L. Klimek

Leitlinie „Rhinosinusitis“ der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie

H.-P. Zenner, Tübingen P. K. Plinkert, Heidelberg HNO 2007 · 55:758–776 DOI 10.1007/s00106-007-1589-6 Online publiziert: 7. September 2007

Pilot study of mobile phone technology in allergic rhinitis in European countries. The MASK-rhinitis study.

The use of Apps running on smartphones and tablets profoundly affects medicine. The MASK‐rhinitis (MACVIA‐ARIA Sentinel NetworK for allergic rhinitis) App (Allergy Diary) assesses allergic rhinitis symptoms, disease control and impact on patients’ lives. It is freely available in 20 countries (iOS and Android platforms).

Work productivity in rhinitis using cell phones: The MASK pilot study.

Allergic rhinitis often impairs social life and performance. The aim of this cross‐sectional study was to use cell phone data to assess the impact on work productivity of uncontrolled rhinitis assessed by visual analogue scale (VAS). A mobile phone app (Allergy Diary, Google Play Store and Apple App Store) collects data from daily visual analogue scales (VAS) for overall allergic symptoms (VAS‐global measured), nasal (VAS‐nasal), ocular (VAS‐ocular) and asthma symptoms (VAS‐asthma) as well as work (VAS‐work). A combined nasal‐ocular score is calculated. The Allergy Diary is available in 21 countries. The app includes the Work Productivity and Activity Impairment Allergic Specific Questionnaire (WPAI:AS) in six EU countries. All consecutive users who completed the VAS‐work from 1 June to 31 October 2016 were included in the study. A total of 1136 users filled in 5818 days of VAS‐work. Symptoms of allergic rhinitis were controlled (VAS‐global <20) in approximately 60% of the days. In users with uncontrolled rhinitis, approximately 90% had some work impairment and over 50% had severe work impairment (VAS‐work >50). There was a significant correlation between VAS‐global calculated and VAS‐work (Rho=0.83, P<0.00001, Spearmans rank test). In 144 users, there was a significant correlation between VAS‐work and WPAI:AS (Rho=0.53, P<0.0001). This pilot study provides not only proof‐of‐concept data on the work impairment collected with the app but also data on the app itself, especially the distribution of responses for the VAS. This supports the interpretation that persons with rhinitis report both the presence and the absence of symptoms.

A high polymerized grass pollen extract is efficacious and safe in a randomized double-blind, placebo-controlled study using a novel up-dosing cluster-protocol

Cluster immunotherapy represents an interesting alternative to conventional up‐dosing schedules because it allows achieving the maintenance dose within a shorter time interval. In this study, the efficacy and safety of cluster immunotherapy with a high polymerized allergen extract of a grass/rye pollen mixture have been evaluated in a randomized, double‐blind, placebo‐controlled, multicenter study.

Diagnostic test allergens used for in vivo diagnosis of allergic diseases are at risk: a European Perspective.

In the European Union (EU), allergens used for diagnostic tests (TAs) are defined as medicinal products and have to be registered by national authorities. The current situation is not homogeneous. Existing authorizations need to be kept in the market in some EU states, while others need complete new authorizations requiring clinical trials, quality assurance methods, stability studies, and periodic safety update reports. Allergen manufacturers argue that offering a comprehensive panel of TAs may be economically disastrous. Expenses for initiation and maintenance of TA authorizations far exceed their related revenues and manufacturers may be forced to significantly limit their allergen portfolios. The availability of a wide range of high‐quality TAs is very important for in vivo diagnoses of IgE‐mediated allergies. Increased regulatory demands induce costs that need to be covered by public health organizations or reimbursed by health insurance companies.

Millet, a potentially life‐threatening allergen

. APART from medication and insect stings, intolerance to food is one of the main triggers of systemic anaphylaxis. In intolerance to food, crustaceans, ®sh, and peanuts are the most relevant allergens (1±3). The patient presented here was a 51-year-old woman in good health without history of anaphylaxis. After ingestion of a millet dumpling, she immediately developed generalized urticaria, mucosal swelling, shortness of breath, and hypotonic reactions. The millet dumpling consisted of millet, leek, celery, nutmeg, carrot, and coarse wholemeal breadcrumbs. The patient could not remember any consumption of millet before, but had tolerated all the other ingredients without allergic reactions in the past. She mentioned having had a budgerigar some years before. Tolerating the bird itself very well, she complained of asthmatic attacks while cleaning the bird cage. All the ingredients of the millet dumpling were tested with dermal scratch tests with native allergens. Ten healthy subjects were used as the control group for positive skin test reactions. Other cereals were tested with intradermal skin tests with commercial allergens. Speci®c IgE against different kinds of millet and cereals was measured with the CAP System. Speci®c IgE measurements for budgerigar feathers and feces were performed, and skin tests were carried out. The skin scratch test showed strongly positive reactions to millet. All the other ingredients were negative. The scratch test with millet was negative in all the healthy controls. Intradermal testing was positive for rye, oats, maize, and barley. There were no skin test reactions to budgerigar allergens. The results of speci®c IgE measurements showed elevated levels for nearly all the tested cereals, especially millet. The results for budgeridgar allergens were negative or only minimally elevated. Anaphylaxis to millet was ®rst reported in 1981 by Parker et al. (4). Since then, other cases have been reported sporadically (5±8), showing that anaphylaxis to millet is still extremely rare. In the presented case, millet was proven to be the cause of anaphylaxis by positive skin tests and elevated speci®c IgE levels. In view of the life-threatening reaction and the unambiguous ®ndings, a double-blind, placebo-controlled food challenge was not performed. The patients asthmatic reactions while cleaning the bird cage in the past were most likely due to the hypersensitivity to millet-containing birdseed; allergy to the bird itself was excluded by the patients history, IgE measurements, and skin tests. Combined inhalative reactions and systemic anaphylaxis has not been reported in the past. Cross-reactivity to cereals could be demonstrated in the presented case and in all the other published reports by positive skin tests and/or speci®c IgE measurements. Clinically relevant cross-reactivity has never been reported. Millet is a rare nutritive and inhalative allergen, but may induce potentially life-threatening anaphylaxis. The increased use of millet in ``natural diets may increase the incidence of millet-related allergic reactions.

