scholarly journals Intralymphatic Immunotherapy: A 3-year Randomized, Double-blind Study in 72 Patients With Allergic Rhinitis Due to Birch and Grass

2020 ◽  
Author(s):  
Lars Ahlbeck ◽  
Emelie Ahlberg ◽  
Janne Björkander ◽  
Caroline Aldén ◽  
Georgia Papapavlou ◽  
...  

Abstract Background: There is need for a fast, efficient, and safe way to induce tolerance in patients with severe allergic rhinitis.Methods: Patients with severe birch and timothy allergy were randomized and received three doses of 0.1 ml of birch and 5-grass allergen extracts (10,000 SQ units/ml, ALK-Abelló), or birch and placebo or 5-grass and placebo by ultrasound-guided injections into inguinal lymph nodes at monthly intervals. We have no clean placebo group but the pollen seasons are mostly divided by time. Rhinoconjunctivitis Total Symptom Score, Medication Score and Rhinoconjunctivitis Quality of Life Questionnaire were evaluated before treatment and after each birch and grass pollen season during three subsequent years. Circulating proportions of T helper subsets and allergen-induced cytokine and chemokine production were analyzed by flow cytometry and Luminex.Results: The three groups reported fewer symptoms, lower use of medication and improved quality of life during the birch and grass pollen seasons each year after treatment at an almost similar rate independently of treatment. Mild local pain was the most common adverse event. IgE levels to birch decreased, whereas birch-induced IL-10 secretion increased in all three groups. IgG4 levels to birch and timothy and skin prick test reactivity remained mainly unchanged. Conjunctival challenge tests with timothy extract showed a higher threshold for allergen. In all three groups, regulatory T cell frequencies were increased three years after treatment.Conclusion: Intralymphatic immunotherapy against grass and birch pollen allergy was safe, seemed to be effective, and to be associated with bystander immune modulatory responses.Trial registration: EudraCT (2013-004726-28). Registered 14 January 2014https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-004726-28

2020 ◽  
Vol 41 (4) ◽  
pp. 271-277
Author(s):  
Andrzej Bozek ◽  
Anna Cudak ◽  
Giorgio Walter Canonica

Background: The effect of prolonged allergen immunotherapy is still insufficiently known, especially in elderly patients. Objective: The effect after a 3-year course of injected allergen-specific immunotherapy (AIT) for grass pollen allergy in elderly patients with allergic rhinitis was observed. Methods: Thirty-eight elderly patients (mean ± standard deviation, 66.2 ± 2.7 years old) who received preseasonal injected AIT or placebo for grass pollen allergy were monitored for 3 years and compared with a placebo group. The combined symptom medication score (CSMS), serum level of immunoglobulin G4 (IgG4) to phleum pratense 5 (Phl p5) and quality of life were assessed immediately after AIT and 3 years later. Results: After AIT, the CSMS was significantly decreased from 2.15 (range, 1.27‐3.00) to 1.13 (range, 0.79‐1.36) (p = 0.03) and remained lower (1.41 ± 0.72 versus 2.41 ± 1.11) than that in the placebo group during the 3 years after AIT. Serum-specific IgG4 against increased during the course of AIT and remained at a high level during further observation. Quality of life, based on the Rhinoconjunctivitis Quality of Life Questionnaire, was significantly decreased in the patients who received AIT from 1.51 (95% confidence interval [CI], 1.21‐1.84) to 1.01 (95% CI, 0.93‐1.87) (p < 0.05) and was decreased to 0.97‐1.26 (95% CI, 0.88‐1.82) during the 3 years after discontinuation of AIT. Conclusion: A prolonged positive effect after AIT for grass pollen allergy was observed in elderly patients with allergic rhinitis. Further trials are needed to confirm this effect.Clinical trial MC56871/12, <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link>.


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. 1-7 ◽  
Author(s):  
Min-Hee Kim ◽  
Jaewoong Son ◽  
Hae Jeong Nam ◽  
Seong-Gyu Ko ◽  
Inhwa Choi

Hyeonggaeyeongyo-tang (HYT) is an ancient formula of oriental medicine traditionally used to treat rhinitis; however, clinical evidence has not yet been established. The aim of this study was to investigate the short-term and long-term efficacy and safety of HYT for chronic rhinitis. Adult subjects with chronic rhinitis symptoms were recruited. The subjects received HYT for 4 weeks and had follow-up period of 8 weeks. Any medicines used to treat nasal symptoms were not permitted during the study. The skin prick test was performed to distinguish the subjects with allergic rhinitis from those with nonallergic rhinitis. After treatment, the total nasal symptoms score and the Rhinoconjunctivitis Quality of Life Questionnaire score significantly improved in the whole subject group, in the allergic rhinitis group, and in the nonallergic rhinitis group, with no adverse events. This improvement lasted during a follow-up period of 8 weeks. Total IgE and eosinophil levels showed no significant difference after treatment in the allergic rhinitis group. HYT improved nasal symptoms and quality of life in patients with allergic rhinitis and nonallergic rhinitis. This is the first clinical study to evaluate the use of HYT to treat patients with rhinitis. This trial has been registered with the ClinicalTrials.gov IdentifierNCT02477293.


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.


Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S25-S32 ◽  
Author(s):  
Albert-Adrien Ramelet

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.


Genes ◽  
2019 ◽  
Vol 10 (11) ◽  
pp. 889 ◽  
Author(s):  
West ◽  
Watts ◽  
Smith ◽  
Zhang ◽  
Besseling-van der Vaart ◽  
...  

