PD33-12 efficacy and safety of quisqualis indica (HU033) for MEN with lower urinary tract symptom; a multi-center, randomized, double-blind, placebo-controlled clinical trial
Abstract
INTRODUCTION AND OBJECTIVE: Recent study demonstrated pharmacological effects of Quisqualis indica (QI) in testosterone-induced benign prostatic hyperplasia rat model. However, clinical trial of QI on male lower urinary symptoms (LUTS) have not yet been conducted. This study was aimed to investigate the efficacy of QI extract (HU033) for male LUTS. METHODS: The present double-blind study randomized 135 male patients with baseline total International Prostate Symptom Score (IPSS) 8 and 19 to HU033 2g/day, HU033 1g/day, or placebo from 3 medical centers in Korea. The primary endpoint was mean change in total IPSS from baseline to 12 weeks compared to placebo. Additionally mean changes of serum testosterone, dihydrotestosterone (DHT), prostate specific antigen (PSA), maximum flow rate and post void residual volume from baseline to 12 weeks were compared to placebo. RESULTS: Mean changes of total IPSS was significantly improved from baseline to end-point with HU033 2g/day (-3.75 5.07, p<0.01) and HU033 1g/day (-6.70 5.58, p<0.01) versus placebo (0.08 6.79). Post void residual volume was significantly improved with HU033 2g/day compared to placebo (-11.09 30.07ml vs 16.86 67.51ml, p[0.03) There was no statistically significant difference of serum testosterone, DHT, PSA and maximum flow rate compare to placebo and baseline in both treating groups. HU033 was generally well tolerated, with a safety profile similar to that of the placebo. CONCLUSIONS: QI extract improved 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: 135 participants or records.
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