Total Nasal Symptom Score Research Articles

Aberrant expression of long non-coding RNA PVT1 in allergic rhinitis children: Correlation with disease risk, symptoms, and Th1/Th2 imbalance.

BackgroundLong non‐coding RNA plasmacytoma variant translocation 1 (lnc‐PVT1) exacerbates inflammation and induces T helper (Th) 1/Th2 imbalance in allergic diseases, but its clinical role in allergic rhinitis (AR) remains unclear. Hence, we conducted this study to compare lnc‐PVT1 expression among AR children, disease controls (DCs), and health controls (HCs), aiming to investigate its clinical application in AR children.MethodsSixty AR children, 30 DCs, and 30 HCs were enrolled in the study, and then, their lnc‐PVT1 expression in peripheral blood mononuclear cell was detected. Serum interferon‐gamma (IFN‐γ), interleukin 10 (IL‐10), Th1, and Th2 cells in AR children were also analyzed. Besides, lnc‐PVT1 was also detected at Week (W)4 after treatment in AR patients.ResultsLnc‐PVT1 was upregulated in AR children compared with DCs and HCs (both p < 0.001). Lnc‐PVT1 was positively related to nasal rhinorrhea score, itching score, congestion score, and total nasal symptom score (TNSS) in AR children (all p < 0.050), instead of sneezing score (p = 0.115). Lnc‐PVT1 negatively associated with Th1 cells in AR children (p = 0.028) also exhibited a negative correlation trend with IFN‐γ (but without statistical significance) (p = 0.065). Differently, lnc‐PVT1 was positively related to Th2 cells (p = 0.012) and IL‐10 (p = 0.021) in AR children. Besides, lnc‐PVT1 and TNSS were reduced at W4 after treatment in AR children (both p < 0.001); notably, lnc‐PVT1 expression decline was correlated with TNSS decline during treatment (p = 0.013).ConclusionLnc‐PVT1 works as a biomarker, whose aberrant expression is related to disease severity, Th1/Th2 imbalance, and its decrement can reflect treatment outcome in AR children.

Non-sedative Antihistamines: Assessment of Efficacy Based on Total Nasal Symptom Score in Patient with Allergic Rhinitis.

Background: Allergic rhinitis is a common and chronic immunoglobulin E–mediated respiratory disorder following allergen exposure that can affect the quality of life and work activities. Antihistamine should be prescribed for the relief of persistent allergic symptoms &amp; advised to avoid known allergens also. Objectives: The objective of the study is to assess the efficacy of non-sedating antihistamines in the treatment of allergic rhinitis based on the total nasal symptom score. Materials and Methods: This is a prospective study of patients with clinically diagnosed allergic rhinitis following inclusion &amp; exclusion criteria at the study center. Patients’ demographic profiles, symptoms and signs were obtained using a specially designed form. The symptoms were scored from baseline to end of treatment by using nasal symptom scoring protocol. The data were collated and analyzed using Microsoft excel &amp; SPSS Version 17 statistical software. Results: Recruited 360 patients with allergic rhinitis, 96.66% presented with running nose as the chief complaint. A large number of patients have total nasal symptom scores of above 9 (n =170; 47.22%), whereas few (n = 42; 11.66%) had symptom scores of below 6 at a baseline level. Upon treatment with rupatadine, a significant reduction of TNSS (p&lt; 0.05) was found from baseline over the 14-day treatment period. The incidence of adverse effects (fatigue 1.3%, headache 2.7%) was found to be less in the rupatadine group. Conclusion: non-sedative antihistamines effectively control persistent allergic rhinitis, where rupatadine is a drug of choice due to its better efficacy and having a low incidence of side effects. KYAMC Journal. 2022;12(04): 231-236

Ameliorating Atopy by Compensating Micronutritional Deficiencies in Immune Cells: A Double-Blind Placebo-Controlled Pilot Study

Functional iron deficiency facilitates allergy development and amplifies the symptom burden in people experiencing allergies. Previously we selectively delivered micronutrients to immune cells with β-lactoglobulin as carrier (holoBLG), resulting in immune resilience and allergy prevention. The clinical efficacy of a food for special medical purposes-lozenge containing β-lactoglobulin with iron, polyphenols, retinoic acid, and zinc (holoBLG lozenge) was assessed in allergic women. In a randomized, double-blind, placebo-controlled pilot study, grass- and/or birch pollen-allergic women (n= 51) were given holoBLG or placebo lozenges over 6 months. Before and after dietary supplementation, participants were nasally challenged and the blood was analyzed for immune and iron parameters. Daily symptoms, medications, pollen concentrations, and well-being were recorded by an electronic health application. Total nasal symptom score after nasal provocations improved by 42% in the holoBLG group versus 13% in the placebo group. The combined symptom medication score during the birch peak and entire season as well as the entire grass pollen season improved in allergic subjects supplemented with the holoBLG lozenge by 45%, 31%, and 40%, respectively, compared with the placebo arm. Participants ingesting the holoBLG lozenge had improved iron status with increased hematocrit values, decreased red cell distribution width, and higher iron levels in circulating CD14+ cells compared with the placebo group. Targeted micronutrition with the holoBLG lozenge seemed to be effective in elevating the labile iron levels in immune cells and reducing the symptom burden in allergic women in this pilot study. The underlying allergen-independent mechanism provides evidence that dietary nutritional supplementation of the immune system is one of the ways to combat atopy.

Efficacy and safety of the Chinese herbal medicine Xiao-qing-long-tang for allergic rhinitis: A systematic review and meta-analysis of randomized controlled trials

Ethnopharmacological relevanceThe classic Chinese herbal medicine formula Xiao-qing-long-tang (XQLT) is commonly recommended to manage allergic rhinitis (AR), but the treatment efficacy and safety of XQLT are uncertain. Aim of the studyThis study aimed to evaluate the effectiveness and safety of XQLT in treating AR. Materials and methodsNine databases were searched from their inception to April 2021. Randomized controlled trials (RCTs) evaluating XQLT for AR were included. The methodological quality of the studies was assessed using the Cochrane risk-of-bias tool. A meta-analysis and a subgroup meta-analysis were conducted to evaluate the effectiveness of XQLT. ResultsTwenty-four RCTs were included in this meta-analysis. XQLT was compared to both placebo and Western medicine (WM), and XQLT combined with WM was compared with WM alone. Meta-analyses were conducted for total nasal symptom scores (TNSS), four individual nasal symptom scores, quality of life (QoL), effective rate, and recurrence rate. The TNSS decreased after XQLT treatment and combination treatment (mean difference (MD): −0.79; 95% confidence interval (CI) [−1.20, −0.38], standardized mean difference (SMD): −1.42; 95% CI [−1.59, −1.24], and SMD: −1.84; 95% CI [−2.08, −1.60]). The two individual nasal symptom scores decreased after XQLT treatment and combination treatment; these nasal symptoms comprised rhinorrhea (SMD: −0.30; 95% CI [−0.58, −0.02] and SMD: −0.48; 95% CI [−0.70, −0.26]), and nasal obstruction (SMD: −0.54; 95% CI [−0.78, −0.30] and SMD: −0.54; 95% CI [−0.76, −0.32). XQLT and XQLT combined with WM achieved a better effective rate than WM (risk ratio (RR): 1.18; 95% CI [1.11, 1.25] and RR: 1.16; 95% CI [1.10, 1.23]) and a lower recurrence rate than WM (RR: 0.24; 95% CI [0.13, 0.43] and RR: 0.47; 95% CI [0.31, 0.72]). XQLT was well tolerated in patients being treated for AR. ConclusionOur results indicated that oral XQLT may alleviate the TNSS, rhinorrhea scores, and nasal obstruction scores of AR and is safe to use in clinical practice. However, more RCTs that follow rigorous methodologies and evaluate well-accepted outcome measures are required to evaluate the effectiveness of XQLT.

A Meta-Analysis of Probiotics for the Treatment of Allergic Airway Diseases in Children and Adolescents.

