Multicenter open prospective randomized study on the efficacy and safety of Canephron N in preventing recurrences of uncomplicated lower urinary tract infection in women

Introduction. In women, urinary tract infections (UTIs) rank second in morbidity after acute respiratory viral infections. Therefore, issues of non-antibacterial prevention and treatment of UTIs are of great relevance. Particular interest is focused on evaluating the efficacy of the herbal medicinal product Canephron® N in UTI prevention under conditions of rapidly increasing antibiotic resistance among uropathogenic bacterial strains, as well as the growing frequency of microbial associations and multidrug-resistant pathogens.

Aim. To assess and update data on the efficacy and safety of Canephron® N for the prevention of recurrent UTIs in outpatient practice.

Materials and methods. A total of 72 female patients with a clinical diagnosis of acute cystitis or exacerbation of chronic cystitis, for whom empirical antibiotic therapy (ABT) was indicated according to the Russian clinical guidelines, were enrolled in a multicenter, open, prospective, randomized study. Thirty-six patients were assigned to the main group, receiving ABT in combination with Canephron^® N (2 tablets three times daily) followed by prophylactic monotherapy with the herbal product for 1 month. Thirty-one patients, receiving ABT only (contact was lost with 5 patients after randomization, and they were excluded from further analysis), were included in the control group. Treatment efficiency and recurrence rates were evaluated for 12 months after completion of therapy.

Results. The mean age of the patients was 37,4 years: 35,1 years in the main group and 39,7 years in the control group. Acute cystitis was diagnosed in 36 (53,7%) patients, and recurrent cystitis in 31 (46,2%). When Canephron^® N was administered at the onset of the disease together with antibiotic therapy and subsequently for one month, recurrences of uncomplicated lower urinary tract infections (LUTIs) within one year were observed in 13,9% of patients, compared with 38,7% in the control group.

Among patients with acute cystitis, a recurrent episode during the year occurred in 5% of those treated with ABT and Canephron^® N, compared with 31,2% in the group without phytotherapy. In patients with recurrent cystitis, the recurrence rate within one year was 25% in the Canephron^® N group versus 46,7% in the control group.

Discussion. Currently, Canephron^® N is one of the herbal medicinal products with the most convincing evidence base, a high safety profile, and a broad range of therapeutic effects. The components of this phytomedicine are included in the 2024 Russian Ministry of Health Clinical Guidelines «Cystitis in Women» as an agent for both the prevention and treatment of recurrent cystitis. Our study demonstrated that the combination of antibiotic therapy with Canephron^® N reduced the recurrence rate by almost threefold (from 38.7% in the control group to 13.9% in the main group) and prolonged the recurrence-free period in both acute and chronic cystitis in outpatient practice.

Conclusion. Evidence has been obtained supporting the therapeutic efficiency of Canephron^® N in the combination treatment and prevention of recurrent UTIs. A positive trend was observed toward improved treatment outcomes and reduced recurrence rates in real clinical practice among patients with uncomplicated cystitis receiving the herbal product in combination with antibiotic therapy.