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International Journal of Phytomedicine and Phytotherapy

Table 3 Clinical studies with Cyclamen europaeum nasal spray

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

Study Study design Population Sample size Main findings
Pfaar O, et al. 2012 [27] Double-blind randomized trial Patients with acute rhinosinusitis n = 48 with CE nasal spray
n = 51 with placebo
Primary outcome:
In the ITT population, the difference in mean total rhinosinusitis symptoms score measured with a visual analogue scale after 5–7 days was not statistically significant between the two groups
Secondary outcomes:
Only the reduction in facial pain and endoscopic evaluation significantly favoured CE nasal spray compared with placebo
Ponikau JU, et al. 2012 [28] Double-blind randomized trial Patients with acute rhinosinusitis n = 24 with CE nasal spray
n = 24 with placebo
Primary outcomes:
The change in sinus opacification from baseline to endpoint was greater in the CE nasal spray group than placebo (mean difference: 16.32; 95% CI: − 32.239 to − 0.396).
However, the predose TSS was not different between the two groups (mean difference: − 0.61; 95% CI: − 1.790 to 0.578)
Secondary outcomes:
No significant differences between treatment groups were observed for symptom change from baseline and mucopurulence and inflammation at Day 8
Zalmanovici Trestioreanu A, et al. 2018 [30] Cochrane meta-analysis Patients with acute rhinosinusitis n = 147 participants in total Main study outcomes:
None of the studies reported the primary outcomes of the meta-analysis (proportion of participants whose symptoms resolved or improved at Day 14 and Day 30). Mild adverse events were more frequent with CE nasal spray (50%) than placebo (24%) (RR: 2.11; 95% CI 1.35 to 3.29)
  1. CE Cyclamen europaeum, CI Confidence interval, ITT Intent-to-treat, RR Risk ratio