Assessment of the tolerability and efficacy of ProstOptima in combination therapy in patients with benign prostatic hyperplasia and mild-to-moderate lower urinary tract symptoms
Abstract
Background. Benign prostatic hyperplasia (BPH) is one of the most common disorders in middle-aged and older men. In the past 10 years, there has been an upward trend in BPH incidence in younger subjects, emphasizing the need for more careful diagnosis by urologists and adequate pharmacotherapy to alleviate the lower urinary tract symptoms (LUTS) and prevent the need for surgical intervention. Recently, combination therapy (α1-blocker and phytotherapeutic agent) has been increasingly used in the management of LUTS due to its positive clinical outcomes and ability to enhance patient quality of life.
Aim. To evaluate the clinical efficacy of the combination of ProstOptima and α1-blocker (tamsulosin) in the treatment of BPH-related mild to moderate LUTS.
Materials and methods. The study included 76 males with BPH and mild-to-moderate LUTS. The patients were randomized into two groups of 38 subjects each. Group 1 (n=38) received standard therapy with tamsulosin 0.4 mg QD for 2 months, Group 2 (n=38) received combination therapy with tamsulosin 0.4 mg QD and ProstOptima 1 capsule QD with food. Therapy was continued for 2 months. Follow-up examinations were performed 1 and 2 months after the start of treatment.
Results. After 2 months of treatment, combination therapy (tamsulosin + ProstOptima) showed a statistically significant superiority over monotherapy, with better trends in key indicators and a more pronounced improvement in the International Prostate Symptom Score (IPSS) and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 38 participants or records.
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