scholarly journals Oral Mucosal Immunotherapy for Allergic Rhinitis: A Pilot Study

2016 ◽  
Vol 7 (1) ◽  
pp. ar.2016.7.0150 ◽  
Author(s):  
William R. Reisacher ◽  
Maria V. Suurna ◽  
Kate Rochlin ◽  
Maria G. Bremberg ◽  
Guy Tropper
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Adverse Events ◽  
Oral Cavity ◽  
Statistical Significance ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Allergenic Extracts ◽  
Sublingual Mucosa

Background The sublingual mucosa has been used for many years to apply allergenic extracts for the purpose of specific immunotherapy (IT). Although sublingual IT (SLIT) is both safe and efficacious, the density of antigen-presenting cells is higher in other regions of the oral cavity and vestibule, which make them a potentially desirable target for IT. Objective To present the concept of oral mucosal IT (OMIT) and to provide pilot data for this extended application of SLIT. Methods An open-label, 12-month, prospective study was undertaken as a preliminary step before a full-scale clinical investigation. Twenty-four individuals with allergic rhinitis received IT by applying allergenic extracts daily to either the oral vestibule plus oral cavity mucosa by using a glycerin-based toothpaste or to the sublingual mucosa by using 50% glycerin liquid drops. Adverse events, adherence rates, total combined scores, rhinoconjunctivitis quality-of-life questionnaire scores, changes in skin reactivity, and changes in serum antibody levels were measured for each participant. Results No severe adverse events occurred in either group. The adherence rate was 80% for the OMIT group and 62% for the SLIT group (p = 0.61). Decreased total combined scores were demonstrated for both the OMIT group (15.6%) and the SLIT group (223%), although this decrease did not reach statistical significance in either group. Both groups achieved a meaningful clinical improvement of at least 0.5 points on rhinoconjunctivitis quality-of-life questionnaire. A statistically significant rise in specific immunoglobulin G4 (IgG4) was seen in both groups over the first 6 months of treatment. Conclusion OMIT and SLIT demonstrated similar safety profiles and adherence rates. Measurements of clinical efficacy improved for both groups, but only changes in IgG4 achieved statistical significance. These pilot data provide enough evidence to proceed with a full-scale investigation to explore the role of OMIT in the long-term management of allergic rhinitis.

scholarly journals Effects of a probiotic treatment (Enterococcus faecalis) and open-label placebo on symptoms of allergic rhinitis: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031339 ◽  
Author(s):  
Michael Schaefer ◽  
Paul Enck
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Study Design ◽  
Controlled Trial ◽  
Life Questionnaire ◽  
Open Label ◽  
Quality Of Life Questionnaire ◽  
Probiotic Treatment ◽  
Randomised Controlled

IntroductionSeveral studies suggest that gut microbiota may play an important role in allergic diseases. The present trial aims to examine effects of the probioticEnterococcus faecalison symptoms of allergic rhinitis in patients. Effects of this probiotic on the immune system have been reported by several studies, but the majority of the previous trials were animal studies. In addition, it is well known that symptoms in allergic rhinitis are prone to exhibit high placebo responses. Moreover, recent studies report that even placebos without deception (open-label placebos) are highly effective in reducing symptoms of allergic rhinitis. Our study design combines both new approaches to assess effects on allergic symptoms in patients. The objective of this study is to compare the effects of a probiotic treatment (E. faecalis) with effects seen by open-label placebo, concealed placebo treatment and no treatment control.Methods and analysisA total of 120 patients with allergic rhinitis will be randomly assigned to one of four different groups: a double-blind probiotic/placebo group (groups 1 and 2), an open-label placebo group (group 3) and a no-treatment group (group 4) to control for spontaneous variation of symptoms. The primary outcome is the evaluation of allergic symptoms using the Combined Symptoms Medication Score. Furthermore, health-related quality of life is examined (Rhinitis Quality of Life Questionnaire). Secondary outcomes include a visual analogue scale on allergic burden and a second quality of life questionnaire. This report describes the study design of the randomised controlled trial.Ethics and disseminationThe study design was approved by the ethical committee of the UKT Department of Psychosomatic Medicine and Psychotherapy, Tübingen, Germany. The trial is registered at the German Clinical Trials Register (www.drks.de, DRKS00015804). The trial results will be published in peer-reviewed journals and at conferences.Trial registration numberGerman Clinical Trials Register (www.drks.de, DRKS00015804); Pre-results.

scholarly journals Correlation of Serumβ-Endorphin and the Quality of Life in Allergic Rhinitis

2016 ◽  
Vol 2016 ◽  
pp. 1-5
Author(s):  
Jichao Sha ◽  
Cuida Meng ◽  
Lin Li ◽  
Na Cui ◽  
Qian Xiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Significant Negative Correlation ◽  
Specific Ige ◽  
Symptom Duration ◽  
Life Questionnaire ◽  
Immunoblot Assay ◽  
Total Ige ◽  
Quality Of Life Questionnaire

Background.Allergic rhinitis (AR) significantly impairs the quality of life of the patients; however, a questionnaire alone is an insufficient and subjective measure of this condition. Obtaining an objective clinical assessment of the level of impairment will be valuable for its treatment.β-Endorphin is one of the most important mediators of both mental state and specific immunity. Thus, we investigated the possibility of usingβ-endorphin as a biomarker for evaluating the impairment level in AR.Methods.This study included 48 patients with AR and 32 healthy volunteers. The serumβ-endorphin level was determined by enzyme immunoassay, and the serum-specific IgE and total IgE levels were determined by immunoblot assay. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used to assess the impairment level in the symptom duration.Results.Theβ-endorphin concentration was significantly decreased in AR patients compared to the healthy controls (p=0.000,p<0.05). There was significant negative correlation between the impairment level and serumβ-endorphin level (correlation coefficient:-0.468;p=0.001;p<0.05), but there was no association between the serumβ-endorphin and total IgE levels (p=0.947,p>0.05).Conclusion.β-Endorphin is a systemic biomarker that has the potential to assess the impairment level in AR and may therefore be a novel therapeutic target for the treatment of AR.

