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- Title
An exploratory trial of Cyclamen europaeum extract for acute rhinosinusitis.
- Authors
Ponikau, Jens U.; Hamilos, Daniel L.; Barreto, Angelique; Cecil, John; Jones, Stephen W.; Manthei, Scott E.; Collins, Jason
- 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.
- Subjects
SINUSITIS treatment; CYCLAMEN; PLANT extracts; SYMPTOMS; PLACEBOS; TOMOGRAPHY; HEALTH outcome assessment
- Publication
Laryngoscope, 2012, Vol 122, Issue 9, p1887
- ISSN
0023-852X
- Publication type
Article
- DOI
10.1002/lary.23366