Narkiewicz 2000.
Study characteristics | ||
Methods | Randomised controlled trial, double‐blind, cross‐over design | |
Participants | 19 healthy young volunteers (18 men and 1 women) with mean age ± SD of 26 ± 2 years participated in the study | |
Interventions |
Consumed over a 30‐minute period |
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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 | "Measurements were obtained by use of a randomized, double‐blind, placebo‐controlled design with 2 experimental sessions, a placebo session and an alcohol session" 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 | "A flavoring (Crystal Light) was added to these solutions to prevent the subjects from distinguishing alcohol from placebo" Comment ‐ blinding of participants was probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Studies were analyzed by investigators blinded to session (alcohol or placebo)" Comment ‐ blinding of outcome assessors was probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Vasovagal responses or discomfort during LBNP in 5 subjects resulted in completion of studies examining the effects of both alcohol and placebo in only 14 subjects (13 men, 1 woman; mean age, 26±2 years)" 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 and SEM |
Selective reporting (reporting bias) For diastolic blood pressure (DBP) | Low risk | Comment ‐ study authors reported DBP and SEM |
Selective reporting (reporting bias) For mean arterial blood pressure (MAP) | Low risk | Comment ‐ study authors reported MAP and SEM |
Selective reporting (reporting bias) For heart rate (HR) | Low risk | Comment ‐ study authors reported HR and SEM |
Other bias (conflict of interest, industry sponsorship) | Low risk | "Dr. Narkiewicz, a visiting research scientist from the Department of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland, was a recipient of an International Research John E. Fogarty Fellowship (NIH 3F05 TW05200) and a Perkins Memorial Award from the American Physiological Society. Dr. Somers is an Established Investigator of the AHA and a Sleep Academic Awardee of the NIH. Other support includes HL61560 and HL65176 (NIH). We thank Diane Davison, RN, MA, for technical assistance" |
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 |