[Effects of standardized Myrtol in therapy of acute sinusitis--results of a double-blind, randomized multicenter study compared with placebo]. / Wirkung von Myrtol standardisiert bei der Therapie der akuten Sinusitis--Ergebnisse einer doppelblinden, randomisierten Multicenterstudie gegen Plazebo.

BACKGROUND: In the management of non-purulent acute sinusitis, alpha adrenergic substances are administered topically and secretolytics systemically. Antibiotic therapy should be restricted to purulent forms. This study was designed to demonstrate the importance of the maintenance of permanent ventilation and drainage of the sinuses as a therapeutic concept. PATIENTS/METHODS: In a multicentric trial the efficacy and safety of myrtol standardized and another essential oil were investigated in 331 patients with acute sinusitis in comparison to placebo. Three hundred thirty patients were evaluated in an intent-to-treat-analysis and 291 patients remained for statistical analysis. The study was conducted in 16 centers in a double-blind, double-dummy, randomized design versus placebo. During an observation-period of 14 days the patients were treated for 6 +/- 2 days with the respective study medication. RESULTS: With respect to efficacy, both myrtol standardized and the other essential oil proved to be significantly superior to placebo. As to the tolerance, a slight advantage of myrtol standardized was demonstrated in comparison to the other verum substance. CONCLUSION: These results which do support the value of essential oils like myrtol as an effective treatment in acute, uncomplicated sinusitis instead of antibiotics as first choice, are confirmed by the existing literature.