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 |
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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 |
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Outcomes | Change in rectal ACF Safety data |
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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 |