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하부요로 증상을 호소하는 남성에서 Quisqualis indica (HU033)의 효능 및 안전성; 다기관, 무작위 배정, 이중 맹검, 위약 대조 임상 시험
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| ¹고려대학교 구로병원 비뇨의학과, ²가톨릭대학교 서울성모병원² |
| 안순태¹,이현수¹,한다은¹,이동현¹,김종욱¹,배웅진²,박홍석¹,김세웅²,문두건¹ |
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.
Material and 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 2 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.
Conclusion: QI extract improved male LUTS assessing with IPSS, however dose-dependent effect could not be confirmed. |
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keywords : benign prostatic hyperplasia; Quisqualis indica; lower urinary symptoms |
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