An extract of ganoderma lucidum in men with lower urinary tract symptoms: A double-blind, placebo-controlled randomized and dose-ranging study

An ethanol extract of Ganoderma lucidum (G. lucidum) which is an edible and medicinal mushroom shows 5 α-reductase inhibitory activity. A double-blind, placebo-controlled randomized and dose-ranging study was conducted to evaluate the safety and efficacy of the extract of G. lucidum in men with lower urinary tract symptoms (LUTS). We enrolled male volunteers (≥50 yr) with an International Prostate Symptom Score (I-PSS; questions 1-7) ≥ 5 and a prostate-specific antigen (PSA) value < 4 ng/ml. Volunteers were randomized into four groups, of placebo (n= 12), and G. lucidum of 0.6 mg (n = 12), 6 mg (n=12) or 60 mg (n=14), administered once daily. Efficacy was measured as a change from baseline in I-PSS and the peak urine flow rate (Q_max). Prostate volume and residual urine were estimated by ultrasonography, and blood tests, including PSA levels, were also measured at baseline and at the end of the treatment. The overall administration was well tolerated, with no major adverse effects. Statistical significances in the magnitude of changes between the experimental groups were observed at week 4 and week 8. No changes were observed with respect to Q_max, residual urine, prostate volume or/and PSA levels. The extract of G. lucidum was well tolerated and an improvement in I-PSS was observed. The recommended dose of the extract of G. lucidum is 6 mg in men with LUTS.