Efficacy of Prunella vulgaris on Male Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Abstract
Purpose To evaluate the efficacy and safety of Prunella vulgaris (PV) extract in men with lower urinary tract symptoms (LUTS). Materials and Methods In this 12-week, randomized, double-blind, placebo-controlled clinical trial, 80 men aged 40–75 years with moderate LUTS (International Prostate Symptom Score [IPSS] ≥8 and ≤19) were randomized to receive PV extract (600 mg/day) or placebo. The primary outcome was the change in total IPSS from baseline to week 12. Secondary outcomes included changes in IPSS subscores, quality of life (QoL), uroflowmetry, and prostate volume. Safety was assessed by adverse events and laboratory parameters. Results A total of 75 participants completed the trial (PV group, n=39; placebo group, n=36). At week 12, the PV group showed a significantly greater reduction in total IPSS compared to placebo (-5.2±4.6 vs. -2.8±4.3; p=0.014). Significant improvements were also observed in voiding subscore (-3.3±3.7 vs. -1.6±3.2; p=0.020) and QoL (-1.2±1.4 vs. -0.7±1.3; p=0.044). There were no significant differences in maximum flow rate or prostate volume. The incidence of adverse events was low and similar between groups. Conclusions PV extract improved LUTS and QoL in men with LUTS was well tolerated. These findings suggest its potential as a safe and effective phytotherapeutic option for managing male LUTS.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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