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

Garland 2006.

Study characteristics
Methods RCT, quadruple‐blind in USA
Participants 178 (male/female: 89/89) participants: 42 (male/female: 21/21) in group A, 63 (male/female: 31/32) in group B and 73 (male/female: 37/36) in group C, 89 men
Interventions Group A: green tea beverage and placebo capsules
Group B: placebo beverage and Polyphenon E capsules (Mitsui‐Norin Co, Ltd, Shizuoka, Japan), corresponding to 800 mg/d of ECGC
Group C: placebo beverage and placebo capsules
Duration: 6 months
Outcomes Primary outcome
Change in levels of biomarkers of oxidative stress
Secondary outcome
Safety data
Green tea in exposure categories N/A
Notes No results on lung cancer prevention published or reported on ClinicalTrials.gov (NCT00363805)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "We are conducting a 6‐month randomized, controlled, double‐blind trial..."
Comment: probably done
Allocation concealment (selection bias) Unclear risk No statement
Blinding of participants and personnel (performance bias)
All outcomes Low risk Review authors do not believe this would introduce bias since all biological analyses were performed
Blinding of outcome assessment (detection bias)
All outcomes Low risk Review authors do not believe this would introduce bias since all biological analyses were performed
Incomplete outcome data (attrition bias)
All outcomes High risk Data on lung cancer NR, only on biomarkers
Selective reporting (reporting bias) Low risk All outcomes reported on ClinicalTrials.gov (NCT00363805)
Other bias Unclear risk The number of withdrawals is low, however since no full publication is available, only an abstract and report on ClinicalTrials.gov, it is difficult to judge if other biases are present.