EFFECTIVENESS AND SAFETY OF THE «DE ALEX» BIO COMPLEX AS MONOTHERAPY AND IN COMBINATION WITH TAMSULOSIN IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA

Abstract

Introduction . Lower urinary tract symptoms (LUTS) are a common complaint in patients with benign prostatic hyperplasia (BPH), and they significantly affect patients’ quality of life. According to the guidelines of the European Association of Urology on management of LUTS (2016), herbal drug preparations can be used as monotherapy and as a part of combination therapy. Plant extracts with anti-inflammatory, spasmolytic, anti-oedemic, anti-androgenic, estrogenic effect can inhibit prostatic growth, stimulation, proliferation factors, α-adrenoreceptors, 5α-reductase, muscarine acetylcholine receptors. The article describes experience of using the «De Alex» bio complex as monotherapy and in combination with tamsulosin in patients with BPH. The study objective is to evaluate effectiveness and safety of the "De Alex" bio complex as monotherapy and in combination with tamsulosin in patients with BPH. Materials and methods . Clinical and laboratory examinations of 30 patients with BPH were performed. The patients were selected at the stage of primary clinical screening in Moscow city polyclinics (branch No. 1 of the City Polyclinic No. 62 of the Moscow Healthcare Department) and Moscow Region polyclinics (City Polyclinic No. 3 of the Orekhovo-Zuyevo Central City Hospital of the Moscow Region). The study duration was 12 weeks. Results . Based on the obtained data, the "De Alex" bio complex has significant anti-inflammatory, spasmolytic effect, can affect prostate volume, increase urine flow rate and control (which was confirmed by the results of the follow-up examination) and therefore increase patients’ quality of life. Conclusion . The "De Alex" bio complex has shown a high level of safety: during the study, the dietary supplement didn’t cause any side effects. Furthermore, the bio complex didn’t significantly affect the total and free levels of prostate-specific antigen and testosterone. The patients demonstrated high compliancy since "De Alex" has proved to be an effective and safe supplement with fast effect. Considering the above, we can recommend the "De Alex" bio complex at dose 1 tablet 2 times a day for 3 months (1–2 courses a year) as an effective and safe preparation that can be used as monotherapy or in combination with alpha-blockers to manage LUTS.