Abstract

The primary objective of this noninterventional, observational study was to assess the effectiveness of the Petasites hybridus leaf extract (Ze 339) on early allergic and late inflammatory symptoms of allergic rhinitis in Swiss outpatients. This study was conducted by general practitioners and allergologists. Data from 226 patients were collected during three documented visits. The intermediate visit was ideally made 2–4 weeks after the baseline visit, followed by the final visit approximately 2–4 months later. The mean study duration was 63 days, with 75% of patients being treated for at least 4 weeks. Of the patients, 58.5% started with Ze 339 monotherapy, and 41.5% received other antiallergic and/or sympathomimetic drugs. In both groups, the allergic total symptom score and the inflammatory total symptom scores were significantly (p < 0.001) reduced, and the scores for quality of life were improved. Both physicians and patients were very satisfied with the treatment and the concept of therapy, not only for short-term (seasonal) therapy but also for long-term therapy. The tolerability was good: only three mild gastrointestinal adverse events occurred. In summary, the effectiveness of P. hybridus leaf extract Ze 339 for the treatment of early allergic and late inflammatory symptoms of allergic rhinitis could be confirmed.

Highlights

  • Allergic rhinitis is an inflammatory disorder of the mucosa in the upper airways with the infiltration of inflammatory cells such as neutrophils, eosinophils, basophils and mast cells [1]

  • It occurs in two subtypes: seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) [2]

  • The results of the present observational study confirmed the clinical effectiveness and safety of Ze 339 in nonselected patients with early allergic and late inflammatory symptoms of AR and revealed new data about the average treatment duration and the preferred dose Ze 339 taken by patients

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Summary

Introduction

Allergic rhinitis is an inflammatory disorder of the mucosa in the upper airways with the infiltration of inflammatory cells such as neutrophils, eosinophils, basophils and mast cells [1]. IgE antibodies bound to high-affinity receptors on the surface of mast cells and basophils in the nasal mucosa [3] This induces degranulation of these cells, resulting in the release of mediators, which are responsible for a cascade of symptoms. The early symptoms of SAR, e.g., sneezing and rhinorrhea, are mainly due to the rapid release of histamine Other mediators, such as prostaglandins, leukotrienes and interleukins, are mainly associated with the late-phase responses, which predominantly cause nasal obstruction (congestion) due to allergic inflammation. The results from controlled clinical efficacy and safety trials have been supported by several postmarketing studies [22] The aim of this noninterventional, observational study was to assess the effectiveness and safety of Ze 339 on early allergic and late inflammatory symptoms of AR under the conditions of daily general practice of Swiss physicians

Results
Actual Treatment of Allergic Symptoms and its Modalities
Treatment-Specific Effectiveness
Effect
Duration of Treatment
Impact on Quality of Life
Effectiveness on Other Allergic and Atopic Symptoms
Tolerability
Discussion
Study Design
Ethics
Study Medication
Exclusion Criteria
Outcome Measures
Statistical Analysis
Conclusions
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