The efficacy and the safety of bromocriptine 7.5 mg daily were investigated in a double-blind versus placebo trial in 32 patients with troublesome symptoms from benign prostatic hypertrophy. Differences between the treatments in respect of uroflowmetry, residual urine and safety parameters were not statistically significant. Differences in respect of nocturia, daytime frequency and overall efficacy were statistically significant in favour of bromocriptine. There could be a place for bromocriptine in the palliative treatment of the functional disability caused by benign prostatic hypertrophy when surgery is refused or contraindicated.
<b><i>Objective</i></b>: To investigate the efficacy of a 6-month fermented soy supplement (equol-containing), measured by prostate-specific antigen (PSA) stabilization or PSA decrease from baseline (PSA modulatory effect) in men with an elevated risk of prostate cancer (PCa), with a WHO performance 0-2 and a follow-up of 12 months. <b><i>Methods</i></b>: The patient population consisted of men with an elevated risk of PCa and a prior negative prostate biopsy within 1 year from starting therapy. Serum PSA values were recorded at inclusion (iPSA), at 6 months (1PSA), and optionally at 12 months (2PSA). Statistical analysis was carried out using the Wilcoxon rank sum test (p < 0.05). <b><i>Results</i></b>: In total, 137 men used fermented soy for any prostatic reason. After inclusion criteria for an elevated risk of PCa and a prior negative prostate biopsy, we selected 58 patients. Among these, there was a significant PSA modulatory effect (iPSA-1PSA, p = 0.003). This modulatory effect was more strongly evident in the subgroup of patients with an elevated iPSA (≥ 4 ng/ml) (n = 33, iPSA-1PSA, p = 0.003, iPSA-2PSA, p = 0.002). <b><i>Conclusions</i></b>: We demonstrated a significant PSA modulatory effect of a 6-month fermented soy supplement in men with an elevated risk of PCa and a prior negative prostate biopsy. This positive effect is currently being investigated in a prospective study. Further evaluation of the role of fermented soy supplements is warranted in a preventive and therapeutic setting of men at an elevated risk of PCa.
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