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Herbal drug BNO 1016 is safe and effective in the treatment of acute viral rhinosinusitis.

Jund R, Mondigler M, Stammer H, Stierna P, Bachert C - Acta Otolaryngol. (2015)

Bottom Line: Efficacy was evaluated by the investigator as the mean major symptom score (MSS) at the end of treatment (visit 5, day 14).MSS improved during the treatment period by a mean of 10.02 ± 1.61 score points to 2.47 ± 2.55 for BNO 1016 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) and patient-assessed quality of life (p = 0.0015) were statistically significant in favor of BNO 1016.

View Article: PubMed Central - PubMed

Affiliation: 1Department of Oto-Rhino-Laryngology, Ghent University Hospital , Ghent , Belgium.

ABSTRACT

Conclusion: Daily intake of 480 mg of BNO 1016 for 15 days is an effective treatment in acute viral rhinosinusitis.

Objectives: The pooled efficacy data of two similar randomized placebo-controlled clinical trials were analyzed. Safety was evaluated on the basis of the individual trials.

Methods: The efficacy analysis was based on 589 patients. Treatment was performed orally with either 3 × 160 mg BNO 1016 (n = 294) or 3 × placebo (n = 295) for 15 days. In both trials patients underwent five visits to the investigational sites. Symptoms were evaluated according to the EPOS 2012 guideline. Ultrasonography was used to confirm the diagnosis at onset of treatment and the remission of symptoms at the last visit. Efficacy was evaluated by the investigator as the mean major symptom score (MSS) at the end of treatment (visit 5, day 14). Patients reported symptoms and social/emotional consequences of rhinosinusitis using a quality of life questionnaire (SNOT-20 GAV).

Results: MSS improved during the treatment period by a mean of 10.02 ± 1.61 score points to 2.47 ± 2.55 for BNO 1016 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) and patient-assessed quality of life (p = 0.0015) were statistically significant in favor of BNO 1016.

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ARhiSi combined analysis of ARhiSi-1 and ARhiSi-2: responder (healed or improved) to treatment from visit 2 (day 3) to visit 5 (day 14) (FAS, full analysis set; n = 589).
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Figure 0003: ARhiSi combined analysis of ARhiSi-1 and ARhiSi-2: responder (healed or improved) to treatment from visit 2 (day 3) to visit 5 (day 14) (FAS, full analysis set; n = 589).

Mentions: Absolute and relative treatment results are summarized in Table III. A statistically significant improvement (for both FAS and PP) in favor of BNO 1016 was seen already on day 7 (visit 3). Figure 3 shows combined analysis of ARhiSi-1 and ARhiSi-2: response (healed or improved) to treatment from visit 2 (day 3) to visit 5 (day 14).


Herbal drug BNO 1016 is safe and effective in the treatment of acute viral rhinosinusitis.

Jund R, Mondigler M, Stammer H, Stierna P, Bachert C - Acta Otolaryngol. (2015)

ARhiSi combined analysis of ARhiSi-1 and ARhiSi-2: responder (healed or improved) to treatment from visit 2 (day 3) to visit 5 (day 14) (FAS, full analysis set; n = 589).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4487568&req=5

Figure 0003: ARhiSi combined analysis of ARhiSi-1 and ARhiSi-2: responder (healed or improved) to treatment from visit 2 (day 3) to visit 5 (day 14) (FAS, full analysis set; n = 589).
Mentions: Absolute and relative treatment results are summarized in Table III. A statistically significant improvement (for both FAS and PP) in favor of BNO 1016 was seen already on day 7 (visit 3). Figure 3 shows combined analysis of ARhiSi-1 and ARhiSi-2: response (healed or improved) to treatment from visit 2 (day 3) to visit 5 (day 14).

Bottom Line: Efficacy was evaluated by the investigator as the mean major symptom score (MSS) at the end of treatment (visit 5, day 14).MSS improved during the treatment period by a mean of 10.02 ± 1.61 score points to 2.47 ± 2.55 for BNO 1016 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) and patient-assessed quality of life (p = 0.0015) were statistically significant in favor of BNO 1016.

View Article: PubMed Central - PubMed

Affiliation: 1Department of Oto-Rhino-Laryngology, Ghent University Hospital , Ghent , Belgium.

ABSTRACT

Conclusion: Daily intake of 480 mg of BNO 1016 for 15 days is an effective treatment in acute viral rhinosinusitis.

Objectives: The pooled efficacy data of two similar randomized placebo-controlled clinical trials were analyzed. Safety was evaluated on the basis of the individual trials.

Methods: The efficacy analysis was based on 589 patients. Treatment was performed orally with either 3 × 160 mg BNO 1016 (n = 294) or 3 × placebo (n = 295) for 15 days. In both trials patients underwent five visits to the investigational sites. Symptoms were evaluated according to the EPOS 2012 guideline. Ultrasonography was used to confirm the diagnosis at onset of treatment and the remission of symptoms at the last visit. Efficacy was evaluated by the investigator as the mean major symptom score (MSS) at the end of treatment (visit 5, day 14). Patients reported symptoms and social/emotional consequences of rhinosinusitis using a quality of life questionnaire (SNOT-20 GAV).

Results: MSS improved during the treatment period by a mean of 10.02 ± 1.61 score points to 2.47 ± 2.55 for BNO 1016 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) and patient-assessed quality of life (p = 0.0015) were statistically significant in favor of BNO 1016.

Show MeSH
Related in: MedlinePlus