R&D Center for Excellence, Vidya Herbs Pvt. Ltd, #14A, Jigani I phase, Bangalore, Karnataka, 560 105, India.
Leads Clinical Research and Bio services Private Ltd., Bangalore, India.
BMC Urol. 2020 Jul 3;20(1):86. doi: 10.1186/s12894-020-00648-9.
The present clinical trial was conducted to evaluate the efficacy and tolerability of a standardized saw palmetto oil containing 3% β-sitosterol in the treatment of benign prostate hyperplasia (BPH) and androgen deficiency.
Subjects aged 40-65 years with symptomatic BPH were randomized to 12-week double-blind treatment with 500 mg doses of β-sitosterol enriched saw palmetto oil, conventional saw palmetto oil and placebo orally in the form of capsules (n = 33 in each group). BPH severity was determined using the International Prostate Symptom Score (IPSS), uroflowmetry, serum measurement of prostate specific antigen (PSA), testosterone and 5α-reductase. During the trial, the androgen deficiency was evaluated using Aging Male Symptoms (AMS) scale, the Androgen Deficiency in the Aging Male (ADAM) questionnaire, serum levels of free testosterone.
Subjects treated with β-sitosterol enriched saw palmetto oil showed significant decrease in IPSS, AMS and ADAM scores along with reduced postvoiding residual volume (p < 0.001), PSA (p < 0.01) and 5α-reductase from baseline to end of 12-week treatment as compared to placebo. There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo.
This study demonstrates the efficacy of β-sitosterol enriched saw palmetto oil superior to conventional oil thus extending the scope of effective BPH and androgen deficiency treatment with improved quality of life through the intake of functional ingredients.
CTRI/2018/12/016724 dated 19/12/2018 prospectively registered. URL: http://ctri.nic.in/Clinicaltrials/advsearch.php.
本临床试验旨在评估含有 3%β-谷甾醇的标准化锯棕榈油治疗良性前列腺增生（BPH）和雄激素缺乏症的疗效和耐受性。
40-65 岁有症状的 BPH 患者随机分为 12 周双盲治疗组，分别给予 500mg 剂量的β-谷甾醇富集锯棕榈油、常规锯棕榈油和安慰剂胶囊口服（每组 33 例）。BPH 严重程度采用国际前列腺症状评分（IPSS）、尿流率、血清前列腺特异性抗原（PSA）、睾酮和 5α-还原酶测定。试验期间，采用男性衰老症状（AMS）量表、男性衰老雄激素缺乏（ADAM）问卷和游离睾酮血清水平评估雄激素缺乏。
与安慰剂组相比，β-谷甾醇富集锯棕榈油治疗组的 IPSS、AMS 和 ADAM 评分显著降低，排尿后残余尿量减少（p<0.001），PSA（p<0.01）和 5α-还原酶从基线到 12 周治疗结束时也显著降低。与安慰剂组相比，富集锯棕榈油治疗组的最大和平均尿流率也显著增加（p<0.001），血清游离睾酮水平也显著增加。
本研究表明，β-谷甾醇富集锯棕榈油的疗效优于常规油，从而通过摄入功能性成分，扩大了有效治疗 BPH 和雄激素缺乏症的范围，并提高了生活质量。
2018 年 12 月 19 日前瞻性注册 CTRI/2018/12/016724，网址：http://ctri.nic.in/Clinicaltrials/advsearch.php。
