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Observational Study
. 2018 Apr;38(2):115-123.
doi: 10.14639/0392-100X-1342.

Cyclamen europaeum improves the effect of oral antibiotics on exacerbations and recurrences of chronic rhinosinusitis: a real-life observational study (CHRONOS)

A S Lopatin  1 , O A Ivanchenko  2 , S S Soshnikov  3 , J Mullol  4
Affiliations
Observational Study

Cyclamen europaeum improves the effect of oral antibiotics on exacerbations and recurrences of chronic rhinosinusitis: a real-life observational study (CHRONOS)

A S Lopatin et al. Acta Otorhinolaryngol Ital. 2018 Apr.

Abstract
in English, Italian

Chronic rhinosinusitis (CRS) is an inflammatory disease of the nose and paranasal sinuses affecting 11% of the European population. Cyclamen europaeum plant extract (CE) has demonstrated efficacy in treating acute rhinosinusitis, but its role in CRS exacerbations remains unknown. In this real-life, prospective, epidemiological, observational study, a total of 317 patients with exacerbations of CRS without nasal polyps (CRSsNP) of moderate severity were treated using three different options: oral antibiotics, CE extract nasal spray, or the combination of oral antibiotic with CE extract. The main outcomes were the effect of treatment on sinonasal symptoms and endoscopic appearance after 6 weeks of therapy, and the number of recurrences of CRS exacerbations after 6 months of follow-up. On the top of oral antibiotics, CE extract significantly improved sinonasal symptoms and endoscopic findings and caused a 4-fold reduction of CRS recurrences. When administered in monotherapy, CE extract was at least as effective as antibiotic in monotherapy on relief of both symptoms and reduction of CRS recurrences. In patients with CRS exacerbation of moderate severity, CE extract nasal spray in monotherapy or added to standard antibiotic treatment significantly reduces sinonasal symptoms and CRS recurrences compared to antibiotics in monotherapy.

L’estratto di Cyclamen europaeum per via intranasale implementa l’effetto degli antibiotici orali nel trattamento delle riacutizzazioni delle rinosinusiti croniche: studio osservazionale in vivo (CHRONOS).

Riassunto: La rinosinusite cronica (CRS) è una malattia infiammatoria delle cavità naso-sinusali che colpisce l’11% della popolazione europea. L’estratto vegetale di Cyclamen europaeum (CE) ha dimostrato efficacia nel trattamento della rinosinusite acuta, ma il suo ruolo nelle riacutizzazioni della CRS rimane sconosciuto. Il presente studio prospettico osservazionale epidemiologico in vivo ha coinvolto 317 pazienti con riacutizzazioni della CRS senza polipi nasali (CRSsNP) di moderata gravità trattati con tre diverse opzioni terapeutiche: antibiotici per os, spray nasale contenente estratto di CE, o la combinazione di antibiotici per via orale con estratto di CE. L’efficacia è stata valutata in base all’efficacia del trattamento sui sintomi sinusali, all’aspetto endoscopico dopo 6 settimane di terapia, al numero di recidive di esacerbazione di CRS con un follow-up di 6 mesi. In combinazione con la terapia antibiotica orale, l’estratto di CE ha migliorato significativamente i sintomi sinusali, i reperti endoscopici ed ha ridotto di 4 volte le recidive di CRS. Quando amministrato come monoterapia l’estratto di CE si è dimostrato almeno altrettanto efficace dell’antibiotico somministrato singolarmente sia riguardo al miglioramento dei sintomi che riguardo alla riduzione delle recidive CRS. Conclusioni: nei pazienti con riacutizzazione di CRS di moderata gravità, lo spray nasale a base di estratto di CE in monoterapia o in aggiunta al trattamento antibiotico standard riduce in modo significativo i sintomi sinusali e le ricorrenze di CRS rispetto agli antibiotici singolarmente somministrati.

Keywords: Antibiotics; Chronic rhinosinusitis; Cyclamen europaeum; Nasal endoscopic score; Observational study; Real life; Symptom score.

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Figures

Fig. 1.
Fig. 1.
Evolution of Total Nasal Symptom score (VAS) during AECR treatment. Comparison between groups (**, p < 0.01; ***, p < 0.001, between groups).
Fig. 2.
Fig. 2.
Evolution of individual symptoms (VAS) during AECR treatment. Nasal congestion (A), nasal discharge (B), facial pain/pressure (C) and loss of smell/hyposmia (D). Comparison between groups (*, p < 0.05; **, p < 0.01; ***, p < 0.001).
Fig. 3.
Fig. 3.
Evolution of endoscopic appearance score (EAS) during AECR treatment. Middle meatus discharge (A) and mucosal oedema (B). Comparison between groups (*, p < 0.05; **, p < 0.01; ***, p < 0.001).
Fig. 4.
Fig. 4.
Patients’ self-perception of treatment efficacy: (A) after discontinuation of therapy (T3, 8 days) (*, p<0.01 compared to group 1; ***, p < 0.01 vs. group 1). (B) short-term follow-up (T4, 6 weeks). (*, p < 0.01 vs. group 1; **, p < 0.01 vs. group 1).
Fig. 5.
Fig. 5.
Number of AECR during 6-month follow-up. Comparison between treatment.
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