RCT with a phytodrug combination of nasturtium herb and horseradish root for uncomplicated acute rhinosinusitis

Purpose A combination herbal remedy containing nasturtium (Tropaeoli majoris herba, 200 mg powder/filmtablet) and horseradish (Armoraciae rusticanae radix, 80 mg powder/filmtablet) has been used as licensed drug in Germany for more than 40 years (Angocin® Anti-Infekt N, Repha, Germany), mainly for the treatment of respiratory infections. This clinical trial was to investigate into its efficacy and safety for uncomplicated acute rhinosinusitis.

Methods 380 patients (m/f, aged 18-75) with nasal obstruction and facial pain for≤3 days were to be randomized in a double-blinded, placebo-controlled, multicenter phase IV study and treated with the recommended dose of 3x4 tablets over 14 days. Primary endpoint was MRSSinv/MRSSpat documented between day 6 and day 10, computed as AUC, assessed by ANCOVA with day 3 as covariate.

Results 380 patients were randomized, 238 were included in the FAS for statistical analysis. Treatment with the herbal combination revealed a significant smaller AUC (14.99) compared to placebo (18.52, p=0.0003, χ2-test). At visit 3, responder rates were significantly higher for patients receiving the herbal combination compared to placebo (92.1% vs. 83.3%, p=0.0418). Adverse events occurred in 21.9% and 18.6% of participants receiving the herbal combination and placebo, respectively. Most common adverse events were headaches and gastrointestinal complaints.

Conclusion The criterium for efficacy of the primary outcome was fulfilled with good tolerance and safety. Further research should concentrate on differential activity by microbiological etiology, reduction of recurrence rates and effects on specific symptoms of rhinosinusitis.

Publication History

Article published online:
13 December 2021