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. 2016 Apr 25;2016(4):CD003455. doi: 10.1002/14651858.CD003455.pub2

Ehrenpreis 2005.

Methods Double‐blind RCT. Duration of study: not reported
Follow‐up: at 90 days
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
Interventions Intervention: Retinol palmitate 10,000 IU by mouth for 90 days
Comparator: Identical placebo capsules
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