Effect of Saw Palmetto Soft Gel Capsule on Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Randomized Trial in Shanghai, China
Received 4 May 2007 published online 13 December 2007.
Refers to article:
Mechanisms by Which a Phytotherapeutic Drug Influences Bladder Activity in Rats
, 14 December 2007
Kimio Sugaya, Saori Nishijima, Shinsuke Tasaki, Katsumi Kadekawa, Minoru Miyazato, Yoshihide Ogawa
The Journal of Urology
February 2008 (Vol. 179, Issue 2, Pages 770-774) Abstract |
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Purpose
We determined the effect of Prostataplex™ in men with lower urinary tract symptoms associated with benign prostatic hyperplasia.
Materials and Methods
A 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.
Results
The 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).
Conclusions
Prostataplex may have short-term effects in improving symptoms and objective measures in Chinese men with lower urinary tract symptoms associated with benign prostatic hyperplasia.
aSchool of Public Health, Shanghai, People’s Republic of China
bRen Ji Hospital, Shanghai, People’s Republic of China
cShanghai Jiao Tong University and Za Pu Community Health Service Center of Shanghai, Shanghai, People’s Republic of China
dDepartment of Urology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California
eDepartment of Pathology and Laboratory Medicine, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California
Correspondence: Department of Pathology and Laboratory Medicine, David Geffen School of Medicine, University of California-Los Angeles, 10833 Le Conte Ave., Los Angeles, California 90095 (telephone: 01-310-794-1567).
For another article on a related topic see page 770.
Study received approval from the research ethics committee at each institution.
ABSTRACT