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The majority of studies included in this review contained many of the critical elements recommended by the ICH E14, which includes the U.S. Food and Drug Administration guidance document for QT/QTc interval assessment. Compared with the thorough QT (TQT) standards, studies are typically well performed but can be bolstered by some study design changes. More than 30% of the included studies showed some degree of ECG changes, suggesting the need for continued cardiovascular safety assessment of dietary supplements.

Introduction: Energy drink usage has been linked to emergency room visits and deaths. Cardiovascular and neurological adverse effects are among the most frequently reported, warranting further exploration of risk factors and cardiovascular outcomes. Hypothesis: We assessed the hypothesis that energy drinks and panax ginseng may contribute to significant electrocardiographic and blood pressure changes in healthy individuals. Methods: This was a randomized, double blinded, placebo controlled, crossover study where young healthy volunteers consumed 3 different study drinks on different days. The interventions included 32 ounces of an energy drink, control drink with 800 mg of panax ginseng or a matching placebo drink, all of which were consumed over a 45 minute period. Primary endpoints of interest were QTc interval and systolic blood pressure. Secondary endpoints included QT interval, PR interval, QRS duration, heart rate, and diastolic blood pressure. All endpoints were assessed at baseline, 1, 2, 3.5, and 5.5 hours post-study drink administration. Results: Twenty seven volunteers completed the study. A significant increase in QTc interval 2 hours post energy drink consumption was evident when compared to placebo (3.37±10.7 msec and -3.19±11.8 msec respectively; p=0.030). Similarly, systolic blood pressure 2 hours post energy drink consumption increased when compared to placebo (2.00±6.37 mmHg and -2.67±5.83 mmHg respectively; p=0.014). The PR interval significantly reduced over a 2 hour period post energy drink use in a clinically non-meaningful manner. Heart rate at 2 hours was not significantly higher in the energy drink group. The QT interval, QRS interval and diastolic blood pressure were not impacted at any time across groups. Conclusions: In conclusion, certain energy drinks consumed at a high volume can significantly increase the QTc interval and systolic blood pressure by over 6 msec and 4 mmHg respectively. Panax ginseng does not have a significant impact on ECG or blood pressure parameters. Future studies are warranted to delineate the electrophysiological and hemodynamic risks of certain energy drinks consumed at different concentrations and durations.