Lane 2018.
| Study characteristics | ||
| Methods | RCT, parallel, double‐blind in UK | |
| Participants | Participants: 133 men at high risk of prostate cancer randomised Inclusion criteria: participants previously enrolled in the Prostate testing for cancer and Treatment (ProtecT) trial. Men aged 50‐69 years, with localised prostate cancer with no history of allergies to lycopene‐containing foods or green tea, current or prior prostate cancer, major co‐morbidities or 5‐ARI medication Recruitment: from December 2009‐May 2011 |
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| Interventions | 3 lycopene (dietary advice, capsules, placebo) and 3 green tea (drink, capsules, placebo) interventions: 9 different interventions for 6 months, particularly regarding green tea: 45 participants in the green tea drink: at least 3 cups/d, around 600 mL/d of tea made with green tea bag, PG Tips, Unilever Ltd 45 participants in the green tea capsules: 2 capsules with 300 mg/d green tea leaf‐derived extracted = 600 mg/d EGCG (Frutarom Ltd.) 43 participants in the green tea placebo Duration: 6 months |
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| Outcomes | Primary outcome Prostate cancer incidence Secondary outcomes PSA levels Safety data |
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| Green tea in exposure categories | N/A | |
| Notes | Funding: Cancer Research UK (C11046/A10052) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomly allocated to one of three lycopene interventions and to one of three green tea interventions using a blocked random allocation [1:1:1 ratio; generated by the trial statistician (C. Metcalfe) using the Stata uniform () "function]" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "opaque envelopes for allocation. The allocation was concealed from the study nurse recruiting individuals" Comment: probably done |
| Blinding of participants and personnel (performance bias) PSA levels | Low risk | Review authors do not believe this would introduce bias |
| Blinding of outcome assessment (detection bias) PSA levels | Low risk | Review authors do not believe this would introduce bias |
| Incomplete outcome data (attrition bias) PSA levels | Unclear risk | Missing outcome data without explanation |
| Selective reporting (reporting bias) | High risk | In the study protocol other outcomes are reported (ClinicalTrials.gov identifier (NCT number): NCT01105338) |
| Other bias | Unclear risk | Some men also took lycopene capsules |