Oscarsson

Hyperbaric oxygen improved symptoms of radiation cystitis compared to no specific treatment

1. Symptom scores and quality of life improved after a course of hyperbaric oxygen
2. More patients had improved grade scores as assessed by the urologist

Citation/s:1.Oscarsson N, Müller B, Rosén A, Lodding P, Mölne J, Giglio D, Hjelle KM, Vaagbø G, Hyldegaard O, Vangedal M, Salling L. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2–3 trial. The Lancet Oncology. 2019 Nov 1;20(11):1602-14.

Three-part Clinical Question:For patients with radiation cystitis, does treatment with hyperbaric oxygen, compared to standard therapy alone, result in any improvement in symptoms?
Search Terms: Radiation cystitis, late radiation effects, pelvic irradiation

The Study:Non-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Adult patients with symptoms suggestive of radiation cystitis following irradiation more than six months previously. Expanded Prostate Index Composite (EPIC) score less than 80 for the urinary domain. Bleeding requiring blood transfusion and necessity for permanent catheterization excluded.
Control group (N = 45; 35 analysed): Continuation of standard care. Offered crossover at about six months.
Experimental group (N = 42; 40 analysed): 100% oxygen breathing at 2.4 ATA for 90 minutes daily Monday to Friday to a total of 30 to 40 sessions.

The Evidence:

Outcome

Time to Outcome

Control Rate

HBO Rate

Relative risk reduction

Absolute risk reduction

NNT

Clinically important improvement in EPIC score (9 points)

6 months

0.27

0.69

158%

0.42

2

95% CIs:

87 to 230%

0.23 to 0.61

2 to 4

Improved LRMGS* grade

6 months

0.13

0.60

347%

0.46

2

95% CIs:

213 to 482%

0.28 to 0.64

2 to 4

 

Measure

Control Group

HBOT Group

Difference

95% CI

Mean

SD

Mean

SD

Improvement in EPIC urinary score at six months

7.7

15.5

17.8

18.4

10.1

-124.8 to 145.0

SF-36 general health score at 6 months

50.9

22.7

62.1

21.0

11.2

-207.9 to 230.2

SF-36 change at six months

-3.9

14.3

9.4

16.5

13.3

-97.6 to 124.2

*Late radiation morbidity grading scheme (scored by examining urologist)

Comments:
1. No sham so all or part of the difference observed could be due to a participation effect.
2. The authors’ analysis suggested the mean differences in outcomes included here were all statistically significant. Reason for the discrepancy is not clear.
3. Authors used the Late Radiation Morbidity Grading Scheme (LRMGS) for the urinary bladder to assess epithelial atrophy, telangiectasia, haematuria, bladder capacity and presence of necrosis or ulcerations.

Appraised by: Mike Bennett; Wednesday, 22 January 2020
Email: m.bennett@unsw.edu.au
Kill or Update By: January 2022

 

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