BackgroundVestibular vertigo is associated with substantially reduced quality of life. Betahistine is effective in improving vertigo-associated symptoms, with longer treatment periods leading to greater improvements; however, it is not known whether these effects persist after treatment cessation.MethodsVIRTUOSO was a prospective, multinational, non-comparative, post-marketing observational programme investigating the effectiveness of betahistine (48 mg/day) and the course of vertigo after the discontinuation of treatment. Patients with vestibular vertigo who were prescribed 48 mg/day betahistine were enrolled in Russia and Ukraine. Treatment duration was up to 2 months, and patients were followed up for 2 months after discontinuation of betahistine. Efficacy endpoints included clinical response (assessed by change in vertigo severity), monthly attack frequency, and physician and patient grading of overall clinical response and improvement of vertigo-associated symptoms.ResultsOverall, 309 patients were enrolled and 305 completed the study. Clinical response was rated as good, very good or excellent in 74.1% of patients at end of treatment, with vertigo severity significantly decreased from baseline (p < 0.001). Monthly vertigo attack frequency decreased significantly during the 2 months of treatment (p < 0.001 from baseline) and further decreased during the 2-month follow-up (p < 0.001 from end of treatment). Overall, clinical response was graded as good or excellent by 94.4% of physicians and 95.4% of patients. Clinical improvement was considered either good or excellent by 82.6–90.5% of physicians and patients for nausea, vomiting and faintness. Only one adverse event was reported, with no serious adverse events.ConclusionOur findings suggest that betahistine (48 mg/day) therapy is effective in treating vertigo in routine clinical settings. The observed effects persisted for 2 months after treatment cessation, suggesting that betahistine may facilitate lasting vestibular compensation.

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Background COVID19 is a high burden for medicine and society as still no specific therapy exists. Most patients depend on symptomatic treatment, comparable to the symptomatic treatment in common respiratory infection e.g., Acetaminophen or Ibuprofen. Many cases of COVID19 show mild forms without need of hospitalization. In this randomized, open-label, multicentre, comparative trial we analysed the efficacy, safety, and tolerability of the herbal medicinal product BNO 1030 in mild cases of COVID-19 to offer an additional symptomatic relive. Methods The study was designed as an open label randomized, prospective, multicentred clinical trial. Out of 133 screened outpatients aged 18 to 70 with mild COVID-19 symptoms 120 patients were randomised (1:1) in 2 parallel groups. The main group received BNO 1030 in addition to symptomatic therapy (acetaminophen or ibuprofen). The control group got a symptomatic therapy only. The patients with laboratory proven COVID 19 were included for the final analyses: 47 – in the main group and 46 – in the control one. The evaluation criteria were dynamics of the symptoms: hyperthermia, myalgia, nasal congestion, nasal discharge, coughing, anosmia, rhinolalia, sore throat, duration of the use of antipyretics (clinically significant fever). These symptoms were assessed during the physician’s visit on a 4-point scale (0 — absent, 1 — insignificant, 2 — moderate, 3 — strong/pronounced) and self- assessed via ten-point visual analogue scale (VAS) daily in a patient’s diary. The primary endpoint was the decrease of the average score compared to the baseline defined as “therapeutic benefit” from the usage of BNO 1030. Results In the comparison of both groups over the treatment time, the main group (n = 47) showed a greater decrease in the severity of symptoms of fever, myalgia, nasal congestion, coughing, anosmia and rhinolalia, assessed by the doctor on a 4-point scale on V2 (4th day) and V3 (14th day) compared to those on V1, as well as a reduction of the antipyretics intake duration (p < 0.05). Significant differences of the main group were obtained, too, based on the results of symptoms self-assessment by the patient. The “therapeutic benefit from the use of BNO 1030 was 3 days. There is an increase in the number of recovered patients from 73.9–96.6 % according to the average symptom score, and a decrease in the number of hospitalized patients from 8.6–4.4 % in the main group., as compared to the data of the control group (p < 0.05). All patients tolerated the herbal medicine well, with no adverse drug reactions being reported. Conclusions BNO 1030 (Imupret®) offers a safe and effective treatment benefit in patients with mild forms of diagnosed COVID-19 aged 18–70 in addition to symptomatic treatment with acetaminophen or NSAIDs. COVID 19 positive patients treated with Imupret showed an earlier relive of symptoms when being treated with BNO 1030. Trial registration This trial was registered in ClinicalTrial.gov: NCT04797936.

