Phytotherapy (BNO 1045) of Acute Lower Uncomplicated Urinary Tract Infection in Women Normalizes Local Host Responses

Abstract

Acute lower uncomplicated urinary tract infection (uUTI) affects a large proportion of women. Increased antimicrobial resistance has created an urgent need for novel therapeutics and the phytotherapeutic drug BNO 1045 (Canephron® N) has previously been shown to be noninferior to standard antimicrobial stewardship. This sub-analysis from a randomized, double-blind, controlled phase III noninferiority clinical trial using BNO 1045 versus fosfomycin to treat uUTI aimed to determine how urine cytokine levels are altered by the two different treatments. Methods. Urine samples from a predefined subset of women diagnosed with uUTI (18–70 years) and treated with BNO 1045 (n=58) or fosfomycin (n=69) were analyzed for urine levels of IL-6 and IL-8, using analyte-to-creatinine ratios. Results. BNO 1045 treatment showed similar effects to fosfomycin treatment in reducing both urine IL-6 and IL-8 levels. Mean IL-6 and IL-8 levels were markedly reduced in all patients regardless of treatment. BNO 1045 treatment decreased urine IL-8 significantly (p=0.0142) and showed a trend toward reduction of urine IL-6 (p=0.0551). Fosfomycin treatment reduced both IL-6 and IL-8 levels significantly (p=0.0038, <0.0001 respectively). Conclusion. BNO 1045 is, in addition to reducing symptoms, comparable to fosfomycin treatment in reducing the local inflammatory response associated with uUTI.