Non-Antibiotic Herbal Therapy (BNO 1045) versus Antibiotic Therapy (Fosfomycin Trometamol) for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections in Women: A Double-Blind, Parallel-Group, Randomized, Multicentre, Non-Inferiority Phase III Trial

Urologia Internationalis
Florian M WagenlehnerK G Naber

Abstract

This randomized, controlled, Phase III non-inferiority clinical trial aimed to determine whether herbal therapy with Canephron® N (BNO 1045) is non-inferior to fosfomycin trometamol (FT) in treating acute lower uncomplicated urinary tract infections (uUTIs). Women aged 18-70 years with typical symptoms of newly diagnosed acute lower uUTIs were randomized to BNO 1045 (n = 325) or FT (n = 334), with corresponding matched placebo. The primary endpoint was the proportion of patients who received additional antibiotics (ABs) to treat uUTIs between Days 1 and 38 ±3. Between Days 1 and 38, 238 (83.5%) patients in the BNO 1045 group and 272 (89.8%) patients in the FT group received no additional ABs. At a 15% non-inferiority margin, BNO 1045 was non-inferior to FT in treating uUTIs (non-AB rate difference: -6.26%; 95% CI -11.99 to -0.53%; 2-sided p = 0.0014). Adverse event rates were similar between groups, with higher rates of gastrointestinal disorders in the FT group and pyelonephritis in the BNO 1045 group. During the trial, no patient died or discontinued due to a treatment-related adverse event. BNO 1045 has the potential to reduce outpatient use of ABs for uUTIs and thus may have a significant impact on antimicrobial stewardship...Continue Reading

Citations

Apr 5, 2019·World Journal of Urology·Matthew DixonVladimir Mouraviev
Apr 3, 2020·Der Urologe. Ausg. A·B Ternes, F M E Wagenlehner
Oct 4, 2020·Current Opinion in Urology·Bianca M BareaChris Harding
Dec 5, 2019·Nature Reviews. Urology·Kurt G Naber, Florian M E Wagenlehner
Jul 8, 2020·Antibiotics·Maria LooseFlorian Wagenlehner
Jun 11, 2021·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·Ildikó GágyorJutta Bleidorn
Jun 26, 2021·International Urogynecology Journal·Jakhongir F AlidjanovFlorian M E Wagenlehner
Aug 24, 2021·The Journal of Alternative and Complementary Medicine : Research on Paradigm, Practice, and Policy·Luciano GarofaloDouglas Hanes
Nov 7, 2021·BJU International·Mary ZareFlorian Wagenlehner
Dec 14, 2021·Journal of Global Antimicrobial Resistance·Florian WagenlehnerSeung-Ju Lee

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