Am J Otolaryngol Head Neck Surg | Volume 2, Issue 4 | Research Article | Open Access

Multicenter, Randomized, Open-Label, Comparative Study of Therapeutic Efficacy, Safety and Tolerability of a Herbal Medicinal Product with the Gentian Root (Radih Gentanye); Primrose Flowers with Calyx (Primulae flos Cum Calycibus), Vervain Herb (Verbenae Herba), Common Sorrel Herb (Rumex Herba); Flowers of Elderberry (Sambuci flos) in the Delayed Antibiotic Prescription Method in Patients with Acute Rhinosinusitis

Popovych VI*, Koshel IV, Beketova HV, Tsodikova OA, Abaturov AE, Kriuchko TA and Vakulenko LI

Department of Otorhinolaryngology, Ivano-Frankivsk National Medical University, Ukraine

*Correspondance to: Popovych VI 

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Abstract

Introduction: Acute Rhinosinusitis (ARS) includes viral and post-viral (in the USA non-viral) forms. Only about 0.5% to 5% of ARS may be characterized as Acute Bacterial Rhinosinusitis (ABRS). Thus, not more than 5% of patients with ARS require antimicrobial therapy. The objective of the study was to determine the efficacy of phytoneering extract BNO-1012 (Sinupret®) in the delayed antibiotic prescription approach in patients with acute rhinosinusitis.
Methods: In the multicenter, randomized, open-label, comparative study 292 children were randomized, where 275 ones with ARS aged 6 years to 11 years who received phytoneering extract of five herbs BNO-1012 (Sinupret®) in addition to standard symptomatic therapy or standard therapy, completed a study. Assessment Criteria: Reduction of nasal congestion, rhinorrhoea, post-nasal drip, assessed by a physician on a 4-point scale at each visit compared with the 1st visit, dynamics of rhinorrhoea self-scoring, headache on a 10-point visual analogue scale, frequency of antibiotic prescription, "Therapeutic benefit" in days from the use of BNO-1021 (Sinupret®).
Results: The use of BNO-1012 (Sinupret®) in addition to the standard symptomatic treatment of acute viral and post-viral rhinosinusitis provides a clinically significant, adequate reduction in the severity of rhinorrhoea, nasal congestion and post-nasal drip, assessed by a physician for V2 (p<0.005). Significant differences were noted in the patient's self-scoring of rhinorrhoea on the second or third day for viral, from the fourth to the eighth day in post-viral RS, headache on the fourth day in acute viral rhinosinusitis, and from the third to the fifth day of post-viral RS treatment (p<0.005). Symptoms of similar intensity in control group were observed at V3. Thus, in the first week of treatment, the treatment group compared to the control one showed a “therapeutic benefit” of three days. The use of BNO-1021 in the delayed antibiotic prescription method in patients with acute viral rhinosinusitis can reduce the justified prescription of antibacterial drugs by 2.7 times, post-viral by 1.4 times. No, on-treatment side effects were observed in any patients.
Conclusion: BNO-1012 (Sinupret®) is a safe and effective drug for the treatment of acute rhinosinusitis in children aged 6 years to 11 years, which provides a significant “therapeutic benefit” when administered in addition to standard symptomatic therapy, reducing the need for antibiotic use.

Keywords:

Acute rhinosinusitis; Sinupret; Delayed antibiotic therapy

Citation:

Popovych VI, Koshel IV, Beketova HV, Tsodikova OA, Abaturov AE, Kriuchko TA, et al. Multicenter, Randomized, Open-Label, Comparative Study of Therapeutic Efficacy, Safety and Tolerability of a Herbal Medicinal Product with the Gentian Root (Radih Gentanye); Primrose Flowers with Calyx (Primulae flos Cum Calycibus), Vervain Herb (Verbenae Herba), Common Sorrel Herb (Rumex Herba); Flowers of Elderberry (Sambuci flos) in the Delayed Antibiotic Prescription Method in Patients with Acute Rhinosinusitis. Am J Otolaryngol Head Neck Surg. 2019;2(4):1049.

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