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

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.

Reduced antibiotic use after initial treatment of acute respiratory infections with phytopharmaceuticals- a retrospective cohort study

“…Various phytopharmaceuticals have been approved in different countries including Germany for the treatment of acute lower and upper tract respiratory infections. Their efficacy and safety have been demonstrated in placebo-controlled clinical trials [12][13][14][15][16]. The use of such phytopharmaceuticals could contribute to a reduction in the number of inappropriate antibiotic prescriptions for lower and upper tract respiratory infections, but further evidence is needed to corroborate this [17].…”

Promising approaches for the treatment and prevention of viral respiratory illnesses

“…72 Another promising compound is BNO 1016, a fixed combination of 5 herbal substances that significantly reduced symptoms and led to faster recovery in patients with acute viral rhinosinusitis. 73 Reported antiviral effects from natural products, regardless of whether obtained from clinical trials or empiric knowledge, can only give clues for further research. However, it appears that we are entering a new golden age of natural product drug discovery.…”

A Systematic Review of Phytotherapy for Acute Rhinosinusitis

“…This study [8] used pooled data of 2 studies [9,10] to confirm the observed treatment effects for a larger sample. Those 2 similar prospective studies were performed between 2009 and 2010 in 37 centers across Germany.…”

“…However, it had no advantageous effects over the tested essential oil in reducing the symptoms of ARS. The effects of BNO 1016 [8] were tested, pooling data of 2 previous studies [9,10]. Results indicate that the use of BNO 1016 in the treatment of ARS might be advisable.…”