Effect of Saw Palmetto Soft Gel Capsule on Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Randomized Trial in Shanghai, China

PurposeWe determined the effect of Prostataplex™ in men with lower urinary tract symptoms associated with benign prostatic hyperplasia.Materials and MethodsA total of 92 Chinese men between 49 and 75 years old with lower urinary tract symptoms were randomly assigned in this double-blind, placebo controlled trial. The 46 patients in the intervention group were given 2 Prostataplex soft gels daily for 12 weeks, while the 46 in the control group were given 2 placebo soft gels for the same time.ResultsThe treated and control groups appeared to have more than a 95% compliance rate, as judged by counting the remaining pills in the bottle collected at the end of trial months 1 to 3. After 12 weeks of intervention the mean ± SD maximum urinary flow rate was significantly higher in the treatment group than in the control group (14.07 ± 2.56 vs 11.74 ± 1.23 ml per second, p <0.001), while relative urinary resistance was significantly lower in the treatment group than in the control group (2.35 ± 0.83 vs 3.02 ± 1.18, p = 0.002). While there was no significant difference in mean prostate volume or International Prostate Symptom Score between the 2 groups, 18 of 46 patients (39.1%) in the treatment group showed an International Prostate Symptom Score improvement (decrease of 3 or greater) after intervention, whereas only 1 of 46 (2.2%) in the control group showed an International Prostate Symptom Score improvement (chi-square test p <0.001).ConclusionsProstataplex may have short-term effects in improving symptoms and objective measures in Chinese men with lower urinary tract symptoms associated with benign prostatic hyperplasia.