A significant role in the pathogenesis of rhinosinusitis is played by an inflammatory reaction in the maxillary sinuses of the nasal cavity. Leukotrienes are the most powerful mediators of inflammation, especially at the early stages. The effect of combined dry extract BNO 1016 could be useful for the inhibition of the inflammation in rhinosinusitis. Thus, it appears reasonable to study the anti-inflammatory activity of the combined dry extract BNO 1016. Materials and methods: The tested drug is the combined dry extract BNO 1016 produced by "Bionorica SE". The reference drug is Ibuprofen. Leukotriene inflammation was induced by subplantar injection of zymozan into the right hind paw of male and female Wistar rats. Volumes of the resulting edema were measured and levels of anti-inflammatory activity together with mean effective dose (ED50) were calculated. Results: The highest anti-inflammatory activity was observed at a dose level of 500 mg/kg of BNO 1016 during all timepoints of the experiment and reached 65.2% 2 h after induction of inflammation. The anti-inflammatory activity of BNO 1016 at 500 mg/kg was credibly higher than that of Ibuprofen at all time-points of the experiment. Based on the data obtained from this leukotriene-dependent inflammation experiment the mean effective dose (ED50) for anti-inflammatory activity of dry combined extract BNO 1016 was calculated with help of Probit analysis. Conclusion: The combined dry extract BNO 1016 shows a high level of anti-inflammatory activity in leukotrienedependent inflammation which is very promising for the improvement of the treatment of patients. However, additional preclinical and clinical research on this drug should be carried out.

Materials and methods: Sixty patients aged 18 to 85 years who were ill with acute bacterial rhinosinusitis were examined. the average age of which was 36 ± 2 years. The research was carried out on the basis of the ENT Department of the City Clinical Emergency Hospital and the Municipal Medical Diagnostic Center of the city of Vinnitsya. All patients were divided into two groups. 30 patients with acute bacterial rhinosinusitis included in the baseline therapy group 1 (group of comparison), which included: systemic antibiotic therapy (selective drugs - cephalosporins II-III generation), anti-inflammatory (topical corticosteroids, non-steroidal anti-inflammatory drugs), irrigation therapy, local decongestants and drugs with mucolytic, secretomotor and secretory effect. Group 2 (main group) consisted of 30 patients with a diagnosis of acute bacterial rhinosinusitis, the bacteriophage (sta- phylococcal or piophage) was added to the baseline therapy. Patients undergoing bacteriophage (staphylococcus or piophage) were injected as drops in the nose, 3-4 drops in each nasal passage three times a day for 7-10 days or after catheterization of the nasal sinus was washed with sterile 0.9% sodium chloride solution, after which was injected through a catheter of 3-5 ml of a bacteriophage into the sinus cavity once a day for 7-10 days. The level of secretory immunoglobulin A (sIgA) was determined using an enzyme-linked immunosorbent assay in nasal secret. The statistical processing of the results was carried out using the statistical computer program Statistica for Windows, v.12 using parametric and nonparametric methods for evaluating the results. Results: Prior to the median treatment, the concentration of sIgA in nasal washes in group 1 was 0.92 mg / L, the interquartile interval of P25-P75 was in the range of 0.74; 1.15 mg / l, and in group 2 - median 0.94 mg / L, P25-P75 - 0.75-1.10 mg / l (p> 0.05). It was found that standard therapy was accompanied by a probable increase The concentration of sIgA in the nasal secret in 7-10 days from the beginning of treatment was 2.1 times (p <0.001), compared to the indicator before treatment, while the rates before treatment and after 12 weeks were not statistically significantly different (p = 0.051). Against the background of combination therapy, which included a bacteriophage, there was a more pronounced increase in the level of sIgA - after 7-10 days in 3 times (p <0,001), in 12 weeks in 2,5 times (p <0,001), compared with the indicator before treatment. A comparison of the mean values of sIgA concentration in the nasal secret between the study groups revealed that in 7-10 days and 12 weeks, the concentration of sIgA in patients receiving a bacteriophage was 21.3% and 43.9% higher, respectively, than in patients in the base group therapy (p = 0.048 and p <0.001). It was established that modified therapy with the use of bacteriophage contributes to the prevention of chronic acute bacterial rhinosinusitis, which was 36.6% less frequent than in the basic therapy group without bacteriophage (CS: 0.18; 95% CI: [0.05-0, 58]).

