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Tavipec in acute rhinosinusitis: a multi-centre, doubleblind, randomized, placebo-controlled, clinical trial

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D. Dejaco - J. Bocian-Sobkowska - W. Szymanski - G. Zacke - V. Hockner - H. Riechelmann

BACKGROUND: This randomized clinical trial was designed to evaluate the efficacy and safety of Tavipec® (Spicae aetheroleum), a phytomedicine obtained by steam distillation of the flowering tops of Lavandula latifolia, as compared to placebo in adult patients suffering from acute viral rhinosinusitis.
METHODOLOGY: Patients with acute viral rhinosinusitis were randomly assigned to treatment with 2 capsules Tavipec® 150 mg or placebo thrice daily over a period of 7 days in a double-blind, parallel-group design. No additional treatment was admitted. The efficacy endpoints comprised the improvement of the main rhinosinusitis symptoms as per Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) as well as of quality of life (QoL) by global assessment scale, evaluated at baseline, day 5 and day 8, respectively.
RESULTS: 288 patients were enrolled and randomized to treatment. At day 8 the patients in the Tavipec® group had a significantly lower MSS compared to placebo and the impact of rhinosinusitis symptoms on QoL was significantly reduced. A significantly higher proportion of Tavipec® treated patients experienced a change in SNOT-22 score greater than or equal to 10 points at day 5 or day 8. No new safety signals were identified.
CONCLUSIONS: The treatment with Tavipec® effectively reduced the symptoms of acute rhinosinusitis in adult patients.

D. Dejaco - J. Bocian-Sobkowska - W. Szymanski - G. Zacke - V. Hockner - H. Riechelmann - Tavipec in acute rhinosinusitis: a multi-centre, doubleblind, randomized, placebo-controlled, clinical trial
Rhinology -: 0-0, 0000