Evaluation of 5 Hour Energy Drink on the Blood Pressure and Electrocardiograph Parameters on Young Healthy Volunteers: A Randomized, Double Blind, Crossover, Placebo-Controlled Trial.

摘要

INTRODUCTION: The impact of energy drinks on the cardiac rhythm remains unknown. QT/QTc interval prolongation has been known to induce life threatening arrhythmias. We sought to determine the impact of 5-Hour Energy shot on the QTc interval after acute and chronic consumption. METHODS: This was a randomized, placebo controlled, crossover study enrolling young healthy volunteers not on any medications. Subjects received the study drink (5 Hour Energy shot or placebo) twice daily separated by approximately 7 hours for the first 7 days. This was followed by a washout period of 6 days and the alternate study drink was consumed for the final 7 days. A 12-lead electrocardiogram (ECG) was performed at baseline, 1, 3 and 5 hours on days 1, 7, 15 and 21. The automated ECG measurements were used for per-treatment and ITT analysis and analyzed using the paired t-test. RESULTS: A total of 24 subjects (29 5.8 years) were included for analysis. QTc values after consumption of a single placebo-dose were 414 18, 413 15, 413 19 and 417 19 milliseconds at baseline, 1, 3 and 5 hours respectively. Post consumption of a single 5 hour Energy dose, QTc values were 415 17, 408 19, 410 20, and 413 17 milliseconds at baseline, 1, 3 and 5 hours, respectively (all time matched inter- group p-values > 0.292). QTc values after consumption of placebo for 7 days were 415 20, 413 18, 409 19, and 413 22 milliseconds at baseline, 1, 3 and 5 hours, respectively. Post consumption of 5 hour Energy for 7 days, resulted in QTc values of 415 22, 413 24, 415 24, and 415 21 milliseconds at baseline, 1, 3 and 5 hours, respectively (all time matched inter- group p-values >0.198 ). There was no difference between the PR interval, QRS duration, QT interval and heart rate between the two groups. CONCLUSION: 5-Hour Energy did not induce any significant changes in the QTc interval or other ECG parameters after single and multiple doses throughout a 7 day period.