Efficacy of a food supplement Lertal® as an adjuvant therapy of patients with moderate-to-severe seasonal allergic rhinoconjunctivitis

Background Lertal® is an oral food supplement containing 80 mg of dry extract of Perilla frutescens, 150 mg of bioflavonoid quercetin, and 5 μg of vitamin D3. The aim of this study was to evaluate the efficacy of Lertal® as a complementary therapy to topical therapy of patients with moderate-to-severe seasonal allergic rhinoconjunctivitis (SAR). Results Seventy (n=70) adult patients with moderate-to-severe SAR were included in this prospective study and treated by four different procedures: (1) 21 patients received azelastine intranasal spray for 30 days and, after that, azelastine spray and Lertal® tablets for the next 30 days; (2) 19 patients received combined azelastine with fluticasone intranasal spray for 30 days and azelastine with fluticasone spray and Lertal® tablets for the next 30 days; (3) 15 patients received azelastine spray only for 60 days; (4) 15 patients received combined azelastine with fluticasone spray only for 60 days. Levels of SAR symptoms (sneezing, tearing, ocular itching, rhinorrhea, nasal obstruction, hyposmia, and cough), as well as Total Symptom Scores (TSS), were evaluated at the start of this investigation (visit 0), after 30 days of treatment (visit 1), and after 60 days of treatment (visit 2) using a visual analog scale. After 30 days of treatment, better effects were achieved in groups in which patients were treated with combined (antihistamine with corticosteroid) spray. After 60 days of therapy, we found the best effects in procedure 2 and slightly worse effects in procedure 1. The high differences in the reduction of TSS between the 60th and 30th day were found for procedure 2 (p<0.001) and procedure 1 (p<0.001). The worse improvement of symptoms we found was in procedure 4 (p<0.01), and, for the procedure 3, we found no significant difference (p=0.140). None of the patients reported adverse effects during the therapy. Conclusion Our results suggest that addition of food supplement Lertal® to the standard topical therapy of patients with moderate-to-severe SAR increases the effects of intranasal therapy in reducing nasal and ocular symptoms.

Intranasal Influenza Vaccine

Intranasal vaccine is a novel candidate that could improve the current injectable vaccine for the to prevent seasonal influenza epidemics. Influenza intranasal spray vaccine causes a local antibody response.

Efficacy Of Lidocaine And Xylometazoline Intranasal Spray In Anesthetizing Maxillary Teeth: An Open Label Randomized Controlled Trial

BACKGROUND: The most commonly used technique to anesthetize maxillary teeth is the infiltration anesthesia that currently is the gold standard. However, infiltration uses a dental needle that is associated with its de merits also. This led to the discovery of novel methods to anesthetize teeth. We in our study have used lidocaine with xylometazoline in the form of an intranasal spray to achieve local anesthesia of maxillary teeth for restorative procedures. The most commonly used technique to anesthetize maxillary teeth is the infiltration anesthesia that currently is the gold standard. However, infiltration uses a dental needle that is associated with its de merits also. This led to the discovery of novel methods to anesthetize teeth. We in our study have used lidocaine with xylometazoline in the form of an intranasal spray to achieve local anesthesia of maxillary teeth for restorative procedures. A total of 60 patients were enrolled in the study. Thirty patients were randomized each to lidocaine/Xylometazoline or to control local anesthesia group. Group A participants received 4% Lidocaine and 0.1% Xylometazoline solution as intranasal spray while Group B participants received injectable local anesthesia. Local anesthesia was then assessed and reading was taken on the Visual Analog Scale. If the reading was ‘0’ the cavity preparation was performed. If the VAS reading was more than ‘0’ a third dose of intranasal spray anesthesia was delivered. If profound local anesthesia was still not achieved the case was labeled as failure of intranasal spray anesthesia and local anesthesia was achieved by conventional infiltration anesthesia. For Group B participants, local anesthesia was achieved by means of conventional infiltration anesthesia. SPSS v.16 was used to analyze the data with level of significance set at p<0.05. Demographic data were analyzed upon the basis of frequency and percentages. Chi-square test and Fischer exact test were applied to see the difference of efficacy among the two groups and any influence of variables on the efficacy. RESULTS: 21 out of 30 (70%) patients from Group A were anesthetized by intranasal spray anesthesia while all 30 (100%) patients from Group B had successful anesthesia by conventional infiltration. The p value computed is <0.05. No statistically significant effects of age group, gender, tooth location or the number of sprays was observed on the efficacy of intranasal spray anesthesia (p>0.05). There was a statistically significant effect of ICDAS score on the efficacy of intranasal spray anesthesia (p<0.05). CONCLUSION: Lidocaine xylometazoline intranasal spray solution was fairly efficacious in anesthetizing maxillary teeth with smaller carious lesions for restorative procedures in patients with a stable medical history. Intranasal spray solution can be used for patients with needle phobia.TRIAL REGISTRATION: The study is registered on clinical trials website via NCT04732104 on 26/01/2021.

