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An exploratory trial of Cyclamen europaeum extract for acute rhinosinusitis§

Authors


  • Presented in part at the 1st Congress of the Confederation of the European ORL-HNS, Barcelona, Spain, July 2–6, 2011.

  • The study sponsors were Dey Pharma, LP, Napa, California, and Hartington Pharmaceutical, Barcelona, Spain. Employees of Dey were involved in the study design and in the collection and analysis of data. Jens U. Ponikau, MD, is a consultant for Dey Pharma and Hartington Pharmaceutical. Angelique Barreto, MD, John Cecil, MD, Stephen W. Jones, MD, and Scott E. Manthei, DO, were clinical trial investigators for the clinical trial described in this article. Dr. Collins was an employee of Dey Pharma at the time of the trial. Authors were assisted by a professional medical writer, Elizabeth Field, PhD, of Field Advantage Medical Communication, LLC, in the preparation of the manuscript, funded by Hartington Pharmaceutical.

  • §

    The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Abstract

Objectives/Hypothesis:

An exploratory US trial in patients with acute rhinosinusitis was conducted to evaluate the efficacy and safety of Cyclamen europeaum extract, a product marketed in Europe that causes reflex nasal discharge and subsequent decongestion.

Study Design:

Prospective, randomized, placebo-controlled, double-blind, and parallel group.

Methods:

Outpatients (n = 29) with cardinal symptoms of acute rhinosinusitis and both endoscopic and radiographic (computed tomography [CT] scan) evidence at 25 US centers were randomized to receive intranasal, lyophilized, reconstituted Cyclamen europeaum extract (Cyclamen) or placebo spray for 7 days. Primary outcomes were reduction in percent sinus opacification on CT scans and reduction in PM predose instantaneous total symptom scores measured on a six-point scale. Secondary outcomes included other measures of symptom score change and endoscopic signs of mucopurulence and inflammation.

Results:

Cyclamen treatment significantly reduced sinus opacification compared with placebo treatment (P < .045). Although Cyclamen treatment reduced total symptom scores from baseline more than placebo treatment (−2.4 vs. −1.4), there were no significant treatment group differences (P = .312). Cyclamen treatment was well tolerated.

Conclusions:

Cyclamen treatment significantly reduced sinus opacification in patients with acute rhinosinusitis. Further exploration of Cyclamen treatment in larger patient populations is warranted.

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