Evidence map›Paper›PMID 35750460›Full record

ArticleBMJ open2022

Barbara Tóth, András Jávorházy, Péter Nyirády, Boglárka Csupor-Löffler, Péter Birinyi, George Zhanel, Kurt Naber, Reinhard Länger, Nóra Vörhendi, Noémi Gede and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05055544 (BeaRberry in the Treatment of Acute UncoMplIcated Cystitis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 51% 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.

NCT05055544 naunknown statusnot on this map

BeaRberry in the Treatment of Acute UncoMplIcated Cystitis (BRUMI)- Protocol of a Multicentre, Randomized Double-Blind Clinical Trial

TypeinterventionalSponsorUniversity of PecsRan2021 to 2025Enrolled504ConditionsCystitisArmsFosfomycin, Bearberry
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 3 countries.

Barbara Tóth *Department of Pharmacognosy, University of Szeged, Szeged, Hungary.
András Jávorházy *Urology Clinic, Medical School, University of Pécs, Pécs, Hungary.
Péter NyirádyDepartment of Urology, Faculty of Medicine, Semmelweis University, Budapest, Hungary.
Boglárka Csupor-LöfflerInstitute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary.
Péter BirinyiDepartment of Pharmacodynamics, Faculty of Pharmacy, Semmelweis University, Budapest, Hungary.
George ZhanelDepartmental of Medical Microbiology/Infectious Diseases, University of Manitoba, Winnipeg, Manitoba, Canada.
Kurt NaberDepartment of Urology, Technical University of Munich, Munich, Germany.ORCID 0000-0003-1304-5403
Reinhard LängerAustrian Medicines and Medical Devices Agency, Vienna, Austria.
Nóra VörhendiInstitute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary.
Noémi GedeInstitute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary.
Szilárd VáncsaCentre for Translational Medicine, Semmelweis University, Budapest, Hungary.
Péter HegyiInstitute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary.ORCID 0000-0003-0399-7259
Dezső CsuporDepartment of Pharmacognosy, University of Szeged, Szeged, Hungary csupor.dezso@szte.hu.ORCID 0000-0002-4088-3333
Semmelweis University · HUUniversity of Pecs · HUUniversity of Szeged · HUTechnical University of Munich · DEUniversity of Manitoba · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBearberry (

objectiveThe objective of the study is to assess the safety and non-inferiority of bearberry as an alternative therapy in the treatment of acute uncomplicated cystitis in comparison with standard antibiotic therapy (fosfomycin). METHODS AND ANALYSIS: This is a randomised controlled double-blinded multicentre trial. Eligible patients will be premenopausal women with a sum score of ≥6 for the typical acute uncomplicated cystitis symptoms (frequency, urgency, painful urination, incomplete emptying, suprapubic pain and visible haematuria) reported on the Acute Cystitis Symptom Score (ACSS) typical domain and pyuria. Patients will be randomly assigned to receive 3 g single dose of fosfomycin powder and two placebo tablets three times a day for 7 days or B a single dose of placebo powder and two tablets containing a dry extract of Uvae ursi folium. At least 504 patients (allocated as 1:1) will need to be enrolled to access non-inferiority with a non-inferiority limit of 14% for the primary endpoint.Improvement of symptoms of uncomplicated cystitis (based on the ACSS score) at day 7 is defined as the primary endpoint, whereas several secondary endpoints such as the number and ratio of patients with bacteriuria at day 7, frequency and severity of side effects; recurrence of urinary tract infection, concurrent use of other over the counter (OTC) medications and food supplements will be determined to elucidate more detailed differences between the groups. The number of recurrences and medications taken for treatment will be monitored for a follow-up period of 90 days (80-100 days). ETHICS AND DISSEMINATION: This study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/4225-1/2021/EKU). The results will be disseminated by publication of peer-reviewed manuscripts. TRIAL REGISTRATION NUMBER: NCT05055544.

Indexed as

ArctostaphylosCystitisFosfomycinAcute DiseaseAnti-Bacterial AgentsDouble-Blind MethodEquivalence Trials as TopicFemaleHumansMulticenter Studies as TopicPowdersRandomized Controlled Trials as TopicTabletsTreatment OutcomeAnti-Bacterial AgentsFosfomycinPowdersTabletsClinical trialsInterstitial cystitisUrinary tract infections

Identifiers

PMID35750460
PMCPMC9234905
OpenAlexW4283385811

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.