Methods |
RCT stratified for node involvement and clinical stage, with allocation concealment not clear, method of randomisation not stated. Patient, outcome assessors and treating team all aware of allocation. No indication of power calculation |
Participants |
233 adults with Stage IIb to IVa carcinoma of the uterine cervix where radiotherapy was the treatment of choice. 109 allocated to HBOT and 124 to control. No dropouts or losses to follow‐up |
Interventions |
Control: between 4000 and 5500 rads by external beam in 20 to 35 fractions over four to five weeks plus radium implant in more advanced cases
HBOT: same regimen, with all external beam radiotherapy conducted at 3 ATA breathing 100% oxygen, total compression time about 40 minutes
|
Outcomes |
Death at 2 years, metastatic disease at 2 years |
Notes |
An interim report that does not seem to have been reported in a complete paper to date. Also see Lindberg 1973 and Fletcher 1975 Schulz rating: randomisation: C; allocation concealment: B; selection bias: A; blinding: C |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |