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International Journal of Phytomedicine and Phytotherapy

Table 2 Clinical studies of Pelargonium sidoides extract (EPs 7630)

From: Evidence-based management of acute rhinosinusitis with herbal products

Study Study design Population Sample size Main findings
Lizogub VG, et al. 2007 [22] Double-blind randomized controlled trial Patients with either two major cold symptoms and one minor cold symptom, or one major cold symptom and three minor cold symptoms. Symptoms had to be present for 24 to 48 h n = 52 with EPs 7630 standard dose
n = 51 with placebo [22]
Primary outcome:
From baseline to Day 5, the mean SSID improved by 14.6 ± 5.3 points in the EPs 7630 group (n = 52) and 7.6 ± 7.5 points in the placebo group (n = 51)
(p < 0.0001)
Secondary outcomes:
Patients in the EPs 7630 group reported greater improvement than patients in the placebo group in individual symptoms of the CIS, ability to work and quality of life
Riley DS, et al. 2018 [23] Double-blind randomized controlled trial Patients with either two major cold symptoms and one minor cold symptom, or one major cold symptom and three minor cold symptoms. Symptoms had to be present for 24 to 48 h n = 52 with EPs 7630 high dose
n = 52 with placebo [23]
Primary outcome:
The mean SSID from baseline through Day 3 to Day 5 was 16.0 ± 7.4 points for the EPs 7630 group and 8.3 ± 7.6 points for placebo (p < 0.0001)
Secondary outcomes:
Patients in the EPs 7630 group reported greater improvement in ability to work and quality of life
Bachert C, et al. 2009 [24] Double-blind randomized controlled trial Patients with acute rhinosinusitis n = 51 with EPs 7630 high dose
n = 52 with placebo
Primary outcome:
The change in SSS after 7 days was greater in the EPs 7630 group (5.5 points) than in the placebo group (2.5 points) (p < 0.00001)
Secondary outcomes:
Quality of life, ability to work, and treatment satisfaction favoured EPs 7630 to placebo
Perić A, et al. 2020 [25] Randomized, open label study Patients with mild to moderate acute bacterial rhinosinusitis n = 25 with EPs 7630 3 × 20 mg daily
n = 25 with amoxicillin 3 × 500 mg daily
Outcomesa:
Greater improvements in TSS, TES and individual symptom scores with EPs 7630 vs amoxicillin (p < 0 .001 for all)
No differences between groups in absolute improvements of rhinorrhea score and postnasal drip score. No reported adverse events in either group.
  1. CIS Cold intensity score, SSID Sum of symptom intensity differences, SSS Sinusitis severity score, TES Total endoscopic score, TSS Total symptom score
  2. aNo differentiation of primary or secondary outcomes reported