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Phytomedicines in Acute Rhinosinusitis: A Prospective, Non-interventional Parallel-Group Trial

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Abstract

Introduction

The objective of this prospective, multicenter, parallel-group, non-interventional clinical trial (NIT) was to characterize the effectiveness of a treatment with the phytomedicines ELOM-080 and BNO 1016 in patients with acute rhinosinusitis (ARS).

Methods

A total of 228 patients suffering from ARS took part in this NIT and were treated for a maximum of 14 days with either BNO 1016 or ELOM-080. Focus was on improvement of rhinosinusitis-associated pain/discomfort and nasal congestion in real-life conditions of primary care setting, as assessed by numeric and verbal rating scale, and five-point Likert scale.

Results

The course of the key ARS symptom facial pain demonstrated a faster recovery in patients with ELOM-080, when compared to BNO 1016. ELOM-080 tended to be superior for several ancillary criteria and induced significantly higher patient satisfaction with regard to the improvement of feeling of general illness. Physicians assessed both products to be very effective and well tolerated. Adverse drug reactions classified as gastrointestinal disorders occurred in both groups to a comparable extent.

Conclusion

This trial demonstrated comparable effectiveness of a therapy of ARS with the phytomedicines ELOM-080 and BNO 1016, although the treatment with ELOM-080 resulted in a more rapid and more complete recovery in ARS key symptoms and tended to be superior for several ancillary criteria. Both treatments were well tolerated.

Trial registration number

NIS-6471.

Funding

G. Pohl-Boskamp GmbH & Co. KG.

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Acknowledgements

The authors would like to thank all patients that contributed to this trial and the investigators at the 34 study centers for including patients in compliance with the observation plan of the non-interventional study. The authors also would like to thank the independent contract research organization (CRO) responsible for conducting and reporting the study (SocraTec R&D GmbH, Oberursel, Germany).

Funding

This study and the journal’s article processing charges were supported by a grant from G. Pohl-Boskamp GmbH & Co. KG.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Authors Contribution

SG, ENT specialist, was responsible for overseeing the entire study including the final publication and provided medical and scientific advice for writing the publication manuscript. KR was involved in drafting the manuscript, revising it critically for important intellectual content, ensuring that questions related to accuracy and integrity of the work are resolved. HC provided medical and scientific advice for the publication manuscript.

Disclosures

Kristina Röschmann is employed by G. Pohl-Boskamp GmbH & Co. KG. Stefan Gottschlich and Henning Candler have nothing to disclose.

Compliance with Ethics Guidelines

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

Data Availability

The data sets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

Author information

Authors and Affiliations

  1. HNO-MED-NORD Klinik GmbH & Co. KG, Rendsburg, Germany

    Stefan Gottschlich & Henning Candler

  2. G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany

    Kristina Röschmann

Authors
  1. Stefan Gottschlich
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  3. Henning Candler
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Corresponding author

Correspondence to Kristina Röschmann.

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Gottschlich, S., Röschmann, K. & Candler, H. Phytomedicines in Acute Rhinosinusitis: A Prospective, Non-interventional Parallel-Group Trial. Adv Ther 35, 1023–1034 (2018). https://doi.org/10.1007/s12325-018-0736-7

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  • DOI: https://doi.org/10.1007/s12325-018-0736-7

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