ArticleResearch and reports in urology2017
Results of a randomized, prospective, double-dummy, double-blind trial to compare efficacy and safety of a herbal combination containing
Article in Research and reports in urology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Current state of research on the clinical benefits of herbal medicines for non-life-threatening ailments.Frontiers in pharmacology · 2023Pooled it
- A 14-Day Double-Blind, Randomized, Controlled Crossover Intervention Study with Anti-Bacterial Benzyl Isothiocyanate from Nasturtium (Nutrients · 2024Trial
- Acute Cystitis Symptom Score questionnaire for measuring patient-reported outcomes in women with acute uncomplicated cystitis: Clinical validation as part of a phase III trial comparing antibiotic and nonantibiotic therapy.Investigative and clinical urology · 2020Trial
- 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 · 2018Trial
- Article
- Management of Acute Cystitis in the Era of COVID-19.Current bladder dysfunction reports · 2023Review
- Contribution of Symptomatic, Herbal Treatment Options to Antibiotic Stewardship and Microbiotic Health.Antibiotics (Basel, Switzerland) · 2022Review
- A systematic review of the outcomes reported in the treatment of uncomplicated urinary tract infection clinical trials.JAC-antimicrobial resistance · 2022Review
- Treatment of Urinary Tract Infections with CanephronAntibiotics (Basel, Switzerland) · 2021Article
- [Uncomplicated urinary tract infections : Use of mustard oils].Der Urologe. Ausg. A · 2021Review
- Floral and Foliar Source Affect the Bee Nest Microbial Community.Microbial ecology · 2019Article
- [Phytotherapy in catheter-associated urinary tract infection : Observational study recording the efficacy and safety of a fixed herbal combination containing Tropaeoli majoris herba and Armoraciae rusticanae radix].Der Urologe. Ausg. A · 2018Observational
- Acute uncomplicated cystitis: is antibiotic unavoidable?Therapeutic advances in urology · 2018Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo demonstrate non-inferiority of an herbal combination (horseradish root and nasturtium herb) to an antibiotic (co-trimoxazole) in acute uncomplicated cystitis.
designRandomized, prospective, double-blind, double-dummy, multicenter, phase III clinical study, using block randomization of 4 blocks (size 2).
settingTwenty-six centers in Germany, from May 2011 to June 2013.
participantsAdult patients (median age, 38.5 years; 90% female) with acute uncomplicated cystitis confirmed via urinalysis and bacterial counts.
interventionsPatients received the herbal combination (five tablets, four times per day) or the antibiotic (two tablets daily) for a period of 7 or 3 days, respectively, followed by a 21-days without drug treatment. Placebos ensured blinding. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was the percentage of responders, expressed as reduction of germ count from >10
resultsOf the 96 randomized patients (intent-to-treat; 45 in the phytotherapy group, 51 in the antibiotic group), 51 were considered per-protocol patients (22 in the phytotherapy group, 29 in the antibiotic group). Responder rates were 10/22 (45.5%) for the phytotherapy group and 15/29 (51.1%) for the antibiotic group (group difference: -6.27% [95% CI: -33.90%-21.3%]). The study was terminated prematurely due to slow recruitment rates. Non-inferiority could not be assumed by predefined criteria. During the follow-up period, one relapse occurred in each group. Both treatments were well tolerated.
conclusionThis clinical trial indicates comparable efficacy of the herbal combination and antibiotic, although non-inferiority was not proved. However, the results and lessons learned are important for the planning of future trials. Issues that led to the premature trial discontinuation were considered.
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Registered trials
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