Ehrenpreis 2005.
Methods | Double‐blind RCT. Duration of study: not reported Follow‐up: at 90 days |
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Participants | 19 people with radiation proctopathy (at least 2 symptoms with a severity score of 3 on at least a weekly basis), however, one participant from each group did not take a single dose of study medication and were therefore excluded from analysis (n = 17). Sex (M/F): 15/2 Comparable groups with respect to baseline RPSAS Dropouts: 1 (reason not explained), but included in final analysis |
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Interventions | Intervention: Retinol palmitate 10,000 IU by mouth for 90 days Comparator: Identical placebo capsules |
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Outcomes | Reduction in the RPSAS scores after 30 days for 90 days | |
Notes | 5 placebo non‐responders who were crossed over to Tx responded | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number system |
Allocation concealment (selection bias) | Low risk | Neither the investigators nor participants were aware of who was receiving intervention treatment or placebo |
Blinding (performance bias and detection bias) | Low risk | Double‐blinded study (participants and investigators were blinded) |
Blinding of outcome assessment subjective | Low risk | Double‐blinded study (participants and investigators were blinded). |
Blinding of outcome assessment objective | Low risk | Double‐blinded study |
Incomplete outcome data: subjective outcomes | Low risk | ITT analyses was performed, number of drop‐outs reported, however reason for drop‐out not reported |
Incomplete outcome data: objective outcomes | Low risk | ITT analyses was performed, number of drop‐outs reported, however reason for drop‐out not reported |
Selective reporting (reporting bias) | Unclear risk | No study protocol available, however all outcomes mentioned in the methods section had been addressed in the results section |
Other bias | Low risk | No indications of other bias |