Methods |
RCT with allocation concealment and randomisation by centrally generated envelope method. Patient, outcome assessors and treating team all aware of allocation. No indication of power calculation |
Participants |
82 adults with Stage IIb or III carcinoma of the uterine cervix where radiotherapy was the treatment of choice. 39 allocated to HBOT and 43 to control. Four dropouts not analysed because treatment incomplete plus five participants crossed over from HBOT to control group when they refused HBOT |
Interventions |
Control: 3150 rads external beam in 10 fractions over two weeks plus three cathetron rod placements of 950 rads each over six weeks
HBOT: same regimen, all external beam radiotherapy conducted at 3 ATA breathing 100% oxygen, total compression time about 30 minutes
|
Outcomes |
Death at 1 and 5 years, local recurrence at 1 and 5 years, metastatic disease at 5 years, radiation tissue injury |
Notes |
Also see Ward 1978, 1973 and 1974 Schulz rating: randomisation: A; allocation concealment: A; selection bias: C; blinding: C |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |