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

• Published in: Advances in therapy 2018-07, Vol.35 (7), p.1023-1034
• Main Authors: Gottschlich, Stefan, Röschmann, Kristina, Candler, Henning
• Format: Article
• Language: English
• Subjects: Acute Disease; Adult; Cardiology; Drug Combinations; Drug Monitoring - methods; Endocrinology; Female; Health technology assessment; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Monoterpenes - administration & dosage; Monoterpenes - adverse effects; NIS; NIS-6471; Oncology; Original Research; Pharmacology/Toxicology; Phytotherapy - methods; Plant Extracts - administration & dosage; Plant Extracts - adverse effects; Prospective Studies; Rheumatology; Rhinitis - diagnosis; Rhinitis - physiopathology; Rhinitis - therapy; Sinusitis - diagnosis; Sinusitis - physiopathology; Sinusitis - therapy; Surveys and Questionnaires; Treatment Outcome
• ISSN: 0741-238X; 1865-8652
• DOI: 10.1007/s12325-018-0736-7

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.