Allergic airway disease is a chronic airway allergic inflammatory disease including allergic rhinitis (AR) and allergic asthma which is common in children and adolescents. Recently the probiotics has been becoming a supplementary or alternative therapy to allergic diseases, however the effect of them has not been clearly established. The purpose of the present meta-analysis was to evaluate the effectiveness of probiotics on allergic airway disease including AR and allergic asthma in children and adolescents. We performed a comprehensive search on PubMed, Cochrane Library, EMBASE for relevant publications from 1 Jan 2000 to 1 July 2021. Physical examinations, Pediatric Rhinoconjunctivitis Quality of Life Questionnaires (PRQLQs), Total Nasal Symptom Score (TNSS), Nasal or Eye Symptom Score (NSS or ESS), serum allergen-specific IgE, and eosinophil were used as evaluating indicators for AR and allergic asthma in children and adolescents. The meta-analysis was performed using Review Manager (RevMan, Version 5.3). 15 randomized controlled trials (RCTs) with a total of 1388 participants were included for the meta-analysis. Among them, 729 patients treated with probiotics served as the probiotics group, and 659 patients with placebo as control group. Significantly greater reduction in PRQLQs from baseline to endpoint (SMD = -2.57, 95% CI [ - 4.66, -0.48] P < 0.01), NSS (SMD = -1.43, 95% CI [ - 1.63, - 1.23], P < 0.01) and ESS (total MD = -1.67, 95% CI [ - 1.79, - 1.55], P < 0.01) were observed in probiotics group compared to control group. Probiotics have no significant effect to serum IgE and eosinophils (P > 0.01). The results of this meta-analysis indicated that probiotics treatment may reduce PRQLQs, NSS, ESS in patients with allergic airway disease. More research involving the mechanism of probiotics are needed to clarify the role of probiotics in AR and allergic asthma in children and adolescents.

Evaluation of shoseiryuto for seasonal allergic rhinitis, using an environmental challenge chamber

BackgroundComplementary and alternative medicine, including Japanese traditional medicine (JTM), has been used for various allergic diseases, but the evidence is limited. Shoseiryuto (Xiao-Qing-Long-Tang), one of the representative JTM drugs, is frequently used to treat allergic rhinitis (AR). However, its efficacy for seasonal AR has not been fully established. Using an Environmental challenge chamber (ECC), we evaluated the therapeutic effects of shoseiryuto on AR induced by Japanese cedar pollen (JCP). MethodsA placebo-controlled double-blind crossover study with shoseiryuto was conducted using the ECC. The shoseiryuto or placebo was orally administered from 2 weeks before the exposure test. The pollen exposure test was conducted for 3 h, and the pollen concentration was set at 8000 pollen/m3. The primary endpoint of the study was the total nasal symptom score (TNSS) during pollen exposure. A physician certified by the Japanese Society of Oriental Medicine as a specialist checked each participant's “pattern”, a comprehensive expression of signs obtained from individual patients' subjective symptoms and other personal findings. Blood samples collected just before the first pollen exposure were stimulated with cedar antigens and used for immunological studies. ResultsThe results of the 46 participants were analyzed, and no significant side effects were detected. There was no significant difference in TNSS during pollen exposure for 3 h in the ECC between the shoseiryuto and placebo groups. However, some symptoms were improved in the shoseiryuto group after leaving the ECC. There was no significant correlation between the “fluid retention pattern” and TNSS. In immunological studies, shoseiryuto did not inhibit Th2-type cytokine production and mRNA expression. ConclusionsOral administration of shoseiryuto from 2 weeks before pollen exposure did not prevent or inhibit immediate symptoms of AR induced by JCP in the ECC. Further study is needed to reevaluate the shoseiryuto specific “pattern” in JTM.

Comparing the Efficacy of Leukotriene Receptor Antagonists and Intra-nasal Steroids in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis

We performed a systematic review and meta-analysis of randomized controlled trials to compare the efficacy of leukotriene receptor antagonists (LTRAs) and intranasal corticosteroids (INCSs) in patients with allergic rhinitis (AR). We searched OVID-MEDLINE (1946 to November 6, 2020), EMBASE, and the Cochrane Library databases for original articles. We used a random-effects model for the meta-analysis to determine the mean difference in the nasal symptom scores between the LTRA and INCS groups. Statistical heterogeneity was assessed using the I2 statistic and chi-squared test. A subgroup analysis was performed using the sample size, treatment duration, and comorbidities. We performed a database search on November 6, 2020, which yielded 922 reports. Of these, five studies were included in the metaanalysis. INCS treatment was more effective than LTRA treatment in relieving the nasal symptom of patients with AR (weighted mean difference [WMD] of the total nasal symptom score change=10.77, 95% confidence interval [CI]: 5.41 to 16.12). The results showed moderate heterogeneity (I2=33%, P=0.20). In the subgroup analysis, the results were homogenous, although some showed heterogeneity and some of the differences between the treatments were not statistically significant. There was moderate heterogeneity in the subgroup analysis (I2=63%, P=0.07), owing to the small sample size (n<600). The results of the study with a long treatment duration (more than 15 days) and those of the studies including patients with asthma were that the difference in the efficacy of INCS treatment and that of LTRA treatment was not statistically significant (WMD=3.86, 95% CI: &#8722;5.8 to 13.52; and WMD=8.18, 95% CI: &#8722;0.29 to 16.65, respectively). Although some of the subgroups showed heterogeneity and did not demonstrate statistically significant differences between the two treatments, the subgroup analysis consistently showed the superiority of INCS in treating patients with AR.

