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.     

Clinical evaluation of surgical treatment for benign prostatic hypertrophy

Prostatectomy was performed on 300 patients at our Hospital for the period of 5 years from January 1978 to December 1982. Among those cases, clinical evaluation was made on 290 patients whose medical records were available. Ages of the subjects ranged from 53 to 92 years with an average age at 71.6. Retropubic prostatectomy (RPP) was performed on 81 cases, and suprapubic prostatectomy (SPP) and transurethral resection of prostate (TUR) on 39 and 170 cases, respectively. Surgery was made on 206 cases under epidural anesthesia, 82 cases under spinal anesthesia, and 2 cases under general anesthesia. Preoperative laboratory tests showed abnormalities in 62% of the total. The most frequent preoperative complications were circulatory abnormality and urinary tract infection. Average surgical time was 78.6 min. for RPP, 69.8 min. for SPP, and 76.9 min. for TUR. Average blood volume transfused during operation was 446.3 ml for RPP, 430.8 ml for SPP, and 80.7 ml for TUR. Average period of catheter retention after surgery was 9.2 days for RPP, 10.1 days for SPP, and 4.9 days for TUR. Average postoperative admission period was 18.6 days for RPP, 20.6 days for SPP, and 14.1 days for TUR. Average weight of the isolated adenoma was 41.8 g for RPP, 30.2 g for SPP, 11.5 g for TUR. Postoperative complications such as epididymitis, traumatic infection, and hepatic dysfunction were often found. Latent prostatic carcinoma found in the isolated adenoma was found in 11 cases (3.8%). The presence of anomalies in preoperative laboratory findings did not influence the frequency of postoperative complications.     

Clinical evaluation of Cernilton on benign prostatic hypertrophy--a multiple center double-blind study with Paraprost]

A multiple center double blind study was performed to study the effectiveness of Cernilton (CN) on benign prostatic hypertrophy in comparison to Paraprost (PP). Among a total of 192 patients, overall effect was studied on 159 patients, overall safety rate on 178 patients and rate of effectiveness on 159 patients. There were no differences between the two groups in the selected patients, criteria for exclusion and drop out cases or background data of the patients. Impression of patients and overall effect by committee and physician judgment were slightly higher in the CN group compared to the PP group, but there was no significant difference between the two groups. For the improvement in subjective symptoms, the rate of moderate improvement or more after 4 weeks by committee judgement was higher in the CN group compared to the PP group. The rate of improvement in protracted miction, which is an effective marker of urinary disturbance, was also higher in the CN group compared to the PP group. An analysis of objective symptoms showed a significant improvement in residual urinary volume, average flow rate, maximum flow rate and prostatic weight in the CN group. A significant improvement in the phased change of residual urinary volume was also seen in the CN group. No side effects or abnormalities in clinical test levels were noted in the CN group. By committee judgement, the rate of more than moderate effectiveness was 49.1% in the CN group compared to 41.2% in the PP group, but there was no significant difference between the two groups. By physician's judgment, the rate of more than moderate effectiveness was 49.4% in the CN group compared to 46.3% in the PP group, but there was also no significant difference between the two groups. These results suggested that Cernilton was an effective drug for benign prostatic hypertrophy.     

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.     

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 effect of allylestrenol on benign prostatic hypertrophy

Allylestrenol at the daily dose of 50 mg was administered to 45 patients with benign prostatic hypertrophy. The treatment was performed for more than 12 weeks in 40 patients, and improvements, marked and moderate, were observed in 22 patients (55%) in the overall judgement. As side effects of this drug, decrease of potency was observed in 3 cases, decrease of libido in 1 case, pigmentation on breasts in 2 cases, palpitation in 2 cases, short breath in 1 case, and gastrointestinal symptoms in 1 case. However, these side effects were not serious. Our trial suggests that the treatment of benign prostatic hypertrophy with allylestrenol can be useful in urological clinics.     

经尿道手术治疗良性前列腺增生三种术式的疗效比较

目的比较经尿道电切(TURP)、经尿道汽化电切(TUVP)、经尿道等离子切割(PKRP)3种手术方法治疗良性前列腺增生(BPH)的疗效及并发症。方法分别采用TURP、TUVP、PKRP 3种方式治疗BPH患者545例。TURP组230例,年龄51～87岁(平均73岁),前列腺重量20～138 g(平均50 g);TUVP组250例,年龄49～92岁(平均73岁),前列腺重量22～143 g (平均53 g);PKRP组65例,年龄51～89岁(平均72岁),前列腺重量25～127 g(平均52 g)。3组病例术前前列腺症状评分(IPSS)、剩余尿量(RUV)、最大尿流率(Qmax)、生活质量评分(QOL)比较差异均无统计学意义(P>0.05)。比较3组手术时间、术中出血量、术后尿管留置时间、住院天数、术后并发症发生率及疗效。结果TURP组成功228例(99%);TUVP组成功245例(98%);PKRP组65例均获成功。TURP、TUVP、PKRP组手术时间分别为38(15～90)、41(25～120)、38(17～120) min,组间比较差异无统计学意义(P>0.05);3组术中出血量分别为79(32～310)、75(43～920)、44 (25～156)ml,组间比较差异有统计学意义(P<0.01);3组术后平均留置尿管时间分别为4.1、4.2、3.5 d(P>0.05);3组平均住院时间分别为6.2、6.7、5.1 d(P<0.01)。TURP组发生尿道口狭窄1例、TURS 2例、尿外渗3例,并发症发生率2.6%。TUVP组并发尿道口狭窄7例、后尿道狭窄2例、术中术后出血3例、尿外渗1例、轻度尿失禁1例、附睾炎3例,并发症发生率6.8%。PKRP组术后并发尿外渗2例,并发症发生率3.1%。术后3、6个月随访,3组IPSS、RUV、QOL均较术前明显下降,Qmax均较术前明显增加,但组间比较差异均无统计学意义(P>0.05)。结论3种方法均有明确的临床效果,临床上可根据患者情况和适应证选择不同方法,以获得更好的临床疗效。     

Prolactin secretion in benign prostatic hypertrophy

Prolactin secretion was evaluated in 22 patients with benign prostatic hypertrophy, before and after thyrotropin-releasing hormone stimulation. Increased prolactin reserve was found. In 11 patients, in whom the test was performed twice, the prolactin response after surgery was higher than in the pre-surgical test. The possible role of prolactin in the genesis of benign prostatic hypertrophy is discussed.     

Urodynamics studies in benign prostatic hypertrophy

A study of patients with benign prostatic hypertrophy indicates that flow rates may well be useful in evaluating the degree of obstruction and the results of therapy. Electromyography and cytometry studies, while demonstrating certain tendencies in benign prostatic hypertrophy, do not give statistically significant data for evaluation and prognostication either by themselves or when correlated with radiographic changes and flow rates.     

Lipids in human benign prostatic hypertrophy

Summary Lipids in human prostate have been the subject of limited research and the most complete studies were published forty years ago. In this study we report on the total lipid, total cholesterol, free cholesterol and triglyceride content in human benign prostatic hypertrophy. By means of thin-layer chromatography, we separated the cholesterolesters in five fractions. The effect of treatment with anti-androgens before prostatectomy was examined.     

Urodynamics in benign prostatic hypertrophy.

Synchronous urinary flow and pressure studies were carried out on 51 male subjects of whom 12 were normal subjects and 39 had benign prostatic hypertrophy with varying degrees of bladder outlet obstruction. A urodynamic scoring system was evolved for accurate and objective diagnosis of bladder outlet obstruction. The minimum urethral resistance was found to be the most valuable single urodynamic parameter for the diagnosis of bladder outlet obstruction. Hitherto this urodynamic parameter was determined through tedious calculations. In the course of the present study a new instrument, the Urethroresistance, was devised for the direct recording of urethral resistance during micturition.     

Clinical studies of transurethral resection in patients with benign prostatic hypertrophy

During the last 9 years, 1,892 patients underwent surgery of the prostate. Benign prostatic hypertrophy (BPH) accounted for 1,812 cases, and prostatic cancer 80 cases. In the case of BPH, transurethral resection was done in 1,645 cases, cryosurgery in 136 cases, and suprapubic prostatectomy in 31 cases. Latent cancer was detected in 54 (3.3%) of the BPH cases. The average patient age of the patients with latent cancer (73.6 +/- 6.9 years) was higher than that of those without latent cancer (69.5 +/- 7.7 years). This suggested a significant relationship between the age of the patient and the occurrence of latent cancer.     

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.     

Induction of benign prostatic hypertrophy in baboons

Hormonal manipulation of intact male baboons has produced prostatic features resembling benign prostatic hypertrophy (BPH) in man. Long-acting androgen, testosterone enanthate (TE), given weekly (200 mg i.m.) for up to six months, caused significant gravimetric and volumetric increases in the prostate; a definite glandular and marked stromal hyperplasia with fibrosis developed in the caudal lobe (CD). After twenty weeks of TE treatment, there were dysplastic (atypical) changes in the glandular lining epithelium in the CD, causing pseudostratification of the lining cells with nuclear hyperchromatism. By the twenty-eighth week, there was an increase of stromal tissue with papillary ingrowth or invagination of glandular epithelium in the CD. Serum levels of testosterone and dihydrotestosterone were significantly elevated from 10 nm/ml and 2-3 ng/ml to 30-40 ng/ml and 5-6 ng/ml, respectively. There was a 3 to 4-fold increase in androstenedione levels and an increase in estradiol-17 beta from 20 pg/ml to 80-90 pg/ml. These steroidal levels may have played a direct role in the induction of early BPH in the baboons. Cytoplasmic and nuclear androgen receptor levels were higher in the CD compared to those of the cranial lobe (CR); AR concentration was increased in the cytosol and decreased in the nuclei of both lobes in TE treated animals. Scanning and transmission electron microscopy revealed heavy deposition of collagen fibers (fibrosis) in the central and periurethral regions of the CD after the administration of TE. Glandular as well as epithelial hyperplasia was most notable in the peripheral zone of the CD. These findings are similar to observations established in human BPH, indicating that the baboon prostate may be a useful model for studying various parameters of BPH.