Herbal Drug EPs 7630versusAmoxicillin in Patients with Uncomplicated Acute Bacterial Rhinosinusitis: A Randomized, Open-Label Study

Abstract

Objective: Previous investigations suggest the use of extract from the root of Pelargonium sidoides (EPs 7630) for the therapy of uncomplicated acute upper airway inflammations, due to its strong antimicrobial and immunomodulatory effect. We aimed to compare clinical efficacy, safety and bactericidal effect of EPs 7630 and amoxicillin monotherapy in treatment of patients with mild to moderate acute bacterial rhinosinusitis (ABRS). Methods: Fifty ABRS patients were divided into two groups by randomization. Group 1 (n = 25) received EPs 7630 tablets, 3 × 20 mg/day per os for 10 days. Group 2 (n = 25) received amoxicillin tablets 3 × 500 mg/day per os, for 10 days. We assessed total symptom score (TSS), individual symptom scores for each symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, loss of the sense of smell), endoscopic findings, including total endoscopic score (TES) and individual endoscopic signs (mucosal edema, mucopurulent secretion), before and after treatment. Samples of discharge taken from the middle meatus of all patients were cultivated for bacteria before and after therapy. Results: Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group ( P < .001 for all parameters). However, there were no differences in absolute improvement of rhinorrhea score and postnasal drip score between groups ( P = .248; P = .679, respectively). Fewer types of bacteria grew on culture from middle meatal samples in EPs 7630 group compared to amoxicillin group. There were no reported adverse events from patients from either group. Conclusion: Our results demonstrated better clinical and antimicrobial efficacy of EPs 7630 than amoxicillin. EPs 7630 was shown as a potent agent and good alternative to antibiotic treatment of uncomplicated ABRS.

Evidence-based management of acute rhinosinusitis with herbal products

“…However, there were no significant differences between groups in the absolute improvements of rhinorrhea score and postnasal drip score. No adverse events were reported in either group, and culture analyses found fewer types of bacteria in middle meatal samples from the EPs 7630 group compared with the amoxicillin group [25].…”

“…The efficacy of EPs 7630 for the treatment of uncomplicated acute bacterial rhinosinusitis (ABRS) was recently assessed by Perić et al [25]. In this prospective, open label, non-inferiority study, 50 patients with mild-tomoderate ABRS were randomized 1:1 to receive treatment with EPs 7630 tablets 3 × 20 mg/day or amoxicillin tablets 3 × 500 mg/day, for 10 days.…”

Medicinal Plants and Their Bacterial Microbiota: A Review on Antimicrobial Compounds Production for Plant and Human Health

“…Previous clinical investigations suggest the use of extracts from the root of Pelargonium sidoides for the therapy of uncomplicated acute upper airway inflammations due to its strong antimicrobial and immunomodulatory effect [10]. The therapy with P. sidoides significantly decreases the frequency of patients with positive cultures of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.…”

Review of the experience of using herbal drugs for the treatment of acute rhinosinusitis from the standpoint of evidence-based medicine

“…Оценку эффективности EPs 7630 для лечения неосложненного ОБРС недавно провели А. Perić и соавт. [25]. В этом проспективном открытом исследовании не меньшей эффективности случайным образом распределили 50 пациентов с ОБРС с легкими или умеренными симптомами 1:1 для получения лечения в форме таблеток EPs 7630 3×20 мг в день или таблеток амоксициллина…”

“…Однако не выявлено значительных различий между группами в абсолютном улучшении при оценке ринореи и стекании слизи в носоглотке. Ни в одной из групп не получено сообщений о НЯ, а анализы культур выявили меньшее количество типов бактерий в образцах из средней части носового хода для группы EPs 7630 по сравнению с группой амоксициллина[25].…”