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A Polyphenol-rich South African Geranium Extract Modulates Chemokine Levels in the Nasal Mucosa of Patients with Acute Postviral Rhinosinusitis

Date 10-29-2021
HC# 032126-675
Keywords:
South African Geranium (Pelargonium sidoides, Geraniaceae)
Acute Rhinosinusitis
EPs 7630®

Perić A, Kovačević SV, Barać A, Gaćeša D, Perić AV, Vojvodić D. Effects of Pelargonium sidoides extract on chemokine levels in nasal secretions of patients with non-purulent acute rhinosinusitis. J Drug Assess. November 4, 2020;9(1):145-150. doi: 10.1080/21556660.2020.1838176.

Acute rhinosinusitis (ARS) — otherwise known as the common cold — is in most cases a viral infection that causes inflammation of the nasal and sinus mucosa. This inflammation stimulates the nasal mucosa to produce and release a variety of cytokines and chemokines in the respiratory epithelial cells. In some cases, acute postviral rhinosinusitis (APRS) can precede ARS, prolonging the duration of nasal symptoms. Herbal preparations made from South African geranium (Pelargonium sidoides, Geraniaceae) roots have traditionally been used for treating respiratory and gastrointestinal infections. Recently, investigations have suggested the use of an herbal drug preparation of the polyphenol-rich extract (EPs 7630®; Umckalor®; Dr. Willmar Schwabe GmbH & Co. KG; Karlsruhe, Germany) for treating ARS. The purpose of this observational, prospective, case-control study was to evaluate the effects of EPs 7630 on chemokine production in nasal mucosa and clinical parameters in patients with APRS.

The study was conducted from March 2018 to December 2019. Twenty-six patients with mild-to-moderate APRS and 25 control participants were included in the study. Exclusion criteria were as follows: younger than 18 years or older than 65 years; chronic rhinosinusitis with or without polyps; surgery of the nose or paranasal sinuses within six months of the study; systemic diseases that affect the nasal cavity and sinuses; seasonal allergic rhinitis; nonsteroidal anti-inflammatory drug-exacerbated respiratory disease; sensitivity to South African geranium extract; use of anticoagulants, salicylates, or antibiotics; use of corticosteroids or antihistamines within four weeks of the study; treatment with decongestants, mucolytics, or hypertonic seawater within seven days of the study; pregnancy or lactation; active cigarette smoking; and signs or symptoms of severe acute bacterial rhinosinusitis.

The patients with APRS were treated with 20 mg film coated tablet of EPs 7630 thrice daily for 10 days. Nasal fluid samples were obtained from all participants at the beginning of the study (Visit 1) and again at day 10 (Visit 2). The concentration of 13 chemokines in the nasal secretions were measured using flow cytometry. The primary endpoints were changes in nasal symptoms and endoscopic findings at visit 1 compared with visit 2.

At baseline, Total Symptom Score (TSS) and concentrations of six chemokines (monocyte chemoattractant protein-1 [MCP-1], macrophage inflammatory protein-1 alpha [MIP-1a], macrophage inflammatory protein-1 beta [MIP-1b], macrophage inflammatory protein-3 alpha [MIP-3a], epithelial-neutrophil activating peptide [ENA-78], and interleukin-8 [IL-8]) were significantly higher in APRS patients compared with the control group.

After treatment with EPs 7630, a significant improvement in all symptoms and endoscopic findings were found in APRS patients (P < 0.001). These improvements were greatest for loss of smell (68.9%), facial pain and pressure (67.2%), and nasal obstruction (66.5%), and lowest for postnasal drip (55.5%) and rhinorrhea (52.9%). The main relative improvement in TSS was 62.4%. For endoscopic findings, the greatest improvements were found for decreased mucopurulent secretions (65.5%) and mucosal edema (63.8%). The main relative improvement in TES was 64.5%. The post-treatment concentrations in nasal secretions were significantly increased for three chemokines (MCP-1, interferon-inducible protein 10 [IP-10], MIP-1b), and significantly decreased for four (MIP-1a; ENA-78; growth-regulated oncogene-alpha [GROa], and IL-8). No adverse events were reported during the study.

Based on the authors' knowledge, their study is the first to investigate the effects of EPs 7630 on chemokine production by nasal mucosa. These results suggest EPs 7630 has modulatory effects on the production of chemokines that regulate the function of neutrophils and monocytes at the site of inflammation in patients with APRS. The authors speculate that the observed reduction of neutrophil chemokines by EPs 7630 leads to a lower production of neutrophil proteases, providing protection and stabilization of the respiratory epithelium. Limitations of the study included the lack of placebo-controlled design and polymerase chain reaction (PCR) analysis of nasal and sinus mucosa.

The authors declare no conflicts of interest.

–Gavin Van De Walle, MS, RDN