RESUMEN
OBJECTIVE: To assess the effects and adverse events of preparation Sinulan forte® containing extracts of five medicinal plants in comparison to mometasone furoate nasal spray (MFNS) in therapy of acute postviral rhinosinusitis (APRS). METHODS: We included 46 APRS patients in this prospective investigation and randomized to two groups. The patients in group 1 (n=23) received MFNS 200 µg two times/day for ten days, and patients in group 2 (n=23) received Sinulan forte®, tablets 225 mg per os, two times/day also for ten days. We evaluated the total symptom score (TSS), the separate scores for individual symptoms (nasal congestion, rhinorrhea, postnasal discharge, facial pain, impaired sense of smell), the quality-of-life outcome, and the findings from nasal endoscopy (edema of the nasal mucosa, nasal secretion) prior and after the therapy. RESULTS: Significantly lower absolute post-treatment scores and better relative improvement were identified for TSS, nasal congestion, facial pain, loss of the sense of smell, edema of the mucosa and nasal secretion in patients receiving herbal preparation (group 2). However, lower absolute post-treatment score and better relative improvement were found for rhinorrhea and postnasal drip in group 1. Clinically important differences were found regarding the TSS and endoscopic findings, with no adverse effects in group 2, but in group 1 two patients had mild nasal bleeding and two had sensation of dryness in the nasal mucosa. CONCLUSION: Herbal product Sinulan forte® can be a safe and effective treatment for APRS. Our results suggest no adverse events of this herbal preparation in comparison to intranasal corticosteroid spray therapy.
RESUMEN
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.