臨床研究等提出・公開システム

Clinical research on the influence of saw palmetto fruit extract on urination problems in women

Verification of safety and efficacy of saw palmetto fruit extract on urination problems in women

76

baseline placebo(n=38), active(n=38). age in year 50 - 59 placebo (5), active (5) 60 - 69 placebo (15), active (15) 70 - 79 placebo (16), active (16) 80 years or older placebo (2), active (2)

76 enrolled, 76 randomized, 38 active group, 38 placebo group, 4 discontinued treatment; active group;' 1 (1 protocol deviation), placebo group;' 3 (1 withdrew consent, 2 protocol deviation). Completed by 12th week active group; 37 analysis object, placebo group; 35 analysis object.

One person in the test food group was discontinued on suspicion of dementia because the oral status could not be confirmed 4 weeks after ingestion and the survey could not be answered. One of the two patients in the placebo group started treatment for cystitis 10 weeks after ingestion, and the other started taking diuretics for diabetes 4 weeks after ingestion and was discontinued.

In this study, Difference between the baseline of active group and placebo group and the mean value during the evaluation test after 12 weeks was performed by analysis of covariance (ANCOVA)as efficacy verification. In FAS (Full Analysis Set) and PPS (Per Protocol Set), active group was significantly reduced in question 1 (Daytime frequency) of CLSS scores and OABSS scores than in placebo group. CLSS; FAS (Active group; -0.8+-0.9, Placebo group; -0.4+-0.8, p=0.02) PPS (Active group; -0.8+-0.9, Placebo group; -0.4+-0.8, p=0.04). OABSS; FAS (Active group; -0.4+-0.6, Placebo group; -0.1+-0.7, p=0.04) PPS (Active group; -0.4 +-0.6, Placebo group; -0.1+-0.7, p=0.04). In question 5 (Stress incontinence) of CLSS scores, placebo group was significantly lower than active group. FAS (active group; -0.2+-0. 8, placebo group; -0.4+-0.6, p=0.04) PPS (active group; -0.2+-0.8, placebo group; -0.4+-0.6, p=0.048) The same results as above were shown in one or more strati-point analysis of CLSS question 1 of PPS. (active group; -1.2+-0.6, placebo group; -0.7+-0.7, p=0.003) CLSS. Question 5 showed a significant decrease in the number of urine in the daytime, as well as a significant decrease in the number of urine at night. CLSS1(active group; -1.0+-0.9, placebo group; -0.3+-0.9, p=0.03) CLSS2(active group; -0.7+-0.7, placebo group; -0.3+-0.5, p=0.04)

Saw palmetto fruit extract showed efficacy in improving the number of urine in the daytime for urination problems in women who had little overactive bladder symptoms.

Aug. 01, 2021

No

no description

https://jrct.mhlw.go.jp/latest-detail/jRCTs041200018

Kageyama Shinji

Kageyama Clinic

9-5 Aioicho, Aoi-ku, Shizuoka

kage3309@vmail.plala.or.jp

Yamada Shizuo

Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka

52-1 Yada, Suruga-ku, Shizuoka

+81-54-264-5625

yamada@u-shizuoka-ken.ac.jp

Complete

June. 15, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

1) A woman aged 50 years or older who has had any of urinary frequency, nocturia or urinary urgency for more than 2 months, and is somewhat in trouble
2)The doctor has recognized that medical treatment is unnecessary

1) The subjects who are treating dysuria.
2) The subjects within 2 months from the end of treatment for dysuria.
3) The subjects who do not want to urinate.
4) The subjects who have difficulty urinating.
5) The subjects with lifestyle-related diseases

Female

Overactive bladder

To evaluate the effect of saw palmetto fruit extract on dysuria in women with urination problems.

Core Lower Urinary Tract Symptom Score (CLSS)

Overactive Bladder Symptom Score, Patient Global Impression; PGI, MOS 36-Item Short-Form Health Survey.

+81-53-435-2680

June. 02, 2020

none