A Novel Powered Nasal Irrigation After Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis: A Preliminary Study

Background and Objectives We aimed to compare the efficacy of a novel powered irrigation system with that of the manual bottle-squeeze method for postoperative healing after endoscopic sinonasal surgery (ESS).Subjects and Method In this prospective randomized clinical trial, 29 patients were enrolled for nasal irrigation (NI) with either NOSSHA® (Womens Care Co., Ltd.) powered irrigation system (NOSSHA® group, n=14) or manual irrigation (control group, n=15). Objective findings were evaluated using the modified Lund-Kennedy scores. Subjective outcomes were assessed using the total nasal endoscopic score (TNES), total nasal symptom score (TNSS), visual analog scale (VAS), and quality of life (QOL) questionnaires in each group at baseline, and 1, 2, 4, 6, and 8 weeks after ESS. We compared the postoperative changes between both groups.Results The mean TNES of patients were significantly higher in the NOSSHA® group than in the control group (p=0.015); however, the improvement in TNES was achieved 2 weeks earlier in the NOSSHA® group. The improvement in TNES (p&lt;0.001) and TNSS (p&lt;0.001) was statistically significant in both groups. The improvement in QOL was statistically significant in the NOSSHA® (p&lt;0.001) and control group (p=0.007). The improvement in the TNSS and QOL was earlier in the NOSSHA® group by 4 and 7 weeks, respectively; no early improvement occurred in the NOSSHA® group for the VAS score.Conclusion We validated the usefulness of postoperative NI using a powered device, which may be useful for patients who cannot tolerate manual NI.

Intranasal low-level laser therapy versus acupuncture treatment for allergic rhinitis: A randomized, noninferiority trial

IntroductionIntranasal low-level laser therapy (LLLT) has already proven its immunosuppressive effects on allergic rhinitis (AR) in experimental studies; however, there is a dearth of clinical evidence supporting its effects in treating AR. The aim of this study was to assess the safety and effectiveness of intranasal LLLT in the treatment of AR compared with acupuncture. MethodsA total of 80 patients with AR participated and were randomly assigned to the intranasal LLLT or acupuncture treatment (AT) group. They were given each treatment for 20 min 3 times a week for 4 weeks. ResultsBoth groups improved the total nasal symptom score (TNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and nasal endoscopy index in patients with AR after 4 weeks of treatment, and these effects extended 4 weeks after the end of treatment. Intranasal LLLT was noninferior to AT in regard to the TNSS. The estimated outcome difference between baseline and the 5th week was −0.38 points (upper 97.5% confidence limit 1.06 points), which was within the noninferiority margin of 2 points. The effect size of the TNSS at the 5th week was 0.19, which was close to Cohen's small effect size. There were no significant differences between two groups regarding the RQLQ, nasal endoscopy index, total serum immunoglobulin E level or absolute eosinophil count. ConclusionThis study showed that intranasal LLLT is noninferior compared to AT in terms of the TNSS; thus, it may be used as an alternative or adjunctive treatment option for relieving symptoms of AR. Trial registrationThis study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).

Efficacy of Anti-Allergen Therapeutics in Preclinical Allergy Model Systems Correlate with Symptomatic Relief in a Clinical Setting

The passive cutaneous anaphylaxis (PCA) mouse model measures local mast cell activation-induced vascular permeability and has been used to study IgE-mediated hypersensitivity. The PCA model was utilized to preclinically select allergen-specific monoclonal antibody (mAb) cocktails subsequently shown to provide symptomatic relief in individuals with birch or cat allergy as measured by significant reductions in total nasal symptom score (TNSS) following nasal allergen challenge (NAC) and reduction in allergen-specific skin prick tests (SPT) relative to baseline.

