Validation Study of the Pediatric Allergic Rhinitis Quality of Life Questionnaire

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031339 ◽  
Author(s):  
Michael Schaefer ◽  
Paul Enck

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.


2016 ◽  
Vol 2016 ◽  
pp. 1-5
Author(s):  
Jichao Sha ◽  
Cuida Meng ◽  
Lin Li ◽  
Na Cui ◽  
Qian Xiu ◽  
...  

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.


2015 ◽  
Vol 193 (4S) ◽  
Author(s):  
Kristina L. Penniston ◽  
Jodi A. Antonelli ◽  
Timothy D. Averch ◽  
Davis P. Viprakasit ◽  
Roger L. Sur ◽  
...  

2006 ◽  
Vol 15 (1) ◽  
pp. 167-172 ◽  
Author(s):  
Chatchawan Silpakit ◽  
Suwanee Sirilerttrakul ◽  
Manmana Jirajarus ◽  
Thitiya Sirisinha ◽  
Ekaphop Sirachainan ◽  
...  

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