Clinical Effects of Formulated Food of P eucedanum japonicum Extract and Saw Palmetto Extract in Male Patients with Lower Urinary Tract Symptoms

Objectives To evaluate changes over time in subjective symptom scores and urination parameters before and after oral administration of formulated food containing a combination of P eucedanum 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 ( I nternational P rostate S ymptom S core [ IPSS and IPSS‐QOL ], O veractive B ladder S ymptom S core [ OABSS ], O veractive B ladder Q uestionnaire [ OAB ‐q], and I nternational I ndex of E rectile F unction [ IIEF ]). Results After the administration of food formulated with these extracts, the following results were obtained: (i) S ubjective findings: T he 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: R esidual urine volume decreased significantly, and blood prostate specific antigen ( PSA ) and urinary 8‐ OHdG levels decreased slightly after the treatment. (iii) Other findings: B lood pressure decreased slightly. No adverse drug reactions were reported. (iv) Patient impressions: 75% of patients gave a rating of “ G ood” 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 .