Phase I Study of a Methanol Extract of Ganoderma Lucidum, Edible and Medicinal Mushroom, in Men with Mild Symptoms of Bladder Outlet Obstruction

Authors: M. Noguchi, T. Kakuma, K. Tomiyasu, F. Konishi, S. Kumamoto, R. Kondo, K. Matsuoka

Journal: Urology

Study Design:

• Intervention: 0.6 mg, 6 mg, or 60 mg of methanol extract of Ganoderma lucidum or placebo once daily
• Participants: 50 male volunteers (50+ years old) with mild symptoms of bladder outlet obstruction (BOO) and a prostate-specific antigen (PSA) value ≤ 4 ng/ml
• Duration: 8 weeks
• Outcome Measures:
  • International Prostate Symptom Score (I-PSS)
  • Peak urine flow rate (Qmax)
  • Prostate volume and residual urine (estimated by ultrasonography)
  • Blood tests, including PSA levels

Summary: This study investigated the safety and efficacy of a methanol extract of Ganoderma lucidum in men with mild bladder outlet obstruction (BOO) symptoms. The extract was well-tolerated, with no adverse effects reported. The 6 mg and 60 mg doses showed statistically significant reductions in the International Prostate Symptom Score (I-PSS) compared to the placebo, indicating an improvement in BOO symptoms. However, there were no significant changes in peak urine flow rate, residual urine, prostate volume, or PSA levels. The study concludes that the extract is safe and the recommended dose for further studies is 6 mg.