Efficacy and Safety of Yinhua Miyanling Tablets for Uncomplicated Urinary Tract Infections: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Non-inferiority Clinical Trial
Abstract
OBJECTIVE: 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: 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: 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 (P0.05). 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: YMT…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 480 participants or records.
Read the paper
Related studies
- Association of lower urinary tract symptoms and OAB severity with quality of life and mental health in China, Taiwan and South Korea: results from a cross-sectional, population-based study
- Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China
- The Role of the NLR and PLR in Urinary Tract Infection
- Threat of Antimicrobial Resistance among Pilgrims with Infectious Diseases during Hajj: Lessons Learnt from COVID-19 Pandemic
- Leclercia adecarboxylata urinary tract infection in a patient with bladder cancer and recurrent hematuria
- A Case Series of Staphylococcus lugdunensis Infection in Cancer Patients at an Academic Cancer Institute in the United States
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.