A phase II randomised double-blind placebo-controlled clinical trial investigating the efficacy and safety of ProstateEZE Max: a herbal medicine preparation for the management of symptoms of benign prostatic hypertrophy.

Summary Objective The aim of the clinical trial was to evaluate the efficacy and safety of ProstateEZE Max, an orally dosed herbal preparation containing Cucurbita pepo , Epilobium parviflorum , lycopene, Pygeum africanum and Serenoa repens in the management of symptoms of medically diagnosed benign prostate hypertrophy (BPH). Design This was a short-term phase II randomized double-blind placebo controlled clinical trial. Setting The trial was conducted on 57 otherwise healthy males aged 40–80 years that presented with medically diagnosed BPH. Intervention The trial participants were assigned to receive 3 months of treatment (1 capsule per day) with either the herbal preparation ( n =32) or a matched placebo capsule ( n =25). Outcome measures The primary outcome measure was the international prostate specific score (IPSS) measured at baseline, 1, 2 and 3 months. The secondary outcomes were the specific questions of the IPSS and day-time and night-time urinary frequency. Results There was a significant reduction in IPSS total median score in the active group of 36% as compared to 8% for the placebo group, during the 3-months intervention ( p p p Conclusion The herbal preparation (ProstateEZE Max) was shown to be well tolerated and have a significant positive effect on physical symptoms of BPH when taken over 3 months, a clinically significant outcome in otherwise healthy men.