Influence of a Specialized Trigonella foenum‐graecum Seed Extract (Libifem), on Testosterone,Estradiol and Sexual Function in Healthy Menstruating Women,a Randomised Placebo Controlled Study

The aim of the study was to evaluate the effect of Trigonella foenum‐graecum (fenugreek) seed extract on sex hormones and sexual function in healthy menstruating women who reported low sexual drive. This short term, single site, double blind, randomised, placebo‐controlled study was conducted on 80 women, aged 20 to 49 years. Participants were randomised to either an oral dose of a standardised T. foenum‐graecum seed extract (libifem) at a dose of 600 mg/day or placebo over two menstrual cycles. Dehydroepiandrosterone sulfate, progesterone, androstenedione, total and free testosterone, estradiol (E2), luteinizing hormone, follicle stimulating hormone, sex hormone binding globulin and cholesterol were measured at baseline and 8 weeks. The individual aspects of sexual function were measured using the Derogatis interview for sexual functioning and female sexual function index self‐administered questionnaires. Stress, fatigue and quality of the relationship with partner were also measured using the PSS (Perceived Stress Scale), MFI‐20 (Multidimensional Fatigue Inventory) and DAS (Dyadic Adjustment Scale) quality of life measures, respectively. There was a significant increase in free testosterone and E2 in the active group as well as sexual desire and arousal compared with the placebo group. The results indicate that this extract of T. foenum‐graecum may be a useful treatment for increasing sexual arousal and desire in women. Copyright © 2015 John Wiley & Sons, Ltd.     

锯叶棕果实提取物对伴有下尿路症状的BPH一期治疗的有效性和安全性分析

目的探讨锯叶棕果实提取物对伴有下尿路症状（LUTS）的BPH一期治疗（12周）的有效性和安全性。方法采用开放性治疗前后对比方法,选择伴有下尿路症状的BPH门诊患者52例,进行12周开放性研究,患者餐后口服锯叶棕果实提取物软胶囊（商品名：沙芭特160mg每天两次）;分别比较患者治疗前后的主要指标：前列腺症状评分（IPSS）、最大尿流率（Qmax）;次要指标：生活质量评分（QOL）、夜尿次数、前列腺体积、剩余尿量等的变化情况以及不良反应的发生率,并进行统计学分析。结果治疗12周后,患者的IPSS评分、QOL评分、最大尿流率、夜尿次数及剩余尿量较治疗前均有明显改善,前列腺体积则无明显变化且患者均未诉明显不良反应。结论锯叶棕果实提取物可有效地改善BPH患者出现的下尿路症状（LUTS）,且安全性高。     

Efficacy of a Proprietary Trigonella foenum‐graecum L. De‐Husked Seed Extract in Reducing Menopausal Symptoms in Otherwise Healthy Women: A Double‐Blind,Randomized, Placebo‐Controlled Study

Trigonella foenum‐graecum seed extract has demonstrated hormone modulatory activity, providing biological plausibility for relieving menopausal symptoms. The study aimed to assess efficacy of a standardized T. foenum‐graecum de‐husked seed extract in reducing menopausal symptoms in healthy aging women. The study was a double‐blind, randomized, placebo‐controlled trial that recruited 115 women aged 40 to 65 years of which 59 were allocated to active (n = 54 completed) and 56 to placebo (n = 50 completed). Active treatment was T. foenum‐graecum de‐husked seed extract, 600 mg per day for 12 weeks. Outcome measures included Menopause‐Specific Quality of Life (MENQOL) questionnaire, frequency of hot flushes and night sweats and serum estradiol levels. There was a significant reduction in menopausal symptoms in the active group compared with placebo as assessed by total MENQOL score (p < 0.001); reflected by significant improvements in the vasomotor (p < 0.001), psychosocial (p < 0.001), physical (p < 0.001) and sexual symptoms (p < 0.001) domains. Vasomotor outcomes correlated with hot flushes, the active group reporting significantly less daytime hot flushes and night sweats at 12 weeks (p < 0.001). The average estradiol levels were similar in both the active group and placebo group after treatment. This study demonstrated that this proprietary T. foenum‐graecum de‐husked seed extract may reduce menopausal symptoms in healthy women. Copyright © 2017 John Wiley & Sons, Ltd.     

