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. 2020 Jul 1;2020(7):CD012787. doi: 10.1002/14651858.CD012787.pub2

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
  • 0.75 g/kg body weight of alcohol in the form of beer, or

  • 600 mL of alcohol‐free lager (Canada Dry Rawlings, Northants, UK)


Consumed within 15 minutes
Outcomes
  • Systolic blood pressure

  • Diastolic blood pressure

  • Pulse rate

  • Plasma catecholamines

  • Plasma cortisol and plasma renin activity

  • Plasma norepinephrine and epinephrine

Notes
  • Washout period was 1 week between interventions

  • All participants abstained from alcohol, caffeine, and tobacco for 24 hours (although diet was otherwise unrestricted), and all fasted for 12 hours before each part of the study

  • Participants were considered to have a family history of hypertension if 1 or both parents had ever received treatment for hypertension or had a resting blood pressure of 160/95 mmHg or more

  • All participants were healthy and were taking no medication

  • We calculated MAP from reported SBP and DBP. SD for the MAP had to be imputed

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