Elie Nemr, Elie El Helou, Georges Mjaess, Albert Semaan, Josselin Abi Chebel
{"title":"前瞻性多中心开放标签单臂试验研究南瓜籽、异黄酮和蔓越莓混合物对下尿路症状/良性前列腺增生的影响:一项初步研究","authors":"Elie Nemr, Elie El Helou, Georges Mjaess, Albert Semaan, Josselin Abi Chebel","doi":"10.1155/2020/6325490","DOIUrl":null,"url":null,"abstract":"<p><p>Phytotherapy for lower urinary tract symptoms (LUTSs) due to benign prostate hyperplasia (BPH) is progressively demanded by patients and trusted by physicians. The aim was to assess the efficacy of a mix of pumpkin seed extract, soy germ isoflavonoids, and cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. Male patients aged ≥40 years, who had had mild to moderate LUTS for >6 months at screening, with no previous therapy or who are still symptomatic despite current use of alpha-blockers, were recruited. Exclusion criteria were an IPSS >19 and an age >80 years. The mixed compound was administered orally, daily, for 3 months. Patients were evaluated by means of IPSS, urological quality of life (uQoL) index, and International Index of Erectile Function (IIEF-5) at 3 visits: baseline (visit 1), 30 days (visit 2), and 90 days after treatment (visit 3). Among 163 screened patients, 128 patients (61.8 ± 9.9 years) were recruited. IPSS improved from 15 (Q1 : 12-Q3 : 17) in visit 1, to 11 (Q1 : 8-Q3 : 14) in visit 2, and to 9 (Q1 : 6-Q3 : 12) in visit 3 (<i>p</i> < 0.001). uQoL improved from 4 (3-4) in visit 1, to 3 (2-3) in visit 2, and to 2 (1-2) in visit 3 (<i>p</i> < 0.001). The patients had an IIEF-5 score of 15 (12-18.7) in visit 1, 15 (12-18) in visit 2, and 17 (13-19) in visit 3 (<i>p</i>=0.99 visits 1 vs. 2, <i>p</i>=0.004 visits 2 vs. 3, and <i>p</i>=0.001 visits 1 vs. 3). Treating mild to moderate LUTS/BPH patients with Novex® might therefore relieve symptoms, improve the quality of life, and have a mild beneficial effect on erectile function.</p>","PeriodicalId":7490,"journal":{"name":"Advances in Urology","volume":" ","pages":"6325490"},"PeriodicalIF":1.8000,"publicationDate":"2020-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1155/2020/6325490","citationCount":"3","resultStr":"{\"title\":\"Prospective Multicenter Open-Label One-Arm Trial Investigating a Pumpkin Seed, Isoflavonoids, and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: A Pilot Study.\",\"authors\":\"Elie Nemr, Elie El Helou, Georges Mjaess, Albert Semaan, Josselin Abi Chebel\",\"doi\":\"10.1155/2020/6325490\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Phytotherapy for lower urinary tract symptoms (LUTSs) due to benign prostate hyperplasia (BPH) is progressively demanded by patients and trusted by physicians. The aim was to assess the efficacy of a mix of pumpkin seed extract, soy germ isoflavonoids, and cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. Male patients aged ≥40 years, who had had mild to moderate LUTS for >6 months at screening, with no previous therapy or who are still symptomatic despite current use of alpha-blockers, were recruited. Exclusion criteria were an IPSS >19 and an age >80 years. The mixed compound was administered orally, daily, for 3 months. Patients were evaluated by means of IPSS, urological quality of life (uQoL) index, and International Index of Erectile Function (IIEF-5) at 3 visits: baseline (visit 1), 30 days (visit 2), and 90 days after treatment (visit 3). Among 163 screened patients, 128 patients (61.8 ± 9.9 years) were recruited. IPSS improved from 15 (Q1 : 12-Q3 : 17) in visit 1, to 11 (Q1 : 8-Q3 : 14) in visit 2, and to 9 (Q1 : 6-Q3 : 12) in visit 3 (<i>p</i> < 0.001). uQoL improved from 4 (3-4) in visit 1, to 3 (2-3) in visit 2, and to 2 (1-2) in visit 3 (<i>p</i> < 0.001). The patients had an IIEF-5 score of 15 (12-18.7) in visit 1, 15 (12-18) in visit 2, and 17 (13-19) in visit 3 (<i>p</i>=0.99 visits 1 vs. 2, <i>p</i>=0.004 visits 2 vs. 3, and <i>p</i>=0.001 visits 1 vs. 3). Treating mild to moderate LUTS/BPH patients with Novex® might therefore relieve symptoms, improve the quality of life, and have a mild beneficial effect on erectile function.