前列腺增生症中医证型与IPSS、PSA、Qmax的相关性研究

目的评价前列腺增生症(BPH)常见3种中医证型与国际前列腺症状评分(IPSS)、最大尿流率(Qmax)、前列腺特异抗原(PSA)的相关性。方法 130例年龄50~85岁BPH患者,根据《中药新药临床研究指导原则评分标准》BPH常见3种中医证型(本研究特定为肾气亏虚证、血瘀下焦证、膀胱湿热证3种证型),并对患者的证型与IPSS、Qmax、PSA之间进行相关性分析。结果肾气亏虚证、血瘀下焦证、膀胱湿热证3种BPH中医证型与IPSS评分密切相关,BPH常见3种中医证型与Qmax、PSA无相关性。结论 BPH常见3种中医证型与IPSS评分存在一定的相关性。     

Physiological Aspects of Male Libido Enhanced by Standardized Trigonella foenum‐graecum Extract and Mineral Formulation

The aim of the clinical study was to evaluate the effect of Testofen, a standardized Trigonella foenum‐graecum (Fenugreek) extract and mineral formulation, on male libido (sexual drive, urge or desire) in a double blind randomized placebo controlled study. The study recruited 60 healthy males aged between 25 and 52, without erectile dysfunction and randomized to an oral dose (two tablets per day) of the active treatment (600 mg Testofen per day) or placebo for 6 weeks. The primary outcome measure was the DISF‐SR (male) self‐administered QOL total score and the four domain scores. The secondary outcome was specific quality of life parameters. Testofen had an overall positive effect on physiological aspects of libido. In particular, there was a significant increase in the subdomains of sexual arousal and orgasm. Testofen had a positive effect on QOL in self‐reported satisfaction with muscle strength, energy and well‐being but did not have an effect on mood or sleep. Serum prolactin and testosterone levels remained within the reference range. It was concluded that Testofen demonstrated a significant positive effect on physiological aspects of libido and may assist to maintain normal healthy testosterone levels. Copyright © 2011 John Wiley & Sons, Ltd.     

A Novel Extract of Fenugreek Husk (FenuSMART™) Alleviates Postmenopausal Symptoms and Helps to Establish the Hormonal Balance: A Randomized,Double‐Blind,Placebo‐Controlled Study

Despite the widespread use of hormone replacement therapy, various reports on its side effects have generated an increasing interest in the development of safe natural agents for the management of postmenopausal discomforts. The present randomized, double‐blinded, placebo‐controlled study investigated the effect of 90‐day supplementation of a standardized extract of fenugreek (Trigonella foenum‐graecum) (FenuSMART?), at a dose of 1000 mg/day, on plasma estrogens and postmenopausal discomforts. Eighty‐eight women having moderate to severe postmenopausal discomforts and poor quality of life (as evidenced from the scores of Greene Climacteric Scale, short form SF‐36® and structured medical interview) were randomized either to extract‐treated (n = 44) or placebo (n = 44) groups. There was a significant (p < 0.01) increase in plasma estradiol (120%) and improvements on various postmenopausal discomforts and quality of life of the participants in the extract‐treated group, as compared with the baseline and placebo. While 32% of the subjects in the extract group reported no hot flashes after supplementation, the others had a reduction to one to two times per day from the baseline stages of three to five times a day. Further analysis of haematological and biochemical parameters revealed the safety of the extract and its plausible role in the management of lipid profile among menopausal women. Copyright © 2016 John Wiley & Sons, Ltd.     

