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International Journal of Phytomedicine and Phytotherapy

Table 1 Clinical studies of Sinupret

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

Study Study design Population Sample size Main findings
Sinupret versus placebo
 Neubauer N, and März. 1994 [9] Double-blind clinical trial Patients with acute bacterial sinusitis showing an opacification of the plain sinus radiogram n = 81 with Sinupret (BNO 101)
n = 79 with placebo
Primary outcomes:
Radiographic findings and patient assessment significantly favoured Sinupret to placebo
Exploratory outcomes:
Mucosal swelling, nasal obstruction, and headache scores were better with Sinupret than placebo
 Jund R, et al. 2012 [14] and Jund R, et al. 2015 [15] Double-blind clinical trial Patients with a diagnosis of acute viral rhinosinusitis confirmed by ultrasonography of the maxillary sinuses ITT analysis [14]
n = 190 with Sinupret (BNO 1016)
n = 190 with placebo
Primary outcome:
The number of patients with investigator-assessed MSS ≤ 1 was 48.4% in the Sinupret group and 35.8% in the placebo group
(p = 0.0063). The NNT for patients to have MSS ≤ 1 was 8
Secondary outcomes:
Patient-assessed MSS, SNOT-20 GAV, and ultrasonography imaging were more favourable with Sinupret than placebo
PP analysis [14, 15]
n = 147 with Sinupret (BNO 1016)
n = 153 with placebo
Secondary outcome:
The investigator-assessed MSS score was 2.07 ± 0.18 in the Sinupret group and 3.47 ± 0.28 in the placebo group (p = 0.0001). The NNT for patients to have MSS ≤ 1 was 7
 Jund R, et al. 2015 [13] Pooled analysis of two randomized clinical trials Patients with a diagnosis of acute viral rhinosinusitis confirmed by ultrasonography of the maxillary sinuses n = 294 with Sinupret (BNO 1016)
n = 295 with placebo
Primary outcome:
MSS improved during the treatment period by a mean of 10.02 ± 1.61 score points to 2.47 ± 2.55 for Sinupret and of 9.87 ± 1.52 to 3.63 ± 3.63 for placebo. Differences between treatment groups at end of therapy (1.16 ± 3.14 score points; p < 0.0001) was statistically significant in favour of Sinupret
Secondary outcome:
Patient-assessed quality of life at the end of treatment significantly favoured Sinupret (p = 0.0015)
Sinupret versus conventional treatments
 Passali D, et al. 2015 [16] Open-label study Patients with acute sinusitis as defined by EPOS 2012 guidelines n = 30 with Sinupret Forte
n = 30 with fluticasone furoate
Primary outcome:
At Day 14, 66.7% and 50% of patients had a MSS ≤ 1 in the Sinupret and fluticasone groups,
respectively
Secondary outcome:
At Day 14, the SNOT-20 scores were 7.0 in the Sinupret group and 6.5 in the fluticasone group
 Weber U, et al. 2002 [17] Non-randomized study Patients with acute sinusitis n = 30 with Sinupret/Cinnabaris 3X
n = 33 with conventional therapy
Main study outcomes
No clinically relevant differences were observed between the two groups on investigator-defined patients’ scores, physicians’ scores and quality of life
  1. EPOS European position paper on rhinosinusitis and nasal polyps, GAV German-adapted version, ITT Intent-to-treat, MSS Major symptom score, NNT Number needed to treat, PP Per-protocol, SNOT-20 Sino-nasal outcome test-20