Presented in part at the 1st Congress of the Confederation of the European ORL-HNS, Barcelona, Spain, July 2–6, 2011.
Article first published online: 6 JUN 2012
Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.
Volume 122, Issue 9, pages 1887–1892, September 2012
How to Cite
Ponikau, J. U., Hamilos, D. L., Barreto, A., Cecil, J., Jones, S. W., Manthei, S. E. and Collins, J. (2012), An exploratory trial of Cyclamen europaeum extract for acute rhinosinusitis. The Laryngoscope, 122: 1887–1892. doi: 10.1002/lary.23366
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.
- Issue published online: 23 AUG 2012
- Article first published online: 6 JUN 2012
- Manuscript Accepted: 28 MAR 2012
- Manuscript Revised: 24 MAR 2012
- Manuscript Received: 26 JAN 2012
- Cyclamen europaeum;
- acute rhinosinusitis;
- sinus opacification;
- computed tomography scans;
- total symptom scores;
- Level of Evidence: 1b
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.
Prospective, randomized, placebo-controlled, double-blind, and parallel group.
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.
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.
Cyclamen treatment significantly reduced sinus opacification in patients with acute rhinosinusitis. Further exploration of Cyclamen treatment in larger patient populations is warranted.