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Pharmacotherapy. 2005 Dec;25(12):1719-24.

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

Author information

  • 1School of Pharmacy, University of Connecticut, Storrs, and Division of Cardiology, Hartford Hospital, Hartford, Connecticut 06102-5037, USA.

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.

PMID:
16305290
[PubMed - indexed for MEDLINE]
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