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. 2012 Apr 18;2012(4):CD005007. doi: 10.1002/14651858.CD005007.pub3

Cade 1967

Methods RCT with allocation concealment and randomisation by centrally generated card method. Two separate studies reported ‐ one for carcinoma of the bronchus and one for carcinoma of the urinary bladder. Patient, outcome assessors and treating team all aware of allocation at start of therapy course. No indication of power calculation
Participants
  • Trial 1: 49 adults with carcinoma of the bronchus, 25 allocated to HBOT and 24 to control

  • Trial 2: 40 adults with carcinoma of the urinary bladder with spread confined to the pelvis, 20 allocated to each of HBOT and control


No drop‐outs or losses to follow‐up in either trial
Interventions
  • Control: 6000 rads by external beam in 40 fractions over eight weeks

  • HBOT: identical radiotherapy schedule conducted at 3 ATA breathing 100% oxygen, total compression time about 40 minutes

Outcomes Death 1 year, metastatic disease 1 to 2 years, oxygen toxicity data (combined for both trials)
Notes Also reported in McEwen 1968 Schulz rating: randomisation: A; allocation concealment: A; selection bias: A; blinding: C
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate