Clinical evaluation of Cernilton on benign prostatic hyperplasia

Twenty-two patients whose average age was 67 years and who had benign prostatic hyperplasia of stage I and II were treated with Cernilton for more than 4 weeks. Subjective symptoms were excellently improved and the improvement rate was over 85% in all of the evaluated symptoms of dysuria. In the overall evaluation, 18 out of 22 patients were rated as moderately improved or better, 2 were slightly improved and 2 remained unaltered. Aggravation of the symptoms was found in none of the patients. Objective findings such as residual urine volume and urinary flow rate were improved in 3 patients, although the shrinkage of the prostate was not observed on rectal palpation, retrograde urethro cystography or transrectal ultrasonography. No adverse reaction was observed during Cernilton therapy. In conclusion, it is suggested that Cernilton may be effective and safe for the conservative treatment of patients with early stage prostatic hyperplasia of non-surgical indication.     

Usefulness of Cernilton in the treatment of benign prostatic hyperplasia

A total of 89 patients with benign prostatic hyperplasia (BPH) were treated pharmacologically for 4 months: 51 received Cernilton and 38 Tadenan (controls). Significant subjective improvement was found in 78% of the patients in the Cernilton group compared to only 55% of the Tadenan-treated patients. The obstructive and irritative symptoms responded best to the therapy. In the Cernilton-treated patients a significant improvement in the uroflow rate, decrease in residual urine and in prostate volume were found. This study shows that Cernilton is an effective therapy for patients with BPH.     

Clinical evaluation of Cernilton in benign prostatic hypertrophy

Twenty patients with benign prostatic hypertrophy were treated with Cernilton, 6 tablets a day for an average of 13.2 weeks. Subjective effectiveness was observed in the improvement of sense of residual urine (92%), retardation (86%), night frequency (85%), strain on urination (56%), protraction (53%) and forceless urinary stream (53%). The overall subjective effectiveness was 80% of patients, and the overall objective effectiveness was 54% of patients. Night frequency, residual urine volume and tidal urine volume were improved significantly. The overall effectiveness was 80%. No side effects were observed.     

A systematic review of Cernilton for the treatment of benign prostatic hyperplasia

OBJECTIVE: To systematically review the evidence for the clinical effects and safety of the rye-grass pollen extract (Cernilton) in men with symptomatic benign prostatic hyperplasia (BPH). METHODS: Trials were identified by searching Medline, specialized databases (EMBASE, Cochrane Library, Phytodok), bibliographies, and contacting relevant trialists and manufacturers. Randomized or controlled clinical trials were included if: men with symptomatic BPH were treated with Cernilton; a control group received either placebo or pharmacological therapy; the treatment duration was >/= 30 days; and clinical outcomes were reported. RESULTS: In all, 444 men were enrolled in two placebo-controlled and two comparative trials lasting 12-24 weeks. Three studies used a double-blind method although the concealment of treatment allocation was unclear in all. Cernilton improved 'self-rated urinary symptoms' (the proportion reporting satisfactory or improving symptoms) vs placebo and another plant product, Tadenan. The weighted mean (95% confidence interval) risk ratio (RR) for self-rated improvement vs placebo was 2.40 (1. 21-4.75) and the weighted RR vs Tadenan was 1.42 (1.21-4.75). Cernilton reduced nocturia compared with placebo or Paraprost (a mixture of amino acids); against placebo, the weighted RR was 2.05 (1.41-3.00), and against Paraprost the weighted mean difference for nocturia was - 0.40 times per evening (- 0.73 to 0.07). Cernilton did not improve urinary flow rates, residual volume or prostate size compared with placebo or the comparative study agents. Adverse events were rare and mild; the withdrawal rate for Cernilton was 4. 8%, compared with 2.7% for placebo and 5.2% for Paraprost. CONCLUSIONS: The Cernilton trials analysed were limited by their short duration, limited number of enrolees, omissions in reported outcomes, and the unknown quality of the preparations used. The comparative trials had no confirmed active control. The available evidence suggests that Cernilton is well tolerated and modestly improves overall urological symptoms, including nocturia. Additional randomized placebo and active-controlled trials are needed to evaluate the long-term clinical effectiveness and safety of Cernilton.     

Treatment of outflow tract obstruction due to benign prostatic hyperplasia with the pollen extract, cernilton. A double-blind, placebo-controlled study.

Whilst prostatectomy remains the "gold standard" for the treatment of outflow tract obstruction due to benign prostatic hyperplasia, medical treatment--if only for symptomatic relief--appears to be an attractive alternative. Most of the pharmacological agents in use block the hormonal or the sympathetic neurological pathways that influence prostate growth and function. All of these drugs are known to have side effects. Sixty patients with outflow obstruction due to benign prostatic hyperplasia (BPH) were entered into a double-blind, placebo-controlled study to evaluate the effect of a 6-month course of the pollen extract, Cernilton. There was a statistically significant subjective improvement with Cernilton (69% of the patients) compared with placebo (30%). There was a significant decrease in residual urine in the patients treated with Cernilton and in the antero-posterior (A-P) diameter of the prostate on ultrasound. However, differences in respect of flow rate and voided volume were not statistically significant. It is concluded that Cernilton has a beneficial effect in BPH and may have a place in the treatment of patients with mild or moderate symptoms of outflow obstruction.     

Clinical evaluation of cernilton in the treatment of the benign prostatic hypertrophy

Cernilton was given clinically to 30 patients with benign prostatic hypertrophy. Cernilton was given orally at least for 12 weeks at a daily dose of 6 tablets in three divided doses. The overall clinical efficacy on subjective symptoms was 80%, and that on objective signs, 43%. During the administration period of Cernilton, no serious untoward effects were observed in either the clinical or laboratory findings. It is, therefore, suggested that, from the clinical point of view, Cernilton is a useful and safe drug in the treatment of benign prostatic hypertrophy.     

Clinical effects of distigmine bromide (Ubretid), a cholinesterase inhibitor, on micturition disturbance by benign prostatic hypertrophy--comparative study of distigmine bromide and the combination of distigmine bromide and adrenergic blocker]

We report the results of a comparative study on the clinical efficacy of the single use of distigmine bromide and its combined use with prazosin hydrochloride in the treatment of benign prostatic hypertrophy. The single use and combined use groups were administered 10 mg/day of distigmine bromide and the same with 1 mg/day of prazosin hydrochloride for a period of 8 weeks respectively. In the single administration group, marked improvement was found in one patient (9%), moderate improvement in 4 patients (36.3%), slight improvement in 3 patients (27.2%) and aggravation in 3 patients. In the combined use group, marked improvement was found in one patient (11.0%), moderate improvement in 5 patients (55.5%), and slight improvement in 3 patients (33.3%). No significant differences were found in the improvement rate between the two groups. However, significant improvements were found in both groups for the subjective symptoms of urinary disturbance, diurnal and nocturnal frequency. As a result of the examination of objective findings, a significant decrease in residual urine ratio was also shown in both groups, while significant improvement for average flow and maximum flow rates were found in only the combined use group. In conclusion, distigmine bromide and distigmine bromide+prazosin hydrochloride are considered very useful for the treatment of miturition disturbance due to benign prostatic hypertrophy.     

A randomized long-term comparative study of clinical efficacy of alpha 1-blocker with or without antiandrogen therapy for benign prostatic hyperplasia: focusing on improvement of I-PSS

This study was conducted to examine the efficacy of administration of tamsulosin hydrochloride alone or in combination with chlormadinone acetate (CMA) against lower urinary tract symptoms for a period of 52 weeks in 33 patients with benign prostatic hyperplasia. The patients were randomly allocated into a group administered tamsulosin alone and a group administered tamsulosin in combination with CMA. Based on the assessment of the total I-PSS (International Prostate Symptom Score), significant symptomatic improvement was noted 4 weeks after the commencement of drug administration in the tamsulosin + CMA group, whereas no significant improvement was observed in the tamsulosin group. Both irritative and obstructive bladder symptoms improved significantly at any time of assessment after 4 weeks of drug administration in the tamsulosin + CMA group; however, significant improvement was noted only at week 16 and week 52 for irritative symptoms and at week 16 for obstructive symptoms in the tamsulosin group. In particular, obstructive symptoms showed significant improvement at week 4 in the tamsulosin + CMA group, as compared with that in the tamsulosin group. The average value of peak urinary flow rate was significantly increased in the tamsulosin + CMA group (10.4 ml/s to 15.6 ml/s) as compared with that in the tamsulosin group (8.5 ml/s to 10.5 ml/s). These findings indicate that combined administration of tamsulosin and CMA resulted in early improvement of lower urinary tract symptoms in these patients. Long-term combined administration of tamsulosin and CMA thus appears to be a promising treatment strategy for the improvement of obstructive symptoms and peak urinary flow rate, particularly, 16 weeks onward after administration in patients with benign prostatic hyperplasia.     

Comparison of 25 and 75 mg/day naftopidil for lower urinary tract symptoms associated with benign prostatic hyperplasia: A prospective, randomized controlled study

BACKGROUND: The present study investigated the efficacy, safety, and utility of starting an alpha(1d)-selective antagonist, naftopidil, at 75 or 25 mg/day in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS: In this prospective comparative study, the subjects comprised 153 patients with LUTS associated with BPH. Patients were randomized to receive either 25 mg/day (Group LD) or 75 mg/day (Group HD) of naftopidil for 4 weeks. The lower urinary tract disease symptom score (LUTDSS), the International Prostate Symptom Score (IPSS), the Quality of life assessment index, the maximum flow rate (Q(max)), and the residual urine volume were compared between the groups. RESULTS: In both groups, the LUTDSS and the IPSS were significantly improved at the endpoint and no significant intergroup differences were identified. However, the improvement in the Q(max) was significantly better for Group HD than for Group LD. The overall efficacy did not differ significantly between the groups. The degree of improvement in voiding symptoms and LUTDSS among patients with moderate symptoms was significantly greater for Group HD than for Group LD. The frequency of adverse reactions did not differ significantly between the groups. CONCLUSIONS: Starting administration at 75 mg/day rather than 25mg/day is helpful for LUTS associated with BPH for patients with moderate symptoms, particularly in improving voiding symptoms. The 75 mg/day administration was considered to be a recommendable therapeutic dose in some patients.     

舒尿宝（棕榈子加三妙散）胶囊治疗前列腺增生随机双盲安慰剂对照临床研究

目的观察三妙散加味治疗良性前列腺增生症的临床疗效。方法随机双盲安慰剂对照试验,40名年龄50～80岁患者,随机分为对照（安慰剂）组和三妙散加味（舒尿宝）组。观察治疗前后患者的国际前列腺症状评分（IPSS）、生活质量指数（QOL）、前列腺体积（PV）、最大尿流率（Qmax）和膀胱残余尿量（PVR）的变化。结果 IPSS总分虽然舒尿宝组改善较安慰剂组明显,但无统计学意义（P=0.120）;IPSS刺激症状在舒尿宝组有明显改善（P=0.053）,夜尿也明显减少（P=0.083）。最大尿流率Qmax在舒尿宝组治疗后有明显增加（P=0.061）。治疗后舒尿宝组的有效率达70%,安慰剂组为36.8%,两组间有显著性差别（P=0.038）。结论舒尿宝有助于改善前列腺增生患者下尿道症状。     

Transurethral incision compared with transurethral resection of the prostate for bladder outlet obstruction: a systematic review and meta-analysis of randomized controlled trials

PURPOSE: Transurethral prostatic resection is the gold standard surgical treatment in men with lower urinary tract symptoms suggestive of bladder outlet obstruction but it has also been related to some risks, such as a relatively high rate of blood transfusion, sexual function problems and so forth. Transurethral prostatic incision is a simpler and less invasive procedure than transurethral prostatic resection. However, it is underused. We systematically reviewed all published randomized controlled trials comparing the effectiveness of transurethral prostatic incision with standard transurethral prostatic resection for bladder outlet obstruction and performed a meta-analysis of the available relevant data. MATERIALS AND METHODS: Nine randomized controlled trials comparing the treatment effectiveness of transurethral prostatic resection and transurethral prostatic incision were identified, evaluated and reviewed in a meta-analysis. The quality of these studies was also appraised. RESULTS: Each treatment achieved clear improvements in subjective and objective outcomes. The improvement in symptoms was equivalent 12 months postoperatively for transurethral prostatic incision and resection. For maximum flow rate transurethral prostatic resection resulted in greater improvement than transurethral prostatic incision. However, transurethral prostatic incision had several advantages over transurethral prostatic resection, such as lower incidence of complications, fewer blood transfusions, decreased risk of retrograde ejaculation, and shorter operative time and hospital stay. Also, the treatments had an equivalent incidence of postoperative catheterization duration and reoperation rate within the first 12 months. Furthermore, patients in each group had a similar subjective view of the treatments received. CONCLUSIONS: In the first 12 months after surgery transurethral prostatic incision has effectiveness that is equivalent to transurethral prostatic resection for treating patients with suspected benign prostatic obstruction who have a relatively small prostate. However, there is little evidence on the relative long-term effectiveness of the 2 treatments 2 to 5 or 10 years after surgery. There is no clear cutoff point for prostate size that leads to good results after transurethral prostatic incision. A large-scale, multicenter randomized controlled trial is now required to evaluate comprehensively the effectiveness, impact on quality of life and overall cost of transurethral prostatic incision compared with transurethral prostatic resection.     

经尿道等离子前列腺剜除术治疗老年良性前列腺增生患者的临床体会

【摘要】 目的 探究良性前列腺增生老年患者行经尿道等离子前列腺剜除手术治疗对相关时间指标、并发症及生活质量的影响和诊治经验。方法〓选取本院2015年1月~2016年1月收治的良性前列腺增生96例老年患者临床资料进行回顾性分析,根据治疗时所用不同治疗方案分成两组,将行经尿道电切手术治疗42例患者设为对照组,将行经尿道等离子前列腺剜除手术治疗54例患者设为观察组,对两组相关时间指标、并发症及生活质量等进行对比。结果〓术后两组最大尿流率对比相当。观察组手术出血量较对照组减少,P<0.05。观察组在手术时间、术后膀胱冲洗与导管留置时间的两组间比较较优,差异有统计学意义。观察组总并发症7.41%,比对照组23.81%低(P<0.05)。观察组在两组治疗后总体健康评分均改善基础上,其改善幅度较对照组显著(P<0.05)。结论〓良性前列腺增生老年患者行经尿道等离子前列腺剜除手术治疗的临床效果显著,能够减少并发症发生。     

Comparative double-blind trial of KN-7 tablet and Robaveron injection in the treatment of neurogenic bladder

The clinical effectiveness, safety and usefulness of KN-7 tablet as a new oral application of the prostatic extract, on urinary dysfunction of neurogenic bladder were compared with those of Robaveron injection by the double-blind test method. In the study, 2 tablets t.i.d. and a shot of intramuscular injection 1 ml a day were given successively for 3 weeks. A total of 233 cases were reported from 37 facilities belonging to the KN-7 Clinical Research Group. Some of them were excluded or dropped out. The number of cases used for analysing the effectiveness, safety and usefulness were 214, 232 and 215, respectively. There was no bias between the two groups with a significant homogeneity in the background. In the overall clinical effectiveness, the effective rate including excellent, moderate and slightly effective was 76.9% with KN-7 and 77.4% with Robaveron. In the clinical usefulness, the rate of usefulness of slightly useful or above was 75.0% with KN-7 and 75.7% with Robaveron. There was no significant difference between the two groups in the clinical effective and useful rates at a significant level of 5%. Side effects were observed in 1 of the 114 (0.9%) patients given KN-7 and 8 of the 118 (6.8%) patients given Robaveron. The incidence of adverse reactions with KN-7 was significantly lower than that with Robaveron. Based on the results, it was concluded that KN-7 tablets, 2 tablets t.i.d., would be as effective and useful as a Robaveron injection 1 ml daily and safer than the latter in the treatment of neurogenic bladder.     

元贝合剂对前列腺增生患者转化生长因子α及尿流率的影响

目的分析元贝合剂对前列腺增生患者转化生长因子α(TGF-α)及尿流率的影响,评价元贝合剂辅助治疗前列腺增生的疗效,分析其起效机制。方法2017年1月至2018年4月,医院泌尿科收治的前列腺增生患者92例入组,均采用保守治疗,对照组和观察组各46例,按照随机数字表达法分组。两组均给予基础治疗,对照组加用爱普列特,5 mg每次,1日2次,持续4周。观察组联合元贝合剂,1日1剂,持续4周。对比治疗前后临床疗效、尿转化生长因子α及尿流率、国际前列腺症状评分(IPSS)。治疗过程中,观察两组不良反应。结果观察组与对照组组内对比尿转化生长因子α低于治疗前,差异有统计学意义(P<0.05),两组组间对比治疗后,观察组尿转化生长因子α水平低于对照组,差异有统计学意义(P<0.05)。治疗后,观察组与对照组组内对比尿流率(Qmax、Qave)高于治疗前,组间对比观察组高于对照组,差异有统计学意义(P<0.05)。治疗后,观察组与对照组组内对比IPSS评分低于治疗前,组间对比观察组低于对照组,差异有统计学意义(P<0.05)。观察组整体疗效优于对照组,差异有统计学意义(P<0.05)。结论元贝合剂治疗前列腺增生疗效肯定,可以降低尿转化生长因子α水平,提升尿流率、缓解患者病情。     

TURP治疗57例前列腺增生并梗阻性肾病的临床观察

目的探讨前列腺增生合并梗阻性肾病TURP手术治疗的安全性及临床疗效。方法57例合并梗阻性肾病的前列腺增生患者,通过留置尿管或耻骨上膀胱造瘘引流尿液,在肾功能改善后应用经尿道前列腺电切术(TURP)进行治疗。结果本组病例有效率100%,未出现死亡病例。术后国际前列腺症状评分(IPSS)平均为8.1分,生活质量评分(QOL)平均为1.4分。结论尿液引流为手术创造条件,TURP是前列腺增生合并梗阻性肾病安全而有效的治疗方法。     

A clinical evaluation of CS-807 in patients with urinary tract infections

CS-807 is a new cephalosporin orally available. The clinical efficacy and safety of this drug were evaluated in 13 patients with urinary tract infection, including 3 with simple cystitis and 10 with complicated infections. According to the response criteria defined by the Japanese UTI committee, the clinical effectiveness in 8 patients with complicated urinary tract infections regarded evaluable was excellent in 2, moderate in 4 and poor in 2, the overall efficacy rate being 75.0%. Only 1 of the 13 patients studied, developed temporary diarrhea as a drug related adverse reaction.     

Randomized trial of a combination of natural products (cernitin,saw palmetto,B-sitosterol,vitamin E) on symptoms of benign prostatic hyperplasia (BPH)

Because benign prostatic hyperplasia (BPH) is relatively common, it is important to discover safe and effective means to treat this often debilitating perturbation. Accordingly, we examined the effectiveness of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) in treating symptoms of BPH. We undertook a randomized, placebo-controlled, double-blind study. Patients were enrolled from 3 urological practices in the USA. 144 subjects were randomized for study. 17 subjects eventually withdrew, leaving 70 patients in the test group and 57 in the placebo group to complete the study. Inclusion criteria consisted of a diagnosis of BPH, no evidence of cancer, and a maximal urinary flow rate between 5 and 15 ml/second. Patients received either placebo or the combined natural products for 3 months. Evaluations were performed via the American Urological Association (AUA) Symptom Index score, urinary flow rate, PSA measurement, and residual bladder volume. Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo (p < 0.001). Daytime frequency was also lessened significantly (p < 0.04). When the average individual total AUA Symptom Index score in the test group was compared to that in the placebo group at the end of the study, the difference proved highly significant (p < 0.014). PSA measurements, maximal and average urinary flow rates, and residual volumes showed no statistically significant differences. When taken for 3 months, a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score. The combination of natural products caused no significant adverse side effects.     

Urodynamic pressure flow studies can predict the clinical outcome after transurethral prostatic resection

PURPOSE: We evaluate whether urodynamic evaluation can determine preoperatively the clinical prognosis of patients treated with transurethral prostatic resection as measured by urinary symptom score and quality of life index. MATERIALS AND METHODS: A total of 253 patients who previously elected transurethral prostatic resection based on clinical symptoms completed the American Urological Association symptom score and quality of life index, and underwent urodynamic evaluation before and after operation. The patients were divided into 7 groups in accordance with detrusor pressure at maximum urinary flow rate. The preoperative and postoperative symptom score and quality of life index were analyzed in each group. RESULTS: Of the patients 42% were not obstructed and could not be distinguished from those who were obstructed preoperatively based on total urinary symptoms (p = 0.95) or subjective impression measured by the quality of life index (p = 0.96). The entire obstructed group demonstrated marked improvement compared to the nonobstructed group (p = 0.018). Analysis of severity also revealed a clear relationship with clinical outcome and subjective satisfaction with obstruction grade, that is the more severely obstructed cases had greater clinical benefit compared to those with little or no obstruction. Furthermore, the nonobstructed subjects did not show any clinical or subjective improvement after transurethral prostatic resection (p = 0.24). CONCLUSIONS: Urodynamic studies provide great predictive value of clinical improvement after prostatic relief but they also properly predict the poor clinical results in nonobstructed patients.     

Two-year follow-up results of a prospective randomized trial comparing hybrid laser prostatectomy with TURP in the treatment of big benign prostates

OBJECTIVE: We compared conventional transurethral electroresection of the prostate (TURP) and hybrid laser treatment in patients with symptomatic bladder outflow obstruction caused by a benign prostate bigger than 40 ml. MATERIAL AND METHODS: Forty-six patients with symptomatic urodynamically confirmed outflow obstruction caused by benign prostate hyperplasia bigger than 40 ml were accepted to the prospective trial and were randomized to receive hybrid laser treatment or TURP. The hybrid laser technique involved initial non-contact Nd:YAG coagulation followed by contact Nd:YAG vaporization to open the prostatic urethra. Patients were re-assessed after 3, 6, 12 and 24 months. RESULTS: Of the 46 patients, 37 (80%) were available at the 24-month follow-up. The re-operation rate was 14.3% in the hybrid laser group and 8.3% in the TURP group. The decrease in DanPSS-1 symptom score from baseline at 24 months was 51.0% in the hybrid laser group (p<0.01) and 80.0% in the TURP group (p<0.001), with no statistically significant differences between the groups. Early improvement in objective urinary parameters of peak urinary flow rate and residual urinary volume showed deterioration in hybrid laser group during longer follow-up, whereas in TURP group the improvement of these variables was sustained. Comparison between groups showed TURP to be superior in peak urinary flow rate (p < 0.001) and residual urinary volume (p < 0.01) at the 24-month follow-up visit. CONCLUSIONS: Both hybrid laser treatment and TURP give good symptomatic relief lasting at least 2 years in the treatment of big obstructing prostates, but hybrid laser treatment is associated with a higher re-operation rate because of inadequate initial prostate tissue removal and with inferior outcome in objective urinary parameters compared with TURP.     

Transurethral microwave thermotherapy for benign prostatic hyperplasia

The clinical efficacy of transurethral microwave thermotherapy using the PROSTCARE apparatus was evaluated in 60 patients with bladder outlet obstruction associated with benign prostatic hyperplasia. All of the 60 patients received a single thermal session for 60 minutes with an average intraprostatic temperature of 45 degrees C. They were evaluated by analyzing the international prostate symptom score (IPSS), quality of life (QOL) index, maximum urinary flow rate and prostate volume at 2 months after the treatment to estimate criteria for efficacy of treatment in BPH. Both IPSS and QOL index improved significantly. The maximum urinary flow rate improved but there was no significant change. There was no significant change in prostate volume. The rates of improvement in IPSS, QOL index and maximum flow rate were 73%, 78% and 47% of the patients respectively. The rate of overall improvement was 78% of the patients. As a complication after the treatment, 2 patients complained of ejaculation disturbance.