Objective:

2

To compare the efficacy and safety of Yinhua Miyanling Tablets (YMT) versus levofloxacin in the treatment of female patients with uncomplicated urinary tract infections (uUTIs).

Methods:

2

A multicenter

randomized

double-blind

double-dummy

active-controlled

non-inferiority clinical trial was conducted from August 2022 to August 2023 in 9 tertiary hospitals across China. By using a block randomization method

480 female patients with uUTI were randomized in a 1:1 ratio to receive either YMT 2 g

4 times daily for 7 consecutive days (plus levofloxacin-matching placebo) or levofloxacin tablets 0.5 g

once daily for 3 consecutive days (plus YMT-matching placebo). The primary outcome was the proportion of patients requiring additional antimicrobial therapy for uUTIs between day 1 and days 38–42 of treatment

while the secondary outcomes included the Acute Cystitis Symptom Score (ACSS) and urinalysis after 42-d treatment. Safety assessments were conducted based on all adverse events (AEs) and abnormal laboratory test results.

Results:

2

A total of 458 women with uUTIs were enrolled in the modified intention-to-treat analysis. Between day 1 and days 38–42 of treatment

the proportion of patients requiring additional antimicrobial therapy was 20.8% (47/226) in the YMT group and 9.9% (23/232) in the levofloxacin group (

P

<

0.01). The non-inferiority criterion (margin δ = 20%) was met. YMT treatment improved ACSS typical symptoms and quality-of-life scores and urinalysis results compared with levofloxacin

although the differences between groups were not statistically significant (

P

>

0.05). The incidence of treatment-emergent AEs was 7.7% (17/226) in the YMT group and 7.0% (16/232) in the levofloxacin group (

P

=0.775).

Conclusions:

2

YMT is non-inferior to levofloxacin in the proportion of patients requiring additional antimicrobial therapy during treatment of uUTIs in women. YMT treatment is as effective as levofloxacin in terms of improving uUTI symptoms and quality-of-life scores. YMT may be used as a promising adjunctive therapy for uUTIs in women. (Trial registration No. ChiCTR2200066312)