An exploratory trial of Cyclamen europaeum extract for acute rhinosinusitis.
OBJECTIVE
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.


METHODS
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.
Department of Otolaryngology, University at Buffalo, State University of New York, Buffalo, New York, USA. jponikau@buffalo.edu
Jens U
JU
Ponikau
Daniel L
DL
Hamilos
Angelique
A
Barreto
John
J
Cecil
Stephen W
SW
Jones
Scott E
SE
Manthei
Jason
J
Collins
D000208:Acute Disease; D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D031824:Cyclamen; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D008517:Phytotherapy / Q000379:methods*; D010865:Pilot Projects; D028321:Plant Preparations / Q000627:therapeutic use*; D011446:Prospective Studies; D012016:Reference Values; D012220:Rhinitis / Q000175:diagnosis / Q000188:drug therapy*; D012852:Sinusitis / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
D059085:Nasal Sprays; D028321:Plant Preparations