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An exploratory trial of Cyclamen europaeum extract for acute rhinosinusitis
Author(s) -
Ponikau Jens U.,
Hamilos Daniel L.,
Barreto Angelique,
Cecil John,
Jones Stephen W.,
Manthei Scott E.,
Collins Jason
Publication year - 2012
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1002/lary.23366
Subject(s) - placebo , medicine , chronic rhinosinusitis , randomized controlled trial , clinical endpoint , clinical trial , pathology , alternative medicine
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.