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. 2020 Mar 2;2020(3):CD005004. doi: 10.1002/14651858.CD005004.pub3

Sinicrope 2017.

Study characteristics
Methods RCT, parallel, double‐blind in USA
Participants 39 (male/female: 14/25) participants: participants with prior advanced adenoma (N = 37), or colon cancer (N = 2)
Inclusion criteria: at least 5 rectal ACF at baseline. 19 (male/female: 6/13) participants in the treatment group and 20 (male/female: 8/12) in the control group
Interventions Group A: GTE (Polyphenon E, 2 capsules of 200 mg twice/d = 800 mg) containing 400 mg of EGCG
Group B: placebo
Duration: 6 months
Outcomes Change in rectal ACF
Safety data
Green tea in exposure categories N/A
Notes ClinicalTrial.gov identifier: NCT01606124
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Described as randomised in the abstract and in ClinicalTrials.gov
Allocation concealment (selection bias) Unclear risk No information about concealment process
Blinding of participants and personnel (performance bias)
All outcomes Low risk Probably done as it is described as double‐blind and placebo capsules were implemented
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Probably done as it is described as double‐blind and placebo capsules were implemented, but no explicit statement
Incomplete outcome data (attrition bias)
All outcomes Unclear risk All results reported for all included participants
Selective reporting (reporting bias) Low risk Results for the trial reported on (ClinicalTrials.gov identifier (NCT number): NCT01606124)
Other bias Low risk No withdrawals reported