Probiotic supplementation for eight weeks with a multi-strain probiotic by individuals with allergic rhinitis (AR) reduced overall symptom severity, the frequency of medication use and improved quality of life. The purported mechanism of action is modulation of the immune system. This analysis examined changes in systemic and mucosal immune gene expression in a subgroup of individuals, classified as either responders or non-responders based on improvement of AR symptoms in response to the probiotic supplement. Based on established criteria of a beneficial change in the mini-rhinoconjunctivitis quality of life questionnaire (mRQLQ), individuals with AR were classified as either responders or non-responders. Systemic and mucosal immune gene expression was assessed using nCounter PanCancer Immune Profiling (Nanostring Technologies, Seattle, WA, USA) kit on blood samples and a nasal lysate. There were 414 immune genes in the blood and 312 immune genes in the mucosal samples expressed above the background threshold. Unsupervised hierarchical clustering of immune genes separated responders from non-responders in blood and mucosal samples at baseline and after supplementation, with key T-cell immune genes differentially expressed between the groups. Striking differences in biological processes and pathways were evident in nasal mucosa but not blood in responders compared to non-responders. These findings support the use of network approaches to understand probiotic-induced changes to the immune system.


2019 ◽  
Vol 160 (6) ◽  
pp. 1118-1123 ◽  
Author(s):  
Grant S. Gillman ◽  
Giuseppe V. Staltari ◽  
Yue-Fang Chang ◽  
Jose L. Mattos

Objective Examine outcomes of septoplasty with turbinate reductions in patients with allergic rhinitis as compared to patients without allergic rhinitis using validated outcome and quality-of-life (QOL) instruments. Study Design Prospective observational cohort study. Setting Single surgeon, university hospital. Subjects and Methods Consecutive study-eligible patients with a symptomatic nasal septal deviation, with (n = 30) or without (n = 30) documented allergic rhinitis, were enrolled from March 2014 to February 2017. All patients subsequently underwent nasal septoplasty and inferior turbinate reductions. Outcomes were studied using the Nasal Obstruction Symptom Evaluation (NOSE) scale, mini–Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ), and Ease-of-Breathing (EOB) Likert scores completed preoperatively and, together with a patient satisfaction Likert, at 3 and 6 months postoperatively. Results NOSE scores, EOB scores, and mini-RQLQ scores improved significantly in both groups at 3 and 6 months postoperatively. Results were sustained from 3 to 6 months. Although mini-RQLQ scores in allergic patients were higher at all intervals, the magnitude of change in scores in both groups was comparable. Conclusion Although patients with allergic rhinitis report greater allergy-related QOL impairment (mini-RQLQ) on a day-to-day basis than nonallergic patients, this does not appear to attenuate the benefit they might experience from septoplasty and turbinate reductions when indicated for nasal obstruction. Furthermore, the symptomatic relief of their structural nasal obstruction appears to significantly improve their overall allergy-related quality of life. If appropriate expectations are set pre-operatively, allergic rhinitis is neither a contraindication nor a deterrent to septoplasty and turbinate reductions and these patients can reasonably expect a high degree of satisfaction post-operatively.


2012 ◽  
Vol 50 (1) ◽  
pp. 33-36
Author(s):  
Antonio Valero ◽  
Rosa Munoz-Cano ◽  
Joaquin Sastre ◽  
Ana M. Navarro ◽  
Enrique Marti-Guadano ◽  
...  

Introduction: Allergic rhinitis (AR) is a common disease with major socieconomic burden and a significant impact on quality of life. Objective: The objective of the study was to assess the impact of AR severity, using the modified ARIA (m-ARIA) severity criterion in order to discriminate among moderate and severe AR, in symptoms and quality of life assessed with the questionnaire ESPRINT-15. Methods: The specific quality of life questionnaire (ESPRINT-15) was applied in over thousand untreated RA patients. Severity was evaluated by the m-ARIA classification, which categorizes AR as mild, moderate, and severe. Nasal symptoms were evaluated by using categorized (none, low, middle, and high) Total Four Symptom Score (T4SS). Results: Using the m-ARIA severity classification, significant differences in quality of life, both global score and specific domains, and categorized T4SS were found among the AR severity groups. Conclusion: Modified ARIA severity classification in mild, moderate, and severe allergic rhinitis clearly discriminates the impact of AR in all domains of quality of life and categorized symptom`s score.


2000 ◽  
Vol 122 (5) ◽  
pp. 681-685
Author(s):  
Jacquelynne P. Corey ◽  
Bryan J. Kemker ◽  
Joseph T. Branca ◽  
Felicia Kuo ◽  
Yuchiao Chang ◽  
...  

Although valid and reliable instruments exist to measure the quality of life of allergic rhinitis patients, a statistically sensitive and clinically meaningful way to evaluate patients undergoing immunotherapy has not been reported. A 21-site prospective, observational study was performed in a population of consecutive patients with allergic rhinitis. Baseline general health measures revealed significant ( P < 0.05) decrements from reported normative levels in 8 domains for patients choosing to undergo immunotherapy and 5 domains for patients choosing not to undergo immunotherapy. The General Health Survey was less sensitive in detecting change than the Nasal Health Survey (Chronic Sinusitis Survey) and allergy-specific (Rhinoconjunctivitis Quality of Life Questionnaire and Allergy Outcome Survey) surveys. Severity of symptoms was associated with both the likelihood to choose immunotherapy and the likelihood for early improvement. We conclude that general and conditionspecific measures can be used to observe patients after immunotherapy; however, obtaining baseline data and controlling for seasonality are important considerations.


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