Planta Med 2013; 79 - PB1
DOI: 10.1055/s-0033-1351946

Non-antibiotic herbal therapy of uncomplicated lower urinary tract infection in women – a pilot study

K Naber 1, H Steindl 2, D Abramov-Sommariva 2, H Eskoetter 2
  • 1Technical University of Munich, Munich, Germany
  • 2Bionorica SE, Neumarkt, Germany

Objectives: Despite of increasing prevalence of bacterial resistance to antibiotics and possible adverse drug reactions (ADRs), uncomplicated lower urinary tract infections (uUTIs) are usually treated with antibiotics. This pilot study had the objective to assess safety and impact of a non-antibiotic therapy with Canephron®N, an herbal medicinal product.

Methods: This open-label, non-randomized, interventional trial was performed in 9 Ukrainian sites. 125 women aged 20 to 65 years suffering from an acute symptomatic episode of uUTI with a sum score of at least 6 for the symptoms dysuria, frequency, urgency (each rated 0 – 4) were enroled. Patients were treated with 3 × 2 tablets Canephron®N for 7 days. Symptom assessment was performed on day 0 (d0), day 7 (d7) and day 37 (d37) by the investigators. The primary endpoint was incidence of ADRs during treatment. Secondary endpoints were clinical responders (all 3 symptoms scored as absent (0) or mild (1)) and symptom severity on d7 and d37, patients requiring antibiotic treatment until d7, duration of uUTI symptoms and patients with recurrence on d37.

Results: None of the reported 19 adverse events (AEs) was considered as drug related (ADR = 0%; no serious AEs). At the end of treatment, 71.2% of patients met the definition of a responder (85.6% at d37). The sum score decreased from 7.3 at d0 to 1.9 (d7) and 0.7 (d37), respectively. The mean values (d0/d7/d37) of the symptoms were: dysuria 2.5/0.6/0.2; frequency 2.7/0.9/0.3; urgency 2.1/0.5/0.2 (all changes from baseline p < 0.001). Three patients (2.4%) required antibiotics between d0 and d7. On average, the time to symptom resolution in days was: 5.1 (frequency), 3.5 (dysuria), 2.9 (urgency). None of the responder had recurrence on d37.

Conclusions: The results of this study substantiate our hypothesis that Canephron®N may be an effective and well tolerated alternative treatment of uUTI, reducing the use of antibiotics. Further controlled clinical trials are considered.