Effect of acupuncture therapy combined with fluticasone propionate in the treatment of persistent allergic rhinitis: study protocol for a randomized controlled trial

BackgroundAllergic rhinitis (AR) is an immunoglobulin E (IgE)-mediated inflammatory response.Persistent allergic rhinitis (PAR) is a subtype of AR, but the treatment of PAR is still a problem. Acupuncture is used as an alternative therapy for AR in clinical practice. The aim of this study is to evaluate the effectiveness of acupuncture therapy combined with fluticasone propionate nasal spray in comparison to fluticasone propionate nasal spray alone in the relief of symptoms for PAR.MethodsThis study is a multicenter, single-blind, randomized controlled trial. A total of 260 eligible patients will be randomly assigned into the treatment group or the control group. The treatment group will receive the nasal fluticasone propionate combined with acupuncture, and the control group will receive fluticasone propionate nasal spray alone for 6 weeks. The primary outcome is the change in the Reflective Total Nasal Symptom Score (rTNSS) from baseline to the end of treatment, and the Total Non Nasal Symptom Score (TNNSS), reflective total ocular symptom score (rTOSS), Rhinitis Quality of Life Questionnaire (RQLQ), use of antiallergic drugs, and the Rhinitis Control Assessment Test (RCAT) are used as secondary outcomes. The participants will be followed up for another 24 weeks after treatment.DiscussionThis clinical trial will be able to provide high level evidence on the acupuncture therapy combined with fluticasone propionate nasal spray in the treatment of PAR.Trial registrationISRCTN Registry, ID: ISRCTN44040506. Registered on 22 July 2020.

Omalizumab and quality of life in nasal polyps: A post hoc analysis.

Omalizumab and quality of life in nasal polyps: A post hoc analysis.

Is Posterior Nasal Nerve Neurectomy Really a Ray of Hope for the Patients of Allergic Rhinitis.

Allergic rhinitis significantly affects the quality of life, it contributes to missed or unproductive time at school or work, disturbed sleep pattern and day time somnolence. Rhinitis is defined clinically as having two or more symptoms of anterior or posterior rhinorrhoea, sneezing, nasal blockage and/or itching of the nose during two or more consecutive days for more than 1 h on most days (International rhinitis management working group, 1994). Allergic rhinitis is diagnosed when these symptoms are caused by allergen exposure leading to an IgE mediated reaction. Nerve irritation causes sneezing and itching, the loss of mucosal integrity causes causes rhinorrhoea and the vascular engrogment leads to nasal blockage. Medical modalities are symptomatically effective in mild cases, with temporary relief and addressable adverse effects. Prolonged treatment with allergy immunotherapy causes a sustainable financial burden while remaining inaccessible at smaller towns. Posterior nasal nerve neurectomy is short, easy and effective alternative. The basic procedure is to selectively cut nerve bundles at the level of the sphenopalatine foramen (SPF) with a trans nasal approach. By denervating the nasal mucosa one renders it unresponsive to any sorts of allergen or allergic reaction. The aim of the study was to evaluate the outcome of posterior nasal nerve neurectomy in cases of severe allergic rhinitis by assessing its impact on the total nasal symptom score. The study is a hospital based prospective study, conducted on 15 patients who presented to the ENT department of Mahatma Gandhi Hospital from march 2021 to October 2021 (6months) suffering from allergic rhinitis and did not show any satisfactory improvement even after 1year of medical treatment. Adult patients in the age group of 20-45 yrs. diagnosed with allergic rhinitis were enrolled into the study after obtaining a due written consent. These included patients having 2 or more symptoms of allergic rhinitis and refractoriness to medical therapy for > 1year along with significantly affected quality of life and elevated IgE level. Patients with drug induced & hormonal causes of rhinitis, chronic rhinosinusitis and any anatomical feature which precipitates to rhinitis such as deviated nasal septum, hypertrophied turbinates, blocked osteomeatal unit, polypoidal nasal mucosa and sinonasal polyposis were excluded from the study. During our study period from march 2021-September 2021, 15 patients were enrolled in the study. All the patients were followed up at 2nd and 6th month postoperatively. Amongst these patients, there were 11 females (73.34%) and 4 were male (26.67%)The mean age of patients was 35.2years. Subjective nasal symptoms of all 15 patients improved over the period of 6months. The mean TNSS improved from 12.067 preoperatively to 8.66 at the end of 2nd month, i.e., 23.1% improvement. By the end of the 6th postoperative month there was a consistent reduction in the tnss, which further reduced to a mean of 3.4 (70.2% reduction) indicating a further improvement in symptoms with time. With the advancement & popularity of endoscopic sinus surgery in the past decade, endoscopic resection of the posterior nasal nerve is emerging as a safe and less invasive technique with long standing results. Medical treatment usually provides mild and symptomatic relief with long duration of treatment period. Thus, PNN is safer, economical & easier alternative to current trend of treatment of allergic rhinitis, proving to be highly efficient in cases of intractable allergic rhinitis.