How Accurate Is Clinician Reporting of Chemotherapy Adverse Effects? A Comparison With Patient-Reported Symptoms From the Quality-of-Life Questionnaire C30

2004 ◽  
Vol 22 (17) ◽  
pp. 3485-3490 ◽  
Author(s):  
Erik K. Fromme ◽  
Kristine M. Eilers ◽  
Motomi Mori ◽  
Yi-Ching Hsieh ◽  
Tomasz M. Beer
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Patient Reported

Purpose Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log. Patients and Methods Thirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log. Results Forty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's κ, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms. Conclusion Even in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed.

scholarly journals Survival-Weighted Health Profiles in Patients Treated for Advanced Oral Cavity Squamous Cell Carcinoma

2021 ◽  
Vol 11 ◽  
Author(s):  
Yao-Te Tsai ◽  
Wen-Cheng Chen ◽  
Cheng-Ming Hsu ◽  
Ming-Shao Tsai ◽  
Geng-He Chang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Squamous Cell Carcinoma ◽  
Oral Cavity ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Life Years ◽  
Study Results

ObjectivesFor patients with oral cavity squamous cell carcinoma (OSCC), particularly for those with advanced disease, quality of life (QoL) is a key outcome measure. Therefore, we estimated survival-weighted psychometric scores (SWPS), life expectancy (LE), and quality-adjusted LE (QALE) in patients with advanced OSCC.Methods and MaterialsFor estimation of survival function, we enrolled 2313 patients with advanced OSCC diagnosed between January 1, 2007, and December 31, 2013. The patients were followed until death or December 31, 2014. To acquire the QoL data, data from 194 patients were collected by employing the Taiwan Chinese versions of the Quality of Life Questionnaire Core 30 and Quality of Life Questionnaire Head and Neck 35 developed by the European Organisation for Research and Treatment of Cancer and the EQ-5D-3L between October 1, 2013, and December 31, 2017. The LE of the patients with OSCC were estimated through linear extrapolation of a logit-transformed curve. SWPS and QALE were determined by integrating the LE and corresponding QoL outcomes.ResultsFor the patients with advanced OSCC, the estimated LE and QALE were 8.7 years and 7.7 quality-adjusted life years (QALYs), respectively. The loss of LE and QALE was 19.0 years and 20.0 QALYs, respectively. The estimated lifetime impairments of swallowing, speech, cognitive functioning, physical functioning, social functioning, and emotional functioning were 8.3, 6.5, 6.5, 6.1, 5.7, and 5.4 years, respectively. The estimated lifetime problems regarding mouth opening, teeth, social eating, and social contact were 6.6, 6.1, 7.5, and 6.1 years, respectively. The duration of feeding tube dependency was estimated to be 1.6 years.ConclusionsPatients with advanced OSCC had an estimated LE of 8.7 years and QALE of 7.7 QALYs. SWPS provided useful information regarding how advanced OSCC affects the subjective assessment of QoL. Our study results may serve as a reference for the allocation of cancer treatment resources.

Clinical Effect of Endoscopic Vidian Neurectomy on Bronchial Asthma Outcomes in Patients with Coexisting Refractory Allergic Rhinitis and Asthma

2018 ◽  
Vol 32 (3) ◽  
pp. 139-146 ◽  
Author(s):  
Jingang Ai ◽  
Zuozhong Xie ◽  
Xiang Qing ◽  
Wei Li ◽  
Honghui Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Bronchial Asthma ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Vidian Neurectomy ◽  
Asthma Outcomes ◽  
Group 1

Background The prevalence of both allergic rhinitis and bronchial asthma is high throughout the world; their mutual influence on each other has been documented in many studies. However, studies regarding surgical intervention are limited. Objective To evaluate the clinical significance of endoscopic vidian neurectomy on bronchial asthma outcomes in patients with coexisting refractory allergic rhinitis and asthma. Methods A total of 109 patients with moderate to severe persistent intractable allergic rhinitis and mild/moderate asthma were allocated to the bilateral endoscopic vidian neurectomy group (group 1) or conservative medication group (group 2) according to the patients’ self-selection. The Rhinoconjunctivitis Quality of Life Questionnaire, Visual Analog Scale, Asthma Quality of Life Questionnaire, Total Asthma Symptom Score, and medication scores were evaluated at six months, one year, and three years after undergoing the initial treatments. Multivariate analysis was performed to determine which triggers of asthma attacks were associated with improved asthma outcomes in patients. Results Ninety-five patients were followed up for at least three years. Postoperative scores of Rhinoconjunctivitis Quality of Life Questionnaire and Visual Analog Scale were significantly lower than preoperative scores during follow-up in group 1 and were significantly lower than those of group 2. Postoperative scores of Asthma Quality of Life Questionnaire at the three follow-up time points were higher than the preoperative scores in group 1. The Total Asthma Symptom Score was not significantly decreased in group 1. The medication scores for allergic rhinitis and asthma were gradually reduced after surgery. At the end of the follow-up, the improvement rates for allergic rhinitis and asthma were 90.6% and 45.3%, respectively. Asthma outcomes were significantly improved by controlling rhinitis symptoms in patients whose asthma attacks were induced by “rhinitis onset” or “weather change.” Conclusion Controlling allergic rhinitis symptoms by bilateral endoscopic vidian neurectomy can significantly improve asthma outcomes in patients whose asthma attacks are induced by rhinitis onset and/or cold air.

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