The Quality of Instructional YouTube Videos for the Administration of Intranasal Spray: Observational Study

Background Allergic rhinitis is a common disorder affecting both children and adults. Recommended treatment consists of intranasal corticosteroid spray administration, but only few patients administer the nasal spray in the correct technical manner. A wrong administration technique may result in side effects and affect the efficacy and adherence, thus making accurate administration instructions indispensable. Unfortunately, information about intranasal drug administration is generally not explained accurately, thereby leading to confusion among patients and inaccuracy in the self-administration of drugs. Objective In this study, we analyzed instructional videos available on YouTube for the administration of nasal sprays for allergic rhinitis. Our aim was to determine if the videos provided instructions in accordance with the standardized nationwide patient protocol in the Netherlands for intranasal spray administration. Methods Instructional videos for the administration of aqueous formulations of nasal spray for allergic rhinitis were found on YouTube. All videos were reviewed by 2 researchers and scored using the instructions from the Dutch standardized protocol. Correct instructions were given a score of 1, while incorrect or missing instructions were given a score of 0. The interrater reliability using Cohen ĸ was used to determine the differences in the scores between the researchers. Results We identified 33 YouTube videos made by different health care professionals and pharmaceutical companies around the world. None of the videos displayed all the steps correctly, while 5 of the 33 (15%) videos displayed over 75% of the steps correctly. The median score of the correctly displayed steps was 11 out of 19 (range 2-17, IQR 6). The interrater reliability using Cohen ĸ was statistically significant (range 0.872-1.00, P<.001). The steps “neutral position of the head,” “breathing out through the mouth,” and “periodically cleaning with water” scored the lowest and were incorrectly displayed in 28 (85%), 28 (85%), and 30 (91%) of the 33 videos, respectively. Conclusions The findings of our study revealed that only few instructional videos on YouTube provided correct instructions for the administration of nasal sprays to patients. The inaccuracy of the instructions for nasal spray administration in the majority of the videos may lead to confusion in patients and incorrect use of nasal sprays. In the future, it is important to make evidence-based instructional videos that show patients the correct technique of nasal spray administration. Trial Registration Not applicable

Efficacy and Safety of Surfrin Intranasal Spray, a Natural Phospholipid Spray, in Treating Patients With Acute Rhinitis: a Multicenter, Randomized, Controlled Trial

Background: Phospholipids form a natural defense and self-cleansing system in the nose, and the phospholipids supplemented via nasal sprays might stabilize or restore the impaired “nasal surfactant,” thereby maintaining the natural moisture film, protecting and moisturizing the nasal mucosa, and facilitating mucociliary clearance. Acute rhinitis is a self-limited, prevalent human disease caused by viral infection of the upper respiratory tract and is characterized by nasal dryness, sneezing, nasal congestion and discharge. Acute rhinitis is currently treated by symptom alleviation. This study investigates the efficacy and safety of a natural phospholipid intranasal spray in attenuating the nasal discomfort of patients with acute rhinitis. Methods: In this randomized, positive control, noninferiority trial, 144 patients with acute rhinitis were recruited by otolaryngologists in two Grade 3A public and research hospitals, and randomly allocated to experimental and control groups in a 1:1 ratio to receive a natural phospholipid spray, i.e., Surfrin® Intranasal Spray (Surfrin®), or a physiological sea water nasal spray, i.e., Bright Nose® Physiological Sea Water Nasal Spray (BNNS), respectively. The primary outcome was the effective rate, which was judged by the nasal sign score reduction index. The secondary outcome was changes in the total scores of nasal symptoms (TNSS). Any adverse events (AEs) of the study were recorded.Results: In the final statistical analysis, there were 68 participants in the experimental group and 71 participants in the control group. The effective rates of Surfrin® and BNNS were 98.5% and 91.5%, respectively. The TNSS decreased from 5.75±1.83 to 0.96±1.35 in the experimental group, and from 5.65±1.48 to 1.20±1.38 in the control group. The experimental group had one AE not related to treatment (1.41%), and another occurred in the control group (1.39%) and was probably related to treatment. No serious AEs or adverse reactions occurred.Conclusions: The results of this trial demonstrate the good safety and efficacy of the natural phospholipid Surfrin® Intranasal Spray as an alternative treatment for acute rhinitis. Trial registration: Chinese Clinical Trial Registry, Identifier: ChiCTR1900025655, September 4, 2019, retrospectively registered).