</p>\",\"PeriodicalId\":7490,\"journal\":{\"name\":\"Advances in Urology\",\"volume\":\" \",\"pages\":\"6325490\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2020-01-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1155/2020/6325490\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Urology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1155/2020/6325490\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2020/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Urology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1155/2020/6325490","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2020/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 3
摘要
由于良性前列腺增生(BPH)引起的下尿路症状(LUTSs)的植物疗法越来越受到患者的要求和医生的信任。目的是评估南瓜籽提取物、大豆胚芽异黄酮和蔓越莓(Novex®)的混合物对BPH患者轻度至中度LUTS的治疗效果。招募年龄≥40岁,筛查时患有轻至中度LUTS >6个月,既往未接受治疗或尽管目前使用α受体阻滞剂仍有症状的男性患者。排除标准为IPSS >19,年龄>80岁。该混合化合物每日口服,持续3个月。通过IPSS、泌尿生活质量指数(uQoL)和国际勃起功能指数(IIEF-5)对患者进行评估,分别在治疗后3次就诊:基线(就诊1)、30天(就诊2)和90天(就诊3)。在163名筛查患者中,招募了128名患者(61.8±9.9岁)。IPSS从访问1的15 (Q1: 12- q3: 17)改善到访问2的11 (Q1: 8-Q3: 14),访问3的9 (Q1: 6-Q3: 12) (p < 0.001)。uQoL从第1次访问时的4(3-4)改善到第2次访问时的3(2-3)和第3次访问时的2 (1-2)(p < 0.001)。患者在第1次就诊时的IIEF-5评分为15(12-18.7),第2次就诊时的IIEF-5评分为15(12-18),第3次就诊时的IIEF-5评分为17 (13-19)(p=0.99 vs. 2, p=0.004 vs. 2, p=0.001 vs. 1)。因此,用Novex®治疗轻中度LUTS/BPH患者可能会缓解症状,改善生活质量,并对勃起功能有轻微的有益影响。
Prospective Multicenter Open-Label One-Arm Trial Investigating a Pumpkin Seed, Isoflavonoids, and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: A Pilot Study.
Phytotherapy for lower urinary tract symptoms (LUTSs) due to benign prostate hyperplasia (BPH) is progressively demanded by patients and trusted by physicians. The aim was to assess the efficacy of a mix of pumpkin seed extract, soy germ isoflavonoids, and cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. Male patients aged ≥40 years, who had had mild to moderate LUTS for >6 months at screening, with no previous therapy or who are still symptomatic despite current use of alpha-blockers, were recruited. Exclusion criteria were an IPSS >19 and an age >80 years. The mixed compound was administered orally, daily, for 3 months. Patients were evaluated by means of IPSS, urological quality of life (uQoL) index, and International Index of Erectile Function (IIEF-5) at 3 visits: baseline (visit 1), 30 days (visit 2), and 90 days after treatment (visit 3). Among 163 screened patients, 128 patients (61.8 ± 9.9 years) were recruited. IPSS improved from 15 (Q1 : 12-Q3 : 17) in visit 1, to 11 (Q1 : 8-Q3 : 14) in visit 2, and to 9 (Q1 : 6-Q3 : 12) in visit 3 (p < 0.001). uQoL improved from 4 (3-4) in visit 1, to 3 (2-3) in visit 2, and to 2 (1-2) in visit 3 (p < 0.001). The patients had an IIEF-5 score of 15 (12-18.7) in visit 1, 15 (12-18) in visit 2, and 17 (13-19) in visit 3 (p=0.99 visits 1 vs. 2, p=0.004 visits 2 vs. 3, and p=0.001 visits 1 vs. 3). Treating mild to moderate LUTS/BPH patients with Novex® might therefore relieve symptoms, improve the quality of life, and have a mild beneficial effect on erectile function.
期刊介绍:
Advances in Urology is a peer-reviewed, open access journal that publishes state-of-the-art reviews and original research papers of wide interest in all fields of urology. The journal strives to provide publication of important manuscripts to the widest possible audience worldwide, without the constraints of expensive, hard-to-access, traditional bound journals. Advances in Urology is designed to improve publication access of both well-established urologic scientists and less well-established writers, by allowing interested scientists worldwide to participate fully.