Cat allergen exposure in a naturalistic exposure chamber: Aprospective observational study in cat-allergic subjects.

BackgroundTo determine the proportion and reproducibility of cat‐allergic mild asthmatics with early asthmatic response (EAR) during cat allergen exposure in a naturalistic exposure chamber (NEC).MethodsThis was a prospective, observational study in 30 cat‐allergic mild asthmatics who received two 180‐min cat‐allergen (Felis domesticus allergen 1 [Fel d 1]) challenges 27 days apart in an NEC.ResultsAn EAR (≥20% reduction from baseline in forced expiratory volume in 1 s [FEV1]) was observed in 67% and 52% of subjects at first and second NEC exposure, respectively, with similar median time to EAR; 44% of subjects had an EAR on days 1 and 28. Late asthmatic response (≥15% reduction in FEV1 within 24 h of NEC exit) was observed in 33% of subjects following either exposure. Average FEV1 and total nasal symptom score during NEC exposure were highly correlated within subjects between NEC exposures (r = 0.91, p < 0.0001; r = 0.73, p < 0.001), but total ocular symptom score was not. Time to EAR, but not average FEV1, was significantly associated with NEC Fel d 1 concentration, which was variable. There were no serious adverse events; 12/30 subjects experienced 20 adverse events (including asthma, 10%; headache, 10%).ConclusionsThe NEC model demonstrates that average FEV1 change is highly reproducible and has a low correlation with cat allergen levels. However, time to EAR and incidence of EAR are less reproducible and are highly correlated with NEC allergen levels. Average FEV1, rather than incidence of EAR or time to EAR, could be considered as an endpoint for interventional trials testing cat‐specific anti‐allergy therapies using an NEC.

Long-term benefits of targeted micronutrition with the holoBLG lozenge in house dust mite allergic patients

Summary Purpose The long-term effects of targeted micronutrition with the holoBLG lozenge in house dust mite (HDM) allergic rhinoconjunctivitis (ARC) patients were evaluated at a follow-up visit in an allergen exposure chamber (AEC). Methods Patients who were supplemented for 3‑months with the holoBLG lozenge in a previous study with two controlled HDM-AEC challenges [visits: V1, V3] were recruited for a third AEC challenge (V5) 7–8 months after cessation of supplementation. Symptoms (nose, conjunctival, bronchial, others), well-being, and lung function parameters were recorded exactly as in the previous study. Primary endpoint was change in median Total Nasal Symptom Score (TNSS) at V5 compared to V1. Secondary endpoints included e.g. change in median Total Symptom Score (TSS) and the exploratory analysis of temporal evolution of symptom scores using linear mixed effects models. Results Of the 32 patients included in the original study, 27 could be recruited for the follow-up visit with a third AEC challenge. An improvement of 20% (p = 0.15) in the primary endpoint TNSS [V1: 2.5 (interquartile range [IQR]: 1–4), V5: 2.0 (IQR: 1–3)] was observed; 40% (p = 0.04) improvement was seen for the TSS [V1: 5.0 (IQR: 3–9), V5: 3.0 (IQR: 2–5.5)]. Analysis of temporal evolution of all symptom scores, and the personal well-being revealed sustained, clinically meaningful improvement at V5 compared to V1. No relevant lung function parameter differences were observed. Conclusions Sustained long-term reduction of TNSS (primary endpoint) and sustained long-term improvement of secondary endpoints (temporal evolution of all symptom scores and well-being) were demonstrated 7–8 months after cessation of holoBLG supplementation, indicative of a long-lasting nature of immune resilience induced by holoBLG. Trial registration The study was registered at clinicaltrials.gov (NCT04872868).

Conception and Clinical Efficacy of an Osmotic, Polymeric, Stable Nasal Filmogen Barrier for Preventive Treatment of Allergen and Pollution Induced Rhinitis and Respiratory Symptoms

Background: Pollution induced allergic rhinitis and respiratory symptoms is becoming a major health problem in the world for which still there is no safe and preventive treatment. Objectives: Conceive and evaluate the allergen preventive properties and clinical efficacy of an osmotic, polymeric, stable filmogen spray, called PCNS. Materials and Methods: Amb A 1 (ragweed), Der P 1 and 2 (dust mite), Bet v 1 (birch), Alt a 1 (Alternaria, fungus), and Fel d 1 (cat dander) allergens were exposed at a concentration of 5µg/ml (20 µl per tube) on the polymeric test product film (120 and 240µl layer) and the allergens crossing the barrier were quantified in the agar gel beneath the film. 0.40% HPMC and PBS solutions, tested identically, served as controls. Clinical efficacy of PCNS nasal spray was evaluated in patients suffering from allergic rhinitis and/or respiratory symptoms (29 in test product v/s 15 in saline controls) for 22 days. Nasal, ocular, respiratory symptoms and Rhino conjunctivitis Quality of Life Questionnaire (RQLQ) were measured. Statistical analyses: The normality of the populations was determined by the Shapiro-Wilk test, then statistical analysis was performed by two-tailed Student’s test for comparisons between two groups and the two-way ANOVA followed by the post hoc Bonferroni’s test for comparisons of multiple groups. p&lt;0.05 was considered statistically significant. The analyses were performed with the software GraphPad Prism (version 8.4.2, La Jolla, USA). NS indicates not significant. Results: PCNS polymeric spray blocked the diffusion of all the allergens while 0.40% HPMC was able to prevent diffusion of only Alt a 1 and Fel d 1 allergens. Mean reflective total nasal symptom scores (rTNSS), reflective total ocular symptom score (rTOSS), and respiratory symptoms including effect on wheezing, cough, dyspnea, and chest tightness were moderately improved in the control saline group, but the improvements were nearly twice better in the PCNS group. RQLQ was improved by 23% in saline spray v/s 46% PCNS group. 4/15 patients in saline group v/s 1/29 in PCNS group required rescue medication during the study. PCNS was highly effective in reducing allergen and pollution induced respiratory symptoms. Conclusion: a polymeric, osmotic, and stable nasal barrier against pollutants and allergens represents an innovative approach against pollution induced respiratory symptoms.

A Clinical Study to Evaluate the Role of Vitamin D3 in Allergic Rhinitis.

Allergic rhinitis is a common and chronic immunoglobulin E-mediated inflammation of nasal mucosa induced after allergen exposure. Allergic rhinitis is a global health problem that causes major illness and affects patient's social life, sleep, school and work performance. Various studies have implicated the association between low serum vitamin D levels and allergic diseases. Active form of Vitamin D3 has been shown to have immunoregulatory effect on both innate and adaptive immunity, which can significantly affect the outcome of allergic responses in allergic rhinitis. The study aims to evaluate effectiveness of Oral Vitamin D3 supplementation as an adjunct to standard therapy, in the management of allergic rhinitis. The present study is a prospective study in which 80 subjects were recruited and were randomly divided into two groups. The study group received oral vitamin D3 (60,000IU) along with intranasal steroid spray while control group received only intranasal steroid spray for 4weeks. The response in both the groups was compared by evaluating total nasal symptom score (TNSS). Subjects of allergic rhinitis showed deficiency in vitamin D indicated by mean serumvitamin D levels of 15 ± 2.42ng/ml inthe study group and 14.72 ± 2.64ng/ml in thecontrol group. The pre treatment mean TNSS score was 10.45 ± 3.1 in thestudy group and 11.43 ± 2.35 in thecontrol group. The post treatment mean TNSS score was 2.1 ± 0.21 in thestudy group and 3.85 ± 0.76 in the control group. A significant reduction in symptoms score was observed after 4weeks of oral vitamin D3 supplementation. The difference between twogroups wasfound to be statistically significant (p value < 0.05).

Nasal cytology can predict clinical efficacy of subcutaneous immunotherapy in intermittent allergic rhinitis.

Allergen immunotherapy (AIT) is the only disease-modifying treatment option available for patients with IgE-mediated allergic rhinitis. The identification of specific biomarkers, which may predict response to AIT, is currently an active field of research in the aspect of recommended personalization of medicine. To assess the changes in rhinological parameters in intermittent allergic rhinitis (IAR) patients resulting from subcutaneous immunotherapy (SCIT). Forty-two patients (female: 19; 45%) with IAR qualified for subcutaneous immunotherapy were enrolled in this study. Fourteen (33.3%) patients were desensitized with grass pollen allergen extracts, 12 (28.6%) with tree pollen allergen extracts, and 16 (38.1%) with grass and tree pollen allergen extracts. The patients were evaluated before AIT during the pollen season and in the next pollen season after introduction of subcutaneous immunotherapy. On both occasions, determination of total nasal symptom score (TNSS), rhinomanometry and nasal cytology were performed. All examined parameters significantly improved after one course of allergen immunotherapy: the percentage of eosinophils in nasal mucosa, TNSS and nasal resistance decreased, whereas the nasal flow rate increased. The decrease in percentage of nasal eosinophils significantly correlated with improvement in TNSS (rs = 0.39, p < 0.05) and was the highest in the subgroup sensitive to grass pollen (44.5 (40-52)). The rhinological assessment confirmed high effectiveness of SCIT in intermittent allergic rhinitis. A high percentage of eosinophils in nasal cytology before subcutaneous immunotherapy can predict its clinical efficacy for intermittent allergic rhinitis, especially in grass pollen allergy.

As-needed versus regular intranasal corticosteroid for allergic rhinitis: A systematic review and meta-analysis.

Daily intranasal corticosteroid (INCS) is recommended for treating allergic rhinitis (AR). Nevertheless, patients are generally not adherent and use it on-demand. The data on the efficacy of as-needed INCS was insufficient. We conducted a systematic review and meta-analysis to assess the efficacy of as-needed INCS compared with regular use for AR. We searched PubMed/MEDLINE, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) until May 2021. A pairwise meta-analysis used a random-effects model to estimate the pooled standardized mean difference (SMD). The primary outcome was the total nasal symptom score (TNSS) changes from baseline at 4 and 6 weeks. Secondary outcomes were the changes of individual nasal symptom score and quality-of-life (QoL) score. We identified five eligible RCTs with a total of 436 patients with AR. Only four studies had adequate data for quantitative synthesis. The TNSS changes of as-needed INCS were not significantly different from the regular use at both 4 (SMD 0.23 [95%CI: -0.14 to 0.60], p = 0.230) and 6 weeks (SMD 0.21 [95%CI: -0.02 to 0.44], p = 0.080). Most of the changes of individual nasal symptom scores and QoL scores were not significantly different between the two regimens. At 50% or more INCS dose of regular use, as-needed and regular INCS provided a similar efficacy. The treatment effect was, however, less sustained with as-needed INCS. The efficacy of as-needed use of INCS at 50% of corticosteroid exposure was comparable to regular use in improving nasal symptoms and QoL.

Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis.

BackgroundTemperature-controlled radiofrequency neurolysis of the posterior nasal nerve has been shown to reduce the symptom burden of patients with chronic rhinitis.ObjectivesTo evaluate the long-term safety and effectiveness of temperature-controlled radiofrequency neurolysis of the posterior nasal nerve for the treatment of chronic rhinitis.MethodsA prospective extension of a 12-month single-arm study, where reflective total nasal symptom score (rTNSS) and the responses to a study-specific quality of life questionnaire and patient satisfaction survey were collected at 24 months.ResultsForty-seven patients completed initial 12-month follow-up after treatment with the study device, of which 34 patients were reconsented and completed 24-month follow-up. The mean rTNSS of the long-term follow-up patients improved from 8.4 (95% confidence interval (CI), 7.7 to 9.0) at baseline to 2.9 (95% CI, 2.1 to 3.6), P < .001 at 24 months, a 65.5% improvement. On a 6-point scale (0-5), postnasal drip improved from a mean of 4.1 (95% CI, 3.6 to 4.6) to 2.1 (95% CI, 1.7 to 2.5) and chronic cough improved from 3.2 (95% CI, 2.7 to 3.6) to 0.9 (95% CI, 0.5 to 1.3) from baseline through 24 months; P < .001 for both measures. The proportion of patients achieving a minimal clinically important difference of 30% improvement from baseline at 24 months was 88.2% (95% CI, 73.4%-95.3%). At 24 months, 24% of patients were taking overall fewer and 15% taking overall more rhinitis medication classes than at baseline. Patients reported a higher quality of life in terms of sleep, well-being, and lower oral medication/nasal spray use at 24 months. There were no serious adverse events considered related to the procedure in the 12-24-month period.ConclusionTemperature-controlled radiofrequency neurolysis results in a significant and durable reduction in the symptom burden of chronic rhinitis and patients reported improved quality of life through 24 months postprocedure.