Results of a randomised controlled study on the efficacy of a combination of saline irrigation and Sinupret syrup phytopreparation in the treatment of acute viral rhinosinusitis in children aged 6 to 11\xa0years

Abstract

BackgroundThis study was designed to demonstrate the effectiveness of the complex herbal medicine Sinupret® syrup in the treatment of acute viral rhinosinusitis in children.MethodsPatients aged 6 to 11 years were included in a randomised controlled study with two parallel groups. Both groups received standard treatment including Weber’s douche and symptomatic medicine on therapeutic grounds. Isotonic sea salt solution was applied four times daily for 10 days. The intervention group received Sinupret® syrup three times daily as add-on therapy. Using a five-point scale (0–4 points) the physicians evaluated the following symptomatic parameters within four successive visits (Day 0, 5, 7, and 10): nasal congestion, nasal discharge, post-nasal drip, headache, and facial pain. Using a 11 -point scale (0–10 points), each patient gave a daily self-assessment of the following parameters from Day 1 to Day 10: rhinorrhoea, headache, and facial pain.ResultsIn total, 184 patients (mean age 8.1 years) were included. In accordance with physicians’ assessment compared to saline irrigation alone, significant improvements were detected in three out of five symptomatic parameters under combined treatment including Sinupret® syrup as assessed by the physicians. The between-group differences in the severity of facial pain and headache were insignificant. The Sinupret® group also showed a trend to an antibiotic-sparing effect (2.17% in the Sinupret® group vs. 5.26% in the control group). Further, the frequency of the transition of viral rhinosinusitis to the post-viral phase tended to decrease (1.08% in the Sinupret® group vs. 5.26% in the control group). No adverse reactions to the herbal medicine occurred during the study period.ConclusionThe complex herbal medicine Sinupret® syrup alleviates effectively the symptoms of acute viral rhinosinusitis in children. Furthermore, the prescription of antibiotics was also reduced.