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

alexandrossfakianakis shared this article with you from Inoreader Phytomedicine ELOM‐080 in Acute Viral Rhinosinusitis: A Randomized, Placebo‐Controlled, Blinded Clinical Trial via The Laryngoscope This state-of-the-art DBPC-trial demonstrates significant superiority of herbal phytomedicine treatment in the reduction of Acute Viral Rhinosinusitis symptom severity and earlier improvement of symptoms when compared to placebo. Furthermore, this is the first RCT conducted with a herbal medicinal product that additionally investigated the influence of treatment on the viral load within samples from affected patients. 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 (MSSINV). Secondary endpoints were changes in MSS assessed by the patients (MSSPAT), 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 MSSINV 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, 2022 View on Web

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