 63 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 |
0.20 |
0.39 |
94% |
0.19 |
5 |
95% CI: |
22% to 165% |
0.04 to 0.33 |
3 to 25 |
Measure |
Sham Group |
HBOT Group |
Difference |
P value | ||
Mean |
SD |
Mean |
SD |
|||
|
LENT-SOMA Score at |
10.23 |
7.48 |
3.75 |
0.002 | ||
Comments:
1. This was the first full report of what was an eight-armed study to examine a range of tissus being treated with HBOT.
2. Numbers presented here are by intention to treat, the report quotes figures excluding patients who did not complete the protocol (30 of 150 enrolled - 20% - did not reach analysis). None of the sham patients healed completely at eight weeks versus five of the HBOT arm..
3. Logistic regression to adjust for confounders supports significant effect of HBOT (LENT-SOMA 5.93 less with HBOT at eight weeks (95% confidence interval 2.04–17.24)
4. The evidence is compelling for short-term benefit of HBOT. After eight weeks, sham group was crossed to received HBOT and subsequently benefited as did the original HBOT group. At five year follow-up there was no important difference between groups in LENT-SOMA score (12.8 down to 4.3 in the initial sham group versus 12.6 down to 3.7 in the original HBOT group). The suggestion is that improvement continues over time after HBOT administration, but this is not a randomised comparison.
Appraised by: Mike Bennett POWH, Sydney ; Tuesday, 13th March 2018 Email: [m.bennett@unsw.edu.au]
Kill or Update By: December 2019
