Prevention and treatment of upper respiratory diseases in the pandemic COVID-19 era.

In the pandemic coronavirus disease 2019 (COVID-19) era, the need to use preventive-curative treatments is compelling. A series of non-pharmacological compounds, including oligo-elements, vitamins, nutraceuticals, and bacteriotherapy, might affect the risk of COVID-19, both reinforcing the immune system and improving the inflammation resolution during respiratory infections. Non-pharmacological remedies are very popular and usually have no relevant side effects. Bacterial and natural products may potentiate the immune system against respiratory viruses. Moreover, these compounds also exert antiinflammatory and antioxidant activity. Consequently, these non-chemical remedies could be prescribed to build up the immune defence and adequately treat the upper respiratory infection. In this way, natural compounds could be used to manage people in the pandemic COVID-19 era.

Probiotics for the management of upper respiratory diseases.

Probiotics represent an intriguing challenge in clinical practice. They are currently used worldwide in all fields of Medicine. The present Supplement reports some Italian experiences concerning a probiotic mixture (Abincol®) employed in patients with upper respiratory diseases. A group of Italian otolaryngologists conducted these experiences in a real-world setting. The results demonstrated that this compound might represent a useful therapeutic option in clinical practice. In particularly, this probiotic mixture was tested in patients with rhinosinusitis, pharyngotonsillitis, otitis media, and laryngotracheitis.

Non-pharmacological remedies for upper respiratory diseases in the pandemic COVID-19 era.

In the pandemic coronavirus disease 2019 (COVID-19) era, the need to use preventive-curative treatments is compelling. A series of non-pharmacological compounds, including supplements (oligoelements and vitamins), probiotics, and nutraceuticals, might affect the risk of COVID-19 or reducing clinical severity. Non-pharmacological remedies are easily available and usually have no relevant side effects. There is evidence that bacterial and molecular substances may potentiate the immune system against respiratory viruses. Moreover, these compounds might exert essential anti-inflammatory and antioxidant activity in COVID-19. Furthermore, nasal lavage may be an additional resource for reducing the viral load and restore the integrity of respiratory patency. Therefore, preventive courses using non-pharmacological remedies could be prescribed to reinforce the immune response and adequate treatment of upper respiratory infection with natural compounds could be considered a reasonable way to manage people in the pandemic COVID-19 era.

Sinerga may prevent recurrent respiratory infections in allergic children.

Recurrent respiratory infections (RRI) are an intriguing challenge for both otolaryngologists and paediatricians. Therefore, to prevent RRI is an ambitious target in clinical practice. In this regard, modulation of the immune system may have a critical role. Sinerga, a dietary supplement (containing: palmitoylethanolamide (PEA), Kluyveromyces marxianus B0399, bovine colostrum, and phenylalanine), was supplemented in 20 allergic children with RRI (20/30 days per 3 months) and treated with standard therapy (antihistamine plus intranasal corticosteroid). Other 20 allergic children with RRI were treated only with standard therapy. Sinerga significantly reduced the number of RI and the size of both inferior and middle turbinate consistently with the postulated mechanisms of action. In conclusion, the current study demonstrated that Sinerga supplementation in allergic children with RRI may significantly prevent RI and reduce events depending on allergic inflammation.

A polycentric, randomized, double blind, parallel-group, placebo-controlled study on Lertal®, a multicomponent nutraceutical, as add-on treatment in children with allergic rhinoconjunctivitis: phase I during active treatment.

Allergic rhinoconjunctivitis (AR) treatment is usually pharmacological in children, but medications are merely symptomatic, may not be completely effective, and may have relevant side effects. Thus, doctors and parents look at complementary medicine, including nutraceuticals. Lertal®, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3 It has been reported that adults with AR diminished allergic symptoms and medication use during Lertal® therapy. Therefore, the current polycentric, randomized, double blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of Lertal® as an add-on treatment in children with AR. In this study, 146 children (94 males and 52 females, mean age 9.1±1.88) were randomly assigned to Lertal® + standard treatment or Placebo + standard treatment and were visited at baseline (W0), and after 2 (W2) and 4 weeks (W4). Standard treatment consisted of continuous antihistaminic schedule. The primary endpoint was the Total Symptom Score (TSS - last 12 hours) change from the baseline to the end of the 4-week treatment. Both groups significantly (p less 0.0001 for both) reduced TSS (last 12 hours) after 4 weeks (% change: - 63.6% in Lertal®-group and - 60.7% in Placebo-group; p= n.s. intergroup analysis). Notably, 24 children had symptom worsening between W2 and W4: 8 in the Lertal®-group and 16 in the Placebo-group, with significant intergroup difference (p less than 0.05). All of them were poly-allergic subjects exposed to multiple allergens. There was no relevant adverse event. The present study documented that Lertal®, as add-on treatment, was able to significantly prevent the occurrence of clinical worsening and was safe in AR poly-allergic children.

Broser® (bromelain, escin and selenium), oral nutraceutical, monotherapy in patients with inflammatory otorhinolaryngological disorders.

Inflammation is a common pathogenic mechanism involved in many otorhinolaryngological (ORL) disorders. Broser® is an oral nutraceutical currently containing bromelain 100 mg, escin 30 mg, and selenium 42.5 mcg. It could exert a safe and effective anti-inflammatory activity by virtue of these components. Therefore, the aim of the current survey, conducted in clinical practice of 84 Italian ORL centers, was to evaluate its safety and efficacy in the treatment of patients.

Focus on gastroesophageal reflux (GER) and laryngopharyngeal reflux (LPR): new pragmatic insights in clinical practice.

Introduction: Gastroesophageal reflux (GER) is a common disease usually limited to the oesophagus. Laryngopharyngeal reflux (LPR) is an inflammatory reaction of the mucosa of pharynx, larynx, and other associated upper respiratory organs, caused by a reflux of stomach contents outside the oesophagus. LPR is considered to be a relatively new clinical entity with a vast number of clinical manifestations which are treated sometimes empirically and without a correct diagnosis. However, there is disagreement between specialists about its definition and management: gastroenterologists consider LPR to be a substantially rare manifestation of gastroesophageal reflux disease (GERD), whereas otolaryngologists believe that LPR is an independent, but common in their practice, disorder. Patients suffering from LPR firstly consult their general practitioners, but a multidisciplinary approach may be fruitful to define a unified strategy based on specific medications and behavioural changes. The present Supplement would review the topic, considering LPR and GER characteristics, pathophysiology, diagnostic work-up, and new therapeutic strategies also comparing different specialist points of view and patient populations. In particular, new insights derive from an interesting gel compound, containing magnesium alginate and E-Gastryal® (hyaluronic acid, hydrolysed keratin, Tara gum, and Xantana gum). In particular, two very large Italian surveys were conducted in real-world setting, such as outpatient clinics. The most relevant outcomes are presented and discussed in the current Issue. Actually, laryngopharyngeal reflux (LPR) is considered an extraesophageal manifestation of the gastroesophageal reflux disease (GERD). Both GERD and its extraesophageal manifestation are very common in clinical practice. Both disorders have a relevant burden for the society: about this topic most of pharmaco-economic studies were conducted in the United States. In population-based studies, 19.8% of North Americans complain of typical symptoms of GERD (heartburn and regurgitation) at least weekly (1). Also in the late 1990s, GERD accounted for $9.3 to $12.1 billion in direct annual healthcare costs in the United States, higher than any other digestive disease. As a result, acid-suppressive agents were the leading pharmaceutical expenditure in the United States. The prevalence of GERD in the primary care setting becomes even more evident when one considers that, in the United States, 4.6 million office encounters annually are primarily for GERD, whereas 9.1 million encounters include GERD in the top 3 diagnoses for the encounter. GERD is also the most frequently first-listed gastrointestinal diagnosis in ambulatory care visits (2, 3) Extraesophageal manifestations of reflux, including LPR, asthma, and chronic cough, have been estimated to cost $5438 per patient in direct medical expenses in the first year after presentation and $13,700 for 5 years.

Salso-bromo-iodine thermal water: a nonpharmacological alternative treatment for postnasal drip-related cough in children with upper respiratory tract infections.

Postnasal drip (PND)-related cough is a very common symptom in patients with upper respiratory tract infections (URTIs). At present, there is not a standard treatment for postnasal drip and postnasal drip-related cough. The aim of this pilot study was to evaluate the efficacy of a specific salso-bromo-iodine thermal water containing hyaluronic acid and grapefruit seed extract (SBI-H-GSE) comparing it with a normal saline solution in children with URTIs who refer PND-related symptoms. The study was randomized, single-blind, and controlled. Study group (75 children) was treated with SBI-H-GSE and control group (65 children) was treated with a normal saline solution; both compounds were administered by nasal nebulization with Rinowash nasal douche twice/day for 10 days a month for 3 consecutive months. Parent Cough-Specific Quality of Life questionnaire (PC-QOL) average score, the prevalence of symptoms and signs related to post-nasal drip, nasal mucociliary transport time (NMTT), duration and number of URTI episodes, antibiotic usage and days of absence from school were evaluated at baseline and after treatment. SBI-H-GSE therapy shows better and statistically significant trend after treatment when compared to control group for PC-QOL average score (p=0.011), NMTT (p=0.047), symptoms and signs related to post-nasal drip (all p<0.005, except for the cobblestone appearance of the mucosa), duration (in days) with URTI symptoms (p=0.023) and a usage of antibiotic therapy (p=0.011). The current randomized-controlled pilot study demonstrated that SBI-H-GSE solution was effective in the treatment of children with URTIs who refer PND-related symptoms.

Phleum pratense molecular pattern across Italy.

SUMMARY: Introduction. Phleum pratense (Timothy grass) is the most frequent cause of grass allergy in Europe. Molecular-based allergy diagnostics have been recently introduced in the clinical practice, allowing to define and characterize exactly the sensitization profile. Aim of the study. The present study was aimed to investigate the possible relationships between Graminaceae pollen data and the pattern of IgE reactivity to different allergen components across Italy. Methods. Pollen data, including duration and quantity, were recorded over a 10-year period in 24 Italian centres located along the Italian peninsula. Phl p molecular patterns (Phl p 1, 5, 7, 12) were evaluated in 4 different Italian geographical areas. Results. There were significant differences about pollen count and sensitization prevalence across Italy. Different molecular patterns were defined considering the different Italian locations. Conclusion. This study demonstrates that Phleum pratense sensitization is relevant in Italy, but there are significant geographical variations variations as far as pollen exposure and pattern of IgE reactivity to the considered allergen components are concerned. This information may have clinical relevance in managing patients allergic to grass pollen.

Sinuclean Nebules treatment in children suffering from otitis media with effusion.

OBJECTIVE: Otitis media with effusion (OME) is an ear disorder defined by the presence of fluid in the middle ear without signs or symptoms of acute infection. The current randomized, double-blind, controlled study aimed to evaluate whether Sinuclean Nebules treatment, administered by nasal douche (Rinowash), could induce ear healing better than isotonic saline in children with OME. METHODS: The study was randomized, double-blind, and controlled. Group A (30 children) was treated with Sinuclean Nebules 45 and Group B (31 children) was treated with isotonic saline; both compounds were administered by nasal nebulization with Rinowash nasal douche twice/day in the morning and in the evening for 10 days, followed by a one-week suspension, and after by a second course as the first. Tympanogram and audiometry were performed at baseline and after treatment. RESULTS: Considering the global evaluation of the treatment: in Group A, 28 (93.3%) patients had complete resolution and 2 (6.7%) had partial resolution; in Group B, all patients had failure of treatment. There was a significant difference between groups (p < 0.0001). CONCLUSION: The current randomized-controlled study demonstrated that Sinuclean Nebules was effective and in the treatment of children with OME.

Intranasal T-LysYal® as adjunctive therapy for patients after functional endoscopic sinus surgery.

Functional Endoscopic Sinus Surgery (FESS) is a common day surgery technique for upper airway disorders. Hyaluronic acid (HA) is a fundamental component of the human connective tissue. HA may exert reparative, anti-inflammatory and immune-modulating activities. Recently, a new intranasal HA formulation has been proposed: a supramolecular system containing lysine hyaluronate, thymine and sodium chloride (T-LysYal®). This randomized study investigated whether intranasal T-LysYal® (RinoLysYal®, Farmigea, Italy) was able to reduce symptom severity, endoscopic features, and nasal cytology in 83 patients (49 males and 34 females mean age 45.4±6.2 years) treated with FESS. All patients were treated with isotonic saline solution for 4 weeks, and a sub-group (active group) was also treated with intranasal T-LysYal®. Patients were visited at baseline, after treatment, and after 4-week follow-up. Intranasal T-LysYal® treatment significantly reduced the quote of patients with symptoms, endoscopic features, and inflammatory cells in comparison to isotonic solution. In conclusion, the present study demonstrates that intranasal T-LysYal® is able to significantly improve patients after FESS and its effect is long lasting.

Nasal irrigation with Nasir® in children: a preliminary experience on nasal cytology.

Allergic rhinitis (AR) and upper airway respiratory infections are frequent in children, and both have a relevant impact on some social aspects, including school attendance and performance, sleep, quality of life (also of the parents), and costs. Saline nasal irrigation is widely employed to reduce nasal congestion and mucopurulent secretion, to stimulate cleansing of the nasal and paranasal cavities, and to induce restoration of mucociliary clearance. The present study evaluated the effects of nasal irrigation on nasal cytology, using the new device Nasir® in 66 children (40 males, 26 females, mean age 7.31±1.7 years, age range 4-17 years) with allergic rhinitis. The patients were treated with nasal irrigation with warm (36°C) Nasir® (250 mL sacs of premixed solution): one sac twice daily for 12 days. Nasal irrigation significantly reduced the neutrophilic infiltrate (baseline median value 2.8±0.7; post treatment value 2±0.5; p less than 0.05). In addition, there was a reduction of eosinophil infiltrate (T0= 3.2±1.1; T1= 2.6±1.2; p= less than 0.05). There was no significant change with regard to bacteria (T0= 2.7±0.9; T1= 2.3±1.02; p= 0.17). In conclusion, this pilot study reports that nasal irrigation with Nasir® might be useful to attenuate upper airway inflammation.

Clinical bystander effect exerted by allergen immunotherapy: a hypothesis.

Allergen Immunotherapy (AIT) is able to restore a physiological Th1 response and Tregs function. This effect is allergen-specific, even though it has been reported that it may also be non-specific, such as also extended to allergens not used in AIT. This immunological phenomenon may also be of clinical nature. This case report shows that a poly-allergic patient, successfully treated with Parietaria extract, also achieved a clinical tolerance towards other causal allergens, such as mites and cat. Of course, this was an anecdote, but it is reasonable to prospect the hypothesis that a bystander clinical effect may be observed during AIT in poly-allergic patients.

Asthma exacerbation in children: Relationship among pollens, weather, and air pollution

BACKGROUND: Asthma exacerbation is an episode of (sub) acute worsening of asthmatic symptoms. Exacerbation may depend on environmental factors. OBJECTIVE: The present study investigated emergency calls for asthma exacerbation in children, analysing: I) their trend over the course of time; and II) their possible relationship with environmental factors, including pollen count, meteorological parameters, and air pollution. METHODS: Emergency calls for exacerbation were recorded for 10 years (from 2002 to 2011) in Genoa (Italy). Betulaceae, Urticaceae, Gramineae, and Oleaceae pollen counts were measured. Meteorological parameters and air pollutants were also measured in the same area and for the same period. RESULTS: The number of emergency calls did not significantly modify during the time studied. Two main peaks were detected: during the autumn and the spring. Wind speed significantly diminished as did most air pollutants. There were significant and relevant relationships between emergency calls and: pollens during the spring (r = 0.498), rainfall (r = 0.818), wind speed (r = 0.727), and air pollutants (r = 0.622 for SO2; r = 0.699 for NO; r = 0.58 for NO2). CONCLUSIONS: This 10-year survey demonstrates that: (I) asthma exacerbations did not diminish over the time; (II) there were seasonal peaks (autumn and spring); (III) pollens (mainly Parietaria), wind speed and rainfall, SO2, NO, O3 and NO2 were strongly associated with asthma exacerbations in children in this area. Therefore, asthma exacerbations may significantly depend on environmental variations

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Asthma exacerbation in children: relationship among pollens, weather, and air pollution.

BACKGROUND: Asthma exacerbation is an episode of (sub)acute worsening of asthmatic symptoms. Exacerbation may depend on environmental factors. OBJECTIVE: The present study investigated emergency calls for asthma exacerbation in children, analysing: i) their trend over the course of time; and ii) their possible relationship with environmental factors, including pollen count, meteorological parameters, and air pollution. METHODS: Emergency calls for exacerbation were recorded for 10 years (from 2002 to 2011) in Genoa (Italy). Betulaceae, Urticaceae, Gramineae, and Oleaceae pollen counts were measured. Meteorological parameters and air pollutants were also measured in the same area and for the same period. RESULTS: The number of emergency calls did not significantly modify during the time studied. Two main peaks were detected: during the autumn and the spring. Wind speed significantly diminished as did most air pollutants. There were significant and relevant relationships between emergency calls and: pollens during the spring (r = 0.498), rainfall (r = 0.818), wind speed (r = 0.727), and air pollutants (r = 0.622 for SO2; r = 0.699 for NO; r = 0.58 for NO2). CONCLUSIONS: This 10-year survey demonstrates that: (i) asthma exacerbations did not diminish over the time; (ii) there were seasonal peaks (autumn and spring); (iii) pollens (mainly Parietaria), wind speed and rainfall, SO2, NO, O3 and NO2 were strongly associated with asthma exacerbations in children in this area. Therefore, asthma exacerbations may significantly depend on environmental variations.