Efficacy and safety of Chinese herbal medicine for benign prostatic hyperplasia: systematic review of randomized controlled trials

Chinese herbal medicine is commonly used as a treatment for benign prostatic hyperplasia (BPH), but its efficacy and safety remain to be examined. To compare the efficacy and adverse events of Chinese herbal medicine alone or used adjuvantly with Western medications for BPH. Two independent reviewers searched the major electronic databases for randomized controlled trials comparing Chinese herbal medicine, either in single or adjuvant use with Western medication, with placebo or Western medication. Relevant journals and grey literature were also hand-searched. The outcome measures included changes in urological symptoms, urodynamic measures, prostate volume and adverse events. The frequency of commonly used herbs was also identified. Out of 13 922 identified citations of publications, 31 studies were included. Eleven studies with a Jadad score ≥3 were selected for meta-analysis. Chinese herbal medicine was superior to Western medication in improving quality of life and reducing prostate volume. The frequency of adverse events in Chinese herbal medicine was similar to that of placebo and less than that of Western medication. The evidence is too weak to support the efficacy of Chinese herbal medicine for BPH due to the poor methodological quality and small number of trials included. The commonly used herbs identified here should provide insights for future clinical practice and research. Larger randomized controlled trials of better quality are needed to truly evaluate the efficacy of Chinese herbal medicine.     

BXL628, a novel vitamin D3 analog arrests prostate growth in patients with benign prostatic hyperplasia: a randomized clinical trial

OBJECTIVE: To evaluate the effect of BXL628, a vitamin D3 analog, on prostate volume in patients with benign prostatic hyperplasia (BPH). METHODS: We conducted a phase II, double blind, randomized, placebo controlled, clinical study. Patients eligible were aged>or=50 years, had a diagnosis of BPH and a prostate volume>or=40 ml. Eligible patients were randomized and given either BXL628 150 mcg daily or placebo for 12 weeks. All randomized patients underwent at baseline and at the end of study pelvic MRI to measure prostatic volume, uroflowmetry (Qmax), American Urological Association Symptom Index (AUASI), serum PSA, testosterone, dihydrotestosterone and luteizing hormone. RESULTS: A total of 119 patients were randomized: 57 patients to BXL628 and 62 to placebo. The percentage change of prostate volume at 12 week was -2.90 in the BXL628 group vs. +4.32 in the placebo group (p-value<0.0001). The estimated difference between treatments (BXL628 minus placebo) was -7.22% (95% confidence limit -9.27 to -5.18). Considering Qmax, mean change vs. baseline was -0.30 in BXL628 vs. +1.50 in the placebo group: this finding was not statistically significant. The mean change of the AUASI total score at final visit vs. baseline was -1.77 in the BXL628 group vs. -3.45 in the placebo group (p=not significant). CONCLUSION: BXL628 was able to arrest prostate growth within 12 weeks in men aged>or=50 years with prostatic volume>or=40 ml. Its unprecedented mechanism of action may offer a new opportunity for the treatment of BPH.     

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。     

Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia

PURPOSE: We tested the effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia (BPH) via a randomized, placebo controlled trial. MATERIALS AND METHODS: We randomized 44 men 45 to 80 years old with symptomatic BPH into a trial of a saw palmetto herbal blend versus placebo. End points included routine clinical measures (symptom score, uroflowmetry and post-void residual urine volume), blood chemistry studies (prostate specific antigen, sex hormones and multiphasic analysis), prostate volumetrics by magnetic resonance imaging, and prostate biopsy for zonal tissue morphometry and semiquantitative histology studies. RESULTS: Saw palmetto herbal blend and placebo groups had improved clinical parameters with a slight advantage in the saw palmetto group (not statistically significant). Neither prostate specific antigen nor prostate volume changed from baseline. Prostate epithelial contraction was noted, especially in the transition zone, where percent epithelium decreased from 17.8% at baseline to 10.7% after 6 months of saw palmetto herbal blend (p <0.01). Histological studies showed that the percent of atrophic glands increased from 25. 2% to 40.9% after treatment with saw palmetto herbal blend (p <0.01). The mechanism of action appeared to be nonhormonal but it was not identified by tissue studies of apoptosis, cellular proliferation, angiogenesis, growth factors or androgen receptor expression. We noted no adverse effects of saw palmetto herbal blend. When the study was no longer blinded, 41 men elected to continue therapy in an open label extension. CONCLUSIONS: Saw palmetto herbal blend appears to be a safe, highly desirable option for men with moderately symptomatic BPH. The secondary outcome measures of clinical effect in our study were only slightly better for saw palmetto herbal blend than placebo (not statistically significant). However, saw palmetto herbal blend therapy was associated with epithelial contraction, especially in the transition zone (p <0.01), indicating a possible mechanism of action underlying the clinical significance detected in other studies.     

Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review

What's known on the subject? and What does the study add? For the past 30 years Serenoa repens has become a widely used phytotherapy in the USA and in Europe, mostly because of positive comparisons to α‐blockers and 5α‐reductase inhibitors. During the last 4 years we have seen two very high quality trials comparing Serenoa repens to placebo and up to 72 weeks' duration. These trials found Serenoa repens no better than placebo, even (in one trial) at escalating doses.

OBJECTIVE

• ? To estimate the effectiveness and harms of Serenoa repens monotherapy in the treatment of lower urinary tract symptoms (LUTS) consistent with benign prostatic hyperplasia (BPH).

MATERIALS AND METHODS

• ? We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and other sources through to January 2012 to identify randomised trials.
• ? Trials were eligible if they randomised men with symptomatic BPH to receive Serenoa repens extract monotherapy for at least 4 weeks in comparison with placebo, and assessed clinical outcomes and urodynamic measurements.
• ? Our primary outcome was improvement in LUTS, based on change in urological symptom‐scale scores.

RESULTS

• ? In all, 17 randomised controlled trials (N= 2008) assessing Serenoa repens monotherapy (typically 320 mg/day) vs placebo met inclusion criteria, although only five reported American Urological Association Symptom Index (AUASI) or International Prostate Symptom Scores (IPSS). Trial lengths ranged from 4 to 72 weeks. The mean age of all enrolees was 64.3 years and most participants were of White race. The mean baseline total score was 14 points, indicating moderately severe symptoms. In all, 16 trials were double blinded and adequate treatment allocation concealment was reported in six trials.
• ? In a meta‐analysis of three high quality long‐to‐moderate term trials (n= 661), Serenoa repens therapy was no better than placebo in reducing LUTS based on the AUASI/IPSS (weighted mean difference [WMD]?0.16 points, 95% confidence interval [CI]–1.45 to 1.14) or maximum urinary flow rate (Q_max; WMD 0.40 mL/s, 95% CI ?0.30 to 1.09). Based on mostly short‐term studies, Q_max measured at study endpoint were also not significantly different between treatment groups (WMD 1.15 mL/s, 95% CI ?0.23 to 2.53) with evidence of substantial heterogeneity (I² 58%).
• ? One long‐term dose escalation trial (72 weeks) found double and triple doses of Serenoa repens extract did not improve AUASI compared with placebo and the proportions of clinical responders (≥3 point decrease in the AUASI) were nearly identical (43% vs 44% for Serenoa repens and placebo, respectively) with a corresponding risk ratio of 0.96 (95% CI 0.76–1.22).
• ? Long‐term, Serenoa repens therapy was no better than placebo in improving nocturia in one high‐quality study (P= 0.19). Pooled analysis of nine short‐term Permixon® trials showed a reduction in the frequency of nocturia (WMD ?0.79 times/night, 95% CI–1.28 to ?0.29), although there was evidence of heterogeneity (I² 76%)
• ? Adverse events of Serenoa repens extracts were few and mild, and incidences were not statistically significantly different vs placebo. Study withdrawals occurred in ≈10% and did not differ between Serenoa repens and placebo.

CONCLUSIONS

• ? Serenoa repens therapy does not improve LUTS or Q_max compared with placebo in men with BPH, even at double and triple the usual dose.
• ? Adverse events were generally mild and comparable to placebo.

