Evidence map›Paper›PMID 30231252›Full record

Trial reportUrologia internationalis2018

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.

Florian M Wagenlehner, Dimitri Abramov-Sommariva, Martina Höller, Hubert Steindl, Kurt G Naber

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIEquivalence TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Urologia internationalis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02639520 (A Double-blind, Controlled, Parallel-group, Randomized, Multicenter Clinical Trial to Assess the Efficacy and Safety of a Herbal Drug Containing Centaury, Lovage Root and Rosemary Leaf), which is not on this map. Cited by 54 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 3 pooled it
9.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02639520 phase3completednot on this map

A Double-blind, Controlled, Parallel-group, Randomized, Multicenter Clinical Trial to Assess the Efficacy and Safety of a Herbal Drug Containing Centaury, Lovage Root and Rosemary Leaf (CLR) in Comparison to Fosfomycin Trometamol for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections (uUTIs) in Women

TypeinterventionalSponsorBionorica SERan2015 to 2017Enrolled659ConditionsUrinary Tract InfectionArmsCanephron® N, Fosfomycin trometamol, Canephron® N-placebo, Fosfomycin trometamol-placebo
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 3 syntheses or guidelines pooled it, 129 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Florian M WagenlehnerClinic for Urology, Pediatric Urology and Andrology, Justus-Liebig University, Giessen, Germany.
Dimitri Abramov-SommarivaBionorica SE, Neumarkt, Germany.
Martina HöllerBionorica SE, Neumarkt, Germany.
Hubert SteindlBionorica SE, Neumarkt, Germany.
Kurt G NaberTechnical University of Munich, Straubing, Germany.
Justus-Liebig-Universität Gießen · DETechnical University of Munich · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis 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). MATERIALS AND

methodsWomen 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.

resultsBetween 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.

conclusionsBNO 1045 has the potential to reduce outpatient use of ABs for uUTIs and thus may have a significant impact on antimicrobial stewardship strategies.

trial registrationNCT02639520, EudraCT number 2013-004529-99.

Indexed as

AdolescentAdultAgedAnti-Bacterial AgentsAnti-Infective AgentsDouble-Blind MethodEuropeFemaleFosfomycinHumansInternational CooperationMiddle AgedOutpatientsPhytotherapyPlant ExtractsPlant PreparationsAnti-Bacterial AgentsAnti-Infective Agentscanephron NFosfomycinPlant ExtractsPlant PreparationsTromethamineAntibioticsHerbal treatmentSymptomatic treatmentUrinary tract infection

Identifiers

PMID30231252
PMCPMC6262678
OpenAlexW2891220635

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.