In a prospective, randomised, double-blinded controlled study, we compared the efficacy and safety of two different treatment options with the herbal medicines cineole and a combination of five different components for acute viral rhinosinusitis. One hundred and fifty patients with acute and viral rhinosinusitis (75 patients in each treatment group) were enrolled. The diagnosis rhinosinusitis was made according to a defined symptoms-sum-score which was based on rhinoscopic and clinical signs which are characteristic for rhinosinusitis. The primary endpoint was the amelioration of the symptoms-sum-score, which includes all relevant characteristics for rhinosinusitis as headache on bending, frontal headache, sensitivity of pressure points of trigeminal nerve, impairment of general condition, nasal obstruction, rhino-secretion, secretion quantity, secretion viscosity and fever in a treatment period of 7 days. The mean reduction of the symptoms-sum-score after 4 days was 6.7 (+/-3.4) and after 7 days 11.0 (+/-3.3) in the cineole group and 3.6 (+/-2.8) after 4 days and 8.0 (+/-3.0) after 7 days in the control group. The differences between both groups were clinically relevant and statistically significant after 4 and 7 days (P <0.0001). This result is validated by the amelioration of the secondary endpoints headache on bending, frontal headache, sensitivity of pressure points of trigeminal nerve, impairment of general condition, nasal obstruction and rhino-secretion. These findings correlate with the statistically significant difference of the estimation of B-scan ultrasonography. It is safe to use both medications for 7 days in patients with acute viral rhinosinusitis. Treatment with cineole is clinically relevant and statistically significant, more effective in comparison to the alternative herbal preparation with five different components.
