A Prospective Open-Label Study to Assess the Efficacy and Safety of a Herbal Medicinal Product (Sinupret) in Patients with Acute Rhinosinusitis
| Autor: | Pasquale Cassano, Michele Loglisci, Hugo Rodríguez, Luisa Bellussi, Desiderio Passali, Giulio Cesare Passali |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Vital signs Administration Oral Fluticasone propionate Phytomedicine Quality of life Internal medicine medicine Acute rhinosinusitis Humans In patient Prospective Studies Sinusitis Prospective cohort study Adverse effect Rhinitis Plant Extracts business.industry Treatment Outcome Otorhinolaryngology Acute Disease Quality of Life Physical therapy Female business Phytotherapy medicine.drug |
| Zdroj: | ORL. 77:27-32 |
| ISSN: | 1423-0275 0301-1569 |
| DOI: | 10.1159/000370123 |
| Popis: | Aims: We present a multicenter, prospective, open-label study to assess the efficacy and safety of a phytomedicine. The aim of the research was to evaluate the efficacy and safety of 14 days of treatment with Sinupret for acute rhinosinusitis. Sinupret is a herbal preparation used to restore and maintain the physiological function of the membranes in the sinus cavity. Methods: Sixty patients with acute rhinosinusitis based on the EPOS guidelines were enrolled in the study. Thirty patients were treated with Sinupret Forte, while 30 patients were treated with intranasal fluticasone furoate. The criteria for the evaluation of efficacy were the major symptom scores according to the investigator and the Health-Related Quality of Life score. The criteria used to evaluate safety were the number of patients with adverse events, the patients' vital signs, and laboratory safety. Results: All patients considered showed significant improvements in symptoms. Among the patients treated with Sinupret, none had an adverse event, while 3 patients treated with fluticasone furoate had minor adverse events. The patients' vital signs and laboratory values were normal. Conclusions: The results of this study suggest that this phytomedicinal preparation has a significant level of efficacy in acute rhinosinusitis and that treatment is safe. |
| Databáze: | OpenAIRE |
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