2016
DOI: 10.1080/19390211.2016.1253633
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Do Studies Evaluating QT/QTc Interval Prolongation with Dietary Supplements Meet FDA Standards: A Systematic Review

Abstract: 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 supplement… Show more

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Cited by 3 publications
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“…E asperula leaves have traditionally been used as a folk medicine to treat a variety of ailments such as hepatitis, liver cirrhosis, and cancer 11 . Furthermore, E asperula prevents or alleviates diabetes, hypertension, and acne 12 . Some researchers have recently revealed the potential pharmacological effects of E asperula in cancer treatment 13 , but there are no trial results using E asperula in cancer therapy.…”
Section: Introductionmentioning
confidence: 99%
“…E asperula leaves have traditionally been used as a folk medicine to treat a variety of ailments such as hepatitis, liver cirrhosis, and cancer 11 . Furthermore, E asperula prevents or alleviates diabetes, hypertension, and acne 12 . Some researchers have recently revealed the potential pharmacological effects of E asperula in cancer treatment 13 , but there are no trial results using E asperula in cancer therapy.…”
Section: Introductionmentioning
confidence: 99%