Improving BPH symptoms and sexual dysfunctions with a saw palmetto preparation? Results from a pilot trial

In elderly men, benign prostatic hyperplasia (BPH) is a major risk factor for sexual dysfunctions (SDys). Additionally, the standard treatments for BPH symptoms, alpha blockers and 5‐alpha‐reductase inhibitors, cause SDys themselves. Preparations from saw palmetto berries are an efficacious and well‐tolerated symptomatic treatment for mild to moderate BPH and have traditionally been used to treat SDys. We conducted an open multicentric clinical pilot trial to investigate whether the saw palmetto berry preparation Prostasan® influenced BPH symptoms and SDys. Eighty‐two patients participated in the 8‐week trial, taking one capsule of 320 mg saw palmetto extract daily. At the end of the treatment, the International Prostate Symptom Score was reduced from 14.4 ± 4.7 to 6.9 ± 5.2 (p < 0.0001); SDys measured with the brief Sexual Function Inventory improved from 22.4 ± 7.2 to 31.4 ± 9.2 (p < 0.0001), and the Urolife BPH QoL‐9 sex total improved from 137.3 ± 47.9 to 195.0 ± 56.3 (p < 0.0001). Investigators' and patients' assessments confirmed the good efficacy, and treatment was very well tolerated and accepted by the patients. Correlation analyses confirmed the relationship between improved BPH symptoms and reduced SDys. This was the first trial with saw palmetto to show improvement in BPH symptoms and SDys as well. [Corrections made here after initial online publication.] Copyright © 2012 John Wiley & Sons, Ltd.     

Efficacy and Safety of Standardized Extract of Trigonella foenum‐graecum L Seeds as an Adjuvant to L‐Dopa in the Management of Patients with Parkinson's Disease

The objective of this study is to evaluate disease modifying efficacy and safety of a standardized extract of Trigonella foenum‐graecum L, Fenugreek (IBHB) (family Fabaceae) as a nutritional adjuvant to Levo‐dopa (L‐Dopa) in Parkinson's disease (PD) patients. We conducted double‐blind placebo‐controlled proof of concept clinical study of IBHB capsules (300 mg, twice daily) with matching placebo for 6 months of period in 50 patients of PD stabilized on L‐Dopa therapy. The efficacy outcome measures were the scores of Unified Parkinson's Disease Rating Scale (UPDRS ‐ total and its subsections), and Hoehn and Yahr (H&Y) staging at baseline and end of 6‐months treatment duration. Safety evaluation included haematology, biochemistry, urinalysis parameters and adverse event monitoring. Total UPDRS scores in IBHB treatment (0.098%) showed slower rise as opposed to steep rise (13.36%) shown by placebo. Further, Clinically Important Difference for total UPDRS scores and scores of motor subsection of UPDRS was found to be 5.3 and 4.8, respectively, in favour of IBHB treatment. Similar improvement was shown by IBHB in terms of H&Y staging as compared with placebo. IBHB was found to have excellent safety and tolerability profile. In conclusion, IBHB can be useful adjuvant treatment with L‐Dopa in management of PD patients. Copyright © 2013 John Wiley & Sons, Ltd.     

双极与单极经尿道切除前列腺对小便和勃起功能的影响

目的评估双极性与传统的单极经尿道前列腺电切除术(TURP)对排尿和勃起功能的影响。方法 160例良性前列腺增生症(BPH)患者被随机分为双极或单极TURP治疗2组,评价2组术后早期变量均在手术后1,3,6个月和12个月使用国际前列腺症状评分(IPSS)、尿流率、排尿后残余尿尿量(PVR)和国际勃起功能指数(IIEF-5)变化。结果双极组手术时间缩短,术后出血和输血的要求2组比较没有显著性差异。单极组比双极组钠含量显著降低。2组患者经尿道切除综合征相似,IPSS值与最大尿流率值显著改善,PVR无改善;122例术前非插管患者IIEF-5评分均明显改善。结论与传统的单极TURP比较,双极TURP是一种安全、有效的手术方法,可显著缩短手术时间,血清钠水平下降减少。     

通癃启闭汤治疗良性前列腺增生的临床研究

目的:观察通癃启闭汤治疗良性前列腺增生(BPH)的临床疗效和安全性。方法:将82例BPH患者随机分为治疗组与对照组,治疗组(41例)口服通癃启闭汤,对照组(41例)口服前列舒乐颗粒。观察治疗前后患者的中医症状评分、国际前列腺症状评分(IPSS)、生活质量评分(QOL)、最大尿流率(Qm ax)、膀胱残余尿量(PRV)、前列腺体积(PV)及血清前列腺特异性抗原(PSA)的变化,并对出现的不良反应进行记录。结果:治疗组总有效率为90.2%,对照组为70.7%,差异有显著性(P<0.05);且治疗组在改善中医症状、减轻患者的IPSS、改善QOL、提高Qm ax和减少PRV等方面,疗效均明显优于对照组(均P<0.05);治疗组PV和血清PSA下降幅度大于对照组,但无显著统计学意义(P>0.05)。结论:通癃启闭汤治疗BPH可以显著改善患者主观症状及客观指标,且安全、有效。     

Eviprostat suppresses urinary oxidative stress in a rabbit model of partial bladder outlet obstruction and in patients with benign prostatic hyperplasia

Eviprostat is a phytotherapeutic agent that has been used widely for more than 40 years in the treatment of benign prostatic hyperplasia (BPH) in Japan and Germany, and is known to have antioxidant activity. The present study investigated the effect of Eviprostat on the levels of the urinary oxidative stress marker 8‐hydroxy‐2′‐deoxyguanosine (8‐OHdG) in a rabbit model of surgical partial bladder outlet obstruction (PBOO) and in patients with lower urinary tract symptoms (LUTS) associated with BPH. In the rabbit model, 8‐OHdG levels in urine collected after 3 weeks of PBOO were 3.8‐fold higher than in the urine of sham‐operated rabbits. When twice‐daily Eviprostat was administered orally throughout the 3‐week PBOO period, the increase in urinary 8‐OHdG levels was suppressed by 70%. In the clinical study, nine patients who received Eviprostat for 4 weeks showed 2.5‐fold lower urinary 8‐OHdG levels than before treatment. During Eviprostat treatment, the total International Prostate Symptom Score (IPSS) decreased from 16.56 ± 2.74 to 13.67 ± 2.30 and the quality of life score from 4.22 ± 0.40 to 3.22 ± 0.46. The findings provide evidence that the antioxidant activity of Eviprostat is responsible for its beneficial effects in the treatment of BPH. Copyright © 2009 John Wiley & Sons, Ltd.     

中西医结合治疗良性前列腺增生症患者下尿路症状32例

目的:观察中西医结合治疗前列腺增生症下尿路症状的临床疗效。方法:将66例患者随机分为中西医结合治疗组(33例)和西医常规治疗对照组(33例),观察两组治疗后国际前列腺症状评分(I—PSS),生活质量评分(QOL),最大尿流率(Qmax),血清前列腺特异性抗原(PSA)变化并比较。结果:两组治疗后,治疗组较对照组在各项观察指标上有显著改善,两组比较差异有统计学意义(P<0.05)。结论:中西医结合治疗前列腺增生症下尿路症状,特别是膀胱刺激征有明显疗效。     

电针配合健康教育治疗前列腺增生症临床观察

目的评价电针配合健康教育治疗前列腺增生症（BPH）的作用。方法将80例患者随机分为治疗组和对照组,每组40例。治疗组采用电针关元、三阴交、肾俞、秩边穴配合健康教育,对照组采用口服普乐安片,治疗1个疗程后评价两组患者的国际前列腺症状积分（IPSS）、生活质量评分（QOL）、前列腺体积（TPV）与残余尿量（RU）、血清前列腺特异性抗原（PSA）。结果两组患者治疗后IPSS和QOL评分显著改善,进一步分析显示治疗组的疗效明显好于对照组（P〈0.05）;治疗组前列腺体积和残余尿量较治疗前明显减少（P〈0.05）,对照组改善不明显。结论电针配合健康教育能有效改善BPH患者症状,显著提高生活质量。     

