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

Williams 2004.

Study characteristics
Methods Randomised controlled trial, open‐label, cross‐over design
Participants 14 men with mean age of 59 ± 7 (SD) years and body weight of 86 ± 13 (SD) kg were included in the study
Inclusion criteria:
  • Men with angiographic evidence of coronary artery disease (CAD)


Exclusion criteria:
  • Men who had experienced an acute coronary event within the preceding 60 days; had significant renal or hepatic disease, uncontrolled hypertension, diabetes mellitus, a recent history of smoking cigarettes, a history of alcohol dependence or abuse; or were receiving oral anticoagulant therapy

Interventions
  • Red wine (Stoneleigh Marlborough Pinot Noir, New Zealand, 1998) or white wine (Jackson Estate Marlborough Sauvignon Blanc, New Zealand, 1998) at a dose of 0.52 g alcohol/kg body weight

  • Isoenergetic, non‐alcoholic beverage (raspberry cordial: Schweppes, Auckland, New Zealand)

Outcomes
  • Plasma levels of IL‐6

  • Systolic blood pressure

  • Diastolic blood pressure

  • Heart rate

  • Plasma concentrations of soluble cell adhesion molecules


BP and HR were measured at baseline and at 1 hour and 6 hours after consumption
Notes
  • Self‐reported drinking habits of participants were recorded

  • Participants were instructed to refrain from drinking alcohol for 1 week before each study visit

  • On study days, men were instructed to consume a light breakfast consisting of 2 slices of toast with jam at home before reporting to the study centre at 9 AM. Tea, coffee, and fruit juices were not permitted

  • Test beverages were consumed with a light meal that was low in antioxidants. This meal was designed to minimise the influence of nutrient and antioxidant intake on study variables while complying with the dictum that alcoholic beverages should be consumed with food. The meal consisted of a small bread roll (58 g) filled with 5 g margarine, 2 leaves of lettuce, half a tomato sliced, a slice of low‐fat cheese (25 g), low‐fat yogurt (200 g), and a banana (total energy, 2,222 kJ (513 kcal); carbohydrate, 62% energy; protein, 18% energy; fat, 20% energy)

  • During the following 6‐hour test period, participants did not consume any food and were permitted only bottled water to drink

  • Washout period between wine interventions was at least 1 week

  • 3 months after the wine study, participants ingested an isoenergetic, non‐alcoholic beverage with the light meal in an identical protocol

  • All men were receiving aspirin therapy, and most were also receiving treatment with statins and β‐blocking drugs. Approximately half of the men were taking angiotensin‐converting enzyme (ACE) inhibitor drugs

  • Nearly all of the men were light to moderate consumers of alcohol


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 "Subjects were randomized to receive red wine (Stoneleigh Marlborough Pinot Noir, New Zealand, 1998) or white wine (Jackson Estate Marlborough Sauvignon Blanc, New Zealand, 1998) followed by the alternate wine with an interval of at least a week between each intervention"
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 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 assessors
Incomplete outcome data (attrition bias)
All outcomes Low risk "One subject was excluded from the present study due to insufficient stored plasma for measurement of cytokines at all time points"
Comment ‐ reasons for exclusion of participants were reported and balanced across groups, so missing data should not affect the final analysis
Selective reporting (reporting bias)
For systolic blood pressure (SBP) Low risk Comment ‐ study authors reported SBP with SD
Selective reporting (reporting bias)
For diastolic blood pressure (DBP) Low risk Comment ‐ study authors reported DBP and 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 and SD
Other bias (conflict of interest, industry sponsorship) Low risk "Supported by the Cardiology Department Research Fund"
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