An exploratory trial of Cyclamen europaeum extract for acute rhinosinusitis.
Laryngoscope
; 122(9): 1887-92, 2012 Sep.
Article
en En
| MEDLINE
| ID: mdl-22674586
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. STUDYDESIGN:
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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Sinusitis
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Rinitis
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Preparaciones de Plantas
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Cyclamen
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Fitoterapia
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Observational_studies
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Prognostic_studies
Límite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Laryngoscope
Asunto de la revista:
OTORRINOLARINGOLOGIA
Año:
2012
Tipo del documento:
Article
País de afiliación:
Estados Unidos