经尿道前列腺汽化电切术治疗前列腺增生60例体会

目的:观察经尿道汽化电切术治疗前列腺增生患者的临床效果。方法:选取60例良性前列腺增生患者行经尿道汽化电切术。结果:全部患者手术均取得成功,手术时间为35~76min。患者术后国际前列腺症状评分(IPSS)、生活质量评分(QOL)、最大尿流量(Qmax)及膀胱残余尿量(RUV)较术前均有明显改善,差异具有统计学差异(P0.05)。结论:经尿道前列腺汽化电切术治疗前列腺增生,疗效确切且安全性高,能够有效改善患者排尿困难等症状,提高患者的生活质量。     

Trigonella foenum graecum (fenugreek) seed extract as an antineoplastic agent

The antineoplastic effect of Trigonella foenum graecum seed extract has been evaluated in the Ehrlich ascites carcinoma (EAC) model in Balb-C mice. Intra-peritoneal administration of the alcohol extract of the seed both before and after inoculation of EAC cell in mice produced more than 70% inhibition of tumour cell growth with respect to the control. Treatment with the extract was found to enhance both the peritoneal exudate cell and macrophage cell counts. The extract also produced a significant antiinflammatory effect. We report here the antiinflammatory and antineoplastic effects, of Trigonella foenum graecum seed extract.     

Evaluation of Benefit and Tolerability of IQP‐CL‐101 (Xanthofen) in the Symptomatic Improvement of Irritable Bowel Syndrome: A Double‐Blinded,Randomised, Placebo‐Controlled Clinical Trial

Irritable bowel syndrome (IBS) is a functional bowel disorder of unknown aetiology. There is currently no known cure, and pharmacological interventions are usually targeting symptomatic relief, where natural and herbal remedies also play a role. This study aimed to evaluate the benefit and tolerability of IQP‐CL‐101 in symptomatic IBS relief. A double‐blinded, randomised, placebo‐controlled trial was conducted over 8 weeks. A total of 99 subjects fulfilling ROME‐III criteria for IBS were randomised into two groups, given either two IQP‐CL‐101 softgels or matching placebo twice daily before main meals. The primary endpoint was the difference in change of IBS Symptom Severity Score (IBS‐SSS) after an 8‐week intake of IQP‐CL‐101 compared to placebo. After 8 weeks, subjects on IQP‐CL‐101 showed a significant reduction in IBS‐SSS (113.0 ± 64.9‐point reduction) compared to subjects on placebo (38.7 ± 64.5‐point reduction) (p < 0.001). A significant improvement could be seen as early as 4 weeks. No serious adverse events were reported throughout. IQP‐CL‐101 can be considered beneficial in the improvement of IBS symptom severity, regardless of IBS type, and therefore able to improve quality of life in patients suffering from abdominal pain and discomfort. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.     

Labda‐8(17),12,14‐trien‐19‐oic Acid Contained in Fruits of Cupressus sempervirens Suppresses Benign Prostatic Hyperplasia in Rat and In Vitro Human Models Through Inhibition of Androgen and STAT‐3 Signaling

