Clinical Effects of Formulated Food of Peucedanum japonicum Extract and Saw Palmetto Extract in Male Patients with Lower Urinary Tract Symptoms.
OBJECTIVE
To evaluate changes over time in subjective symptom scores and urination parameters before and after oral administration of formulated food containing a combination of Peucedanum japonicum (P. japonicum) extract and saw palmetto extract (SPE) in male patients with lower urinary tract symptoms (LUTS).


METHODS
This study was conducted in an open label manner on male patients with untreated LUTS. The urination state of patients was evaluated before and after administration of food formulated with P. japonicum extract and SPE for 4 weeks, based on urodynamic parameters and subjective symptom scores (International Prostate Symptom Score [IPSS and IPSS-QOL], Overactive Bladder Symptom Score [OABSS], Overactive Bladder Questionnaire [OAB-q], and International Index of Erectile Function [IIEF]).


RESULTS
After the administration of food formulated with these extracts, the following results were obtained: (i) Subjective findings: The IPSS-QOL score improved significantly; both parameters related to nocturia, i.e., frequency of nighttime urination and OABSS-2, improved significantly; other ratings for subjective symptoms slightly improved. (ii) Objective findings: Residual urine volume decreased significantly, and blood prostate specific antigen (PSA) and urinary 8-OHdG levels decreased slightly after the treatment. (iii) Other findings: Blood pressure decreased slightly. No adverse drug reactions were reported. (iv) Patient impressions: 75% of patients gave a rating of "Good" or higher, with 15 out of 20 patients wanting to continue treatment after the end of 4-week administration period.


CONCLUSIONS
Food formulated with P. japonicum extract and SPE may be useful to decrease frequency of nighttime urination and residual urine volume in male patients with LUTS.
Kageyama Urology Clinic, Shizuoka, Japan.
Shinji
S
Kageyama
Beppu Nephrology and Urology Clinic, Shizuoka, Japan.
Masanori
M
Beppu
Takara Bio Inc., Shiga, Japan.
Hiromu
H
Ohnogi
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Sayaka
S
Miyazaki
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Akihiro
A
Haruno
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Yoshihiko
Y
Ito
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Shizuo
S
Yamada
D000284:Administration, Oral; D000368:Aged; D019661:Apiaceae; D001794:Blood Pressure / Q000502:physiology; D005526:Food, Formulated; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009929:Organ Size; D017060:Patient Satisfaction; D008517:Phytotherapy / Q000009:adverse effects / Q000379:methods*; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects; D011470:Prostatic Hyperplasia / Q000150:complications / Q000473:pathology; D028024:Serenoa; D016896:Treatment Outcome; D014554:Urination / Q000187:drug effects
D010936:Plant Extracts; C040972:saw palmetto extract
lower urinary tract symptoms; male patients; plant extracts