Lenz 2010.
| Methods | RCT. Duration: 2005 to 2008 Follow‐up: 1 year |
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| Participants | 30 people with recurrent rectal bleeding, started 6 months after radiotherapy Mean age 67.4 (SD 11.8); 10% grade 1; 43.3% grade 2; 26.7% grade 3; 20% grade 4. Comparable groups Dropouts: APC group: 2 (1 died, 1 refused further therapy after successful reduction of her rectal bleeding (score from 4 to 2 points)) |
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| Interventions | Intervention: BEC Comparator: APC |
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| Outcomes | Efficacy, complications, relapse | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation was done by sequential opening of numbered, opaque envelopes |
| Allocation concealment (selection bias) | Low risk | Randomisation was done by sequential opening of numbered, opaque envelopes |
| Blinding (performance bias and detection bias) | Low risk | Unclear whether participants had been blinded, but as both arms received a similar active intervention, it seems unlikely that this would have introduced performance bias |
| Blinding of outcome assessment subjective | Low risk | Unclear whether participants had been blinded, but as both arms received a similar active intervention, it seems unlikely that this would have introduced performance bias |
| Blinding of outcome assessment objective | Low risk | No information on blinding. However, it is unlikely that objective outcomes were influenced |
| Incomplete outcome data: subjective outcomes | Low risk | 2 participants (APC group) did not complete the treatment, despite clinical improvement. The clinical score of 1 of these participants improved from 4 to 3 points, but he died due to pneumonia. The other refused further therapy after successful reduction of her rectal bleeding (score from 4 to 2 points) |
| Incomplete outcome data: objective outcomes | Low risk | 2 participants (APC group) did not complete the treatment, despite clinical improvement. The clinical score of 1 of these participants improved from 4 to 3 points, but he died due to pneumonia. The other refused further therapy after successful reduction of her rectal bleeding (score from 4 to 2 points) |
| Selective reporting (reporting bias) | Low risk | Protocol was registered on ClinicalTrials.gov (NCT00725244), and all prespecified outcomes have been reported in the article |
| Other bias | Low risk | There was no significant difference between the groups regarding pelvic cancer, age, gender, aspirin use, previous medical therapy, or disease severity |