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Introduction: Acute diffuse otitis externa is a spread skin inflammation of the external ear canal of the bacterial origin. It is reported at an incidence of up to 10% among healthy population of all age groups. Treatment is known to be based on the empirical approach for prescribing topical antibacterials. Therefore studying the bacterial spectrum of otitis externa causative agents is of great value in terms of relevant antimicrobial therapy. Aim: The objective of the study was to evaluate microbial spectrum in diffuse otitis externa in patients – residents of Ukraine. Materials and methods: Four hundred and ninety-three out-patients diagnosed with acute diffuse otitis externa were enrolled. Microbial composition of the external ear canal microflora was tested and aetiologically relevant titres of colony-forming units (CFU) were determined. Criteria for evaluation: titres of 104 to 106 CFU and >106 CFU were considered aetiologically relevant. titres of <104 CFU were considered aetiologically nonrelevant. Results and discussion: In the majority of cases of acute diffuse otitis externa, infection with Staphylococcus aureus in aetiologically relevant titres is reported in 53.2% and Pseudomonas aeruginosa in 23.6%. Cases of multimicrobial infection predominantly involving Gram-negative flora were also reported in 27.9%; each of them results in no more than 2 to 3% of otitis externa. Titres of Candida spp. (3.2%) and Staphylococcus epidermidis (2.6%) were measured as aetiologically non-relevant. Conclusion: common microbial pathogens in acute diffuse otitis externa in patients of the Ukrainian population are Staphylococcus aureus and Pseudomonas aeruginosa. Multimicrobial associations predominantly involving Gram-negative flora, which do not exceed 2 to 3% of cases. Fungal infections are a rare cause of otitis externa.

Fungal flora is one of the causes of inflammatory, including polypous, processes in the nasal cavity. In this regard, studies aimed at reducing the effect of fungal sensitization (FS) on the course of chronic polypous rhinosinusitis (CPRS) are relevant. The objective of the study was to evaluate the effect of various treatment options on the clinical course of the disease in patients with chronic polypous rhinosinusitis against the background of sensitization to fungi. The study included 90 patients with chronic polypous rhinosinusitis in combination with FS. The patients were divided into two groups – the first clinical group (G1) and the second clinical group (G2). G1 patients received allergen-specific immunotherapy (ASIT) according to the scheme. G2 patients received basic treatment. Evaluation of the clinical efficiency of ASIT was made based on complaints, assessment of symptom severity on a visual analog scale (VAS), and rhinoendoscopic examination. The treatment outcomes were evaluated on a 4-point scale, with excellent results (4 points) – complete remission of the disease during the follow-up period (6–12 months); good (3 points) – exacerbation of the disease 1-2 times a year, in mild form and removed by expectant treatment; satisfactory (2 points) – the number of exacerbations did not decrease. The use of ASIT therapy is pathogenetically justified and leads to a significant improvement in the clinical condition of patients with CPRS with FS.