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. |