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Effects of saw palmetto fruit extract intake on improving urination issues in Japanese men: A randomized, double-blind, parallel-group, placebo-controlled study.

ABSTRACT: The aim of the present study was to investigate the effects of 12-week consumption of saw palmetto fruit extract (320 mg per day) on urination issues. A total of 44 Japanese men aged 40-69 years who experienced urination issues and awaken ?2 times at night to urinate participated in a randomized, double-blind, placebo-controlled study between June and December 2017. All subjects were randomly allocated into a saw palmetto fruit extract group (SP group, n = 22) or a placebo group (P group, n = 22) using a computerized random number generator. Each group took their assigned one capsule every day for 12 weeks. Subjective symptoms and impact on daily life were assessed using the international prostate symptom score (IPSS) as a primary outcome, King's health questionnaire (KHQ), and overactive bladder symptom score. A safety evaluation was also performed. A total of 20 subjects in each group were analyzed. There was a significant group-time interaction for total IPSS. The SP group also showed a significant decrease in IPSS at 8 weeks compared with the P group, suggesting reduced subjective symptoms related to urination issues. We observed no adverse effects. The consumption of saw palmetto fruit extract capsule for 12 weeks relieved subjective symptoms related to urination, which suggests improvement of the issue in healthy Japanese men.

SUBMITTER: Ishii I

PROVIDER: S-EPMC7455929 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Effects of saw palmetto fruit extract intake on improving urination issues in Japanese men: A randomized, double-blind, parallel-group, placebo-controlled study.

Ishii Ikuya I Wada Tatsuya T Takara Tsuyoshi T

Food science & nutrition 20200617 8

The aim of the present study was to investigate the effects of 12-week consumption of saw palmetto fruit extract (320 mg per day) on urination issues. A total of 44 Japanese men aged 40-69 years who experienced urination issues and awaken ≥2 times at night to urinate participated in a randomized, double-blind, placebo-controlled study between June and December 2017. All subjects were randomly allocated into a saw palmetto fruit extract group (SP group, <i>n</i> = 22) or a placebo group (P group, ...[more]

PMID: 32884683

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Project description:ContextSaw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH); however, recent clinical trials have questioned their efficacy, at least at standard doses (320 mg/d).ObjectiveTo determine the effect of saw palmetto extract (Serenoa repens, from saw palmetto berries) at up to 3 times the standard dose on lower urinary tract symptoms attributed to BPH.Design, setting, and participantsA double-blind, multicenter, placebo-controlled randomized trial at 11 North American clinical sites conducted between June 5, 2008, and October 10, 2010, of 369 men aged 45 years or older, with a peak urinary flow rate of at least 4 mL/s, an American Urological Association Symptom Index (AUASI) score of between 8 and 24 at 2 screening visits, and no exclusions.InterventionsOne, 2, and then 3 doses (320 mg/d) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks.Main outcome measuresDifference in AUASI score between baseline and 72 weeks. Secondary outcomes included measures of urinary bother, nocturia, peak uroflow, postvoid residual volume, prostate-specific antigen level, participants' global assessments, and indices of sexual function, continence, sleep quality, and prostatitis symptoms.ResultsBetween baseline and 72 weeks, mean AUASI scores decreased from 14.42 to 12.22 points (-2.20 points; 95% CI, -3.04 to -1.36) [corrected]with saw palmetto extract and from 14.69 to 11.70 points (-2.99 points; 95% CI, -3.81 to -2.17) with placebo. The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo (upper bound of the 1-sided 95% CI most favorable to saw palmetto extract was 1.77 points, 1-sided P = .91). Saw palmetto extract was no more effective than placebo for any secondary outcome. No clearly attributable adverse effects were identified.ConclusionIncreasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo.Trial registrationclinicaltrials.gov Identifier: NCT00603304.

Dataset Information

Effects of saw palmetto fruit extract intake on improving urination issues in Japanese men: A randomized, double-blind, parallel-group, placebo-controlled study.

Publications

Effects of saw palmetto fruit extract intake on improving urination issues in Japanese men: A randomized, double-blind, parallel-group, placebo-controlled study.

Similar Datasets

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