     

Office-based transurethral microwave thermotherapy using the TherMatrx TMx-2000

BACKGROUND AND PURPOSE: Transurethral microwave thermotherapy (TUMT) is an effective therapy for symptomatic benign prostatic hyperplasia (BPH), but the trade-off between the magnitude of clinical improvement and side effects and patient tolerance has limited its appeal to patients and urologists. This study, using the TherMatrx TMx-2000, a TUMT device that directly heats the transition zone to greater than 50 degrees C, has been focused on resolving these issues and developing a truly office-based therapy that is well tolerated with a benign post-treatment course. PATIENTS AND METHODS: This study was multi-institutional and designed as a blinded, randomized, and sham-controlled trial. A series of 200 patients with an AUA Symptom Index (AUASI) of >12, a peak flow rate of <12 mL/sec, and cystoscopic evidence of BPH were randomized 2:1 (active to sham) and treated in seven physician offices under a Food and Drug Administration-supervised and audited premarket approval protocol. No intravenous sedation was used in any patient. Follow-up for the sham-treatment group was 3 months, at which time, patients could cross over to an active treatment. A total of 119 patients have completed 1-year follow-up. RESULTS: The active and sham groups were statistically identical at baseline. The 1-hour total treatment was extremely well tolerated using urethral lidocaine and oral medications; not a single prostate block or parental dose of medication was required. The active-treatment group demonstrated a statistically significant reduction (p < 0.05) in AUASI at 3 months compared with sham treatment, with an AUASI decrease from 22.4 to 12.4 (n = 124) for active v 22.9 to 17 for sham (n = 62). For the 119 patients in the active arm who have reached 12 months, the AUASI has fallen to 10.6 points (47.1% decrease), and the peak flow rate has increased 5.0 mL/sec (58.1%). Postprocedure catheterization was typically 2 or 3 days, and the 16.8% of patients who failed their first voiding trial all voided within 1 week. No major adverse events such as stricture, rectal findings, or ejaculatory changes have been reported. CONCLUSIONS: This study demonstrates that the TherMatrx TMx-2000 TUMT effectively treats symptomatic BPH in the physician office with minimal morbidity.     

Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial

OBJECTIVE: To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In a double-blind placebo-controlled randomized trial between January 1999 and March 2000, 100 men with symptoms of BPH, aged < 80 years, with a maximum urinary flow rate of 5-15 mL/s for a voiding volume of 150 mL, were randomly and equally allocated to 320 mg S. repens extract or placebo (paraffin oil). The main outcome measures were the International Prostate Symptom Score (IPSS), peak urinary flow rate, and the Rosen International Index of Erectile Function (IIEF) questionnaire. RESULTS: There was no significant difference between the treatments over the 12 weeks of the study in the IPSS, peak urinary flow rate or for the IIEF questionnaire. CONCLUSIONS: During the trial all participants had some improvement in their symptoms of BPH but there was no significant beneficial effect of this S. repens extract over placebo in this 12-week trial.     

Efficacy of transurethral needle ablation of the prostate for the treatment of benign prostatic hyperplasia

BACKGROUND: We evaluated the efficacy and safety of transurethral needle ablation (TUNA) of the prostate for treatment of symptomatic benign prostatic hyperplasia (BPH) as one institute participating in a Japanese clinical trial. METHODS: Thirty-three patients with symptomatic BPH were treated with the TUNA procedure in our institute. The international prostate symptom score (IPSS), quality of life (QOL) score, residual urine volume (RV), prostate volume (PV) and peak urinary flow rates (Qmax) were measured and complications were assessed. RESULTS: We followed and evaluated 30 of the 33 cases. At 12 months there were significant improvements in the IPSS (20.7 to 11.2, P < 0.0001), QOL score (4.9 to 2.1, P < 0.0001), RV (46.6 to 22.6 mL, P < 0.01), PV (37.8 to 30.0 mL3, P < 0.002) and Qmax (8.00 to 11.0 mL/s, P < 0.002). There were no serious complications. CONCLUSION: This trial shows that the TUNA procedure is a safe and efficacious treatment for symptomatic BPH.     

Combinations of maximum urinary flow rate and American Urological Association symptom index that are more specific for identifying obstructive and non-obstructive prostatism

Uroflowmetry and the American Urological Association symptom index (AUASI) are often used clinically to evaluate patients with benign prostatic hyperplasia (BPH). Since results from these tests may be used to determine a treatment course, including surgical intervention, we investigated if specific combinations of uroflowmetry and AUASI parameters could better predict urodynamically confirmed prostatic obstruction. Data from 134 men (mean age: 67.8 ± 8.9 years) with prostatism were analyzed. The patients underwent uroflowmetry in the standing position after completing the AUASI; the post-void residual volume (PVR) was determined. The presence and severity of prostatic obstruction was assessed by video urodynamics, which included micturitional urethral pressure profilometry (MUPP). Of the 134 total patients, 66 were found to be obstructed by MUPP. Correlations of maximum urinary flow rate (Q_max), PVR, and AUASI with the degree of obstruction were poor and not substantially improved using combinations of these parameters. Threshold values of Q_max and AUASI, when used in combination, allowed accurate prediction of obstruction or non-obstruction in a small subset of the patient population. Of 14 men with both Q_max <10 ml/s and AUASI ≥20, 13 were obstructed (specificity = 98%). Eight of 9 men with both Q_max ≥15 ml/s and AUASI <10 were non-obstructed. The combined Q_max and AUASI criteria categorized only 20% of the patients as obstructed or non-obstructed. Once other causes of urinary dysfunction are ruled out, use of these criteria will enable the urologist to make an accurate diagnosis of obstruction, select a treatment more likely to benefit the patient, and make further diagnostic testing unnecessary in this small subset of patients. In a large volume clinical practice of adult male voiding dysfunctions, diagnosis of even this small proportion of patients using this simple approach can reduce patient care costs. © 1996 Wiley-Liss, Inc.     

The American Urological Association Symptom Index for Benign Prostatic Hyperplasia as a Function of Age, Volume and Ultrasonic Appearance of the Prostate

Purpose

Our study was conducted to reveal quantitatively the relative effects of age and ultrasonic appearance of benign prostatic hyperplasia (BPH) on urinary symptoms as evaluated by the American Urological Association (AUA) symptom index score.

Materials and Methods

In 929 examinees (732 with a normal prostate and 197 with BPH) on a mass screening program for prostatic diseases using transrectal ultrasonography in Japan, the AUA symptom score was compared to age, prostatic volume and presumed circle area ratio using simple and multiple regression analyses.

Results

Simple regression analysis demonstrated the symptom score to correlate significantly with age (R = 0.162, p <0.0001), prostatic volume (R = 0.072, p = 0.0281) and presumed circle area ratio (R = 0.150, p <0.0001). However, multiple regression analysis demonstrated that age and presumed circle area ratio were significant independent determinants of the total symptom score. Among 7 symptoms included in the AUA symptom index weak stream and hesitancy scores were not influenced by age, prostatic volume or presumed circle area ratio.

Conclusions

As a parameter representing the degree of BPH in terms of the severity of urinary symptoms, presumed circle area ratio was preferable to prostatic volume. Regression analyses confirmed again that the AUA symptom index was influenced considerably by age and was not specific to BPH.     

福施乐治疗良性前列腺增生的临床研究

目的:观察福施乐治疗BPH的有效性和安全性。方法:采用多中心、开放性、自身前后对照的临床研究方法,对60例BPH患者采用福施乐治疗12周。以国际前列腺症状评分(IPSS)、最大尿流率(Qmax)、膀胱残余尿(PVR)和前列腺体积为主要疗效指标,以生活质量评分(QOL)和平均尿流率(Qave)为次要疗效指标,来评价福施乐治疗BPH的效果。结果:治疗12周后,患者IPSS评分、Qmax、PVR、QOL评分、Qave均比治疗前明显改善(P<0.01),而前列腺体积治疗前后无显著性差异(P>0.05)。结论:福施乐可明显改善BPH患者的排尿症状,增加尿流率,减少残余尿,无明显不良反应,治疗BPH安全、有效。     

What do I tell patients about saw palmetto for benign prostatic hyperplasia?

Saw palmetto is widely used to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Although there is passionate support for herbal and complementary therapies for LUTS, clinical evidence is mixed. Because there is a well-recognized, profound placebo effect in tests of efficacy for agents treating LUTS, it is imperative that all therapies be tested in placebo-controlled trials. This article reviews evidence of the efficacy and safety of saw palmetto for men with LUTS caused by BPH, with particular emphasis on published randomized clinical trials and the upcoming Complementary and Alternative Medicine for Urologic Symptoms (CAMUS) trial.     

THE IMPACT OF MEDICAL THERAPY ON BOTHER DUE TO SYMPTOMS, QUALITY OF LIFE AND GLOBAL OUTCOME, AND FACTORS PREDICTING RESPONSE

Purpose

We determine the effect of placebo, finasteride, terazosin and a combination of drugs on bother due to symptoms, quality of life and patient perception of improvement, and identify baseline clinical factors that predict clinical response to medical therapy.

