Potter 1986.
Study characteristics | ||
Methods | Randomised controlled trial, double‐blind, cross‐over design | |
Participants | 16 normotensive male medical students (8 with a family history of hypertension) with mean age of 22 years and mean body weight of 77 kg were included in the study | |
Interventions |
Consumed within 15 minutes |
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Outcomes |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Each subject then drank 600 ml of Barbican, an alcohol‐free lager (Canada Dry Rawlings, Northants, UK) kept at room temperature, with or without the addition of 50% alcohol in a double‐blind, random‐order crossover design" Comment ‐ method of randomisation was not described |
Allocation concealment (selection bias) | Unclear risk | Comment ‐ method of allocation concealment was not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "At the end of each part of the study, subjects were asked to indicate whether they thought they had received the placebo (alcohol‐free beer) or placebo with added alcohol" "Subjects were blinded to the order of treatment, and only eight of the 16 subjects recognized both stages correctly, indicating that the blinding procedure was reasonably successful" Comment ‐ blinding of participants was probably done |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment ‐ method of blinding of outcome assessors was not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment ‐ all participants were included in the final analysis |
Selective reporting (reporting bias) For systolic blood pressure (SBP) | Low risk | Comment ‐ study authors reported SBP and SEM in a figure |
Selective reporting (reporting bias) For diastolic blood pressure (DBP) | Low risk | .Comment ‐ study authors reported DBP and SEM in a figure |
Selective reporting (reporting bias) For mean arterial blood pressure (MAP) | High risk | Comment ‐ study authors did not report MAP and SEM |
Selective reporting (reporting bias) For heart rate (HR) | Low risk | Comment ‐ study authors reported HR and SEM in a figure |
Other bias (conflict of interest, industry sponsorship) | Low risk | "Dr. Potter was supported by a research grant from the British Heart Foundation" |
Other bias (was the study registered in clinical trials.gov/ was the protocol available?) | High risk | Comment ‐ protocol was not registered and study identifier was not reported |