Cyclamen europaeum nasal spray, a novel phytotherapeutic product for the management of acute rhinosinusitis: a randomized double-blind, placebo-controlled trial.

AIMnTo evaluate the efficacy and safety of a phytotherapeutic nasal spray containing Cyclamen europaeum (CE) in the treatment of acute rhinosinusitis (ARS).nnnMATERIAL/METHODSnWe performed a randomized, double-blind, placebo-controlled trial of CE nasal spray once daily for 15 days in 99 adult patients with moderate-to-severe ARS who also received amoxicillin 500 mg three times daily for the first 8 days. The primary endpoint was the change in mean total symptom scores (TSS) on day 7. Secondary endpoints included individual symptom scores (nasal congestion, mucus secretion, facial pain, impairment of smell) and endoscopic findings on days 7 and 15 and others.nnnRESULTSnNo statistically significant difference in TSS was noted for CE versus placebo on day 7. Moreover, the individual scores were not statistically different between the groups for the ITT-population on day 7. However, both a reduction in facial pain and an improvement in endoscopically-assessed mucosal obstruction significantly favoured CE on day 7. The most common adverse events were nasal burning and mild epistaxis, but no severe adverse events were documented.nnnCONCLUSIONnIn summary, this is the first randomized controlled trial on phytotherapy in patients with moderate-to-severe ARS demonstrating clinical safety and some encouraging effects of CE which merit to investigate phytotherapeutic products in further large-scale clinical trials.

Efficacy and safety of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis

IntroductionThis study evaluated the efficacy and safety of mometasone furoate nasal spray (MFNS) in patients with chronic sinusitis.MethodsIn this double-blind, placebocontrolled, multicenter, parallel-group study, 60 patients with persistent sinusitis symptoms were randomized to receive either MFNS 200 μg twice daily or placebo, for 16 weeks (112 days). Eventually, 53 patients terminated the study in regular course.ResultsTotal Symptom Scores (TSS) in patients receiving MFNS changed by a mean of −7.27 (95% CI −9.71, −4.84), versus −5.35 (95% CI −6.73, −3.96) in the placebo group (P=0.51). MFNS reduced nasal congestion and discharge scores, and improved patients’ olfactory function. There were few side effects. Considerably more patients in the MFNS group were satisfied with the treatment than those who had received placebo (P<0.05). Also, more patients would take the medication again in the event of symptoms, compared with those who had taken placebo (P<0.05). Furthermore, the MFNS patients would recommend it to others.ConclusionThe positive patient assessment and few side effects are reflected in the efficacy evaluation performed by the physicians. The endoscopic results under MFNS were always numerically more favorable than those under placebo, and the overall difference reached statistical significance (P<0.01). MFNS offers an effective and safe treatment for chronic rhinosinusitis.

[Rhinosinusitis guidelines of the German Society for Otorhinolaryngology, Head and Neck Surgery].

H.-P. Zenner, Tübingen P. K. Plinkert, Heidelberg HNO 2007 · 55:758–776 DOI 10.1007/s00106-007-1589-6 Online publiziert: 7. September 2007

Aktuelle Aspekte der nasalen Glukokortikosteroidtherapie

Glukokortikosteroide werden seit über 50 Jahren in der Therapie entzündlicher Erkrankungen eingesetzt. Nachdem es 1936 drei verschiedenen Forschergruppen gelang, die Substanz “Compound E” aus Rinder-Nebennieren zu isolieren, wurde diese 1948 erstmals therapeutisch genutzt. P. Hench (Mayo-Clinic, Rochester, USA) injizierte sie seiner später berühmt gewordenen Patientin “Mrs. G.” bei einem schweren Schub einer rheumatoiden Arthritis, wodurch es rasch zu einer erheblichen Besserung des Krankheitsbildes kam. Hierdurch war eine neue Ära der antientzündlichen Therapie eingeleitet. Die klinischen Erfolge waren so beeindruckend, dass die neue Substanz als Wunderdroge bezeichnet wurde und die beteiligten Wissenschaftler bereits 1950 den Medizin-Nobelpreis erhielten. Schon in den frühen 50er Jahren wurden jedoch auch schwere Nebenwirkungen beschrieben, weshalb erste Überlegungen über Möglichkeiten der Dosisreduktion angestellt wurden. Diese führten auch zur Entwicklung lokal applizierbarer Formulierungen. Seit 1973 stehen potente Glukokortikosteroide (GKS) zur nasalen Anwendung zur Verfügung, die Thema des folgenden Beitrags sind.