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Absence of QTc‐Interval–Prolonging or Hemodynamic Effects of a Single Dose of Bitter‐Orange Extract in Healthy Subjects
Author(s) -
Min Bokyung,
Cios Deborah,
Kluger Jeffrey,
White C. Michael
Publication year - 2005
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1592/phco.2005.25.12.1719
Subject(s) - qt interval , orange (colour) , hemodynamics , medicine , cardiology , anesthesia , pharmacology , chemistry , food science
Study Objective . To evaluate the hemodynamic and electrocardiographic effects of a single dose of commercially available bitter‐orange dried‐fruit extract, which is increasingly being used in dietary supplements. Design . Randomized, double‐blind, placebo‐controlled, crossover study. Setting . University of Connecticut, Storrs Campus. Subjects . Eighteen healthy volunteers aged 18 years or older. Intervention . Subjects were given either placebo or bitter‐orange dried‐fruit extract (450 mg standardized to 27 mg of m‐ or p‐synephrine) in phase 1. The opposite treatment was given during phase 2 after a washout period of at least 7 days. Measurements and Main Results . The rate‐corrected QT (QTc) interval and blood pressure were measured before dosing and at 1, 3, 5, and 8 hours after dosing. Mean ± SD values of the maximum postdose values were compared between groups. Subjects receiving bitter‐orange extract versus those receiving placebo had similar postdose QTc intervals (402 ± 29 vs 403 ± 24 msec, p=0.653), systolic blood pressure (114 ± 10 vs 115 ± 8 mm Hg, p=0.686) and diastolic blood pressure (68 ± 9 vs 68 ± 8, p=0.879). Conclusion . Bitter‐orange dried‐fruit extract standardized to m‐ or p‐synephrine 27 mg did not significantly alter the QTc interval or blood pressure after a single dose was administered. Future studies are necessary to ensure the safety of this herbal product with multiple doses.