Comparison of Outcomes Between Mometasone Furoate Intranasal Spray and Oral Montelukast in Patients with Allergic Rhinitis

Background: Allergic rhinitis is a common ailment with rising trend and worldwide prevalence of some 400 million. Methods: This prospective randomized crosssectional study was done at the Department of Otorhinolaryngology and Head and Neck Surgery, Tribhuvan University, Teaching Hospital, Kathmandu, Nepal from June 2016 to August 2017. They were randomly assigned to two groups by lottery method. Group A received mometasone furoate intranasal spray and Group B received oral montelukast for a total duration of one month. Prior to starting medication and one month after medications, total nasal symptom score was documented. Statistical analysis was done using SPSS version 18.Results: Total of 126 patients between 16 to 52 years were enrolled in the study. The mean duration of symptoms was 3.93 years. The mean value of serum total IgE was 833.49 IU/ml. The mean pre and post medication score for mometasone furoate intranasal spray group was 16.32 and 5.44 respectively, which was significant. Similarly, the mean pre and post medication score for oral montelukast group was 15.24 and 7.87 respectively which was also found to be significant. Comparing the means of scores for both the groups, mometasone furoate was found to be more effective than oral montelukast.Conclusions: Both mometasone furoate intranasal spray and oral montelukast were effective in the treatment of patient with allergic rhinitis. Oral montelukast can therefore be used as a first line treatment for patients with allergic rhinitis. Keywords: Allergic rhinitis; mometasone furoate intranasal spray; montelukast; serum total IgE; total nasal symptom score.

The Quality of Instructional YouTube Videos for the Administration of Intranasal Spray: Observational Study (Preprint)

BACKGROUND Allergic rhinitis is a common disorder affecting both children and adults. Recommended treatment consists of intranasal corticosteroid spray administration, but only few patients administer the nasal spray in the correct technical manner. A wrong administration technique may result in side effects and affect the efficacy and adherence, thus making accurate administration instructions indispensable. Unfortunately, information about intranasal drug administration is generally not explained accurately, thereby leading to confusion among patients and inaccuracy in the self-administration of drugs. OBJECTIVE In this study, we analyzed instructional videos available on YouTube for the administration of nasal sprays for allergic rhinitis. Our aim was to determine if the videos provided instructions in accordance with the standardized nationwide patient protocol in the Netherlands for intranasal spray administration. METHODS Instructional videos for the administration of aqueous formulations of nasal spray for allergic rhinitis were found on YouTube. All videos were reviewed by 2 researchers and scored using the instructions from the Dutch standardized protocol. Correct instructions were given a score of 1, while incorrect or missing instructions were given a score of 0. The interrater reliability using Cohen ĸ was used to determine the differences in the scores between the researchers. RESULTS We identified 33 YouTube videos made by different health care professionals and pharmaceutical companies around the world. None of the videos displayed all the steps correctly, while 5 of the 33 (15%) videos displayed over 75% of the steps correctly. The median score of the correctly displayed steps was 11 out of 19 (range 2-17, IQR 6). The interrater reliability using Cohen ĸ was statistically significant (range 0.872-1.00, <i>P</i>&lt;.001)<i>.</i> The steps “neutral position of the head,” “breathing out through the mouth,” and “periodically cleaning with water” scored the lowest and were incorrectly displayed in 28 (85%), 28 (85%), and 30 (91%) of the 33 videos, respectively. CONCLUSIONS The findings of our study revealed that only few instructional videos on YouTube provided correct instructions for the administration of nasal sprays to patients. The inaccuracy of the instructions for nasal spray administration in the majority of the videos may lead to confusion in patients and incorrect use of nasal sprays. In the future, it is important to make evidence-based instructional videos that show patients the correct technique of nasal spray administration. CLINICALTRIAL Not applicable