Hyperbaric oxygen therapy did not improve arm volume or functional scores in
post-radiation lymphoedema.
|
1. No evidence of a clinically significant reduction in arm volume or
functional scores in lymphoedema following radiotherapy one year after
hyperbaric therapy. |
Citation/s:
1. Gothard L, Haviland J, Bryson P, Laden G, Glover M, Harrison S, Woods M, Cook
G, Peckitt C, Pearson A, Somaiah N, Stanton A, Mortimer P, Yarnold J. Randomised
phase II trial of hyperbaric oxygen therapy in patients with chronic arm
lymphoedema after radiotherapy for cancer. Radiotherapy and Oncology 2010;
97:101-107.
Lead author's name and fax: john.yarnold@icr.ac.uk
Three-part Clinical Question:
For patients with lymphoedema in the upper limb following axillary or
supraclavicular radiotherapy, does the application of HBOT improve arm volume?
Search Terms: Hyperbaric oxygen, lymphoedema, radiotherapy, breast cancer
The Study:
Non-blinded randomised controlled trial without intention-to-treat. 2:1
randomisation schedule.
The Study Patients: Women previously irradiated in the axillla or
supraclavicalur area and who have developed lymphoedema in the arm resistant to
standard therapy and with increased arm volume of at least 15%.
Control group (N = 20; 16 analysed): Best standard lymphoedema care
according to a 2006 international consensus- no sham therapy.
Experimental group (N = 38; 30 analysed): Best care as above plus daily
HBOT at 2.4ATA for 90 minutes to 30 treatments over six weeks.
The Evidence:
|
Outcome |
Time to Outcome |
Control group |
HBO group |
Relative risk reduction |
Absolute risk reduction |
NNT |
|
>8% change in volume
|
1 year |
0.150 |
0.237 |
58% |
0.09 |
11 |
|
|
95% CIs: |
-80% to 196% |
-0.12 to 0. 29 |
NNT = 8 to INF; NNH = 3 to INF |
|
Non-Event Outcomes |
Time to outcome |
Control group |
Experimental group |
P-value |
|
Self-assessment lymphoedema quesionnaire (0- best to 100- worst) Median
and IQR |
6 months |
47.9 (18.7 to 64.1) |
32.3 (17.7 to 53.6) |
? |
|
As above
|
12 months |
45.8 (13.0 to 62.5) |
37.5 (20.8 to 52.1) |
? |
Comments:
1. High dropout rate reduces our confidence in these figures.
2. Authors were unable to enrol sufficient patients to satisfy their power
calculations and this study is therefore underpowered.
3. There was some indication of benefit in functional lymphoedema scores at six
months but no significance testing was reported.
4. Average interval from onset to
therapy was 12 years – this may have biased against a treatment effect
Appraised by: Mike Bennett, POWH; Thursday, 18 November 2010
Email: m.bennett@unsw.edu.au
Kill or Update By: November 2012