Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial
Bachert C, Schapowal A, et al
Published in Rhinology
Methodology
Double-blind, randomised, placebo-controlled, parallel-group multicentre trial with a group-sequential adaptive design; EPs 7630 60 drops three times daily for up to 22 days; primary outcome change in Sinusitis Severity Score at day 7.
Key Findings
103 patients with radiographically and clinically confirmed acute rhinosinusitis (Sinusitis Severity Score of at least 12 of 24) received Pelargonium sidoides EPs 7630, 60 drops three times daily, or placebo. After 7 days the Sinusitis Severity Score fell 5.5 points with EPs 7630 versus 2.5 with placebo, a difference of 3.0 points (95% CI 2.0 to 3.9, p < 0.00001). All secondary measures pointed the same way, and the trial was stopped at the planned interim analysis once efficacy was proven; the extract was well tolerated.
Conclusions
EPs 7630 was well tolerated and superior in efficacy to placebo in acute rhinosinusitis of presumably bacterial origin.
Limitations
Stopped early at a planned interim analysis, which can overstate effect size; short 7-day primary endpoint and a manufacturer-linked herbal preparation, and the abstract does not report funding.
Related Health Concerns
Study Details
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