A Prospective Open-Label Study to Assess the Efficacy and Safety of a Herbal Medicinal Product (Sinupret) in Patients with Acute Rhinosinusitis

Abstract

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.

Evidence and evidence gaps in therapies of nasal obstruction and rhinosinusitis

“…In addition, a recent prospective, placebo-controlled study with 386 patients demonstrated the effectiveness of phytopharmaceuticals with several components in comparison with placebo [114]. Another open trial recently confirmed these results [115]. …”

Treatment options of the nasal cavity and paranasal sinuses diseases

“…Следует отметить растительный препарат с доказанной эффективностью -препарат Синупрет ® . Эффективность препарата была подтверждена в клинических исследованиях, в которых он применялся как раз как вспомогательное средство лечения острого и хронического РС у взрослых и у детей [9]. Tcanecu с соавт.…”

Approaches to Therapy of Acute Rhinosinusites in Children

“…А по данным ряда авторов, активность препарата сопоставима с эффективностью назальных кортикостероидов относительно ОРС, в частности флутиказона фуроата. При этом в основной группе в отличие от группы ИНГКС, где отмечались легкие побочные эффекты, нежелательных явлений зарегистрировано не было [30].…”