Volume: 50 - Issue: 4
First page: 417 - Last page: 426
R. Jund - M. Mondliger - H. Steindl - H. Stammer - P. Stierna - C. Bachert - on behalf of the ARhiSi II study group
OBJECTIVE: A herbal drug combination (Dry Extract BNO 1016) has been assessed for efficacy and tolerability in patients with acute viral rhinosinusitis.
METHODOLOGY: In this randomised, controlled trial patients with symptom duration of ≤3 days, mild to moderate facial pain and
a Major Symptom Score (MSS) of ≥ 8 and ≤ 12 were treated for 15 days with BNO 1016 or placebo (coated tablets administered orally). Primary efficacy endpoint was mean MSS at end of treatment. Secondary outcome measures included treatment response and changes in paranasal sinuses assessed by ultrasonography.
RESULTS: Treatment resulted in clinically relevant, significant differences in mean MSS for BNO 1016 versus placebo. BNO 1016 provided symptom relief two days earlier than placebo. The number needed to treat for healing is 8. BNO 1016 was superior regarding responder rates at Day 10 and Day 14 and percentage of patients without signs of acute viral rhinosinusitis assessed by ultrasonography at end of treatment. BNO 1016 was well tolerated; no serious adverse events were reported.
CONCLUSION: The herbal dry extract BNO 1016 is efficacious and well tolerated in patients with acute viral rhinosinusitis. Trial registration: ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT01146860; EudraCT: 2009-016682-28).
Rhinology 50-4: 417-426, 2012
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