Absence of QTc-interval-prolonging or hemodynamic effects of a single dose of bitter-orange extract in healthy subjects.

Abstract:

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.

journal_name

Pharmacotherapy

journal_title

Pharmacotherapy

authors

Min B,Cios D,Kluger J,White CM

doi

10.1592/phco.2005.25.12.1719

subject

Has Abstract

pub_date

2005-12-01 00:00:00

pages

1719-24

issue

12

eissn

0277-0008

issn

1875-9114

journal_volume

25

pub_type

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