Phytomedicine ELOM-080 in Acute Viral Rhinosinusitis: A Randomized, Placebo-Controlled, Blinded Clinical Trial.

Autor: Pfaar O; Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany., Beule AG; Department of Otolaryngology University Hospital Muenster, Muenster, Germany and Department of Otolaryngology, Head and Neck Cancer, University Clinic Greifswald, Greifswald, Germany., Jobst D; Institute for Pharmacology and Toxicology, University of Bonn, Bonn and University of Witten-Herdecke, Herdecke, Germany., Kraft K; Chair of Naturopathic Medicine, University Medicine Rostock, Rostock, Germany., Stammer H; PHARMALOG Institut für klinische Forschung GmbH, Ismaning, Germany., Röschmann-Doose KIL; G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany., Wittig T; G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany., Stuck BA; Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.
Jazyk: angličtina
Zdroj: The Laryngoscope [Laryngoscope] 2023 Jul; Vol. 133 (7), pp. 1576-1583. Date of Electronic Publication: 2022 Oct 12.
DOI: 10.1002/lary.30418
Abstrakt: Background: ELOM-080 is a phytomedicine approved for the treatment of acute and chronic inflammatory diseases of the respiratory tract, sinusitis, and bronchitis in particular. This prospective, randomized, placebo-controlled, double-blind clinical trial was conducted to assess efficacy and safety of ELOM-080 in the treatment of acute viral rhinosinusitis (AVRS).
Methods: Patients with AVRS received oral treatment (4 × 1 capsule per day) with either ELOM-080 or matching placebo. Primary endpoints were the change in major symptom score (MSS) after 7 and 14 days of treatment assessed by the investigator (MSS INV ). Secondary endpoints were changes in MSS assessed by the patients (MSS PAT ), olfactory function (12-item Sniffin' Sticks), 20-Item Sino-Nasal Outcome Test (SNOT-20 GAV; German adapted version), influence of treatment on viral load, and safety.
Results: Four hundred and sixty-three patients were randomized. At day 4, subjective burden of disease (MSS) was significantly ameliorated compared to placebo (p = 0.012). During the first treatment week MSS scores improved about 1 day earlier, and 3 days earlier in the second week. Effect with ELOM-080 on mean MSS INV was statistically significantly superior to placebo at visit 3 (p = 0.016) and visit 4 (p = 0.014). In chemosensory testing identification scores improved comparably in both treatments. The improvement of the SNOT-20 GAV was more pronounced in ELOM-080 patients. Treatment with ELOM-080 indicated a potential for decreasing viral load. Both treatments were well tolerated.
Conclusion: ELOM-080 improves the burden of AVRS significantly in comparison to placebo, remission of symptoms occurred 3 days earlier. The results confirm the efficacy and safety of ELOM-080 for treatment of AVRS.
Level of Evidence: 1 Laryngoscope, 133:1576-1583, 2023.
(© 2022 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.)
Databáze: MEDLINE
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