Materials and Methods

A total of 1,229 subjects with clinical benign prostatic hyperplasia (BPH) were randomized to 1 year of placebo, finasteride, terazosin or drug combination. The primary outcome measures were American Urological Association (AUA) symptom score and peak flow rate. Relevant secondary outcome measures were symptom problem score, BPH impact score and global rating of improvement.

Results

Group mean differences in symptom problem and BPH impact scores between the finasteride versus placebo, and terazosin versus combination groups were not statistically or clinically significant. Group mean differences in all outcome measures were highly statistically significant between the terazosin and finasteride, and combination and finasteride groups. The percentage of subjects who rated improvement as marked or moderate with placebo, finasteride, terazosin and combination was 39, 44, 61 and 65%, respectively. In the subsets of men in the placebo, finasteride, terazosin and combination groups with prostates greater than 50 cm.³ group mean decrease from baseline in AUA symptom score was -2.5, -3.6, -6 and -7, group mean increase in peak flow rate was 0.6, 2.7, 3.6 and 3.7 ml. per second, group mean decrease in symptom problem score was -2.2, -1.9, -3.1 and -4.5, and group mean decrease in BPH impact score was -0.6, -0.3, -1.1 and -1.5, respectively. A correlational analysis failed to show a significant relationship between baseline prostate volume and treatment response to finasteride. There was a significant but weak relationship between change in AUA symptom score and peak flow rate in the finasteride and combination groups. The symptom responses with terazosin were independent of baseline peak flow rate.

Conclusions

In men with clinical BPH finasteride and placebo are equally effective, while terazosin and combination are significantly more effective. In men with clinical BPH and large prostates the advantage of finasteride over placebo in terms of symptom reduction, impact on bother due to symptoms and quality of life is small at best, while the advantage of terazosin and combination over finasteride and placebo is highly significant. Baseline prostate volume was not a predictor of response to finasteride in the overall study population. On the basis of our results alpha 1 blockers, such as terazosin, should be first line medical treatment for BPH.     

A randomized placebo-controlled study: Phellodendron Bawei tablets combined with standard management can improve storage symptoms,sleep quality,and medication compliance in patients with benign prostatic hyperplasia compared to placebo with standard management

BackgroundBenign prostatic hyperplasia (BPH) is a common micturition disorder in middle-aged and elderly males, and it is one of the most common urology-related diseases worldwide. However, standard therapeutic drugs (α1-receptor blockers + 5α reductase inhibitors) do not provide anti-inflammatory or anti-infective effects. The Phellodendron Bawei tablet is a proprietary Chinese medicine with anti-inflammatory and anti-infective effects. Here, we analyzed whether the combination of standard therapeutic drugs and Phellodendron Bawei tablets has more advantages than placebo with standard management in improving the lower urinary tract symptoms (LUTs), sleep quality, sexual function, and medication compliance in patients with BPH.MethodsThis study was a prospective, double-blind, single-center, 6-month clinical trial in patients with BPH. Male patients, 45–75 years old, a history of moderate-to-severe BPH/LUTs for more than 6 months, moderate-to-severe LUTs [International Prostate Symptom Score (IPSS) ≥8], maximum urine flow rate (Qmax) of <15 mL/s, and prostate volume (PV) of >30 mL. All patients were randomly divided into two cohorts at baseline. The standard management (SM) group was treated with tamsulosin + finasteride + placebo, while the experimental group was treated with tamsulosin + finasteride + Phellodendron Bawei tablets. The clinical indicators were as follows: Age, body mass index (BMI), blood prostate-specific antigen (PSA), PV, Qmax, IPSS; IPSS voiding subscore (IPSS-V), IPSS storage subscore (IPSS-S), and IPSS quality of life (IPSS-QOL)], five-item version of the International Index of Erectile Function (IEFF-5) score, Athens Insomnia Scale (AIS) score, and the Medication Adherence Questionnaire (MAQ). And adverse drug reactions were observed. Student’s t-test was used to analyze results.ResultsWe randomly divided 120 patients into two groups, with 60 patients in each group, and a total of 105 patients completed the study. IPSS-S (P=0.027) and AIS scores (P<0.001) improved more significantly in the Phellodendron Bawei tablets + SM group, and the MAQ score in this group was lower (P=0.003).ConclusionsPhellodendron Bawei tablets combined with α1-receptor blockers and 5α-reductase inhibitors can improve lower urinary tract symptoms associated with urine storage, sleep quality, and medication compliance in patients with benign prostatic hyperplasia compared to placebo with standard management.Trial RegistrationChinese Clinical Trial Registry ChiCTR2100046463.     

