Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2006; 11: 04
To evaluate the efficacy and safety of a liquid herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630, marketed in Germany as Umckaloabo; manufacturer: ISO Arzneimittel, Ettlingen) vs. placebo in acute bacterial maxillary sinusitis (ABMS), which is one of the most common infections of the upper respiratory tract.
In a randomised, double-blind, placebo-controlled trial, 103 adults with radiographically and clinically confirmed ABMS received EPs 7630 or placebo for a maximum of 22 days (3 × 60 drops/day) with an observational phase. Primary outcome parameter was the change in the Sinusitis Severity Score (SSS) after 7 days. State of health, activity level and general well-being were assessed as secondary parameters.
During the treatment phase, SSS decreased by 5.5vs. 2.5 points (EPs 7630vs. placebo; means; difference=3.0 points; 95% CI: 2.0 to 3.9, P < 0.00001). At treatment end, 32 patients treated with EPs 7630vs. four placebo-treated patients showed a complete recovery. State of health, activity level and general well-being were also clearly better in the EPs 7630 group than in the placebo group. Serious adverse events did not occur during the whole trial.
EPs 7630 was well tolerated and superior in efficacy compared to placebo in the treatment of ABMS.
This study was funded by ISO Arzneimittel, Ettlingen, Germany.
