Placebo-controlled clinical trial of the effectiveness of D-Mannose Supercomplex in the prevention of recurrent UTI.
Authors:   Institute of Urology and Human Reproductive Health, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moskvina Z.V. ,   Moscow, Russia, Boldyreva M.N. ,   State Research Center Institute of Immunology of the Federal Medical and Biological Agency of Russia; Moscow, Russia, Rossolovskaya K.A. ,   Department of Obstetrics and Gynecology No. 1, I.M. Sechenov Institute of Clinical Medicine. N.V. Sklifosovsky Institute of Cardiology of the First Moscow State Medical University named after I.M. Sechenov (Sechenov University); Moscow, Russia, Evdokimov M.S. ,   Family Polyclinic No. 4; Korolev, Russia, Platonova D.V. ,   Clinical Research Department, Clinical Hospital 85, Federal Medical and Biological Agency; Moscow, Russia, Magomedov Ts.G. ,   the Institute of Urology and Human Reproductive Health of the First Moscow State Medical University named after I.M. Sechenov; Moscow, Russia, Spivak L.G. ,   the Institute of Urology and Human Reproductive Health of the Federal State Autonomous Educational Institution of Higher Education «First Moscow State Medical University named after I.M. Sechenov» of the Ministry of Health of the Russian Federation (Sechenov University); Moscow, Russia
Published: November 2024

Introduction. In recent years, the use of D-mannose as an alternative to antimicrobial agents has been widely discussed in the literature due to the fact that when applied topically, it reduces the ability of E. coli to bind to the urothelium. The aim of this study was to evaluate the change in the number of relapses during the observation period in patients who used «D-Mannose Supercomplex» as a metaphylaxis of cystitis in comparison with the control group, which received a placebo instead of this product. Materials and methods. A multicenter, randomized, double-blind, placebo-controlled, prospective clinical study was conducted to evaluate the efficacy and safety of a dietary supplement containing 2000 mg of D-mannose, 100 mg of cranberry extract, 80 mg of bearberry extract (8 mg of arbutin), and 30 mg of magnesium. Results. In animal models, the use of D-mannose led to a significant decrease in the bacterial load. The use of «D-Mannose Supercomplex» prolongs the relapse-free period in patients with RUTI after the end of antibacterial therapy. The duration of the relapse-free period correlates with the duration of D-mannose intake, which is consistent with modern concepts of the mechanism of action of the drug. The drug is well tolerated by patients. The number of adverse events (AE) in the «D-Mannose Supercomplex» and placebo groups was comparable. AE and allergic reactions associated, according to the researchers, with the use of the study drug, were not registered during the administration of the drug. Conclusions. The presented study data indicate that complex drugs containing D-mannose, cranberry extract, bearberry and magnesium (for example, «D-Mannose Supercomplex») can be considered from the standpoint of evidence-based medicine as a promising means of complex etiopathogenetic therapy for prolonging the relapse-free period in patients with exacerbation of recurrent urinary tract infection (RUTI).