爱普列特治疗良性前列腺增生的有效性及安全性

目的 评价爱普列特治疗BPH的有效性和安全性.方法 采用随机、双盲、双模拟及安慰剂对照的多中心临床试验方法.分3组:爱普列特组10例,平均年龄(72±10)岁;非那雄胺(商品名:保列治)组13例.平均年龄(70±10)岁;安慰剂组16例,平均年龄(70±7)岁.3组患者接受治疗时间均为6个月.每月随访1次,随访评估内容包括IPSS、困扰评分、前列腺体积、尿流率、残余尿量、PSA及国际勃起功能评分问卷(IIEF-5)等,治疗前所有评估指标3组间比较差异均无统计学意义(P值均＞0.05).采用SAS 9.0统计学软件,双侧检验,计量数据组间比较采用t检验,计数数据组间比较采用χ~2检验,a=0.05.结果 爱普列特组IPSS评分F降50.0%±10.3%,与保列治组(37.0%±11.2%)比较差异无统计学意义(P=0.94),但均高于安慰剂组(22.0%±7.6%,P＜0.05);爱普列特组前列腺体积缩小40.0%±12.1%,明显高于保列治组(19.1%±7.3%,P=0.041)及安慰剂组(4.3%±3.2%,P=0.004),保列治组前列腺体积缩小百分比与安慰剂组比较差异无统计学意义(P=0.348).爱普列特组患者Q_(max)改善70.2%±13.9%,与保列治组(50.0%±9.7%)比较差异无统计学意义(P=0.630),但均显著高于安慰剂组(0.5%±0.8%,P＜0.05).其他几项评估指标3组间比较差异无统计学意义.结论 爱普列特能安全有效地治疗BPH,与保列治比较,缩小前列腺体积的疗效更快且更显著.     

Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia

Objectives:   To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).
Methods:   This was a randomized, double-blind, placebo-controlled, parallel-group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated.
Results:   Continued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug-related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting.
Conclusions:   Dutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one-year treatment period.     

Polymorphisms in the 5alpha reductase type 2 gene and urologic measures of BPH

BACKGROUND: The objective of the study was to examine associations between SRD5A2 polymorphisms and measures of benign prostatic hyperplasia (BPH). METHODS: Participants were 510 Caucasian men (median age 60 years), randomly selected from the Olmsted County, MN community to participate in a longitudinal study of BPH. From 1990 through 2000, biennial measurements of lower urinary tract symptom severity (assessed from the American Urological Association Symptom Index, AUASI), peak urinary flow rates (Qmax), and prostate volume were made. Genotyping of SRD5A2 V89L, A49T, and TA repeat polymorphisms were performed. RESULTS: Compared with the VV genotype, the LL genotype was associated with an enlarged prostate (Hazard ratio (HR)=1.62, 95% confidence interval (CI)=1.06, 2.43) but not with AUASI, Qmax, or PSA. The A49T and TA repeat polymorphisms were not associated with BPH. When the LL/VL, AT/TT, and TA0/TA0 genotypes were considered high risk, the number of high risk genotypes increased with increasing prostate volume (32.3, 30.7, 34.1, and 38.7, respectively, P for trend=0.04). CONCLUSIONS: These findings do not demonstrate consistent associations between SRD5A2 genotypes and BPH. However, they suggest that the associations of V89L polymorphisms and prostate volume should be investigated further.     

