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

Rossinen 1997.

Study characteristics
Methods Randomised controlled trial, open‐label, cross‐over design
Participants 20 individuals (17 men and 3 women, aged 39 to 68 years) with angiographically verified coronary heart disease and electrocardiographic evidence of myocardial ischaemia were included in the study
Inclusion criteria:
  • Patients with luminal diameter narrowing ≥ 50% in at least 1 of the major epicardial coronary arteries and ischaemia verified by exercise test within 6 months were eligible for the study


Exclusion criteria:
  • Patients with acute myocardial infarction within 1 month, New York Heart Association Class IV symptoms, luminal diameter narrowing ≥ 50% in the left main coronary artery or luminal diameter narrowing ≥ 80% in all 3 major epicardial vessels, ejection fraction ≤ 25% on left ventricular cineangiography

  • Previous sustained ventricular tachycardia or fibrillation, and

  • Presence of other than sinus rhythm, or

  • History of alcohol abuse

Interventions
  • 1.25 g of ethyl alcohol per body weight in kilograms diluted to 15% juice, yielding volumes of 700 ± 126 mL, or

  • An equivalent volume of juice


Participants were instructed to drink at an even pace over the 1 and 1/2 hours
Outcomes
  • Heart rate variability

  • Systolic blood pressure

Notes
  • Washout period: 7 ± 3 days (range 4 to 14)

  • Regular daily medication was continued throughout the study

  • 19 patients were taking β‐blockers and long‐acting nitrates, 17 aspirin, 7 calcium antagonists, and 4 angiotensin‐converting enzyme inhibitors

  • 9 participants had arterial hypertension

  • 12 had had at least 1 myocardial infarction

  • None had diabetes mellitus

  • 7 participants had New York Heart Association Class II, and 13 participants Class III, symptoms

  • 8 participants had 1‐vessel, 8 had 2‐vessel, and 4 had 3‐vessel disease on coronary angiography

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomized to either alcohol or juice in a crossover manner"
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 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 with SD
Selective reporting (reporting bias)
For diastolic blood pressure (DBP) High risk Comment ‐ study authors did not report DBP
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) Unclear risk Comment ‐ study authors did not report any conflict of interest nor 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