Henk 1977a
Methods | RCT stratified by site of tumour (nasal and oral, laryngeal, laryngopharyngeal and other) 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 | 295 adults with SCC of the head and neck where radiotherapy was the treatment of choice. 143 allocated to HBOT and 152 to control Dropouts identified (18 from HBOT group, 1 from control) but not included in analysis | |
Interventions |
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Outcomes | Death at 1 to 5 years, local control of tumour at 3 months, local recurrence rates at 1 to 5 years, significant radiation tissue effects at 6 months | |
Notes | Other reports of this trial in Henk 1974, Henk 1975, Kunkler 1968 Schulz rating: randomisation: C; allocation concealment: B; selection bias: B; blinding: C | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |