[Clinical efficacy of a herbal drug combination in acute viral rhinosinusitis]. / Klinische Wirksamkeit eines pflanzlichen Kombinationspräparates in der Behandlung der akuten viralen Rhinosinusitis.

BACKGROUND: Acute rhinosinusitis is a frequent inflammatory disease of the mucosa of the nose and paranasal sinuses, usually associated with substantial morbidity having considerable socioeconomic impact. A new herbal drug based on a dry extract of a combination of 5 medicinal drugs (Sinupret® extract Dragees) was tested in a confirmatory trial in patients with acute viral rhinosinusitis. METHODS: 386 patients with symptomatic acute viral rhinosinusitis have been treated with the herbal drug combination (daily dosage 3 × 160 mg) or placebo in a double-blind, randomised, placebo-controlled clinical trial for 15 days. Primary efficacy endpoint was the investigator assessed symptom score at the end of therapy (Major Symptom Score, MSSINV). RESULTS: Treatment with verum lead to a statistically significant, clinically relevant improvement of the symptom score (2.07 ± 0.18 [SEM] vs. 3.47 ± 0.28 score points, p = 0.0001; PP: N = 300) compared to placebo at visit 5. The Number Needed to Treat (NNT) was 7 (PP). Adverse events occurred in 9.8% of the patients treated with verum and 14.1% of the patients treated with placebo. No serious adverse event was observed. The investigators assessed the tolerability of the herbal drug combination predominantly as good and very good (96.4% verum, 95.3% placebo). CONCLUSION: The results prove the efficacy and tolerability of the herbal drug in the indication acute viral rhinosinusitis. Especially due to the favorable benefit-risk ratio the drug represents a suitable treatment alternative.

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

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.

The DNA region of phage BF23 encoding receptor binding protein and receptor blocking lipoprotein lacks homology to the corresponding region of closely related phage T5.

Analysis of the DNA region upstream of the BF23 hrs gene revealed a genetic organisation similar to that of closely related phage T5. A gene encoding a lipoprotein (llp(BF23)) is located directly upstream of the gene encoding the receptor binding protein (hrs) but is transcribed in opposite direction. The gene is followed by four open reading frames transcribed in the same direction. The llp (BF23) gene product does not show similarity to the corresponding T5 Llp(T5) protein, however, like Llp(T5) does for FhuA it blocks the BtuB receptor for BF23 infection. While no similarity between BF23 and T5 was observed for the DNA region encoding Llp and the receptor binding protein, the flanking regions were highly similar. Based on our results we conclude that a genetic module, the receptor-binding/receptor-blocking module, exists in phages BF23 and T5. Due to exclusion of homologous recombination within this module, it is hereditary only as an intact module: separation of the receptor-binding gene from the receptor-blocking gene, which apparently results in reduced fitness of the phage due to inactivation of progeny phage by active receptor proteins in the outer membranes of lysed cells, is thus effectively prevented.