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

Chen 1986.

Study characteristics
Methods Randomised controlled trial, parallel‐group assignment, open‐label study
Participants 20 college students, both male and female, between the ages of 19 and 32 years, participated in the study
Inclusion criteria:
  • Non‐smoker

  • Non‐alcoholic or with no drinking problem

  • No blood pressure problem

  • Good general health

Interventions
  • Sufficient quantities of beer or wine to achieve a blood level of 0.05%

  • No alcohol

Outcomes
  • Heart rate

  • Systolic blood pressure

  • Diastolic blood pressure

  • Respiratory rate

  • Subjective ratings of anxiety level

Notes
  • All tests were conducted in a group setting in the laboratory. Alcohol and control groups were tested separately at about the same time of day to control possible variation due to change in biological rhythms

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "After the initial screening, subjects were randomly assigned to either an alcohol group or a control group"
Comment ‐ method of randomisation was not reported; baseline characteristics of groups were not reported either
Allocation concealment (selection bias) Unclear risk Comment ‐ method of allocation concealment not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment ‐ study was not blinded for participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment ‐ study was not blinded for outcome assessor
Incomplete outcome data (attrition bias)
All outcomes High risk "Two subjects in the alcohol group dropped from the study for unknown reasons. Data analyses were based on 8 subjects in the alcohol group and 10 subjects in the control group"
Comment ‐ 2 participants withdrew from alcohol‐receiving group; reasons for withdrawal are not mentioned
Selective reporting (reporting bias)
For systolic blood pressure (SBP) Low risk Comment ‐ study authors reported SBP along with standard deviation (SD)
Selective reporting (reporting bias)
For diastolic blood pressure (DBP) Low risk Comment ‐ study authors reported DBP along with standard deviation (SD)
Selective reporting (reporting bias)
For mean arterial blood pressure (MAP) High risk Comment ‐ study authors did not report MAP
Selective reporting (reporting bias)
For heart rate (HR) Low risk Comment ‐ study authors reported HR along with standard deviation (SD)
Other bias (conflict of interest, industry sponsorship) Unclear risk Comment ‐ study authors did not report any conflicts of interest or sponsorship
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