爱活尿通治疗良性前列腺增生的临床研究

目的:探讨爱活尿通(Eviprostat)治疗良性前列腺增生(BPH)的安全性及有效性。方法:采用开放、多中心的临床试验方法,对100例BPH患者进行了为期12周的观察。患者服用爱活尿通每次2片,每天3次,共12周。主要疗效指标为国际前列腺症状评分(IPSS),最大尿流率(Qm ax),膀胱残余尿量(Ru)和前列腺体积(V);次要指标为生活质量评分(QOL)和平均尿流率(Qave)。结果:服药12周后,IPSS评分较治疗前平均降低5.67分(P<0.001),QOL评分平均降低1.44分(P<0.001),Qm ax较治疗前平均增加1.70 m l/s(P<0.001),Qave平均增加1.15 m l/s(P<0.001),膀胱残余尿量(Ru)平均减少5.07 m l(P=0.046),PSA平均下降0.129μg/L(P<0.017)。临床不良反应发生率为1%。结论:爱活尿通可明显改善BPH患者的排尿症状、增加尿流率、减少残余尿量,不良反应发生率低,是一种安全、有效的治疗BPH的药物。     

Photoselective laser vaporization prostatectomy for acute urinary retention in China

PURPOSE: To assess the clinical efficacy and safety of photoselective laser vaporization of the prostate (PVP) in the treatment of patients with acute urinary retention (AUR) secondary to benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Forty-two patients (mean age 72 +/- 5 years, range 65-89) with AUR because of BPH were treated with a prospective trial of PVP with the potassium-titanyl-phosphate (KTP) laser. The treatment outcome was evaluated with subjective and objective tests at 1, 3, 6, and 12 months after PVP using the International Prostate Symptom Score (IPSS), disease-specific quality of life (QoL) score, postvoid residual (PVR) urine volume, and maximum urinary flow rate (Qmax). The International Index of Erectile Function questionnaire and a self-designed ejaculatory questionnaire were completed at different follow-up times to determine patient satisfaction and changes in sexual function. RESULTS: After preliminary urine drainage and adequate preoperative preparation, PVP was performed and bladder outlet obstruction was effectively relieved. The mean prostate volume was 62.5 +/- 11.7 cc, and the mean residual volume with retention was 650 mL (range 240-1200 mL). Mean operative time was 28.6 +/- 5.7 minutes. Mean catheterization duration was 5.6 days (range 3-14 d). There was significant subjective improvement of symptoms and objective improvement in urinary flow rates at 12 months. The mean IPSS and QoL score decreased significantly (P < 0.05). Mean PVR volume also decreased. The mean Qmax was 16.2 +/- 4.6 mL/sec after treatment. Only two patients had recurrent urinary retention during follow-up. There were no intraoperative or postoperative adverse events. CONCLUSIONS: The early clinical results suggest that the PVP is a promising safe, effective, and less-invasive treatment with minimal morbidity for patients with urine retention secondary to BPH.     

The efficacy and safety of silodosin in treating BPH: a systematic review and meta-analysis

Purpose

Pharmacological therapy is typically the first-line treatment for patients with benign prostatic hyperplasia (BPH). We carried out a systematic review and meta-analysis to assess the efficacy and safety of silodosin for treating BPH.

Methods

A literature review was performed to identify all published randomized placebo-controlled trials (RCT) of silodosin for the treatment of BPH. The search included the following databases: PUBMED, EMBASE, and the Cochrane Controlled Trail Register of Controlled Trials. The reference lists of retrieved studies were also investigated. A systematic review and meta-analysis were conducted.

Results

Four publications involving a total of 2,543 patients were used in the analysis, including 3 RCTs that compared silodosin with placebo and 3 RCTs that compared silodosin with tamsulosin. We found that silodosin was effective in treating BPH in our meta-analysis. Total international prostate symptom score (IPSS) (P?=?0.92 SWD?=?2.92 95?% CI?=?2.19?C3.65 the mean decrease of total IPSS was from 6.4 to 10.6), voiding symptom score, storage symptom score, and quality-of-life score indicated that silodosin was more effective than the placebo. Silodosin??s efficacy is similar to that of tamsulosin (P?=?0.37 SWD?=?1.14 95?% CI?=?0.18?C2.11) in our meta-analysis. However, the incidence of abnormal ejaculation was higher in patients treated with tamsulosin therapy compared with the placebo (234/1128?=?20.74?% 12/680?=?1.76?% 6/736?=?0.82?%).

Conclusions

This meta-analysis proves silodosin to be an effective and safe treatment for the relief of lower urinary tract symptom associated with BPH. Silodosin and tamsulosin were similar in terms of efficacy. The major adverse event associated with silodosin treatment was abnormal ejaculation.