Fruit extract of Cupressus sempervirens (CS), which is used traditionally to treat Benign Prostatic Hyperplasia (BPH)‐like urinary symptoms in patients, was scientifically validated for anti‐BPH activity. The ethanolic fruit extract of CS inhibited proliferation of human BPH‐stromal cells and the activity was localized to its chloroform‐soluble, diterpene‐rich fraction. Eight major diterpenes isolated from this fraction exhibited moderate to potent activity and the most active diterpene (labda‐8(17),12,14‐trien‐19‐oic acid) exhibited an IC₅₀ of 37.5 μM (antiproliferative activity against human BPH‐stromal cells). It significantly inhibited activation (phosphorylation) of Stat‐3 in BPH‐stromal cells and prevented transactivation of androgen sensitive KLK3/PSA and TMPRSS2 genes in LNCaP cells. Labda‐8(17),12,14‐trien‐19‐oic acid‐rich CS fraction prevented prostatic hyperplasia in rat model and caused TUNEL labeling of stromal cells with lower expressions of IGF‐I, TGF‐ß and PCNA, and bcl‐2/bax ratio. Human BPH tissues exhibited precise lowering of stromal component after incubation in labda‐8(17),12,14‐trien‐19‐oic acid, ex vivo. We conclude that labda‐8(17),12,14‐trien‐19‐oic acid contained in CS exhibits anti‐BPH activity through inhibition of stromal proliferation and suppression of androgen action in the prostate, presenting a unique lead structure for further optimization of anti‐BPH activity. Copyright © 2014 John Wiley & Sons, Ltd.     

电针对前列腺增生症患者夜间尿频的影响

目的观察电针治疗良性前列腺增生症患者夜间尿频症状的临床疗效。方法对48例良性前列腺增生症患者采用电针肾俞、会阳穴进行治疗,观察治疗前后国际前列腺症状评分(I-PSS)、生活质量评分(QOL)、残余尿量(PVR)及夜间多尿指数(NPi)变化,并着重观察其对夜尿次数的影响。结果 48例患者治疗后I-PSS、QOL、PVR、夜尿次数及NPi均减少,其中I-PSS、QOL、PVR、夜尿次数与治疗前比较,差异均具有统计学意义(P0.01)。结论电针肾俞、会阳穴可有效改善良性前列腺增生症患者的夜间尿频症状。     

前列消癥汤治疗前列腺良性增生61例

[目的]探讨运用前列消癥汤治疗前列腺良性增生的疗效。[方法]61例应用前列消癥汤口服,均连续服药1个疗程以上,以国际前列腺症状评分(I—PSS),结合直肠指检和B超提示前列腺体积缩小范围及临床症状改善为标准进行判定。[结果]临床控制28例,占46.9%,有效30例,占49.1%,无效3例,占4%,总有效率96%。     

Inhibitory Effect of Thymoquinone on Testosterone‐Induced Benign Prostatic Hyperplasia in Wistar Rats

This study addresses the possible protective effects of thymoquinone (TQ) against the development of experimentally‐induced benign prostatic hyperplasia (BPH) in Wistar rats. Eighteen adult male rats were divided into three groups; the negative control group (n = 6) received vehicle, and two groups received subcutaneous testosterone injection (3 mg/kg). Animals receiving testosterone were randomized to untreated BPH group (n = 6) and BPH + TQ treated group (n = 6, 50 mg/kg orally for 14 days). Histological changes and the mRNA levels of transforming growth factor‐β₁ (TGF‐β₁) and vascular endothelial growth factor‐A (VEGF‐A) were analyzed. Additionally, dihydrotestosterone and interleukin‐6 (IL‐6) serum levels were determined. The presented research shows significant increases in prostate weight/body weight ratio, prostate epithelial thickness, serum IL‐6 and dihydrotestosterone levels, and the prostatic expressions of TGF‐β₁ and VEGF‐A in the untreated BPH rats. Histological examination of the prostate tissues in the BPH rats showed an elevated level of proliferation in the stromal area and glandular epithelia with abundant intraluminal papillary folds. However, a reduction in prostate weight/body weight ratio, epithelial hyperplasia, serum IL‐6 levels, and the expressions of TGF‐β₁ and VEGF‐A were observed in the BPH + TQ treated rats compared with the untreated BPH rats. The findings support TQ as a useful natural treatment for animal BPH model. Copyright © 2017 John Wiley & Sons, Ltd.