Dishe
There was no improved survival or local control with the addition of hyperbaric oxygenation to standard radiotherapy for patients with carcinoma of the uterine cervix.
Clinical Bottom Line: 1. No advantage in survival or local tumour control in hyperbaric group.
Appraised by: Mike Bennett, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital Sydney ; Friday, 27 October 2000
Clinical Scenario: A patient with Stage II carcinoma of the cervix suitable for radiotherapy. Three-part Question: For patients with carcinoma of the cervix requiring radiotherapy, does the administration of radiotherapy in a hyperbaric oxygen environment, compared to administration in air, result in any improvement in survival? Search Terms: hyperbaric oxygenation, carcinoma of the cervix, radiotherapy
The Study: Double-blinded concealed randomised controlled trial intention-to-treat unknown. Stage III or Stage IIb carcinoma of the cervix and suitable for both DXRT and HBOT. Patients excluded if intercurrent illness likely to reduce survival after treatment, if deemed unlikely to return for follow-up or if over 75 years. Control group (N = 173; 168 analysed): DXRT total dose 45Gy over 10 fractions in 5 weeks OR 58Gy in 27 fractions over 5.5 weeks. Some patients also had intra-cavitary treatment as well. Experimental group (N = 147; 142 analysed): Same DXRT as above, but treatment administered while in a hyperbaric oxygen environment at 3 ATA for about 20 minutes.
The Evidence:
| Outcome | Time to Outcome | Air group | HBO group | Relative risk increase | Absolute risk increase | Number needed to treat |
| Death | 5 years | .62 | .67 | 8% | 0.05 | 20 |
| 95% CI: | -9% to 15% | -0.06 to 0.16 | NNH 6 to INF NNT = 18 to INF | |||
| Death | 10 years | .69 | .77 | 12% | 0.08 | 12 |
| 95% CI: | -3% to 26% | -0.02 to 0.18 | NNH 6 to INF NNT = 54 to INF | |||
| Local recurrence | 5 years | .58 | .59 | 2% | 0.01 | 100 |
| 95% CI: | -17% to 21% | -0.1 to 0.12 | NNH 8 to INF NNT = 10 to INF |
Comments: 1. Less than half of the total case load were entered into the trial. 2. Radiation morbidity as cause of death was more common if randomised to oxygen or 10 fractions 3. Interpretation of findings difficult due to differential patient entry criteria and treatment options during the study period.
Expiry date:January 2004
References: 1. Dische S, Saunders M, Sealy R, Werner I, Verma N, Foy C, Bentzen S. Carcinoma of the cervix and the use of hyperbaric oxygen with radiotherapy: a report of a randomised controlled trial. Radiotherapy and Oncology 1999; 53:93-98.
File:Http://www.hboevidence.com/ themes/copy-of-sumi-painting/sumhorsa.gif
