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

Shi, Rong; Xie, Qiungwen; Gang, X.; Lun, Jing; Cheng, Life; Pantuck, Allan; Rao, Jianyu

doi:10.1016/j.juro.2007.09.032

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Volume 179, Issue 2 , Pages 610-615, February 2008

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

Rong Shi
- School of Public Health, Shanghai, People’s Republic of China
Qiungwen Xie
- School of Public Health, Shanghai, People’s Republic of China
X. Gang
- School of Public Health, Shanghai, People’s Republic of China
Jing Lun
- Ren Ji Hospital, Shanghai, People’s Republic of China
Life Cheng
- Shanghai Jiao Tong University and Za Pu Community Health Service Center of Shanghai, Shanghai, People’s Republic of China
Allan Pantuck
- Department of Urology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California
Jianyu Rao
- Department 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).

Received 4 May 2007 published online 13 December 2007.

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.

Key Words: Serenoa, prostate, prostatic hyperplasia, urination disorders

Abbreviations and Acronyms: BPH, benign prostatic hyperplasia, BUN, blood urea nitrogen, DRE, digital rectal examination, I-PSS, International Prostate Symptom Score, LUTS, lower urinary tract symptoms, MFR, maximum flow rate, RUR, relative urinary resistance

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Study received approval from the research ethics committee at each institution.

Supported by the Journal of Longevity.

PII: S0022-5347(07)02532-3

doi:10.1016/j.juro.2007.09.032

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The Journal of Urology February 2008 (Vol. 179, Issue 2, Pages 770-774)