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Mark Phillips, DO; Bridgette Sullivan, PharmD; Brenda Snyder, DO; Paul J. Allegretti, DO; Brian F. McBride, PharmD

Arch Intern Med. 2010;170(15):1402-1404. doi:10.1001/archinternmed.2010.254

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Dietary supplements represent a distinct class of biologically active compounds which, unlike prescription and over-the-counter products, have been available to the public without regulatory oversight for nearly 15 years and are responsible for more than 13 000 adverse events annually.^1-2 Like many dietary supplements, Enzyte (Vianda, Cincinnati, Ohio)—a dietary supplement marketed for "male enhancement," a euphemism for erectile dysfunction—is a multicomponent preparation marketed to consumers without stringent regulatory oversight or premarketing evaluation of pharmacokinetics, pharmacodynamic, or drug interaction studies, including thorough QT and corrected QT (QTc) studies to assess proarrhythmic risk. Considering this information, we conducted a randomized, double-blind, double-dummy, placebo-controlled, dose-ranging, crossover study of the effects of Enzyte on the electrocardiographic (ECG) parameters including the QTc interval.

Methods

Consenting healthy male volunteers were randomized using a double-blind, double-dummy (ie, masking the difference in shape, . . . [Full Text of this Article]

Results

Comment

AUTHOR INFORMATION
Author Affiliations: Chicago College of Osteopathic Medicine, Chicago College of Pharmacy Midwestern University, Downers Grove, Illinois (Drs Phillips, Sullivan, Snyder, and Allegretti); and Marcella Niehoff School of Nursing and Stritch School of Medicine, Loyola University Chicago (Dr McBride).

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